The FDA is currently developing what they term “Risk Evaluation and Mitigation Strategies” or REMS in relation to opioid pain medications. What that means is they are working on a plan to ensure that the benefits of opioid medications outweigh the risks, which include misuse, abuse and accidental overdose.
It's no secret that the abuse of prescription drugs has increased dramatically over the past several years. The FDA is developing REMS in an effort to curb that abuse. But it's up to us to ensure that, in their efforts to curb drug abuse, they don't severely limit the ability of pain patients to get essential medications.
The opioid medications under review are: fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. Some of the possible REMS being considered include:
• Removing extended-release forms of the drugs from the market.
• Requiring doctors to have special education and certification to dispense the drugs.
• Requiring pharmacists to have special certification to dispense the drugs.
• Dispensing the drug to patients only in specific health care settings.
• Monitoring each patient using the drug.
• Requiring patients using the drug to enroll in a special registry.
What You Can Do
The FDA wants to hear from you. They are accepting public comment until June 30, 2009. You can be sure they are hearing from people who have lost loved ones to drug abuse and want to see opioids banned entirely. It's up to us to make sure they also hear from chronic pain patients who need these medications in order to have any quality of life.
This is a rare opportunity. It's not often we have a chance to make our voices heard at the FDA and influence their decisions. Please don't let this opportunity pass you by. What they decide will impact your pain care for years to come.
The FDA has provided an online form to make it easy for you to express your opinion on this issue. Click here to access the submission form, then click "Submit Comment."
If you're not sure what to say, check out the American Pain Foundation's action alert for links to more information about REMS, the APF's recommendations, and the testimonies of four pain advocates who spoke at the FDA hearing last month. APF's Urgent Call To Action
When you write to the FDA, please comment below to let us know – and feel free to share a copy of your letter if you'd like.
Thanks for taking action!
Published On: June 10, 2009