Reporting Loss/Theft of Controlled Substances

 The DEA is mindful that any kind of shortage in controlled substances can mean that undesirable elements are at play. It requires that registrants should report such cases using the requisite form.

Healthcare practitioners, pharmacies, hospitals and other entities that handle controlled substances are required to register themselves with the Drug Enforcement Administration (DEA). The law requires them to abide by various rules regarding the storage, security, recordkeeping, inventory and other parameters related to the controlled substances.

Indeed, the regulations are there for good reason as these scheduled drugs have high scope for misuse and abuse. The DEA registrants do follow the protocols to the letter and ensure utmost safety of such drugs. However, discrepancies are still likely to crop up given the potential for misuse.

So what is a healthcare professional or entity to do when they notice a variance in the physical stock vis-à-vis the records?

The regulations require that registrants should use DEA Form 106 to report theft or significant loss of controlled substances. The same should be reported in writing to the area DEA Field Division Office (either electronically or manually) within one business day of discovery. This will have to be followed by updates for up to 2 months after the initial report as and when the source or cause is uncovered.

Illegal diversion of controlled substances can stem from robbery, burglary or employee theft. Losses may be experienced due to unintentional dropping or misplacing of a couple of drugs.

Challenges in reporting

Reporting loss or theft of controlled substances may sound a straightforward task at first. However, complications can arise pertaining to what comprises a significant loss. The following factors have to be considered for the same:

• The actual quantity of controlled substances lost in relation to the type of business
• The specific controlled substances lost
• Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals
• Whether the loss can be attributed to unique activities that may take place involving the controlled substances
• A pattern of losses over a specific time period
• Whether the specific controlled substances are likely candidates for diversion
• Local trends and other indicators of the diversion potential of the missing controlled substance

This requires careful attention to any shortages in the stock of controlled substances before ascertaining whether they have been lost or stolen. The DEA registrant has to judge the circumstances based on the above-listed factors and decide on how to proceed accordingly.

Given the heavy burden of detecting and reporting theft/losses, it is better to entrust the task to a professional DEA compliance consultant. Expert service providers like the Titan Group can handle all regulations related to controlled substances – right from registration formalities to recordkeeping, storage, inventory and more. They will be aware of the nitty-gritty requirements at every juncture and can deal with them accordingly. Additionally, they will also prepare the facility for audits and be handy for handling any irregularities, should they surface.