Under various state laws and DEA regulations, every pharmacist must resolve “red flags” before dispensing a prescription for controlled substances. Most of the pharmacy state boards have published lists of what constitutes such red flags. For example, the California State Board of Pharmacy has published the following list of red flags (other states use the same criteria):
- Irregularities on the face of the prescription itself
- Nervous patient demeanor
- Age or presentation of patient (e.g., youthful patients seeking chronic pain medications)
- Multiple patients all with the same address
- Multiple prescribers for the same patient for duplicate therapy
- Cash payments
- Requests for early refills of prescriptions
- Prescriptions written for an unusually large quantity of drugs
- Prescriptions written for duplicative drug therapy
- Initial prescriptions written for strong opiates
- Long distances traveled from the patient’s home to the prescriber’s office or to the pharmacy
- Irregularities in the prescriber’s qualifications in relation to the type of medication(s) prescribed
- Prescriptions that are written outside of the prescriber’s medical specialty
- Prescriptions for medications with no logical connection to an illness or condition.
If any of the above are present, the pharmacist must document how the red flags were resolved. The key word here is “document.” I cannot stress enough the importance of documentation. While representing independent pharmacies in DEA audits and investigations for many years, I have seen large monetary penalties imposed simply because there was no documentation on how pharmacists cleared red flags. For example, I recently had a case where the DEA claimed that the red flags were not resolved and was proposing a multi-million dollar settlement. After interviewing the client, I learned that the pharmacist in fact did resolve the red flags. For example, he spoke to the prescribers regarding medical necessity and to the patients to inquire why they were traveling long distances and paying cash. The pharmacist, however, failed to document these inquires and we had no evidence (besides the pharmacist’s statement) that the pharmacy performed its due diligence in filling these scripts.
Specifically, the DEA has recently been targeting pharmacies with excessive filling or ordering, suspicious drug combinations, and pattern prescribing. Some examples of such drug combinations:
– An opioid, a benzodiazepine, and a muscle relaxer for overlapping days of supply
– An opioid, a benzodiazepine, and a muscle relaxer on the same day, and all the prescriptions were written by the same prescriber
– An opioid and a benzodiazepine within 30 days of one another
– An opioid and a benzodiazepine on the same day, and both prescriptions were written by the same prescriber
In the DEA’s opinion, there is no legitimate medical reason for such combinations.
Some examples of excessive dispensing (from recent cases):
– Pharmacy dispensed two short-acting opioid drugs on the same day
– Pharmacy dispensed an opioid prescription of over 200 MME per day
– Pharmacy dispensed more than 210 “days of supply” of all opioids combined in a 6-month period.
Pattern prescribing example: an opioid was dispensed to at least 4 different patients on the same day and the opioid prescriptions were for the same base drug, strength, and dosage form and were written by the same prescriber.
Recently, the importance to resolve red flags was illustrated by a legal action against Walgreens. The city and county of San Francisco filed a law-suit against drug manufacturers and Walgreens for contributing to the opioid epidemic in San Francisco. A crucial factor in the court’s holding for the city was its determination that Walgreens failed to document red flags.
San Francisco was able to prove that multiple opioid prescription contained red flags which were not resolved by Walgreens’ pharmacists. According to San Francisco’s expert only 5% of the prescriptions were adequately verified and red flags resolved. Walgreens was not able to present documentation on how its pharmacists resolved red flags (such as long distance, cash payment, and dangerous combination of controlled substances). As a result, Walgreens is facing a multi-million dollar settlement.
(By the way, I encourage you to read the court opinion as it goes over the history of San Francisco’s opioid crisis, discusses red flags and pressure that many chain pharmacists face).
In a nutshell: the presence of a red flag triggers a pharmacist’s duty to perform a reasonable inquiry to determine whether the prescription is legitimate before dispensing it. Pharmacists should document how they resolved such red flags. Prescriptions should not be dispensed if the red flags are not resolved and there is no documentation how the pharmacist resolved them.
Remember a guiding principle of pharmacy: “if you didn’t document it, it didn’t happen.”