Failure to Verify Prescriber’s State License Via Computer System Leads to DOJ Action
The Department of Justice (“DOJ” or the “Government”) and Bartell Drug, Inc. (“Bartell”), a Washington State pharmacy chain of approximately 70 pharmacies, recently reached a civil settlement in which Bartell agreed to pay a fine $800,000.00 without an admission of liability. The settlement resolved allegations that, between July 2016 and August 2020, Bartell filled invalid prescriptions in violation of the Controlled Substances Act (“CSA”). The Government’s theory of liability was based on further allegations that Bartell filled approximately 400 invalid prescriptions for controlled substance prescriptions written by four prescribers who were not appropriately licensed including instances in which the prescribers’ licenses had been suspended or otherwise restricted by the Washington Medical Commission. The Government alleged that these types of improper fills stemmed from Bartell failing to implement a computer system capable of conducting these automatic license verification checks and simultaneously failing to conduct manual checks.
In order for a prescription for a controlled substance to be effective, it “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Although the primary responsibility for the proper prescribing of controlled substances is upon the prescribing practitioner, a “corresponding responsibility” under the CSA rests with the pharmacist who fills the prescription. The exact definition of the pharmacist’s “corresponding responsibility” has remained elusive as the CSA and its implementing regulations do not clearly define this duty, nor do they specify how pharmacists and pharmacies should evaluate prescriptions for controlled substances., Although the DEA does offer a Pharmacist’s Manual pertaining to the CSA, including a section entitled “Correspond Responsibility, the guidance on fulfilling that responsibility is short on specifics, stating only general standards that “a pharmacist is required to exercise sound professional judgment, and to adhere to professional standards, when making a determination about the legitimacy of a controlled substance prescription”, and that a pharmacist is not required to dispense prescriptions ” of doubtful, questionable, or suspicious medical legitimacy.” In addition, the DOJ’s contentions that failure to verify a prescriber’s DEA registration amounts to a per se violation of the CSA cannot be found anywhere in the text of the CSA or in any DEA regulation, and is absent from most state pharmacy regulations. Nonetheless the Government considers, as one of the primary aspects of the pharmacist’s “corresponding responsibility” analysis, whether the pharmacist took reasonable measures to determine whether the prescription was issued by an appropriately licensed practitioner.
In meeting the “corresponding responsibility“ requirement, a pharmacist must be assured that the prescriber is appropriately licensed to issue the prescription, and if there is any doubt or uncertainty, must take affirmative steps to confirm proper licensure. In addition, the pharmacist needs to address any “red flags” that may exist and, if they cannot be satisfactorily cleared up, refuse to dispense the prescription. Regarding licensure of the prescriber, where the dispensing pharmacist is not certain that the prescriber is appropriately licensed, in most cases, the pharmacist should be able to confirm licensure status of the prescriber by verifying the prescriber’s registrant status on the State Medical Board website and by validating DEA status on the Internet. The process is cumbersome but manageable. Some prescription systems have the capability for license verification simultaneously with prescription entry.
In the Bartell case, the Government does not indicate that the typical “red flags” of diversion, which would normally require prescription verification with the prescriber (e.g., an altered prescription or inappropriate dosage and quantity) were present, nor did the Government allege other corrupt practices such as allegations that pharmacists were taking kickbacks or had inappropriate referral relationships with the patients or prescribers. Rather, the sole issue in this matter is that the writing prescribers were not appropriately licensed to write the prescriptions for controlled substances and that the pharmacist in questions failed to detect the same.
This case makes it clear that the Government is increasing its enforcement efforts and is becoming increasingly creative in its theories of liability. Regardless of a lack of evidence of pharmacist ill intent or knowledge that filling the prescription was improper, this case makes clear that the Government is placing more of a burden on the pharmacist to “play detective” in ensuring a prescription is properly dispensed, which includes asserting requirements even if they are not spelled out by statute or regulation.
How Frier Levitt Can Help
As enforcement efforts to combat the opioid epidemic increase, every participant along the supply chain continuum potentially faces criminal, civil, and/or administrative liability, for the improper dispensing of a prescription. The best way for participants to protect themselves is to adopt and implement and follow a robust opioid compliance that takes reasonable measures to ensure the proper dispensing of a valid prescription, that accounts for recent changes in law as well as lessons learned from previous enforcement actions. For more information, contact us immediately to speak to an attorney in its Life Sciences Regulatory or Government Investigations sections.
 21 CFR 1304.06.
 21 CFR 1301.36.