Inside a DEA Mock Audit: Pharmacy Students Gain Real-World Compliance Experience

By Lisa Lebovitz, JD, MS, assistant dean for academic affairs and assessment

Background: Understanding the DEA’s Closed System of Distribution

The Drug Enforcement Administration (DEA) regulates a closed system framework of controlled substances where every entity that manufactures, distributes, imports, exports, or dispenses controlled substances must be registered with the DEA. Registrants are required to maintain strict inventories, records, and security measures to prevent diversion, which is the illegal transfer of a controlled substance from the person it was prescribed for to someone else. This framework ensures a documented chain of custody, where every transfer of controlled substances is tracked from the point of manufacture to the final patient.

The closed system of distribution aims to prevent diversion and protect public health by ensuring these drugs are only used for legitimate medical purposes. The DEA regularly performs unannounced inspection audits of registrants throughout the supply chain to ensure compliance with the Controlled Substances Act and to detect and prevent diversion of controlled substances.

Simulating a DEA Inspection Audit

As course manager of the required Pharmacy Law course in the third year of the School’s Doctor of Pharmacy curriculum, I invited a team from the DEA Baltimore District Office Diversion Group to visit with our third-year pharmacy students and simulate a DEA inspection audit of a busy community pharmacy. Students volunteered to role-play as pharmacists and customers, and DEA officers provided instructions and scripts. Amy Ives, PharmD, BCPS, associate professor of practice, sciences, and health outcomes research, oversaw the pharmacist skills in the role of pharmacy district manager.

The inspection began as investigators presented their credentials and a Notice of Inspection (DEA Form 82) to the pharmacists. At one table, pharmacists and investigators examined the last two years of inventory, dispensing records, purchasing invoices, and DEA Forms 222 or the Controlled Substance Ordering System for Schedule II medications, comparing what was ordered to what was dispensed.

At another table, pharmacists counted their candy “controlled substances” in stock under investigators’ watchful eyes and calculated any shortages or overages. At the same time, a steady stream of customers came into the pharmacy with questions, and an inspector playing a technician pulled the pharmacists away from the audit to respond – adding to the realism and complexity of the experience.

Perspectives on the Experience

The students and the inspectors found this experience both valuable and engaging.

Vijay Modi, a third-year student pharmacist, commented, “Communicating with DEA professionals about their careers was an incredibly rewarding learning opportunity. This added a helpful practical element to our Pharmacy Law course. As someone with interest in pharmacy law enforcement as a subject and potential career option, I was thrilled to participate and to work with the team from the DEA.”

Ashleigh Oliver, MHS, a third-year student pharmacist, remarked, “This experience was so realistic and valuable. I have been somewhat aware of this process, as I have worked in a community pharmacy. I knew about the biennial control counts, but getting to know the “why” behind all the different actions was very informative.” She continued, “It also helped reduce the pressure that would be present in a real-world scenario. I am glad that the DEA gave us a chance to experience what it would be like, and to see the reasoning behind the regulation.”

Miya Ross, a third-year student pharmacist, commented, “I am glad I was able to participate in the DEA Controlled Substance Audit simulation as part of the Pharmacy Law course. Even though it was a simulation, I felt the pressure of making sure I was counting the controlled substances correctly, while also trying to stay aware of what was going on in the busy pharmacy. It was fun to translate what we’ve learned in the classroom to real-world scenarios, and the DEA officers did an excellent job of painting the picture of our future reality!”

Nicole Yeager, diversion group supervisor of the DEA’s Baltimore District Office said, “Collaborating on a DEA Mock Pharmacy Audit with Ms. Lebovitz and Dr. Ives at the University of Maryland School of Pharmacy strengthens compliance, sharpens clinical judgment, builds confidence for real world accountability, and connects education to responsibility.”