Pharmacists Need to Understand Law Related to Controlled Substances

The opioid epidemic is still raging across the country, and many affected patients require emergency medical services every day as a result.

Those patients are in addition to individuals with other emergencies, such as heart attacks, seizures, and injuries from serious accidents. These patients will more than likely require narcotic pain medication or another controlled substance either en route to the emergency department (ED) or during their stay in the ED. Pharmacists must continue to provide necessary medications to patients while ensuring that the amount of controlled substances being dispensed is appropriate. The Protecting Patient Access to Emergency Medications Act, which was signed into law on November 17, 2017, was designed for this purpose.¹ This law modified the Controlled Substances Act that was already in place so that emergency medical services (EMS), as well as EDs, could better care for patients.¹ The newer legislation targets ED personnel and EMS staff members who are administering schedules II to V controlled substances to patients who need the medications.²

This law specifically amended the Controlled Substances Act “to ensure that paramedics and other emergency medical services professionals are able to continue to administer controlled substances, such as pain narcotics and antiseizure medications, pursuant to standing or verbal orders when authorized by state law.”¹

With this amendment, patients will be able to receive the medication they need in a more efficient manner.

According to the law, an EMS organization must submit an application to the Drug Enforcement Administration (DEA).³ This application is 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.³ With an approved application from the DEA, the EMS organization can “store, deliver, and receive controlled medications.”¹ These controlled medications can then be given to the patient when they are en route to the hospital.¹ 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.”³

An EMS agency must adhere to 3 regulations to stay compliant with the application it submitted to the DEA. First, the storage of these controlled substances must be at a registered agency or in a designated vehicle from the agency.² Second, during delivery, an agency with a DEA registration must deliver the controlled substances to EMS.² 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.²

Under this amendment to the Controlled Substances Act, patients can receive the care they need in a more streamlined and efficient manner. Moreover, this serves to bring clarity to an important issue that has raised many questions over the years. That in turn provides great benefit for patients as well as clarity to pharmacists whose organizations stock and restock controlled substances for EMS organizations.

Heather N. Wolf is a PharmD candidate at the University of Kentucky College of Pharmacy in Lexington.Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy.

References

• Protecting Patient Access to Emergency Medications Act of 2017 signed into law November 17, 2017. Fire Service Based EMS Advocates website. fireserviceems.com/protecting-patient-access-to-emergency-medications-act-of-2017-signed-into-law-november-17-2017/. Published November 17, 2017. Accessed December 27, 2018.
• Pub L No. 115—83, 131 Stat 1267.
• Protecting Patient Access to Emergency Medications Act of 2017, HR 304, 115th Congress, Sec 2 (2017-2018).