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Meeting Information


September 11, 2012



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Attendees: Francis Kwakwa, Chair; Doris Auth, Rod Campbell, Tony D’Ambrosio, Pamela Ball, Mark Baczkowski, Susie Flynn, Ed Kennedy, Myoung Kim, Anjum Malkana, Sue McGuinness, Andrea Morgan, Anshu Sawhney, Valerie Smothers, Lorraine Spencer, John Sweeney, and Dimitra Travlos.

Agenda Items

1 Review minutes of last meeting

The minutes were approved as submitted.

2 Discuss REMS documents

Valerie began the discussion by alerting everyone that the REMS document was not for circulation beyond this group.  Francis noted that Part two covered data points we are interested in tracking.  Valerie walked the group through the Education Related Sections of REMS supporting document part 2 and Table 1,  Components of the Shared Extended-Release/Long-Acting

Opioid Analgesics REMS Assessment Plan. The first assessment element is how many prescribers have successfully completed the computer training. That includes an aggregate level description of the completers.  Mark commented that they are looking for different prescriber types:  family practice, MD, nurse practitioner, physician assistant, and those types of demographics.  Pam from AOA suggested we might want to break down by specialty as well.  Valerie asked Doris to comment.  Doris agreed that specialty type was relevant. She commented that personally she would be interested in how many prescribers taking the program are licensed in states that have their own opioid training program, but that she was not speaking on behalf of the FDA on that point.

Valerie commented that the current specification may have data points that could be used to meet those requirements.  One of the things we can do on a subsequent call is to take all the requirements and line them up with the current specifications. The number completing training and aggregate description seems to be one requirement.  Providers will send data to accreditors and accreditors will send to the RPC.  Francis asked if data will always go through the accreditors.  Valerie stated she did speak to accreditors and that for CE activities, data go to accreditors and then be sent on to the RPC. 

Valerie commented that item 2 in the table is about the audit provision, which doesn’t apply to data standard the group is working to develop.  Item 3 includes both RPC conducted surveys as well as the long-term outcomes evaluation of the prescribers who completed REMS compliant CE.  It’s not necessarily the CE itself, but other assessments.  Mark commented that there will be a baseline and 2 years post outside of the CE activities. The RPC is interested in the long term outcomes of CE.  Valerie asked Mark if that meant the RPC would have to collect survey data in a standard format.  Mark answered that there would probably only be one to two providers that with whom they will work directly.  Susie asked for clarification on the post assessment.  Mark noted it’s more to guauge the impact of the training at the end of CE course itself.  Ultimately they want to measure behavioral changes. Francis clarified that there would still be a posttest component of the CE activity.

Lorraine asked if the post test is given at the end of the training to signify successful completion.   Mark and Myoung answered that was correct. In addition to the CE posttest, there would be a separate evaluation.  Francis asked if we should be thinking about pre-tests.  Valerie and Pam commented that pretests were not discussed in the REMS document.  Valerie noted the providers are going to create the posttests, but they have to be based on FDA blueprints. 

Valerie referenced the method of analysis on page 4.  “Each accredited provider of CE will be required to periodically report data on the numbers of prescribers who have successfully completed their organization’s training program. Subgroups by specialty or prescriber type may be included if the data supplied by the accredited CE providers permits such a level of analysis.”  Mark agreed that sounds like something the specification should support. 

3 Review revised use cases

Valerie continued with an explanation of the revised use cases.  There were a number of comments on the last call, and revisions have been made to address those comments. The changes are in purple.  The first change is to the definition of Educational Management Systems. Valerie added “may be paper based”.   She also added the role of Regulator (FDA) and the key concept of blueprint.  Under MEMS2-1 the title changed to account for designing systems to support the blueprint.  The Description has changed as well to include: “The Technology provider also designs the system to ensure that it can connect activities to a blueprint when needed” and “The Technology provider may adapt the system to ensure that it can connect activities to a blueprint when needed.”

Valerie edited use case 2-5, Researcher or Research Group examines outcomes data looking for trends or to answer specific research questions. The trigger now includes “Regulator requires report on outcomes data.” Valerie commented that she added 2-6, Provider or Researcher sends outcomes data to a Research group outcomes database,” to support the exchange of survey data and long term prescriber evaluation data described in element 3 of Education related sections of REMS Supporting Document 2. Valerie asked the group to email her any comments that came up after the call.

Lorraine questioned the use of provider outcomes database instead of accreditor outcomes database in use case 2-5. Valerie offered to change the use case. {Note: After the call Valerie corresponded with Lorraine. The proposed change was retracted since the use case is essential for CE providers conducting internal evaluations. ]

4 Discuss data requirements

a From accreditors

Pamela commented that accreditors had not had enough time to digest the new document.  She suggested having another call amongst the accreditors. Valerie commented she had some challenges scheduling that.

b From FDA

Valerie mentioned that she would be speaking with Doris and some of her colleagues to get a better sense of requirements around the blueprint.  We should have more details on the next call.

c From others

Valerie asked if there were any other data requirements from others on the call to consider. She asked the group to send any comments that arise to her or to the working group as a whole.

5 Open discussion



Action Items

  • Valerie will communicate with accreditors to solidify their requirements.
  • The group will communicate other requirements as needed.
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