Guidance on reporting loss or theft of controlled substances and precursors (CS-GD-005): Types of incidents
Examples of incidents and whether to report them
| Incident type | Incident sub-type | Definition | Report? |
|---|---|---|---|
| Loss | Loss unexplained | A loss that cannot be attributed to any particular cause or action on the basis of normally accepted business activities | Yes |
| Manufacturer's shortage | The content of a sealed bottle is less than expected after counting |
No, if the quantity is smaller than or equal to permitted value listed in FDR C.01.061. Yes, if it is greater than permitted value. |
|
| Wrong dispensing | Documented dispensing the wrong quantity or to the wrong patient |
No, if the substance is returned by patient. Yes, if it is not returned by patient |
|
| Breakage and liquid spillage | Change in the dosage form, or other known incident preventing dispensing (for example crushed tablet) |
No, if the substance is retrieved or destroyed on clean up. Yes, if it is not fully or partially retrieved and not destroyed. |
|
| Solid spillage | Incidents preventing dispensing such as dropped tablets |
No, if the substance is retrieved or destroyed during spillage. Yes, if it is not retrieved or destroyed during spillage. |
|
| Unusual waste | Waste or destruction of inventory beyond what is expected on the basis of normally accepted business practices. This could arise from unusual yield loss due to problems in the manufacturing process or broken equipment. | Yes | |
| Miscounts | Error made in counting during inventory reconciliation or during dispensing |
No, if it is documented and part of normal business practices. Yes, if the error is only assumed, then it is reportable as Loss Unexplained. |
|
| Overages | Quantity found to be in excess of inventory | No | |
| Destruction | Denaturation of a controlled substance to an extent that its consumption is rendered impossible or improbable | No | |
| Other | Any other type of loss not described above | Yes | |
| Theft | Filled forged prescription | Dispensing of a prescription that was found to be fraudulent | Yes |
| Unfilled forged prescription | Forged prescription that was not dispensed | No | |
| Armed robbery | Theft accomplished through threats of violence toward personnel at a site | Yes | |
| Pilferage (internal theft) | Theft from a site by authorized personnel | Yes | |
| Grab theft | Theft from a site during working hours without warning. The person conducting the theft 'grabs' the product and escapes. | Yes | |
| Break and entry | Theft from a site by forced entry | Yes | |
| Impersonation | An individual impersonating the individual for which the prescription has been dispensed | Yes | |
| Other | Any other type of theft not described above | Yes |
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