Controlled Substances Proposed Rule: Missed Opportunity?

In early September, the Drug EnforcementAdministration (DEA) proposedan amendment to current regulationsto allow practitioners to providepatients with multiple prescriptions forCII substances, which would in effectallow patients to receive a 90-day supplyof a substance. I appreciate that theintent of the change is to enable patientswith chronic pain and other conditions toavoid unnecessary trips to a prescriber.Furthermore, I agree that a visit to thephysician just to have a prescription writtento comply with a federal regulation issomething 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 wasinitially imposed in an attempt to minimizeabuse and diversion. This proposedrule enables prescribers to write 3 prescriptionsto be filled sequentially with aspecified date, before which the secondand third prescriptions cannot be filledby any pharmacy. I suggest that while wemay have saved patients with chronicpain conditions a few trips to their physician,we have created a new cottageindustry in which even more prescriptionscan now be diverted for illegitimatepurposes. Instead of a singleprescription being used fordiversion purposes, the successful"entrepreneur" willreceive 3.

It seems to me that the originalintent of the amended rulecould be met through collaborativepractices establishedbetween pharmacist andphysician. The patient wouldthus be required to return tothe same pharmacy for fillingall 3 prescriptions. Based onthe collaborative relationship,the patient can be referredback to the physician if thepharmacist believes there is aneed to modify the prescription—whether it would includea dosage adjustment (up or down), orreassessment of pain managementbased on patient compliance. Requiringthe prescription to be filled at the samepharmacy all 3 times minimizes diversionpotential since the pharmacist can verifyidentical patient identification for refillsand ensure compliance with intendedrefill dates each time.

Even more enlightening is a quotefrom the DEA in a September 6, 2006,news release which acknowledges thatthey "...listened to over 600 physicians,pharmacists?," which resulted in its proposedrule making. This statement validateswhat we teach our professionalstudents. The voices of a relative few canoften have a profound impact on legislationand regulation. Comments to theDEA must be received by November 6,2006. If you have thoughts on this topic,let them be heard where you can make adifference.

Mr. McAllister is director of pharmacyat University of North Carolina (UNC)Hospitals and Clinics and associatedean for clinical affairs at UNCSchool of Pharmacy, Chapel Hill.