ACP course helps prescribers safely prescribe opioids, meet FDA requirements

The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for all brand and generic extended-release (ER) and long-acting (LA) opioid pain medicines to ensure that the benefits of prescribing a drug outweigh its risks for patients.

Under the single, shared REMS for ER/LA opioids analgesics, the companies that manufacture the medications are required to make independent, accredited education/training available to all ER/LA opioid analgesic prescribers. The FDA required manufacturers of ER/LA opioid analgesics, known as the REMS Program Companies (RPC), comprised of 11 pharmaceutical companies, to support education for prescribers of these medications. RPC-supported REMS education is to be provided through accredited continuing education (CE) activities supported by independent educational grants from these ER/LA opioid analgesic companies.

To assist in this effort, the FDA has developed a Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (“FDA Blueprint”) that is posted on the website. More than 30 CME and CE providers, including ACP and its curriculum partner Pri-Med, have been approved by the RPC to deliver the FDA's REMS-compliant curriculum.

ACP and other CME and CE providers are required to deliver the curriculum as provided by the FDA and created by their experts with no deviation, including the use of brand names. The FDA's intent was to standardize the curriculum and have the exact same message and content delivered regardless of the CME or CE provider. It is the provider's responsibility to ensure that their program maintains compliance with Blueprint requirements. The ACP course launched on June 15, 2013. It offers CME credit and is available through ACP and Pri-Med.