Last month the U.S. Attorney's Office for the Northern District of Illinois announced that Walgreens agreed to pay up to $350,000,000 to resolve allegations that its pharmacies illegally filled millions of invalid prescriptions for opioids and other controlled substances in violation of the federal Controlled Substances Act, and sought payment for filling many of those prescriptions by federal health care programs, violating the False Claims Act. Press Release, Walgreens Agrees To Pay Up to $350M for Illegally Filling Unlawful Opioid Prescriptions and Submitting False Claims, U.S. Attorney's Office, Northern District of Illinois, April 21, 2025. The government complaint, filed January 16, 2025, and amended April 18th, alleged that Walgreens pharmacies "knowingly filled millions of unlawful controlled substance prescriptions" between August 2012 and March 2023 "despite clear red flags indicating a high likelihood that the prescriptions were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice." Id.
We have regularly posted on recognized prescribing red flags that pharmacists have ignored that resulted in administrative or civil actions by the Drug Enforcement Administration ("DEA") including against Gulf Med and Coconut Grove pharmacies in Florida and Zarzamora Healthcare LLC in Texas. We thought that it would be instructive to review the prescribing red flags alleged in the recent high-profile Walgreens settlement and complaint for an insight into current DEA dispensing expectations.
As mentioned in Federal Register Vol. 86, 72703 (December 22, 2021), DEA emphasized in the Gulf Med decision that prescribing "[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm." While the presence of a dispensing red flag does not prohibit a pharmacist from filling a controlled substance, it "means that there is a potential concern with the prescription, which the pharmacist must address and...make a record of its resolution, assuming it is resolvable." Id.
For a controlled substance prescription to be "effective," that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. 21 C.F.R. ยง 1306.04(a). Prescribers are responsible for the proper prescribing and dispensing of controlled substances, but pharmacists have a corresponding responsibility to ensure that prescriptions they fill are issued for legitimate medical purpose and in the usual course of professional practice. Id. As the Walgreen's Amended Complaint notes, "Pharmacists are professionally educated and trained to recognize and assess red flags and to determine whether a prescription is valid." Complaint, ⁋ 82.
The Walgreens Amended Complaint recognizes the following prescribing red flags:
- Prescribers who prescribe the same medication, with the same directions, for the same quantity, for a large number of individuals. ⁋ 81.
- Prescriptions of drugs or drug combinations that are frequently sought by individuals known to abuse or misuse prescription drugs, including the combination of an opioid, a benzodiazepine and a muscle relaxant, known as the "trinity." ⁋⁋ 81, 86, 251.
- Patients who repeatedly seek early fills of schedule II prescriptions or refills of schedule III-V prescriptions earlier than the date the drug would have run out if taken according to the prescriber's instructions. ⁋⁋ 81, 89, 251.
- Opioid prescriptions for high dosages and quantities, including prescriptions that individually or in combination, provide patients with daily dosages of greater than or equal to 300 Morphine Milligram Equivalents ("MMEs"). ⁋⁋ 84, 251.
- Patients filling prescriptions from multiple prescribers, particularly for the same type of controlled substance or dangerous combinations of drugs. ⁋ 87.
- Patients filling prescriptions at the same time at multiple pharmacies. ⁋ 88.
- Patients traveling long distances to the prescriber and/or to the pharmacy. ⁋ 90.
- Patients paying cash or a cash equivalent for controlled substance prescriptions, especially when they use insurance to pay for other prescriptions. ⁋ 92.
The Walgreens Amended Complaint notes that pharmacists "may be able to resolve a red flag by reviewing the patient's diagnosis to confirm the drug prescribed is an appropriate treatment for the patient's condition, reviewing the pharmacy's dispensing history for the patient or prescriber, contacting the prescriber, or checking the state prescription drug monitoring program (PDMP) database to see all of the prescriptions obtained by the patient." ⁋ 93.
As noted in the Press Release, along with the monetary payment, Walgreens entered into a seven-year Memorandum of Agreement ("MOA") with DEA to implement measures to prevent dispensing controlled substances without resolving red flags. The MOA requires Walgreens to maintain policies and procedures requiring pharmacists to confirm the validity of prescriptions prior to filling, provide annual training to employees about their obligations related to controlled substances, ensure that staffing is sufficient to enable employees to comply with their obligations and maintain a system that blocks prescriptions issued by prescribers known to write non-legitimate prescriptions. Walgreens also entered a five-year Corporate Integrity Agreement with Health and Human Services-Office of the Inspector General also related to controlled substance dispensing by its pharmacies.
The Amended Complaint, MOA and Corporate Integrity Agreement provide sound framework for identifying and not filling prescriptions exhibiting red flags.
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