What is Considered Significant Loss?

I was listening to a lecture on controlled substance loss and theft. They mentioned the need to report any significant loss to the DEA. Significant loss or theft must be reported to the DEA within 1 day of the loss or discovery. These guidelines are clear; however, I have seen the question come up over and over regarding “significant loss”. How much is significant? The DEA does not specify. Every discussion I have seen talks only about the amount – the amount lost compared to the amount ordered or dispensed monthly. Here are five factors to consider when determining significant loss.

  1. The specific substance lost and the likelihood for diversion of that substance
  2. The quantity lost and the type of business (the amount may be a lot for a small pharmacy but quite minimal for a busy pharmacy in another city)
  3. The individuals with access to the drug
  4. Any history or pattern of losses or local diversion issues
  5. Any unique circumstances surrounding the loss

Consider each factor separately, as well as collectively. For example, if there is a high demand for a particular drug in your area and that is the drug that is missing, it is most likely significant. If there has been more than one incident of loss and the same person has had access each time, this is most likely significant. This list suggests there are more factors to consider than just the number “lost”.

Terri Vidals
Terri Vidals

Terri has been a pharmacist for over 30 years and is a drug diversion mitigation and monitoring subject matter expert. Her years of experience in various roles within hospital pharmacy have given her real-world insight into risk, compliance, and regulatory requirements, as well as best practices for medication and patient safety.

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