September 5, 2017
3 PM EDT/2 PM CDT/1 PM MDT/12 PM PDT
Attending: Francis Kwakwa, Chair; Doris Auth, Caitlin Briggs, Igor Cerny, Leslie Christy, Ilana Hardesty, Shelly Harris, Bradley Hamilton, Kyle Klassen, Joanna Krause, Jack Kues, Matthew Lewin, Tom McKeithen, Rahul Natarajan, Sophie Peloquin, Kate Regnier, Shelly Rodrigues, Dimitra Travlos, and Julie White
1 Review minutes
The minutes were accepted as submitted with minor edits.
2 Discuss pilot data from Boston University
Valerie mentioned the data from Boston University was used by the CCCE to conduct a pilot study to determine what data was useful to CME providers regarding REMS CE. Joanna briefly discussed the findings. They found about 19,000 providers have a DEA license but did not answer yes to being registered with the DEA to prescribe schedule 2 and/or 3 controlled substances; 7000 were unsure. Frances was surprised at the number of “unsure” answers. Doris asked if this was a trend in past years. Joanna offered to look at that question. Tom conducted more qualitative work and was uncertain if providers had changed jobs and covered under previous license. Valerie asked if respondents were newer physicians. Tom noted they conducted 20-30 interviews, but could not make correlation between years in practice and their responses. Julie added 19-20% of their learners said they had not prescribed, but they had prescribed, which calls into question the accuracy of self-reported prescribing data. Ilana suggested looking at physicians regardless of whether or not they prescribe.
Jack noted the majority of participants are in Family Medicine and Internal medicine. He questioned the benefit of the extensive list of specialties. Doris clarified that the FDA was interested in specialty because they had survey data that included specialty and wanted to determine if it was representative of completers. Jack noted the significant number of non-prescriber professionals that attended. Ilana replied that speaks to the value of teaching the entire team.
Kate noted the FDA is interested in understanding years in practice of those engaged in education and comparing this data with prescriber data on years in practice. She added that data on the geographical reach of the education does not tell why engagement is low in certain other divisions. It is important to understand what the FDA is looking for in the data to ensure we are collecting and answering their questions.
Doris noted the original impetus for expanding the collected data was to compare learners to survey participants. Now that the program is changing, the target will be broader. Francis asked if the FDA was using just BU’s data or if other institutions are capturing data on these prescribers. Doris noted the programs are nationwide and that BU’s data is a snapshot of one provider. Ilana added that BU’s geographical distribution would be different than other providers, such as CORE.
Valerie asked how this intersects with the additional data requests from the FDA expanding data collected by CME providers. The work that BU has done gives us great insight of what is useful, particularly with regards to the specialty data. She asked the group for their evaluation of the usefulness of collecting data on forty different specialties.
Jack suggested collecting data on larger groups of specialties. Francis agreed. Valerie clarified the current way we are reporting is primary care, pain specialists and non-pain specialist. Ilana commented each profession has its own set of specialties that will be cumbersome and confusing for users. Doris referred to the list on slide 6 as being confusing. Jack shared the same concerns, but noted this is self-identification. Doris suggested thinking about how granular we want to be. Francis asked what list of specialties the survey developer uses and where that list comes from. Doris commented the contract vendor determines the list of specialties.
The discussion continued on what specialty data to include. Valerie clarified the Conjoint Committee work group will be creating a set of recommendations but it will be the FDA decision as to what they ask for. Kate suggested taking the data and seeing what questions can be answered. The Conjoint Committee will have a longer more detailed conversation. Doris would prefer that happen sooner than later. Igor noted that it would be worth it to know what professions within a particular specialty are prescribing. Valerie acknowledged the challenge is can the questions be answered by the data set, we cannot share learner level data but aggregate data, does not lend itself to slicing and dicing.
Kate explained that the Conjoint Committee will meet and will provide recommendations back to the FDA. Kate will send Norm an email suggesting the get together to include FDA folks; taking each of these fields we are currently collecting then recommend back to FDA what could make it more useful and consider additional fields, years in practice, geographical location, to give FDA good information. Ilana offered if there were other things this working group wanted BU to dig deeper on, they can talk about that.
This committee will reconvene after the Conjoint Committee has issued their recommendations.