Restrictions on Rx Narcotics Are Coming--February 2009

February 12, 2009
Eileen Koutnik-Fotopoulos

The FDA is taking steps to reduce the deaths and injuries from inappropriate use of narcotic drugs.

The FDA is targeting narcotic use with a new control program to reduce the unsafe use of 24 narcotic products like OxyContin, fentanyl patches, methadone tablets, and some morphine tablets. These products are classified as Schedule II narcotics.

“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products,” John K. Jenkins, MD, director of the FDA’s new drug center, said in a news conference February 9.

US pharmacies dispensed 21 million prescriptions for the 24 opioid products, used by 3.7 million patients. Despite label warnings and collaborations with the FDA and other federal agencies, misuse, abuse, and accidental overdoses of the products have increased over the past decade, he said.

The agency said that physicians who prescribe poorly, patients who do not pay attention to instructions or get access to the medicines inappropriately, and companies that have marketed their products illegally are to blame.

The 16 companies that make the 24 products received FDA letters stating that their drugs are required to have a Risk Evaluation and Mitigation Strategy (REMS). A law passed in 2007 allows the FDA to place strong restrictions on certain drugs. The agency believes that establishing a REMS for opioids will lower these risks, while ensuring that patients with legitimate need for these drugs will continue to have appropriate access.

Whereas no immediate changes in access to the drugs are planned, the FDA will meet March 3 with the companies that market the affected opioid drugs to discuss REMS development. Additional steps will include discussions with other stakeholders, including patient and consumer advocates, representatives of the pain and addiction treatment communities, and other health care professionals. The FDA is planning a public meeting in late spring or early summer to allow for broader public input and participation. A complete list of the drugs targeted is available at www.fda.gov/cder.

For other articles in this issue, see:

Pharmacist Follow-up Decreases Rehospitalization

Counterfeit Drugs Present a Growing Threat

Patients Looking for Lower Cost Prescriptions