- From: Eric Prud'hommeaux <eric@w3.org>
- Date: Fri, 17 May 2019 22:12:06 +0200
- To: "Boyce, Richard David" <rdb20@pitt.edu>
- Cc: Michel Dumontier <michel.dumontier@gmail.com>, "public-hclscg@w3.org" <public-hclscg@w3.org>, "public-hclscg-contrib@w3.org" <public-hclscg-contrib@w3.org>
On Fri, May 17, 2019 at 07:36:54PM +0000, Boyce, Richard David wrote:
> On 5/17/19 2:09 PM, Eric Prud'hommeaux wrote:
> > On Fri, May 17, 2019 at 12:48:00PM +0200, Michel Dumontier wrote:
> >> Great - then we just need Eric to copy the file to the w3c server, and then
> >> you can also update the w3id URL
> > I believe the chair has to be the one to (export from respect and) upload the doc using the web interface for the community group page. (I've never seen it in action 'cause I'm not a chair.) Spot-checking the respoc output against <https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.w3.org%2Fcommunity%2Freports%2Freqs%2F&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573984985&sdata=%2Bh14ZOuKY1GpQA3l6rYCo6e0U7tDrIxnKoNjYAjn%2Fcs%3D&reserved=0>, I think respec is doing the right thing.
> >
> > I submitted a PR which takes care of a bunch of encoding issues, fixes up the sections to match what I think was intended, and indents the JSON examples nicely. I wanted to compare these side-by-side:
>
> Thank you Eric. I did not realize that the last version I pushed screwed
> up the TOC numbering so bad. Glad you were able to fix it and thank you
> for your time doing it. I found a couple of very minor issues (e.,g
> stray character) and fixed it. Now pushed to git hub and viewable at
> https://w3id.org/hclscg/pddi
Quite welcome, glad it was fruitful.
Should A.2 User Stories be B. User Storoes, etc?
> Michel, I exported the HTML from the link above using ResPec and
> attached in case it works...
>
>
>
>
> > before: https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fericprud.github.io%2Fhcls-drug-drug-interaction%2F&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573984985&sdata=MMAlGqT9ZbL1lTKVKuLPyOP8vqlRulgmOx1qqVK%2F6EY%3D&reserved=0
> > after: https://dbmi-icode-01.dbmi.pitt.edu/dikb-evidence/hcls-drug-drug-interaction/index.html
> >
> > but in my haste, but the click act that I expected to merge into ericprud/hcls-drug-drug-interaction apparently merged into w3c/hcls-drug-drug-interaction instead. Anyways, please take a look and see if I made the correct assumptions. Also, maybe github.io will come back to life in a bit and enable side-by-side comparison in a browswer.
> >
> >
> >> m.
> >>
> >> On Fri, May 17, 2019 at 11:50 AM Boyce, Richard David <rdb20@pitt.edu>
> >> wrote:
> >>
> >>> Michel and Eric, The final document is ready now. I changed the report
> >>> status to CG-FINAL and pushed to github. Please let me know if there is
> >>> anything else that I need to do. thank you, -R
> >>>
> >>> On 5/17/19 5:41 AM, Michel Dumontier wrote:
> >>>
> >>> Dear Rich,
> >>> Great news! I've published the draft report on the homepage
> >>> https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.w3.org%2Fcommunity%2Fhclscg%2F&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573984985&sdata=PQxA7%2BBFlSXIdbmpLNJrtlCUPkNZbk1bN4ZjvE1rZ2Q%3D&reserved=0
> >>> <https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.w3.org%2Fcommunity%2Fhclscg%2F&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573984985&sdata=PQxA7%2BBFlSXIdbmpLNJrtlCUPkNZbk1bN4ZjvE1rZ2Q%3D&reserved=0>
> >>> now to publish the final report, we need to copy the document to the W3C
> >>> site and update the URL. I've been in contact with Eric to do this.
> >>> Indicate to us when the final document will be ready.
> >>>
> >>> m.
> >>>
> >>>
> >>> On Tue, May 14, 2019 at 7:55 PM Boyce, Richard David <rdb20@pitt.edu>
> >>> wrote:
> >>>
> >>>> Michel and David,
> >>>>
> >>>> I am please to announce that we have addressed all of the comments we
> >>>> received from the W3C lists (including yours) and are now ready to publish
> >>>> "A Minimum Representation of Potential Drug-Drug Interaction Knowledge and
> >>>> Evidence - Technical and User-centered Foundation."
> >>>>
> >>>> I am waiting for one person to let me know if they want to be listed as
> >>>> an author but that is all. Would it be possible to publish by the end of
> >>>> next week?
> >>>>
> >>>> The note: https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fw3id.org%2Fhclscg%2Fpddi&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573984985&sdata=WFVwp2tQ1syHWlbqeyGoZNcoB7ECb%2FEJFteyVDFq%2FwI%3D&reserved=0
> >>>> <https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fw3id.org%2Fhclscg%2Fpddi&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573984985&sdata=WFVwp2tQ1syHWlbqeyGoZNcoB7ECb%2FEJFteyVDFq%2FwI%3D&reserved=0>
> >>>>
> >>>> Github: https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgithub.com%2Fw3c%2Fhcls-drug-drug-interaction%2F&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573984985&sdata=Dpt2A%2Bqn4S9iGoeIFx%2FjnVVkk5Br0uzIpvWjvM6kEIo%3D&reserved=0
> >>>> <https://nam05.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgithub.com%2Fw3c%2Fhcls-drug-drug-interaction%2F&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573984985&sdata=Dpt2A%2Bqn4S9iGoeIFx%2FjnVVkk5Br0uzIpvWjvM6kEIo%3D&reserved=0>
> >>>>
> >>>> thank you for the favor of a reply,
> >>>>
> >>>> -Rich
> >>>>
> >>>> --
> >>>> Richard D Boyce, PhD
> >>>> Associate Professor of Biomedical Informatics and Clinical and Translational Science in the Clinical and Translational
> >>>> Science Institute
> >>>> University of Pittsburghrdb20@pitt.edu
> >>>> Office: 412-648-9219
> >>>> Twitter: @bhaapgh
> >>>>
> >>>>
> >>> --
> >>> Michel Dumontier
> >>> Distinguished Professor of Data Science
> >>> Maastricht University
> >>> https://nam05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fdumontierlab.com&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573994994&sdata=09vbQ9EVByWeDlvQPIam3KWbS%2BlP4eB4QKzCgXfSqX0%3D&reserved=0
> >>> <https://nam05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fdumontierlab.com&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573994994&sdata=09vbQ9EVByWeDlvQPIam3KWbS%2BlP4eB4QKzCgXfSqX0%3D&reserved=0>
> >>>
> >>>
> >>> --
> >>> Richard D Boyce, PhD
> >>> Associate Professor of Biomedical Informatics and Clinical and Translational Science in the Clinical and Translational
> >>> Science Institute
> >>> University of Pittsburghrdb20@pitt.edu
> >>> Office: 412-648-9219
> >>> Twitter: @bhaapgh
> >>>
> >>>
> >> --
> >> Michel Dumontier
> >> Distinguished Professor of Data Science
> >> Maastricht University
> >> https://nam05.safelinks.protection.outlook.com/?url=http%3A%2F%2Fdumontierlab.com&data=02%7C01%7Crdb20%40pitt.edu%7C9d7992de854b4b4d04a008d6daf2c5f8%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636937133573994994&sdata=09vbQ9EVByWeDlvQPIam3KWbS%2BlP4eB4QKzCgXfSqX0%3D&reserved=0
>
>
> --
> Richard D Boyce, PhD
> Associate Professor of Biomedical Informatics and Clinical and Translational Science in the Clinical and Translational
> Science Institute
> University of Pittsburgh
> rdb20@pitt.edu
> Office: 412-648-9219
> Twitter: @bhaapgh
>
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> "Joseph Hanlon",
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> "osheroff-cds": {
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> ],
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> "href": "https://healthit.ahrq.gov/ahrq-funded-projects/current-health-it-priorities/clinical-decision-support-cds/chapter-1-approaching-clinical-decision/section-2-overview-cds-five-rights"
> },
> "sprycel-2015": {
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> "publisher": "Bristol-Myers Squibb Company, Princeton, NJ",
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> "bosulif-2015": {
> "title": "Bosulif",
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> "Giuseppe Saglio",
> "Timothy P. Hughes",
> "Andreas Hochhaus",
> "Hagop M. Kantarjian",
> "Richard A. Larson"
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> "publisher": "Cancer Chemotherapy and Pharmacology",
> "pages": "345-350",
> "date": "2012",
> "href": "https://www.ncbi.nlm.nih.gov/pubmed/22623211",
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> "publisher": "ARIAD Pharmaceuticals, Inc., Cambridge, MA",
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> "Leonard R. Appleman",
> "Robert L. Redner",
> "Brian M. Miller",
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> "publisher": "British Journal of Clinical Pharmacology",
> "pages": "370-374",
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> "company": "Department of Biomedical Informatics, University of Pittsburgh, USA"
> },
> {
> "name": "Serkan Ayvaz",
> "company": "Department of Software Engineering, Bahcesehir University, Istanbul, Turkey"
> },
> {
> "name": "Ratnesh Sahay",
> "company": "Insight Center for Data Analytics, NUI Galway, Ireland"
> },
> {
> "name": "Michel Dumontier",
> "company": "Institute of Data Science, Maastricht University, Netherlands"
> }
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> }</script><meta name="description" content="The purpose of this Community Group Report is to provide a
> technical and user-centered foundation for a minimum
> information model for information about potential drug-drug
> interactions. The Report provides non-ambiguous definitions
> for 10 core information items. It also provides 8 detailed
> best practice recommendations related to the 10 core
> information items. The definitions and recommendations are
> shown as both narrative and prototype JSON artifacts using 2
> exemplar potential drug-drug interactions. Twelve user stories
> with related goals illustrate use cases for the information
> model. Adoption of the recommendations by developers of PDDI
> knowledge artifacts will improve the usefulness of the
> artifacts within clinical workflows. Intended downstream
> applications include clinical decision support, drug product
> label enhancement, cohort identification, and other activities
> relevant to protecting patients from harmful drug
> interactions."><link rel="stylesheet" href="https://www.w3.org/StyleSheets/TR/2016/cg-final"></head>
> <body class="h-entry informative"><div class="head">
> <a class="logo" href="https://www.w3.org/"><img alt="W3C" width="72" height="48" src="https://www.w3.org/StyleSheets/TR/2016/logos/W3C"></a>
> <h1 class="title p-name" id="title">A Minimum Representation of Potential Drug-Drug Interaction Knowledge and Evidence - Technical and User-centered Foundation</h1>
>
> <h2>
> Final Community Group Report
> <time class="dt-published" datetime="2019-05-17">17 May 2019</time>
> </h2>
> <dl>
>
>
> <dt>Latest editor's draft:</dt><dd><a href="https://w3id.org/hclscg/pddi">https://w3id.org/hclscg/pddi</a></dd>
>
>
>
>
>
> <dt>Editors:</dt>
> <dd class="p-author h-card vcard"><a class="u-url url p-name fn" href="www.dbmi.pitt.edu/person/richard-boyce-phd">Richard D. Boyce</a>
> (Department of Biomedical Informatics, University of Pittsburgh, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Elizabeth A. Garcia</span>
> (Pharmacy Consulting International (PCI), USA)
> </dd><dd class="p-author h-card vcard"><a class="u-url url p-name fn" href="www.dbmi.pitt.edu/person/harry-hochheiser-phd">Harry Hochheiser</a>
> (Department of Biomedical Informatics, University of Pittsburgh, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Serkan Ayvaz</span>
> (Department of Software Engineering, Bahcesehir University, Istanbul, Turkey)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Ratnesh Sahay</span>
> (Insight Center for Data Analytics, NUI Galway, Ireland)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Michel Dumontier</span>
> (Institute of Data Science, Maastricht University, Netherlands)
> </dd>
>
> <dt>
> Authors:
> </dt><dd class="p-author h-card vcard"><span class="p-name fn">Juan M. Banda</span>
> (Stanford University, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Oya Beyan</span>
> (Fraunhofer FIT, Germany)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Mathias Brochhausen</span>
> (University of Arkansas for Medical Sciences, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Evan Draper</span>
> (Pharmacy Services, Mayo Clinic, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Sam Habiel</span>
> (Open Source Electronic Health Records Alliance (OSEHRA), USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Oktie Hassanzadeh</span>
> (IBM Research, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Maria Herrero-Zazo</span>
> (King???s College London, United Kingdom )
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Brian Hocum</span>
> (Genelex, Seattle, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">John Horn</span>
> (School of Pharmacy, University of Washington, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Xia Jing</span>
> (Ohio University, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Brian LeBaron</span>
> (Southeast Louisiana Veterans Health Care System, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Daniel C. Malone</span>
> (College of Pharmacy, University of Arizona, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Gerald McEvoy</span>
> (USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">??ystein Nytr??</span>
> (Norwegian University of Science and Technology, Norway)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Thomas Reese</span>
> (University of Utah, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Katrina Romagnoli</span>
> (University of Pittsburgh Medical Center, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Jodi Schneider</span>
> (University of Illinois at Urbana-Champaign, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Lorne Walker</span>
> (University of Pittsburgh Medical Center, USA)
> </dd><dd class="p-author h-card vcard"><span class="p-name fn">Louisa (Yu) Zhang</span>
> (University of Pittsburgh, USA)
> </dd>
> <dt>Participate:</dt><dd>
> <a href="https://github.com/w3c/hcls-drug-drug-interaction/">GitHub w3c/hcls-drug-drug-interaction</a>
> </dd><dd>
> <a href="https://github.com/w3c/hcls-drug-drug-interaction/issues/">File a bug</a>
> </dd><dd>
> <a href="https://github.com/w3c/hcls-drug-drug-interaction/commits/gh-pages">Commit history</a>
> </dd><dd>
> <a href="https://github.com/w3c/hcls-drug-drug-interaction/pulls/">Pull requests</a>
> </dd>
> </dl>
>
> <p class="copyright">
> <a href="https://www.w3.org/Consortium/Legal/ipr-notice#Copyright">Copyright</a>
> ??
> 2019
>
> the Contributors to the A Minimum Representation of Potential Drug-Drug Interaction Knowledge and Evidence - Technical and User-centered Foundation Specification, published by the
> <a href="https://www.w3.org/community/hclscg/">Semantic Web in Health Care and Life Sciences Community Group</a> under the
> <a href="https://www.w3.org/community/about/agreements/fsa/">W3C Community Final Specification Agreement (FSA)</a>. A human-readable
> <a href="https://www.w3.org/community/about/agreements/fsa-deed/">summary</a>
> is available.
>
> </p>
> <hr title="Separator for header">
> </div>
> <section id="abstract" class="introductory"><h2>Abstract</h2>
> <p>
> The purpose of this Community Group Report is to provide a
> technical and user-centered foundation for a minimum
> information model for information about potential drug-drug
> interactions. The Report provides non-ambiguous definitions
> for 10 core information items. It also provides 8 detailed
> best practice recommendations related to the 10 core
> information items. The definitions and recommendations are
> shown as both narrative and prototype JSON artifacts using 2
> exemplar potential drug-drug interactions. Twelve user stories
> with related goals illustrate use cases for the information
> model. Adoption of the recommendations by developers of PDDI
> knowledge artifacts will improve the usefulness of the
> artifacts within clinical workflows. Intended downstream
> applications include clinical decision support, drug product
> label enhancement, cohort identification, and other activities
> relevant to protecting patients from harmful drug
> interactions.
> </p>
> </section>
> <section id="sotd" class="introductory"><h2>Status of This Document</h2><p>
> This specification was published by the
> <a href="https://www.w3.org/community/hclscg/">Semantic Web in Health Care and Life Sciences Community Group</a>. It is not a W3C Standard nor is it
> on the W3C Standards Track.
>
> Please note that under the
> <a href="https://www.w3.org/community/about/agreements/final/">W3C Community Final Specification Agreement (FSA)</a>
> other conditions apply.
>
> Learn more about
> <a href="https://www.w3.org/community/">W3C Community and Business Groups</a>.
> </p>
> <p>
> This document is governed by the <a href="https://www.w3.org/community/reports/reqs/">W3C requirements of the Community and Business Group Process related to deliverables</a>.
> </p>
> <p>
> If you wish to make comments regarding this document, please send
> them to
> <a href="mailto:public-hclscg@w3.org">public-hclscg@w3.org</a>
> (<a href="mailto:public-hclscg-request@w3.org?subject=subscribe">subscribe</a>,
> <a href="https://lists.w3.org/Archives/Public/public-hclscg/">archives</a>).
> </p></section><nav id="toc"><h2 class="introductory" id="table-of-contents">Table of Contents</h2><ol class="toc"><li class="tocline"><a class="tocxref" href="#introduction"><bdi class="secno">1. </bdi>Introduction</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#need-envisioned-workflow-and-high-level-requirements"><bdi class="secno">1.1 </bdi>Need, envisioned workflow, and high-level requirements</a></li></ol></li><li class="tocline"><a class="tocxref" href="#the-model"><bdi class="secno">2. </bdi>The Minimum Information Model</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#user-centered-def"><bdi class="secno">2.1 </bdi>Definitions of Core Information Items</a></li></ol></li><li class="tocline"><a class="tocxref" href="#recommendations-summary"><bdi class="secno">3. </bdi>A summary of recommendations related to the minimum information model</a></li><li class="tocline"><a class="tocxref" href="#KR-discussion"><bdi class="secno">4. </bdi>Knowledge representation for the minimal information model</a></li><li class="tocline"><a class="tocxref" href="#examples"><bdi class="secno">5. </bdi>Examples of the use of the minimal information model</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#ex-warfarin-nsaids"><bdi class="secno">5.1 </bdi>Applying the Minimal Information Model definitions to the PDDI between warfarin
> and non-steroidal anti-inflammatory drugs (NSAIDs)</a></li><li class="tocline"><a class="tocxref" href="#ex-tki-ppi"><bdi class="secno">5.2 </bdi>Applying the Minimal Information Model definitions to the PDDI between BCR-ABL
> Tyrosine Kinase Inhibitors (TKI) + Proton Pump Inhibitors (PPI)</a></li></ol></li><li class="tocline"><a class="tocxref" href="#justification"><bdi class="secno">6. </bdi>Background and use cases</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#overarching-use-case"><bdi class="secno">6.1 </bdi>The overarching use case for the minimum information model</a></li><li class="tocline"><a class="tocxref" href="#spec-user-stories"><bdi class="secno">6.2 </bdi>End-users of the minimum information model</a></li></ol></li><li class="tocline"><a class="tocxref" href="#discussion"><bdi class="secno">7. </bdi>Discussion</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#ex-pddi-cds-hl7"><bdi class="secno">7.1 </bdi>Shareable PDDI Clinical Decision Support Using HL7 Standards </a></li><li class="tocline"><a class="tocxref" href="#ex-SPL"><bdi class="secno">7.2 </bdi>Enhancing the Drug-drug Interaction Section of Structured Product Labeling</a></li><li class="tocline"><a class="tocxref" href="#ex-cohort-desc"><bdi class="secno">7.3 </bdi>Highlighting and Filling Gaps in Evidence Needed to Develop PDDI Decision Support</a></li></ol></li><li class="tocline"><a class="tocxref" href="#conclusion"><bdi class="secno">8. </bdi>Conclusion</a></li><li class="tocline"><a class="tocxref" href="#acknowledgments"><bdi class="secno">9. </bdi>Acknowledgments</a></li><li class="tocline"><a class="tocxref" href="#appendices"><bdi class="secno">A. </bdi>Appendices</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#development-process"><bdi class="secno">A.1 </bdi>Development Process</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#Decision-Trees"><bdi class="secno">A.1.1 </bdi>Decision Trees</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#selecting-PDDIs"><bdi class="secno">A.1.1.1 </bdi>Selecting PDDIs to implement using the minimum information
> model</a></li><li class="tocline"><a class="tocxref" href="#decision-trees"><bdi class="secno">A.1.1.2 </bdi>Decision Trees Created for the Minimum Information Model Domain Analysis</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#warfarin-nsaids-dt"><bdi class="secno">A.1.1.2.1 </bdi>Example PDDI:Warfarin + NSAIDs</a></li><li class="tocline"><a class="tocxref" href="#BCR-ABL"><bdi class="secno">A.1.1.2.2 </bdi>Example PDDI: BCR-ABL Tyrosine Kinase Inhibitors (TKI) + Proton Pump Inhibitors (PPI)</a></li></ol></li></ol></li></ol></li><li class="tocline"><a class="tocxref" href="#user-stories-goals"><bdi class="secno">A.2 </bdi>User Stories</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#user-story-workflow"><bdi class="secno">A.2.1 </bdi>Workflow for arriving at stories and goals</a></li><li class="tocline"><a class="tocxref" href="#final-stories"><bdi class="secno">A.2.2 </bdi>User stories for the minimum information model</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#user-story-color-coding"><bdi class="secno">A.2.2.1 </bdi>Color codes used in user stories</a></li><li class="tocline"><a class="tocxref" href="#med-rec-use-cases"><bdi class="secno">A.2.2.2 </bdi>A set of user stories focused on medication reconciliation</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#use-story-1-hospital-pharmacist-medication-reconciliation-upon-admission"><bdi class="secno">A.2.2.2.1 </bdi>Use Story 1: Hospital Pharmacist, Medication Reconciliation upon Admission</a></li><li class="tocline"><a class="tocxref" href="#user-story-2-hospital-pharmacist-medication-reconciliation-upon-discharge"><bdi class="secno">A.2.2.2.2 </bdi>User Story 2: Hospital Pharmacist, Medication
> Reconciliation upon Discharge</a></li><li class="tocline"><a class="tocxref" href="#user-story-3-consultant-pharmacist-medication-reconciliation-upon-readmission"><bdi class="secno">A.2.2.2.3 </bdi>User Story 3: Consultant Pharmacist, Medication Reconciliation upon Readmission</a></li></ol></li><li class="tocline"><a class="tocxref" href="#treatment-planning-phys"><bdi class="secno">A.2.2.3 </bdi>Treatment Planning, Physician</a></li><li class="tocline"><a class="tocxref" href="#eval-management-options-phys"><bdi class="secno">A.2.2.4 </bdi>Evaluation of Management Options for Drug-Drug Interactions, Physician</a></li><li class="tocline"><a class="tocxref" href="#eval-management-options-pharm"><bdi class="secno">A.2.2.5 </bdi>Evaluation of Management Options for Drug-Drug Interactions, Pharmacist</a></li><li class="tocline"><a class="tocxref" href="#nurse-screening"><bdi class="secno">A.2.2.6 </bdi>Screening for Drug-Drug Interactions, Nurse</a></li><li class="tocline"><a class="tocxref" href="#editor-synthesis-dissemination"><bdi class="secno">A.2.2.7 </bdi>Synthesis for Dissemination, Drug Compendium Editor</a></li><li class="tocline"><a class="tocxref" href="#librarian-dissemination"><bdi class="secno">A.2.2.8 </bdi>Synthesis for Dissemination, Librarian</a></li><li class="tocline"><a class="tocxref" href="#cds-team"><bdi class="secno">A.2.2.9 </bdi>Synthesis for Dissemination, Clinical Decision Support Team - Systems Analyst & Content Specialist</a></li><li class="tocline"><a class="tocxref" href="#out-of-scope-stories"><bdi class="secno">A.2.2.10 </bdi>Out of scope user stories</a></li></ol></li></ol></li><li class="tocline"><a class="tocxref" href="#kr-process-apdx"><bdi class="secno">A.3 </bdi>Definition of guidelines for knowledge representation</a></li><li class="tocline"><a class="tocxref" href="#Value-Sets"><bdi class="secno">A.4 </bdi>Value Sets to Support PDDI Examples</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#intro-to-value-sets"><bdi class="secno">A.4.1 </bdi>Some Background on Concept Identification and 'Value Sets' </a></li><li class="tocline"><a class="tocxref" href="#aldosterone-antagonists"><bdi class="secno">A.4.2 </bdi>aldosterone antagonists and products containing an aldosterone receptor antagonist (RxNorm)</a></li><li class="tocline"><a class="tocxref" href="#bosutinib"><bdi class="secno">A.4.3 </bdi>bosutinib (ATC)</a></li><li class="tocline"><a class="tocxref" href="#cereb-hemm"><bdi class="secno">A.4.4 </bdi>cerebral hemorrhage (ICD-10-CM)</a></li><li class="tocline"><a class="tocxref" href="#acml"><bdi class="secno">A.4.5 </bdi>chronic myeloid leukemia (SNOMED-CT)</a></li><li class="tocline"><a class="tocxref" href="#dasatinib"><bdi class="secno">A.4.6 </bdi>dasatinib (ATC)</a></li><li class="tocline"><a class="tocxref" href="#gi-bleeding"><bdi class="secno">A.4.7 </bdi>upper gastrointestinal bleeding or peptic ulcer (ICD-10-CM)</a></li><li class="tocline"><a class="tocxref" href="#imatinib"><bdi class="secno">A.4.8 </bdi>imatinib (ATC)</a></li><li class="tocline"><a class="tocxref" href="#icran-hemm"><bdi class="secno">A.4.9 </bdi>intracranial hemorrhage (ICD-10-CM)</a></li><li class="tocline"><a class="tocxref" href="#misoprostol"><bdi class="secno">A.4.10 </bdi>misoprostol (RxNorm)</a></li><li class="tocline"><a class="tocxref" href="#nilotinib"><bdi class="secno">A.4.11 </bdi>nilotinib (ATC)</a></li><li class="tocline"><a class="tocxref" href="#NSAIDS-drugs"><bdi class="secno">A.4.12 </bdi>Systemic non-steroidal anti-inflammatory drugs (NSAIDs) (RxNorm)</a></li><li class="tocline"><a class="tocxref" href="#ponatinib"><bdi class="secno">A.4.13 </bdi>ponatinib (ATC)</a></li><li class="tocline"><a class="tocxref" href="#proton-pump-inhibitor-atc"><bdi class="secno">A.4.14 </bdi>proton pump inhibitor (ATC)</a></li><li class="tocline"><a class="tocxref" href="#proton-pump-inhibitor"><bdi class="secno">A.4.15 </bdi>proton pump inhibitor (RxNorm)</a></li><li class="tocline"><a class="tocxref" href="#systemic-cortico"><bdi class="secno">A.4.16 </bdi>systemic corticosteroids (RxNorm)</a></li><li class="tocline"><a class="tocxref" href="#topical-diclof"><bdi class="secno">A.4.17 </bdi>topical or opthalamic diclofenac (RxNorm)</a></li><li class="tocline"><a class="tocxref" href="#TKIs"><bdi class="secno">A.4.18 </bdi>tyrosine kinase inhibitors (TKIs) (ATC)</a></li><li class="tocline"><a class="tocxref" href="#warfarins"><bdi class="secno">A.4.19 </bdi>warfarin (RxNorm)</a></li></ol></li><li class="tocline"><a class="tocxref" href="#appendix-json"><bdi class="secno">A.5 </bdi>JSON Examples</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#example-1-warfarin-and-systemic-non-steroidal-anti-inflammatory-drugs-nsaids"><bdi class="secno">A.5.1 </bdi>Example 1: warfarin and systemic non-steroidal anti-inflammatory drugs (NSAIDs)</a></li><li class="tocline"><a class="tocxref" href="#example-2-tyrosine-kinase-inhibitors-and-medications-that-increase-gastric-ph"><bdi class="secno">A.5.2 </bdi>Example 2: Tyrosine Kinase inhibitors and medications that increase gastric pH</a></li></ol></li></ol></li><li class="tocline"><a class="tocxref" href="#references"><bdi class="secno">B. </bdi>References</a><ol class="toc"><li class="tocline"><a class="tocxref" href="#normative-references"><bdi class="secno">B.1 </bdi>Normative references</a></li><li class="tocline"><a class="tocxref" href="#informative-references"><bdi class="secno">B.2 </bdi>Informative references</a></li></ol></li></ol></nav>
>
>
> <section class="informative" id="introduction">
> <h2 id="x1-introduction"><bdi class="secno">1. </bdi>Introduction<a class="self-link" aria-label="??" href="#introduction"></a></h2><p><em>This section is non-normative.</em></p>
> <p>
> Ensuring medication therapy occurs safely and to the maximum benefit for any given patient is of great
> interest to clinicians [<cite><a class="bibref" href="#bib-institute-medicine-2006" title="Preventing Medication Errors">institute-medicine-2006</a></cite>]. One possible threat to patient safety comes from exposure
> to two or more drugs that may interact (i.e., potential drug-drug interactions or PDDIs), and could therefore
> lead to a clinically observable effect on the patient (i.e., an actual drug-drug interaction). While the effects
> that may occur due to exposure to some PDDIs can benefit patients (e.g., some HIV therapies use a low-dose of ritonavir
> to increase plasma concentrations of co-administered protease inhibitors by inhibiting their metabolism), PDDIs are
> more often a patient safety concern. Clinically important events attributable to PDDI exposure have been identified in multiple studies, with rates ranging from
> 5.3% - 14.3% of inpatients, and up to 231,000 emergency department visits each year in
> the United States alone [<cite><a class="bibref" href="#bib-magro-2012" title="Epidemiology and characteristics of adverse drug reactions caused by drug-drug interactions">magro-2012</a></cite>][<cite><a class="bibref" href="#bib-cdc-faststats" title="FastStats">cdc-faststats</a></cite>]. A recent systematic review and meta-analysis of 13 studies conducted
> on 3 continents found the median rate of PDDI associated hospital admissions to be 22.2%
> (interquartile range 16.6 - 36.0%) [<cite><a class="bibref" href="#bib-dechanont-2014" title="Hospital admissions/visits associated with drug-drug interactions: a systematic review and meta-analysis">dechanont-2014</a></cite>]. The potential for harm from PDDIs is an international concern reflected in
> guidance documents of regulatory agencies around the world [<cite><a class="bibref" href="#bib-rekic-2017" title="Clinical Drug-Drug Interaction Evaluations to Inform Drug Use and Enable Drug Access">rekic-2017</a></cite>][<cite><a class="bibref" href="#bib-european-medicines-2012" title="Guideline on the investigation of drug interactions">european-medicines-2012</a></cite>][<cite><a class="bibref" href="#bib-usdhhs-2017" title="Clinical Drug Interaction Studies ??? Study Design, Data Analysis, and Clinical Implications">usdhhs-2017</a></cite>]. Moreover, in the United States, PDDI alerting is a criteria included in the so-called Meaningful Use criteria
> for Electronic Health Records [<cite><a class="bibref" href="#bib-cms-2013" title="Eligible Professional Meaningful Use Core Measures, Measure 2 of 15">cms-2013</a></cite>][<cite><a class="bibref" href="#bib-ridgely-2012" title="Too Many Alerts, Too Much Liability: Sorting through the Malpractice Implications of Drug-Drug Interaction Clinical Decision Support Clinical Support Systems for Drug-Drug Interactions: Implementing Effective Systems, Limiting Malpractice Liability">ridgely-2012</a></cite>]), and population-based strategies for tracking exposure
> are promoted by organizations such as the Pharmacy Quality Alliance [<cite><a class="bibref" href="#bib-ahrq-drug-drug" title="Drug-drug interactions: percentage of patients who received a prescription for a target medication during the measurement period and who were dispensed a concurrent prescription for a precipitant medication. National Quality Measures Clearinghouse">ahrq-drug-drug</a></cite>].
