The Controlled Substances Act (CSA) establishes federal requirements regarding controlled substances and the Drug Enforcement Administration (DEA) is the agency tasked with enforcement of the CSA. The DEA seeks to ensure that all controlled substance transactions take place within a “closed system” of distribution, meaning that all legitimate handlers of controlled substances—manufacturers, distributors, providers, pharmacies, and others—must be registered with DEA (a pharmacy must renew its DEA registration every three years) and maintain strict accounting for all controlled substance transactions.
The DEA performs routine inspections and audits of pharmacies to confirm compliance with the CSA. While an accountability audit is “routine,” the DEA could take adverse action against a pharmacy if the DEA believes that the pharmacy has violated the CSA. Pharmacy owners and pharmacists must be well-versed in what to expect during an unannounced DEA audit.
How Can a DEA Audit Attorney Help You?
The DEA most likely will arrive unannounced, come in a team of two investigators, and begin reviewing records immediately. A DEA Audit Attorney can work with pharmacies to ensure that they have comprehensive written policies in place for dispensing controlled substances that demonstrate proactive measures to prevent theft and misuse. These policies should include a comprehensive compliance program with adequate provisions for diversion control. To that end, pharmacies should ensure that their employees are trained on the policies and procedures as part of their onboarding process and throughout their employment.
A DEA Audit Attorney will also be instrumental in communicating with the DEA during and after the audit to provide information and answer any questions that the DEA may have without interrupting the pharmacist in charge and the day-to-day operations of the pharmacy.
Understanding DEA Audits: Key Concepts and Procedures
One important point to note about DEA Audits is that the DEA is only there to audit controlled substances. However, this will entail a thorough review of supplier purchases, invoices, and receipts as well as the pharmacy’s biennial inventories and on-hand inventory. It is critical that the pharmacy keep a current inventory of controls so that the DEA does not identify any discrepancies. A robust policy and procedures is a start, but accurate and up-to-date record-keeping is important.
Steps to Take When Facing a DEA Audit
Below are common violations and compliance issues identified by DEA investigators during an audit. It is helpful for pharmacies to be aware of them to ensure they do not occur during their own audit.
- Inadequate Documentation for Narcotics Prescriptions: Implement and document thorough measures to validate narcotics prescriptions, confirming medical necessity and mitigating risks of abuse or diversion.
- Disorganized Record-Keeping: Maintain organized records, readily accessible during audits, to showcase compliance with registration, documentation, and inventory requirements.
- Inventory Error Rates: While mistakes are inevitable, consistently high error rates, especially in inventory management, may prompt further investigation by the DEA.
- Dispensing High-Risk Drugs in Excess: Be cautious of dispensing a high volume of sought-after drugs (e.g., Oxy 30mg), as it may attract DEA attention, particularly if refill patterns seem suspicious.
- Dispensing Dangerous Drug Combinations: Avoid dispensing known dangerous drug combinations like the “Holy Trinity” (benzodiazepine, opioid, muscle relaxant), as it raises serious concerns during audits.
Our Expertise in DEA Audit Defense
As enforcement efforts increase, pharmacies and pharmacists must ensure that they are complying with federal regulations and are properly identifying and resolving red flags when filling prescriptions for opioids or other controlled substances. The best way for pharmacies to protect themselves from potential liability is to adopt and implement a robust compliance plan. Frier Levitt’s attorneys have the in-depth knowledge and experience to provide your pharmacy with thorough compliance procedures that will assist you in identifying and resolving red flags.
Frier Levitt attorneys have successfully challenged and overturned DEA audit findings and have represented clients in DEA administrative proceedings.
Conclusion
Understanding audits proactively will help pharmacies navigate DEA audits successfully and avoid legal repercussions. It is always best for the pharmacy to self-audit and be prepared with a binder of all documents ready for any unannounced DEA audit. Otherwise, the pharmacy will find it difficult to gather the requested information and undoubtedly miss documentation, which the DEA might use against the pharmacy when it completes the audit.