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FDA releases new program to avoid misuse, abuse of opioid painkillers

Filed July 12th, 2012 Laurie

The Food and Drug Administration has released new guidelines for the use of opioid painkiller drugs to avoid misuse or abuse of these drugs.

Opioid painkillers are generally controlled substances but that does not make access to them in today’s market any less strict. Some studies have suggested that use of prescription opioid painkillers like OxyContin is greater than the use of some street drugs. They are available just as much as any “illegal” narcotic.

The FDA’s risk evaluation and mitigation strategy (REMS) released this week focuses mostly on those who receive prescriptions for the drugs and advises those patients and their prescribing physicians on the best means to avoid overuse, misuse, or abuse of these drugs.

Opioid painkillers are extremely powerful and can cause dependency if they’re taken for any extended period of time.

FDA Commissioner Margaret Hamburg said, “Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge. The FDA’s goal with this REMS 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.”

The FDA’s program has no mandate but contains key components which the agency hopes drug makers and prescribing physicians follow to avoid these potentially life-threatening side effects to taking these particularly potent medications:

Training for prescribers. Based on an FDA Blueprint, developed with input from stakeholders, educational programs for prescribers of ER/LA opioids will include 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 these drugs. In addition, the education will include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction, and general and specific drug information for ER/LA opioid analgesics.
Updated Medication Guide and patient counseling document. These materials contain consumer-friendly information on the safe use, storage and disposal of ER/ LA opioid analgesics. Included are instructions to consult one’s physician or other prescribing health care professional before changing doses; signs of potential overdose and emergency contact instructions; and specific advice on safe storage to prevent accidental exposure to family members and household visitors.
Assessment/auditing. Companies will be expected 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 assessments also cover whether the REMS is adversely affecting patient access to necessary pain medications, which manufacturers must report to FDA as part of periodic required assessments.

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