Preventing drug diversion is critical to keeping patients safe, but also to prevent compliance headaches.
By Russ Nix
A surge in Department of Justice (DOJ) crackdowns on opioid distributors is sending a message to healthcare systems that regulators take drug diversion seriously. In July, the DOJ reportedly indicted two licensed pharmacists and two corporate executives for drug distribution. It’s the second time this year the agency moved to hold opioid distributors within healthcare organizations criminally liable.
These incidents are another indicator that times have changed. What was once a blip on the radar of healthcare inspectors a decade ago, before opioid misuse reached crisis levels, is now a priority for the DOJ’s Drug Enforcement Agency (DEA).
But for healthcare leaders, these incidents raise a larger question: If regulators come knocking on your organization’s door, would your drug diversion prevention plan suffice?
As legal experts have observed, the wave of enforcement is only the beginning. In the next ten years, healthcare organizations could very well see new thresholds set in: stronger laws and tougher penalties for everyone in the healthcare value chain. It might be similar to what we’re now seeing under HIPAA, whereupon healthcare organizations with inadequate privacy protections are held accountable for even minor data breaches.
Zeroing in on Enforcement
Many healthcare organizations will say their drug diversion programs are sufficient, and in compliance with federal regulations.
For example, an organization might say its medication disposal procedures follow the electronic Code of Federal Regulations (e-CFR) Part 1317.92, which specifies the need for “two employees of the transferring registrant” to “load and unload or observe the loading and unloading of any controlled substances.”
That’s a nice start, but unfortunately, it’s not enough, given the government’s clear mission to combat drug misuse and diversion.
The problem is that healthcare leaders aren’t used to high-level scrutiny for their policies involving opioids and drug diversion. In the recent past, regulations around controlled substance distribution lacked teeth. An organization that did one or two things wrong (e.g., disposing medication incorrectly) might get slapped with a fine. But not anymore. As of early 2019, when the administration rolled out its DEA 360 initiative, we’re seeing an increase in fines and repercussions in all levels of violations, including less severe infractions. As part of its efforts to combat drug diversion, the agency’s new program calls for:
- Closer collaboration with law enforcement, medical practitioners and anti-drug organizations;
- Enhanced data to identify and track problems
- Increased resources to identify and tackle drug diversion threats
The bottom line is that health systems need to do a better job of creating or tailoring existing programs that align with these goals to show the DEA they take this problem seriously.
Updating Your Program
When healthcare leaders reach out for guidance on starting or improving their programs, I always advise the following:
1. Increase education and training. Having a compliance team that thoroughly understands federal regulations is a great start, but healthcare executives should make sure drug diversion prevention strategies infiltrate every level of their organization. That means everyone from hiring managers and medical assistants to janitors or C-level executives should know how to handle potential drug diversion: how to recognize the signs, what to do when an employee is diverting medication, and how to report an incident to law enforcement and/or licensing board.
2. Understand federal and state legislation. While much of the emphasis is on the DEA, healthcare groups are also feeling the heat from state health boards in states like Maryland, which recently created a Board of Control Substances. The end result is more enforcers coming from all directions, which puts hospitals at a higher risk of an inspection that leads to a sanction or other consequence. The more an organization understands the roles and objectives of state and federal regulators, the better it can proactively plan around respective requirements.
3. Organize within. Health systems with the best drug-diversion programs bring together stakeholders from every department — clinical, operational and technology. One organization I worked with saw a marked increase in detecting incidents of potential drug diversion after forming an opioid taskforce whose primary purpose is to raise awareness around opioids and drug diversion. Regular meetings enable leaders to assess the success of approaches and the implementation of new approaches.
4. Utilize smarter technology. Tracking the movement of drugs across the supply chain isn’t limited to RFID or supply-chain management applications. Using smarter AI programs that enable healthcare organizations to track both the movement of drugs and other data (e.g., employee behaviors and reported incidents) has been shown to alert supervisors much sooner to potential diversion incidents. Healthcare leaders should take another look at these technologies, and how they can support a stronger drug-diversion program.
While preventing drug diversion can be a difficult and often painful task, healthcare leaders that take a proactive approach by employing some of these strategies will be best positioned for the future — not only in preventing compliance issues, but in keeping patients and their communities safe.
About Russ Nix:
Russ Nix is founder and consultant at Aegis RX. He has over 20 years of investigations experience with 15 years of experience in criminal narcotics investigations. Russ serves on the board of directors for the Healthcare Diversion Network, a nonprofit association dedicated to preventing drug diversion.