Corresponding Responsibility: A Pharmacist's Obligation to Understand

Why is understanding corresponding responsibility important to me as a practicing pharmacist?

In short, enforcement actions against pharmacies occur most often when pharmacists fail to exercise their corresponding responsibility as addressed by the Drug Enforcement Agency (DEA) in its regulations (21 CFR 1306.04) which 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.”

Thus, in interpreting the regulations, a pharmacist’s position is nearly identical to the practitioner who issued the prescription, though the pharmacist did not examine the patient or review their medical records. Therefore, the pharmacist filling a controlled substance prescription should proceed with caution and use their professional judgment to determine if a prescription for a controlled substance was issued for a legitimate medical purpose during the course of his or her usual professional practice.

Ultimately, a pharmacist is required to exercise sound professional judgment with determining the legitimacy of a controlled substance prescription. When a pharmacist is presented with a doubtful, questionable or suspicious prescription, the law does not require a pharmacist to dispense the prescription. On the contray, a pharmacist who deliberately ignores a questionable prescription when there is reason to believe the prescription was not issued for a legitimate medical purpose may be prosecuted along with the prescribing physician for knowing and intentionally distributing controlled substances.

In 2010, the DEA published a decision that addressed a pharmacist’s corresponding reliability, the East Main Street Pharmacy (EMS) Case, and identified certain “red flags” that could assist pharmacists in identifying prescriptions that are not legitimate.

Common red flags include but are not limited to:

  • Pattern prescribing (i.e. prescriptions for the same drugs and the same quantities from the same doctors);
  • Irregularities on the face of the prescription itself;
  • Nervous patient demeanor;
  • Multiple or duplicative therapies (i.e. Oxycontin and MS Contin);
  • Prescribing of combinations or “cocktails” of frequent abused controlled substances;
  • Geographic anomalies;
  • Shared Addresses;
  • Filling a larger percentage of cash prescriptions;
  • Customers with the same diagnosis code from the same doctor;
  • Prescriptions written that are not consistent with their area of specialty;
  • Prescriptions for medications with no logical connection to diagnosis or treatment;
  • Consistent requests for early refills; and
  • (Re)filling prescriptions of patients or doctors located hundreds of miles away
While there are no clear and concise answers or guidelines, a pharmacist should always exercise his or her independent judgment when determining whether a prescription was issued for a legitimate medical purpose by a prescriber in their normal course of professional practice. And, pharmacists should always document all correspondences with any providers and/or their offices.