The Food and Drug Administration (FDA) has launched a new risk evaluation and mitigation strategy (REMS) to combat widespread prescription painkiller abuse. How will it impact patients who take prescription medications for chronic pain? Here, the facts to help you work with the FDA's painkiller abuse strategy.
From the White House to the doctor's office, it's a common held belief that prescription drug abuse is epidemic. It has replaced illegal drugs as the number one drug problem in America. The White House Office of National Drug Control Policy is working on a plan to cut the rate of abuse by 15 percent within five years. Along with other agencies and organizations, the FDA is developing strategies to tackle this problem and meet the White House goal.
Their newly announced REMS will work to educate patients and doctors on proper use and prescribing of extended-release (long-acting) prescription pain medications, like Oxycontin, Fentanyl, Duragesic and extended-release Morphine. Surprisingly, an FDA advisory committee voted against this specific plan because they didn't think it went far enough. They wanted to include short-acting pain medications like Vicodin and Percocet too.
The FDA decided this first educational step, which is designed to help make doctors and patients aware of abuse potential, keep prescription pain drugs out of the hands of potential abusers, and help them with safer prescription and pain management plans. The FDA will provide educational materials to doctors and pharmacies, and a medication guide that uses consumer-friendly language to explain safe use and disposal. They won't, however, require doctors or patients to participate in educational programs.
Why not include short-acting medications? The FDA doesn't want to impede patients who genuinely need pain medications from getting them and they feel that long-acting drugs pose more of a public threat for addiction and overdose.
What should patients do about the FDAs new plan?
- Start out with a frank discussion with your physician.
- Patients who are appropriate candidates for long-acting pain medication shouldn't worry they won't be able to get the drug they need.
- Patients who might be over-using or abusing their prescription might need to discuss their drug-use habits and options and talk about how to reduce use and get help.
Don't be surprised if your doctor asks you to sign an office contract that spells out:
- When you should and shouldn't take your medicine,
- When you can refill your prescription, and
- Under what conditions your refill request might be denied.
The FDA's plan might provide a good opportunity for patients to request better medications or a more effective dose, especially if they find the prescription they currently have isn't doing the job well enough. It may also encourage patients and physicians to research other pain management options like exercise, massage, meditation, acupuncture, Tai Chi, physical therapy and psychological therapies. The goal of the White House and FDA is not to be punitive or overly controlling. It's to reduce drug abuse and prevent needless deaths.
Sources:
Food and Drug Administration
FDA Acts to Reduce Harm from Opioid Drugs
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm251830.htm
The White House
Office of National Drug Control Policy
http://www.whitehousedrugpolicy.gov/
