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X Waiver: Good Riddance

When the FDA approved buprenorphine for maintenance treatment (MAT) of opioid dependence, an injectable form of the drug had already been available for years as an analgesic for use in hospitals, and methadone was the only drug that physicians could legally prescribe for MAT, but only within licensed methadone programs. For decades prior, federal law prevented physicians from prescribing addictive drugs to a person addicted to them. Under the old law, which "waived" the restriction, even for physicians in private offices, the physician had to qualify for a special DEA number starting with "X" by demonstrating completion of a special course. According to news reports the Feds have dropped this ill-conceived law.

Ironically, the FDA only approved buprenorphine for use to treat addicts. In other words, one of the most important prerequisites to prescribing was to confirm that the patient had been addicted to opioids. In theory, physicians could legally prescribe the drug to non-addicts off-label, but a pharmacy would probably refuse to fill the prescription unless the physician's DEA number started with "X." Another prerequisite to prescribing: Warn that prospective patient that if they take buprenorphine while still dependent on another opioid, it will, like naloxone or naltrexone, send them into withdrawal. Unfortunately, we still may not know whether this means that buprenorphine can reverse a fentanyl overdose, since fentanyl has been (or was) a go-to drug for treating pain in a MAT patient whose levels of buprenorphine block the analgesic effects of other opioid analgesics. 

Although prolonged regular use of buprenorphine can clearly lead to addiction, it rarely kills in overdose and so can boast a vastly better safety record than nicotine or alcohol, both of which kill hundreds of thousands of users yearly. 

Abandoning the X-waiver requirement takes us one step closer to making this wonder drug available over-the-counter to competent adults.

Berry Edwards, MD

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