> </p>
> <p>
> Clinicians often face barriers to the effective and appropriate management of PDDI exposures [<cite><a class="bibref" href="#bib-nabovati-2017" title="A survey of attitudes, practices, and knowledge regarding drug-drug interactions among medical residents in Iran">nabovati-2017</a></cite>].
> Barriers include PDDI alerts with poor specificity and incomplete clinician knowledge about PDDIs [<cite><a class="bibref" href="#bib-abarca-2004" title="Concordance of severity ratings provided in four drug interaction compendia">abarca-2004</a></cite>][<cite><a class="bibref" href="#bib-van-der-sijs-2006" title="Overriding of drug safety alerts in computerized physician order entry">van-der-sijs-2006</a></cite>]. An awareness of the need for PDDI decision support prompts clinicians to use various drug
> knowledge resources including print or online drug information references, drug interaction checking tools, and alerting systems.
> Unfortunately, poor specificity leads clinicians to be overwhelmed by PDDI information that is ???difficult to retrieve, sort and
> digest into clinical decision making??? [<cite><a class="bibref" href="#bib-bottiger-2009" title="{SFINX}-a drug-drug interaction database designed for clinical decision support systems">bottiger-2009</a></cite>]. PDDI alerts are often criticized for ???over-alerting??? that
> obfuscates the most important information, hinders the usability of the decision support system, and leads to alert fatigue
> and clinician dissatisfaction [<cite><a class="bibref" href="#bib-bottiger-2009" title="{SFINX}-a drug-drug interaction database designed for clinical decision support systems">bottiger-2009</a></cite>][<cite><a class="bibref" href="#bib-payne-2015" title="Recommendations to improve the usability of drug-drug interaction clinical decision support alerts">payne-2015</a></cite>]. Moreover, while many compilations of
> PDDI evidence exist to help improve prescriber and pharmacist knowledge, they are not concordant in their coverage,
> accuracy, and agreement [<cite><a class="bibref" href="#bib-wang-2010" title="Black box warning contraindicated comedications: concordance among three major drug interaction screening programs">wang-2010</a></cite>][<cite><a class="bibref" href="#bib-saverno-2011" title="Ability of pharmacy clinical decision-support software to alert users about clinically important drug-drug interactions">saverno-2011</a></cite>][<cite><a class="bibref" href="#bib-ayvaz-2015" title="Toward a complete dataset of drug-drug interaction information from publicly available sources">ayvaz-2015</a></cite>][<cite><a class="bibref" href="#bib-fung-2017" title="Comparison of three commercial knowledge bases for detection of drug-drug interactions in clinical decision support">fung-2017</a></cite>]. Together, these
> shortcomings suggest the need for harmonized approaches for documenting and sharing PDDI information. <strong>The purpose of this Community Group Report is to provide a technical and user-centered foundation for a minimum information model for information about potential drug-drug interactions.</strong>
> </p>
> <section id="need-envisioned-workflow-and-high-level-requirements">
> <h3 id="x1-1-need-envisioned-workflow-and-high-level-requirements"><bdi class="secno">1.1 </bdi>Need, envisioned workflow, and high-level requirements<a class="self-link" aria-label="??" href="#need-envisioned-workflow-and-high-level-requirements"></a></h3>
> <p>New information regarding PDDIs is published every day in
> primary sources such as drug product labeling and the scientific
> literature. A PubMed search for publications indexed with the
> Medical Subject Headings keyword ???Drug interactions??? shows
> growth from a little more than 6,000 publications in the year
> 2000 to more than 9,000 publications in 2018. This suggests that
> the body of evidence about PDDIs is overwhelming and dynamic. As
> it is impossible for clinicians to keep up with the PDDI
> evidence base, drug experts generate summaries of PDDI evidence
> from primary sources. These summaries bring PDDI knowledge to
> clinicians in the form of published drug information compendium,
> clinical decision support rules, and interaction checking
> applications.
> <strong>However, there are currently no broadly accepted standards to guide these experts in the organization, content, and presentation of PDDI
> information.</strong>
> </p>
>
> <p><a href="#PDDI-MI-APPLICATIONS" class="fig-ref" title="An overview of the role envisioned for a PDDI minimal information model. Starting from the top of the figure, drug experts synthesize drug-drug interaction evidence from pre-clinical studies, clinical studies, and clinical observation into knowledge artifacts annotated using information categories in the PDDI minimal information model. The annotated knowledge artifacts can be shared in a knowledgebase, and applied to a variety of use cases including clinical decision support, structuring PDDI information in drug product labeling, and to inform cohort descriptions useful for generating evidence from retrospective health records.">Figure <bdi class="figno">1</bdi></a> provides an overview of
> the roles envisioned for a PDDI minimal information model. Drug
> experts would generate summaries of PDDI evidence from primary
> sources using the information elements from the PDDI minimal
> information model. The information elements would cover the
> minimum set of information required for the effective clinical
> management of PDDI exposure. The resulting common representation
> of PDDI summaries would facilitate curation and information
> exchange. The annotated knowledge artifacts could be shared in
> a knowledgebase and applied to a variety of use cases.
> </p>
> <p>
> Downstream applications would process these representations into
> forms amenable for clinical decision support (see
> Section <a href="#ex-pddi-cds-hl7" class="sec-ref">?? <bdi class="secno">7.1 </bdi>Shareable PDDI Clinical Decision Support Using HL7 Standards </a>), drug product label
> enhancement (see Section <a href="#ex-SPL" class="sec-ref">?? <bdi class="secno">7.2 </bdi>Enhancing the Drug-drug Interaction Section of Structured Product Labeling</a>), to inform
> cohort descriptions useful for generating evidence from
> retrospective health records (see
> Section <a href="#ex-cohort-desc" class="sec-ref">?? <bdi class="secno">7.3 </bdi>Highlighting and Filling Gaps in Evidence Needed to Develop PDDI Decision Support</a>), and other medication
> safety activities.
> </p>
>
> <figure id="PDDI-MI-APPLICATIONS">
> <img src="Presentations/images/info-model-value-proposition.png" width="1152" height="864">
> <figcaption>Figure <bdi class="figno">1</bdi> <span class="fig-title">An overview of the role envisioned for a PDDI minimal information model. Starting from the top of the figure, drug experts synthesize drug-drug interaction evidence from pre-clinical studies, clinical studies, and clinical observation into knowledge artifacts annotated using information categories in the PDDI minimal information model. The annotated knowledge artifacts can be shared in a knowledgebase, and applied to a variety of use cases including <a href="#ex-pddi-cds-hl7">clinical decision support</a>, <a href="#ex-SPL">structuring PDDI information in drug product labeling</a>, and to <a href="#ex-cohort-desc">inform cohort descriptions useful for generating evidence</a> from retrospective health records. </span></figcaption>
> </figure>
>
> <p>
> To achieve the envisioned roles, the minimal information model
> must be grounded in non-trivial real world use cases. Where
> possible, model elements should draw upon accepted biomedical
> taxonomies and ontologies to represent medications, diagnoses,
> and descriptions of potential adverse reactions. Being
> a <i>minimum</i> information model, the goal is not to represent
> every aspect of a PDDI using formal logic and
> ontologies. Rather, the model should 1) specify the key
> information that is needed for effective clinical decision
> making, and 2) provide recommendations on how to minimize
> ambiguity common to free-text descriptions about PDDIs
> </p>
>
> <p>The purpose of this Community Group Report is to provide a
> technical and user-centered foundation for a minimum
> information model for PDDI information. The principal
> contributions include:
> </p><ol>
>
> <li>Definitions for the model's 10 core information items,
> examples of using these definitions to represent two PDDIs,
> and a set of additional PDDIs selected as case studies for
> future work on the information model.</li>
> <li>Eight detailed best practice recommendations for developers of PDDI knowledge artifacts related to
> the 10 core information items. </li>
> <li>A statement on the appropriate scope of knowledge representation
> for the information model. </li>
> <li>Clarification on the intended users of the information model
> in the form of 12 use stories with specific information needs. </li>
> <li>Prototype representations of 2 exemplar PDDIs as narrative and JSON.</li>
> </ol>
> <p></p>
> </section>
> </section>
>
> <section id="the-model" class="normative">
> <h2 id="x2-the-minimum-information-model"><bdi class="secno">2. </bdi>The Minimum Information Model<a class="self-link" aria-label="??" href="#the-model"></a></h2>
>
> <section id="user-centered-def">
> <h3 id="x2-1-definitions-of-core-information-items"><bdi class="secno">2.1 </bdi>Definitions of Core Information Items<a class="self-link" aria-label="??" href="#user-centered-def"></a></h3>
> <p>
> The minimum information model contains a total of 10 core
> information items. Definitions are given below; descriptions of
> considerations informing the definitions of these term can be
> found in the <a target="new" href="https://github.com/w3c/hcls-drug-drug-interaction/tree/master/User-centered-definitions">user-centered definition working documents on github</a>.
> </p>
> <ul>
> <li><dfn data-dfn-type="dfn" id="dfn-drugs-involved">Drugs Involved</dfn> Two or more drugs considered to be
> possible participants in a potential drug-drug
> interaction. Drugs may be specified as drug classes, specific chemicals, products, or in any other
> appropriate level of granularity. Specification of each drug involved in a PDDI
> may include the use of a single <i>drug identifier</i>
> (<a target="new" href="http://purl.obolibrary.org/obo/APOLLO_SV_00000461">http://purl.obolibrary.org/obo/APOLLO_SV_00000461</a>) from a medical terminology, or a <i>drug concept set
> identifier</i> (<a target="new" href="http://purl.obolibrary.org/obo/DIDEO_00000128">http://purl.obolibrary.org/obo/DIDEO_00000128</a>) that identifies two or more relevant drug identifiers.
> </li>
>
> <li><dfn data-dfn-type="dfn" id="dfn-clinical-consequences">Clinical Consequences</dfn> (<a target="new" href="http://purl.obolibrary.org/obo/MPIO_0000002">http://purl.obolibrary.org/obo/MPIO_0000002</a>):
> Changes in patient health status from baseline that can be observed or measured by a
> clinician or reported by a patient.</li>
>
> <li> <dfn data-lt="seriousness|serious" data-dfn-type="dfn" id="dfn-seriousness">Seriousness</dfn> (<a target="new" href="http://purl.obolibrary.org/obo/MPIO_0000009">http://purl.obolibrary.org/obo/MPIO_0000009</a>):
> As defined by the World Health Organization an event is
> serious if it "results in death; requires hospitalization
> or extension of hospital stay; results in persistent or
> significant disability or incapacity; is
> life-threatening" [<cite><a class="bibref" href="#bib-who-umc-glossary" title="UMC - Glossary">who-umc-glossary</a></cite>]. Seriousness may
> determine the type and speed of clinician intervention. Note
> that seriousness is also an important concept for
> pharmacovigilance and pharmacoepidemiological studies. The
> adoption of this term aligns this effort with definitions
> adopted by the World Health Organization[<cite><a class="bibref" href="#bib-who-umc-glossary" title="UMC - Glossary">who-umc-glossary</a></cite>],
> the United States Food and Drug Administration
> [<cite><a class="bibref" href="#bib-usdhhs-2011" title="Guidance for Industry - Providing Regulatory Submissions in Electronic Format - Content of Labeling">usdhhs-2011</a></cite>], and other organizations involved in
> pharmacovigilance efforts.
> </li>
>
> <li> <dfn data-dfn-type="dfn" data-plurals="operational classification statements" id="dfn-operational-classification-statement">Operational Classification Statement</dfn> (<a target="new" href="http://purl.obolibrary.org/obo/MPIO_0000005">http://purl.obolibrary.org/obo/MPIO_0000111</a>):
> A short risk classification statement that suggests a specific management criteria for a specific patient context. For example, the OpeRational ClassificAtion of Drug Interactions [<cite><a class="bibref" href="#bib-hansten-2001" title="ORCA:OpeRational ClassificAtion of Drug Interactions.">hansten-2001</a></cite>] system suggests the following categories:</li>
> <ul>
> <li>Avoid Combination (Risk of combination outweighs benefit)</li>
>
> <li>Usually Avoid Combination (Use only under special circumstances)</li>
> <ul>
> <li>Interactions for which there are clearly preferable alternatives for one or both drugs.</li>
> <li>Interactions to avoid by using an alternative drug or other therapy unless the benefit is judged to outweigh the increased risk.</li>
> </ul>
>
> <li>Minimize Risk (Assess risk and take one or more of the following actions if needed)</li>
> <ul>
> <li>Consider alternatives: Alternatives may be available that are less likely to interact.</li>
> <li>Circumvent: Take action to minimize the interaction (without avoiding combination).</li>
> </ul>
>
> <li>Monitor: Early detection can minimize the risk of an adverse outcome.</li>
>
> <li>No Special Precautions (Risk of adverse outcome appears small)</li>
>
> <li>Ignore (Evidence suggests that the drugs do not interact)</li>
> </ul>
>
>
> <li><dfn data-dfn-type="dfn" data-plurals="recommended actions" id="dfn-recommended-action">Recommended Action</dfn> (<a target="new" href="http://purl.obolibrary.org/obo/MPIO_0000008">http://purl.obolibrary.org/obo/MPIO_0000008</a>):
> An evidence-based strategy to mitigate the potential clinical consequences of a drug-drug interaction such as a drug change, adjust drug dose, and monitor lab values. A Recommended Action should provide specific detailed suggestions that complement the <a href="#dfn-operational-classification-statement" class="internalDFN" data-link-type="dfn">Operational Classification Statement</a>. </li>
>
> <li><dfn data-lt="mechanism of interaction|mechanism of a pddi" data-dfn-type="dfn" id="dfn-mechanism-of-interaction">Mechanism of Interaction</dfn> (<a target="new" href="http://purl.obolibrary.org/obo/MPIO_0000005">http://purl.obolibrary.org/obo/MPIO_0000005</a>):
> The process(es) by which a drug-drug interaction with clinical
> consequence occurs.</li>
>
> <li><dfn data-dfn-type="dfn" data-plurals="contextual information/modifying factor" id="dfn-contextual-information-modifying-factors">Contextual information/modifying factors</dfn>
> (<a target="new" href="http://purl.obolibrary.org/obo/MPIO_0000000">http://purl.obolibrary.org/obo/MPIO_0000000</a>):
> Factors such as patient age, patient health conditions, route of administration, product formulation, drug dose, pharmacogenetics,
> or concurrent medications that might alter the risk of a drug-drug interaction clinical consequence or its seriousness. </li>
>
> <li><dfn data-lt="evidence about a suspected drug-drug interaction|evidence" data-dfn-type="dfn" id="dfn-evidence-about-a-suspected-drug-drug-interaction">Evidence About a Suspected Drug-Drug Interaction</dfn> (<a target="new" href="http://purl.obolibrary.org/obo/MPIO_0000004">http://purl.obolibrary.org/obo/MPIO_0000004</a>):
> The support for or refutation of a drug-drug interaction in humans, potentially including data resulting
> from clinical studies, clinical observation, physiological experiments, or extrapolation based
> on drug-drug interaction mechanisms. It is also acceptable to refer to this information item as "Evidence About a <i>Potential</i> Drug-Drug Interaction." </li>
>
> <li><dfn data-lt="frequency of exposure to the pddi|frequency of exposure" data-dfn-type="dfn" id="dfn-frequency-of-exposure-to-the-pddi">Frequency of Exposure to the PDDI</dfn> (<a target="new" href="http://purl.obolibrary.org/obo/MPIO_0000007">http://purl.obolibrary.org/obo/MPIO_0000007</a>):
> When available, the number of individuals within a cohort that are exposed to a drug-drug interaction over a specified time
> period divided by the total number of patients in the cohort.</li>
>
> <li><dfn data-lt="frequency of harm for persons who have been exposed to the pddi|frequency of harm" data-dfn-type="dfn" id="dfn-frequency-of-harm-for-persons-who-have-been-exposed-to-the-pddi">Frequency of Harm for persons who have been exposed to the PDDI</dfn> (<a target="new" href="http://purl.obolibrary.org/obo/MPIO_0000006">http://purl.obolibrary.org/obo/MPIO_0000006</a> ):
> When available, the number of individuals within a cohort that experience a clinical consequence of a drug-drug interaction clinical consequence divided by the total number of patients co-exposed to the drugs involved.</li>
>
>
> </ul>
> </section>
> </section>
>
> <section id="recommendations-summary" class="normative">
> <h2 id="x3-a-summary-of-recommendations-related-to-the-minimum-information-model"><bdi class="secno">3. </bdi>A summary of recommendations related to the minimum information model<a class="self-link" aria-label="??" href="#recommendations-summary"></a></h2>
>
> <p>
> This section summarizes the Community Group's recommendations related to the minimum information model. <a href="#recommended-approaches" class="fig-ref" title="An visual overview of the 8 recommendations that are labeled R1 to R8 in the paragraphs below. Note that the bubbles are ordered for simpler visual presentation and not meant to suggest an editorial workflow. The figure indicates fundamental recommendations using bubbles with solid lines and knowledge dependent recommendations using bubbles with dashed lines. Boxes indicate entities discussed in the recommendations such as value sets and evidence support. Arrows indicate relationships between information items and entities discussed in the recommendations. Black arrows indicate fundamental information items or entities that MUST be reported together while gray arrows indicate items or entities that SHOULD be reported together if known. ??? If the PDDI mechanism is not known, state "not known".">Figure <bdi class="figno">2</bdi></a> shows an overview of the recommendations and how they related to one another. A brief summary of each recommendation is provided below the figure. Each recommendation summary uses capitalized keywords (<em class="rfc2119" title="MUST">MUST</em>, <em class="rfc2119" title="MUST NOT">MUST NOT</em>, <em class="rfc2119" title="REQUIRED">REQUIRED</em>, <em class="rfc2119" title="SHALL">SHALL</em>, <em class="rfc2119" title="SHALL NOT">SHALL NOT</em>, <em class="rfc2119" title="SHOULD">SHOULD</em>, <em class="rfc2119" title="SHOULD NOT">SHOULD NOT</em>, <em class="rfc2119" title="RECOMMENDED">RECOMMENDED</em>, <em class="rfc2119" title="MAY">MAY</em>, AND <em class="rfc2119" title="OPTIONAL">OPTIONAL</em>) defined in RFC 2119 [<cite><a class="bibref" href="#bib-rfc2119" title="Key words for use in RFCs to Indicate Requirement Levels">RFC2119</a></cite>]. Two examples of applying the recommendations to PDDIs are provided in <a href="#examples" class="sec-ref">?? <bdi class="secno">5. </bdi>Examples of the use of the minimal information model</a>.
> </p>
>
> <figure id="recommended-approaches">
> <img src="W3C-Images/recommendations-overview.png" width="1152">
> <figcaption>Figure <bdi class="figno">2</bdi> <span class="fig-title">An visual overview of the 8 recommendations that are labeled R1 to R8 in the paragraphs below. Note that the bubbles are ordered for simpler visual presentation and not meant to suggest an editorial workflow. The figure indicates fundamental recommendations using bubbles with solid lines and knowledge dependent recommendations using bubbles with dashed lines. Boxes indicate entities discussed in the recommendations such as value sets and evidence support. Arrows indicate relationships between information items and entities discussed in the recommendations. Black arrows indicate fundamental information items or entities that <em class="rfc2119" title="MUST">MUST</em> be reported together while gray arrows indicate items or entities that <em class="rfc2119" title="SHOULD">SHOULD</em> be reported together if known. ??? If the PDDI mechanism is not known, state "not known".
> </span></figcaption>
> </figure>
>
> <div class="practice" id="bp-drugs-involved">
> <b><i>R1 - Explicitly state the drugs involved:</i></b> The <a href="#dfn-drugs-involved" class="internalDFN" data-link-type="dfn">drugs involved</a> in a PDDI <em class="rfc2119" title="MUST">MUST</em> be explicitly stated. To reduce ambiguity and support a computable representation of the PDDI, the drugs involved <em class="rfc2119" title="SHOULD">SHOULD</em> be listed as sets of terms from a terminology such as <a href="https://www.nlm.nih.gov/research/umls/rxnorm/" target="new">RxNorm</a> or the <a href="https://www.whocc.no/atc/structure_and_principles/" target="new">Anatomical Therapeutic Chemical Classification System (ATC)</a>. Such so called <i>value sets</i> <em class="rfc2119" title="MAY">MAY</em> be referenced by a <i>drug concept set identifier</i> (<a target="new" href="http://purl.obolibrary.org/obo/DIDEO_00000128">http://purl.obolibrary.org/obo/DIDEO_00000128</a>) such as a URI to a public repository such as the <a href="https://vsac.nlm.nih.gov/" target="new">Value Set Authority Center</a> that is maintained by the <a href="https://www.nlm.nih.gov/" target="new">United States National Library of Medicine</a>. The implementer <em class="rfc2119" title="MAY">MAY</em> choose any terminology they think appropriate. To promote broader accessibility to PDDI knowledge, the implementer <em class="rfc2119" title="SHOULD">SHOULD</em> use a terminology that is actively maintained and freely accessible to the public.
> </div>
>
>
> <div class="practice" id="bp-mechanism">
> <b><i>R2 - Report a mechanism if known:</i></b> The <a href="#dfn-mechanism-of-interaction" class="internalDFN" data-link-type="dfn">mechanism of a PDDI</a> <em class="rfc2119" title="MUST">MUST</em> be reported if known. If the mechanism is not known, that <em class="rfc2119" title="MUST">MUST</em> be explicitly stated. The description <em class="rfc2119" title="SHOULD">SHOULD</em> be written for a clinician audience and include details that help the clinician decide what course of management action to take. To reduce ambiguity, the description <em class="rfc2119" title="MAY">MAY</em> refer to specific drugs or health conditions using codes from terminologies.
> </div>
>
> <div class="practice" id="bp-freq-exp">
> <b><i>R3 - State the frequency of harm relative to frequency of exposure if known:</i></b> Information about the <a href="#dfn-frequency-of-harm-for-persons-who-have-been-exposed-to-the-pddi" class="internalDFN" data-link-type="dfn">frequency of harm</a> of exposure to a PDDI relative to <a href="#dfn-frequency-of-exposure-to-the-pddi" class="internalDFN" data-link-type="dfn">frequency of exposure</a> and is rarely available. If such information is available, it can help a clinician assess the risk/benefit trade-off of exposure to PDDI. Therefore, if such information is not available, an explicit statement declaring this fact <em class="rfc2119" title="MUST">MUST</em> be provided. However, if such information is available and considered reliable, it <em class="rfc2119" title="MUST">MUST</em> be provided. Wherever possible, each frequency of harm and frequency of exposure datum <em class="rfc2119" title="SHOULD">SHOULD</em> refer to a specific source in the form of a citation.
> </div>
>
>
> <div class="practice" id="bp-clinical-consequences">
> <b><i>R4 - Explicitly state clinical consequences:</i></b> The <a href="#dfn-clinical-consequences" class="internalDFN" data-link-type="dfn">clinical consequences</a> associated with a PDDI <em class="rfc2119" title="MUST">MUST</em> be reported if known. Clinical consequences <em class="rfc2119" title="MUST">MUST</em> refer health outcomes as specifically as possible. To reduce ambiguity and support a computable representation of the PDDI, clinical consequences <em class="rfc2119" title="SHOULD">SHOULD</em> be represented as one or more sets of terms from a terminology such as <a href="http://www.who.int/classifications/icd/en/" target="new">ICD-10</a> or <a href="https://www.snomed.org/snomed-ct" target="new">SNOMED-CT</a>. Such so called <i>value sets</i> <em class="rfc2119" title="MAY">MAY</em> be referenced by a URI to a public repository such as the <a href="https://vsac.nlm.nih.gov/" target="new">Value Set Authority Center</a> that is maintained by the <a href="https://www.nlm.nih.gov/" target="new">United States National Library of Medicine</a>. The implementer <em class="rfc2119" title="MAY">MAY</em> choose any terminology they think appropriate. To promote broader accessibility to PDDI knowledge, the implementer <em class="rfc2119" title="SHOULD">SHOULD</em> use a terminology that is actively maintained and freely accessible to the public.
> </div>
>
> <div class="practice" id="bp-serious">
> <b><i>R5 - Note if a clinical consequence is serious:</i></b> A clinical consequence associated with a PDDI <em class="rfc2119" title="MUST">MUST</em> be noted as <a href="#dfn-seriousness" class="internalDFN" data-link-type="dfn">serious</a> if it can result in death, life-threatening hospitalization, congenital anomaly, disability, or if it requires intervention to prevent permanent impairment or damage.
> </div>
>
> <div class="practice" id="bp-operational-classification">
> <b><i>R6 - Include an operational classification statement:</i></b> A PDDI <em class="rfc2119" title="MUST">MUST</em> report at least one <a href="#dfn-operational-classification-statement" class="internalDFN" data-link-type="dfn">operational classification statement</a>. The description <em class="rfc2119" title="MAY">MAY</em> include more than one operational classification statements as long as each statement depends on a single set of <a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">contextual information/modifying factors</a>. If there is more than one operational classification statement, each operational classification statement <em class="rfc2119" title="MUST">MUST</em> be mentioned along with the specific contextual information/modifying factor that applies to the situation. While implementers <em class="rfc2119" title="MAY">MAY</em> use any system that provides clear operational classification statements, the use of the OpeRational ClassificAtion of Drug Interactions [hansten-2001] is <em class="rfc2119" title="RECOMMENDED">RECOMMENDED</em>.
> </div>
>
>
> <div class="practice" id="bp-contextual">
> <b><i>R7 - State each known risk modifying factor or patient context:</i></b> <a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">Contextual information/modifying factors</a> are necessary for alerts that
> are both sensitive and specific. Like clinical consequences, each known factor <em class="rfc2119" title="MUST">MUST</em> be stated as specifically as possible. The factors <em class="rfc2119" title="SHOULD">SHOULD</em> be amenable to implementation as executable logic using value sets from clinical terminologies such as <a href="https://www.nlm.nih.gov/research/umls/rxnorm/" target="new">RxNorm</a>, the <a href="https://www.whocc.no/atc/structure_and_principles/" target="new">Anatomical Therapeutic Chemical Classification System (ATC)</a>, <a href="http://www.who.int/classifications/icd/en/" target="new">ICD-10</a>, and <a href="https://www.snomed.org/snomed-ct" target="new">SNOMED-CT</a>. Each factor <em class="rfc2119" title="SHOULD">SHOULD</em> be related to a specific <a href="#dfn-operational-classification-statement" class="internalDFN" data-link-type="dfn">operational classification statement</a> that is supported by the <a href="#dfn-evidence-about-a-suspected-drug-drug-interaction" class="internalDFN" data-link-type="dfn">evidence about a suspected drug-drug interaction</a>. Wherever possible, each evidence statement <em class="rfc2119" title="SHOULD">SHOULD</em> refer to a specific source in the form of a citation.
> </div>
>
> <div class="practice" id="bp-recommended-action">
> <b><i>R8 - State a recommended action if one is known:</i></b> If known, a <a href="#dfn-recommended-action" class="internalDFN" data-link-type="dfn">recommended action</a> <em class="rfc2119" title="MUST">MUST</em> be stated. Any recommended actions that apply to all patient exposures <em class="rfc2119" title="MUST">MUST</em> be stated. It is desirable that each recommended action is written in clear and concise language. Each recommended action statement <em class="rfc2119" title="SHOULD">SHOULD</em> provide citations to <a href="#dfn-evidence-about-a-suspected-drug-drug-interaction" class="internalDFN" data-link-type="dfn">evidence about a suspected drug-drug interaction</a> (not provided in this example). Recommendations that depend on specific <a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">contextual information/modifying factors</a> <em class="rfc2119" title="SHOULD">SHOULD</em> be mentioned so as to support a context-specific presentation of such information.
> </div>
> </section>
>
>
> <section id="KR-discussion" class="normative">
> <h2 id="x4-knowledge-representation-for-the-minimal-information-model"><bdi class="secno">4. </bdi>Knowledge representation for the minimal information model<a class="self-link" aria-label="??" href="#KR-discussion"></a></h2>
>
> <p>
> <i>The intended audience for this section includes persons interested in recommendations related to information model knowledge representation. Persons interested in the clinically-oriented application of the information model can skip this section.</i>
> </p>
>
> <p>
> The wide range of potential use cases for the information model
> requires flexibility in the knowledge representation. Moreover, the
> number of pre-existing ontologies relevant to this domain clearly
> demonstrates the richness of the domain [<cite><a class="bibref" href="#bib-herrero-zazo-2015" title="DINTO: Using OWL Ontologies and SWRL Rules to Infer Drug-Drug Interactions and Their Mechanisms">herrero-zazo-2015</a></cite>]. To
> keep the minimum information model lean and ensure its
> maintainability and usability, it was necessary to develop a clear
> scope for the knowledge representation including
> issues such as:
>
> </p><ul>
> <li> How should terms related to the core information items
> (see <a href="#user-centered-def" class="sec-ref">?? <bdi class="secno">2.1 </bdi>Definitions of Core Information Items</a>) be modeled?</li>
>
> <li>What is the role of an upper ontology?</li>
>
> <li>What is the relationship between the core information items and other existing ontologies?</li>
>
> <li>Should terms from other resources, such as medical terminologies, be reused?</li>
>
> </ul>
>
> The following strategies are suggested for the representation of PDDI
> minimal information (see <a href="#kr-process-apdx" class="sec-ref">?? <bdi class="secno">A.3 </bdi>Definition of guidelines for knowledge representation</a> for a
> description of the process used to develop these recommendations):
>
> <ol>
> <li>The Minimum PDDI Information Ontology
> (<a href="https://github.com/MPIO-Developers/MPIO" target="new">MPIO</a>) should be used for the core information
> items relevant to the PDDI domain (see
> Section <a href="#user-centered-def" class="sec-ref">?? <bdi class="secno">2.1 </bdi>Definitions of Core Information Items</a>). The ontology is
> limited in its semantic richness by design, but remains
> compatible with semantically rich models such as <a target="new" href="http://purl.obolibrary.org/obo/dideo.owL"> the Drug-drug
> Interaction and Drug-drug Interaction Evidence Ontology
> (DIDEO)</a> and <a target="new" href="http://purl.obolibrary.org/obo/dinto.owl">the Drug-Drugs
> Interaction Ontology (DINTO)</a>.
