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Meeting Information


April 23, 2013



Attending: Francis Kwakwa, Chair; Mark Baczkowski, Stephanie Cordato, Jennifer Dunleavy, Brad Hill, Edward Kennedy, Linda Kitlinski, Joanna Krause, Sue McGuinness, Tom McKeithen, Rajesh Patel, Valerie Smothers, Lorraine Spencer, John Sweeney, Emma Trucks, and John West.

Agenda Items

1 Review minutes of last meeting

Minutes were accepted as submitted.

2 Discuss FDA versioning of REMS documents

Valerie had a follow-up call with Doris Auth from the FDA.  They discussed supporting of different versions of REMS.  Doris mentioned there was support within the FDA to do that, and they were discussing logistics.  The FDA plans to hold another meeting within the next two weeks. Hopefully we can hear more details on that soon.  There is no firm commitment yet for publishing different versions of the REMS.  Francis asked which version of REMS we will refer them to.  Valerie explained we point to REMS through a URL.  The current practice within the FDA is to upload to a link that is always the same.  Since there may be changes to the blueprint; it would behoove us to point to a specific version of the REMS that the activity supports.  If the FDA is able to implement versioning, they could publish different versions on their website. Otherwise we would have to come up with a work around.  

3 Discuss incorporating additional fields in implementation guidelines

Number of participants successfully completing

Number of participants successfully completing registered to prescribe schedule 2 and 3 drugs

Proposed definition of registered prescriber (see

Valerie mentioned this issue came up at the MedBiquitous annual conference during the presentation by Linda Kitlinski, Kate Regnier, and Emma Trucks.   Emma presented data Boston University has been gathering, and it became clear that there are a lot of learners who were registered to prescribe schedule 2 and 3 drugs but weren’t necessarily active prescribers.  The RPC saw that as important data to collect.  Emma commented it was interesting to see. A lot of people are licensed to prescribe, but something is preventing them from prescribing. 

Linda clarified that the RPC is not trying to increase the numberof those prescribing ER/LA-Opioids.  The FDA talked about using a dominator of 1.4 million registrants to prescribe opioids in calculating the metrics for REMS evaluation.  Discussion with the FDA resulted in focusing on active prescribers.  The reasoning was that those clinicians who are not active prescribers would not want to participate in a 3 hour course on ER/LA opioids. It seems that was inaccurate. Almost 50% (about half) of people who completed the activity were not currently prescribing ER/LA opioids.  Prescribers are managing patients but not writing scripts.  The FDA may be interested in what education was meaningful and was contributing to people’s knowledge and competence. 

Julie added that they are concerned that this might be a subset of people prescribing  short acting opioids for chronic pain.  It seemed like during the discussion it was good needs assessment data. 

Valerie said as a result, RPC had proposed adding instructions for the following data points to the implementation guidelines:   

  • Number of participants successfully completing
  • Number of participants successfully completing registered to prescribe schedule 2 and 3 drugs

She added that we need a definition of registered prescriber to enable this. A draft definition is linked from the agenda: An individual clinician who is registered with the DEA and is eligible to prescribe Schedule 2 and 3 drugs.  If we all agree we could then point to that and be able to convey the number of registered prescribers who successfully completed. 

Valerie asked the group if they wanted to include instructions containing that data in the implementation guidelines.  Are accreditors willing to collect that data?   Francis asked if this will be self reported data.  Valerie answered yes; it is not something anyone would need to verify with the DEA.  Valerie asked the group for comments.  Jennifer commented the more data that we can collect the more valuable it will be for the system as a whole. But we need to consider the complexity of the data and what it means for provider and acreditors collecting it.  We have to balance having the data verses the complexity it creates in our reporting system.  Valerie asked if we limit it to these two fields, does that make it manageable.  Jennifer thought the data that BU collected is interesting. ER/LA REMS has received a lot of attention; people are just trying to stay current. The simpler we can make it the better.  Is active prescriber in the last twelve months still a valuable data point to collect? 

Linda shared that the FDA requires that the RPC collect data on DEA registrants who had written a prescription in the last twelve months.  That is a key metric of how successful we are at reaching the right audience in CE.  The preliminary data is showing as many people completing CE who haven’t been an opioid prescriber in the last year.  Qualitatively that should inform what CE is accomplishing.  There is more to it than just writing prescriptions. 

Francis asked the AOA participants if this would be something they would be willing to track.  Valerie noted Pamela was not on the call this week.  He asked if the ACCME is willing to do this.  Ed, John and Jennifer couldn’t commit on behalf of the ACCME, but they believed it would be valuable information to have and that the addition of the two fields was not a substantial burden.  They are thinking about what sub-strands could emerge.  Valerie mentioned as long as we don’t go down the rabbit hole, it could remain manageable.   Julie commented for them, it’s a critical needs assessment piece of information.  She would advocate for including it.  

