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FDA Committee Report Recommends Increasing Opioid Prescription Drug Regulation

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FDA Committee Report Recommends Increasing Opioid Prescription Drug Regulation

A new report commissioned the Food and Drug Administration advocates for a continuous national campaign to battle the opioid epidemic, including increased drug regulation of opioids, as well as a dramatic change in opioid prescribing.

The report, which was researched and composed by the National Academies of Sciences, Engineering, and Medicine (NASEM), concentrates mainly on restricting the prescription opioid supply.

Committee chair Richard Bonnie:

“This report provides an action plan directed particularly at the health professions and government agencies responsible for regulating them.”

He went on to say that the plan seeks to help the “millions of people who suffer from chronic pain” while simultaneously mitigating unnecessary opioid prescribing through improved drug regulation.

He also noted that the epidemic will “take years to unravel.”

Using data that is aligned with that found by the Centers for Disease Control and Prevention, the report states at least two million U.S. residents have an opioid use disorder related to painkillers, and nearly 600,000 have a use disorder related to heroin.

Of note, opioid prescribing has been declining for the last few years, and in 2017, the Drug Enforcement Administration reduced the prescription opioid supply on average by 25%. Recently, several U.S. senators sent a letter to the DEA asking them to do it again in 2018.

Drug Regulation | Just Believe Recovery PAThat said, so far the reduction in opioid supply and prescribing doesn’t appear to be reflected in overdose deaths related to painkillers to any significant extent.

The report also stated that people are transitioning to heroin after becoming addicted to prescription opioids, and indeed, deaths related to heroin and fentanyl have tripled in recent years.

While the CDC acknowledges that 4 in 5 new heroin users first became addicted to prescription opioids, they also deny that legitimate patients are switching to heroin.

Deborah Dowell, MD, CDC in the Annals of Internal Medicine:

“Evidence does not support the hypothesis that initiatives intended to reduce opioid prescribing increase illicit opioid-related overdose at a population level.”

The committee stated:

“Although more research is needed, limited evidence suggests that state and local interventions aimed at reducing the supply of prescription opioids in the community may help curtail access.”

They also noted, however, that none of the studies examined the effect of reduced access “on the well-being of individuals suffering from pain whose access to opioids was curtailed.”

Importantly, the report also recommended increased insurance coverage for non-opioid pain medications and better education for doctors in pain management.

Finally, the committee recommended that the FDA undergo a complete review of all approved opioids. Indeed, last month the FDA requested that Opana ER be removed from the prescription drug market due to its potential for abuse. Endo Pharmaceuticals later agreed.

~ G. Nathalee Serrels, M.A., Psychology

References

https://www.nap.edu/resource/24781/Opioids-ReleaseSlides.pdf

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