> </li>
> <li> The MPIO is written in
> the <a href="http://www.w3.org/TR/owl2-primer/">Web Ontology
> Language (OWL 2)</a> [<cite><a class="bibref" href="#bib-owl2-overview" title="OWL 2 Web Ontology Language Document Overview (Second Edition)">owl2-overview</a></cite>]. The individual classes
> in the MPIO are sub-classes of classes provided by
> the <a href="https://github.com/bfo-ontology/BFO/wiki"> Basic
> Formal Ontology (BFO)</a> upper ontology. This enables
> integration with numerous other ontologies written in OWL 2 that
> use the same upper ontology. This approach fosters integration
> with a number of existing formal ontology efforts including
> DIDEO, DINTO, <a href="http://obi-ontology.org/" target="new">Ontology for Biomedical Investigations</a>, and
> the <a href="http://www.oae-ontology.org/"> Ontology of Adverse
> Events</a>.
>
>
> </li>
> <li>The core PDDI information items in the MPIO are
> all <a href="http://purl.obolibrary.org/obo/IAO_0000030">information
> content entities</a>. This approach is chosen to reflect the
> hypothetical nature of the information represented. As
> abstract descriptions of events and relationships that might occur,
> instances of the PDDI model do not make any claims that these
> interactions must actually exist. However, as OWL models are
> generally interpreted to discuss objects that exist in the
> world, knowledge representations must take care to avoid
> making these claims of any of the PDDI information. To address
> this problem, MPIO classifies items in the minimal information
> model as <em>information content entities</em>, essentially
> saying that they are "about something" Thus, each
> element of the model essentially exists as a statement about
> the PDDI. As a result, the OWL 2 entities do not
> refer to the actual material entities or processes. Rather, all
> properties of the core information items are terminological in
> nature and refer to relations between the term and other
> terms.
> </li>
> <li>An important requirement of the PDDI minimum information model
> is that it allow for integration of terms from existing
> biomedical terminologies such as ICD-10, SNOMED-CT, RxNorm, and
> LOINC. This presents a challenge since these terminologies
> represent similar items at different levels of semantic richness,
> methodological rigor, and semantic commitments. While it is
> highly unlikely that it would be possible to unify all external
> terms semantically at an upper level with the core PDDI
> information items (see
> Section <a href="#user-centered-def" class="sec-ref">?? <bdi class="secno">2.1 </bdi>Definitions of Core Information Items</a>), terms for which a
> human understandable, non-circular, definition exist, <em class="rfc2119" title="MAY">MAY</em> be
> re-used in the MPIO. Re-use <em class="rfc2119" title="SHALL">SHALL</em> be accomplished by
> representing an information content entity about the object
> referenced by the term. For example, the diagnosis referred to
> by a diagnostic code from ICD 10 would be reused in the MPIO by
> representing an information content entity corresponding to the
> ICD 10 code. Practically speaking, concepts from any of the
> terminologies might be used, but they should be represented
> whenever possible by unambiguous identifiers for both the source
> terminology and the specific concept.
> </li>
> </ol>
> <p></p>
> </section>
>
> <section id="examples" class="informative">
> <h2 id="x5-examples-of-the-use-of-the-minimal-information-model"><bdi class="secno">5. </bdi>Examples of the use of the minimal information model<a class="self-link" aria-label="??" href="#examples"></a></h2><p><em>This section is non-normative.</em></p> In
> this section, we provide limited discussion of the information
> model's definitions and recommendations in the form of two example
> PDDIs. These examples are in narrative form and were chosen from a
> larger set exemplar PDDIs examined during the development of the
> minimal information model (see
> Appendix <a href="#decision-trees" class="sec-ref">?? <bdi class="secno">A.1.1.2 </bdi>Decision Trees Created for the Minimum Information Model Domain Analysis</a>). <b>Note that while the
> examples shown here are realistic, they are not intended for direct
> integration into a clinical applications.</b> The same 2 PDDIs examples
> shown below are also represented as prototype JSON documents in
> Appendix <a href="#appendix-json" class="sec-ref">?? <bdi class="secno">A.5 </bdi>JSON Examples</a>
>
> <section id="ex-warfarin-nsaids">
> <h3 id="x5-1-applying-the-minimal-information-model-definitions-to-the-pddi-between-warfarin-and-non-steroidal-anti-inflammatory-drugs-nsaids"><bdi class="secno">5.1 </bdi>Applying the Minimal Information Model definitions to the PDDI between warfarin
> and non-steroidal anti-inflammatory drugs (NSAIDs)<a class="self-link" aria-label="??" href="#ex-warfarin-nsaids"></a></h3>
> <p>
> We illustrate here the application of the Minimum Information Model definitions to representing the PDDI involving warfarin
> and systemic non-steroidal anti-inflammatory drugs (NSAIDs). Details of
> the development process can be found
> in Appendix <a href="#warfarin-nsaids-dt" class="sec-ref">?? <bdi class="secno">A.1.1.2.1 </bdi>Example PDDI:Warfarin + NSAIDs</a>.
> </p>
>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><strong>Drugs involved</strong>: <a href="#warfarins">Warfarin</a> and <a href="#NSAIDS-drugs">systemic non-steroidal anti-inflammatory drugs (NSAIDs)</a> </td>
> </tr>
> <tr>
> <td>
> <strong>Comment:</strong> Per the recommendation <a href="#bp-drugs-involved">R1 - Explicitly state the drugs involved</a>, value sets for warfarin and NSAIDs are explicitly enumerated. This example states systemic NSAIDs generally and then refers to more specific NSAID formulations in Contextual information/modifying factors (since the interaction is only relevant for bioavailable forms). We note that the drugs involved can be described at various levels of abstraction, from drug classes at one level to more closely defined medicinal product concepts at the other. The information carried by the other attributes of the minimum information model <em class="rfc2119" title="MUST">MUST</em> remain clinically accurate for the particular level of abstraction chosen for the interactants. Also, we note that this example explicitly lists the drugs involved. As Appendix <a href="#intro-to-value-sets" class="sec-ref">?? <bdi class="secno">A.4.1 </bdi>Some Background on Concept Identification and 'Value Sets' </a> mentions, this <i>extensional definition</i> is one approach to declaring value sets. It is also possible to define an algorithm that, when executed by a machine (or interpreted by a human), yields a set of such elements. Such a <i>intensional definition</i> is also an acceptable approach to declaring the drugs involved.
> </td>
> </tr>
> </tbody></table>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><a href="#dfn-mechanism-of-interaction" class="internalDFN" data-link-type="dfn">Mechanism of Interaction</a>: <a href="#NSAIDS-drugs">Systemic non-steroidal anti-inflammatory drugs (NSAIDs)</a> have
> antiplatelet effects which increase the bleeding risk when combined with oral anticoagulants such as
> <a href="#warfarins">warfarin</a>. The antiplatelet effect of systemic NSAIDs lasts only as long as the NSAID is present in the circulation,
> unlike aspirin???s antiplatelet effect, which lasts for up to 2 weeks after aspirin is discontinued. NSAIDs also
> can cause peptic ulcers and most of the evidence about increased bleeding risk with NSAIDs plus warfarin is due to
> upper gastrointestinal bleeding (UGIB).</td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per recommendation <a href="#bp-mechanism">R2 - Report a mechanism if known</a>, there is a clear statement of the <a href="#dfn-mechanism-of-interaction" class="internalDFN" data-link-type="dfn">mechanism of interaction</a> written for a clinician audience. </td>
> </tr>
> </tbody></table>
>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><strong>Frequency of Harm Relative to Frequency of Exposure to the PDDI:</strong> Unknown</td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per recommendation <a href="#bp-freq-exp">R3 - State the frequency of harm relative to frequency of exposure if known</a>, an explicit statement is made declaring that information on frequency of harm relative to frequency of exposure to the PDDI is not available. </td>
> </tr>
> </tbody></table>
>
>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><a href="#dfn-clinical-consequences" class="internalDFN" data-link-type="dfn">Clinical Consequences</a>: Increased risk of bleeding including <a href="#gi-bleeding">gastrointestinal bleeding</a>, <a href="#icran-hemm">intracranial hemorrhage</a>, and <a href="#cereb-hemm">cerebral hemorrhage</a></td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per the recommendation <a href="#bp-clinical-consequences">R4 - Explicitly state clinical consequences</a>, value sets for the clinical consequences are explicitly enumerated. As Appendix <a href="#intro-to-value-sets" class="sec-ref">?? <bdi class="secno">A.4.1 </bdi>Some Background on Concept Identification and 'Value Sets' </a> mentions, this <i>extensional definition</i> is one approach to declaring value sets. It is also possible to define an algorithm that, when executed by a machine (or interpreted by a human), yields a set of such elements. Such a <i>intensional definition</i> is also an acceptable approach to declaring clinical conseqences.</td>
> </tr>
> </tbody></table>
>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><a href="#dfn-seriousness" class="internalDFN" data-link-type="dfn">Seriousness</a>: Bleeding is a serious potential clinical consequence because it can result in death, life-threatening hospitalization, and disability. </td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per the recommendation <a href="#bp-serious">R5 - Note if a clinical consequence is serious</a>, there is a clear statement that the potential clinical consequence of bleeding <a href="#dfn-seriousness" class="internalDFN" data-link-type="dfn">serious</a>.</td>
> </tr>
> </tbody></table>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><a href="#dfn-operational-classification-statement" class="internalDFN" data-link-type="dfn">Operational Classification Statement</a>: Depending on the patient context, there are different operational classification statements for the warfarin-NSAIDs PDDI. See the <a href="#warfarin-specific-context">contextual information/modifying factors for this interaction</a>.</td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per recommendation <a href="#bp-operational-classification">R6 - Include an operational classification statement</a>, the PDDI description includes more than one <a href="#dfn-operational-classification-statement" class="internalDFN" data-link-type="dfn">operational classification statements</a>. Because there is multiple <a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">contextual information/modifying factors</a>, no single general operational classification statement can be mentioned. Rather, an operational classification statement is provided for each factor. </td>
> </tr>
> </tbody></table>
> </section>
>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">Contextual information/modifying factors</a>:
> <ol>
> <li>The <a href="#NSAIDS-drugs">NSAID</a> is <a href="#topical-diclof">topical or ophthalmic diclofenac</a></li>
> <ul>
> <li><strong>Operational Classification Statement:</strong> No special precautions</li>
> <li><strong>Evidence About a Suspected Drug-Drug Interaction:</strong> <a href="#topical-diclof">Both topical and ophthalmic formulations of diclofenac</a> have relatively low systemic absorption; in one study a topical gel (16 g/day) produced about 6% of the absorption seen with systemic administration of 150 mg/day. A higher than recommended dose of topical gel (48 g/day) produced 20% of a systemic dose of diclofenac. The UK Summary of Product Characteristics for Voltarol Ophtha Multidose Eye Drops states, "No measurable levels of diclofenac could be found in humans after ocular application of diclofenac sodium eye drops". The FDA-approved SPL for Diclofenac Sodium Ophthalmic Solution 0.1% states, "Results from a bioavailability study established that plasma levels of diclofenac following ocular instillation of two drops of Diclofenac sodium ophthalmic solution, 0.1% to each eye were below the limit of quantification (10 ng/mL) over a 4-hour period. This study suggests that limited, if any, systemic absorption occurs with Diclofenac sodium ophthalmic solution". </li>
> </ul>
>
> <li>The NSAID is NEITHER <a href="#topical-diclof">topical nor ophthalmic diclofenac</a> but the patient is concomitantly taking a
> <a href="#proton-pump-inhibitor">proton pump inhibitor</a> or <a href="#misoprostol">misoprostol</a></li>
> <ul>
> <li><strong>Operational Classification Statement:</strong> Assess risk and take action if necessary</li>
> <li><strong>Evidence About a Suspected Drug-Drug Interaction:</strong> <a href="#proton-pump-inhibitor">Proton pump inhibitors</a> and <a href="#misoprostol">misoprostol</a> may reduce the risk of UGIB in patients receiving NSAIDs and warfarin. </li>
> </ul>
> <li>The NSAID is NEITHER <a href="#topical-diclof">topical nor ophthalmic diclofenac</a>, the patient is NOT concomitantly taking a <a href="#proton-pump-inhibitor">proton pump inhibitor</a> or <a href="#misoprostol">misoprostol</a>, and the patient has one or more of the following risk factors:</li>
> <ul>
> <li>History of <a href="#gi-bleeding">upper gastrointestinal bleeding (UGIB) or peptic ulcer</a> or age > 65 years old</li>
> <ul>
> <li><strong>Operational Classification Statement:</strong> Use only if benefit outweighs risk</li>
> <li><strong>Evidence About a Suspected Drug-Drug Interaction:</strong> Patients with a
> history of UGIB or peptic ulcer may have an increased risk of UGIB from this interaction.
> The extent to which older age is an independent risk factor for UGIB due to these interactions
> is not firmly established, but UGIB in general is known to increase with age.</li>
> </ul>
>
> <li>Concomitantly taking <a href="#systemic-cortico">systemic corticosteroids</a>, <a href="#aldosterone-antagonists">aldosterone antagonists</a>, or high dose or multiple <a href="#NSAIDS-drugs">systemic NSAIDs</a></li>
> <ul>
> <li><strong>Operational Classification Statement:</strong> Use only if benefit outweighs risk</li>
> <li><strong>Evidence About a Suspected Drug-Drug Interaction:</strong> Both corticosteroids
> and aldosterone antagonists have been shown to substantially increase the risk of UGIB in
> patients on systemic NSAIDs, with relative risks of 12.8 and 11 respectively compared
> to a risk of 4.3 with NSAIDs alone [<cite><a class="bibref" href="#bib-masclee-2014" title="Risk of upper gastrointestinal bleeding from different drug combinations.">masclee-2014</a></cite>]</li>
> </ul>
> </ul>
> </ol>
> </td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per recommendation <a href="#bp-operational-classification">R6 - Include an operational classification statement</a>, the PDDI description includes one or more <a href="#dfn-operational-classification-statement" class="internalDFN" data-link-type="dfn">operational classification statements</a>. Because there is multiple <a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">contextual information/modifying factors</a>, no single general operational classification statement can be mentioned. Rather, an operational classification statement is provided for each factor. Per recommendation <a href="#bp-contextual">R7 - each known risk modifying factor or patient context</a>, each known <a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">contextual information/modifying factor</a> is stated specifically. Value sets for the <a href="#dfn-clinical-consequences" class="internalDFN" data-link-type="dfn">clinical consequences</a> are explicitly enumerated. As Appendix <a href="#intro-to-value-sets" class="sec-ref">?? <bdi class="secno">A.4.1 </bdi>Some Background on Concept Identification and 'Value Sets' </a> mentions, this <i>extensional definition</i> is one approach to declaring value sets. It is also possible to define an algorithm that, when executed by a machine (or interpreted by a human), yields a set of such elements. Such a <i>intensional definition</i> is also an acceptable approach to declaring clinical conseqences. An <a href="#dfn-operational-classification-statement" class="internalDFN" data-link-type="dfn">operational classification statement</a> is provided for each <a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">contextual information/modifying factor</a> and each evidence statement refers to a specific source in the form of a citation. </td>
> </tr>
> </tbody></table>
>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><a href="#dfn-recommended-action" class="internalDFN" data-link-type="dfn">Recommended Action</a>: If the systemic NSAID is being used as an analgesic or antipyretic,
> it would be prudent to use an alternative such as acetaminophen. In some people, acetaminophen can
> increase the anticoagulant effect of warfarin, so monitor the INR if acetaminophen is used in doses
> over 2 g/day for a few days. For more severe pain consider short-term opioids in place of the NSAID.</td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per recommendation <a href="#bp-recommended-action">R8 - State a recommended action if one is known</a>, a <a href="#dfn-recommended-action" class="internalDFN" data-link-type="dfn">recommended action</a> is stated using clear and concise language. Unfortunately, the statement provides no specific citation to evidence in the form of a citation.</td>
> </tr>
> </tbody></table>
>
> <section id="ex-tki-ppi">
> <h3 id="x5-2-applying-the-minimal-information-model-definitions-to-the-pddi-between-bcr-abl-tyrosine-kinase-inhibitors-tki-proton-pump-inhibitors-ppi"><bdi class="secno">5.2 </bdi>Applying the Minimal Information Model definitions to the PDDI between BCR-ABL
> Tyrosine Kinase Inhibitors (TKI) + Proton Pump Inhibitors (PPI)<a class="self-link" aria-label="??" href="#ex-tki-ppi"></a></h3>
> <p> Minimal information Model definitions and discussion comments
> for the PDDI involving BCR-ABL Tyrosine Kinase Inhibitors (TKIs)
> + Proton Pump Inhibitors (PPIs).
> </p>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><emph>Drugs involved</emph>: <a href="#TKIs">Tyrosine Kinase Inhibitors (TKIs)</a> and <a href="#proton-pump-inhibitor-atc">Proton Pump Inhibitors (PPIs)</a></td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per the recommendation <a href="#bp-drugs-involved">R1 - Explicitly state the drugs involved</a>, value sets for TKIs and PPIs are provided. Note that in the <a href="#ex-warfarin-nsaids">warfarin-NSAIDs example</a> the drugs involved are specified using RxNorm while this example uses ATC. This is to emphasize that, while the drugs involved <em class="rfc2119" title="SHOULD">SHOULD</em> be listed as sets of terms from a terminology such as <a href="https://www.nlm.nih.gov/research/umls/rxnorm/" target="new">RxNorm</a> or the <a href="https://www.whocc.no/atc/structure_and_principles/" target="new">Anatomical Therapeutic Chemical Classification System (ATC)</a>, the implementer <em class="rfc2119" title="MAY">MAY</em> choose any terminology they think appropriate. To promote broader accessibility to PDDI knowledge, implementer <em class="rfc2119" title="SHOULD">SHOULD</em> use a terminology that is actively maintained and freely accessible to the public.</td>
> </tr>
> </tbody></table>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><strong>Mechanism of Interaction:</strong> BCR-ABL Tyrosine Kinase inhibitors demonstrate pH
> dependent absorption for oral administration which may result in decreased efficacy when given
> concomitantly with medications that increase gastric pH. </td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per recommendation <a href="#bp-mechanism">R2 - Report a mechanism if known</a>, there is a clear statement of the <a href="#dfn-mechanism-of-interaction" class="internalDFN" data-link-type="dfn">mechanism of interaction</a> written for a clinician audience. A limitation of this example is that it refers to 'medications that increase gastric pH' without reference any specific drugs or codes from a drug terminology. </td>
> </tr>
> </tbody></table>
>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><strong>Frequency of Harm Relative to Frequency of Exposure to the PDDI:</strong> Unknown</td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per recommendation <a href="#bp-freq-exp">R3 - State the frequency of harm relative to frequency of exposure if known</a>, an explicit statement is made declaring that information on frequency of harm relative to frequency of exposure to the PDDI is not available. </td>
> </tr>
> </tbody></table>
>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><strong>Clinical Consequences:</strong> Decreased efficacy relative to treatment for <a href="#acml">chronic myeloid leukemia</a></td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per the recommendation <a href="#bp-clinical-consequences">R4 - Explicitly state clinical consequences</a>, a value set for the clinical consequence is explicitly enumerated. Note that in the <a href="#ex-warfarin-nsaids">warfarin-NSAIDs example</a>, the clinical consequences involved are specified using <a href="http://www.who.int/classifications/icd/en/" target="new">ICD-10</a> while this example uses <a href="https://www.snomed.org/snomed-ct" target="new">SNOMED-CT</a>. This is to emphasize that, while the clinical consequences <em class="rfc2119" title="SHOULD">SHOULD</em> be listed as sets of terms from a terminology such as ICD-10 or SNOMED-CT, the implementer <em class="rfc2119" title="MAY">MAY</em> choose any terminology they think appropriate. To promote broader accessibility to PDDI knowledge, implementers <em class="rfc2119" title="SHOULD">SHOULD</em> use a terminology that is actively maintained and freely accessible to the public.</td>
> </tr>
> </tbody></table>
>
> <table>
> <tbody><tr>
> <td style="background-color: #f4fff2"><strong>Seriousness:</strong> A decrease in chronic myeloid leukemia treatment efficacy is
> a serious potential clinical consequence because it can result in death, life-threatening
> hospitalization, and disability. </td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per the recommendation <a href="#bp-serious">R5 - Note if a clinical consequence is serious</a>, there is a clear statement that the potential clinical consequence of a decrease in chronic myeloid leukemia treatment efficacy is <a href="#dfn-seriousness" class="internalDFN" data-link-type="dfn">serious</a>.</td>
> </tr>
> </tbody></table>
> <table id="warfarin-specific-context">
> <tbody><tr>
> <td style="background-color: #f4fff2"><strong>Contextual information/modifying factors:</strong></td>
> </tr>
> <tr>
> <td>
> <ul>
> <li>The TKI is <a href="#imatinib">imatinib</a> or <a href="#ponatinib">ponatinib</a></li>
> <ul>
> <li><strong>Operational Classification Statement:</strong> No special precautions</li>
> <li><strong>Evidence About a Suspected Drug-Drug Interaction:</strong> Imatinib and ponatinib AUCs are not appreciably
> decreased by PPI co-administration </li>
> <ul>
> <li>Iclusig [package insert]. Cambridge, MA: ARIAD Pharmaceuticals, Inc. 2016., and </li>
> <li>Egorin MJ, Shah DD, Christner SM, et al. Effect of a proton pump inhibitor on the
> pharmacokinetics of imatinib. Br J Clin Pharmacol. 2009;68(3):370-374.)</li>
> </ul>
> </ul>
> <li>The TKI is <a href="#nilotinib">nilotinib</a></li>
> <ul>
> <li><strong>Operational Classification Statement:</strong> Assess risk and take action if necessary</li>
> <li><strong>Evidence About a Suspected Drug-Drug Interaction:</strong>Bosutinib and nilotinib AUCs
> are decreased with concomitant PPIs but antacids and H2 antagonists may be considered if
> TKI is given 2 hours before the antacid/H2 antagonist. However, for nilotinib a retrospective
> study has shown no difference in cytogenetic response rates for patients taking PPIs.</li>
> <ul>
> <li>Yin OQ, Giles FJ, Baccarani M, et al. Concurrent use of proton pump inhibitors or H2
> blockers did not adversely affect nilotinib efficacy in patients with chronic myeloid
> leukemia. Cancer Chemother Pharmacol. 2012;70(2):345-350.</li>
> </ul>
> </ul>
> <li>The TKI is <a href="#bosutinib">bosutinib</a> or <a href="#dasatinib">dasatinib</a></li>
> <ul>
> <li><strong>Operational Classification Statement:</strong> Use only if benefit outweighs risk</li>
> <li><strong>Evidence About a Suspected Drug-Drug Interaction:</strong>Bosutinib and nilotinib
> AUCs are decreased with concomitant PPIs but antacids and H2 antagonists may be considered
> if TKI is given 2 hours before the antacid/H2 antagonist.</li>
> <ul>
> <li>Sprycel [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2015</li>
> <li>Bosulif [package insert]. New York, NY: Pfizer Labs; 2015.</li>
> <li>Tasigna [package insert]. East Hanover, NJ: Novartis; 2015.</li>
> </ul>
> </ul>
> </ul>
> </td>
> </tr>
> <tr>
> <td><strong>Comment:</strong> Per recommendation <a href="#bp-contextual">R7 - each known risk modifying factor or patient context</a>, each known <a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">contextual information/modifying factor</a> is stated specifically. Value sets for the <a href="#dfn-clinical-consequences" class="internalDFN" data-link-type="dfn">clinical consequences</a> are explicitly enumerated. Notice that there is no <a href="#dfn-recommended-action" class="internalDFN" data-link-type="dfn">recommended action</a> statement to complement the <a href="#dfn-operational-classification-statement" class="internalDFN" data-link-type="dfn">operational classification statements</a>. Such a statement would be most useful for the recommendation to "assess risk and take action if necessary." In this case, there is not sufficient evidence for a recommended action statement to provide more information than the operational classification statement already provides. Notice that this example could be improved because it references coded terms for TKIs but not for antacids and H2 antagonists. </td>
> </tr>
> </tbody></table>
>
> </section>
> </section>
>
> <section id="justification" class="informative">
> <h2 id="x6-background-and-use-cases"><bdi class="secno">6. </bdi>Background and use cases<a class="self-link" aria-label="??" href="#justification"></a></h2><p><em>This section is non-normative.</em></p>
>
> <section id="overarching-use-case">
> <h3 id="x6-1-the-overarching-use-case-for-the-minimum-information-model"><bdi class="secno">6.1 </bdi>The overarching use case for the minimum information model<a class="self-link" aria-label="??" href="#overarching-use-case"></a></h3>
> <p>
> The overarching use case for a minimum information model for
> representing PDDI information in a clinical context
> is <strong>to provide a technical foundation for effective PDDI
> clinical decision support</strong>. Unfortunately, existing drug
> information sources generally organize interaction information into
> a more or less narrative format and include only some of the core
> PDDI information elements. To illustrate, consider the PDDI
> between oral anticoagulants and non-steroidal anti-inflammatory
> drugs (NSAIDs) reported in the well-curated French Thesaurus des interactions m??dicamenteuses PDDI dataset [<cite><a class="bibref" href="#bib-ansm-2016" title="Thesaurus des interactions medicamenteuses">ansm-2016</a></cite>] shown
> in <a href="#NSAID-Example" class="fig-ref" title="PDDI example from a French compendium">Figure <bdi class="figno">3</bdi></a>.
> </p>
> <figure id="NSAID-Example">
> <img src="W3C-Images/NSAID-Example.png" height="1136" width="953">
> <figcaption>Figure <bdi class="figno">3</bdi> <span class="fig-title">PDDI example from a French compendium</span></figcaption>
> </figure>
> <p>
> The PDDI narrative shown is structured into short and easy-to-read description and management
> sections. However, the narrative does not satisfy the proposed minimum information model:
> </p>
> <ul>
> <li><a href="#dfn-drugs-involved" class="internalDFN" data-link-type="dfn">Drugs Involved</a> - textual, non-standardized, non-coded lists of ingredients that have been
> classified as either NSAIDs or as oral anticoagulants</li>
> <li><a href="#dfn-clinical-consequences" class="internalDFN" data-link-type="dfn">Clinical Consequences</a> - textual, non-standardized, non-coded mention of ???hemorrhage??? </li>
> <li><a href="#dfn-seriousness" class="internalDFN" data-link-type="dfn">Seriousness</a> - not explicit. However, the statement ???not recommended??? would suggest a risk of clinically significant consequence</li>
> <li><a href="#dfn-operational-classification-statement" class="internalDFN" data-link-type="dfn">Operational Classification Statement</a> - a direct "not recommended" statement</li>
> <li><a href="#dfn-recommended-action" class="internalDFN" data-link-type="dfn">Recommended Actions</a> - avoidance if possible and monitoring otherwise</li>
> <li><a href="#dfn-evidence-about-a-suspected-drug-drug-interaction" class="internalDFN" data-link-type="dfn">Evidence About a Suspected Drug-Drug Interaction</a> - no mention</li>
> <li><a href="#dfn-mechanism-of-interaction" class="internalDFN" data-link-type="dfn">Mechanism of Interaction</a> - textual, non-standardized, mention of gastroduodenal irritation by the NSAID</li>
> <li><a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">Contextual Information/Modifying Factors</a> - no mention</li>
> <li><a href="#dfn-frequency-of-exposure-to-the-pddi" class="internalDFN" data-link-type="dfn">Frequency of Exposure to the PDDI</a> - no mention </li>
> <li><a href="#dfn-frequency-of-harm-for-persons-who-have-been-exposed-to-the-pddi" class="internalDFN" data-link-type="dfn">Frequency of Harm for Persons who have been Exposed to the PDDI</a> - no mention</li>
> </ul>
> <p>
> As is evident from the listing above, there are four minimum information items that are not provided in the
> narrative (<a href="#dfn-contextual-information-modifying-factors" class="internalDFN" data-link-type="dfn">contextual information/modifying factors</a>, <a href="#dfn-frequency-of-exposure-to-the-pddi" class="internalDFN" data-link-type="dfn">frequency of exposure to the PDDI</a>, <a href="#dfn-frequency-of-harm-for-persons-who-have-been-exposed-to-the-pddi" class="internalDFN" data-link-type="dfn">frequency of harm for persons who have been exposed to the PDDI</a>, and <a href="#dfn-evidence-about-a-suspected-drug-drug-interaction" class="internalDFN" data-link-type="dfn">Evidence About a Suspected Drug-Drug Interaction</a>). Contextual information
> would include drug and patient characteristics factors that might increase or mitigate the risk of harm from exposure
> to the interaction drug pair. Such information often complements, and sometimes is based on, information on the
> frequency information items (frequency of exposure to the PDDI and frequency of harm for exposed persons who have
> been exposed). Together, these information items help to inform the clinician about the risk-benefit trade-off of PDDI
> exposure. In fact, it has been shown that effective clinical decision support that improves patient outcomes can be
> built using such information. For example, Tamblyn et al. found that a novel medication clinical decision support system
> that provided patient-specific risk estimates of injury due to falls reduced fall-related injury by 1.7 injuries per 1000
> patients (95% CI 0.2/1000 to 3.2/1000 p=0.02) [<cite><a class="bibref" href="#bib-tamblyn-2012" title="The effectiveness of a new generation of computerized drug alerts in reducing the risk of injury from drug side effects: a cluster randomized trial">tamblyn-2012</a></cite>]. Conversely, when a PDDI summary provides no context
> about risk and no frequency information, only clinical decision support alerts based on simple exposure to the drug
> combination can be built. This leads to highly sensitive but unspecific alerts and is a primary cause of alert fatigue and
> clinician dissatisfaction [<cite><a class="bibref" href="#bib-van-der-sijs-2006" title="Overriding of drug safety alerts in computerized physician order entry">van-der-sijs-2006</a></cite>].
> </p>
> <p>
> Further, the PDDI narrative in <a href="#NSAID-Example" class="fig-ref" title="PDDI example from a French compendium">Figure <bdi class="figno">3</bdi></a>
> provides information without citing supporting evidence.
> Previous community efforts concluded that ???providing access to the evidence is a critical component
> of weighing the risks and benefits of co-prescribing drugs that have the potential to result in a drug-drug interaction???
> [<cite><a class="bibref" href="#bib-tilson-2016" title="Recommendations for selecting drug-drug interactions for clinical decision support">tilson-2016</a></cite>]. Evidence in supporting PDDIs includes physiological and pharmacological observations from
> clinical studies; mechanistic knowledge derived from pre-clinical and clinical studies; and observational data
> including case reports and various non-randomized studies [<cite><a class="bibref" href="#bib-utecht-2017" title="Formalizing Evidence Type Definitions for Drug-Drug Interaction Studies to Improve Evidence Base Curation">utecht-2017</a></cite>][<cite><a class="bibref" href="#bib-brochhausen-2014" title="Towards a foundational representation of potential drug- drug interaction knowledge">brochhausen-2014</a></cite>]. Evidence
> may be useful for establishing the existence of an interaction without providing information about the potential
> clinical effect. Other evidence can help to answer questions about the associated clinical effects and their magnitude,
> variability, and estimated frequency [<cite><a class="bibref" href="#bib-scheife-2015" title="Consensus recommendations for systematic evaluation of drug-drug interaction evidence for clinical decision support">scheife-2015</a></cite>]. A PDDI representation should cite specific supporting
> evidence items and provide some acceptable appraisal of the total body of evidence [<cite><a class="bibref" href="#bib-tilson-2016" title="Recommendations for selecting drug-drug interactions for clinical decision support">tilson-2016</a></cite>].
