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Meeting Information


July 13, 2017


11 EDT/10 CDT/9 MDT/8 PDT

Attending: Francis Kwakwa, Chair; Doris Auth, Leslie Christy, Ilana Hardesty, Brian Kilmartin, Kyle Klassen, Joanna Krause, Kate Regnier, Valerie Smothers, Amy Tan, Dimitra Travlos, Mark Tyrrell, and Julie White

Agenda Items

1 Review minutes

The minutes were accepted as submitted. 

2 Review survey results

Francis summarized the survey results and the consensus was to switch to the new definitions on Jan 1, 2018.  

3 Discuss recommendations from the Conjoint Committee on CME

He mentioned Valerie attended the recent CCCE meeting, along with others on the call. The CCCE work group proposed that they make recommendations to the FDA as to what data should be collected. 

Valerie briefly described the Committee as representing a number of different health organizations involved in CE. The CCCE’s current focus is on REMS CE and learning how to improve performance of the health system with regards to prescribing opioids.  The group reviewed FDA’s blueprints.  One group in particular focused on data collection that relates to work of this working group.  The group as whole put together a response to the FDA blueprint for both extended and immediate release opioids, looking at pain management more broadly.  They had a number of recommendations relevant to work of this group, hopefully shaping the FDA’s thinking moving forward. 

She noted the CCCE is in favor of counting all clinician members of practice teams who successfully complete REMS-compliant CE, which has implications of how we collect our data.  They place less emphasis on prescriber completers and more emphasis on successful completion.  Committee actions listed on page four of the document and a pilot study will be developed in the working group on data collections of learner data to evaluate.  The results of the evaluation will come back to this working group. 

Doris mentioned people are asking about the timeline.  She agreed the pilot would be valuable as the results can be taken back to FDA as they work on REMS.  Francis asked about timeline for research.  Valerie understood the FDA wanted to come out with something by the end of year.  She thought a three month timeline was reasonable, and Doris agreed.  The next steps are to send out all of those letters at the FDA.  Illana agreed the timeline was achievable for BU.  Kate added it would depend on looking at data that BU already has and mining that in a way to frame recommendations.  There may be other recommendations in addition to demographics. 

Francis asked about the members of practice teams.  Valerie provided context and a link to vocabularies page on MedBiq website.  Kate noted that we will look at the data and see what is useful data about completers.  Illana was hesitant to prescribe who that is because it differs from practice to practice.  Valerie suggested looking at REMS limited set of professions that includes Physician, Advanced practice nurse, Pharmacist, Dentist, Optometrist, Physician Assistant, Podiatrist, and Other.  Valerie and Francis questioned whether the list was broad enough.  Ilana requires them to put something in “Other”; they could look within their data and make recommendations from the list.  Dimitra added their list based on LOM 1.0 and is more extensive.  Kate though it made sense to revisit a broader list.  Doris added they want to capture all nurses, not just APN. Ilana added mental health professions including psychologists and nursing would be important. 

Francis mentioned the idea of self-reporting of prescriber broadens to include IR’s.  Valerie expressed concern about self-reporting behavior not being valid.  She would prefer focusing on who has the ability to prescribe.  Julie noted that BU asked their partner, Haymarket, about prescribing. They said 18 to 20% of responses were inaccurate, indicating the learner had not prescribed, but they had prescribed. That is an indication of the validity.  From a CME point of view, we want people to feel they know how to prescribe if appropriate.  She supported dropping that question.

Ilana will share results with the group.  Doris mentioned there is a huge gap between completers that count and completers that do not count.  She suggested waiting on implementing the definitions, noting they may have two data collections for a while.  Ilana noted that collecting two sets of data would be difficult.  Doris added another option is to have a hard deadline.  Kate commented they would look at it in the pilot and make recommendations to the FDA. The data could be a subset of what is currently collected.   The CCE will do the research and come back to group within three months.  Kate suggested looking at BU data, answer pilot questions feed into another metrics and then schedule another call if there is something to report.

Valerie will schedule another call six weeks out pending OK from CCCE working group.  

4 Discuss what new definitions might be helpful for the expanded blueprint (see current revisions to definitions and proposed blueprint)

The group decided to put this item on hold.

Action Items

The CCCE Data Work Group will bring its pilot data back to this group for review in six weeks.

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