Reason for New Rule:
The rule change clarifies what constitutes a significant loss of prescription drugs or controlled substances and the time frame in which the loss should be reported to the Board.
New Rule Language:
7.00.10 Reporting Violations. The pharmacist manager of a prescription drug outlet shall report to the Board, in writing, within the timelines set forth below:
a. Diversion, theft or significant unaccountable loss of prescription drugs or controlled substances from the pharmacy, hospital or health maintenance organization (as defined in Section 10-16-102, C.R.S) within one business day of discovery. When a Drug Enforcement Administration (DEA) Form 106 is submitted to the DEA in instances involving controlled substances, a copy of the completed DEA Form 106 along with a detailed written explanation shall be submitted to the Board. When determining whether an accountable loss is significant, the pharmacist manager shall consider, among other factors, the following:
- The actual quantity of drug lost in relation to the type of business;
- The specific drug lost;
- Whether the loss of the drug can be associated with access to those drugs by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the drug;
- A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses;
- Whether the specific drug is a likely candidate for diversion; and
- Local trends and other indicators of the diversion potential of the missing drug.
b. Security breaches within the pharmacy or pharmacy area of the establishment within 10 days of discovery.
Implications for Pharmacies:
With the increasing trends of opioid misuse and diversion, pharmacy managers must carefully monitor inventory of controlled substances and report significant losses to the Board within one business day. Failure to report may result in disciplinary action.