> </p>
> <p>
> The narrative in <a href="#NSAID-Example" class="fig-ref" title="PDDI example from a French compendium">Figure <bdi class="figno">3</bdi></a> also fails to provide critical information in computable form suitable for creation
> of personalized decision support presentation. The interaction described above notes that the mechanism of the
> interaction involves gastroduodenal irritation by the NSAID, suggesting gastrointestinal hemorrhage as a possible
> consequence. Such an occurrence would seem unlikely to occur for NSAIDs administered topically rather than orally.
> However, this constraint on the applicability of this PDDI is not stated: the formulation of the NSAID
> being described is ambiguous, and the importance of the means of administration is implied, but not stated directly.
> Describing PDDI evidence in terms of drugs in established drug terminologies, such as RxNorm
> (<a href="https://www.nlm.nih.gov/research/umls/rxnorm/">https://www.nlm.nih.gov/research/umls/rxnorm/</a>), will reduce ambiguity and enable computation through rules
> and inference used to turn the PDDI descriptions into actionable content for clinical decision support.
> </p>
> <p>
> By comparing the narrative in <a href="#NSAID-Example" class="fig-ref" title="PDDI example from a French compendium">Figure <bdi class="figno">3</bdi></a> with
> the core elements of the minimum information model, we see that,
> despite being readable, the information provided lacks both the
> structure and semantics necessary for effective decision
> support. Problems like these are not unique to the French
> Thesaurus des interactions m??dicamenteuses. For example, a search for the
> same Oral Anticoagulant / NSAID interaction executed at the drug
> ingredient level in the freely accessible database DrugBank
> returns a single statement that vaguely describes the clinical
> effect but with no other information from the core items
> mentioned above:
> </p>
> <p style="text-align: center">???Ibuprofen may increase the anticoagulant activities of Warfarin.???</p>
> <p>
> As <a href="#COUMADIN-warfarin-product-label" class="fig-ref" title="An oral Anticoagulant / NSAID PDDI shown at the drug ingredient level from the United States drug product label for COUMADIN- warfarin sodium tablet.[bristol-myers-warfarin]">Figure <bdi class="figno">4</bdi></a> shows,
> slightly more information is provided in United States drug
> product labeling than in DrugBank but there are still many
> information gaps relative to the core PDDI information items
> suggested by conference series attendees.[<cite><a class="bibref" href="#bib-bristol-myers-warfarin" title="{DailyMed} - {COUMADIN}- warfarin sodium tablet">bristol-myers-warfarin</a></cite>])
> </p>
> <figure id="COUMADIN-warfarin-product-label">
> <img src="W3C-Images/warfarin-product-label.png" height="684" width="1047">
> <figcaption>Figure <bdi class="figno">4</bdi> <span class="fig-title">An oral Anticoagulant / NSAID PDDI shown at the drug ingredient level
> from the United States drug product label for COUMADIN- warfarin sodium tablet.[<cite><a class="bibref" href="#bib-bristol-myers-warfarin" title="{DailyMed} - {COUMADIN}- warfarin sodium tablet">bristol-myers-warfarin</a></cite>] </span></figcaption>
> </figure>
> <p>
> Although missing information is the primary concern for the examples discussed, the minimum information
> model would also increase the utility of narratives that are abundant with information. For example, a
> search for oral anticoagulant / NSAID in the online interaction checking tool provided by Drugs.com returns
> a very detailed narrative that includes mention of clinical effect, mechanism, management options, some
> contextualized risk information, and specific citations of evidence.[<cite><a class="bibref" href="#bib-drugs-dot-com-interaction" title="Drug Interaction Report">drugs-dot-com-interaction</a></cite>] In this
> case, the minimum information model would be useful for suggesting how to provide structure and semantics
> to the description to best enable clinical decision support systems through the use of coded drugs names,
> clinical consequences, and contextual information and modifying factors. The provision of these details
> in a standardized, computable form will facilitate integration of PDDI information with data in a patient's
> electronic health record, thus enabling patient-specific alerting and decision support.
> </p>
> </section>
>
> <section id="spec-user-stories">
> <h3 id="x6-2-end-users-of-the-minimum-information-model"><bdi class="secno">6.2 </bdi>End-users of the minimum information model<a class="self-link" aria-label="??" href="#spec-user-stories"></a></h3>
> <p>
> Twelve user stories with related goals were developed to clarify
> specific use cases of the minimum information model's core
> information elements (see
> Appendix <a href="#med-rec-use-cases" class="sec-ref">?? <bdi class="secno">A.2.2.2 </bdi>A set of user stories focused on medication reconciliation</a>). These stories are
> associated with seven types of users (physicians, pharmacists,
> nurses, drug compendia editors, health science librarians,
> systems analysts, and content specialists.
> </p>
> <p>
> Three user stories focus on the critical process of
> medication reconciliation for PDDIS: See <a href="#med-rec-use-cases" class="sec-ref">?? <bdi class="secno">A.2.2.2 </bdi>A set of user stories focused on medication reconciliation</a>
> </p>
> <p>
> Three user stories focus on physicians conducting treatment planning: See <a href="#treatment-planning-phys" class="sec-ref">?? <bdi class="secno">A.2.2.3 </bdi>Treatment Planning, Physician</a>
> </p>
> <p>
> The remaining six stories cover a variety of other use cases:
> </p><ul>
> <li><a href="#eval-management-options-pharm" class="sec-ref">?? <bdi class="secno">A.2.2.5 </bdi>Evaluation of Management Options for Drug-Drug Interactions, Pharmacist</a></li>
> <li><a href="#eval-management-options-phys" class="sec-ref">?? <bdi class="secno">A.2.2.4 </bdi>Evaluation of Management Options for Drug-Drug Interactions, Physician</a></li>
> <li><a href="#nurse-screening" class="sec-ref">?? <bdi class="secno">A.2.2.6 </bdi>Screening for Drug-Drug Interactions, Nurse</a></li>
> <li><a href="#editor-synthesis-dissemination" class="sec-ref">?? <bdi class="secno">A.2.2.7 </bdi>Synthesis for Dissemination, Drug Compendium Editor</a></li>
> <li><a href="#librarian-dissemination" class="sec-ref">?? <bdi class="secno">A.2.2.8 </bdi>Synthesis for Dissemination, Librarian</a></li>
> <li><a href="#cds-team" class="sec-ref">?? <bdi class="secno">A.2.2.9 </bdi>Synthesis for Dissemination, Clinical Decision Support Team - Systems Analyst & Content Specialist</a></li>
> </ul>
> Additional user types considered ???out of scope??? are listed in Appendix <a href="#out-of-scope-stories" class="sec-ref">?? <bdi class="secno">A.2.2.10 </bdi>Out of scope user stories</a>.
> <p></p>
> <p>Each user story was color coded
> for mention of core information items in the minimum information
> model (see <a href="#user-story-color-coding" class="sec-ref">?? <bdi class="secno">A.2.2.1 </bdi>Color codes used in user stories</a>).
> </p>
> </section>
> </section>
>
>
>
> <section class="informative" id="discussion">
> <h2 id="x7-discussion"><bdi class="secno">7. </bdi>Discussion<a class="self-link" aria-label="??" href="#discussion"></a></h2><p><em>This section is non-normative.</em></p>
> <p>
> This Community Group Report provides a concrete, user centered,
> basis for design and implementation activities using the PDDI
> minimum information model. The non-ambiguous definitions
> for <a href="#user-centered-def">core information items</a> are
> consistent with recently published consensus recommendations
> [<cite><a class="bibref" href="#bib-scheife-2015" title="Consensus recommendations for systematic evaluation of drug-drug interaction evidence for clinical decision support">scheife-2015</a></cite>][<cite><a class="bibref" href="#bib-payne-2015" title="Recommendations to improve the usability of drug-drug interaction clinical decision support alerts">payne-2015</a></cite>] and the results of a separate
> international Delphi study on how to improve the delivery of
> medication alerts within computerized physician order entry
> systems
> [<cite><a class="bibref" href="#bib-riedmann-2011" title="How to improve the delivery of medication alerts within computerized physician order entry systems: an international Delphi study">riedmann-2011</a></cite>]. The <a href="#recommendations-summary">eight
> minimum information model recommendations</a> are similarly based
> on recently published consensus recommendations
> [<cite><a class="bibref" href="#bib-scheife-2015" title="Consensus recommendations for systematic evaluation of drug-drug interaction evidence for clinical decision support">scheife-2015</a></cite>][<cite><a class="bibref" href="#bib-payne-2015" title="Recommendations to improve the usability of drug-drug interaction clinical decision support alerts">payne-2015</a></cite>] and an analysis of a wide variety of
> PDDIs and real-world use cases.
> </p>
> <p>
> Detailed descriptions of the PDDIs
> that informed the model, including specific clinical contexts, are
> available in the Appendix
> (see <a href="#decision-trees" class="sec-ref">?? <bdi class="secno">A.1.1.2 </bdi>Decision Trees Created for the Minimum Information Model Domain Analysis</a>). Two example PDDIs were
> annotated with the core information items along with detailed
> recommendations (see Sections <a href="#ex-warfarin-nsaids" class="sec-ref">?? <bdi class="secno">5.1 </bdi>Applying the Minimal Information Model definitions to the PDDI between warfarin
> and non-steroidal anti-inflammatory drugs (NSAIDs)</a>
> and <a href="#ex-tki-ppi" class="sec-ref">?? <bdi class="secno">5.2 </bdi>Applying the Minimal Information Model definitions to the PDDI between BCR-ABL
> Tyrosine Kinase Inhibitors (TKI) + Proton Pump Inhibitors (PPI)</a>. Twelve user stories with related
> goals show how the PDDI minimum information model would support
> various users (see <a href="#spec-user-stories" class="sec-ref">?? <bdi class="secno">6.2 </bdi>End-users of the minimum information model</a>). A subset of
> the user stories and selected PDDIs were integrated into three
> medication reconciliation use cases (see Section
> <a href="#med-rec-use-cases" class="sec-ref">?? <bdi class="secno">A.2.2.2 </bdi>A set of user stories focused on medication reconciliation</a>).
> </p>
> <p>
> The next sub-sections provide a discussion of three potential
> applications of the minimum information that are shown
> in <a href="#PDDI-MI-APPLICATIONS" class="fig-ref" title="An overview of the role envisioned for a PDDI minimal information model. Starting from the top of the figure, drug experts synthesize drug-drug interaction evidence from pre-clinical studies, clinical studies, and clinical observation into knowledge artifacts annotated using information categories in the PDDI minimal information model. The annotated knowledge artifacts can be shared in a knowledgebase, and applied to a variety of use cases including clinical decision support, structuring PDDI information in drug product labeling, and to inform cohort descriptions useful for generating evidence from retrospective health records.">Figure <bdi class="figno">1</bdi></a>
> </p>
>
> <section id="ex-pddi-cds-hl7">
> <h3 id="x7-1-shareable-pddi-clinical-decision-support-using-hl7-standards"><bdi class="secno">7.1 </bdi>Shareable PDDI Clinical Decision Support Using HL7 Standards <a class="self-link" aria-label="??" href="#ex-pddi-cds-hl7"></a></h3>
> <p>
> The creation and maintenance of PDDI clinical decision support
> (CDS) generally requires considerable time and energy from
> highly trained domain experts. An additional need is to
> standardize the electronic health records context that is used
> to trigger CDS services. This can include context parameters
> that currently might not available but that, if present, would
> be useful for increasing the specificity of the PDDI CDS
> alerts. Achieving this sort of standardization is important to
> ensure that PDDI decision support can be implemented across a
> variety of systems.
> </p>
> <p>
> Fast Health Interoperability Resources (FHIR) provides a
> possible solution to the challenge of seamless information
> exchange and data interoperability of information resources in
> health care related environments
> [<cite><a class="bibref" href="#bib-bender-2013" title="HL7 FHIR: An Agile and RESTful approach to healthcare information exchange">bender-2013</a></cite>][<cite><a class="bibref" href="#bib-mandel-2016" title="SMART on FHIR: a standards-based, interoperable apps platform for electronic health records">mandel-2016</a></cite>]. FHIR provides a collection of
> specifications for resources
> in healthcare settings for the purpose of overcoming the data
> exchange challenges in healthcare. FHIR defines a set of
> standardized data models for health care covering key areas
> including Clinical information, Diagnostics, and
> Medications. For instance, the Medication resource contains
> medication codes, ingredient details, packaging information and
> related information. FHIR resources are API-based, making it
> possible for third party systems to access electronic health
> records data for the purpose of supporting new use cases.
> </p>
> <p>
> FHIR encodings of PDDI information could form the basis of
> information exchange for more standardized PDDI clinical
> decision support. Indeed, a
> new <a href="http://wiki.hl7.org/index.php?title=PDDI_CDS" target="new"> HL7 project related to PDDI decision support</a>
> has been recently approved by the
> HL7 <a href="http://wiki.hl7.org/index.php?title=Clinical_Decision_Support_Workgroup" target="new">Clinical Decision Support</a>
> and <a href="http://wiki.hl7.org/index.php?title=Pharmacy_WG" target="new">Pharmacy Workgroups</a>. The project seeks to
> develop an implementation guide for PDDI CDS that will specify
> both a knowledge representation format for PDDI logic and CDS
> services for PDDI with electronic health record (EHR)
> systems. Specifically, the implementation guide will include
> specifications for:
>
> </p><ol>
> <li>How to represent PDDI logic in the
> HL7 <a href="http://wiki.hl7.org/index.php?title=Clinical_Quality_Language" target="new">Clinical Quality Language</a> (CQL) using the FHIR Clinical Reasoning
> module.</li>
> <li>How to use the emerging <a href="https://cds-hooks.org/" target="new">CDS Hooks</a> standard as a mechanism for
> electronic health records to request PDDI CDS from CDS
> services.</li>
> </ol>
> <p></p>
> <p>
> As is stated in
> the <a href="https://github.com/HL7/PDDI-CDS/blob/master/Documents/ProjectScopeStatement/PDDI%20CDS%20PSS%2002-15-2018.docx?raw=true" target="new">project's scope statement</a>, the HL7 PDDI CDS
> project will draw from the technical foundation, PDDI
> information, and user centered design artifacts reported in this
> Community Group Report. It is anticipated that representation of
> PDDI minimal information may require the creation of new FHIR
> resource(s) (e.g., a resource to represent drug
> interactions) and/or FHIR profile(s) (e,g, for
> PDDI context representation). At the time of this writing,
> participation in the PDDI CDS project is open to public
> participation. Person interested in participation can find more
> information on the <a target="new" href="http://wiki.hl7.org/index.php?title=PDDI_CDS">HL7 PDDI CDS
> project wiki</a>.
> </p>
> </section>
>
> <section id="ex-SPL">
> <h3 id="x7-2-enhancing-the-drug-drug-interaction-section-of-structured-product-labeling"><bdi class="secno">7.2 </bdi>Enhancing the Drug-drug Interaction Section of Structured Product Labeling<a class="self-link" aria-label="??" href="#ex-SPL"></a></h3>
> <p>
> Serious consequences for patients could result if information
> about known drug interactions is missing from a drug???s product
> labeling. To address this potential risk, the United States Food
> and Drug Administration (FDA) mandated in 2006 that all product
> labels for FDA-approved prescription drugs include clinically
> significant interactions (c.f., CFR 21 201.57(c)(8)), as well as
> the results of pharmacokinetic studies that establish the
> absence of effect (c.f., CFR 21 201.57(c)(13)(C)) [<cite><a class="bibref" href="#bib-fda-cfr-21-4" title="CFR - Code of Federal Regulations Title 21, Volume 4">fda-cfr-21-4</a></cite>]. Similar requirements have been
> enacted by the European Medicine's Agency for their equivalent
> of product labeling
> called <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3248251/" target="new">Summary of Product Characteristics</a>.
> </p>
> <p>
> As mentioned in the section <a href="#overarching-use-case" class="sec-ref">?? <bdi class="secno">6.1 </bdi>The overarching use case for the minimum information model</a>, drug product
> labeling can contain many gaps in information relative to the
> core PDDI information. Other prior work has shown that many
> known PDDIs are not mentioned in drug labels [<cite><a class="bibref" href="#bib-boyce-2013" title="Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness">boyce-2013</a></cite>]. This problem is not unique to United States
> labeling. For instance, Pfistermeister et al. reported that
> critical drug???drug interaction warnings are frequently missing,
> or are mentioned inconsistently in the United States, United
> Kingdom, and German labels of the involved drugs [<cite><a class="bibref" href="#bib-pfistermeister-2014" title="Inconsistencies and misleading information in officially approved prescribing information from three major drug markets">pfistermeister-2014</a></cite>].
> </p>
> <p>
> As is shown <a href="#PDDI-MI-APPLICATIONS" class="fig-ref" title="An overview of the role envisioned for a PDDI minimal information model. Starting from the top of the figure, drug experts synthesize drug-drug interaction evidence from pre-clinical studies, clinical studies, and clinical observation into knowledge artifacts annotated using information categories in the PDDI minimal information model. The annotated knowledge artifacts can be shared in a knowledgebase, and applied to a variety of use cases including clinical decision support, structuring PDDI information in drug product labeling, and to inform cohort descriptions useful for generating evidence from retrospective health records.">Figure <bdi class="figno">1</bdi></a>, the PDDI
> minimum information model could help address this issue by making PDDI information reported in product labeling more
> complete and clinically useful. In the United States and other
> parts of the world, the content of a drug's product label is
> written by the company that owns the drug as part of the drug
> approval process. There is currently no information model to
> guide product label authors as they write drug interaction
> information. The PDDI minimum information model could provide
> authors with clear guidance on the core information items that
> they should discuss.
> </p>
> <p>
> This approach might require an annotation tool to help authors
> tag the core PDDI information items correctly and
> consistently. Once the PDDI information is authored using the
> minimum information model, it could be published in a
> computer readable format. In the United States, this would
> currently be accomplished using
> the <a href="https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/" target="new"> Structured Product Label (SPL)</a> standard. Other
> standards, such as
> the <a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001849.jsp&mid=WC0b01ac0580bf85bb" target="new"> International Organization for Standardization
> (ISO) for the identification of medicinal products (IDMP)</a>
> serve a similar function outside of the United States. Focusing
> on the United States as case study, SPLs are XML documents
> written using the HL7 SPL specification that the FDA requires
> industry to use when submitting drug product label content (FDA
> 2005). The
> HL7 <a href="https://www.hl7.org/Special/committees/rcrim/overview.cfm" target="new">Biomedical Research and Regulation</a> developed
> and maintains the SPL standard. Currently, the SPLs for all drug
> products marketed in the United States are available for
> download from the National Library of Medicine's DailyMed
> resource [<cite><a class="bibref" href="#bib-dailymed-about" title="DailyMed - About">dailymed-about</a></cite>]. At the time of
> this writing, DailyMed provides access to drug product labeling
> for more than 30,000 prescription products.
> </p>
> <p>
> PDDI information annotated using the minimum information model
> could be published in a computer readable format using what is
> called an SPL <i>indexing file</i>. Indexing files
> provide additional useful information augmenting official FDA
> drug SPLs. Currently, indexing files are used to specify
> pharmacologic classes, billing units, warning letter alerts, and
> other information [<cite><a class="bibref" href="#bib-dailymed-indexing" title="SPL RESOURCES: Download All Indexing &amp; REMS Files">dailymed-indexing</a></cite>]. Supplemental indexing files including the elements of the
> PDDI minimum information model might be stored in XML and,
> through the use of XSL and XSLT, be used to render the data in
> various formats including HTML, and PDF, and character-delimited
> tables.
> </p>
> </section>
>
> <section id="ex-cohort-desc">
> <h3 id="x7-3-highlighting-and-filling-gaps-in-evidence-needed-to-develop-pddi-decision-support"><bdi class="secno">7.3 </bdi>Highlighting and Filling Gaps in Evidence Needed to Develop PDDI Decision Support<a class="self-link" aria-label="??" href="#ex-cohort-desc"></a></h3>
> <p>
> Existing PDDI knowledge is heterogeneous with respect to
> coverage of the core information elements. For example,
> frequency of exposure and frequency of harm evidence was not
> available for either of the two PDDI examples detailed in this
> Report (see Sections <a href="#ex-warfarin-nsaids" class="sec-ref">?? <bdi class="secno">5.1 </bdi>Applying the Minimal Information Model definitions to the PDDI between warfarin
> and non-steroidal anti-inflammatory drugs (NSAIDs)</a>
> and <a href="#ex-tki-ppi" class="sec-ref">?? <bdi class="secno">5.2 </bdi>Applying the Minimal Information Model definitions to the PDDI between BCR-ABL
> Tyrosine Kinase Inhibitors (TKI) + Proton Pump Inhibitors (PPI)</a>). Other examples of knowledge
> gaps are mentioned in Appendix <a href="#decision-trees" class="sec-ref">?? <bdi class="secno">A.1.1.2 </bdi>Decision Trees Created for the Minimum Information Model Domain Analysis</a>,
> such as the poorly understood mechanism of the PDDI between
> warfarin and Ifosfamide/Etoposide.
> </p>
> <p>
> Part of the reason that there are many knowledge gaps is that
> many drug interactions are identified in case reports or
> observational studies that provide little or no indication of
> causal mechanisms. Other interactions, especially
> pharmacokinetic interactions, are established based on small
> clinical studies that rarely suggest a clinical
> consequence. Still other interactions might be inferred from the
> pharmacodynamic properties of two drugs, leaving unanswered
> questions about contextual factors that might increase or
> mitigate patient risks. Moreover, gaps in knowledge can exist
> about the risk factors or appropriate management options for a
> given interaction, even when solid evidence is available for its
> existence, the mechanism of its occurrence, and the likely
> clinical consequence from exposure.
> </p>
> <p>
> The information model can also act as a template for drug
> experts to use while synthesizing PDDI evidence. As the experts
> compile evidence for each of the core information
> categories, critical gaps in knowledge will become apparent.
> These gaps might be used to develop prioritized research agendas
> aimed at providing evidence for clinical recommendations.
> </p>
> <p>
> Similarly, the PDDI model might be used to address knowledge
> gaps through the creation of computable cohort descriptions ???
> serialized queries that combine concept sets with logical
> operations to extract specific patient sub-populations from a
> clinical data repository. Computable cohort descriptions are a
> cornerstone for research on PDDIs using real world data. A
> recent project showed the feasibility of converting PDDI
> descriptions created as part of this Report to computable cohort
> definitions [<cite><a class="bibref" href="#bib-rosko-2017" title="Toward shareable individualized drug interaction alerts.">rosko-2017</a></cite>]. The target for
> translation was the Atlas clinical research tool created by the
> Observational Data Health and Informatics collaborative. Atlas
> has a powerful interface for creating, running, and sharing
> cohort descriptions [<cite><a class="bibref" href="#bib-ohdsi-atlas" title="OHDSI - Atlas: is an open source software tool for researchers to conduct scientific analyses on standardized observational data">ohdsi-atlas</a></cite>]. Once created, the
> cohort descriptions were executed over a clinical dataset for a
> simulated population stored in the OHDSI common data model. The
> code, concept sets, and cohort descriptions for the
> demonstration are stored
> in <a href="https://github.com/dbmi-pitt/iDIA_Rules">a GitHub
> repository</a>
> and <a href="https://github.com/dbmi-pitt/docker-iDIA-Rules">Docker
> container</a>.
> </p>
> </section>
> </section>
>
>
> <section class="informative" id="conclusion">
> <h2 id="x8-conclusion"><bdi class="secno">8. </bdi>Conclusion<a class="self-link" aria-label="??" href="#conclusion"></a></h2><p><em>This section is non-normative.</em></p>
> <p>
> This Community Group Report provides motivation and a detailed
> domain analysis for a minimum information model for PDDI
> information. The Report also suggests potential applications of the
> minimum information model that could lead to improvements in
> patient safety with respect to PDDIs. The overarching goal of
> these contributions is to provide a technical foundation for
> effective PDDI clinical decision support. A reference
> implementation of the information model is the subject of future
> work.
> </p>
> </section>
>
> <section class="informative" id="acknowledgments">
> <h2 id="x9-acknowledgments"><bdi class="secno">9. </bdi>Acknowledgments<a class="self-link" aria-label="??" href="#acknowledgments"></a></h2><p><em>This section is non-normative.</em></p>
> <p>
> Development of this Community Group Report was partially supported by
> a grant from the United States National Library of Medicine
> (R01LM011838) and Agency for Healthcare Research and Quality
> (R21-HS023826). The opinions expressed in this note do not
> necessarily reflect the opinions of the funding agencies.
> </p>
> </section>
>
> <section class="appendix informative" id="appendices">
> <h2 id="a-appendices"><bdi class="secno">A. </bdi>Appendices<a class="self-link" aria-label="??" href="#appendices"></a></h2><p><em>This section is non-normative.</em></p>
>
> <section id="development-process">
> <h3 id="a-1-development-process"><bdi class="secno">A.1 </bdi>Development Process<a class="self-link" aria-label="??" href="#development-process"></a></h3>
>
> <p>Toward the goal of developing such a model, a volunteer-based Task Force force was formed by the Health
> Care and Life Sciences Interest Group, an interest group that operates publicly through the World Wide
> Web Consortium (W3C). This Task Force has taken a user-centered design approach to designing the
> minimal information model through the a series of complementary activities:</p>
> <ol>
> <li>Development of decision trees of more than a dozen PDDIs to
> represent using the new information model.</li>
> <li>Creation of user stories and use cases that define the
> requirements for the minimum information model.</li>
> <li>Definition of guidelines for knowledge representation</li>
> </ol>
>
> <section id="Decision-Trees">
> <h4 id="a-1-1-decision-trees"><bdi class="secno">A.1.1 </bdi>Decision Trees<a class="self-link" aria-label="??" href="#Decision-Trees"></a></h4>
> <section id="selecting-PDDIs">
> <h5 id="a-1-1-1-selecting-pddis-to-implement-using-the-minimum-information-model"><bdi class="secno">A.1.1.1 </bdi>Selecting PDDIs to implement using the minimum information
> model<a class="self-link" aria-label="??" href="#selecting-PDDIs"></a></h5>
>
> <p>Prior work by some members of the Task Force has sought to develop evidence-based clinical
> algorithms that consider a patient???s electronic health record information to provide a clinician
> with actionable information tailored to the patient???s specific context. <sup>1</sup>The algorithms are formulated
> as decision trees to provide concise information including the interaction description, the purported
> mechanism and possible effects, the evidence supporting the mechanism and effects along with citations
> listed in the footnotes. Two sample decision trees illustrating the management options can be found in
> the appendix (see Appendix <a href="#decision-trees">DECISION TREES</a>).</p>
> <blockquote style="font-size: small"><sup>1</sup>The initial decision trees were developed through the ???Individualized Drug Interaction Alerts???
> AHRQ grant by Task Force members Dan Malone and John Horn, as well as Phil Hansten (AHRQ Project: R21-HS023826-01;
> Title: Individualized Drug Interaction Alerts; Authors: Daniel C. Malone, University of Arizona; John Horn,
> Philip Hansten, University of Washington).</blockquote>
> <p>The Task Force built on this prior work by selecting PDDIs to demonstrate the new minimum
> information model and then creating decision trees for each of the PDDIs that they selected.
> Task Force drug experts selected the PDDIs and identified contextual information/modifying factors that
> would warrant any of three different recommended actions - <em>No special precautions, Assess risk and take action
> if necessary, and Use only if benefit outweighs risk</em>. Draft decision trees were presented during sub-team
> monthly meetings for thorough discussion. Revisions were made iteratively until the group reached consensus
> on the presented drafts and finalized the decision trees.</p>
> <p>
> The Task Force began with a discussion of how to select the PDDIs for developing decision trees.
> One option was to select the most serious PDDIs. However, it was noted that the seriousness of a PDDI
> depends a great deal on the patient characteristics context. This meant that it would be difficult to
> identify PDDIs that were considered the most serious in all clinical settings and for all patients. An
> alternative approach was to choose PDDIs that would allow the Task Force to demonstrate how the
> information model should be used when facing known issues with PDDI evidence and knowledge. Toward that
> aim, participants were requested to provide suggestions of PDDIs meeting at least one or more of the
> following criteria which follow from the aforementioned information categories suggested by attendees
> of the multi-stakeholder conference meetings/series mentioned in Section <a href="#justification" class="sec-ref">?? <bdi class="secno">6. </bdi>Background and use cases</a>:
> </p>
> <ol type="A">
> <li>The interaction could (and should) be contextualized for specific patients or clinical circumstances.</li>
> <li>The interaction applies at the drug class level.</li>
> <li>The interaction does not apply at the drug class level.</li>
> <li>The mechanism is known and is pharmacokinetic.</li>
> <li>The mechanism is known and is pharmacodynamic. </li>
> <li>The mechanism is poorly described, not well elucidated.</li>
> <li>The evidence supporting the interaction is strong.</li>
> <li>The evidence supporting the interaction is weak.</li>
> <li>The frequency of exposure data is available.</li>
> <li>The frequency of exposure data is not available.</li>
> <li>The frequency of adverse event data is available.</li>
> <li>The frequency of adverse event data is not available.</li>
> <li>The recommended action is ???monitor??? or ???take note???.</li>
> <li>The recommended action is ???avoid???.</li>
> <li>The recommended action is ???a clear alternative drug and dose???.</li>
> </ol>
>
> </section>
> <section id="decision-trees">
> <h5 id="a-1-1-2-decision-trees-created-for-the-minimum-information-model-domain-analysis"><bdi class="secno">A.1.1.2 </bdi>Decision Trees Created for the Minimum Information Model Domain Analysis<a class="self-link" aria-label="??" href="#decision-trees"></a></h5>
> <p>
> The Task Force force developed 14 PDDI decision trees detailing
> the steps taken in using the the minimal information model to
> describe PDDIS. These exemplars were chosen to represent
> questions identified by the Task Force force as potentially
> affecting the search and syntheses of PDDI information. The
> potential interactions and the information situations they were
> selected for are listed in <em>Table 1</em>. Value sets defining
> relevant drug classes and clinical consequences are given in <a href="#Value-Sets" class="sec-ref">?? <bdi class="secno">A.4 </bdi>Value Sets to Support PDDI Examples</a>.
> </p>
>
> <p><strong><em>Table 1</em></strong></p>
> <table>
> <tbody><tr>
> <th width="200">Exemplar potential drug-drug interactions</th>
> <th width="150">Drug or Drug Class 1</th>
> <th width="150">Drug or Drug Class 2</th>
> <th width="300">Explanation/Justification</th>
> </tr>
> <tr>
> <td rowspan="2">Can (and should) be contextualized for specific patients or clinical circumstances</td>
> <td>Tamoxifen</td>
> <td>Paroxetine</td>
> <td>Patients with extensive CYP2D6 status on paroxetine will derive no benefit from tamoxifen. (Status: completed, <a href="https://zenodo.org/record/1471714">view at Zenodo</a>).
