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Overview and Performance of the Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics

Several agencies within the U.S. Federal government are focused on reducing the prescription drug crisis the country is experiencing. How significant is the crisis?

Over the course of a given year, approximately 100 million people in the United States suffer from pain. An estimated 9 to 12 million have chronic or persistent pain, while the remainder have short-term pain from injuries, illnesses, or medical procedures.1 Education and treatment of pain management, specifically the impact of opioid drug prescription use, continues to challenge the medical community. 

Since 1999, the quantity of prescription opioids sold in the United States has nearly quadrupled, resulting in an average of 650,000 opioid prescriptions dispensed daily. Deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have also quadrupled, causing more than 165,000 deaths in the United States within a 15-year time period (1999–2014). Additionally, an estimated 1.9 million people in the United States suffer from substance-use disorders related to prescription opioid pain medicines.2

While the various government agencies, including the FDA, have taken numerous actions, this post will focus on the purpose and impact of the Risk Evaluation and Mitigation Strategy (REMS) for extended-release (ER) and long-acting (LA) opioid analgesics.

REMS purpose

The goal of REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, or abuse of ER or LA analgesics while maintaining patient access to pain medications.

Opioid drug manufacturers’ participation in REMS

REMS participation is a requirement for manufacturers of ER/LA opioid analgesic products. Manufacturers of these products are required to provide:

  • Education for prescribers of these medications through accredited continuing education activities supported by independent educational grants from ER/LA opioid analgesic companies: The content of REMS-compliant training must be based on the learning objectives outlined within the FDA Blueprint.
  • Medicine guides: These must be supplied to prescribers and they contain information that the prescribers can use when counseling patients about the risks and benefits associated with ER/LA opioid analgesic use. The requirements for the medicine guides are detailed in 21 CFR 208.24.

The requirements for the two types of activities are detailed in the FDA’s Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) document, which was most recently updated in June 2015.

How successful has REMS been in mitigating the opioid addiction crisis?

A total of 23 companies that make ER/LA opioids, including Purdue, Pfizer, and Endo Pharmaceuticals, formed a consortium called the REMS Program Companies (RPC). These companies amass funds to develop the education programs required by REMS. Although, as mentioned above, REMS is required for opioid drug manufacturers, participation in continuing education is voluntary for prescribers. As of February 29, 2016, 66,219 prescribers had completed this training—about half of the targeted training enrollment number.

For years, the FDA has supported legislation that would require mandatory prescriber education for obtaining or renewing the DEA registration needed to prescribe controlled substances. The majority of companies in the RPC support tying DEA registration and re-registration to an opioid education/certification mechanism of some kind.

While the REMS program does not appear to have interfered with access to opioid drugs for patients who need them, the success of the program is far from clear. Have the rates of addiction, overdoses, deaths and criminal activities associated with these drugs been reduced by REMS? The answer to this question is not known.3

For more information about the complex opioid epidemic and how regulators and industry alike are working to introduce abuse-deterrent products and other measures, read An Opioid Abuse-Deterrent Roadmap for the Pharmaceutical Industry – Combating the Prescription Drug Abuse Epidemic.An Opioid Abuse-Deterrent Roadmap for the Pharmaceutical Industry

 

Sources:

  1. "A Proactive Response to Prescription Opioid Abuse," The New England Journal of Medicine, April 14, 2016
  2. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2016
  3. “Opioid REMS Falls Short on Reaching Docs,” Medpage Today, April 28, 2016
Topics: Thought Leadership Abuse-Deterrence