September 26, 2016
2 PM EDT/1 PM CDT/12 PM MDT/11 AM PDT
Attending: Francis Kwakwa, Chair; Doris Auth, Caitlin Briggs, Nathan Copper, Jennifer Dunleavy, Ilana Hardesty, Shelly Harris, Cynthia Kear, Ed Kennedy, Joanna Krause, Kim Laerfeld, Marie Michelle Leger, Tom McKeithen, Andy Rabin, Kate Regnier, Marsha Stanton, Mark Tyrrell, Dimitra Travlos, and Julie White
1 Review minutes
The minutes were accepted as submitted.
2 Discuss FDA Advisory committee recommendations and related activity (see minutes, discussion summary beginning pg 8)
Doris noted that the ER/LA Opioid REMS was approved July 2012, and it utilizes education as part of REMS. As of September, there were 65 new drug applications and 33 sponsors. The REMS has a training goal of 80,000 prescribers. The Advisory Committee convened in May recommended changes to the REMS program, and the FDA continues to consider those recommendations. Broadening training to include pain management would require major expansion of FDA blueprint, however; mandatory pain management was encouraged. The committee recommendation was to continue to engage outside stakeholders and community licensing boards and others with issues regarding current reporting. Change recommendations include adding immediate release opioids, which would greatly expand the program, including pain management in the training blueprint, and linking to DEA registration or other regulatory requirement.
Of the 157,500 completers, only 66,000 counted as prescribers. They would like to know how many prescribers may be acting under an institutional DEA registration rather than an individual registration. They would like view CE metrics data alongside prescriber data from IMS and provider survey data. The FDA would like a better understanding of who is taking the training, but concerns have been expressed about adding data fields. The proposed fields were circulated.
Kate asked if the FDA wanted to collect aggregate information or participant level data, which would require participant consent. Doris replied that aggregate counts are fine. Ilana questioned the need to include degree if you are already asking for profession. Degree may be off putting to NPs and PAs. Doris noted they are trying to align with the survey data; she will provide information on degree.
The group decided that questions on prescribing volume and analgesics prescribed would deter participation, and they were removed from consideration. Cynthia noted that they surveyed learners to see if they would be willing to report data to the FDA, and the response was overwhelmingly negative. She added that the survey is already long. A discussion followed about specialty and sub-specialty types and the need to define in a consistent and implementable manner. Valerie and Doris will look at the LOM standard and present information on specialties on the next call. Kate noted they can modify PARS to collect data in a standardized way they just need to know which fields to swap in.
Francis asked about the learner level or aggregate data. Kate and Doris will get specifics on that for the next meeting.
3 Discuss next steps
Valerie summarized that the group will further consider adding medical degree, specialty, and years in practice, geographical region and gender. We will also create a way to capture institutional prescribers separately. Cynthia mentioned the limited space and time for survey questions. Valerie asked Cynthia if there was information that is captured during the registration process that could be used. Cynthia noted registration is for the whole event; the data they receive is not necessarily reflective of individual learners. Marie added it’s not possible to match sign in sheets with assessment sheets. Francis concluded the next steps would be to consider how the new proposal fits into the current specification and guidelines. Valerie and Doris will work on a definition of institutional prescribers, revisit the new requirements, and clarify the level of reporting. Ilana added the limited attention span is of more concern than the limited space on the form. There is a higher than normal drop off rate for those reaching the demographic questions. Doris will share any details about how the current survey and prescriber database characterize demographics with the group.
The implementation guidelines and specification will continue to exclude the following fields:
- Prescribing volume in the past month on average
- ER/LA opioid analgesics prescribed within the past 6 months
- Valerie and Doris will work on a definition of institutional prescribers, revisit the new requirements, and clarify the level of reporting.
- Doris will share any details about how the current survey and prescriber database characterize demographics.