The U.S. Drug Enforcement Administration (DEA) has published a proposed rule that would reverse an interim policy enacted more than two years ago prohibiting the practice of writing multiple prescriptions on the same date for medications regulated by Schedule II of the Controlled Substances Act.
Medications listed on Schedule II of the Controlled Substances Act include opiate pain medications and stimulants used to treat attention-deficit/hyperactivity disorder (ADHD) and narcolepsy.
The proposed rule authorizes a 90-day supply of a Schedule II medication written as three prescriptions, provided that the prescriber “writes instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill the prescription.”
“We listened to the comments of more than 600 physicians, pharmacists, nurses, patients, and advocates for pain treatment and studied their concerns carefully,” said DEA Administrator Karen Tandy at a press briefing last month announcing the proposed rule. Tandy also unveiled a DEA“ policy statement” explaining the history of the issue and the major points leading up to the proposed rule.
“Today's policy statement is the result of that collaboration [between DEA and clinicians, patients, and advocates]. The policy statement reiterates the DEA's commitment to striking the proper balance to ensure that people who need pain relief get it, and those who abuse it, don't.”
Under the policy set forth in the statement, physicians may write a prescription for a Schedule II medication without requiring a patient to come into the office for a visit every month. However, the interim policy requires a new prescription be written for each 30 day supply of medication. The prescription can be picked up by the patient without seeing the prescriber face to face or it can be mailed to the patient or faxed to the patient's pharmacy.
While the Controlled Substances Act prohibits refills of Schedule II medications (and limits Schedule III and Schedule IV medications to five refills over a six-month period), it does not address the writing of multiple prescriptions on the same date. Therefore, the DEA was responsible for addressing the issue through regulations.
The proposed rule also requires prescribers to “properly determine that there is a legitimate medical purpose for the prescriptions” and that multiple prescriptions do not “create an undue risk of diversion or abuse.”
Finally, the rule notes that nothing in the regulation supersedes or replaces state regulations, which may be more strict than the proposed rule.
The proposed rule is open to public comment through November 6. Comments submitted in writing must be postmarked by November 6, or they can be submitted electronically at the federal “eRulemaking” portal at<www.regulations.gov>. Comments should include the notation “Docket No. DEA-287N.”
The text of the DEA proposed rule is posted at<www.deadiversion.usdoj.gov/fed_regs/rules/2006/fr0906.htm>.▪
