DEA to Allow 90-Day Supply of Schedule II Drugs

A Drug Enforcement Administration (DEA) regulation has expanded from 30 days to 90 days the supply of potentially addictive medications physicians can prescribe for a patient.

The new regulation, which went into effect December 19, 2007, allows physicians to prescribe up to a 90-day supply of Schedule II controlled substances during a single patient visit through the use of up to three separate prescriptions. Prior to the new regulation, physicians could only prescribe up to a 30-day supply. The change allows physicians more flexibility in treating patients with conditions requiring long-term use of Schedule II medications.

The change drew praise from physician groups as a way to give patients better access to the prescription drugs they need, with minimal risks to public health and safety.

“Physicians need the oversight and ability to write stable patients a reasonable amount of prescriptions that contain directions for dispensing controlled substances on future specified dates,” said Rebecca Patchin, M.D., an AMA board member, adding that the new regulation will “decrease the likelihood that patients will run out of drugs that provide critical relief from moderate to severe chronic pain.”

The AMA, APA, and other specialty societies long urged the DEA to take action on this issue for the sake of chronically ill patients.

The regulation change is permissive, not mandatory. It does not allow refilling of Schedule II medications—long prohibited under federal law—thus the need for three prescriptions for a 90-day supply. Schedule II drugs have recognized medical uses as well as a potential for dependence and abuse.

Physicians can prescribe the 90-day supply if several conditions are met, including providing instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription. The regulation allows prescriptions that include directions for pharmacists to refuse to fill at least two of the prescriptions before a certain date. Clinicians also must conclude that providing the patient with multiple prescriptions will not create an undue risk of diversion or abuse of the medication.

The issuance of multiple prescriptions also must be permitted under applicable state laws. Some states impose specific limits on the amount of a Schedule II controlled substance that physicians may prescribe.

The DEA received nearly 300 comments after it proposed the change, most of which supported it.

Among the comments by supporters were that the 90-day prescriptions would drastically reduce the work of physicians' offices and free up valuable practitioner-patient time. Many also pointed out that “stable'” patients, such as those with attention-deficit/hyperactivity disorder, do not have a medical need for monthly examinations. In such cases, the old requirement that patients make monthly visits to their physician was an unnecessary hardship on patients, they said.

Monthly visits were especially burdensome to people with some mental illnesses, with the result being “serious problems from a lapse in taking psychotherapeutic medication,” according to a comment letter from APA Medical Director James H. Scully Jr., M.D.

In contrast, some critics of the regulatory change said monthly examinations of patients prescribed addictive drugs were needed to ensure proper medical supervision and to lessen the likelihood of drug addiction and abuse.

The regulatory change also drew strong support from physicians in the area of pain management and the patients they treat.

The American Academy of Pain Medicine (AAPM) supported the change and described it as a positive indication of recently improved communication between the medical community and law enforcement.

“This welcome policy reversal by the DEA has eliminated the burden previously imposed on patients with cancer or chronic pain who were forced to visit their physician every month for new pain medicine prescriptions when there was no medical necessity to do so,” according to a statement from the AAPM.

The regulatory change did not affect DEA controls on drugs in Schedule III and Schedule IV. Physicians may prescribe up to a six-month supply of those drugs with a single prescription indicating up to five one-month refills.

The DEA regulation is posted at<www.deadiversion.usdoj.gov/fed_regs/rules/2007/fr1119.htm>.▪