> </td>
> </tr>
> <tr>
> <td>Potassium (KCL)</td>
> <td>Potassium-sparing Diuretics</td>
> <td>Combination has known patient-specific risk factors. (Status: completed, <a href="mailto:public-hclscg@w3.org">email HCLS CG</a> to request)</td>
> </tr>
> <tr>
> <td>Applies at the class level</td>
> <td>Monoamine Oxidase Inhibitors (MAOIs)</td>
> <td>Indirect Sympathomimetics</td>
> <td>A class interaction involving all drugs in the class. (Status: completed, <a href="https://zenodo.org/record/1472473">view at Zenodo</a>).</td>
> </tr>
> <tr>
> <td>Does not apply at the class level</td>
> <td>Tyrosine Kinase Inhibitors</td>
> <td>Proton Pump Inhibitors</td>
> <td>Not all kinase inhibitors have pH dependent absorption. Imatinib, nilotinib, dasatinib, bosutinib, and ponatinib are BCR???ABL tyrosine kinase inhibitors. Imatinib and ponatinib do not have a significant interaction due to pH dependent absorption with proton pump inhibitors, whereas nilotinib, dasatinib, and bosutinib do (Lexi???comp and Micromedex). (Status: completed, <a href="https://zenodo.org/record/1472469">view at Zenodo</a>).</td>
> </tr>
> <tr>
> <td rowspan="2">The mechanism is known and is pharmacokinetic</td>
> <td>Warfarin</td>
> <td>CYP2C9 Inhibitors (ie. Bactrim)</td>
> <td>A CYP-mediated pharmacokinetic interaction. (Status: completed, <a href="https://zenodo.org/record/1472464">view at Zenodo</a>)</td>
> </tr>
> <tr>
> <td>Digoxin</td>
> <td>Cyclosporin</td>
> <td>A transport protein (p-glycoprotein) mediated interaction. (Status: completed, <a href="mailto:public-hclscg@w3.org">email HCLS CG</a> to request)</td>
> </tr>
> <tr>
> <td>The mechanism is known and is pharmacodynamic</td>
> <td>Epinephrine</td>
> <td>Beta-Blockers</td>
> <td>The interaction is different differentiates between selective and non-selective beta blockers. The clinical outcome is a; hypertensive crisis. (Status: completed, <a href="mailto:public-hclscg@w3.org">email HCLS CG</a> to request)</td>
> </tr>
> <tr>
> <td>The mechanism is not well elucidated/known</td>
> <td>Warfarin</td>
> <td>Ifosfamide/Etoposide</td>
> <td>Drugs for treating cancers of the blood drugs. - Clinical effect is INR change buts no mention of what mechanism could be found. (Status: completed, <a href="https://zenodo.org/record/1472471">view at Zenodo</a>)</td>
> </tr>
> <tr>
> <td rowspan="2">The evidence supporting the interaction is strong</td>
> <td>Epinephrine</td>
> <td>Beta-Blockers</td>
> <td>Widely known interaction with considerable available evidence. (Status: completed, <a href="mailto:public-hclscg@w3.org">email HCLS CG</a> to request)</td>
> </tr>
> <tr>
> <td>Simvastatin, Atorvastatin, Lovastatin</td>
> <td>Clarithromycin</td>
> <td>Widely known interaction with considerable available evidence. (Status: completed, <a href="https://zenodo.org/record/1472460">view at Zenodo</a>)</td>
> </tr>
> <tr>
> <td>The evidence supporting the interaction is weak</td>
> <td>Warfarin</td>
> <td>Antibiotics for which it is uncertain if inhibition of CYP2C9 affects warfarin</td>
> <td>Hard to find evidence for the interaction. (Status: completed, <a href="https://zenodo.org/record/1472471">view at Zenodo</a>) </td>
> </tr>
> <tr>
> <td>The frequency of exposure data is available</td>
> <td>Warfarin</td>
> <td>Non-steroidal anti-inflammatory drugs (NSAIDs)</td>
> <td>Paper by Malone et al. - National sample. (Status: completed, <a href="https://zenodo.org/record/1472475">view at Zenodo</a>).</td>
> </tr>
> <tr>
> <td>The frequency of exposure data is not available</td>
> <td>Simvastatin</td>
> <td>Fluconazole</td>
> <td>Based on literature search. (Status: completed, <a href="https://zenodo.org/record/1472441">view at Zenodo</a>).</td>
> </tr>
> <tr>
> <td>The frequency of adverse event data is available</td>
> <td>Spironolactone</td>
> <td>Potassium supplements</td>
> <td>Associated with Risk of hospitalization. (Status: completed, <a href="mailto:public-hclscg@w3.org">email HCLS CG</a> to request)</td>
> </tr>
> <tr>
> <td>The frequency of adverse event data is not available</td>
> <td>Simvastatin</td>
> <td>Fluconazole</td>
> <td>Literature search did not find frequency of adverse event data. (Status: completed, <a href="https://zenodo.org/record/1472441">view at Zenodo</a>).</td>
> </tr>
> <tr>
> <td>The recommended action is ???monitor??? or ???take note???</td>
> <td>Potassium (KCL)</td>
> <td>Potassium-sparing Diuretics</td>
> <td>See explanation above. (Status: completed, <a href="mailto:public-hclscg@w3.org">email HCLS CG</a> to request)</td>
> </tr>
> <tr>
> <td>The recommended action is ???avoid???</td>
> <td>Monoamine Oxidase Inhibitors (MAOIs)</td>
> <td>Indirect Sympathomimetics</td>
> <td>See explanation above. (Status: completed, <a href="https://zenodo.org/record/1472473">view at Zenodo</a>).</td>
> </tr>
> <tr>
> <td>The recommended action is a clear alternative drug and dose</td>
> <td>Simvastatin</td>
> <td>Amiodarone</td>
> <td>The target of a drug safety communication from a regulatory agency [<cite><a class="bibref" href="#bib-fda-simvastatin-amiodarone" title="FDA Drug Safety Communication: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone">fda-simvastatin-amiodarone</a></cite>]. (Status: completed, <a href="https://zenodo.org/record/1472434">view at Zenodo</a>).</td>
> </tr>
> </tbody></table>
> <section id="warfarin-nsaids-dt">
> <h6 id="a-1-1-2-1-example-pddi-warfarin-nsaids"><bdi class="secno">A.1.1.2.1 </bdi>Example PDDI:Warfarin + NSAIDs<a class="self-link" aria-label="??" href="#warfarin-nsaids-dt"></a></h6>
> <p>
> Non-steroidal anti-inflammatory drugs (NSAIDs) have antiplatelet effects which
> increase the bleeding risk when combined with oral anticoagulants such as warfarin.
> The antiplatelet effect of NSAIDs lasts only as long as the NSAID is present in the
> circulation, unlike aspirin???s antiplatelet effect, which lasts for up to 2 weeks
> after aspirin is discontinued. NSAIDs also can cause peptic ulcers and most of the
> evidence for increased bleeding risk with NSAIDs plus warfarin is due to upper
> gastrointestinal bleeding (UGIB).
> </p>
> <figure id="Warfarin-NSAID-TREE">
> <img src="W3C-Images/Warfarin-NSAID-TREE-opthalmic-addition.png" height="701" width="1039">
> <figcaption>Figure <bdi class="figno">5</bdi> <span class="fig-title"> <span style="color: #30d529">??</span> = No special precautions.
> <span style="color: #f9bd3b">n</span> = Assess risk and take action if necessary.
> <span style="color: #fb0082">u</span> = Use only if benefit
> outweighs risk. Originally
> developed through "Individualized Drug
> Interactions" (AHRQ Project R21-HS023826-01) by Task
> Force Members Daniel Malone, John Horn, and Philp Hansten.
>
>
> <p style="text-align: left"><strong>Footnotes:</strong></p>
> <ol type="1">
> <li style="text-align: left">Topical diclofenac has relatively low systemic absorption; in one study a topical gel (16 g/day) produced about 6% of the absorption seen with systemic administration of 150 mg/day. A higher than recommended dose of topical gel (48 g/day) produced 20% of a systemic dose of diclofenac. The UK Summary of Product Characteristics for Voltarol Ophtha Multidose Eye Drops states, "No measurable levels of diclofenac could be found in humans after ocular application of diclofenac sodium eye drops". The FDA-approved SPL for Diclofenac Sodium Ophthalmic Solution 0.1% states, "Results from a bioavailability study established that plasma levels of diclofenac following ocular instillation of two drops of Diclofenac sodium ophthalmic solution, 0.1% to each eye were below the limit of quantification (10 ng/mL) over a 4-hour period. This study suggests that limited, if any, systemic absorption occurs with Diclofenac sodium ophthalmic solution". </li>
> <li style="text-align: left">If the NSAID is being used as an analgesic or antipyretic, it would be prudent to use an alternative such as acetaminophen. In some people, acetaminophen can increase the anticoagulant effect of warfarin, so monitor the INR if acetaminophen is used in doses over 2 g/day for a few days. For more severe pain consider short-term opioids in place of the NSAID.</li>
> <li style="text-align: left">Proton pump inhibitors and misoprostol may reduce the risk of UGIB in patients receiving NSAIDs and warfarin.</li>
> <li style="text-align: left">Patients with a history of UGIB or peptic ulcer may have an increased risk of UGIB from this interaction. The extent to which older age is an independent risk factor for UGIB due to these interactions is not firmly established, but UGIB in general is known to increase with age.</li>
> <li style="text-align: left">Both corticosteroids and aldosterone antagonists have been shown to substantially increase the risk of UGIB in patients on NSAIDs, with relative risks of 12.8 and 11 respectively compared to a risk of 4.3 with NSAIDs alone [<cite><a class="bibref" href="#bib-masclee-2014" title="Risk of upper gastrointestinal bleeding from different drug combinations.">masclee-2014</a></cite>]</li>
> </ol>
> </span></figcaption>
> </figure>
> </section>
> <section id="BCR-ABL">
> <h6 id="a-1-1-2-2-example-pddi-bcr-abl-tyrosine-kinase-inhibitors-tki-proton-pump-inhibitors-ppi"><bdi class="secno">A.1.1.2.2 </bdi>Example PDDI: BCR-ABL Tyrosine Kinase Inhibitors (TKI) + Proton Pump Inhibitors (PPI)<a class="self-link" aria-label="??" href="#BCR-ABL"></a></h6>
> <p>
> BCR-ABL Tyrosine Kinase inhibitors bosutinib, dasatinib, imatinib, nilotinib, and
> ponatinib are indicated for Philadelphia chromosome-positive chronic myeloid leukemia.
> Ponatinib is only approved in T315I-positive patients. These TKIs demonstrate pH dependent
> absorption for oral administration which may result in decreased efficacy when given
> concomitantly with medications that increase gastric pH. Dasatinib area under the curve
> (AUC) is decreased when co-administered with antacids, H2 antagonists, and PPIs.<sup>2</sup> Bosutinib and nilotinib AUCs are decreased with concomitant PPIs but antacids and H2
> antagonists may be considered if TKI is given 2 hours before the antacid/H2 antagonist.<sup>3,4</sup>
> However, for nilotinib a retrospective study has shown no difference in cytogenetic response
> rates for patients taking PPIs.<sup>5</sup> Imatinib and ponatinib AUCs are not appreciably decreased
> by PPI co-administration.<sup>6,7</sup>
> </p>
> <figure id="fig-no-special-precautions-n-assess-risk-and-take-action-if-necessary-u-use-only-if-benefit-outweighs-risk-originally-developed-through-addressing-gaps-in-clinically-useful-evidence-on-drug-drug-interactions-r01lm011838-nih-grant-by-task-force-members-evan-draper-daniel-c-malone-john-horn-and-philip-hansten-footnotes-sprycel-2015-bosulif-2015-tasigna-2015-yin-2012-iclusig-2016-egorin-2009">
> <img src="W3C-Images/BCR-ABL-tree.png" height="311" width="876">
> <figcaption>Figure <bdi class="figno">6</bdi> <span class="fig-title"><span style="color: #30d529">??</span> = No special precautions.
> <span style="color: #f9bd3b">n</span> = Assess risk and take action if necessary.
> <span style="color: #fb0082">u</span> = Use only if benefit
> outweighs risk. Originally developed through "Addressing gaps
> in clinically useful evidence on drug-drug interactions" (R01LM011838)
> NIH Grant by Task Force Members Evan Draper, Daniel
> C. Malone, John Horn, and Philip Hansten. <br>
>
> <p style="text-align: left"><strong>Footnotes:</strong></p>
> <ol type="1">
> <li style="text-align: left">[<cite><a class="bibref" href="#bib-sprycel-2015" title="Sprycel">sprycel-2015</a></cite>]</li>
> <li style="text-align: left">[<cite><a class="bibref" href="#bib-bosulif-2015" title="Bosulif">bosulif-2015</a></cite>]</li>
> <li style="text-align: left">[<cite><a class="bibref" href="#bib-tasigna-2015" title="Tasigna">tasigna-2015</a></cite>]</li>
> <li style="text-align: left">[<cite><a class="bibref" href="#bib-yin-2012" title="Concurrent use of proton pump inhibitors or H2 blockers did not adversely affect nilotinib efficacy in patients with chronic myeloid leukemia">yin-2012</a></cite>]</li>
> <li style="text-align: left">[<cite><a class="bibref" href="#bib-iclusig-2016" title="Iclusig">iclusig-2016</a></cite>]</li>
> <li style="text-align: left">[<cite><a class="bibref" href="#bib-egorin-2009" title="Effect of a proton pump inhibitor on the pharmacokinetics of imatinib">egorin-2009</a></cite>]</li>
> </ol>
> </span></figcaption>
> </figure>
> </section>
> </section>
> </section>
> </section>
>
> <section id="user-stories-goals" class="informative">
> <h3 id="a-2-user-stories"><bdi class="secno">A.2 </bdi>User Stories<a class="self-link" aria-label="??" href="#user-stories-goals"></a></h3><p><em>This section is non-normative.</em></p>
>
> <section id="user-story-workflow">
> <h4 id="a-2-1-workflow-for-arriving-at-stories-and-goals"><bdi class="secno">A.2.1 </bdi>Workflow for arriving at stories and goals<a class="self-link" aria-label="??" href="#user-story-workflow"></a></h4>
> <p>
> User stories and goals were developed in order to showcase how the PDDI minimum information model
> will support users. The Task Force began developing the Stakeholder Description document and
> the PDDI Minimum Information Model User Scenarios document in order to identify key users. These
> stakeholder descriptions and user scenarios were used as the basis for further brainstorming with
> the assistance of a user experience expert to develop a master list of tasks, users, information needs,
> information values, and barriers to drug-drug interaction based decision-making in a variety of situations.
> A core set of user types was selected for development of user stories based on the scope of the minimum
> information model.
> </p>
> <p>
> To develop the user stories for the core user types, Task Force members created an
> initial information needs list and then was supplemented it with user interviews, interview transcripts
> collected as a part of a recently published manuscript on PDDI information needs of drug information
> compendium editors [<cite><a class="bibref" href="#bib-romagnoli-2017" title="Information needs for making clinical recommendations about potential drug-drug interactions: a synthesis of literature review and interviews">romagnoli-2017</a></cite>], and the published literature. Where possible, user stories
> were based on PDDIs suggested by the Task Force???s PDDI experts. All user stories were reviewed
> during team meetings to solicit feedback and comments. Based on Task Force member suggestions,
> the user stories were edited to make them more clinically relevant, accurate and appropriate. Information
> model items were highlighted based on a color-coded key to indicate the minimum information model
> information item in question.
> </p>
>
>
> </section>
>
> <section id="final-stories">
> <h4 id="a-2-2-user-stories-for-the-minimum-information-model"><bdi class="secno">A.2.2 </bdi>User stories for the minimum information model<a class="self-link" aria-label="??" href="#final-stories"></a></h4>
> <p>
> The following user stories use the
> color-coding described
> in <a href="user-story-color-coding"></a> to represent core
> information items defined for the minimum information model. A
> table
> summarizing the information needs exposed by these use cases is also presented in Appendix <a href="#med-rec-use-cases" class="sec-ref">?? <bdi class="secno">A.2.2.2 </bdi>A set of user stories focused on medication reconciliation</a>.
> </p>
>
> <section id="user-story-color-coding" class="informative">
> <h5 id="a-2-2-1-color-codes-used-in-user-stories"><bdi class="secno">A.2.2.1 </bdi>Color codes used in user stories<a class="self-link" aria-label="??" href="#user-story-color-coding"></a></h5><p><em>This section is non-normative.</em></p>
> <p>The following table illustrates the colors used to describe
> user stories. Note that frequency of exposure is not addressed in any of the user stories.</p>
>
> <table>
> <tbody><tr>
> <td style="background-color: #fee087" width="150"></td>
> <td width="300" style="text-align: center">Clinical Consequences</td>
> </tr>
> <tr>
> <td style="background-color: #bed1f6" width="150"></td>
> <td width="300" style="text-align: center">Evidence</td>
> </tr>
> <tr>
> <td style="background-color: #dfa99f" width="150"></td>
> <td width="300" style="text-align: center">Recommended Actions</td>
> </tr>
> <tr>
> <td style="background-color: #a9d098" width="150"></td>
> <td width="300" style="text-align: center">Mechanism of Interaction</td>
> </tr>
> <tr>
> <td style="background-color: #d0c7e3" width="150"></td>
> <td width="300" style="text-align: center">Contextual Evidence/Modifying Factors</td>
> </tr>
> <tr>
> <td style="background-color: #f6bf8b" width="150"></td>
> <td width="300" style="text-align: center">Seriousness Rating</td>
> </tr>
>
> <tr>
> <td style="background-color: #a8a8a8" width="150"></td>
> <td width="300" style="text-align: center">Frequency of Harm</td>
> </tr>
>
> <tr>
> <td style="background-color: #ffcccc" width="150"></td>
> <td width="300" style="text-align: center">Frequency of Exposure</td>
> </tr>
>
>
> </tbody></table>
>
> </section>
>
> <section id="med-rec-use-cases" class="informative">
> <h5 id="a-2-2-2-a-set-of-user-stories-focused-on-medication-reconciliation"><bdi class="secno">A.2.2.2 </bdi>A set of user stories focused on medication reconciliation<a class="self-link" aria-label="??" href="#med-rec-use-cases"></a></h5><p><em>This section is non-normative.</em></p>
> <section id="use-story-1-hospital-pharmacist-medication-reconciliation-upon-admission">
> <h6 id="a-2-2-2-1-use-story-1-hospital-pharmacist-medication-reconciliation-upon-admission"><bdi class="secno">A.2.2.2.1 </bdi>Use Story 1: Hospital Pharmacist, Medication Reconciliation upon Admission<a class="self-link" aria-label="??" href="#use-story-1-hospital-pharmacist-medication-reconciliation-upon-admission"></a></h6>
> <ul>
> <li>A PDDI with unknown modifying factors: Linezolid + SSRIs (sertraline)</li>
> </ul>
> <p>Beth is a hospital pharmacist who is reviewing the medications in the
> physician admission order for Bill, an
> <span style="background-color: #d0c7e3">85-year-old male
> dementia patient</span> who was transferred from a skilled nursing
> facility to the hospital after being diagnosed with a
> vancomycin-resistant Enterococcus faecium (VRE) infection.
> At the nursing home, Bill was prescribed sertraline to treat
> depression. Beth receives an alert that linezolid, which is being
> considered to treat the VRE infection, has a potential interaction
> with the sertraline that Bill is currently taking. <span style="background-color: #a9d098">Linezolid is a
> weak monoamine oxidase inhibitor</span>, and has been shown to
> <span style="background-color: #fee087">increase the
> risk of serotonin syndrome when taken concurrently with an SSRI such
> as sertraline</span>. Beth would like to know the risks and benefits of
> continuing the sertraline and adding on the linezolid, the
> <span style="background-color: #f6bf8b">potential
> seriousness</span> of the interaction???s clinical consequence, and
> <span style="background-color: #dfa99f">recommended
> management options, such as selecting an alternative medication or
> discontinuing the sertraline</span>. She would like to see the
> <span style="background-color: #bed1f6">current evidence
> behind the interaction</span>, so that she can determine if Bill has an
> increased risk of serotonin syndrome. In order to gather this
> information, she reviews Bill???s history, lab results, and allergies
> from the health records faxed by his skilled nursing facility, as
> well as his medication list upon admission. She reviews Lexicomp&trade;
> and the hospital???s intranet resources for additional information,
> but is having trouble finding information that is relevant to Bill???s
> situation. She does a literature search using PubMed in order to
> try to locate information about the
> <span style="background-color: #a8a8a8">frequency of adverse events in
> due to this potential interaction in other patients like Bill</span>, but
> she does not have access to all of the articles in the search results.</p>
> </section>
> <section id="user-story-2-hospital-pharmacist-medication-reconciliation-upon-discharge">
> <h6 id="a-2-2-2-2-user-story-2-hospital-pharmacist-medication-reconciliation-upon-discharge"><bdi class="secno">A.2.2.2.2 </bdi>User Story 2: Hospital Pharmacist, Medication
> Reconciliation upon Discharge<a class="self-link" aria-label="??" href="#user-story-2-hospital-pharmacist-medication-reconciliation-upon-discharge"></a></h6>
>
> <ul>
> <li>A PDDI that can (and should) be contextualized for specific patients or clinical circumstances: KCL (potassium chloride) + K-sparing Diuretics (spironolactone)</li>
> </ul>
> <p>
> Beth is reviewing the physician???s discharge order for Maria.
> Maria is a <span style="background-color: #d0c7e3">72-year old woman</span>
> who was admitted to the hospital with
> <span style="background-color: #d0c7e3">acute decompensated heart failure</span>.
> While reviewing Maria???s medications,
> Beth sees that Maria is being discharged with spironolactone, a
> potassium-sparing diuretic that could potentially interact with the
> potassium chloride that Maria had been taking to treat low potassium
> levels. Spironolactone <span style="background-color: #a9d098">may increase potassium levels in Maria???s blood,
> leading to hyperkalemia</span>. Beth reviews Maria???s electronic health record
> in order to view her lab results and her other medications. She sees
> that Maria is also
> <span style="background-color: #d0c7e3">taking the ACE inhibitor lisinopril for heart failure</span>,
> and since ACE inhibitors can also increase potassium levels, Beth would
> like to know how much this <span style="background-color: #d0c7e3">modifying factor</span>
> might increase Maria???s <span style="background-color: #fee087">risk of
> hyperkalemia</span> due to the interaction between potassium chloride and
> spironolactone. Beth would like to know how likely it is that Maria
> will experience hyperkalemia, <span style="background-color: #f6bf8b">how serious hyperkalemia may be</span>, and
> <span style="background-color: #dfa99f">how to manage the interaction, such as by discontinuing one of Maria???s
> medications</span>. Beth reviews the hospital???s intranet, as well as
> Micromedex&trade;, for recommendations. She would also like more
> information about the potassium chloride that Maria was taking
> as one of her home medications, so she will need to contact
> Maria???s community pharmacy in order to find out the strength
> of the medication and if the prescription was still current.
> </p>
> </section>
> <section id="user-story-3-consultant-pharmacist-medication-reconciliation-upon-readmission">
> <h6 id="a-2-2-2-3-user-story-3-consultant-pharmacist-medication-reconciliation-upon-readmission"><bdi class="secno">A.2.2.2.3 </bdi>User Story 3: Consultant Pharmacist, Medication Reconciliation upon Readmission<a class="self-link" aria-label="??" href="#user-story-3-consultant-pharmacist-medication-reconciliation-upon-readmission"></a></h6>
> <ul>
> <li>A PDDI with a known, pharmacokinetic mechanism: Warfarin + 2C9 inhibitors (metronidazole)</li>
> </ul>
> <p>
> Patrick is a nursing home consultant pharmacist who is reviewing the
> medications of a readmitted patient, Nancy. Nancy is a
> <span style="background-color: #d0c7e3">78 year-old
> woman</span> who is being transferred back to her skilled nursing facility
> after a hospital admission for a Clostridium difficile (C. diff)
> infection; prior to the hospital admission, she was prescribed
> warfarin at the skilled nursing facility for <span style="background-color: #d0c7e3">deep vein thrombosis
> (DVT) treatment</span>. Based on the hospital discharge summary, it
> appears that Nancy was taken off of the warfarin at the hospital
> due to an increased INR, and returned to the skilled nursing
> facility without an order for warfarin. Patrick sees that a
> potential interaction may occur with the warfarin that Nancy
> had been prescribed prior to her hospitalization, and the
> metronidazole now used to treat her infection, since
> <span style="background-color: #a9d098">metronidazole is a CYP2C9 inhibitor and may increase the
> plasma concentration of warfarin</span>. A clinical consequence of
> this interaction would be an
> <span style="background-color: #fee087">increased INR leading to an increased
> risk of bleeding</span>. Patrick would like to gather
> <span style="background-color: #dfa99f">management
> recommendations</span> for this interaction prior to contacting Nancy???s
> physician. He is interested in Nancy???s duration of therapy for
> both the warfarin and the metronidazole, her current risk factors
> for a DVT, and if she is indicated for prophylactic therapy.
> Patrick also wants to know <span style="background-color: #dfa99f">if and when warfarin should be restarted,
> and at what dose, in order to reduce the risk of bleeding due to
> the interaction</span>. He would also like to know <span style="background-color: #dfa99f">if metronidazole is
> the best option to continue treating Nancy???s C. diff infection,
> or if there is an alternative option that may not interact with
> warfarin</span>. To gather this information, he reviews Nancy???s
> previous INR values, medication list, and history. He also
> contacts the hospital to determine whether warfarin
> had been given at any point during Nancy???s stay, if the dosage
> had been adjusted, what other medications she was given, and if
> any of her other medications were discontinued. He reviews
> his company???s intranet resources for additional information about
> the interaction and possible <span style="background-color: #dfa99f">evidence-based recommendations</span>.
> Finally, Patrick is interested in the <span style="background-color: #a8a8a8">frequency of serious bleeding
> events </span><span style="background-color: #d0c7e3">in geriatric patients co-prescribed warfarin and
> metronidazole</span>, and the <span style="background-color: #bed1f6">literature surrounding the interaction</span>.
> </p>
> </section>
> </section>
>
> <section id="treatment-planning-phys" class="informative">
> <h5 id="a-2-2-3-treatment-planning-physician"><bdi class="secno">A.2.2.3 </bdi>Treatment Planning, Physician<a class="self-link" aria-label="??" href="#treatment-planning-phys"></a></h5><p><em>This section is non-normative.</em></p>
> <p><strong>Simvastatin + Amiodarone</strong></p>
> <ul>
> <li>Kathleen is a physician who is treating a patient who has a ventricular arrhythmia. Kathleen
> would normally prescribe amiodarone for this particular patient, but he is being treated with
> simvastatin for dyslipidemia, and she knows that a <span style="background-color: #f6bf8b">potentially serious interaction</span> may occur
> leading to <span style="background-color: #fee087">rhabdomyolysis</span>. Kathleen wants to know <span style="background-color: #d0c7e3">what the patient???s risk factors are for
> rhabdomyolysis</span>, what the benefits and risks would be to <span style="background-color: #dfa99f">switching him to an alternative statin</span>,
> and if amiodarone is not the best option for this patient, what <span style="background-color: #dfa99f">alternatives to amiodarone</span> exist
> for this patient, and what the available <span style="background-color: #bed1f6">evidence</span> shows in terms of ventricular arrhythmia
> patient outcomes.</li>
> </ul>
> <p><strong>(Pediatrics) Fluoxetine + Ondansetron</strong></p>
> <ul>
> <li>Evelyn is a pediatric emergency medicine physician caring for an adolescent with a history
> of major depressive disorder treated with fluoxetine, who presents with acute onset of
> vomiting and diarrhea. Evelyn???s usual first-line antiemetic for acute gastroenteritis is
> ondansetron, but Evelyn knows that both fluoxetine and ondansetron are listed as
> <span style="background-color: #fee087">QTc-prolonging medications</span>.
> Evelyn would like to know the <span style="background-color: #a8a8a8">likelihood of </span><span style="background-color: #f6bf8b">clinically
> significant QTc prolongation</span> due to a brief course of co-administration of fluoxetine
> and ondansetron, and if there is a <span style="background-color: #dfa99f">recommendation for dose adjustment or an alternate antiemetic</span>.</li>
> </ul>
> <p><strong>(Pediatrics) Azole antifungals + Tacrolimus</strong></p>
> <ul>
> <li>William is a pediatric hospitalist caring for a child with a history of liver transplant
> due to congenital liver disease, treated with tacrolimus to prevent organ rejection.
> The patient is admitted with a fever and starts broad anti-infective therapy, including
> vancomycin, piperacillin-tazobactam and fluconazole. William knows that azole antifungals
> can increase tacrolimus levels and wants to know if there is <span style="background-color: #bed1f6">evidence</span>
> to guide a <span style="background-color: #dfa99f">decrease the patient???s tacrolimus dose</span> to prevent
> <span style="background-color: #fee087">tacrolimus toxicity</span>. He additionally wants to
> know the <span style="background-color: #a9d098">mechanism of interaction</span> to
> <span style="background-color: #dfa99f">avoid further interacting medications</span>.</li>
> </ul>
> </section>
> <section id="eval-management-options-phys" class="informative">
> <h5 id="a-2-2-4-evaluation-of-management-options-for-drug-drug-interactions-physician"><bdi class="secno">A.2.2.4 </bdi>Evaluation of Management Options for Drug-Drug Interactions, Physician<a class="self-link" aria-label="??" href="#eval-management-options-phys"></a></h5><p><em>This section is non-normative.</em></p>
> <p><strong>Warfarin + Naproxen</strong></p>
> <ul>
> <li>Melissa is a family physician whose patient called because he is
> experiencing noticeable <span style="background-color: #fee087">bruising</span>. Melissa knows that the patient is
> taking warfarin, but he has not experienced bruising before. She asks if
> the patient has taken any new medications recently, and he mentions that
> he visited a pain clinic for his chronic back pain and they prescribed the
> NSAID naproxen. Melissa knows that NSAIDs can <span style="background-color: #fee087">increase the risk of bleeding</span>
> when taken with warfarin, and she wants to know the <span style="background-color: #dfa99f">best way to manage this interaction</span>.</li>
> </ul>
> </section>
> <section id="eval-management-options-pharm" class="informative">
> <h5 id="a-2-2-5-evaluation-of-management-options-for-drug-drug-interactions-pharmacist"><bdi class="secno">A.2.2.5 </bdi>Evaluation of Management Options for Drug-Drug Interactions, Pharmacist<a class="self-link" aria-label="??" href="#eval-management-options-pharm"></a></h5><p><em>This section is non-normative.</em></p>
> <p><strong>Atorvastatin + Clarithromycin</strong></p>
> <ul>
> <li>James is a community pharmacist reviewing an electronic prescription
> that just came in for clarithromycin; an alert in his pharmacy???s
> information system indicates that there is a potential interaction
> between the clarithromycin and the atorvastatin that the patient was
> prescribed a year ago by different physician. James calls the patient
> in order to discuss her medications; she tells him that she is taking
> the atorvastatin as prescribed, and cannot remember if she has ever taken
> clarithromycin in the past. In preparation for following up with the patient???s
> physician, James would like to know the <span style="background-color: #a8a8a8">likelihood of an adverse drug event</span>
> such as <span style="background-color: #fee087">rhabdomyolysis</span>
> occurring due to a potential interaction and <span style="background-color: #f6bf8b">how serious
> the interaction could be</span>. He would also like to know if <span style="background-color: #dfa99f">monitoring would be
> appropriate for this patient, or if a dose adjustment or temporary discontinuation
> of one of the drugs</span> would be best.</li>
> </ul>
> </section>
> <section id="nurse-screening" class="informative">
> <h5 id="a-2-2-6-screening-for-drug-drug-interactions-nurse"><bdi class="secno">A.2.2.6 </bdi>Screening for Drug-Drug Interactions, Nurse<a class="self-link" aria-label="??" href="#nurse-screening"></a></h5><p><em>This section is non-normative.</em></p>
> <p><strong>Glipizide + Lisinopril (Sulfonylureas + ACE Inhibitors)</strong></p>
> <ul>
> <li>Nancy is a licensed practice nurse who works in a skilled nursing facility.
