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NIH, FDA Leaders Highlight Need to Improve Drug-Detection Tools

In a commentary published Monday by the New England Journal of Medicine, leaders from the National Institutes of Health (NIH) and the US Food and Drug Administration (FDA) have highlighted the need to address gaps in research, development, and implementation of rapid drug-detecting tools to prevent overdose deaths.

Despite demonstrating the potential to save lives and serve as a key piece of harm reduction toolkits, fentanyl test strips and other such detection tools have remained inaccessible to many because of gaps in research and state prohibitions. Officials from the NIH and FDA called for new research collaborations to ensure fentanyl test strip effectiveness, promoted the development of additional drug-checking technologies, and implored a reduction of barriers that inhibit the use of such tools.

“Fentanyl and its analogues are crucial targets for harm-reduction efforts,” the authors wrote. “These substances are increasingly found both in counterfeit pills and in substances sold as heroin, methamphetamine, and cocaine. Increases in availability of illicitly manufactured fentanyl have fueled the US overdose epidemic by placing more people—many of whom are unaware of what they are consuming — at risk for fentanyl overdose.”

While positive drug-checking test results have been associated with more cautious drug-taking behaviors—avoiding the use of contaminated drugs, reducing quantities consumed, or injecting more slowly—additional research “is needed to inform guidelines on preparing drug samples for testing and to better characterize the reproducibility and operating characteristics of various types of fentanyl test strips,” according to NIH and FDA officials. They also recommended assessments of other drug-checking strategies typically used in laboratories to determine if they are feasible in community settings.

NIH said in a news release that it welcomes research proposals on fentanyl test strips and other screening tools.

“The FDA has provided premarket clearance for laboratory-based tests to detect fentanyl in urine and hair and welcomes the opportunity to work with manufacturers on point-of-care devices intended for testing human specimens,” according to the release. “This would be particularly valuable in clinical settings to help monitor critical trends and outcomes and aid in clinical evaluations of substance use.”

 

References

Volkow ND, Califf RM, Sokolowska M, Tabak LA, Compton WM. Testing for fentanyl — urgent need for practice-relevant and Public Health Research. New England Journal of Medicine. Published online 2023. doi:10.1056/nejmp2302857

NIH and FDA leaders call for more research, lower barriers to improve and implement drug-checking tools amid overdose epidemic. News release. National Institutes of Health. June 12, 2023. Accessed June 12, 2023.

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