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Re: PDDI Min Info Model Task Force - survey results - please VOTE by 10/4

From: Sam Habiel <sam.habiel@gmail.com>
Date: Fri, 28 Sep 2018 09:24:26 -0400
Message-ID: <CABHT963iP+chxjoFg=UtC7GESwgbzUwzTRXkWj_nhq6UVFERJQ@mail.gmail.com>
To: Richard Boyce <rdb20@pitt.edu>
Cc: public-semweb-lifesci@w3.org, public-hclscg@w3.org, Yu Lin <linikujp@gmail.com>, Brian LeBaron <brian.lebaron@va.gov>, hocumrx@gmail.com, Christopher.Vitale@ama-assn.org, Cui.Tao@uth.tmc.edu, Dan Malone <malone@pharmacy.arizona.edu>, Daniela Oliveira <daniela.oliveira@insight-centre.org>, Eric Miller <eric@squishymedia.com>, draper.evan@mayo.edu, George Lilly <glilly@glilly.net>, gmcevoy@ashp.org, Jodi Schneider <jschneider@pobox.com>, Harry Hochheiser <harryh@pitt.edu>, Jeff Nielson <jeffnielson@gmail.com>, Jaideep Sundaram <sundaram.medimmune@gmail.com>, jrhorn@u.washington.edu, jklimek@ncpdp.org, jp@rxdoc.me, jmbanda@stanford.edu, kim.nolen@pfizer.com, Laura Slaughter <laura.slaughter@gmail.com>, lori.idemoto@gmail.com, peters@pharmacy.arizona.edu, maria.herrero@kcl.ac.uk, mkbreit@mail.med.upenn.edu, MBrochhausen@uams.edu, Matthias Samwald <matthias.samwald@meduniwien.ac.at>, michel.dumontier@maastrichtuniversity.nl, mdmiller53@comcast.net, Michael Henderson <mike@easterninformatics.com>, Michael Liebman <michael.liebman@ipqanalytics.com>, Ming Jack Po <mail@jackpo.org>, Nancy Anthracite <nancy@worldvista.org>, nick.tatonetti@columbia.edu, hassanzadeh@us.ibm.com, "He, Yongqun" <yongqunh@med.umich.edu>, Olivier Bodenreider <olivier@nlm.nih.gov>, beyan@dbis.rwth-aachen.de, Øystein Nytrø <nytroe@idi.ntnu.no>, rthirumaran@genelex.com, ratnesh.sahay@insight-centre.org, Freimuth.Robert@mayo.edu, Scott Nelson <scott.nelson.rx@gmail.com>, Serkan A <serkanayvaz@gmail.com>, SPE@usp.org, twc8q@virginia.edu, valerielbaron@gmail.com, Xia Jing <xjing2007@gmail.com>, Lizzy Garcia <eag60@pitt.edu>, Thomas Reese <Thomas.Reese@hsc.utah.edu>, Howard Strasberg <Howard.Strasberg@wolterskluwer.com>, Guilherme Del Fiol <guilherme.delfiol@utah.edu>, "Wiggins, Austin" <AUW9@pitt.edu>
This is great, thank you! This looks really simple; I must have read
it and forgotten about it. I agree with using it then.

