The DEA has revoked the agency registration of a Houston-based pharmacy after finding that the company continually failed to fulfill its obligation to resolve red flags of abuse and diversion presented by controlled substance prescriptions that it filled (Awesome Care Pharmacy, Inc.; Decision and Order, 89 Fed. Reg. 75573 (Sept. 16, 2024)).

In June 2023, the DEA informed Awesome Care Pharmacy Inc. of the immediate suspension of its certificate of registration, The agency alleged that the business’s continued registration would constitute an imminent danger to the public health or safety.

Following a hearing, in February 2024 a DEA administrative law judge recommended the revocation of the pharmacy’s registration.

Red Flags Identified

During the hearing, a government expert testified that the pharmacy’s Prescription Monitoring Program history, its dispensing history and a set of patient profiles revealed a number of red flags, including:

• prescriptions for drug cocktails, with four patients receiving the dangerous cocktail of hydrocodone and carisoprodol;
• pattern prescribing, including the pharmacy repeatedly dispensing large quantities of carisoprodol and hydrocodone in the highest strength available to the four patients;
• prescriptions lacking specific diagnoses, with the pharmacy generally lacking documentation on the face of a prescription related to a diagnosis, and with the diagnoses “pain” or “chronic pain syndrome” being not specific enough under the Texas Administrative Code and therefore triggering the need for a red flag analysis; and
• gaps in prescriptions — i.e., gaps in usually consistent monthly prescriptions exceeding a month, indicating that the patient was not taking the controlled substance as prescribed.

The decision and order detailed the government expert’s analysis of the prescriptions for the four patients that she reviewed.

Dispensing to One Patient

For example, she testified, one patient was given pattern prescriptions for a dangerous cocktail of hydrocodone and carisoprodol and was receiving the same controlled substances from at least six prescribers.

The patient received high doses of carisoprodol along with a high quantity of hydrocodone, a strong opioid that in fact is best when limited to short-term use.

Moreover, many of the patient’s prescriptions lacked a diagnosis code or any language indicating the purpose of the prescription, and others contained a nonspecific diagnosis code of “chronic pain syndrome.”

Also, according to the expert, there was a gap in the patient’s prescriptions for more than a month that indicated that she was not taking the medications as prescribed.

There was no documentation indicating that the pharmacy had identified or resolved any of these red flags, the expert said, and so the pharmacy had failed to exercise its corresponding responsibility and to abide by the standard of care established in Texas in its dispensing to the patient.

Pharmacy’s Arguments Rejected

For its part, the pharmacy argued that determining whether a red flag exists is subjective and that the determination is made by the pharmacist based on the totality of circumstances at the time of dispensing. “An expert witness’s testimony cannot replace the subjective thoughts of a pharmacist when they are filling a prescription,” the pharmacy insisted.

The DEA said that it “has repeatedly rejected these arguments.” Rather, it said, the pharmacy’s position “reflects a troubling indifference towards Texas law and supports a finding that [it] was willfully blind to the numerous red flags presented by the prescriptions in this case.”

The pharmacy also argued that the prescriptions had been issued for legitimate medical purposes because the pharmacist had spoken to the doctors and knew that they had valid doctor-patient relationships with the patients at issue.

“This argument again reflects a deep misunderstanding of a pharmacist’s professional obligations under federal and Texas law,” the DEA said. “A pharmacist must always exercise his corresponding responsibility to identify, resolve and document red flags, even where the prescriptions are ultimately determined to be legitimate, and even where there ultimately is a valid doctor-patient relationship. [The pharmacy] undeniably failed to fulfill this obligation.”

Finally, the DEA rejected the pharmacy’s argument that the government had failed to prove that the prescriptions were invalid, that they were issued for nontherapeutic purposes, or that the pharmacy dispensed them inaccurately.

The pharmacy had misconstrued the applicable legal standard, the agency said. “The government need not demonstrate that a prescription was invalid, nontherapeutic or illegitimate in order to prove that a pharmacist violated his corresponding responsibility,” the DEA insisted. “The government need only prove that the pharmacist failed to identify, resolve and document red flags presented by a prescription, which, here, [the pharmacy] repeated failed to do.”

Accordingly, the DEA revoked the pharmacy’s certificate of registration, effective Oct. 16.