> She has noticed that her patient is experiencing symptoms of
> <span style="background-color: #fee087">hypoglycemia</span>.
> She sees that the patient was recently prescribed lisinopril, and is wondering
> if it interacts with one of the five medications that she is taking.
> Nancy remembers reading about a potential interaction with the glipizide
> that the patient is currently taking. She would like to know <span style="background-color: #fee087">if the
> patient???s symptoms are a possible consequence of an interaction</span> between
> the glipizide and the lisinopril, or the lisinopril and one of the other
> medications that the patient is taking, and if so, <span style="background-color: #dfa99f">what information she
> should pass along to the registered nurse in charge in order to help
> treat the patient</span>.</li>
> </ul>
> </section>
> <section id="editor-synthesis-dissemination" class="informative">
> <h5 id="a-2-2-7-synthesis-for-dissemination-drug-compendium-editor"><bdi class="secno">A.2.2.7 </bdi>Synthesis for Dissemination, Drug Compendium Editor<a class="self-link" aria-label="??" href="#editor-synthesis-dissemination"></a></h5><p><em>This section is non-normative.</em></p>
> <p><strong>Tyrosine Kinase Inhibitors + Proton Pump Inhibitors</strong></p>
> <ul>
> <li>Olivia is a drug compendium editor who is reviewing the available
> literature for the potential interaction between tyrosine kinase
> inhibitors and proton pump inhibitors. She would like to review
> the most recent literature available surrounding the interaction,
> and would like to compare it against the existing entry in her drug
> compendium. She would like to understand more about the <span style="background-color: #a9d098">mechanism
> of the interaction</span>, whether it applies to all drugs within the classes,
> <span style="background-color: #d0c7e3">whether certain populations are at greater risk</span>, and the types and
> strength of the <span style="background-color: #bed1f6">evidence</span> available. She would also like to learn
> more about <span style="background-color: #dfa99f">recommended management options</span>.</li>
> </ul>
> </section>
> <section id="librarian-dissemination" class="informative">
> <h5 id="a-2-2-8-synthesis-for-dissemination-librarian"><bdi class="secno">A.2.2.8 </bdi>Synthesis for Dissemination, Librarian<a class="self-link" aria-label="??" href="#librarian-dissemination"></a></h5><p><em>This section is non-normative.</em></p>
> <ul>
> <li>Michael is a librarian who works for the medication safety unit in a regulatory
> agency. He has graduate training in library and information science, and
> has a good understanding of medical reference sources. When he is asked
> to locate information about a potential drug-drug interaction, he wants to
> understand more about the terms used to describe the drugs so that he can
> develop search strategies to run daily, weekly, and monthly searches.
> He would like to find terms used to describe the specific drugs involved
> in the interaction, drug class concepts, <span style="background-color: #fee087">clinical consequences</span> of the
> interaction, and existing types of <span style="background-color: #bed1f6">evidence</span> of the interaction.</li>
> </ul>
> </section>
> <section id="cds-team" class="informative">
> <h5 id="a-2-2-9-synthesis-for-dissemination-clinical-decision-support-team-systems-analyst-content-specialist"><bdi class="secno">A.2.2.9 </bdi>Synthesis for Dissemination, Clinical Decision Support Team - Systems Analyst & Content Specialist<a class="self-link" aria-label="??" href="#cds-team"></a></h5><p><em>This section is non-normative.</em></p>
> <ul>
> <li>Richard is a systems analyst who is working with Joe, a content
> specialist, in order to design a new clinical information system
> which can provide personalized clinical knowledge and patient information
> for clinicians to improve healthcare quality. Richard is professionally
> trained in algorithms, databases, and programming. He also has some
> knowledge about electronic medical records. In order to help Richard
> design and implement the system, Joe would like to know about the
> <span style="background-color: #bed1f6">evidence</span>,
> <span style="background-color: #fee087">clinical consequences</span>, and
> <span style="background-color: #a9d098">mechanisms of interactions</span> of
> potential drug-drug interactions so that he can develop rules for
> the most clinically relevant interactions. With that information,
> he can help Richard create linkages and designs algorithms based
> on electronic medical records. Joe can also help Richard prioritize
> what to display and how to display information or alerts for clinicians.</li>
> </ul>
> </section>
> <section id="out-of-scope-stories" class="informative">
> <h5 id="a-2-2-10-out-of-scope-user-stories"><bdi class="secno">A.2.2.10 </bdi>Out of scope user stories<a class="self-link" aria-label="??" href="#out-of-scope-stories"></a></h5><p><em>This section is non-normative.</em></p>
> <p>The following user stories were considered as outside of scope of the task of developing the PDDI minimum
> information model, since the goals of the user stories were to determine how healthcare providers use
> PDDI information in patient care, what PDDI resources healthcare providers use when making patient care
> decisions, and how those PDDI resources are developed.</p>
> <p>Synthesis for Dissemination, Clinical Decision Support User Interface Designer<br>
> Synthesis for Dissemination, Data Scientist<br>
> Population Management, Pharmacoepidemiologist<br>
> Population Management, Insurance Companies<br>
> Population Management, P&T Committee (Formulary Development)<br>
> Population Management, Med Safety Department (Pharmaceutical Industry)<br>
> Passive Role, Patient</p>
> </section>
> </section>
> </section>
>
> <section id="kr-process-apdx" class="informative">
> <h3 id="a-3-definition-of-guidelines-for-knowledge-representation"><bdi class="secno">A.3 </bdi>Definition of guidelines for knowledge representation<a class="self-link" aria-label="??" href="#kr-process-apdx"></a></h3><p><em>This section is non-normative.</em></p>
>
> A sub-team of the task force focused on setting the scope of
> knowledge representation for the minimum information model. A
> series of teleconferences bringing together domain experts,
> biomedical informatics specialists, and knowledge representation
> experts across the task force. Starting with a core set of
> questions, topics were discussed, arguments for different
> approaches were laid out and, agreement among the participants was
> sought. Besides the conversation during the teleconferences,
> participants had the opportunity to add comments and voice their
> opinion to the statements in the document. When the task force
> arrived at a consolidated version, the group voted by
> teleconference and through e-mail. The result of that vote was
> written into a draft document. The final version of the document
> was revised and written as Section <a href="#KR-discussion" class="sec-ref">?? <bdi class="secno">4. </bdi>Knowledge representation for the minimal information model</a>
> of this document.
> </section>
>
> <section id="Value-Sets" class="informative">
> <h3 id="a-4-value-sets-to-support-pddi-examples"><bdi class="secno">A.4 </bdi>Value Sets to Support PDDI Examples<a class="self-link" aria-label="??" href="#Value-Sets"></a></h3><p><em>This section is non-normative.</em></p>
> <section id="intro-to-value-sets">
> <h4 id="a-4-1-some-background-on-concept-identification-and-value-sets"><bdi class="secno">A.4.1 </bdi>Some Background on Concept Identification and 'Value Sets' <a class="self-link" aria-label="??" href="#intro-to-value-sets"></a></h4>
> <p>
> According to the National Library of Medicine, value sets are
> lists of codes and corresponding terms from standard clinical
> vocabularies (such as SNOMED CT??, RxNorm, LOINC?? and others), that
> define clinical concepts to support effective and interoperable
> health information exchange.[<cite><a class="bibref" href="#bib-nlm-vsac-2019" title="Value Set Authority Center - U.S. National Library of Medicine">NLM-vsac-2019</a></cite>] Value sets are also
> referred to as "concept
> sets". <a href="#ddi-model-value-sets" class="fig-ref" title="Sources of value sets for two of the core information items of PDDI. Identifiers may come from above mentioned code systems or other relevant terminologies. As is typical for value sets, version, original code system and the code system version are required. The National Library of Medicine's Value Set Authority Center is a public site commonly used to store individual value sets.">Figure <bdi class="figno">7</bdi></a> shows some of the
> terminology sources that provide codes useful for constructing
> values sets for information items in the PDDI information
> model. Value sets may be <i>explicitly defined</i> by containing a
> terminology code for each term in the value set concepts. They can
> also be <i>intensionally defined</i> using an algorithm that, when
> executed by a machine (or interpreted by a human), yields a set of
> such
> elements. An <a href="http://wiki.hl7.org/index.php?title=PDDI_CDS" target="new">HL7 project related to PDDI decision support</a>
> effort is currently underway within HL7. The work has produced a
> draft implementation guide that includes a specification for
> constructing value sets for the drugs included in a
> PDDI.[<cite><a class="bibref" href="#bib-hl7-cds-pddi-draft" title="Potential Drug-Drug Interaction (PDDI) CDS IG : Ballot for Comment 2 - Terminology page">HL7-cds-PDDI-draft</a></cite>]
> </p>
> <figure id="ddi-model-value-sets">
> <img src="Presentations/images/value-set-overview.png" width="700">
> <figcaption>Figure <bdi class="figno">7</bdi> <span class="fig-title">Sources of value sets for two of the core information items of PDDI. Identifiers may come from above mentioned code systems or other relevant terminologies. As is typical for value sets, version, original code system and the code system version are required. The National Library of Medicine's Value Set Authority Center is a public site commonly used to store individual value sets.</span></figcaption>
> </figure>
> </section>
>
> <section id="aldosterone-antagonists">
> <h4 id="a-4-2-aldosterone-antagonists-and-products-containing-an-aldosterone-receptor-antagonist-rxnorm"><bdi class="secno">A.4.2 </bdi>aldosterone antagonists and products containing an aldosterone receptor antagonist (RxNorm)<a class="self-link" aria-label="??" href="#aldosterone-antagonists"></a></h4>
> <pre aria-busy="false"><code class="hljs">298869 - eplerenone
> 9997 - Spironolactone
> 351256 - eplerenone 25 MG Oral Tablet
> 351257 - eplerenone 50 MG Oral Tablet
> 198224 - Hydrochlorothiazide 25 MG / Spironolactone 25 MG Oral Tablet
> 198225 - Hydrochlorothiazide 50 MG / Spironolactone 50 MG Oral Tablet
> 198222 - Spironolactone 100 MG Oral Tablet
> 313096 - Spironolactone 25 MG Oral Tablet
> 198223 - Spironolactone 50 MG Oral Tablet</code></pre>
> </section>
>
> <section id="bosutinib">
> <h4 id="a-4-3-bosutinib-atc"><bdi class="secno">A.4.3 </bdi>bosutinib (ATC)<a class="self-link" aria-label="??" href="#bosutinib"></a></h4>
> <pre aria-busy="false"><code class="hljs">L01XE14 - bosutinib</code></pre>
> </section>
>
>
> <section id="cereb-hemm">
> <h4 id="a-4-4-cerebral-hemorrhage-icd-10-cm"><bdi class="secno">A.4.4 </bdi>cerebral hemorrhage (ICD-10-CM)<a class="self-link" aria-label="??" href="#cereb-hemm"></a></h4>
> <pre aria-busy="false"><code class="hljs css"><span class="hljs-selector-tag">I61</span><span class="hljs-selector-class">.0</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">intracerebral</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">in</span> <span class="hljs-selector-tag">hemisphere</span>, <span class="hljs-selector-tag">subcortical</span>
> <span class="hljs-selector-tag">I61</span><span class="hljs-selector-class">.1</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">intracerebral</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">in</span> <span class="hljs-selector-tag">hemisphere</span>, <span class="hljs-selector-tag">cortical</span>
> <span class="hljs-selector-tag">I61</span><span class="hljs-selector-class">.2</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">intracerebral</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">in</span> <span class="hljs-selector-tag">hemisphere</span>, <span class="hljs-selector-tag">unspecified</span>
> <span class="hljs-selector-tag">I61</span><span class="hljs-selector-class">.3</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">intracerebral</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">in</span> <span class="hljs-selector-tag">brain</span> <span class="hljs-selector-tag">stem</span>
> <span class="hljs-selector-tag">I61</span><span class="hljs-selector-class">.4</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">intracerebral</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">in</span> <span class="hljs-selector-tag">cerebellum</span>
> <span class="hljs-selector-tag">I61</span><span class="hljs-selector-class">.5</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">intracerebral</span> <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">intraventricular</span>
> <span class="hljs-selector-tag">I61</span><span class="hljs-selector-class">.6</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">intracerebral</span> <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">multiple</span> <span class="hljs-selector-tag">localized</span>
> <span class="hljs-selector-tag">I61</span><span class="hljs-selector-class">.9</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">intracerebral</span> <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">unspecified</span>
> <span class="hljs-selector-tag">P10</span><span class="hljs-selector-class">.2</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intraventricular</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">due</span> <span class="hljs-selector-tag">to</span> <span class="hljs-selector-tag">birth</span> <span class="hljs-selector-tag">injury</span>
> <span class="hljs-selector-tag">P10</span><span class="hljs-selector-class">.4</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Tentorial</span> <span class="hljs-selector-tag">tear</span> <span class="hljs-selector-tag">due</span> <span class="hljs-selector-tag">to</span> <span class="hljs-selector-tag">birth</span> <span class="hljs-selector-tag">injury</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.0</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intraventricular</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">grade</span> 1, <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.1</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intraventricular</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">grade</span> 2, <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.2</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intraventricular</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">grade</span> 3 <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">grade</span> 4, <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.3</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Unspecified</span> <span class="hljs-selector-tag">intraventricular</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.4</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intracerebral</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.9</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intracranial</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>, <span class="hljs-selector-tag">unspecified</span></code></pre>
> </section>
>
> <section id="acml">
> <h4 id="a-4-5-chronic-myeloid-leukemia-snomed-ct"><bdi class="secno">A.4.5 </bdi>chronic myeloid leukemia (SNOMED-CT)<a class="self-link" aria-label="??" href="#acml"></a></h4>
> <pre aria-busy="false"><code class="hljs">415287001 - Relapsing chronic myeloid leukemia
> 277589003 - Atypical chronic myeloid leukemia
> 277587001 - Juvenile chronic myeloid leukemia</code></pre>
> </section>
>
> <section id="dasatinib">
> <h4 id="a-4-6-dasatinib-atc"><bdi class="secno">A.4.6 </bdi>dasatinib (ATC)<a class="self-link" aria-label="??" href="#dasatinib"></a></h4>
> <pre aria-busy="false"><code class="hljs">L01XE06 - dasatinib</code></pre>
> </section>
>
>
>
> <section id="gi-bleeding">
> <h4 id="a-4-7-upper-gastrointestinal-bleeding-or-peptic-ulcer-icd-10-cm"><bdi class="secno">A.4.7 </bdi>upper gastrointestinal bleeding or peptic ulcer (ICD-10-CM)<a class="self-link" aria-label="??" href="#gi-bleeding"></a></h4>
> <pre aria-busy="false"><code class="hljs css"><span class="hljs-selector-tag">k92</span><span class="hljs-selector-class">.2</span> ??? <span class="hljs-selector-tag">Gastrointestinal</span> <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">unspecified</span>
> <span class="hljs-selector-tag">k25</span><span class="hljs-selector-class">.0</span> ??? <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">gastric</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">k25</span><span class="hljs-selector-class">.2</span> ??? <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">gastric</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">perforation</span>
> <span class="hljs-selector-tag">k25</span><span class="hljs-selector-class">.4</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">or</span> <span class="hljs-selector-tag">unspecified</span> <span class="hljs-selector-tag">gastric</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">k25</span><span class="hljs-selector-class">.6</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">or</span> <span class="hljs-selector-tag">unspecified</span> <span class="hljs-selector-tag">gastric</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">both</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">perforation</span>
> <span class="hljs-selector-tag">k26</span><span class="hljs-selector-class">.0</span> ??? <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">duodenal</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">k26</span><span class="hljs-selector-class">.2</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">duodenal</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">perforation</span>
> <span class="hljs-selector-tag">k26</span><span class="hljs-selector-class">.4</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">duodenal</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">k26</span><span class="hljs-selector-class">.6</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">duodenal</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">perforation</span>
> <span class="hljs-selector-tag">k27</span><span class="hljs-selector-class">.0</span> ??? <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">peptic</span> <span class="hljs-selector-tag">ulcer</span>, <span class="hljs-selector-tag">site</span> <span class="hljs-selector-tag">unspecified</span>, <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">k27</span><span class="hljs-selector-class">.2</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">peptic</span> <span class="hljs-selector-tag">ulcer</span>, <span class="hljs-selector-tag">site</span> <span class="hljs-selector-tag">unspecified</span>, <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">perforation</span>
> <span class="hljs-selector-tag">k27</span><span class="hljs-selector-class">.4</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">peptic</span> <span class="hljs-selector-tag">ulcer</span>, <span class="hljs-selector-tag">site</span> <span class="hljs-selector-tag">unspecified</span>, <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">k27</span><span class="hljs-selector-class">.6</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">peptic</span> <span class="hljs-selector-tag">ulcer</span>, <span class="hljs-selector-tag">site</span> <span class="hljs-selector-tag">unspecified</span>, <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">perforation</span>
> <span class="hljs-selector-tag">k28</span><span class="hljs-selector-class">.0</span> ??? <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">gastrojejunel</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">k28</span><span class="hljs-selector-class">.2</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">gastrojejunel</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">perforation</span>
> <span class="hljs-selector-tag">k28</span><span class="hljs-selector-class">.4</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">gastrojejunel</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">k28</span><span class="hljs-selector-class">.6</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">gastrojejunel</span> <span class="hljs-selector-tag">ulcer</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">perforation</span>
> <span class="hljs-selector-tag">k29</span><span class="hljs-selector-class">.01</span> ??? <span class="hljs-selector-tag">Acute</span> <span class="hljs-selector-tag">gastritis</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">bleeding</span>
> <span class="hljs-selector-tag">k29</span><span class="hljs-selector-class">.31</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">gastritis</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">bleeding</span>
> <span class="hljs-selector-tag">k29</span><span class="hljs-selector-class">.41</span> ??? <span class="hljs-selector-tag">Chronic</span> <span class="hljs-selector-tag">atrophic</span> <span class="hljs-selector-tag">gastritis</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">bleeding</span>
> <span class="hljs-selector-tag">k29</span><span class="hljs-selector-class">.51</span> ??? <span class="hljs-selector-tag">Unspecified</span> <span class="hljs-selector-tag">chronic</span> <span class="hljs-selector-tag">gastritis</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">bleeding</span>
> <span class="hljs-selector-tag">k29</span><span class="hljs-selector-class">.61</span> ??? <span class="hljs-selector-tag">Other</span> <span class="hljs-selector-tag">gastritis</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">bleeding</span>
> <span class="hljs-selector-tag">k29</span><span class="hljs-selector-class">.71</span> ??? <span class="hljs-selector-tag">Gastritis</span>, <span class="hljs-selector-tag">unspecified</span>, <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">bleeding</span>
> <span class="hljs-selector-tag">k29</span><span class="hljs-selector-class">.81</span> ??? <span class="hljs-selector-tag">Duodenitis</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">bleeding</span>
> <span class="hljs-selector-tag">k29</span><span class="hljs-selector-class">.91</span> ??? <span class="hljs-selector-tag">Gastroduodenitis</span>, <span class="hljs-selector-tag">unspecified</span>, <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">bleeding</span>
> <span class="hljs-selector-tag">k31</span><span class="hljs-selector-class">.811</span> ??? <span class="hljs-selector-tag">Angiodysplasia</span> ???<span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">stomach</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">duodenum</span> <span class="hljs-selector-tag">with</span> <span class="hljs-selector-tag">bleeding</span>
> <span class="hljs-selector-tag">k31</span><span class="hljs-selector-class">.82</span> ??? <span class="hljs-selector-tag">Dieulafoy</span> <span class="hljs-selector-tag">lesion</span> (<span class="hljs-selector-tag">hemorrhagic</span>) <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">stomach</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">duodenum</span></code></pre>
> </section>
>
> <section id="imatinib">
> <h4 id="a-4-8-imatinib-atc"><bdi class="secno">A.4.8 </bdi>imatinib (ATC)<a class="self-link" aria-label="??" href="#imatinib"></a></h4>
> <pre aria-busy="false"><code class="hljs">L01XE01 - imatinib</code></pre>
> </section>
>
>
> <section id="icran-hemm">
> <h4 id="a-4-9-intracranial-hemorrhage-icd-10-cm"><bdi class="secno">A.4.9 </bdi>intracranial hemorrhage (ICD-10-CM)<a class="self-link" aria-label="??" href="#icran-hemm"></a></h4>
> <pre aria-busy="false"><code class="hljs css"><span class="hljs-selector-tag">I62</span><span class="hljs-selector-class">.0</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">subdural</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">I62</span><span class="hljs-selector-class">.1</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">extradural</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">I62</span><span class="hljs-selector-class">.9</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Nontraumatic</span> <span class="hljs-selector-tag">intracranial</span> <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">unspecified</span>
> <span class="hljs-selector-tag">I69</span><span class="hljs-selector-class">.2</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Sequelae</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">other</span> <span class="hljs-selector-tag">nontraumatic</span> <span class="hljs-selector-tag">intracranial</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">P10</span><span class="hljs-selector-class">.0</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Subdural</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">due</span> <span class="hljs-selector-tag">to</span> <span class="hljs-selector-tag">birth</span> <span class="hljs-selector-tag">injury</span>
> <span class="hljs-selector-tag">P10</span><span class="hljs-selector-class">.1</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Cerebral</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">due</span> <span class="hljs-selector-tag">to</span> <span class="hljs-selector-tag">birth</span> <span class="hljs-selector-tag">injury</span>
> <span class="hljs-selector-tag">P10</span><span class="hljs-selector-class">.2</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intraventricular</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">due</span> <span class="hljs-selector-tag">to</span> <span class="hljs-selector-tag">birth</span> <span class="hljs-selector-tag">injury</span>
> <span class="hljs-selector-tag">P10</span><span class="hljs-selector-class">.3</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Subarachnoid</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">due</span> <span class="hljs-selector-tag">to</span> <span class="hljs-selector-tag">birth</span> <span class="hljs-selector-tag">injury</span>
> <span class="hljs-selector-tag">P10</span><span class="hljs-selector-class">.4</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Tentorial</span> <span class="hljs-selector-tag">tear</span> <span class="hljs-selector-tag">due</span> <span class="hljs-selector-tag">to</span> <span class="hljs-selector-tag">birth</span> <span class="hljs-selector-tag">injury</span>
> <span class="hljs-selector-tag">P10</span><span class="hljs-selector-class">.8</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Other</span> <span class="hljs-selector-tag">intracranial</span> <span class="hljs-selector-tag">lacerations</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">hemorrhages</span> <span class="hljs-selector-tag">due</span> <span class="hljs-selector-tag">to</span> <span class="hljs-selector-tag">birth</span> <span class="hljs-selector-tag">injury</span>
> <span class="hljs-selector-tag">P10</span><span class="hljs-selector-class">.9</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Unspecified</span> <span class="hljs-selector-tag">intracranial</span> <span class="hljs-selector-tag">laceration</span> <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">due</span> <span class="hljs-selector-tag">to</span> <span class="hljs-selector-tag">birth</span> <span class="hljs-selector-tag">injury</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.0</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intraventricular</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">grade</span> 1, <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.1</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intraventricular</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">grade</span> 2, <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.2</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intraventricular</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span>, <span class="hljs-selector-tag">grade</span> 3 <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">grade</span> 4, <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.3</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Unspecified</span> <span class="hljs-selector-tag">intraventricular</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.4</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intracerebral</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.5</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Subarachnoid</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.6</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Cerebellar</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">and</span> <span class="hljs-selector-tag">posterior</span> <span class="hljs-selector-tag">fossa</span> <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.8</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Other</span> <span class="hljs-selector-tag">intracranial</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhages</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>
> <span class="hljs-selector-tag">P52</span><span class="hljs-selector-class">.9</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Intracranial</span> (<span class="hljs-selector-tag">nontraumatic</span>) <span class="hljs-selector-tag">hemorrhage</span> <span class="hljs-selector-tag">of</span> <span class="hljs-selector-tag">newborn</span>, <span class="hljs-selector-tag">unspecified</span>
> <span class="hljs-selector-tag">S06</span><span class="hljs-selector-class">.5</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Traumatic</span> <span class="hljs-selector-tag">subdural</span> <span class="hljs-selector-tag">hemorrhage</span>
> <span class="hljs-selector-tag">S06</span><span class="hljs-selector-class">.8</span> <span class="hljs-selector-tag">-</span> <span class="hljs-selector-tag">Other</span> <span class="hljs-selector-tag">specified</span> <span class="hljs-selector-tag">intracranial</span> <span class="hljs-selector-tag">injuries</span></code></pre>
> </section>
>
> <section id="misoprostol">
> <h4 id="a-4-10-misoprostol-rxnorm"><bdi class="secno">A.4.10 </bdi>misoprostol (RxNorm)<a class="self-link" aria-label="??" href="#misoprostol"></a></h4>
> <pre aria-busy="false"><code class="hljs">42331 - Misoprostol</code></pre>
> </section>
>
> <section id="nilotinib">
> <h4 id="a-4-11-nilotinib-atc"><bdi class="secno">A.4.11 </bdi>nilotinib (ATC)<a class="self-link" aria-label="??" href="#nilotinib"></a></h4>
> <pre aria-busy="false"><code class="hljs">L01XE08 - nilotinib</code></pre>
> </section>
>
>
> <section id="NSAIDS-drugs">
> <h4 id="a-4-12-systemic-non-steroidal-anti-inflammatory-drugs-nsaids-rxnorm"><bdi class="secno">A.4.12 </bdi>Systemic non-steroidal anti-inflammatory drugs (NSAIDs) (RxNorm)<a class="self-link" aria-label="??" href="#NSAIDS-drugs"></a></h4>
> <pre aria-busy="false"><code class="hljs">1665675 - 1 ML Ketorolac Tromethamine 15 MG/ML Cartridge
> 860092 - 1 ML Ketorolac Tromethamine 15 MG/ML Injection
> 860113 - 1 ML Ketorolac Tromethamine 15 MG/ML Prefilled Syringe
> 1665679 - 1 ML Ketorolac Tromethamine 30 MG/ML Cartridge
> 1665461 - 1 ML Ketorolac Tromethamine 30 MG/ML Injection
> 860114 - 1 ML Ketorolac Tromethamine 30 MG/ML Prefilled Syringe
> 1367426 - 12 HR Naproxen sodium 220 MG / Pseudoephedrine Hydrochloride 120 MG Extended Release Oral Tablet
> 1665682 - 2 ML Ketorolac Tromethamine 30 MG/ML Cartridge
> 1665459 - 2 ML Ketorolac Tromethamine 30 MG/ML Injection
> 860115 - 2 ML Ketorolac Tromethamine 30 MG/ML Prefilled Syringe
> 855657 - 24 HR Diclofenac Sodium 100 MG Extended Release Oral Tablet
> 310245 - 24 HR Etodolac 400 MG Extended Release Oral Tablet
> 359500 - 24 HR Etodolac 500 MG Extended Release Oral Tablet
> 310247 - 24 HR Etodolac 600 MG Extended Release Oral Tablet
> 314059 - 24 HR Ketoprofen 100 MG Extended Release Oral Capsule
> 311230 - 24 HR Ketoprofen 150 MG Extended Release Oral Capsule
> 359697 - 24 HR Ketoprofen 200 MG Extended Release Oral Capsule
> 433845 - 24 HR Naproxen 1000 MG Extended Release Oral Tablet
> 1116320 - 24 HR Naproxen 375 MG Extended Release Oral Tablet
> 1116339 - 24 HR Naproxen 500 MG Extended Release Oral Tablet
> 1116349 - 24 HR Naproxen 750 MG Extended Release Oral Tablet
> 992420 - 8 ACTUAT Ketorolac Tromethamine 15.8 MG/ACTUAT Nasal Inhaler
> 205322 - celecoxib 100 MG Oral Capsule
> 205323 - celecoxib 200 MG Oral Capsule
> 349514 - celecoxib 400 MG Oral Capsule
> 686379 - celecoxib 50 MG Oral Capsule
> 1297390 - Chlorpheniramine Maleate 2 MG / Ibuprofen 200 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet
> 1310503 - Chlorpheniramine Maleate 4 MG / Ibuprofen 200 MG / Phenylephrine Hydrochloride 10 MG Oral Tablet
> 1442116 - Diclofenac 18 MG Oral Capsule
> 1442128 - Diclofenac 35 MG Oral Capsule
> 859063 - Diclofenac Potassium 1.67 MG/ML Oral Solution
> 858342 - Diclofenac Potassium 25 MG Oral Capsule
> 857702 - Diclofenac Potassium 25 MG Oral Tablet
> 855942 - Diclofenac Potassium 50 MG Oral Tablet