--Sam
On Fri, Sep 28, 2018 at 9:21 AM Boyce, Richard David <rdb20@pitt.edu> wrote:
>
> Sam, ORCA was clearly described in the recent survey and is used in Hansten and Horn's Top 100 and at least on commercial database. See attached for the original paper (the one you tried to access) and below for what we said in the survey. The most recent formulation of ORCA is shown in the same slide with the proposed solution in the attached powerpoint.  If you don't like the suggested solution, please vote 'No'.  Thanks, -R
>
> ---- from the survey ----
>
> Option 4) Operational classification based on management criteria that apply to a risk pathway.
>
>
>
> Definitions:
>
> Operational Class Assessment – Risk assessment based upon clinical management of drug interactions rather than clinical significance alone.
>
>
>
> Example using ORCA (see below for more about ORCA):
>
>        Warfarin - NSAIDs
>
> The NSAIDs is topical diclofenac:
>
> Recommended Action: No special precautions
>
> The NSAID is NOT topical diclofenac but the patient is concomitantly taking a proton pump inhibitor or misoprostol:
>
> Recommended Action: Assess risk and take action if necessary
>
> The NSAID is NOT topical diclofenac, the patient is NOT concomitantly taking a proton pump inhibitor or misoprostol, and the patient has one or more of the following risk factors:
>
> History of upper gastrointestinal bleeding (UGIB) or peptic ulcer or age > 65 years old
> Recommended Action: Use only if benefit outweighs risk
>
> Concomitantly taking systemic corticosteroids, aldosterone antagonists, or high dose or multiple NSAID
>
> Recommended Action: Use only if benefit outweighs risk
>
>
>
> Two Example Operational Classification Criteria:
>
>
> OperRational ClassificAtion (ORCA) System for Classifying Drug Interactions:
>
> Contraindicated – No situations have been identified where the benefit of the combination outweighs the risk.
> Provisionally Contraindicated – The combination increases the risk of adverse effects. Avoid concurrent use unless interaction is desired or no alternative is available. If the combination is used, increased monitoring may be necessary.
> Conditional – Risk may be increased, depending on the clinical situation. Assess risk and take action as needed.
> Minimal Risk – Risk of adverse outcome appears small. No special precautions appear necessary.
> No interaction – Evidence suggests that drugs do not interact.
>
> ***Note: only top three are included in Top 100 Drug Interactions by John Horn and Philip D. Hansten
>
> LexiComp:
>
> A: No Known Interation - Data have not demonstrated either parmacodynamic or pharmacokinetic interactions between the specifid agents
> B: No Action Needed - Data demonstrate that the specified agents may interact with each other, but there is little to no evidence of clinical concern resulting from their concomitant use
> C: Monitor Therapy - Data demonstrate that the specified agents may interact with each other in a clinically significant manner. The benefits of concomitant use of these two medications usually outweigh the risks. An appropriate monitoring plan should be implemented to identify potential negative effects. Dosage adjustments of one or both agents may be needed in a minority of patients.
> D: Consider Therapy Modification - Data demonstrate that the two medications may interact with each other in a clinically significant manner. A patient-specific assessment must be conducted to determine whether the benefits of concomitant therapy outweigh the risks. Specific actions must be taken in order to realize the benefits and/or minimize the toxicity resulting from concomitant use of the agents. These actions may include aggressive monitoring, empiric dosage changes, or choosing alternative agents.
> X: Avoid Combination -  Data demonstrate that the specified agents may interact with each other in a clinically significant manner. The risks associated with concomitant use of these agents usually outweigh the benefits. These agents are generally considered contraindicated.
>
>
>
>
>
> On 09/28/2018 09:15 AM, Sam Habiel wrote:
>
> I found the article. It's behind a paywall. Another reason not to use
> it: https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.japha.org%2Farticle%2FS1086-5802(16)31244-X%2Fpdf&amp;data=02%7C01%7Crdb20%40pitt.edu%7C2975570c6e84421c0b2708d625447b38%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636737373387406497&amp;sdata=n9yrYLx%2BxfVfmOlzXXG1%2BrLHFwR7BNH8l9IcyiIWf3g%3D&amp;reserved=0.
>
> On Fri, Sep 28, 2018 at 9:12 AM Sam Habiel <sam.habiel@gmail.com> wrote:
>
> I have never heard of "ORCA: OpeRational ClassificAtion of Drug
> Interactions". Did we discuss that on any call?
>
> If I haven't heard of it--and I worked in this field as a clinician
> for a while--I doubt that I would want to include that in a proposal.
> The vote doesn't give us an option for one and two.
>
>
> On Fri, Sep 28, 2018 at 6:03 AM Boyce, Richard David <rdb20@pitt.edu> wrote:
>
> Dear PDDI Task Force,
>
> We have compiled all results from the Qualtrics survey on options to represent seriousness/severity concepts in the min info model. Many thanks to all who participated! Attached please find a powerpoint that provides a summary of the results. The attached PDF has detailed results including all comments.
>
> The second to last slide in the powerpoint has a proposal that I think makes sense based on the submitted opinions and comments. I have created a poll (one question) so that everyone can register their anonymous vote on the proposal. Please complete the poll within the next 6 days (by 10/4).
>
> https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fsurvey.zohopublic.com%2Fzs%2FAHCsfr&amp;data=02%7C01%7Crdb20%40pitt.edu%7C2975570c6e84421c0b2708d625447b38%7C9ef9f489e0a04eeb87cc3a526112fd0d%7C1%7C0%7C636737373387406497&amp;sdata=q4l%2BCmxwjvdM2HjBCI1Ob05HukqeBio6sTzAqheFgr0%3D&amp;reserved=0
>
> If a majority agrees with the proposal then we will  make the change to the W3C Community Group Note and then move for final approval to publish. Otherwise, will send out a doodle for a call to discuss other options.
>
> --
>
> kind regards,
>
> -Rich
>
>
> --
> Richard D Boyce, PhD
> Associate Professor of Biomedical Informatics and Clinical and Translational Science in the Clinical and Translational
> Science Institute
> Director of the Informatics Core for the Center of Excellence for Natural Product- Drug Interaction Research (NaPDI)
> Faculty, Center for Pharmaceutical Policy and Prescribing
> Faculty, Geriatric Pharmaceutical Outcomes and Gero-Informatics Research and Training Program
> University of Pittsburgh
> rdb20@pitt.edu
> Office: 412-648-9219
> Twitter: @bhaapgh
>
>
> --
> Richard D Boyce, PhD
> Associate Professor of Biomedical Informatics and Clinical and Translational Science in the Clinical and Translational
> Science Institute
> Director of the Informatics Core for the Center of Excellence for Natural Product- Drug Interaction Research (NaPDI)
> Faculty, Center for Pharmaceutical Policy and Prescribing
> Faculty, Geriatric Pharmaceutical Outcomes and Gero-Informatics Research and Training Program
> University of Pittsburgh
> rdb20@pitt.edu
> Office: 412-648-9219
> Twitter: @bhaapgh
Received on Friday, 28 September 2018 13:25:01 UTC

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