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Ignore Red Flags at Your Own Peril

By Larry P. Cote on June 13, 2024
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Today, the Drug Enforcement Administration announced the revocation of Coconut Grove Pharmacy’s DEA registration. 

DEA issued an Order to Show Cause and Immediate Suspension of Registration back in September 2022, premised on Coconut Grove’s alleged failure to identify, resolve, and document the resolution of potential red flags associated with prescriptions for controlled substances.  If you have been hiding in a bunker for the past few decades and do not understand what a “red flag” is in the context of controlled substance prescriptions, please take a look at my previous tutorial on the subject.   

Coconut Grove argued that it did identify and resolve many of the red flags presented by the agency in its case-in-chief.  Through its expert witness (who was generally determined by the Agency to have provided testimony that was “not consistent nor logical (particularly compared to his prior testimony in other matters)”), Coconut contended that notations on prescriptions indicating “verified” demonstrate resolution and documentation of red flags.  DEA, however, disagreed and found that writing “verified” on prescriptions does not meet the standard of care for pharmacists in Florida with respect to identifying and documenting the resolution of red flags. 

The red flags present in this case are what we typically see in DEA enforcement actions: prescription drug cocktails, immediate-release, and high dosage opioids, and alternating between cash and insurance.  The Agency concluded that the presence of these red flags and the failure to resolve the red flags was “egregious” conduct which supported the Agency’s decision that Coconut Grove’s continued registration is inconsistent with the public interest and that a lesser sanction “would send a message to the registrant community that the failure to properly address and document resolution of red flags can be excused.”

Coconut Grove will certainly not be the last pharmacy to lose its DEA registration for failing to identify and resolve red flags.  Such results, however, are avoidable.   Visit https://cssolutionsusa.com/ and learn how you can confidently identify and investigate red flags to mitigate your compliance risks.

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  • Posted in:
    Administrative and Regulatory
  • Blog:
    DEA Chronicles
  • Organization:
    Cote Law PLLC
  • Article: View Original Source

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