The line manager and site manager have the professional and legal obligation to submit a prompt report over the theft or loss of a controlled substance. According to the case study, the CRA manager and a contractor collaborated to steal a schedule 2 compound, oxytocin. Ito et al. (2019) informs that the controlled substance can be used to manufacture harmful nerve agents and can equally be abused as a recreational drug. Upon discovery of the theft, the first step is to take note of the specific controlled substance involved, including the amount lost or stolen (U.S. DoJ, n.d.).
The second step is to notify law enforcement and the relevant pharmacy board. In this case, the notified body will be the State Board of Pharmacy. Lastly, federal regulations require the responsible party to notify the DEA of the theft or loss. Registrants will complete form 106, which contains the details and guidelines that should be followed when reporting the loss or theft of a controlled substance (U.S. DoJ, n.d.). The report should also indicate whether the loss can be linked to specific parties or unique activities involving the use of the controlled substance. The report can be submitted manually or digitally, and should take place within a day of the discovery.
Following the submission of a formal report, the business should prepare for a random DEA pharmacy audit. The DEA will appear without notice to ensure the enterprise complies with standards of practice and regulations. Due to the missing controlled substances, the business should expect DEA inspections to become routine practice. Therefore, it is essential the business ensures it keeps and updates all required records. On the other hand, the contractor can face hefty legal fines or time served in prison if found guilty/liable for the theft or loss of the controlled substance. The contractor can also expect their licence to trade in controlled substances to be terminated.
References
Ito, E., Shima, R., & Yoshioka, T. (2019). A novel role of oxytocin: Oxytocin-induced well-being in humans. Biophysics and Physico-biology, 16, 132–139. https://doi.org/10.2142/biophysico.16.0_132
U.S. Department of Justice. (n.d.). Diversion control division. DoJ, https://www.deadiversion.usdoj.gov/21cfr_reports/surrend/index.html