REMS Update Puts Spotlight on ER/LA Opioids

The Food and Drug Administration Amendments Act of 2007 expanded the FDA’s authority to several new areas, one of which helps prescribers and patients weigh the benefits and risks of medications. Additionally, this federal Risk Evaluation and Mitigation Strategy (REMS) program allows the FDA to require manufacturers to develop mitigation programs for drugs considered to be high risk. Without REMS, FDA representatives have indicated the agency would need to remove some drugs from the market or refuse to approve new drug applications.

While some REMS programs only require medication guides for patients, others restrict a drug’s distribution to trained, certified pharmacies, thus propelling the agents onto specialty pharmacy shelves. In these cases, community pharmacists who cannot dispense the drug must guide patients to pharmacies that can.

Pursuant to this program, a new slang term used among health care professionals was born: REMS patient. This term hints at the increased workload that is generated when a patient needs a drug covered by a REMS plan.

Today, 67 individual drugs have REMS programs, and 6 are shared by multiple products. Included in the latter category is a REMS program that covers extended-release, long-acting (ER/LA) opioid analgesics. This REMS was recently updated in an attempt to stem the flow of opioids to recreational abusers and addicts while ensuring patients experiencing severe pain retain access.

New this month is language that allows the FDA to require manufacturers to fund prescriber education programs covering risks, safe prescribing, and safe use practices for opioids. A manufacturer consortium known as the REMS Program Companies (RPC) is funding educational grants to accredited continuing education (CE) providers to ensure the cost to prescribers is nominal or free.

Also new is the FDA’s blueprint of core educational messages embedded in the 43-page document. Accrediting bodies and CE providers that create educational programs must now provide educations accredited by the Accreditation Council for Continuing Medical Education or similar CE-accrediting bodies and comply with standards for commercial support.

Additionally, all medication guides are being updated to include consumer-friendly literature on how to use, store, and dispose of ER/LA opioids safely. Warnings that address changing doses without physician supervision, signs of potential overdose, and emergency contact instructions are also currently mandated.

Under FDA review, drug manufacturers must now assess their REMS implementation strategies periodically to determine whether they meet their goals. Because medication guides are part of FDA-approved labeling, failing to provide them as required could be deemed mislabeling, which raises the possibility of civil liability and pharmacy board actions.