In a reversal, the Drug Enforcement Administration will now allow physicians to write up to three prescriptions for a 90-day supply of schedule II controlled substances.
The final rule, published in November, is viewed as a victory by pain medicine specialists, said Dr. B. Todd Sitzman, American Academy of Pain Medicine president and director of advanced pain therapy at the Forrest General Hospital's cancer center in Hattiesburg, Miss.
“It's an indication that [DEA officials] have listened to pain physicians and to the pain patient community,” he said in an interview.
The rule overturns an interim policy that prohibited the dispensing of multiple prescriptions at a single office visit and clarifies the DEA's expectations, said Dr. Sitzman.
Under the new policy, physicians may write prescriptions labeled “do not fill until,” with a preset date. This means patients can get a new prescription every 30 days, for 3 months, without having to return to the physician's office.
The prescriptions do not qualify as refills. They still must be taken to a pharmacy to be filled. DEA also said that the 90-day limit is the maximum according to its interpretation of congressional intent and the statute covering schedule II controlled substances.
In the rule, the DEA addressed several areas of concern to prescribing physicians.
The agency said it “wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to 'target' physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability).”
The agency noted that in any given year, fewer than 1 in 10,000 physicians lose their controlled substance registration because of a DEA investigation.
But, added the agency, the rule does not alter longstanding state and federal requirements that controlled substances can only be prescribed, administered or dispensed for a legitimate medical purpose by a physician acting in the usual course of professional practice.
The changes were first proposed in 2006, when the DEA was asked by commenters to issue specific guidance on how a clinician could assess pain, when a physician should prescribe an opioid, or how to use opioids.
But the agency said it would not do so, noting it does not regulate the practice of medicine and these topics are better addressed by professional organizations, medical schools, and postgraduate medical training.
Dr. Sitzman said the lack of strict guidelines is a positive thing.
Other organizations were also heartened by the rule change. In a statement, Dr. Rebecca Patchin, an American Medical Association board member, said the change “will give patients better access to the prescription drugs they need and continue to minimize the risks controlled substances pose to public health and safety.”