FDA Announces New Safety Measures for Opioid Medications

July 17, 2012

The FDA has approved a new strategy to evaluate the risk and safety of both extended-release and long-acting opioid analgesic, called a Risk Evaluation and Mitigation Strategy (REMS). The drug class are synthetic versions of opium, that have had a long history of regulated control to mitigate their abuse and illegal distribution.

The US Food and Drug Administration (FDA) has approved a new strategy to evaluate the risk and safety of both extended-release and long-acting opioid analgesic, called the Risk Evaluation and Mitigation Strategy (REMS). The drug class are synthetic versions of opium, that have had a long history of regulated control to mitigate their abuse and illegal distribution. Among the opioids most frequently prescribed include oxycodone (OxyContin), morphine sulfate (Avinza), methadone (Dolophine), and fentanyl transdermal (Duragesic). The FDA is targeting a total of 12 extended-release and long-acting opioid analgesics.

According to an FDA survey conducted in 2007, more than half of those who abuse opioids obtained them from a friend or relative. The new safety action is part of a federal initiative to address overdose, abuse, and misuse of the drugs.

The REMS program is part of the FDA Amendments Act of 2007, requiring manufacturers to assess whether the benefits a drug or biologic outweigh the risks. Manufacturers are required to report all major adverse events to the FDA under a REMS plan for a specific agent. Currently more than 20 companies with more than 30 products are affected by the REMS.

The new opioid analgesics REMS will require companies that manufacture these agents to provide educational material and training to health professionals that dispense the medications on how to properly prescribe the pain agents including risks and benefits of the drugs, and managing and monitoring patients. Information on identifying drug abuse, misuse, and addition will also be included. It will require the manufacturers to provide educational material to prescribers and patients on the safe use of these pain medications. The FDA is establishing goals to assess and audit this training. According to the FDA, the first educational activities will be offered to prescribers by March of 2013.

The FDA says that about 320,000 clinicians regularly prescribe extended-release and long-acting opioid analgesics. The FDA expects to train about a quarter of these at the end of 2013 and about half after the first 2 years of the program.

Educational material, including safe use and disposal of opioid analgesics for patients is also required and will need FDA approval.

Part of the National Prescription Drug Abuse Plan

This new REMS is part of a plan announced by the Obama administration in 2011 to help stop prescription drug abuse. The plan, called “Epidemic: Responding to America’s Prescription Drug Abuse Crisis,” is a collaboration between the Justice Department, Department of Veterans Affairs, Defense Department , and Health and Human Services among others. “We share a responsibility to protect our communities from the damage done by prescription drug abuse,” said Gil Kerlikowske, director of the White House Office of National Drug Control Policy, in a statement in 2011.

According to the Centers for Disease Control and Prevention, there were 15,597 deaths in 2009 that involved an opioid medication and almost 425,000 emergency room visits of people who used these drugs for nonmedical use. The FDA report says that more than 33 million people in America misused these drugs in 2007, and that the numbers are on the rise.

Opioid analgesics are important for the treatment of acute medical pain treatment as well as for hospice care for cancer patients. The new REMS, and better prescriber and patient awareness may lower any stigma or negative perceptions for use of these pain medications for the patients who need them for pain management and better quality of life.