A risk-management program set up in 2012 by the U.S. Food and Drug Administration to curb improper prescribing of extended-release and long-acting opioids may not have been effective because of shortcomings in the program's design and execution, according to a paper from researchers at the Johns Hopkins Bloomberg School of Public Health. Extended-release and long-acting opioids, which include oxycontin, account for a significant proportion of the prescription opioid market and are among the most misused.
The paper was published online December 30, 2019 in JAMA Internal Medicine .
For their analysis, the researchers reviewed more than 9,000 pages of internal FDA documents, obtained through a Freedom of Information Act (FOIA) request, on the agency's Risk Evaluation and Mitigation Strategies program for extended-release and long-acting opioids. The authors concluded that the program never had proper evaluation procedures in place--essentially leaving the FDA without critical information about whether the program was working.
In their review, the authors found a number of critical design flaws in the evaluation program, including an over-reliance on surveys rather than other sources of health care information such as clinical records; use of non-representative and self-selected patient and prescriber populations; and a failure to directly link prescribing behaviors with program participation.
The FDA's Risk Evaluation and Mitigation Strategies program is a primary way to promote the safe use of these medicines, but we found that the mechanisms for assessing the program's effectiveness were deficient from the start." Caleb Alexander, MD, paper's senior author, professor in the Bloomberg School's Department of Epidemiology and former chair of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee
The current opioid crisis in the U.S. originated largely from the wide availability and misuse risks of prescribed opioid painkillers. The crisis has now expanded to 50,000 opioid-related overdoses per year and millions of cases of opioid-use disorder. Among the more dangerous prescription opioids are extended-release and long-acting versions of oxycodone, morphine, and other painkillers, designed to deliver opioids into the body over longer periods of time than immediate-release forms of these drugs. Studies suggest that compared to immediate-release forms, extended-release and long-acting opioids are more likely to be used non-medically, and more likely to lead to opioid use disorder as well as overdoses.
To reduce the risks of extended-release and long-acting opioids, the FDA set up a Risk Evaluation and Mitigation Strategies program for these drugs in 2012. It required extended-release and long-acting opioid manufacturers to provide FDA-approved educational materials to both prescribers and patients in order to instruct them on the safe and appropriate use of these products. During the program, extended-release and long-acting opioid manufacturers also were required to monitor and report annually on prescriber knowledge and behavior associated with these drugs, as well as on data related to patient access and safety. Related Stories
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