Controlled Substances Proposed Rule: Missed Opportunity?

OCTOBER 01, 2006
James C. McAllister III, MS, FASHP; Pharmacy Times Editor, Health-Systems Pharmacy Section

In early September, the Drug Enforcement Administration (DEA) proposed an amendment to current regulations to allow practitioners to provide patients with multiple prescriptions for CII substances, which would in effect allow patients to receive a 90-day supply of a substance. I appreciate that the intent of the change is to enable patients with chronic pain and other conditions to avoid unnecessary trips to a prescriber. Furthermore, I agree that a visit to the physician just to have a prescription written to comply with a federal regulation is something that we should strive to avoid. If this proposed rule is adopted, however, what problems have we solved?

The 30-day limit for CII substances was initially imposed in an attempt to minimize abuse and diversion. This proposed rule enables prescribers to write 3 prescriptions to be filled sequentially with a specified date, before which the second and third prescriptions cannot be filled by any pharmacy. I suggest that while we may have saved patients with chronic pain conditions a few trips to their physician, we have created a new cottage industry in which even more prescriptions can now be diverted for illegitimate purposes. Instead of a single prescription being used for diversion purposes, the successful "entrepreneur" will receive 3.

It seems to me that the original intent of the amended rule could be met through collaborative practices established between pharmacist and physician. The patient would thus be required to return to the same pharmacy for filling all 3 prescriptions. Based on the collaborative relationship, the patient can be referred back to the physician if the pharmacist believes there is a need to modify the prescription—whether it would include a dosage adjustment (up or down), or reassessment of pain management based on patient compliance. Requiring the prescription to be filled at the same pharmacy all 3 times minimizes diversion potential since the pharmacist can verify identical patient identification for refills and ensure compliance with intended refill dates each time.

Even more enlightening is a quote from the DEA in a September 6, 2006, news release which acknowledges that they "...listened to over 600 physicians, pharmacists?," which resulted in its proposed rule making. This statement validates what we teach our professional students. The voices of a relative few can often have a profound impact on legislation and regulation. Comments to the DEA must be received by November 6, 2006. If you have thoughts on this topic, let them be heard where you can make a difference.

Mr. McAllister is director of pharmacy at University of North Carolina (UNC) Hospitals and Clinics and associate dean for clinical affairs at UNC School of Pharmacy, Chapel Hill.