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Meeting Information

Date:

December 6, 2016

Time:

2 EST/1 CST/12 MST/11 PST

Attendees: Francis Kwakwa, Chair; Doris Auth, Caitlin Briggs, Ilana Hardesty, Robin Hayden, Edward Kennedy, Kai Klassen, Nathan Kopper, Joanna Krause, Tom McKeithen, Marsha Stanton, Valerie Smothers, Amy Tan, Dimitra Travlos, Mark Tyrrell, and Julie White

.

Agenda Items

1 Review minutes

The minutes were accepted as submitted.

2 Review definition of institutional prescriber

Valerie drafted the definition for institutional prescriber,  “An individual clinician who uses an institution’s DEA registration to prescribe Schedule 2 and/or 3 controlled substances and who has written at least one ER/LA opioid script in the past year.” The term is intended to capture those prescribing under an institutional DEA registration.  Ilana questioned how this definition would be operationalized.  Valerie was hesitant to provide operational guidance but suggested possibly adding a question describing DEA registration status.  Ilana questioned whether they will still be reporting one or two data points? Doris confirmed the FDA wants this capture prescribing under institutional registration as a separate data point.  Ilana noted they could capture that with two questions: Are you currently registered and what type of registration do you have. 

Valerie will add the definition as a new term and add information to the implementation guidelines.

3 Discuss proposed FDA requirements and view current FDA characterization of prescriber demographics (note: full slides available)

The discussion continued on the proposed additional fields the FDA wants to include to align with other evaluation data.  Francis noted the proposed fields are mainly demographics and requested feedback.

Doris supported removing #1 Medical Degree due to the overlap with Profession. 

#2 Specialty, Julie thought a specialty list had previously been adopted last year.  Valerie noted this list was similar to the specialties in Healthcare LOM. Currently MEMS takes a minimalistic approach that includes practice type as primary care, pain specialist, and non-pain specialist, also dental specialties.  Doris agreed they wanted to keep it simple and for most purposes this list was granular enough.  She suggested comparing lists and determining the differences.  Valerie asked if the group found the list useful.  Valerie mentioned the list was profession specific specialties and could be broken out into medical and dental specific specialties.  Valerie and Francis agreed to look at the different lists and offer a solution by the next meeting. 

#3 Years in practice – Francis mentioned practice years have been broken down into ranges, 0-5, 6-15, 15+.  Valerie noted 15+ should be 16+.  Doris commented the question is consensus and aligning surveys with whatever the group decides.   Julie mentioned their ranges were made up years ago.  Francis thought it would be helpful to know about other surveys before making any decision.  He and Valerie agreed to explore this field as well.    

#4 Gender has two values.  Ilana questioned how the data is used.  Doris mentioned it is more data to compare two populations but doesn’t matter that much.  Tom added it is not helpful and may have a negative impact on compliance.  Doris will discuss further with the FDA and provide their feedback. 

#5. Geographic region, (state).  Julie noted the need to clarify state of practice vs. state of residence due to people practicing in multiple states.  Ilana added they ask in what state your primary practice is located.  Doris agreed.  Valerie noted on the wiki page primary state of practice. 

Doris mentioned #6 and #7 were eliminated due to issues with data privacy recall.   Julie expressed concern they may not obtain accurate data, and she also had concerns about privacy.  They don’t ask about prescribing behavior as CME providers.  Ilana agreed and mentioned they ask guideline based questions, not specific prescribing behavior.  The consensus was #6 and 7 will remain excluded. Valerie noted these decisions on the wiki page with the proposed definitions.

Decisions

The definition of institutional prescriber was approved.

Action Items

  • Valerie will add the definition as a new term and add information to the implementation guidelines.
  • Valerie and Francis will provide more details on lists for specialties.
  • Valerie and Francis will explore options for years in practice.
  • Doris will discuss gender with her FDA colleagues to determine the importance of the data point.
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