A recent letter from the Drug Enforcement Administration (DEA) to doctors certified to prescribe buprenorphine sparked concerns about intimidation and a perceived attempt to suppress the number of physicians prescribing the anti-opiate medication — an impression that the Obama administration moved quickly to dispel.
The July 24 letter was addressed to individual healthcare providers who had received waivers from the Drug Addiction Treatment Act (DATA) in order to prescribe Subutex and Suboxone, both buprenorphine-based drugs that are used as an alternative to methadone maintenance.
DEA Miami Field Office diversion manager Barbara A. McGrath wrote that waiver recipients are “subject to inspection” by the DEA and that the agency was developing plans “to include inspections of DATA-waiver practitioners.” About 18,000 physicians currently are authorized to prescribe buprenorphine.
“To accurately plan for and properly allocate resources effectively and efficiently, we are attempting to discern whether the DATA-waived portion of your medical practice will need to be inspected,” according to McGrath, who advised recipients of the letter who don't want to prescribe the drug can exit the program by filling out an attached form. “Once DEA receives and processes your request, we can remove your name from the list of those medical practices scheduled for inspection,” McGrath wrote.
The letter then goes on to require that physicians who want to continue prescribing or dispensing buprenorphine for treatment of opioid addiction complete a questionnaire and prepare for an inspection visit by having a variety of documents on hand, including DEA forms, their state license, treatment documentation, and their CSAT certification and waiver letter.
Objectively, the letter could be read as a simple administrative missive aimed at determining which doctors are subject to inspection under the DATA law. But given DEA's reputation among some doctors for choosing heavy-handed enforcement over patient needs — along with a perceived hostility toward buprenorphine and other opiate-replacement therapies — the letter resulted in an immediate outcry from recipients.
“Clearly these letters suggest to physicians that if they don't want a DEA inspection they can just opt out of prescribing Suboxone,” said Richard Saitz, M.D., a board-certified addiction medicine specialist and professor at the Boston University School of Medicine, who received one of the DEA letters at his home address. Saitz said that the letters may have led some doctors to conclude that “it is the last straw and not worth it to them to put up with all of the challenges one needs to surmount to prescribe buprenorphine.”
Charles O'Keeffe, a professor at Virginia Commonwealth University School of Medicine and an epidemiology and community health expert at the school's Institute for Drug and Alcohol Studies, noted that the majority of letter recipients were family practitioners and internal-medicine specialists who “went to the trouble to take the courses and get certified to prescribe” — in other words, just the kind of providers that buprenorphine backers are hoping will embrace the drug as a way to treat addiction in office-based practices rather than clinical settings.
“Overall, the feeling was that it was inappropriate to single out these physicians,” who may be especially vulnerable to feeling pressured by the DEA, said O'Keeffe.
Tom McLellan, deputy director of the Office of National Drug Control Policy (ONDCP), said the field's reaction was understandable, and that the Obama administration is working on a followup letter that will explicitly encourage physicians to become certified to prescribe buprenorphine.
“If you didn't know where the (DEA) letters came from it could be interpreted as a purely administrative document,” said McLellan. “The problem is if you get a letter from the IRS or the DEA, it evokes strong emotional reactions.”
McLellan told Join Together that acting DEA administrator Michelle Leonhardt “understood immediately” how the letter could have been misinterpreted. “She repeatedly assured me that neither she nor the DEA are against buprenorphine or are trying to discourage the use of buprenorphine,” said McLellan. “They are merely trying to carry out their regulatory responsibilities.”
“Let's cut DEA some slack on this,” McLellan continued. “The field has to understand that this is not your father's ONDCP or DEA — we're trying to work together to increase the appropriate availability of buprenorphine.”