U.S. ends confusion and expands prescribing of opioid-fighting medication

bupe-300x188Health workers with legal prescribing privileges have gotten newly revised federal guidelines — once again — making it easier for them to help those addicted to powerful opioid painkillers by prescribing buprenorphine, another powerful medication.

This action could be beneficial in battling the opioid abuse and drug overdose crisis that ebbed in recent times and then worsened during the coronavirus pandemic, overall killing hundreds of thousands of Americans.

As the Washington Post reported of regulators’ latest decisions:

“[D]octors, physician assistants, nurse practitioners and other providers of care no longer will need to undergo training before they are allowed to prescribe [this] form of treatment known to reduce overdose deaths. Studies have shown that people taking the medication are less likely to develop HIV or hepatitis C, or to be unemployed or imprisoned.”

Congress had passed laws requiring prescribers to not only obtain federal permission but also to undergo special training and counseling before receiving an “X waiver” to use buprenorphine with patients. This was done because experts had early fears that the drug, itself a type of opioid, might create its own nightmares if too freely used. But the X waiver became an obstacle to wider and appropriate use of a medication that was found to be less harmful than methadone and beneficial in caring for the opioid addicted.

This is how the Oregon Health and Science University pharmacology experts describe buprenorphine:

“Buprenorphine, approved by the Food and Drug Administration in 2002, relieves withdrawal symptoms and pain, and normalizes brain function by acting on the same targets in the brain as prescription opioids or heroin. It is one of three medicines approved by the FDA to treat opioid dependence, along with methadone and naltrexone.”

The Trump Administration tried to ease the drugs’ prescribing late in its term. But Biden Administration officials said their predecessors’ hasty executive order was legally problematic and reversed it. For several months the process for prescribing buprenorphine was jumbled anew and the current administration took heat for this. As the Washington Post reported, however:

“Under the new guidelines, physicians and other health-care practitioners still must apply to the Drug Enforcement Administration for a waiver but no longer need to go through training, as long as they are prescribing the medication for no more than 30 patients at a time.”

Experts praised the new guidelines, the newspaper also noted:

“Patrice A. Harris, the American Medical Association’s immediate past president and chair of its opioid task force, said the guidelines are ‘a critically important first step’ that remove ‘burdensome and stigmatizing requirements’ that have discouraged doctors from being certified to prescribe buprenorphine. But Harris and other physicians called on Congress to pass legislation that would get rid of waivers for the prescription of the drug, rather than merely making it easier to get permission. Miriam Komaromy, medical director of Boston Medical Center’s Grayken Center for Addiction, predicted the new rules will have ‘a measurable but modest effect.’ Komaromy said the guidelines could make it easier for a doctor or other practitioner to ‘get a taste of doing this kind of work,’ by seeking a waiver without taking time for the training. Still, she said, compelling specific federal permission to prescribe the treatment has a chilling effect. ‘It’s not going to be the solution we’re looking for,’ she said, ‘to conquering the opioid overdose epidemic.’”

The opioid crisis — which federal experts have estimated claimed 500,000 lives between 1999 and 2019 — persists as a leading public health threat, the Washington Post reported:

“Preliminary federal figures suggest that 90,000 people in the United States died of drug overdoses in the 12 months ending in September, a record number. Nearly 67,000 of them were fatal overdoses from opioids.”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by dangerous drugs. Over the years, Big Pharma, doctors, hospitals, insurers, and others in health care — fueled by a relentless and excessive push for profits — created the opioid-overdose crisis. Abuse of powerful painkillers, especially the synthetic varieties, also opened the door to nightmares with overdoses, notably of illegal drugs.

It has taken Herculean efforts to deal with the mess, thus far, including dragging drug makers into long, costly court battles, and with expensive federal, state, and local government interventions to assist far too many addicted, debilitated, and overdosing people. It’s a good step to carefully allow medicated treatment of people with opioid abuse issues. But we’ve still got a lot of work to do to put down this killer public health challenge.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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