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  • Proposed guideline changes, profession, specialty, and prescriber
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The RPC would like to propose a change to the MEMS 2.0 Specifications, in which CE Providers are required to collect data regarding the Profession and Specialty Type of individuals who complete REMS-compliant CE, but do not meet the definition of an ER/LA Opioid Prescriber Completer, as well as tracking those Completers who prescribe under an institutional or collaborative DEA license.

The RPC collects data from CE Providers on a quarterly basis, to track the number of Participants, Completers, and ER/LA Opioid Prescriber Completers who have participated in RPC-supported, REMS-compliant CE.  As part of this tracking process, it was noted that of the healthcare professionals (HCPs) who complete RPC-supported, REMS-compliant CE, only a small percentage are eligible to be counted as an ER/LA Opioid Prescriber Completer.  These data were communicated to FDA as part of the 36-Month Assessment Report.

On 7/21/15, following submission of the 36-Month Assessment Report, the RPC received an Information Request from FDA asking that the RPC “Provide any data you may have on the numbers of prescribers completing REMS-compliant training who either have not written a prescription for an ER/LA Opioid Analgesic in the past year as well as those prescribers who are practicing under an institutional DEA registration”.  The RPC was unable to provide any additional clarity to FDA, as profession and specialty type are only recorded for those HCPs who meet the definition of an ER/LA Opioid Prescriber Completer, and no records are kept on those HCPs who prescribe under an institutional or collaborative DEA license. 

Moving forward, the RPC would like to suggest that a required field for CE Providers include reporting on the profession and specialty type for all Completers of REMS-compliant CE as well as those Completers of REMS-compliant CE who prescribe ER/LA Opioids under an institutional or collaborative DEA license.  This will allow the RPC to provide these metrics to FDA in future Assessment Reports.

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