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ASHP Policy Position 2511

SAFE AND SECURE TRANSFER OF CONTROLLED SUBSTANCES

Status: Current

To advocate for the standardization of policies, procedures, and practices in the handling of controlled substance medications throughout the care process, including transfers involving emergency medical services and during interfacility transport; further,

To promote closed loop communication and chain of custody documentation processes related to controlled substance medication management during patient transfers; further,

To collaborate with emergency medical services and other stakeholders involved in pre- and post-hospital and interfacility transfers of controlled substances to improve patient safety, increase standardization, and ensure compliance. 

Rationale

Compliance with Drug Enforcement Administration (DEA) regulations and applicable state laws and regulations is crucial for protecting public health and preventing misuse and diversion of controlled substances (CS). Health systems are required to provide leadership and oversight of handling and storage of CS. They are also required to comply with laws and regulations in the transfer of CS between institutions and other DEA registrants. This can be a complex process, particularly in the absence of clear federal and state policies.

There is a lack of uniformity and clarity in allowances and processes for the transfer of CS from a hospital or health system to nonhospital-based emergency medical services (EMS) (e.g., state or local government-owned agencies) and vice versa. To address this, the Protecting Patient Access to Emergency Medications Act of 2017 (PPAEMA) authorized the DEA to amend the Controlled Substances Act to clarify the receipt, movement, and storage of CS for an EMS agency.4,5 PPAEMA states that CS can be stored in the DEA-registered EMS agency location, in EMS vehicles used by the agency, and in unregistered locations as long as the US Attorney General is notified of the location at least 30 days before the CS is initially delivered for storage. In addition, hospitals may restock CS for an EMS agency following an emergency response. However, the DEA has not finalized regulations as authorized by PPAEMA, creating challenges for states and hospitals to interpret federal regulations while implementing systems and solutions for the safe and lawful transfer of CS to EMS. A uniform approach or standard development may assure accountability and prevent diversion while meeting patient care needs.