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Member Research and Reports

Member Research and Reports

Johns Hopkins: Analysis of FDA Documents Reveals Inadequate Monitoring of Key Program to Promote Safe Opioid Use

A risk-management program set up in 2012 by the U.S. Food and Drug Administration (FDA) 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.

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