A national LTC pharmacy – AlixaRx – agreed to pay federal government $2.75 mil to resolve allegations that it improperly dispensed controlled substances at long-term care (LTC) facilities. AlixaRx dispensed prescriptions drugs to LTC patients primary through its on-site automatic dispensing units (ADU). According to the complaint, the pharmacy violated the federal Controlled Substances Act (CSA) in its dispensing pursuant to purported “emergency prescriptions.”  Federal investigators alleged that the pharmacy routinely abused the emergency prescription provisions of the CSA by requesting and obtaining verbal “emergency” refills from prescribers, in the absence of any true emergency.

To remind, the CSA requires a written prescription by a physician for dispensing Schedule II drugs and refills are not permitted by law.  Pharmacists may dispense controlled substances without a written prescription only in true emergencies and, even then, only for the quantity of drugs necessary to treat the patient during the emergency period.  Emergency prescriptions must promptly be reduced to writing and signed by an authorizing physician within seven days of issuance.  See 21 CFR § 1306.11.

The complaint against the pharmacy alleges that the purported emergency was created by the pharmacy’s ADU machines, which did not alert nurses when the medication was about to end. When LTC staff realized that there were no more fills, they called the hub pharmacist responsible for the remote operation of the ADU and asked for a “refill.” The pharmacist, in turn, called the LTC’s Medical Director and obtained a verbal authorization to program the ADU to dispense additional controlled substances for the patient as “emergency” fills. Allegedly, the pharmacy did not receive follow up written prescriptions to document the new fills for most of its “emergency” dispensing. Later – when the investigation was ongoing – the pharmacy attempted to obtain backdated written prescriptions for these fills.

As a result of this practice, the pharmacy faced several federal investigations conducted by the U.S. Attorney’s Office, the DEA, the OIG, and the FBI and agreed to settle the case for $2.75 million.

This case is a good reminder that even if a pharmacy is pressured to dispense immediately, it must follow all regulatory requirements (in this case, obtain the prescriber’s written authorization within 7 days of the fill). Many LTC pharmacies face the same issues.

The California law mirrors federal requirements and allows emergency dispensing only when failure to dispense a controlled substance may result in loss of life or intense suffering (and of course, this must be documented). These requirements do not apply to terminally ill patients (See Health & Safety Code § 11159.2).