> 1234493 - Diclofenac Sodium 100 MG Oral Capsule
> 857696 - Diclofenac Sodium 100 MG Rectal Suppository
> 857698 - Diclofenac Sodium 12.5 MG Rectal Suppository
> 855664 - Diclofenac Sodium 25 MG Delayed Release Oral Tablet
> 857703 - Diclofenac Sodium 25 MG Rectal Suppository
> 1599787 - Diclofenac Sodium 37.5 MG/ML Injectable Solution
> 857706 - Diclofenac Sodium 50 MG / Misoprostol 0.2 MG Oral Tablet
> 855906 - Diclofenac Sodium 50 MG Delayed Release Oral Tablet
> 857709 - Diclofenac Sodium 50 MG Rectal Suppository
> 1359105 - Diclofenac Sodium 75 MG / Misoprostol 0.2 MG Oral Tablet
> 855926 - Diclofenac Sodium 75 MG Delayed Release Oral Tablet
> 895664 - Diphenhydramine Citrate 38 MG / Ibuprofen 200 MG Oral Tablet
> 901814 - Diphenhydramine Hydrochloride 25 MG / Ibuprofen 200 MG Oral Capsule
> 1550957 - Diphenhydramine Hydrochloride 25 MG / Naproxen sodium 220 MG Oral Tablet
> 994005 - Esomeprazole 20 MG / Naproxen 375 MG Delayed Release Oral Tablet
> 994008 - Esomeprazole 20 MG / Naproxen 500 MG Delayed Release Oral Tablet
> 197684 - Etodolac 200 MG Oral Capsule
> 197685 - Etodolac 300 MG Oral Capsule
> 197686 - Etodolac 400 MG Oral Tablet
> 199390 - Etodolac 500 MG Oral Tablet
> 1100066 - Famotidine 26.6 MG / Ibuprofen 800 MG Oral Tablet
> 199740 - fenbufen 450 MG Oral Tablet
> 197694 - Fenoprofen 200 MG Oral Capsule
> 858116 - Fenoprofen 400 MG Oral Capsule
> 310291 - Fenoprofen 600 MG Oral Tablet
> 197724 - Flurbiprofen 100 MG Oral Tablet
> 199749 - Flurbiprofen 200 MG Extended Release Oral Capsule
> 197725 - Flurbiprofen 50 MG Oral Tablet
> 859315 - Hydrocodone Bitartrate 10 MG / Ibuprofen 200 MG Oral Tablet
> 858770 - Hydrocodone Bitartrate 2.5 MG / Ibuprofen 200 MG Oral Tablet
> 858778 - Hydrocodone Bitartrate 5 MG / Ibuprofen 200 MG Oral Tablet
> 858798 - Hydrocodone Bitartrate 7.5 MG / Ibuprofen 200 MG Oral Tablet
> 310963 - Ibuprofen 100 MG Chewable Tablet
> 198405 - Ibuprofen 100 MG Oral Tablet
> 854183 - Ibuprofen 100 MG/ML Injectable Solution
> 1310487 - Ibuprofen 20 MG/ML / Pseudoephedrine Hydrochloride 3 MG/ML Oral Suspension
> 197803 - Ibuprofen 20 MG/ML Oral Suspension
> 1369775 - Ibuprofen 200 MG / Phenylephrine Hydrochloride 10 MG Oral Tablet
> 1299018 - Ibuprofen 200 MG / Pseudoephedrine Hydrochloride 30 MG Oral Capsule
> 1299021 - Ibuprofen 200 MG / Pseudoephedrine Hydrochloride 30 MG Oral Tablet
> 310964 - Ibuprofen 200 MG Oral Capsule
> 310965 - Ibuprofen 200 MG Oral Tablet
> 204442 - Ibuprofen 40 MG/ML Oral Suspension
> 1049589 - Ibuprofen 400 MG / Oxycodone Hydrochloride 5 MG Oral Tablet
> 197805 - Ibuprofen 400 MG Oral Tablet
> 197806 - Ibuprofen 600 MG Oral Tablet
> 197807 - Ibuprofen 800 MG Oral Tablet
> 346508 - Indomethacin 1 MG/ML Injectable Solution
> 199549 - Indomethacin 100 MG Rectal Suppository
> 1490727 - Indomethacin 20 MG Oral Capsule
> 197817 - Indomethacin 25 MG Oral Capsule
> 1491529 - Indomethacin 40 MG Oral Capsule
> 310991 - Indomethacin 5 MG/ML Oral Suspension
> 197818 - Indomethacin 50 MG Oral Capsule
> 197819 - Indomethacin 50 MG Rectal Suppository
> 310992 - Indomethacin 75 MG Extended Release Oral Capsule
> 199321 - Ketoprofen 100 MG Oral Capsule
> 249482 - Ketoprofen 100 MG Oral Tablet
> 199553 - Ketoprofen 100 MG Rectal Suppository
> 431823 - Ketoprofen 150 MG Extended Release Oral Tablet
> 429192 - Ketoprofen 25 MG Oral Tablet
> 197855 - Ketoprofen 50 MG Oral Capsule
> 247630 - Ketoprofen 50 MG Rectal Suppository
> 197856 - Ketoprofen 75 MG Oral Capsule
> 834022 - Ketorolac Tromethamine 10 MG Oral Tablet
> 860096 - Ketorolac Tromethamine 30 MG/ML Injectable Solution
> 618552 - Meclofenamate 100 MG Oral Capsule
> 618557 - Meclofenamate 50 MG Oral Capsule
> 597406 - meloxicam 1.5 MG/ML Oral Suspension
> 152695 - meloxicam 15 MG Oral Tablet
> 311486 - meloxicam 7.5 MG Oral Tablet
> 311892 - nabumetone 500 MG Oral Tablet
> 311893 - nabumetone 750 MG Oral Tablet
> 245420 - Naproxen 125 MG Oral Tablet
> 311913 - Naproxen 25 MG/ML Oral Suspension
> 198013 - Naproxen 250 MG Oral Tablet
> 603103 - Naproxen 375 MG Delayed Release Oral Tablet
> 198012 - Naproxen 375 MG Oral Tablet
> 311915 - Naproxen 500 MG Delayed Release Oral Tablet
> 198014 - Naproxen 500 MG Oral Tablet
> 199490 - Naproxen 500 MG Rectal Suppository
> 1112231 - Naproxen sodium 220 MG Oral Capsule
> 849574 - Naproxen sodium 220 MG Oral Tablet
> 849398 - Naproxen sodium 275 MG Oral Tablet
> 849450 - Naproxen sodium 500 MG / Sumatriptan 85 MG Oral Tablet
> 849431 - Naproxen sodium 550 MG Oral Tablet
> 1653765 - Naproxen sodium 60 MG / Sumatriptan 10 MG Oral Tablet
> 312132 - oxaprozin 600 MG Oral Tablet
> 198107 - Piroxicam 10 MG Oral Capsule
> 199559 - Piroxicam 10 MG Oral Tablet
> 247066 - Piroxicam 10 MG Rectal Suppository
> 198108 - Piroxicam 20 MG Oral Capsule
> 199560 - Piroxicam 20 MG Oral Tablet
> 105942 - Piroxicam 20 MG Rectal Suppository
> 199279 - Sulindac 100 MG Oral Tablet
> 198238 - Sulindac 150 MG Oral Tablet
> 198239 - Sulindac 200 MG Oral Tablet
> 199516 - tenoxicam 10 MG Oral Tablet
> 105954 - tenoxicam 20 MG Oral Tablet
> 250197 - tenoxicam 20 MG Rectal Suppository
> 198295 - Tolmetin 200 MG Oral Tablet
> 198296 - Tolmetin 400 MG Oral Capsule
> 198297 - Tolmetin 600 MG Oral Tablet
> 349319 - valdecoxib 10 MG Oral Tablet
> 349321 - valdecoxib 20 MG Oral Tablet</code></pre>
> </section>
>
>
> <section id="ponatinib">
> <h4 id="a-4-13-ponatinib-atc"><bdi class="secno">A.4.13 </bdi>ponatinib (ATC)<a class="self-link" aria-label="??" href="#ponatinib"></a></h4>
> <pre aria-busy="false"><code class="hljs">L01XE24 - ponatinib</code></pre>
> </section>
>
>
> <section id="proton-pump-inhibitor-atc">
> <h4 id="a-4-14-proton-pump-inhibitor-atc"><bdi class="secno">A.4.14 </bdi>proton pump inhibitor (ATC)<a class="self-link" aria-label="??" href="#proton-pump-inhibitor-atc"></a></h4>
> <pre aria-busy="false"><code class="hljs">A02BC06 - dexlansoprazole
> A02BC05 - esomeprazole
> A02BC03 - lansoprazole
> A02BC01 - omeprazole
> A02BC02 - pantoprazole
> A02BC04 - rabeprazole</code></pre>
> </section>
>
>
> <section id="proton-pump-inhibitor">
> <h4 id="a-4-15-proton-pump-inhibitor-rxnorm"><bdi class="secno">A.4.15 </bdi>proton pump inhibitor (RxNorm)<a class="self-link" aria-label="??" href="#proton-pump-inhibitor"></a></h4>
> <pre aria-busy="false"><code class="hljs">816346 - Dexlansoprazole
> 283742 - Esomeprazole
> 17128 - Lansoprazole
> 7646 - Omeprazole
> 40790 - Pantoprazole
> 114979 - Rabeprazole</code></pre>
> </section>
>
>
>
> <section id="systemic-cortico">
> <h4 id="a-4-16-systemic-corticosteroids-rxnorm"><bdi class="secno">A.4.16 </bdi>systemic corticosteroids (RxNorm)<a class="self-link" aria-label="??" href="#systemic-cortico"></a></h4>
> <pre aria-busy="false"><code class="hljs">1514 - Betamethasone
> 2878 - Cortisone
> 3264 - Dexamethasone
> 4452 - Fludrocortisone
> 5492 - Hydrocortisone
> 6902 - Methylprednisolone
> 8638 - prednisolone
> 8640 - Prednisone
> 10759 - Triamcinolone
> 1085795 - 100 ACTUAT Triamcinolone Acetonide 0.055 MG/ACTUAT Nasal Inhaler
> 833245 - 120 ACTUAT Triamcinolone Acetonide 0.05 MG/ACTUAT Nasal Inhaler
> 1085798 - 120 ACTUAT Triamcinolone Acetonide 0.055 MG/ACTUAT Nasal Inhaler
> 1493473 - 60 ACTUAT Triamcinolone Acetonide 0.055 MG/ACTUAT Nasal Inhaler
> 670084 - Betamethasone 0.12 MG/ML Oral Solution
> 308709 - Betamethasone 0.6 MG Oral Tablet
> 578803 - Betamethasone 3 MG/ML / Betamethasone acetate 3 MG/ML Injectable Suspension
> 197543 - Cortisone 10 MG Oral Tablet
> 197545 - Cortisone 5 MG Oral Tablet
> 828248 - cortisone acetate 25 MG Oral Tablet
> 309686 - Dexamethasone 0.1 MG/ML Oral Solution
> 197577 - Dexamethasone 0.5 MG Oral Tablet
> 854177 - Dexamethasone 0.7 MG Drug Implant
> 343033 - Dexamethasone 0.75 MG Oral Tablet
> 197579 - Dexamethasone 1 MG Oral Tablet
> 309684 - Dexamethasone 1 MG/ML Oral Solution
> 197580 - Dexamethasone 1.5 MG Oral Tablet
> 309696 - Dexamethasone 10 MG/ML Injectable Solution
> 197581 - Dexamethasone 2 MG Oral Tablet
> 197582 - Dexamethasone 4 MG Oral Tablet
> 197583 - Dexamethasone 6 MG Oral Tablet
> 1116927 - Dexamethasone phosphate 4 MG/ML Injectable Solution
> 313979 - Fludrocortisone 0.1 MG Oral Tablet
> 260192 - Hydrocortisone 0.01 MG/MG Rectal Ointment
> 310878 - Hydrocortisone 1.67 MG/ML Enema
> 197782 - Hydrocortisone 10 MG Oral Tablet
> 310868 - Hydrocortisone 10 MG/ML Rectal Cream
> 1494032 - Hydrocortisone 10 MG/ML Vaginal Cream
> 310899 - Hydrocortisone 2 MG/ML Oral Suspension
> 197783 - Hydrocortisone 20 MG Oral Tablet
> 1246528 - Hydrocortisone 25 MG/ML / Pramoxine hydrochloride 10 MG/ML Rectal Cream
> 310879 - Hydrocortisone 25 MG/ML Rectal Cream
> 199320 - Hydrocortisone 4 MG Oral Tablet
> 197787 - Hydrocortisone 5 MG Oral Tablet
> 238755 - Hydrocortisone 50 MG/ML Injectable Solution
> 1012221 - hydrocortisone acetate 0.0055 MG/MG / Lidocaine Hydrochloride 0.028 MG/MG Rectal Gel
> 1012223 - hydrocortisone acetate 0.025 MG/MG / Lidocaine Hydrochloride 0.03 MG/MG Rectal Gel
> 1012229 - hydrocortisone acetate 10 MG/ML / Lidocaine Hydrochloride 30 MG/ML Rectal Cream
> 1235049 - hydrocortisone acetate 10 MG/ML / Pramoxine hydrochloride 10 MG/ML Rectal Cream
> 828362 - hydrocortisone acetate 10 MG/ML / Pramoxine hydrochloride 10 MG/ML Rectal Foam
> 1545172 - hydrocortisone acetate 100 MG/ML Rectal Foam
> 1114854 - hydrocortisone acetate 18.5 MG/ML / Pramoxine hydrochloride 11.5 MG/ML Rectal Cream
> 1012233 - hydrocortisone acetate 20 MG/ML / Lidocaine Hydrochloride 20 MG/ML Rectal Cream
> 1094443 - hydrocortisone acetate 23.5 MG/ML / Pramoxine hydrochloride 10 MG/ML Rectal Cream
> 1291082 - hydrocortisone acetate 25 MG Rectal Suppository
> 1294025 - hydrocortisone acetate 25 MG/ML / Pramoxine hydrochloride 10 MG/ML Rectal Cream
> 1291085 - hydrocortisone acetate 30 MG Rectal Suppository
> 1012235 - hydrocortisone acetate 5 MG/ML / Lidocaine Hydrochloride 30 MG/ML Rectal Cream
> 199771 - Methylprednisolone 100 MG Oral Tablet
> 328161 - Methylprednisolone 16 MG Oral Tablet
> 197969 - Methylprednisolone 2 MG Oral Tablet
> 197970 - Methylprednisolone 24 MG Oral Tablet
> 197971 - Methylprednisolone 32 MG Oral Tablet
> 259966 - Methylprednisolone 4 MG Oral Tablet
> 311659 - Methylprednisolone 40 MG/ML Injectable Solution
> 314099 - Methylprednisolone 62.5 MG/ML Injectable Solution
> 1357886 - Methylprednisolone 65.4 MG/ML Injectable Solution
> 197973 - Methylprednisolone 8 MG Oral Tablet
> 1358510 - methylprednisolone acetate 20 MG/ML Injectable Suspension
> 1358610 - methylprednisolone acetate 40 MG/ML Injectable Suspension
> 1358617 - methylprednisolone acetate 80 MG/ML Injectable Suspension
> 199343 - prednisolone 1 MG Oral Tablet
> 312614 - prednisolone 1 MG/ML Oral Solution
> 643123 - prednisolone 10 MG Disintegrating Oral Tablet
> 643125 - prednisolone 15 MG Disintegrating Oral Tablet
> 794979 - prednisolone 2 MG/ML Oral Solution
> 429199 - prednisolone 20 MG Oral Tablet
> 199967 - prednisolone 25 MG Oral Tablet
> 283077 - prednisolone 3 MG/ML Oral Solution
> 793099 - prednisolone 3 MG/ML Oral Suspension
> 643127 - prednisolone 30 MG Disintegrating Oral Tablet
> 702306 - prednisolone 4 MG/ML Oral Solution
> 198142 - prednisolone 5 MG Oral Tablet
> 249066 - prednisolone 5 MG/ML Oral Solution
> 1303125 - Prednisone 1 MG Delayed Release Oral Tablet
> 198144 - Prednisone 1 MG Oral Tablet
> 315187 - Prednisone 1 MG/ML Oral Solution
> 198145 - Prednisone 10 MG Oral Tablet
> 1303132 - Prednisone 2 MG Delayed Release Oral Tablet
> 198146 - Prednisone 2.5 MG Oral Tablet
> 312615 - Prednisone 20 MG Oral Tablet
> 1303135 - Prednisone 5 MG Delayed Release Oral Tablet
> 312617 - Prednisone 5 MG Oral Tablet
> 205301 - Prednisone 5 MG/ML Oral Solution
> 198148 - Prednisone 50 MG Oral Tablet
> 198301 - Triamcinolone 1 MG Oral Tablet
> 1085728 - Triamcinolone Acetonide 0.001 MG/MG Oral Paste
> 1085750 - Triamcinolone Acetonide 10 MG/ML Injectable Suspension
> 1085754 - Triamcinolone Acetonide 40 MG/ML Injectable Suspension
> 1085996 - triamcinolone hexacetonide 20 MG/ML Injectable Suspension
> 1085992 - triamcinolone hexacetonide 5 MG/ML Injectable Suspension</code></pre>
> </section>
>
>
> <section id="topical-diclof">
> <h4 id="a-4-17-topical-or-opthalamic-diclofenac-rxnorm"><bdi class="secno">A.4.17 </bdi>topical or opthalamic diclofenac (RxNorm)<a class="self-link" aria-label="??" href="#topical-diclof"></a></h4>
> <pre aria-busy="false"><code class="hljs">1234735 - diclofenac epolamine 0.0129 MG/MG Topical Gel
> 854801 - Diclofenac Sodium Ophthalmic Solution</code></pre>
> </section>
>
> <section id="TKIs">
> <h4 id="a-4-18-tyrosine-kinase-inhibitors-tkis-atc"><bdi class="secno">A.4.18 </bdi>tyrosine kinase inhibitors (TKIs) (ATC)<a class="self-link" aria-label="??" href="#TKIs"></a></h4>
> <pre aria-busy="false"><code class="hljs">L01XE04 - sunitinib
> L01XC03 - trastuzumab
> L01XC14 - ado-trastuzumab emtansine</code></pre>
> </section>
>
>
> <section id="warfarins">
> <h4 id="a-4-19-warfarin-rxnorm"><bdi class="secno">A.4.19 </bdi>warfarin (RxNorm)<a class="self-link" aria-label="??" href="#warfarins"></a></h4>
> <pre aria-busy="false"><code class="hljs">855288 - Warfarin Sodium 1 MG Oral Tablet
> 855296 - Warfarin Sodium 10 MG Oral Tablet
> 855302 - Warfarin Sodium 2 MG Oral Tablet
> 855308 - Warfarin Sodium 2 MG/ML Injectable Solution
> 855312 - Warfarin Sodium 2.5 MG Oral Tablet
> 855318 - Warfarin Sodium 3 MG Oral Tablet
> 855324 - Warfarin Sodium 4 MG Oral Tablet
> 855332 - Warfarin Sodium 5 MG Oral Tablet
> 855338 - Warfarin Sodium 6 MG Oral Tablet
> 855344 - Warfarin Sodium 7.5 MG Oral Tablet
> 11289 - Warfarin</code></pre>
> </section>
> </section>
>
> <section id="appendix-json" class="informative">
> <h3 id="a-5-json-examples"><bdi class="secno">A.5 </bdi>JSON Examples<a class="self-link" aria-label="??" href="#appendix-json"></a></h3><p><em>This section is non-normative.</em></p>
>
> <p>Here, we present prototype JSON documents for the two
> example PDDIs described in Section <a href="#examples" class="sec-ref">?? <bdi class="secno">5. </bdi>Examples of the use of the minimal information model</a>. These
> examples should be considered informative (non-normative) and
> subject to revision.
> </p>
> <p>
> Both of the examples below follow the recommendations provided in
> this Community Group Report. The examples are intended to show a
> simple approach to applying the recommendations to PDDIs using
> JSON, the Web Annotation Data Model [<cite><a class="bibref" href="#bib-web-annotation-model" title="Web Annotation Data Model">web-annotation-model</a></cite>], and
> BibJSON [<cite><a class="bibref" href="#bib-bib-json" title="How to do BibJSON">bib-json</a></cite>].
> </p>
> <p>
> An entirely different approach that is also compliant with the
> recommendations in this Report is the HL7 CDS Workgroup's draft
> Implementation Guide for PDDI CDS as a service
> [<cite><a class="bibref" href="#bib-hl7-pddi-cds-ig-git" title="Potential Drug-Drug Interaction (PDDI) CDS Implementation Guide project">hl7-pddi-cds-ig-git</a></cite>]. The Implentation Guide integrates the
> PDDI minimum information model into PDDI CDS using the health
> information technology standards <a href="https://www.hl7.org/fhir/" target="new">FHIR</a>, <a href="http://wiki.hl7.org/index.php?title=Clinical_Quality_Language" target="new">Clinical Quality Language</a>, and <a href="https://cds-hooks.org/" target="new">CDS Hooks</a>.
> </p>
> <p>
> The following
> non-normative conventions apply to the examples shown below:
> </p>
> <ol>
> <li> The core information items are represented as key-value pairs.</li>
> <li> The string labels of the core information items (e.g., "drugs involved", "clinical consequences", etc.) are the keys. </li>
> <li> An identifier for the core information item class is provided in the "type" field of the value assocated with each infomation item. For example, the type of any value assigned to "clinical consequences" is "MPIO_0000003". A persistent URL can be constructed from each identifier by concatenating "http://purl.obolibrary.org/obo/" to the beginning of the identifier string (e.g., <a href="http://purl.obolibrary.org/obo/MPIO_0000003" target="new">http://purl.obolibrary.org/obo/MPIO_0000003</a>.</li>
> <li>A unique URN identifier is used to identify each information item instance in the "id" field of the value assocated with each infomation item.</li>
> <li>The "display" field of the value assocated with each infomation item shows human readable content relevant to the associated information item </li>
> <li>There are many cases the unstructured text in a "display" field refers to an entity that is more clearly defined using a value set. In such cases, the value object has a "concept set references" field that holds a list of objects that can be used to unambiguously associate text mentions with concept sets. These objects use the Web Annotation Data Model [<cite><a class="bibref" href="#bib-web-annotation-model" title="Web Annotation Data Model">web-annotation-model</a></cite>] as follows: </li>
> <ol>
> <li> The type of each object is a Web Annotation Data Model "TextQuoteSelector". </li>
> <li> The value assigned to the Web Annotation Data Model "exact" field is used to indicate the specific text mention that is being mapped </li>
> <li> The value assigned to the Web Annotation Data Model "body" field is an object that links the text mention to a concept set object provided within the JSON document. The concept set object is present in a list value assigned to the "concept sets" key within the same JSON document as the concept set reference. The the "value" field of the "body" of the concept set reference object holds the URN that uniquely identifies the specific concept set.</li>
> <ul><li> As an example, the following "clinical consequences" value has three concept set references for entities mentioned in the description. One for the mention of "gastrointestinal bleeding", one for the mention of "intracranial hemorrhage", and one for the mention of "cerebral hemorrhage". Each concept set reference object points to the exact value set using the URN assigned to the "value" field of the "body".</li>
> <div class="example" id="example-1">
> <div class="marker">
> <a class="self-link" href="#example-1">Example<bdi> 1</bdi></a>
> </div> <pre style="white-space: pre-wrap" aria-busy="false"><code class="hljs javascript"><span class="hljs-string">"clinical consequences"</span>: {
> <span class="hljs-string">"type"</span>: <span class="hljs-string">"MPIO_0000003"</span>,
> <span class="hljs-string">"id"</span>: <span class="hljs-string">"5476c5b5-b52b-4750-882d-cc47f4fa52f4"</span>,
> <span class="hljs-string">"display"</span>: <span class="hljs-string">"Increased risk of bleeding including gastrointestinal bleeding, intracranial hemorrhage, and cerebral hemorrhage"</span>,
> <span class="hljs-string">"concept set references"</span>: [
> {
> <span class="hljs-string">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-string">"exact"</span>: <span class="hljs-string">"gastrointestinal bleeding"</span>,
> <span class="hljs-string">"body"</span>: {
> <span class="hljs-string">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-string">"value"</span>: <span class="hljs-string">"af3209ab-082f-40e6-9c37-6f2945afa850"</span>
> }
> },
> {
> <span class="hljs-string">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-string">"exact"</span>: <span class="hljs-string">"intracranial hemorrhage"</span>,
> <span class="hljs-string">"body"</span>: {
> <span class="hljs-string">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-string">"value"</span>: <span class="hljs-string">"2b083e55-755c-432a-9d78-ac5f55787737"</span>
> }
> },
> {
> <span class="hljs-string">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-string">"exact"</span>: <span class="hljs-string">"cerebral hemorrhage"</span>,
> <span class="hljs-string">"body"</span>: {
> <span class="hljs-string">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-string">"value"</span>: <span class="hljs-string">"5d5cf201-0a37-4c10-8397-da1aa774811e"</span>
> }
> }
> ]}</code></pre>
> </div>
> </ul>
> <li> Whenever "evidence about a suspected drug-drug interaction" refers to a citable evidence item, a reference to that item is provided as BibJSON (a JSON version of BibTex) [<cite><a class="bibref" href="#bib-bib-json" title="How to do BibJSON">bib-json</a></cite>]</li>
>
> </ol>
> </ol>
>
> <section id="example-1-warfarin-and-systemic-non-steroidal-anti-inflammatory-drugs-nsaids">
> <h4 id="a-5-1-example-1-warfarin-and-systemic-non-steroidal-anti-inflammatory-drugs-nsaids"><bdi class="secno">A.5.1 </bdi>Example 1: warfarin and systemic non-steroidal anti-inflammatory drugs (NSAIDs)<a class="self-link" aria-label="??" href="#example-1-warfarin-and-systemic-non-steroidal-anti-inflammatory-drugs-nsaids"></a></h4>
> <div class="example" id="example-2-warfarin-and-systemic-non-steroidal-anti-inflammatory-drugs-nsaids">
> <div class="marker">
> <a class="self-link" href="#example-2-warfarin-and-systemic-non-steroidal-anti-inflammatory-drugs-nsaids">Example<bdi> 2</bdi></a><span class="example-title">: Warfarin and systemic non-steroidal anti-inflammatory drugs
> (NSAIDs)</span>
> </div> <pre style="white-space: pre-wrap" aria-busy="false"><code class="hljs json">{
> <span class="hljs-attr">"drugs involved"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"13d483d8-a955-49d1-af34-a762c6ad182c"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"7eecfe1a-073c-4af0-a14d-54b06d64455d"</span>
> }
> ],
> <span class="hljs-attr">"clinical consequences"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000003"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"5476c5b5-b52b-4750-882d-cc47f4fa52f4"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Increased risk of bleeding including gastrointestinal bleeding, intracranial hemorrhage, and cerebral hemorrhage"</span>,
> <span class="hljs-attr">"concept set references"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"upper gastrointestinal bleeding"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"af3209ab-082f-40e6-9c37-6f2945afa850"</span>
> }
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"intracranial hemorrhage"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"2b083e55-755c-432a-9d78-ac5f55787737"</span>
> }
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"cerebral hemorrhage"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"5d5cf201-0a37-4c10-8397-da1aa774811e"</span>
> }
> }
> ]
> },
> <span class="hljs-attr">"seriousness"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000009"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"06dea7b0-5cef-4587-86a2-54052a8d0457"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"serious"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Bleeding is a serious potential clinical consequence because it can result in death, life-threatening hospitalization, and disability."</span>
> },
> <span class="hljs-attr">"mechanism of interaction information"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000005"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"8a8ce6c0-c78e-4d38-bda2-835118f976ea"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Systemic non-steroidal anti-inflammatory drugs (NSAIDs) have antiplatelet effects which increase the bleeding risk when combined with oral anticoagulants such as warfarin. The antiplatelet effect of NSAIDs lasts only as long as the NSAID is present in the circulation, unlike aspirin's antiplatelet effect, which lasts for up to 2 weeks after aspirin is discontinued. NSAIDs also can cause peptic ulcers and most of the evidence for increased bleeding risk with NSAIDs plus warfarin is due to upper gastrointestinal bleeding (UGIB)."</span>,
> <span class="hljs-attr">"concept set references"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"Non-steroidal anti-inflammatory drugs (NSAIDs)"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"7eecfe1a-073c-4af0-a14d-54b06d64455d"</span>
> }
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"NSAIDs"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"7eecfe1a-073c-4af0-a14d-54b06d64455d"</span>
> }
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"warfarin"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"13d483d8-a955-49d1-af34-a762c6ad182c"</span>
> }
> }
> ]
> },
> <span class="hljs-attr">"recommended action"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000008"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"b05ddcfe-c72a-4009-ad7e-c89221bb1ec7"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"If the NSAID is being used as an analgesic or antipyretic, it would be prudent to use an alternative such as acetaminophen. In some people, acetaminophen can increase the anticoagulant effect of warfarin, so monitor the INR if acetaminophen is used in doses over 2 g/day for a few days. For more severe pain consider short-term opioids in place of the NSAID."</span>
> },
> <span class="hljs-attr">"frequency of exposure to the PDDI"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000007"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"f8885290-1507-40a5-85cb-247756cb0064"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Unknown"</span>
> },
> <span class="hljs-attr">"frequency of harm for persons who have been exposed to the PDDI"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000006"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"03853fb2-e398-42a0-a07b-a93141931bd4"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Unknown"</span>
> },
> <span class="hljs-attr">"modifying factors information"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000000"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"56a7ba39-467b-42c7-b117-485fecacb91d"</span>,
> <span class="hljs-attr">"expressionLogic"</span>: <span class="hljs-string">"human readable"</span>,
> <span class="hljs-attr">"members"</span>: [
> {
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"The NSAID is topical or ophthalmic diclofenac"</span>,
> <span class="hljs-attr">"operational classification statement"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000111"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"No special precautions."</span>
> },
> <span class="hljs-attr">"evidence about a suspected drug-drug interaction"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000004"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Topical diclofenac has relatively low systemic absorption; in one study a topical gel (16 g/day) produced about 6% of the absorption seen with systemic administration of 150 mg/day. A higher than recommended dose of topical gel (48 g/day) produced 20% of a systemic dose of diclofenac."</span>
> },
> <span class="hljs-attr">"concept set references"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"topical or ophthalmic diclofenac"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"484ef188-5765-408d-b8c3-f2f38ae8066c"</span>
> }
> }
> ]
> },
> {
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"The NSAID is NOT topical diclofenac but the patient is concomitantly taking a proton pump inhibitor or misoprostol"</span>,
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> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000111"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Assess risk and take action if necessary."</span>
> },
> <span class="hljs-attr">"evidence about a suspected drug-drug interaction"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000004"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Proton pump inhibitors and misoprostol may reduce the risk of UGIB in patients receiving NSAIDs and warfarin."</span>
> },
> <span class="hljs-attr">"concept set references"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"topical or ophthalmic diclofenac"</span>,
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> }
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"proton pump inhibitor"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"818e9fed-e18d-45de-b900-1edbedee8c89"</span>
> }
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"misoprostol"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"ab5731f3-a127-4ce7-bfe8-cfcafd6e3b86"</span>
> }
> }
> ]
> },
> {
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"The NSAID is NOT topical diclofenac, the patient is NOT concomitantly taking a proton pump inhibitor or misoprostol, and the patient 1) has a history of upper gastrointestinal bleeding (UGIB) or peptic ulcer or 2) age > 65 years old"</span>,
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000111"</span>,
> <span class="hljs-attr">"operational classification statement"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000111"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Use only if benefit outweighs risk."</span>
> },
> <span class="hljs-attr">"evidence about a suspected drug-drug interaction"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000004"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Patients with a history of UGIB or peptic ulcer may have an increased risk of UGIB from this interaction. The extent to which older age is an independent risk factor for UGIB due to these interactions is not firmly established, but UGIB in general is known to increase with age."</span>
> },
> <span class="hljs-attr">"concept set references"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"proton pump inhibitor"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"misoprostol"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"ab5731f3-a127-4ce7-bfe8-cfcafd6e3b86"</span>
> }
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"upper gastrointestinal bleeding (UGIB) or peptic ulcer"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
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> }
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> },
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> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"The NSAID is NOT topical diclofenac, the patient is NOT concomitantly taking a proton pump inhibitor or misoprostol, and the patient is concomitantly taking systemic corticosteroids, aldosterone antagonists, or high dose or multiple NSAIDs"</span>,
> <span class="hljs-attr">"operational classification statement"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000111"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Use only if benefit outweighs risk."</span>
> },
> <span class="hljs-attr">"evidence about a suspected drug-drug interaction"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000004"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Both corticosteroids and aldosterone antagonists have been shown to substantially increase the risk of UGIB in patients on NSAIDs, with relative risks of 12.8 and 11 respectively compared to a risk of 4.3 with NSAIDs alone [masclee-2014]."</span>,
> <span class="hljs-attr">"References"</span>: [
> {
> <span class="hljs-attr">"title"</span>: <span class="hljs-string">"Risk of upper gastrointestinal bleeding from different drug combinations"</span>,
> <span class="hljs-attr">"author"</span>: [
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Gwen MC Masclee "</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Vera E Valkhoff"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Preciosa M Coloma"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Maria de Ridder"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Silvana Romio"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Martijn J Schuemie"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Ron Herings"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Giampiero Mazzaglia"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Gino Picelli"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"L Scotti"</span>
> }
> ],
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"article"</span>,
> <span class="hljs-attr">"year"</span>: <span class="hljs-string">"2014"</span>,
> <span class="hljs-attr">"journal"</span>: {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Gastroenterology"</span>,
> <span class="hljs-attr">"volume"</span>: <span class="hljs-string">"147"</span>,
> <span class="hljs-attr">"number"</span>: <span class="hljs-string">"4"</span>,
> <span class="hljs-attr">"pages"</span>: <span class="hljs-string">"784--792"</span>
> },
> <span class="hljs-attr">"link"</span>: [
> {
> <span class="hljs-attr">"url"</span>: <span class="hljs-string">"https://www.gastrojournal.org/article/S0016-5085%2814%2900768-9/fulltext"</span>
> }
> ],
> <span class="hljs-attr">"identifier"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"doi"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"10.1053/j.gastro.2014.06.007"</span>
> }
> ]
> }
> ]
> },
> <span class="hljs-attr">"concept set references"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"topical or ophthalmic diclofenac"</span>,
> <span class="hljs-attr">"body"</span>: {
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
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> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"proton pump inhibitor"</span>,
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"misoprostol"</span>,
> <span class="hljs-attr">"body"</span>: {
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"corticosteroids"</span>,
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> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"aldosterone antagonists"</span>,
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> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"a32b4ed0-1aff-4520-a973-879f705a0366"</span>
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> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"systemic NSAIDs"</span>,
