Sunday, October 4, 2009

The DEA & Opioid REMS – An Intimidating Future?

Involvement of the U.S. Drug Enforcement Administration (DEA) in the FDA’s plans for an opioid-REMS (Risk Evaluation and Mitigation Strategy) initiative is still unknown. However, if what is happening with the prescribing of buprenorphine is any example, practitioners prescribing opioids for pain may be headed for considerable aggravation in the name of “regulatory responsibility.”

During the past several years, practitioners in the U.S. have been strongly encouraged to acquire the necessary training — usually a one-day course, often conducted at conferences in the pain field — to become authorized by the DEA to prescribe buprenorphine (Subutex® or Suboxone®) for treating opioid addiction, including dependence on opioid analgesics. About 18,000 physicians currently have obtained authorization, called a “waiver.” Now, according to a news feature from Join Together [Curley 2009], a letter from the DEA sent to these physicians has sparked concerns about intimidation and a perceived attempt to suppress the number of practitioners prescribing the medication. The letter sent late last July from DEA diversion manager Barbara A. McGrath said that the agency was developing plans to inspect buprenorphine-waiver recipients.

The letter noted, "…we are attempting to discern whether the DATA-waived portion of your medical practice will need to be inspected." Recipients of the letter choosing to discontinue prescribing the drug could exit the program simply by filling out an attached form. Continuing physicians were informed to complete a questionnaire and to prepare for an inspection visit by having a variety of documents on hand, including DEA forms, licenses, treatment documentation, and waiver certificates. While the Join Together article concedes that the letter could be viewed as a simple administrative procedure, it observes that “… 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.”

More from Join Together: According to Richard Saitz, MD, at the Boston University School of Medicine, 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 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 proponents were hoping would embrace the drug as a way to treat addiction in office-based practices. "Overall, the feeling was that it was inappropriate to single out these physicians," who may be especially vulnerable to feeling pressured by the DEA, O'Keeffe said.

Tom McLellan, deputy director of the U.S. Office of National Drug Control Policy (ONDCP), acknowledged to Join Together, "The problem is if you get a letter from the IRS or the DEA, it evokes strong emotional reactions." He said that the administration is working on a followup response to belay fears and that acting DEA administrator Michelle Leonhardt understood how the letter could have been misinterpreted. "They [the DEA] are merely trying to carry out their regulatory responsibilities," McLellan noted.

Followup comment: While the vast majority of buprenorphine prescribers would probably have nothing to fear from DEA inspections, healthcare providers are understandably loathe to have government agencies scrutinizing their practices for any reason. Many will no doubt opt out of the buprenorphine program. Is this what the future might hold in store for opioid analgesics under REMS initiatives?

Already, there are some otherwise qualified practitioners who do not prescribe opioid analgesics, rather than risk any possibility of running afoul of regulatory agencies. Also, we have previously noted that recently announced REMS programs for Onsolis® (see blogpost 7/17/09) and Exalgo™ (see 9/26/09) involve special prescriber registration and education (of unknown extent), but the ultimate enforcement of adherence to REMS requirements and restrictions is still largely undetermined; especially, what role the DEA may play. This is worthy of consideration, because if the mandated requirements and perceived regulatory risks of prescribing opioids become overbearing many healthcare providers will simply not do so. And, unknown numbers of patients will suffer as a result. Do you think all of this is of concern, or are we overreacting? (You can comment below.)

Reference: Curley B. DEA letter sparks fears about intimidation of buprenorphine docs. Join Together (online from the National Center on Addiction & Substance Abuse [CASA] at Columbia University). October 1, 2009 [article available here].