New FDA strategy targets long-acting and extended-release opioids
The risk evaluation and mitigation strategy pertains specifically to extended release and long-acting opioids. ER/LA opioids are more of a safety concern than immediate-release formulas because they are stronger and either stay in the body longer or are released into the body over longer periods of time, the FDA said.
The agency has authority to require companies to develop and implement a risk evaluation and mitigation strategy to ensure the benefits of a drug or biological product outweigh its risks.
More than 20 manufacturers will be required to make education programs available to prescribers based on an FDA blueprint. The companies are expected to provide educational grants to continuing education providers, who will develop and deliver the training to prescribers by March 2013.
"The FDA's goal with this risk evaluation and mitigation strategy approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs," said Dr. Margaret A. Hamburg, FDA commissioner.
The FDA estimates that nearly 23 million prescriptions for ER/LA opioid analgesics were written in 2011. More than 320,000 prescribers registered with the Drug Enforcement Administration wrote prescriptions for the drugs that year.
"ER/LA opioid analgesics are associated with serious risks of overuse, abuse, misuse and death and the numbers continue to rise," according to an FDA statement. "According to the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioids in 2008. In 2009, there were 15,597 deaths involving these medications -- nearly four times as many deaths compared to 1999."
Prescribers are not required to participate in the training. However, the risk evaluation and mitigation strategy includes the following requirements of manufacturers:
- Training for prescribers, including information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of the drugs. The education will include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction.
- An updated medication guide and patient counseling document that contains information on the safe use, storage, and disposal of ER/LA opioid analgesics. They must include instructions to consult a physician before changing doses, as well as signs of potential overdose and emergency contact instructions.
- Assessment/auditing to achieve certain FDA-established goals for the percentage of prescribers of ER/LA opioids who complete the training, as well as assess prescribers' understanding of important risk information over time.
The risk evaluation and mitigation strategy is part of a national strategy to combat the opioid epidemic. The Obama administration is currently pursuing legislative changes that would implement a mandatory training program on responsible opioid prescribing practices that would be linked to DEA registration by providers.
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August 2, 2012
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