ASK THE BUSINESS LICENSE GURU

By David Yount

Question:

“What are the requirements for an Emergency Medical Services organization to administer controlled substances?”

Answer:

In 1970, the federal Controlled Substances Act (CSA) was created to regulate substances that have the potential to be abused. At the time, the CSA lacked instructions for the maintenance and use of these substances by emergency medical services (EMS). Thus, States created their own EMS-related controlled substances requirements. In 2017, the Protecting Patient Access to Emergency Medications Act (PPAEMA) was introduced in US Congress to amend the CSA to include EMS requirements.

According to the law, an EMS organization must submit an application to the Drug Enforcement Administration (DEA) for registration and for demonstration that the applicant organization can provide the needed services in the specific state. The application is reviewed by the DEA and can be either accepted or denied. With an approved application from the DEA, the EMS organization can store, deliver, and receive controlled medications. These controlled medications can then be given to the patient when they are en-route to the hospital. Furthermore, instead of applying for a new registration through the DEA for each separate EMS facility, an EMS agency may obtain a single registration in each state instead of a separate registration for each location.

An EMS agency must adhere to 3 regulations to stay compliant with federal law: First, the storage of these controlled substances must be at a registered agency or in a designated vehicle from the agency. Second, during delivery, an agency with a DEA registration must deliver the controlled substances to EMS. Finally, record keeping for these controlled substances can be done either electronically or on paper, but the approach must be specified and the records kept in a designated area. 

References

https://www.pharmacytimes.com/publications/issue/2019/january2019/pharmacists-need-to-understand-law-related-to-controlled-substances

www.ireserviceems.com/protecting-patient-access-to-emergency-medications-act-of-2017-signed-into-law-november-17-2017/

https://www.cdc.gov/phlp/publications/topic/briefs/ema/index.html