Opium-based medications have been used for pain management for centuries. Despite stricter government regulations and medical advancements to make them safer, addiction, overdose, and overprescribing of those drugs continues to persist.
The Food and Drug Administration has introduced a risk evaluation and mitigation strategy to address the issue of misuse of extended-release and long-acting opioids (ER/LA), without making them unduly difficult to obtain for patients who truly need the drugs. The new safety measures will focus on providing training for medical professionals on the safe use of the drugs.
The FDA estimates that nearly 22.9 million ER/LA opioid prescriptions were dispensed in 2011. More than 320,000 prescribers are registered with the Drug Enforcement Administration, nearly all of whom wrote at least one prescription for the opioids in question.
The Centers for Disease Control and Prevention estimates the misuse of opioids led to nearly 425,000 emergency department visits and caused 15,600 deaths in 2009, Fox News reported.
“Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” FDA Commissioner Margaret A. Hamburg said in a FDA press release. “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.”(What’s REMS?)
More than 20 drug manufacturers will be required to provide education programs to prescribers and patients. These education programs must be available to at least 60% of the 320,000 medical professionals who prescribe these drugs no later than March 2013.
The FDA stipulates that prescriber training should cover “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 opioid misuse, abuse, and addiction.”
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