DEA Refill Policy Could Cause `Undue Burdens' For Psychiatrists

APA and the American Academy of Child and Adolescent Psychiatry (AACAP) have submitted detailed comments to the U.S. Drug Enforcement Administration (DEA) regarding its interim policy statement on dispensing controlled substances for the treatment of pain.

Of particular interest is a section on Schedule II medications that effectively contravenes a DEA “Frequently Asked Questions (FAQ)” bulletin posted on the agency's Office of Diversion Control Web site in August 2004. While the original FAQ document and the interim policy itself—written to explain why the FAQ was withdrawn and to correct its“ errors”—both addressed the specific issue of the use of Schedule II substances to treat pain, APA and AACAP quickly noted the potential impact of the interim policy on the use of Schedule II medications for other therapeutic purposes.

The interim policy, which was filed in November 2004 and published in the Federal Register on January 18, contains sections that could potentially lead to “undue burdens imposed on psychiatrists and their patients,” stated APA and AACAP.

“Input from APA members and district branch/state association executive staff in North Carolina and many other states brought a practical, patient-centered perspective to the actual impact of the policy change,” said APA Government Relations Director Nicholas Meyers. “We're very appreciative of our members' efforts.”

The FAQ document originally indicated that “Schedule II prescriptions may not be refilled; however, a physician may prepare multiple prescriptions on the same day with instructions to fill on different dates.” Schedule II includes drugs with “high abuse potential with severe dependence liability,” such as narcotics, amphetamines, and some barbiturates.

While anecdotal accounts suggest that this practice occurs regularly, the agency had, until this point, never endorsed it.

For example, a psychiatrist might write more than one prescription in a single office visit for the same Schedule II stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD). The psychiatrist then instructs the patient—usually verbally—to fill the first one-month prescription on a specific date and the second prescription one month later, the third two months later, and so on. The practice effectively eliminates the need for a clinically stable patient to visit the office each month just to pick up a prescription.

The FAQ appeared to codify the practice by allowing physicians to write on the prescription a “to be filled on” date, in addition to the date that the actual prescription was written.

Within days of its posting, however, the FAQ document was removed from the DEA Web site after agency officials noted “erroneous statements,” including the view that writing multiple Schedule II prescriptions on a single date was permissible. That practice, DEA said, would undoubtedly increase the risk of diversion and abuse and was tantamount to simply refilling a Schedule II prescription, which is barred by law.

In the submitted comments, APA and AACAP noted that “the method of preparing multiple prescriptions described in the FAQ comports with applicable law; it is not prohibited or contravened by law in any way.” The method“ minimizes extraneous patient visits and allows the patient to have a steady stream of prescription medication at hand for a prolonged period. At the same time, it does not allow excessive amounts of the drug into the stream of distribution at any one point in time. The real effect of this drug-dispensing process is not different than if the patient receives multiple, successive prescriptions, one at a time, over the same time period.”

APA and AACAP concluded that this prescribing option “streamlines the process, eliminates the need for extra or unproductive visits, and maximizes the patient's opportunity to stay in compliance with their drug regimen.” It also reduces undue burden and promotes more cost-effective mental health services.

The DEA is expected to publish a final policy statement regarding this issue in the Federal Register; however, at press time, the agency had not indicated when that might occur.

The DEA's interim policy on prescriptions for Schedule II medications, titled “Dispensing Controlled Substances for the Treatment of Pain,” is posted online at<www.deadiversion.usdoj.gov/fed_regs/rules/2004/fr1116.htm>. The APA/AACAP comments are posted at<www.psych.org/advocacy_policy/reg_comments/apacommentsDEA03232005.pdf>.▪