Federal Controlled Substance Act regulations require that prescriptions for controlled substances be issued only for legitimate medical purposes by individual practitioners acting in their usual course of professional practice, and that a “corresponding responsibility rests with the pharmacist who fills the prescription.”[1] Knowingly filling a prescription that is not issued in the usual course of professional treatment is a violation of the federal Controlled Substances Act. While not often discussed, the “legitimate medical purpose” assessment imposes a dual obligation on providers and filling pharmacists to ensure that controlled substances being prescribed and dispensed are for legitimate medical purposes in the ordinary course. A pharmacy that does not empower its pharmacists to fulfill their gatekeeper role or does not take its pharmacists’ concerns seriously risks significant penalties.
The Drug Enforcement Administration’s (DEA’s) pharmacist manual does not contemplate what pharmacists must consider for controlled substance prescriptions to be issued for legitimate medical purposes. The DEA also has not issued commentary or guidance on what steps pharmacists must take to assess legitimate medical purposes, but has issued guidance on how to assess diversion risks posed by practitioners’ behavior. Diversion risk guidance, prior DEA commentary at conferences and DEA Final Orders highlight that pharmacists must monitor for “red flags” that may indicate illegitimate prescriptions and trigger enforcement actions or civil penalties.[2]
Common red flags [3] include:
- Dispensing a high volume of controlled substances compared to similarly situated pharmacies.
- Receiving a high percentage of cash payments for controlled substances as opposed to insurance.
- Patients travelling to fill prescriptions, implying “doctor shopping.”
- Not tailoring prescriptions to medical need by ordering virtually identical prescriptions for numerous patients.
- Prescriptions written by doctors for illnesses that are not consistent with their area of specialty.
- Prescribing the “holy trinity” of opioids, benzodiazepines and muscle relaxants in combination (frequently abused controlled substances).
Such suspicious activity can give rise to allegations that the pharmacist had a “reason to know” the prescription might be illegitimate and should be addressed through diligent inquiry with the prescriber.[4] Failure to react to signs of wrongdoing can expose pharmacists to accusations of willful blindness.
Interference with a pharmacist’s corresponding responsibilities can result in substantial liability for a pharmacy, and inadequate compliance oversight may enable or perpetuate unlawful prescribing activity. To mitigate regulatory risk, pharmacies should take several proactive measures.
- Train pharmacists to identify red flags and empower them to act on concerns, including by conducting due diligence if a prescription appears suspicious and documenting rationale for approving or denying the prescription thereafter.
- Foster a culture of reporting, giving pharmacists the means to report concerns internally and escalate issues as needed.
- Demonstrate that pharmacists’ concerns are taken seriously, investigated and addressed.
- Act as secondary gatekeepers by identifying and refusing prescriptions from providers exhibiting concerning prescribing behavior.
- Stay current with DEA guidance and evolving best practices in controlled substances dispensing.
Pharmacies must recognize that their liability under the Controlled Substances Act for dispensing improper controlled substance prescriptions is direct, and pharmacists should approach each prescription for a controlled substance with a critical eye.
Special thanks to summer associate Katherine S. Janda who contributed to the alert. She is not licensed to practice law.
[1] 21 CFR § 1306.04
[2] See Holiday CVS, L.L.C. d/b/a CVS/Pharmacy Nos. 219 and 5195; Decision and Order, 77 Fed. Reg. 62,316, 62,341 (Oct. 12, 2012); Jones Total Healthcare Pharmacy, L.L.C. and SND Health Care, L.L.C.; Decision and Order, 81 Fed. Reg. 79,188, 79,218-19 (Nov. 10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed. Reg. 66,149, 66,150 (Oct. 27, 2010).
[3] See Holiday CVS, 77 Fed. Reg. at 62,318; see Gulf Med Pharmacy; Decision and Order, 86 Fed. Reg. 72,694, 72,695 (Dec. 22, 2021).
[4] See Holiday CVS, 77 Fed. Reg. at 62,341 (quoting Bob’s Pharmacy & Diabetic Supplies; Revocation of Registration, 74 Fed. Reg. 19,599, 19,601 (Apr. 29, 2009)).
