As part of the new painkiller abuse reduction plan, the FDA is going to require manufacturers of all long-action opioids to develop a Risk Evaluation and Mitigation Strategy (REMS) that will focus on keeping the drugs out of the hands of abusers and prevent prescription drug overdoses.
The FDA Opioid Strategy will require educating doctors on proper pain management, patient selection and will educate patients on their proper use, dangers and disposal of the drugs.
Other federal agencies intend to expand state-based prescription drug monitoring programs, find ways to get unused medications out of homes, support education programs and go after so-called “pill mills”; doctors and clinics that prescribe powerful painkillers at the drop of a hat. Health and Human Services, the Justice Department, Veterans Affairs and the Department of Defense are just some of the agencies involved in the initiative, known as “Epidemic: Responding to America’s Prescription Drug Abuse Crisis.”
The FDA identified a dozen extended-release, long-acting brand-name opioids and four types of generic opioids that will have to develop a REMS program. FDA officials say they hope the drug manufacturers will work together to develop a single REMS system.
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.
The FDA is also hoping to make doctor training on prescribing such drugs mandatory by requiring physician training to get the Drug Enforcement Administration (DEA) registration number doctors need to prescribe controlled substances.
The initiative comes several months after a government report revealed that drug overdoses are now a more common cause of death than gun or alcohol-related deaths. According to the drug-induced death report, released in January by the U.S. Centers for Disease Control and Prevention (CDC), abuse of prescription drugs is driving the increase in drug overdose deaths.
CDC researchers analyzed data from the National Vital Statistics System and compared data on the basis of gender, race and ethnicity. They found that the rate of death for males from drug overdoses consistently exceeded the rate of deaths among females. They also found that the abuse of prescription drugs had a major effect on who is most likely to die from a drug overdose.
In the 1980s and 1990s, more blacks died of drug overdose, due to the abuse of illicit drugs, than any other racial group. That changed in 2002 and now more whites die of drug overdose per year than blacks.