Controlled Substances: Centralized Service Centers

In today’s environment, creating Centralized Service Centers (CSCs) to standardize medication processes, increase efficiency, improve safety, and to save money is quickly becoming a reality for many health systems. Centralized packaging, sterile and non-sterile compounding, and targeted purchasing allows the individual sites in a health system to order EXACTLY what they need instead of being forced to order the pack size available from the manufacturer. These services reduce the workload at the sites, the medication outdates and waste, along with the cost associated with each of these activities. Highly trained individuals that are working in an environment free from interruptions reduces errors and improves medication safety. It is easy to see why this is appealing to health systems as these CSCs have the ability to serve several inpatient pharmacies and outpatient clinics simultaneously.

Since this industry is moving so quickly in this direction, it is easy to forget that centralizing the services that involve controlled substances can be tricky and must be managed carefully. Remember, that the five percent rule remains in effect for CSCs that are registered as a hospital/clinic with the Drug Enforcement Administration (DEA). What this means is that the total number of dosage units of all controlled substances distributed by a pharmacy may not exceed five percent of all controlled substances dispensed by the pharmacy during a calendar year. If at any time the controlled substances distributed exceed five percent, the pharmacy is required to register as a distributor.

In addition, if the controlled substances are manipulated, such as being repackaged or used in compounding, the pharmacy may also need to register as a manufacturer. To add to this burden, distributors and manufacturers have additional record keeping and reporting requirements when compared to a pharmacy.

Remember, it is critical to have the correct DEA registrations in place BEFORE providing centralized services that involve controlled substances! If your health system needs experts to evaluate the activities of their CSC or to analyze their controlled substance compliance, please email [email protected].