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Warning: Seemingly Predatory DEA Inspections May Be On The Rise

Oct 24, 2022

Independent pharmacies are widely known to be our nation’s most accessible, trusted healthcare providers. From patient care and support, to vaccinations and hands-on involvement in their local communities - independent community pharmacies are a critical component of accessible healthcare services nationwide.

The fight for survival of independent pharmacies - especially those in rural and underserved areas - despite corporate pharmacy benefit manager (PBM) predatory business practices, has been documented by medical groups and news media. It came as a surprise to hear that a government agency was possibly employing similar abusive tactics.

U.S. Drug Enforcement Agency (DEA) inspections of pharmacies are a necessary occurrence. When conducted properly and paired with state Board of Pharmacy audits, the risk of improper dispensing and/or distribution of narcotic medications can be significantly reduced. But auditing small business independent pharmacies for the purpose of extracting the largest amount of money possible is a tactic we normally have only seen used by PBM-paid auditors… until now.

A local pharmacist recently alerted us to a dramatic increase in seemingly predatory east coast area DEA inspections. These inspections appear laser-focused on administrative processes, levying hefty penalties for reasonably minor clerical missteps.

The pharmacist* noted, “Our pharmacy has never had a red flag or been cited by a regulatory agency, yet the agent seemed intent on finding any possible means to assess an exorbitant fine, no matter how irrelevant... These fines are outrageous for simple administrative infractions. They can be appealed through legal means, but that type of cost can be prohibitive for a small business. I want to ensure that others are warned about these so-called inspections.”

Penalties upwards of $15,000 per occurrence have reportedly been assessed for:

- Omission of blank sheets of paper between medication schedule level documentation;
- Inventory discrepancies on non-opioid medications;
- Incomplete inventory counts when the inspector shows up prior to DEA designated deadlines.

Inspector practices such as counting filled prescriptions back into physical inventory without adjusting pharmacy software counts have also been documented.

National chains like CVS, Walgreens, and Wal-Mart have been prosecuted in recent years for their role in the opioid epidemic after failing “to stop pain pills from flooding the counties and false prescriptions from being filled.” And while the 2022 DEA Pharmacist's Manual states clearly that “the proper dispensing of controlled substances is critical to the health of patients and helps protect society against drug misuse and diversion,” (and we agree!) the question remains; how do inspections that generally ignore potentially addictive medications in favor of searching for operational faux pas like missing blank sheets of paper assist with the agency’s regulatory mission?

Now that national chain pharmacies are being prosecuted into compliance, has the DEA placed a financial target on the backs of small business pharmacies?

PUTT supports the mission of the DEA to combat the continuing opioid epidemic, but inspections of this nature seem suspect in purpose when the fines assessed far outweigh the errors cited. In the war on opioid abuse, local pharmacies without flags or citations should be considered soldiers in the fight - not pawns in a quest to pad funding.

*name withheld to protect against retaliation

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