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.
What to Do to Prepare for an Audit
First, pharmacies should ensure they maintain accurate and up-to-date DEA registration records, prominently displaying the DEA Certificate in an approved location. Pharmacies should also 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.
In advance or in anticipation of a DEA audit, pharmacies should identify and designate one employee as having the responsibility of gathering records and information for an investigator. It is important that this employee be aware of the pharmacy’s policies, particularly as it relates to compliance with the CSA. Further, by designating one individual to assist during an audit, pharmacies can ensure that their ordinary pharmacy operations are not interrupted while the DEA is on premises. [Tip – always be helpful and courteous, feel free to answer basic questions regarding the pharmacy and records, but be aware that you do not have to answer questions or be interrogated – pharmacies have the right to not speak or have a lawyer present].
What to Expect during an Audit
The DEA most likely will arrive unannounced, come in a team of two investigators, and present the owner or pharmacist in charge (PIC) with an informed consent notice (Form 82). They will request a number of documents and records from the pharmacy in the course of their review. Specifically, they will pull and review random prescriptions for controlled substances to ensure the prescriptions are otherwise valid and do not reflect any red flags. In addition, the DEA will request a copy of the pharmacy’s biennial inventory, along with the pharmacy’s purchase and dispensing records for controlled substances. This documentation will allow the DEA to complete an invoice reconciliation for a number of select controlled substances by comparing the quantities the pharmacy dispensed and billed against the quantities the pharmacy purchased, ensuring that the pharmacy does not have an inventory shortage during the period of review. Notably, the scope of an audit should be limited to prescription records and dispensing and purchase records related to controlled substances, but should not extend to the pharmacy’s financial information.
With the basics in hand, it is critical that a pharmacy owner or PIC avoids DEA audit pitfalls and takes measures to maintain compliance with the CSA.
Typical Violations Found by DEA during Audits
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.
Common Red Flags DEA Investigators Look for
DEA investigators often look for “red flags” that cause reasonable suspicion regarding the legitimacy of a prescription or on the pharmacy’s practices of compliance with the CSA.
- Excessive Cash Payments: Document all cash transactions, ensuring transparency and avoiding suspicions of catering to a clientele primarily paying in cash.
- Out-of-state patients: Review carefully any prescriptions from patients, particularly any significant number of patients, from out of state.
- Frequent Refills without Proper Validation: Prioritize confirming the medical necessity of refills, avoiding indiscriminate refill practices that may lead to allegations of prescription fraud.
- History of Admonishment or Failed Inspections: Past issues can impact future audits; however, resolved compliance concerns with proper documentation can aid in overcoming previous challenges.
Conclusion:
While these red flags are common in DEA audits, pharmacy owners and PICs must remain vigilant about various potential issues. Understanding and addressing these concerns 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.
How Frier Levitt Can Help
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. Contact us to better protect your pharmacy from potential liability.
