The US Drug Enforcement Agency (DEA) confirmed in its annual National Drug Threat Assessment that abuse of controlled prescription drugs was more common in 2015 than that of cocaine, methamphetamine, heroin, MDMA, and PCP combined. The assessment reveals misuse of prescription drugs is now an epidemic: drug-poisoning deaths outnumber deaths by firearms, motor vehicle crashes, suicide, and homicide, killing 129 people every day in the US.1

Demand for highly addictive controlled substances continues to place pressure on health system pharmacies to heighten security measures aimed at avoiding drug diversion. The cost of this pervasive issue is difficult to quantify given the effects on operations, employee and patient safety, and our communities’ well-being. Nevertheless, pharmacy must expand its knowledge of controlled substance regulations, stay abreast of new technologies and services, and create a proactive strategy for managing drug diversion.

A Formerly Taboo Topic

Many health systems have been reluctant to address this subject both because of the regulatory complexity and the fear of exposing systemic vulnerabilities. But increasing regulation, costs, and societal implications leave pharmacy leadership with no choice but to take action. Industry professionals and associations are now addressing the issues surrounding drug diversion and offering guidance on how to implement formal procedures that help decrease employee diversion.

Certainly, controlled substance regulation is confusing, with regulations issued by different agencies. The policies guiding management of controlled substances, for example, fall under the DEA’s purview, while the EPA enforces proper disposal. In a survey of pharmaceutical waste management practices published by Pharmacy Purchasing & Products in 2014, hospital pharmacy directors cited the complexity of regulations as their number one concern.2

At Indiana University Health North in Carmel, Indiana, pharmacy made the case for launching a proactive controlled substance disposal management program to our executive team. While managing controlled substances as a separate and formal waste stream is new for many hospitals, and one that we believe eventually will be mandated, our hospital is committed to being ahead of the regulatory curve by installing a formal disposal system. Our goal was to create multiple layers of accountability and implement sustainable practices that would benefit the environment while also preventing diversion.

Utilizing a Disposal System to Minimize Diversion Risk

After making our case by emphasizing the risks of inaction, the executive team supported our initiative and prioritized funding for appropriate disposal and diversion prevention. Our goal was to adopt a simple solution that would allow nurses to dispose of all wasted narcotics into one receptacle, regardless of dosage form (ie, tablets, injectables, etc). We preferred a container with a one-way cover for disposing of controlled substances while keeping out sharps. We chose a system that deactivates controlled substances, deters ingestion, and labels and secures controlled substance containers.

The benefit of adopting a simple system is that there was little-to-no education necessary; nurses quickly mastered the system without requiring any one-on-one training or inservices. It is important to note that as health systems consolidate, it is increasingly crucial to simplify and standardize processes across locations, allowing employees who travel between facilities to apply similar approaches to their practice.

Expanding the Diversion Team

The pharmacy department is an integral part of Indiana University Health North’s diversion program and conducts diversion audits. Our diversion team has grown beyond pharmacy and nursing to include staff from risk management, human resources, and security. Diversion risks are woven into every facet of health care operations; as such, the more departments involved, the better. We are currently forming a multidisciplinary proactive diversion team to look at education, standard operating procedures, and prevention strategies. While it is important to establish a team with breadth, it only makes sense that pharmacy—the resident medication experts—should lead these efforts.

Discrepancy Management Lessens Risk

In some cases, nurses may not remove the requested medication from the automated dispensing cabinet, or they may err in the quantity requested or access the wrong medication pocket. Discrepancy management, the practice of searching for anomalies—such as a system user removing a greater quantity than requested—is key to identifying potential diversion. For example, anesthesia waste at OR pharmacy satellites must be audited to match the quantity of controlled substances returned, the doctor-reported usage, and the amount recorded on the patient’s chart. Both nursing and pharmacy teams must be accountable for proper monitoring and discrepancy documentation.

Whether the issue is missing controlled substances or an impaired clinician, consistency in diversion detection, investigation, and resolution is critical. Our hospital is no longer focused on watching and waiting for an issue to occur; rather, it is imperative that we proactively address diversion risks. We are now preventing incidents as well as protecting our local water system thanks to staff awareness and a safe, secure controlled substance disposal program.

References

1. Drug Enforcement Administration. 2016 national drug threat assessment. DEA website. https://www.dea.gov/resource-center/2016%20NDTA%20Summary.pdf. Accessed December 11, 2016.
2. Halvorsen D. New waste regulations. Pharm Purch Prod (Going Green supplement). 2014;11(12):S1-S5.

Janice M. Vadas, BS Pharm, RPh, is the inpatient pharmacy manager at Indiana University (IU) Health North Hospital. She is a graduate of Butler University and has been working with IU Health for 27 years. Janice’s professional interests include utilizing LEAN tools within the pharmacy environment.