On The Docket
David B. Brushwood, BSPharm, JD
Numerous reports of judicial rulings have blamed pharmacists for the opioid crisis. These rulings have been annoying at best and infuriating at worst. The basic narrative is that pharmacists did not recognize, resolve, and record so-called “red flags” that raised suspicions of opioid diversion. A recent ruling from a federal judge in Utah provided a welcome respite from this short-sighted approach.
Background
A DEA diversion investigator opened an investigation into a pharmacy after a physician reported that a former employee had forged prescriptions for herself and her husband. The investigation revealed that 167 prescriptions had been honored by the defendant pharmacy for the former employee and her husband over a period of several years. The plaintiff, United States of America, charged the defendant pharmacy with violation of the federal Controlled Substance Act (CSA). The charges listed red flags that these prescriptions exhibited, including “suspicious or stamped signatures, dangerous drug combinations, irregular dispensing intervals, odd dosages and pill quantities, cash payment, early fills, errors or missing information, brand name requests, patient calling in her own prescription, pattern prescribing, and other odd behavior.”
The plaintiff moved the court for summary judgment, contending that the facts and circumstantial evidence showed that the defendant’s pharmacists had honored the prescriptions despite recognizing red flags indicating their illegitimacy. If the court were to grant this motion, it would be an automatic win for the plaintiff, with no opportunity for a jury to consider the evidence. A motion for summary judgment can be granted only if there is no genuine issue of material fact.
Rationale
The court first referred to the DEA’s “corresponding responsibility” regulation that says a pharmacist may not “knowingly” honor a purported prescription. The court concluded that “the undisputed facts are insufficient to demonstrate that the pharmacists knowingly violated the CSA as a matter of law.”
The court explained, “Plaintiff has not met its burden showing that the pharmacists subjectively believed that there was a high probability that the prescriptions were illegitimate. To prove that the red flags were obvious, plaintiff offers a list of every prescription the pharmacists filled, showing that nearly every prescription exhibited red flags. While these red flags, in isolation, may be compelling evidence that the pharmacists should have recognized the ‘high probability’ that the prescriptions were illegitimate, the amount of red flags by itself does not show, as a matter of law, that the pharmacists actually recognized the red flags. Indeed, whether a red flag is present depends on a pharmacist’s professional judgment and specific circumstances of the prescription, including a holistic review of the prescription, patient, and situation.”
The court also noted that “there is no codified standard for what constitutes a red flag and how they should be resolved under the CSA.”
The court ruled that the lack of evidence as to the pharmacists’ subjective knowledge, and the ambiguity about what constitutes a red flag indicate that there continued to be genuine issues of material fact. The plaintiff’s motion for summary judgment against the defendant pharmacy was denied. The case must be tried by a jury.
Takeaways
What a relief this ruling is. At least one judge gets it.
Long lists of controlled substance prescriptions on spreadsheets may look suspicious, but pharmacists examine prescriptions and not spreadsheets. Pharmacists interact with patients whose medical condition is not recorded on a spreadsheet. A pharmacist’s evaluation of prescriptions is situational, and spreadsheets don’t describe the situation. Spreadsheets are misleading.
The judge in this case has adopted a subjective standard for determining whether a pharmacist “knowingly” honored a purported prescription. It is up to the jury to evaluate the evidence and determine each pharmacist’s subjective belief about each prescription.
The judge also recognized the unfairness of the ambiguous responsibility that the DEA’s undefined and unexplained red flags concept creates.
Whether this enlightened approach will be adopted by other judges remains to be seen. ■