CMS Conditions of Participation states, “Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate.” (482.25(b)(7).
Survey Procedures for this are:
- Interview the pharmacists, or pharmacy employees to determine their understanding of the controlled drug policies.
- Conduct a spot check of drug use and other inventory records to ensure that drugs are properly accounted for.
- Review reports of pharmaceutical services to determine if there are reported problems with controlled drugs and what actions have been taken to correct the situation.
- Interview the Pharmacy Director, pharmacist and pharmacy employees to determine their understanding of the controlled drug policies. Is there a policy and procedure for handling controlled drug discrepancies?
- Review reports of pharmaceutical services to determine if there are reported problems with controlled drugs and what actions have been taken to correct the situation.
- Determine if controlled drug losses were reported to appropriate authorities in accordance with State and Federal laws.
Pharmacy staff need to have an understanding of what policies and procedures are in place for controlled substance security. Not only because they are often the eyes and ears to what is going on within the pharmacy as well as on the nursing units, but they may be interviewed by a surveyor, and they need to be able to speak to the policies. If the staff don’t understand the big picture of why controlled substance security is important and what to do if in the event of an odd occurrence or unaccounted for med, then controlled substance security at the facility is not as tight as you may think it is.
