Beware: DEA and Wholesalers are Cracking Down on Controlled Substance Dispensing

• Dangerous drug cocktails (e.g., opioids with benzodiazepines, muscle relaxants, and/or stimulants)
  • Often known as the ‘Holy Trinity’ on the street: opioid, benzodiazepines, and muscle relaxant
• High opioid doses that far exceed FDA dosage guidance
• Controlled substance prescriptions for patients traveling long distances
• A patient who uses multiple prescribers and multiple pharmacies to fill their controlled substances
• Suspicious prescriptions from providers who are now sanctioned by state and federal authorities
  • When a prescriber is sanctioned, the DEA will look downstream at pharmacies that ultimately dispensed medications from the prescriber
• Providing early refills of opioid prescriptions
• Schedule II prescriptions for opioid dependence, which is not a legitimate medical purpose

Dispensing combinations of controlled substances that have no legitimate medical purpose, are highly addictive and specifically used to create or enhance abusive and euphoric effects, is a violation of 21 CFR 1306.04(a). Pharmacists have a responsibility to ensure the appropriateness of the prescriptions they are dispensing. While turning away business is never easy, being fined and sanctioned by the DEA is a much more painful process to endure.

Consider a few DEA settlements over the last couple years:

1. Pharmacy Agrees to Pay $1.5 million to resolve allegations it filled illegitimate controlled substance prescriptions (May 2022)
2. Pharmacist to pay $275,000 to settle claims related to the alleged unlawful dispensing of controlled substances (including the ‘holy trinity’) (November 2021)
3. Pharmacy, pharmacist to pay $2.1 million for dispensing illegitimate prescriptions (March 2020) Note: This settlement was the fifth prosecution of pharmacies/pharmacists affiliated with a convicted pill-mill doctor

Drug wholesalers are also pulled into the fray with their responsibility to identify and report “suspicious orders” of controlled substances. McKesson, Cardinal Health, and AmerisourceBergen have all had settlements and/or civil penalties (as high as $150 million) related to Controlled Substance Act violations. In 2019, there were felony criminal charges filed against a distributor and its executives for illegal distribution of controlled substances. Their failure to effectively oversee suspicious orders caused them to go out of business.

Consequently, wholesalers are increasing their constraints on controlled substance purchasing. There are more rigorous applications, wholesaler audits, and purchasing thresholds which cannot be exceeded. PAAS National^® has also become aware of wholesalers (nearly immediately) terminating a pharmacy’s ability to purchase controlled substances. In its notice to the pharmacy, the wholesaler flagged the following practices:

• Dispensing antagonistic combinations concurrently (benzodiazepines or opioids with amphetamines)
• Dispensing therapeutic duplications (two benzodiazepines or two IR/ER opioids)
• Dispensing opioids and benzodiazepines concurrently
• Dispensing controlled substance prescriptions for prescribers with current, or historical, discipline – particularly as it relates to prescribing concerns
• Lacking policies and procedures to ensure against the diversion of controlled substances

PAAS Tips:

• Review the DEA Pharmacist’s Manual (updated in 2020)
• Utilize your state’s controlled substance Prescription Drug Monitoring Program to identify early refills, polypharmacy, and multiple prescribers
• Educate all staff on high risk dispensings