Health Tháng Bảy 24, 2024

Reporting an incident: 3 Elements your healthcare facility should prepare for a thorough drug diversion investigation

Key Takeaways

  • A thorough drug diversion report must include detailed timelines, witness statements, and evidence from automated dispensing cabinets.
  • Promptly reporting incidents to regulatory bodies and law enforcement is essential to maintain licensure and public trust.
  • Establishing a clear chain of custody for evidence protects the integrity of the investigation and supports legal action if needed.
healthcare meeting with computer

Drug diversion incidents and mishandling of controlled substances can pose significant challenges to your health system, warranting immediate and precise action. Diligence and proactive surveillance are only the first part of a thorough drug diversion program.

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.

Compiling detailed documentation

Documentation is key to demonstrating compliance and cooperation throughout the investigation. Regulatory bodies urge hospitals and health systems to maintain detailed records of the investigation process, including signed statements or notes where possible. Along with physical evidence, electronic documentation systems, data analytics platforms, and surveillance technologies can all contribute to documentation. Centralizing copies of all records in electronic or physical formats for easy access—for example, in a binder, file folder, or flash drive – will usually be helpful when moving forward with an official DEA investigation. 

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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 establish a consistent system of recordkeeping for investigations, as records may need to be accessed quickly upon the DEA's request.

In addition, targeted questioning of the suspected employee should focus on tampering with medications, which may have increased the risk of transmission of blood-borne pathogens to 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.

Navigating DEA investigations after a drug diversion incident demands promptness and thoroughness. By adhering to established protocols, healthcare facilities can demonstrate proactive compliance and cooperation with regulatory authorities, thereby reducing the burden on their teams.

 

Embracing technological solutions like Sentri7 Drug Diversion can further strengthen compliance efforts, facilitating record maintenance and efficient incident reporting, as well as proactively guarding against future incidents of drug diversion. In addition, health systems should regularly review and update protocols and procedures to align with current standards and best practices. By building these steps into your drug diversion program, organizations can ensure they are ready to carry out all the appropriate steps of a thorough investigation to help support optimal patient and staff safety. 

Looking for additional resources on drug diversion best practices? Check out these recent articles. 

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