Drug diversion incidents and mishandling of controlled substances present crucial challenges for health systems, necessitating prompt, precise action. Proactive surveillance is essential but forms just the initial phase of a comprehensive drug diversion strategy.
Once an incident is flagged, a healthcare system must follow the necessary procedures for compiling an investigation file, including reporting, investigating, and documenting the incident.
Following regulatory bodies' guidance, healthcare facilities should have a standardized and detailed process for responding to drug diversion incidents. ASHP emphasizes the importance of a dedicated committee for proactive prevention efforts and addressing prevention control, drug diversion detection, incident investigation, reporting procedures, and quality improvement activities. By having individuals dedicated to maintaining this process, health systems and hospitals can ensure each step is followed with diligence and proper documentation.
Reporting suspected drug diversion
When drug diversion incidents are suspected in a health system, they must be reported immediately. Health systems are responsible for determining what is significant to their respective practice, but in cases of significant drug diversion, healthcare facilities are recommended to notify the Drug Enforcement Administration (DEA) and relevant authorities immediately upon suspicion. If a theft, loss, or death relating to the diversion of controlled substances is discovered, the DEA Diversion Control Division website notes a DEA registrant must preliminarily notify the DEA in writing within one business day. Of note, the DEA updated the regulations and timeline regarding formal reporting of theft or significant losses of controlled substances in 2023, which includes mandatory electronic reporting of applicable forms. In addition to reporting suspected drug diversion to the DEA, facilities should review reporting requirements at the state and local levels. This information can often be found on each state’s Board of Pharmacy Website. Local law enforcement may also aid in conducting a thorough investigation.
Conducting a thorough investigation
A systematic approach to investigation is imperative. A health system should conduct thorough interviews with all involved parties. This may include interviews with patients and staff and asking witnesses to provide and sign written statements. It can be helpful for the team investigating the incident internally to record interviews or other aspects of the investigation to prevent details from being missed between steps, where possible, and with legally required consent as needed. The investigation should also include scrutiny of current systems, compilation of any evidence like screenshots, and meticulous documentation of all findings. An organization should determine a consistent system of record keeping for investigations, as records may need to be accessed quickly upon request of the DEA.
In addition, a targeted line of questioning of the suspected employee should focus on tampering with medications, which may have increased the risk of transmission of blood-borne pathogens among patients. This is particularly true when diverting injectable medication as it may lead to unsafe injection practices and pose a risk to patients. Contaminated injection equipment and supplies in the care environment could lead to patient exposure. Failure to adhere to aseptic techniques and safe injection practices will constitute breaches in infection control. In these cases, additional reporting to public health authorities and the FDA (Food & Drug Administration) may be required.