June 18, 2013
10 AM PDT/11 AM MDT/12 PM CDT/1 PM EDT
Attending: Francis Kwakwa, Chair; Doris Auth, Pamela Ball, Mark Baczkowski, Jennifer Baumgartner, Joanna Krause, Jack Kues, John Lay, Tom McKeithen, Valerie Smothers, Marissa Seligman, Lorraine Spencer, Dimitra Travlos, Emma Trucks, John West, and Julie White.
1 Review minutes of last meeting
Francis began the meeting by thanking everyone for their attendance on the calls and their contributions offline. There were no changes to the minutes so they were approved as submitted.
2 Update from the FDA regarding versioning support
Doris stated she didn’t have any updates on the publication of previous versions on the website; they are still working on it. Valerie asked about a timeline and Doris mentioned they didn’t have any kind of timeline. Valerie asked whether they investigated the feasibility. Doris commented it is definitely feasible and they are creating a separate box for the approval letter that will have previous versions of REMS. She is just waiting for them to say they are finished.
3 Review updates to definitions
Valerie continued with two updates of the definitions for ER/LA Opioid prescribers. The definition ER/LA opioid prescriber now uses the term controlled substances instead of drugs. The definition of schedule 2 or 3 registered prescriber was also updated to use the term controlled substances. Francis asked the group if they had any further comments and if this was set in stone or whether Valerie needed more comments from the group. Valerie mentioned nothing is set in stone till we ballot the Standards Committee, so comments are still welcomed. Francis suggested emailing any comments to Valerie.
4 Review updates to implementation guidelines
Valerie continued with an update to the implementation guidelines. She explained there were two sets of changes made since the last call. There was an update to the registration question in the appendix with examples of Opioid Analgesics on page 22 (example from Boston University) and supporting documentation learners could access if they wanted more information. They provided a list here and that has been updated. Valerie asked the participants from Boston University if they had any additional comments to make and they had none. The next change was changing the wording, “drugs” to “controlled substances in the description of Participation Metrics on page 15. Valerie will add “or” between schedule 2 and 3 (should be schedule 2 and/or 3). A minor correction was made on page 16 regarding how to represent prescribers, it was important to convey the number of prescriber participants not just the number of prescribers in general.
Linda from the RPC thanked everyone for all the work putting the document together; it was valuable to providers going forward. Valerie also agreed it was a great project and thanked Linda for the PRC’s participation and Francis for chairing the group.
5 Implementation updates
Linda briefly commented she was happy with the work from this group laying out definitions, identifying questions and items that would be needed by providers to report to accreditors, and third party aggregators. The data reporting process to the FDA went very smoothly. On June 7th the providers reported their data, then the accreditors had a day or two to take a look at it, and make sure fields were as they should be and check on anything that needed confirming. Then they transmitted to the third party data aggregator Polaris. The data reporting went very smoothly. They are in the process of compiling information and reporting it to the FDA. Linda appreciated the group effort; for providers and accreditors it truly was a yeoman’s effort in a short amount of time. The information was turned in accurately and any questions were resolved, it was great teamwork.
Francis asked about the deadline for the report due July 9th. Linda noted it was the anniversary of the date REMS was first approved. We can share updates with the working group going forward.
Tom McKeithen was curious about issues or problems encountered by providers in submitting data. He thought it might be helpful to know the nature of the issues and how they were resolved, like a summary event. Linda that was a good question. From Boston University, or from the accreditors perspective we would be interested in enhancement or anything shared by others to makes sure the process goes smoothly.
Pam, from the AOA, mentioned they had the pleasure of getting their one activity in, which forced them to pay attention to what they wanted their sponsors to know. It helped them to streamline what they wanted to communicate when sponsors report back to them. They were able to work out the kinks at the beginning. Pam thanked Linda and Polaris for answering all her questions. It should be a seamless process.
Linda commented each accreditor may have some use for an RPC identifier, other accreditors record needed to be listed as a REMS compliant activity.
c CE Providers
Joanna, from Boston, shared the first challenge they faced was to report data from three different time frames. They spoke with accreditors and came to consensus for reporting a period. In the next period they will know well in advance what the reporting period will be. Linda agreed that was a good point. The reporting data period wasn’t clear. It was the first activity date started, with no uniform reporting period. Francis asked if anybody from Polaris dealt with multiple records. Linda commented it was easy for Polaris to see the number of physicians, so nothing was double counted. Valerie noted she did correspond with Jennifer Dunleavy, from the ACCME, who shared a link from the wiki on modifications to PARS supplemented by a spreadsheet.
6 Open discussion
Valerie commented she will include the precise URL’s from the FDA to be included in the guidelines and specification when they are available.
Francis asked about the next steps in getting in the standard approved. Valerie mentioned the working group needs to come to a consensus. We can poll everyone and make sure there is agreement. Once the working group agrees, the specification is sent to the Standards Committee for review and balloting. The Standards Committee reviews the specification and xml schema. The Standards Committee may have comments or questions. The comments and questions are brought back to the working group and together with the Standards Committee they work to resolve issues. After that process there is a public review for 45 days, and if there are any comments, the Standards Committee would work with the working group to address those comments. The last step in the process is the balloting. Francis suggested a call in the next two to three months. We can approve any changes to the specification by email prior to sending to the Standards Committee. Francis thought the group could reconvene when there are comments to discuss. The group agreed. Linda thanked everyone for their collaborative efforts, on behalf of the RPC, in making this so successful. She thanked Valerie for her work and Francis for chairing the group.
- Valerie will update the implementation guidelines and add “or” between schedule 2 and 3 (should be schedule 2 and/or 3) in the description of participation metrics on page 15.
- Doris will inform the group when URLs for specific versions of the REMS are available. The implementation guidelines will be updated accordingly.
- When we are finished, we will verify consensus by poll and email and send the specification to the Standards Committee for review and balloting.
- The group will reconvene when there are comments to address.