January 17, 2017
2 PM EST/1 PM CST/12 PM MST/11 AM PST
Attending: Francis Kwakwa, Chair; Doris Auth, Caitlin Briggs, Jennifer Dunleavy, Ilana Hardesty, Cynthia Kear, Kyle Klassen, Brian Kilmartin, Nathan Kopper, Tom McKeithen, Kate Regnier, Amy Smith, Valerie Smothers, Marsha Stanton, Amy Tan, Sangeeta Tandon, Mark Tyrrell, and Julie White
1 Review minutes
The minutes were accepted as submitted
2 Review list of specialties by profession and specialty data to collect (Prescribers successfully completing by specialty? Anything else?)
Valerie led a discussion on the list of specialties by profession. The list of 40 Healthcare LOM specialties applies to physicians, advanced practice nursing, and physician assistants. A recommendation was made to include Advance Practice Nursing for consistency. The ACPE recommended against collecting pharmacy specialist information. Marsha noted the difficulty including nurse practitioners due to the lack of certifications. Valerie noted the list could grow exponentially depending on the granularity.
Kate questioned the end goal and the benefit of more granularity. Doris explained the FDA would like to standardize specialties across instruments to enable comparisons of REMS learners and REMS survey respondents. Kate suggested determining what additional fields to define and integrate into PARS.
Ilana mentioned Boston collects specialty data as part of their registration for online and live meetings. She will send their form to the group as an example. Cynthia noted that rolling this out across 600 live meetings would be difficult; their demographic information is already spotty. Tom agreed, noting that they would have to add a page to their forms to request specialty information. Francis asked if the data is collected at registration or evaluation. Tom replied both, with most data being collected at the time of evaluation.
Julie will send their version to forward to the group that requires an answer for specialty regardless of their answer on profession. Doris will request approval from the FDA on specialties. Cynthia will need to ask the Partner groups before committing to anything.
Kate mentioned the ACCME still had concerns about branching from profession or single choice, the totals would need to be a one to one match. Valerie suggested the working group could develop guidelines for implementation as needed. MedBiquitous would support selecting a primary specialty to avoid using “Other” as a choice. Valerie asked if this would eliminate the need for the practice type question, and Doris concurred.
Valerie suggested reaching out to other providers who are aggregating data and reporting it to the RPC. The group agreed to assist Valerie to develop that list and provide contact information. Cynthia asked that we avoid duplicative data collection and include other REMS CE providers in the decision.
3 Discuss practice year breakdown
Francis provided an overview of the category sequence grouped by five’s. He asked the group for feedback on whether this should be determined by our recommendations or the FDA discussions. Doris looked at the different ranges from FDA survey datas and noted the FDA uses similar ranges with a slight adaptation and would be supportive of the current structure.
4 Discuss gender as a data point
Doris commented the FDA recommended eliminating gender from the data collection.
5 Review proposed changes to definitions and data collection
Valerie briefly discussed the two definitions impacted; ER/LA Opioid Institutional Prescriber and ER/LA Opioid institutional prescriber successfully completing. Doris mentioned the FDA looked at reporting numbers and determined they are probably not capturing institutional prescribers properly. Kate noted that they are reporting the combined number of prescriber completers and asked if the ER/LA_opioid_prescriber definition should be modified to include institutional prescribers. Valerie clarified the reason for combining was the FDA wanted to look at those numbers discreetly; the definition can be altered. Doris requested time to clarify this with the FDA. Julie and Ilana will also asked their group for feedback. Ilana suggested changing the definition rather than adding new fields. Marsha asked how Hospitalists fit into this definition. Valerie clarified Hospitalists are a specialty in the expanded list.
Valerie will summarize key questions and send out to the group asking for feedback due a week before the next call.
- The proposed breakdown of practice years was accepted.
- Gender will be removed as a data point.
- Valerie will contact group members and other REMS CE providers to request their feedback on collecting specialty data using the proposed vocabulary.
- Doris will seek feedback within the FDA on the list of specialties by profession.
- Valerie will summarize the questions from the call and send to the full group for feedback.