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The federal Controlled Substances Act (CSA) of 1970 regulates substances that can be abused. It did not deal with the particular needs of emergency medical services (EMS), which use controlled substances such as opioids and benzodiazepines for advanced life support, often when time is critical. States and EMS agencies filled the gap in different ways, and practice varied.

The Protecting Patient Access to Emergency Medications Act (PPAEMA), passed in 2017, added rules for EMS to the CSA to end the confusion, standardise how EMS works and improve patient care.

The gap

  • The CSA required anyone who makes, distributes, administers or studies controlled substances to register with the Drug Enforcement Administration (DEA). With no guidance for EMS, some states and agencies took this to mean they could give controlled substances under the DEA registration of the medical director or hospital overseeing their patient care.
  • Some states read the CSA as allowing controlled substances to be given under standing orders: written protocols approved in advance by a medical director, so that crews did not have to call a doctor for instructions for each patient.
  • In 2011 the DEA said the CSA did not allow controlled substances to be dispensed under a standing order, and in 2014 it announced that it intended to ban standing orders. That proposal prompted the PPAEMA.

What the act changed

AreaRule
DEA registrationAn EMS agency can hold its own registration. An agency serving several states needs one for each state; a hospital-based agency can use its hospital's registration.
Standing ordersAn agency may "administer controlled substances in schedule II, III, IV, or V outside the physical presence of a medical director or authorizing medical professional", if state law authorises it and it has a standing or verbal order from a medical director or authorising medical professional.
StorageControlled substances may be kept at the agency's DEA-registered location, at unregistered locations and in its vehicles. The U.S. Attorney General must be told of every unregistered location at least 30 days before controlled substances are first delivered there.
RestockingAfter an emergency response, an agency can restock its vehicles with controlled substances from a hospital without filling in CSA order forms.
RecordsAgencies follow the CSA's record rules: every delivery of controlled substances is recorded, and the records are kept where the substances are received, administered and disposed of.
LiabilityAgencies, under their medical director's supervision, are responsible for the proper use, upkeep, reporting and security of their controlled substances.

Sources

  • Centers for Disease Control and Prevention, Public Health Law Program, "Protecting Patient Access to Emergency Medications Act." https://www.cdc.gov/phlp/php/publications/protecting-patient-access-to-emergency-medications-act.html
  • Written for the Public Health Law Program by Emily Sargent, a program intern, with Gregory Sunshine (Cherokee Nation Assurance) and Matthew Penn (Public Health Law Program). Its conclusions are the author's, not necessarily CDC's, and it is not legal advice.
  • Corrected: the original description abbreviates the act "PPEAMA"; its text uses "PPAEMA".
  • Words on this page from people and organisations outside the federal government are paraphrased; rewritten in hubnx's own words.
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Licence: CC0 1.0 (public domain) · Adapted from www.cdc.gov

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