October 9, 2012
10 AM PDT/11 AM MDT/12 PM CDT/1 PM EDT
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Attendees: Francis Kwakwa, Chair; Tony D'Ambrosio, Pamela Ball, Mark Baczkowski, Rod Campbell, Jemma Contreras, Stephanie Cordato, Susie Flynn, Edward Kennedy, Anjum Malkana, Stephanie Mercado, Sherice Mills, Jill Olexa Andy Rabin, Nikki Reyes, Anshu Sawhney, Valerie Smothers, Lorraine Spencer, John Sweeney, Dimitra Travlos, and Mary Willy.
1 Review minutes of last meeting
The minutes were approved as submitted.
2 Discuss use case revisions
Valerie began with changes to the use cases. She thanked Sue McGuinness for reviewing and editing. Sue suggested adding accreditor outcomes data base as an actor in use case five. Under assumptions it now indicates that the group making data available has policies and processes in place for determining when to grant researcher requests for data. The assumptions section also indicates that if the group has policies prohibiting such access, this use case would not be applicable. Valerie asked the group to send any other changes to her.
3 Discuss data requirements from accreditors and others
Valerie continued with a discussion on the data requirements. The linked document was put together from written comments from the ACCME and phone calls with AAFP, AOA, and ACPE. She sent the document to the accreditors for review just yesterday afternoon. The accreditors haven’t had a chance to review yet, so there may be changes to the document.
The section on page 1 includes the ACCME introductory comments. They make clear the role that they are willing to play regarding reporting data related to education. Secondly, they recognize data needs to be in a standardized format and made available to the FDA industry for their use. The third point is about serving as a conduit for data. The fourth point is that if they are able to add fields to PARS system, they would be optional fields, leaving it up to the provider to provide data. The ACCME will decide what fields it can add to PARS. Lastly, section 1 states it is up to the data provider to share data.
Valerie reviewed the structure of Table one beginning on page two. The first column provides a number for each row. The second column is the general area of the proposed datapoint. The third column is the proposed data point as deduced from FDA/Industry documents reviewed. The fourth column is the organization commenting. The fifth column shows their comments. The final column is a column for MedBiquitous notes and comments for the discussion.
The first group of comments is related to participants and completion rates. Row two lists the number of participants and row three is the number of prescriber participants. This addresses how many prescribers are being trained and the need to delineate the number of prescriber participants. Prescriber participants are not currently captured in accreditor systems. The AAFP could add this field at a later time however; it would require new processes to collect. Pam mentioned that AOA would need to create something that pulls out the prescribers taking the course. Valerie noted that is where the other accreditors are as well. She mentioned we would need to have a question asking are you a prescriber and incorporate what we define as a prescriber into that question.
Susie commented that in that scenario, data would be self reported. Would there be verification by registration number? Valerie commented she wasn’t sure accreditors would be willing to go there; it hasn’t come up in discussions yet. Andy asked if the FDA defines prescriber. Valerie asked Mary, who was representing the FDA on the call, if she knew. Mary answered she didn’t know that it is clearly defined but she could go back and look at it.
Francis asked as far as the number of prescriber participants, what lengths we should go to verify? The word “prescriber” is used repeatedly throughout the supporting documents. Pam commented that it would be worth taking back to the group to verify. Andy shared there is a letter sent out notifying DEA prescribers that gets sent out. Mark commented the denominator is the number of DEA registrants. they have tried to define the number of active prescribers, Valerie commented that this points to the need for a clear definition whatever we decide.
Valerie continued running through the table. Line five is the number successfully completing. All of the accreditors raised questions about the definitions of success. We can come back to the FDA to make sure we understand their ideas about success. Francis asked if there is always going to be immediate post course assessment. Valerie answered most accreditors require that. Mark mentioned there will be something that captures that if the program is broken down into several activities; the participants must complete all activities to be considered. Valerie commented they will have to look at that in great detail so that providers can indicate if the activity addresses part or the entire REMS. There was another comment Dimitra made related to successful completion; if that is a data requirement, we would need to track that. We need clarification from the FDA.
Francis asked if assessment should be standardized. Valerie answered the assessment has to assess every component of REMS; that is the level of standardization. Francis asked if there would be a review process. Valerie noted the audit process will address that. REMS compliant CE activities are subject to audits for certain things, including whether the assessment addresses all components of the REMS.
Valerie commented that row nine reflects here question: if we are tracking the number of prescribers, would we need to also track the number of prescribers successfully completing. Pam reiterated the point that seems the most pertinent is the prescriber; other participants are not as important to the FDA’s report. Andy shared that in the existing metrics standard, people could have a report filtered by prescriber and then other participants. Valerie mentioned she hasn’t compared the requirements to the existing specifications yet, but a more straightforward solution may be needed.
Valerie continued with the description in row ten. ACCME identified the learner’s completion date as a requirement based on their reading of the supporting documents. That is not currently in PARS, and for enduring material Valerie is not sure that is necessary. Lorraine asked if data points are aggregate numbers. Learner completion date is individual, and she thought we were not reporting at the individual level. Valerie commented if we moved forward it would become a two part thing: the number of learners completing on that date. She asked the group if that level of specificity is essential. Mark commented that the RPC will have to provide the percent completed in a certain time period. They need to track when participants took their training so that they can segment it.
Valerie continued with Row 11, the number that completed knowledge assessment. The data point is not currently in PARS, it would require a MedBiquitous definition of ‘completed’ and of ‘Knowledge assessment.’ Row twelve is the number knowledgeable; that has to do with successful completion. Line thirteen identifies individual professions of participants. The ACCME questioned if this had been deemed an essential requirement of an FDA-determined ‘adequate’ data set. In the MedBiq notes, Valerie questioned whether this was the number of people from a given profession registered, participating, registered or successfully completed. Francis commented that these requirements would put a greater burden on providers. Lorraine added that it also puts a burden on participants. Pam agreed. Valerie noted that is something we can go back to the FDA on.
Valerie continued. Row fourteen addresses the location of the prescriber. Row 15 addresses the number of prescribers that completed a particular element of the REMS blueprint. Row 16 addresses the number of prescribers that partially completed. In the Medbiq section it was noted do we even need that number if we have the number participating and the number successfully completing? Francis asked if successfully completed addresses going through the whole program. What happens if you take the program assessment and you are still not successful? Valerie thought Francis brought up a very good point. She retracted that comment regarding partially complete, successfully complete, completed some elements and completed all elements.
From line 20-22 addresses data points related to the REMS blueprint. One point regards is this a REMS activity? We need clarity there and we need to be able to point to specific versions of the REMS. Line twenty one brings up which specific REMS Blueprint elements are addressed in the activity. We want to be able to recognize courses that address only some components of the REMS blueprint. Dimitra commented that there may be some providers that might not want to sit through three hours if they only need one hour. Andy asked if providers determine what elements they include. Valerie answered the RPC would have to provide document saying what data providers have to include. Dimitra commented she is interested to know what the FDA wants. Susan asked if there was any timeline for answers to the questions we pose to the FDA. Mary commented the FDA will look for those questions and rule on them as quickly as possible.
4 Identify next steps
Valerie summarized that the RPC summarizing questions and putting them forward to the FDA. Valerie noted that there are an awful lot of unknowns. She asked for additional comments on mega attestation verses partial attestation.
5 Open discussion