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> }
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> }
> ]
> },
> <span class="hljs-attr">"concept sets"</span>: [
> {
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"13d483d8-a955-49d1-af34-a762c6ad182c"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"warfarin"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"11289"</span>,
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"855288"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Warfarin Sodium 1 MG Oral Tablet"</span>
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> {
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> {
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> {
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> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> {
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> {
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> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"k29.41"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"k29.51"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"k29.61"</span>,
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> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"k29.91"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"k31.811"</span>,
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> {
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"k31.82"</span>,
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> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Nontraumatic subdural hemorrhage"</span>
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"I62.1"</span>,
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> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"351256"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"eplerenone 25 MG Oral Tablet"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"351257"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"eplerenone 50 MG Oral Tablet"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"198224"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Hydrochlorothiazide 25 MG / Spironolactone 25 MG Oral Tablet"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"198225"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Hydrochlorothiazide 50 MG / Spironolactone 50 MG Oral Tablet"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"198222"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Spironolactone 100 MG Oral Tablet"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"313096"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Spironolactone 25 MG Oral Tablet"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"198223"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Spironolactone 50 MG Oral Tablet"</span>
> }
> ]
> }
> ]
> }</code></pre>
> </div>
> </section>
> <section id="example-2-tyrosine-kinase-inhibitors-and-medications-that-increase-gastric-ph">
> <h4 id="a-5-2-example-2-tyrosine-kinase-inhibitors-and-medications-that-increase-gastric-ph"><bdi class="secno">A.5.2 </bdi>Example 2: Tyrosine Kinase inhibitors and medications that increase gastric pH<a class="self-link" aria-label="??" href="#example-2-tyrosine-kinase-inhibitors-and-medications-that-increase-gastric-ph"></a></h4>
> <div class="example" id="example-3-tyrosine-kinase-inhibitors-and-medications-that-increase-gastric-ph">
> <div class="marker">
> <a class="self-link" href="#example-3-tyrosine-kinase-inhibitors-and-medications-that-increase-gastric-ph">Example<bdi> 3</bdi></a><span class="example-title">: Tyrosine Kinase inhibitors and medications that
> increase gastric pH</span>
> </div> <pre style="white-space: pre-wrap" aria-busy="false"><code class="hljs json">{
> <span class="hljs-attr">"drugs involved"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"48695d2d-9545-4a31-80d1-201d7d7e2cdb"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"05b06c16-a763-4ef4-90d8-899abb34abd8"</span>
> }
> ],
> <span class="hljs-attr">"clinical consequences"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000003"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"5476c5b5-b52b-4750-882d-cc47f4fa52f4"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Decreased efficacy relative to treatment for chronic myeloid leukemia."</span>,
> <span class="hljs-attr">"concept set references"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"chronic myeloid leukemia"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"2e1bca79-953c-4ea3-9c40-4c16da2dde31"</span>
> }
> }
> ]
> },
> <span class="hljs-attr">"seriousness"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000009"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"d8ea3c5c-bc25-4cca-b9a8-ed742742e741"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"serious"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"A decrease in chronic myeloid leukemia treatment efficacy is a serious potential clinical consequence because it can result in death, life-threatening hospitalization, and disability."</span>
> },
> <span class="hljs-attr">"mechanism of interaction information"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000005"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"8a8ce6c0-c78e-4d38-bda2-835118f976ea"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"These TKIs demonstrate pH dependent absorption for oral administration which may result in decreased efficacy when given concomitantly with medications that increase gastric pH."</span>
> },
> <span class="hljs-attr">"frequency of exposure to the PDDI"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000007"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"56ebf54f-a148-4f2d-9924-b44f174ea72e"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Unknown"</span>
> },
> <span class="hljs-attr">"frequency of harm for persons who have been exposed to the PDDI"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000006"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"207ae890-3098-436d-b248-578279c65d9c"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Unknown"</span>
> },
> <span class="hljs-attr">"modifying factors information"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000000"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"b4566e23-3884-495f-93e1-04a0b5c9a008"</span>,
> <span class="hljs-attr">"expressionLogic"</span>: <span class="hljs-string">"human readable"</span>,
> <span class="hljs-attr">"members"</span>: [
> {
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"The TKI is imatinib or ponatinib"</span>,
> <span class="hljs-attr">"operational classification statement"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000111"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"No special precautions."</span>
> },
> <span class="hljs-attr">"evidence about a suspected drug-drug interaction"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000004"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Imatinib and ponatinib AUCs are not appreciably decreased by PPI co-administration."</span>,
> <span class="hljs-attr">"References"</span>: [
> {
> <span class="hljs-attr">"title"</span>: <span class="hljs-string">"Iclusig"</span>,
> <span class="hljs-attr">"author"</span>: [
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"ARIAD Pharmaceuticals, Inc."</span>
> }
> ],
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"package insert"</span>,
> <span class="hljs-attr">"year"</span>: <span class="hljs-string">"2016"</span>,
> <span class="hljs-attr">"link"</span>: [
> {
> <span class="hljs-attr">"url"</span>: <span class="hljs-string">"https://specialtydrug.magellanprovider.com/media/32235/iclusig.pdf"</span>
> }
> ]
> },
> {
> <span class="hljs-attr">"title"</span>: <span class="hljs-string">"Effect of a proton pump inhibitor on the pharmacokinetics of imatinib"</span>,
> <span class="hljs-attr">"author"</span>: [
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Merrill J Egorin"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Dhvani D Shah"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Susan M Christner"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Mara A Yerk"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Kristin A Komazec"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Leonard R Appleman"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Robert L Redner"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Brian M Miller"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Jan H Beumer"</span>
> }
> ],
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"article"</span>,
> <span class="hljs-attr">"year"</span>: <span class="hljs-string">"2009"</span>,
> <span class="hljs-attr">"journal"</span>: {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"British journal of clinical pharmacology"</span>,
> <span class="hljs-attr">"volume"</span>: <span class="hljs-string">"68"</span>,
> <span class="hljs-attr">"number"</span>: <span class="hljs-string">"3"</span>,
> <span class="hljs-attr">"pages"</span>: <span class="hljs-string">"370--374"</span>
> },
> <span class="hljs-attr">"link"</span>: [
> {
> <span class="hljs-attr">"url"</span>: <span class="hljs-string">"https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/j.1365-2125.2009.03466.x"</span>
> }
> ],
> <span class="hljs-attr">"identifier"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"doi"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"10.1111/j.1365-2125.2009.03466.x"</span>
> }
> ]
> }
> ]
> },
> <span class="hljs-attr">"concept set references"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"Imatinib"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"bd1da3d0-0543-42b6-9698-62f672d20ea4"</span>
> }
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"ponatinib"</span>,
> <span class="hljs-attr">"body"</span>: {
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> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"901791fd-5575-49fd-b043-a865743432b6"</span>
> }
> }
> ]
> },
> {
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"The TKI is nilotinib"</span>,
> <span class="hljs-attr">"operational classification statement"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000111"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Assess risk and take action if necessary."</span>
> },
> <span class="hljs-attr">"evidence about a suspected drug-drug interaction"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000004"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Bosutinib and nilotinib AUCs are decreased with concomitant PPIs but antacids and H2 antagonists may be considered if TKI is given 2 hours before the antacid/H2 antagonist. However, for nilotinib a retrospective study has shown no difference in cytogenetic response rates for patients taking PPIs."</span>,
> <span class="hljs-attr">"References"</span>: [
> {
> <span class="hljs-attr">"title"</span>: <span class="hljs-string">"Concurrent use of proton pump inhibitors or H2 blockers did not adversely affect nilotinib efficacy in patients with chronic myeloid leukemia"</span>,
> <span class="hljs-attr">"author"</span>: [
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Ophelia QP Yin"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Frank J Giles "</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Michele Baccarani"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Philipp Le Coutre"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Ovidiu Chiparus"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Neil Gallagher"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Giuseppe Saglio"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Timothy P Hughes"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Andreas Hochhaus"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Hagop M Kantarjian"</span>
> },
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"RA Larson"</span>
> }
> ],
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"article"</span>,
> <span class="hljs-attr">"year"</span>: <span class="hljs-string">"2012"</span>,
> <span class="hljs-attr">"journal"</span>: {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Cancer chemotherapy and pharmacology"</span>,
> <span class="hljs-attr">"volume"</span>: <span class="hljs-string">"70"</span>,
> <span class="hljs-attr">"number"</span>: <span class="hljs-string">"2"</span>,
> <span class="hljs-attr">"pages"</span>: <span class="hljs-string">"345--350"</span>
> },
> <span class="hljs-attr">"link"</span>: [
> {
> <span class="hljs-attr">"url"</span>: <span class="hljs-string">"https://link.springer.com/article/10.1007/s00280-012-1881-3"</span>
> }
> ],
> <span class="hljs-attr">"identifier"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"doi"</span>,
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"10.1007/s00280-012-1881-3"</span>
> }
> ]
> }
> ]
> },
> <span class="hljs-attr">"concept set references"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"TextQuoteSelector"</span>,
> <span class="hljs-attr">"attribute"</span>: <span class="hljs-string">"display"</span>,
> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"nilotinib"</span>,
> <span class="hljs-attr">"body"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SemanticTag"</span>,
> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"d8dc65de-aefc-45a1-a0b5-d576838bcb1b"</span>
> }
> }
> ]
> },
> {
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"The TKI is bosutinib or dasatinib"</span>,
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000111"</span>,
> <span class="hljs-attr">"operational classification statement"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000111"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Use only if benefit outweighs risk."</span>
> },
> <span class="hljs-attr">"evidence about a suspected drug-drug interaction"</span>: {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"MPIO_0000004"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Bosutinib and nilotinib AUCs are decreased with concomitant PPIs but antacids and H2 antagonists may be considered if TKI is given 2 hours before the antacid/H2 antagonist."</span>,
> <span class="hljs-attr">"References"</span>: [
> {
> <span class="hljs-attr">"title"</span>: <span class="hljs-string">"Sprycel"</span>,
> <span class="hljs-attr">"author"</span>: [
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Bristol-Myers Squibb Company"</span>
> }
> ],
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"package insert"</span>,
> <span class="hljs-attr">"year"</span>: <span class="hljs-string">"2015"</span>,
> <span class="hljs-attr">"link"</span>: [
> {
> <span class="hljs-attr">"url"</span>: <span class="hljs-string">"https://packageinserts.bms.com/pi/pi_sprycel.pdf"</span>
> }
> ]
> },
> {
> <span class="hljs-attr">"title"</span>: <span class="hljs-string">"Bosulif"</span>,
> <span class="hljs-attr">"author"</span>: [
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Pfizer Labs"</span>
> }
> ],
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"package insert"</span>,
> <span class="hljs-attr">"year"</span>: <span class="hljs-string">"2015"</span>,
> <span class="hljs-attr">"link"</span>: [
> {
> <span class="hljs-attr">"url"</span>: <span class="hljs-string">"https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203341lbl.pdf"</span>
> }
> ]
> },
> {
> <span class="hljs-attr">"title"</span>: <span class="hljs-string">"Tasigna"</span>,
> <span class="hljs-attr">"author"</span>: [
> {
> <span class="hljs-attr">"name"</span>: <span class="hljs-string">"Novartis"</span>
> }
> ],
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"package insert"</span>,
> <span class="hljs-attr">"year"</span>: <span class="hljs-string">"2015"</span>,
> <span class="hljs-attr">"link"</span>: [
> {
> <span class="hljs-attr">"url"</span>: <span class="hljs-string">"https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022068lbl.pdf"</span>
> }
> ]
> }
> ]
> },
> <span class="hljs-attr">"concept set references"</span>: [
> {
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> <span class="hljs-attr">"value"</span>: <span class="hljs-string">"3b4fd6a6-15a8-4520-8ec4-ffb62898bc33"</span>
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> },
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> <span class="hljs-attr">"exact"</span>: <span class="hljs-string">"dasatinib"</span>,
> <span class="hljs-attr">"body"</span>: {
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> }
> }
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> }
> ]
> },
> <span class="hljs-attr">"concept sets"</span>: [
> {
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"2e1bca79-953c-4ea3-9c40-4c16da2dde31"</span>,
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> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"SNOMED-CT"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.nlm.nih.gov/healthit/snomedct/"</span>,
> <span class="hljs-attr">"members"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"415287001"</span>,
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> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"277589003"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Atypical chronic myeloid leukemia"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"277587001"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Juvenile chronic myeloid leukemia"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"IAO_0020000"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.nlm.nih.gov/healthit/snomedct/"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"128826001"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Atypical chronic myeloid leukemia, BCR/ABL negative"</span>
> }
> ]
> },
> {
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"48695d2d-9545-4a31-80d1-201d7d7e2cdb"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">" tyrosine kinase inhibitors (TKIs)"</span>,
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"members"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"ATC"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"L01XE04"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"sunitinib"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"ATC"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"L01XC03"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"trastuzumab"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"ATC"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"L01XC14"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"ado-trastuzumab emtansine"</span>
> }
> ]
> },
> {
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"05b06c16-a763-4ef4-90d8-899abb34abd8"</span>,
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> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
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> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"816346"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">" Dexlansoprazole"</span>
> },
> {
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> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"283742"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">" Esomeprazole"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"17128"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">" Lansoprazole"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"7646"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">" Omeprazole"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"40790"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">" Pantoprazole"</span>
> },
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"APOLLO_SV_00000461"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"http://www.nlm.nih.gov/research/umls/rxnorm"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"114979"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">" Rabeprazole"</span>
> }
> ]
> },
> {
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> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"Imatinib"</span>,
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> {
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> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"L01XE01"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"imatinib"</span>
> }
> ]
> },
> {
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> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"ponatinib"</span>,
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"members"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"ATC"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"L01XE08"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"ponatinib"</span>
> }
> ]
> },
> {
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> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"nilotinib"</span>,
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"members"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"ATC"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"L01XE08"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"nilotinib"</span>
> }
> ]
> },
> {
> <span class="hljs-attr">"id"</span>: <span class="hljs-string">"3b4fd6a6-15a8-4520-8ec4-ffb62898bc33"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"bosutinib"</span>,
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"members"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"ATC"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"L01XE14"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"bosutinib"</span>
> }
> ]
> },
> {
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> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"dasatinib"</span>,
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"DIDEO_00000128"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"members"</span>: [
> {
> <span class="hljs-attr">"type"</span>: <span class="hljs-string">"ATC"</span>,
> <span class="hljs-attr">"system"</span>: <span class="hljs-string">"https://www.whocc.no/atc_ddd_index"</span>,
> <span class="hljs-attr">"code"</span>: <span class="hljs-string">"L01XE06"</span>,
> <span class="hljs-attr">"display"</span>: <span class="hljs-string">"dasatinib"</span>
> }
> ]
> }
> ]
> }</code></pre>
> </div>
> </section>
> </section>
> </section>
>
>
>
>
> <section id="references" class="appendix">
> <h2 id="b-references"><bdi class="secno">B. </bdi>References<a class="self-link" aria-label="??" href="#references"></a></h2>
>
> <section id="normative-references">
> <h3 id="b-1-normative-references"><bdi class="secno">B.1 </bdi>Normative references<a class="self-link" aria-label="??" href="#normative-references"></a></h3>
> <dl class="bibliography">
> <dt id="bib-hansten-2001">[hansten-2001]</dt><dd><cite>ORCA:OpeRational ClassificAtion of Drug Interactions.</cite>. Philip Hansten; John R. Horn; Thomas K. Hazlet. Journal of the American Pharmaceutical Association. March/April 2001. </dd><dt id="bib-herrero-zazo-2015">[herrero-zazo-2015]</dt><dd><a href="https://www.ncbi.nlm.nih.gov/pubmed/26147071"><cite>DINTO: Using OWL Ontologies and SWRL Rules to Infer Drug-Drug Interactions and Their Mechanisms</cite></a>. Maria Herrero-Zazo; Isabel Segura-Bedmar; Janna Hastings; Paloma Martinez. Journal of Chemical Information and Modeling. Aug 24, 2015. URL: <a href="https://www.ncbi.nlm.nih.gov/pubmed/26147071">https://www.ncbi.nlm.nih.gov/pubmed/26147071</a></dd><dt id="bib-owl2-overview">[owl2-overview]</dt><dd><a href="https://www.w3.org/TR/owl2-overview/"><cite>OWL 2 Web Ontology Language Document Overview (Second Edition)</cite></a>. W3C OWL Working Group. W3C. 11 December 2012. W3C Recommendation. URL: <a href="https://www.w3.org/TR/owl2-overview/">https://www.w3.org/TR/owl2-overview/</a></dd><dt id="bib-rfc2119">[RFC2119]</dt><dd><a href="https://tools.ietf.org/html/rfc2119"><cite>Key words for use in RFCs to Indicate Requirement Levels</cite></a>. S. Bradner. IETF. March 1997. Best Current Practice. URL: <a href="https://tools.ietf.org/html/rfc2119">https://tools.ietf.org/html/rfc2119</a></dd><dt id="bib-usdhhs-2011">[usdhhs-2011]</dt><dd><a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072331.pdf"><cite>Guidance for Industry - Providing Regulatory Submissions in Electronic Format - Content of Labeling</cite></a>. U.S. Department of Health and Human Services. 2011. URL: <a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072331.pdf">https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072331.pdf</a></dd><dt id="bib-who-umc-glossary">[who-umc-glossary]</dt><dd><a href="https://www.who-umc.org/global-pharmacovigilance/global-pharmacovigilance/glossary/"><cite>UMC - Glossary</cite></a>. World Health Organization. 2017. URL: <a href="https://www.who-umc.org/global-pharmacovigilance/global-pharmacovigilance/glossary/">https://www.who-umc.org/global-pharmacovigilance/global-pharmacovigilance/glossary/</a></dd>
> </dl></section><section id="informative-references">
> <h3 id="b-2-informative-references"><bdi class="secno">B.2 </bdi>Informative references<a class="self-link" aria-label="??" href="#informative-references"></a></h3>
> <dl class="bibliography">
> <dt id="bib-abarca-2004">[abarca-2004]</dt><dd><a href="https://www.ncbi.nlm.nih.gov/pubmed/15098847"><cite>Concordance of severity ratings provided in four drug interaction compendia</cite></a>. Jacob Abarca; Daniel Malone; Edward Armstrong; Amy Grizzle; Philip Hansten; Robin Van, Bergen; Richard Lipton. Journal of the American Pharmacists Association: JAPhA. April 2004. URL: <a href="https://www.ncbi.nlm.nih.gov/pubmed/15098847">https://www.ncbi.nlm.nih.gov/pubmed/15098847</a></dd><dt id="bib-ahrq-drug-drug">[ahrq-drug-drug]</dt><dd><a href="https://qualitymeasures.ahrq.gov/summaries/summary/47511/drugdrug-interactions-percentage-of-patients-who-received-a-prescription-for-a-target-medication-during-the-measurement-period-and-who-were-dispensed-a-concurrent-prescription-for-a-precipitant-medication?q=drugdrug+interactions"><cite>Drug-drug interactions: percentage of patients who received a prescription for a target medication during the measurement period and who were dispensed a concurrent prescription for a precipitant medication. National Quality Measures Clearinghouse</cite></a>. AHRQ. URL: <a href="https://qualitymeasures.ahrq.gov/summaries/summary/47511/drugdrug-interactions-percentage-of-patients-who-received-a-prescription-for-a-target-medication-during-the-measurement-period-and-who-were-dispensed-a-concurrent-prescription-for-a-precipitant-medication?q=drugdrug+interactions">https://qualitymeasures.ahrq.gov/summaries/summary/47511/drugdrug-interactions-percentage-of-patients-who-received-a-prescription-for-a-target-medication-during-the-measurement-period-and-who-were-dispensed-a-concurrent-prescription-for-a-precipitant-medication?q=drugdrug+interactions</a></dd><dt id="bib-ansm-2016">[ansm-2016]</dt><dd><a href="http://ansm.sante.fr/var/ansm_site/storage/original/application/de444ea9eb4bc084905c917c902a805f.pdf"><cite>Thesaurus des interactions medicamenteuses</cite></a>. ANSM. 2016. URL: <a href="http://ansm.sante.fr/var/ansm_site/storage/original/application/de444ea9eb4bc084905c917c902a805f.pdf">http://ansm.sante.fr/var/ansm_site/storage/original/application/de444ea9eb4bc084905c917c902a805f.pdf</a></dd><dt id="bib-ayvaz-2015">[ayvaz-2015]</dt><dd><a href="https://www.ncbi.nlm.nih.gov/pubmed/25917055"><cite>Toward a complete dataset of drug-drug interaction information from publicly available sources</cite></a>. Serkan Ayvaz; John Horn; Oktie Hassanzadeh; Qian Zhu; Johann Stan; Nicholas Tatonetti; Santiago Vilar; Mathias Brochhausen; Matthias Samwald; Majid Rastegar-Mojarad; Michel Dumontier; Richard Boyce. Journal of Biomedical Informatics. Jun 2015. URL: <a href="https://www.ncbi.nlm.nih.gov/pubmed/25917055">https://www.ncbi.nlm.nih.gov/pubmed/25917055</a></dd><dt id="bib-bender-2013">[bender-2013]</dt><dd><a href="http://ieeexplore.ieee.org/document/6627810/?reload=true"><cite>HL7 FHIR: An Agile and RESTful approach to healthcare information exchange</cite></a>. D. Bender; K. Sartipi. June 2013. URL: <a href="http://ieeexplore.ieee.org/document/6627810/?reload=true">http://ieeexplore.ieee.org/document/6627810/?reload=true</a></dd><dt id="bib-bib-json">[bib-json]</dt><dd><a href="http://okfnlabs.org/bibjson/"><cite>How to do BibJSON</cite></a>. Open Knowledge Foundatoin. 2016. URL: <a href="http://okfnlabs.org/bibjson/">http://okfnlabs.org/bibjson/</a></dd><dt id="bib-bosulif-2015">[bosulif-2015]</dt><dd><cite>Bosulif</cite>. Pfizer Labs, New York, NY. 2015. </dd><dt id="bib-bottiger-2009">[bottiger-2009]</dt><dd><a href="https://www.ncbi.nlm.nih.gov/pubmed/19205683"><cite>{SFINX}-a drug-drug interaction database designed for clinical decision support systems</cite></a>. Ylva Bottiger; Kari Laine; Marine Andersson; Tuomas Korhonen; Bjorn Molin; Marie-Louise Ovesjo; Tuire Tirkkonen; Anders Rane; Lars Gustafsson; Birgit Eiermann. European Journal of Clinical Pharmacology. Jun 2009. URL: <a href="https://www.ncbi.nlm.nih.gov/pubmed/19205683">https://www.ncbi.nlm.nih.gov/pubmed/19205683</a></dd><dt id="bib-boyce-2013">[boyce-2013]</dt><dd><a href="https://jbiomedsem.biomedcentral.com/track/pdf/10.1186/2041-1480-4-5?site=jbiomedsem.biomedcentral.com"><cite>Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness</cite></a>. Richard Boyce; John Horn; Oktie Hassanzadeh; Anita De Waard; Jodi Schneider; Joanne Luciano; Majid Rastegar-Mojarad; Maria Liakata. Journal of Biomedical Semantics. URL: <a href="https://jbiomedsem.biomedcentral.com/track/pdf/10.1186/2041-1480-4-5?site=jbiomedsem.biomedcentral.com">https://jbiomedsem.biomedcentral.com/track/pdf/10.1186/2041-1480-4-5?site=jbiomedsem.biomedcentral.com</a></dd><dt id="bib-bristol-myers-warfarin">[bristol-myers-warfarin]</dt><dd><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d91934a0-902e-c26c-23ca-d5accc4151b6"><cite>{DailyMed} - {COUMADIN}- warfarin sodium tablet</cite></a>. Bristol-Myers Squibb. 2017. URL: <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d91934a0-902e-c26c-23ca-d5accc4151b6">https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d91934a0-902e-c26c-23ca-d5accc4151b6</a></dd><dt id="bib-brochhausen-2014">[brochhausen-2014]</dt><dd><a href="http://ceur-ws.org/Vol-1309/paper2.pdf"><cite>Towards a foundational representation of potential drug- drug interaction knowledge</cite></a>. Mathias Brochhausen; Jodi Schneider; Daniel Malone; Philip Empey; R. Hogan; Richard Boyce. URL: <a href="http://ceur-ws.org/Vol-1309/paper2.pdf">http://ceur-ws.org/Vol-1309/paper2.pdf</a></dd><dt id="bib-cdc-faststats">[cdc-faststats]</dt><dd><a href="https://www.cdc.gov/nchs/fastats/emergency-department.htm"><cite>FastStats</cite></a>. CDC. FASTSTATS. URL: <a href="https://www.cdc.gov/nchs/fastats/emergency-department.htm">https://www.cdc.gov/nchs/fastats/emergency-department.htm</a></dd><dt id="bib-cms-2013">[cms-2013]</dt><dd><a href="http://www.opendental.com/manual/EHR%202011/2%20Drug%20Interaction%20Checks%202012-07%2027.pdf"><cite>Eligible Professional Meaningful Use Core Measures, Measure 2 of 15</cite></a>. CMS. 2013. URL: <a href="http://www.opendental.com/manual/EHR%202011/2%20Drug%20Interaction%20Checks%202012-07%2027.pdf">http://www.opendental.com/manual/EHR%202011/2%20Drug%20Interaction%20Checks%202012-07%2027.pdf</a></dd><dt id="bib-dailymed-about">[dailymed-about]</dt><dd><a href="https://dailymed.nlm.nih.gov/dailymed/about-dailymed.cfm"><cite>DailyMed - About</cite></a>. DailyMed. 2019. URL: <a href="https://dailymed.nlm.nih.gov/dailymed/about-dailymed.cfm">https://dailymed.nlm.nih.gov/dailymed/about-dailymed.cfm</a></dd><dt id="bib-dailymed-indexing">[dailymed-indexing]</dt><dd><a href="https://dailymed.nlm.nih.gov/dailymed/spl-resources-all-indexing-files.cfm"><cite>SPL RESOURCES: Download All Indexing & REMS Files</cite></a>. DailyMed. 2019. URL: <a href="https://dailymed.nlm.nih.gov/dailymed/spl-resources-all-indexing-files.cfm">https://dailymed.nlm.nih.gov/dailymed/spl-resources-all-indexing-files.cfm</a></dd><dt id="bib-dechanont-2014">[dechanont-2014]</dt><dd><a href="http://www.ncbi.nlm.nih.gov/pubmed/24616171"><cite>Hospital admissions/visits associated with drug-drug interactions: a systematic review and meta-analysis</cite></a>. Supinya Dechanont; Sirada Maphanta; Bodin Butthum; Chuenjid Kongkaew. Pharmacoepidemiology and Drug Safety. May 2014. URL: <a href="http://www.ncbi.nlm.nih.gov/pubmed/24616171">http://www.ncbi.nlm.nih.gov/pubmed/24616171</a></dd><dt id="bib-drugs-dot-com-interaction">[drugs-dot-com-interaction]</dt><dd><a href="https://www.drugs.com/interactions-check.php?drug_list=1310-0%2C2311-0&professional=1&types%5B%5D=major"><cite>Drug Interaction Report</cite></a>. Drugs.com. 1/28/2019. URL: <a href="https://www.drugs.com/interactions-check.php?drug_list=1310-0%2C2311-0&professional=1&types%5B%5D=major">https://www.drugs.com/interactions-check.php?drug_list=1310-0%2C2311-0&professional=1&types%5B%5D=major</a></dd><dt id="bib-egorin-2009">[egorin-2009]</dt><dd><a href="https://www.ncbi.nlm.nih.gov/pubmed/19740393"><cite>Effect of a proton pump inhibitor on the pharmacokinetics of imatinib</cite></a>. Merrill J. Egorin; Dhvani D. Shah; Susan M. Christner; Mara A. Yerk; Kristin A. Komazec; Leonard R. Appleman; Robert L. Redner; Brian M. Miller; Jan H. Beumer. British Journal of Clinical Pharmacology. 2009. URL: <a href="https://www.ncbi.nlm.nih.gov/pubmed/19740393">https://www.ncbi.nlm.nih.gov/pubmed/19740393</a></dd><dt id="bib-european-medicines-2012">[european-medicines-2012]</dt><dd><a href="http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500129606.pdf"><cite>Guideline on the investigation of drug interactions</cite></a>. 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