Francis asked if there were comments on the definition.  Lorraine commented it was unclear to call them registered prescribers as ER/LA Opioid prescribers are also registered prescribers.  Valerie thought that was a good point to clarify; this definition is intended to cover both categories of registered prescribers: people who have written prescriptions and those who haven’t.  Lorraine recommended clarifying the name.  Valerie suggested calling it schedule 2 and 3 registered prescribers and she asked Lorraine if that addressed her concerns.  Lorraine agreed it did.  Francis noted the definition remains the same.  Francis asked the group if they wanted to think it through, or come up an agreement today.  It would make the data richer.  Valerie will circulate in the implementation guidelines and ask for comments when she circulates for review. 

4 Presentations and webinars

Valerie touted the presentation given by Kate Regnier, Linda Kitlinski, and Emma Trucks  at the MedBiquitous Annual Conference on April 9.  The materials will be posted soon.  There is also a webinar coming up to which the group is invited.  Linda described the webinar coming up.  They wanted to provide a webinar when REMS was first announced to be able to let the national provider organization be updated on the progress and specifics of REMS.  The accreditors have been very involved in that and suggested we needed to make sure the national provider organizations had access to information to share with their constituents.  The webinar is scheduled for May 7th and she can provide a copy of the invitation. Everyone on the working group is on the distribution list, and everyone is welcome.  It is from 4:00-5:00 p.m. Eastern Time.  Stephanie commented that Valerie can circulate the information she was given to the working group members along with the meeting invitation.  She will resend the information to Valerie and Valerie can forward it on. 

5 Open discussion

Valerie mentioned the next step would be to revise the implementation guidelines adding the two new data fields and instructions on how they will be conveyed. They are still waiting on FDA for a decision with regard to versioning.  She suggested discussing when this group should meet again.  There is a call scheduled for next Tuesday April 30th and June 18.  Do we want to schedule another follow-up call? 

Francis and Valerie talked about having an example survey as an appendix to the implementation guidelines, and they wanted to float that past Julie.  Julie was happy to share. Francis asked Tom if CORE would be interested in sharing. He replied that they are happy to share the way they posed the questions.  Tom mentioned CORE is willing to go along with what the group decides.  The sentiment was not to continue to add questions because of learner fatigue.  Francis asked how much will adding two questions impact implementation?  Tom answered it was not a lot of work; the evaluation piece is slightly different for each provider.  They ask different questions for different accreditors, and it was not a big deal to ask two more questions. 

Valerie commented that Julie and Tom have done a lot of thinking about this, and other people could benefit from their thinking.  It would be great to share in some way. Having it as an appendix with examples that are not normative, ie stating you don’t have to use these questions and exact wording to be conformant to specifications, could be very helpful.  Valerie asked if there were other suggestions for things to include. 

Tom mentioned the core providers have all the materials the core is using; they are happy to provide that to anyone else who is trying to do the REMS programs. They have knowledge assessment and competence assessment on version 4.  Valerie asked Tom if there were any potential risks associated with sharing assessment and including the assessment in the implementation guidelines.  Tom commented there is care taken with the shared assessment; the chance is small it would affect the outcomes results.  He will run it by his Executive Committee and clear it with them. 

Valerie commented that in the assessment sharing efforts that she knew of in undergraduate medical education, you have to have a special login to make sure you can access the questions and the assessments.  That goes beyond MedBiquitous’ scope; MedEdPortal does things like that.  Their DREAM initiative provides a scholarly write up about the assessment instruments and they published that with the instrument.  Linda mentioned the additional information that core and BU could share is how to structure the assessment.  Operational learnings are insightful as well.  Valerie thought what Linda was speaking about would make a great article.  It wouldn’t necessarily go in an appendix, but something you might publish somewhere.  Valerie hoped the providers on the call are thinking about publishing.  Julie said they definitely are. 

Linda commented that the first annual report is due July 9th; they would want to have a good sense well in advance of that.   Polaris will need to work with accreditors to make sure they aren’t using incorrect wording.  That is accomplished via email. They don’t want to change labels mid-stream.  If we make revisions and circulate them for comments by next week, then we can have field names for Polaris. 

The group agreed to schedule the next call for May 14th at 1 PM EDT.  There will be no call on April 30.




The next call is May 14th at 1 PM EDT.  There will be no call on April 30.

Action Items

  • Valerie will change the term registered_prescriber to schedule_2_and_3_registered_prescriber.
  • Valerie will incorporate instructions for representing the following data points into the implementation guidelines and circulate the guidelines for comment:
    • Number of participants successfully completing
    • Number of participants successfully completing registered to prescribe schedule 2 and 3 drugs
  • valerie will circulate the webinar invitation to the working group.
  • Valerie will include example surveys in an appendix to the implementation guidelines.
  • Julie and Tom will send Valerie their survey questions.
  • Tom will explore the feasibility of sharing assessments.


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