Corresponding responsibility is perhaps one of the most commonly misunderstood and/or (unfortunately) unknown concepts found in DEA’s regulations. And yet, enforcement actions against pharmacies are most frequently initiated when a pharmacist fails to exercise his/her corresponding responsibility. I have had countless conversations with practicing pharmacists who are either unfamiliar with the concept of a “corresponding responsibility” or don’t understand how to apply it in their daily practice. The DEA’s regulations (21 C.F.R. § 1306.04) addressing corresponding responsibility state A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
In layman’s terms the regulation states that the pharmacist is in the same position as the practitioner who issued the prescription (but without having actually conducted a medical examination of the patient) and must exercise professional judgment to determine whether a prescription for a controlled substance was issued for a legitimate reason. While the regulations do not provide additional insight on how to exercise corresponding responsibility, DEA has created the notion that pharmacists must identify (and resolve) certain red flags before a prescription for controlled substances is dispensed. Discussions of common red flags can be found in Final Orders issued by the DEA in administrative proceedings and in presentations given by the Agency in public forums. Red flags may include:
- “Pattern prescribing’’ – prescriptions for the same drugs and the same quantities coming from the same doctor;
- Prescribing combinations or “cocktails” of frequently abused controlled substances;
- Geographic anomalies;
- Shared addresses by customers presenting on the same day;
- The prescribing of controlled substances in general;
- Quantity and strength;
- Paying cash;
- Customers with the same diagnosis code from the same doctor;
- Prescriptions written by doctors for infirmaries not consistent with their area of specialty;
- Fraudulent prescriptions.
But does identifying red flags really mean you are exercising your corresponding responsibility as required by the regulations? In the DEA’s eyes, are pharmacists only appropriately exercising their corresponding responsibility when they decide not to dispense controlled substances to a patient whose prescription sets off one or more red flags? How many and/or what combination of red flags must be present for a pharmacist to decline dispensing a particular prescription? Is it time for the DEA to update its regulations to provide clearer guidance to pharmacists? While the answers to these and other questions are not readily forthcoming, it is clear that a pharmacist cannot simply defer to the prescribing practitioner and must exercise his/her independent judgment when determining whether a prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.