Safeguarding Pharmacy Integrity: Strategies Against Drug Diversion

When it comes to reporting any type of incident, suspected, or real diversion or discrepancy in a federal pharmacy, communication is imperative, explained Erica Harker, PharmD, MPH, lieutenant commander, United States Public Health Service and pharmacy consultant, Indian Health Service (IHS) Navajo Area, during a presentation at the American Pharmacists Association (APhA) 2024 Annual Meeting & Exposition in Orlando, Florida. The pharmacist’s role in managing and preventing drug diversion cases is also critical, which is why agency’s such as the Drug Enforcement Administration (DEA) and Office of the Inspector General (OIG) include pharmacists in drug diversion enforcement and prevention efforts, according to Harker.

“In my tenure as a pharmacist, I have been able to serve as a lead investigator for small, suspected diversion cases and very large, real diversion drug cases that involve over 100,000 diverted doses. I've had the pleasure of working side by side with DEA agents and OIG agents,” Harker said during the APhA session. “In the overall scope of drug diversion cases for small or large suspected or actual diversion, the manner in which you hold your pharmacy program accountable will ensure your ability to have optimal drug diversion prevention skills. How your program can attain, maintain, or ensure accountability in all aspects will enhance prevention.”

Harker stressed several elements of compliance during the session, including policy and procedures; education and training; oversight by a compliance officer or narcotic officer; monitoring and auditing; reporting and investigating; accountability; and response and prevention.

“These [elements of compliance] are also lessons learned as a lead investigator working side by side [with DEA and OIG agents],” Harker said during the session. “[Additionally, I worked as a] part of the agency and was brought on to another facility to take a look at the systems design to find out where vulnerabilities are and how diversion could have been prevented.”

In 2019, the Substance Abuse and Mental Health Services Administration (SAMSA) reported about 10% of US health care workers abused controlled substances, according to Harker.

“SAMSA found most of the drug diversion cases by health care workers aren’t discovered, as very small amounts that are identified are often not even reported further up the chain,” Harker said during the session. “High quality and visible drug diversion detection methods are key for detecting diversion faster and are significant in preventing health care workers from jeopardizing patient safety, or even their own health care and careers.”

For the policy and procedures element of compliance, Harker explained that it is essential to create policies at the pharmacy that establish roles and responsibilities that reflect DEA regulations and align with national policies. To this end, the DEA’s Pharmacist’s Manual is a valuable resource, according to Harker.

For the policy and procedures element of compliance, Harker explained that it is essential to create policies at the pharmacy that establish roles and responsibilities that reflect DEA regulations and align with national policies. Image Credit: © TensorSpark - stock.adobe.com

“It's a great reference and a broad overview of DEA regulations that is very applicable when you get into the field,” Harker said during the session. “If you have national policies that are very specific to your procedures [those are also valuable to include]. For example, for my agency within IHS, we have very specific national policies and procedures.”

Harker noted that one example of such a procedure from the IHS that is specific to that organization at a national level is how the IHS wants pharmacists to receive controlled substances and other narcotics.

“We're required to have a witness when we are receiving. In addition to that, we have to ensure that the person who is ordering is not the same person checking in,” Harker said. “But that's very specific to us.”

Additionally, Harker noted that one important takeaway as a lead investigator working with the DEA and OIG was that both agencies work together to review a pharmacy’s policies to see how compliant that pharmacy is with the agency’s national policies. For this reason, Harker explained that she highly recommends that federal pharmacies review their policies and make sure they reflect either regional or national policies for the various agencies that may review their compliance.

“I also highly recommend you have procedures within your policies on how you handle losses, theft, and diversion,” Harker said during the session. “There are situations in which there's potential breakage, accidental loss, and destruction, and how you handle wastage [is important]. So those are some things that I highly recommend, after lessons learned with diversion cases, to include into your policies.”

Additionally, Harker noted that it is important to create an environment that encourages pharmacists to communicate with supervisors if they notice something pertaining to drug diversion. Specifically, Harker explained that there should be clear communication on who to report that information to so that there is no confusion when the need arises.

“Knowing who to report up to and having that open communication will foster that environment to prevent drug diversion. Educating your program staff, your leadership, and above the leadership chain outside of the pharmacy program ensures drug diversion prevention, just as we do with disease state management or vaccinations,” Harker said during the session. “All of that education helps to bring awareness of the subject to improve outcomes. Educating staff on drug diversion creates the environment where your staff feel like they can say something if they do see something.”

REFERENCE

Harker E. Preventing Drug Diversion in Federal Pharmacy. American Pharmacists Association 2024 Annual Meeting & Exposition; March 22-25, 2024; Orlando, Florida.