FDA Develops REMS for Pain Medication

The United States Food and Drug Administration (FDA) is working on developing a plan known as Risk Evaluation and Mitigation Strategies (REMS) in order to evaluate the risks and benefits of pain medication and to address pain medication abuse, misuse, and accidental overdose. Though the aim of REMS on certain opioid medications is meant to reduce the incidence of misuse, abuse, and accidental overdose, it will also make getting pain medication even harder for individuals who need it, those who suffer from chronic pain.

On February 6, 2009, the FDA sent out letters to 15 different drug manufacturing companies informing them that new Risk Evaluation and Mitigation Strategies will be required of specific opioid medications. Medications that will be effected by the REMS include: hydromorphone, morphine, oxycodone, oxymorphone, and methadone. The FDA will hold several meetings with healthcare professionals, pain and addiction communities, and patient advocacy groups as they form the REMS.

According to the American Pharmacists' Association, many efforts have already been made to reduce the incidence of opioid accidental overdose, misuse, and abuse. These efforts have included: additional warnings on product labels, interagency collaborations, risk management plans, and direct communication with prescribers and patients. However, despite these efforts, the FDA asserts that opioid abuse, misuse, and accidental overdose have continued to increase over the past 10 years.

Some of the new regulations being considered for opioid pain medications include: requiring doctors to get special education and certification to prescribe the drugs, removing extended-release versions of the drug from the market, requiring patients who utilize the drugs to enroll in a special registry, requiring pharmacists who dispense the drugs to have a special certification, monitoring every patient who utilizes the drugs, and giving the drugs to patients only in specific healthcare settings.

This will likely make getting pain medication for those who need it more difficult. In addition, the extended-release forms of opioid medications help many individuals who suffer with chronic pain and often provide more continuous pain relief than non-extended-release versions of pain medication.

If you would like to express your opinions on the FDA REMS for opioid pain medication, you may do so by going to the FDA-provided form here.

Sources:

American Pharmacists' Association: FDA Looking to Add REMDS to Certain Opioids:

http://www.pharmacist.com/AM/Template.cfm?Template=/CM/ContentDisplay.cfm&ContentID=18609

Chronic Pain Connection: FDA May Remove or Limit Access to Opioid Pain Medications:

http://www.healthcentral.com/chronic-pain/c/5949/74180/medications?ic=6042