Painkiller Overdoses Target of New FDA Safety Measures

Federal drug regulators have unveiled a new plan that they hope will cut back on prescription painkiller overdoses, which have increasingly become a serious health concern in the United States. 

On July 9, the FDA announced new safety measures for extended-release and long-acting opioid medications, like OxyContin, which includes new educational courses for patients and prescribing doctors.

The program is part of a Risk Evaluation and Mitigation Strategy (REMS), which is typically put in place when a drug has been deemed dangerous but necessary.

The REMS plan requires more than 20 companies that make opioid painkillers to provide access to education programs that will be built on an FDA-approved model. The strategy also requires that the companies provide new educational material for patients.

The brand-name drugs affected by the strategy include Duragesic, Palladone, Dolophine, Avinza, Kadian, MS Contin, Oramorph, Embeda, OxyContin, Opana ER, Exalgo and Butrans. The generic drugs affected by the strategy include fentanyl, methadone, morphine, and oxycodone.

Education Targets Doctors and Patients

Doctors will be taught how to choose patients appropriately, how to teach their patients safe use of powerful painkillers and what signs to look for in order to spot abuse and addiction.

Through the program, patients will be provided with updated medication guides and other documents that instruct them on the proper care of the drugs, signs of overdose, advice on how to store the drugs safely and emergency contact information.

Opioid painkillers, also known as opioid pain relievers (OPRs) are a class of analgesics that includes methoadone, oxycodone and hydrocodone, among others. They are controlled substances that are supposed to only be obtained through prescription for the alleviation of pain. However, abuse of the drugs has increased steadily through the years.

The new FDA program does not provide a plan for dealing with prescribing doctors who intentionally run what have been called “pill mills,” where they supply a steady stream of patients with powerful painkiller prescriptions with no questions asked. However, the program requires both companies and the FDA to periodically review how well the REMS is performing.

The FDA estimates that the new education programs will begin to be available by March 1, 2013. However, there is no mandatory requirement that doctors participate.

According to the FDA, long-acting and extended-release painkillers were prescribed 22.9 million times last year. The prevalence of the drugs has led to prescription painkiller overdose deaths surpassing the number of deaths linked to abuse of illegal substances like cocaine according to an overdose report last year by the U.S. Centers for Disease Control and Prevention (CDC). The CDC notes that there were 15,597 opioid overdose deaths in 2009; four times the number of such deaths recorded in 1999.