New law stops potential criminalization of EMS ‘standing orders’ for timely controlled-substance use

A new bipartisan law, the Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, signed by President Trump on November 17, 2017, amends the Controlled Substances Act (CSA) (P.L. 91-513) to clarify that emergency medical services (EMS) professionals (including nurses, paramedics, and emergency medical technicians) are able to continue administering controlled substances (contained in schedules II, II, IV, or V) to critical patients, such as pain narcotics and anti-seizure medications, pursuant to standing (written medical protocol) or verbal (oral directive) orders when authorized by state law (Protecting Patient Access to Emergency Medications Act of 2017, P.L. 115-83, enacted November 17, 2017).

It has been a long-standing practice for medical directors of EMS agencies to write standing orders for the administration of controlled substances by EMS professionals. As reported by Emergency Physicians Monthly, in a January 2015 meeting with the National Association of EMS Physicians (NAEMSP) Executive Committee to discuss possible EMS regulations, the Drug Enforcement Administration (DEA) stated its position that the CSA only allows for patient-specific orders for controlled substances and that it is illegal for EMS agencies to deliver any controlled substances under written medical protocols or standing orders. Therefore, absent this new legislation, it was the position of the DEA that any regulations concerning EMS agencies would be required to prohibit the continued use of standing orders for EMS professionals.

The law also allows EMS agencies the option of having a single DEA registration in each state where the EMS agency administers controlled substances, in lieu of requiring a separate registration for each location of the EMS agency within the state, as long as certain transportation, storage, re-stocking, and recordkeeping rules for controlled substances are followed by the EMS agency. The act further provides that a hospital-based EMS agency may use the DEA registration of the hospital to administer controlled substances without an additional registration of its EMS agency.

The law was introduced as H.R. 304 in the House of Representatives by Reps. Richard Hudson (R-NC) and G.K. Butterfield (D-NC). The Senate version, S. 916, was introduced by Sens. Bill Cassidy (R-La) and Michael Bennet (D-Colo). H.R. 304 initially passed the House by a vote of 404-0 on January 9, 2017. It passed the Senate, as amended, by unanimous consent, on October 24, 2017.

DEA has much to do to fully address recent GAO recommendations

Recent testimony before the Senate Judiciary Committee by Diana C. Maurer, Director of Homeland Security and Justice at the Government Accountability Office (GAO), indicated that while the Drug Enforcement Administration (DEA) has taken some steps to address 2015 GAO recommendations, it still has work to do regarding its administration of the controlled substance quota process, efforts to address controlled substance drug shortages, providing information and guidance to DEA registrants, and complying with guidelines for overseeing confidential informants.

The Controlled Substance Act (CSA) requires the DEA to set quotas that limit the amount of certain controlled substances that are available in the United States. The CSA also requires those handling controlled substances to register with the DEA. In addition, the DEA works to disrupt and dismantle major drug trafficking organizations and uses confidential informants to help facilitate its investigative efforts.

On February 2, June 25, and September 15, 2015, the GAO issued reports related to these DEA practices. In those reports, the GAO made 11 recommendations to the DEA. Maurer testified that, to date, the DEA has taken some actions to address these recommendations but has fully implemented only two of them.

Quota process

The GAO made four recommendations regarding the DEA’s administration of the controlled substance quota process: (1) strengthen its internal controls of its Year-End Reporting and Quota Management System (YERS/QMS), (2) establish performance measures related to quotas, (3) monitor and analyze YERS/QMS data, and (4) develop internal policies for processing quota applications and setting quotas.

Maurer testified that the DEA has implemented the first recommendation but has not been fully responsive to the second recommendation. She further testified that the GAO is awaiting further documentation from the DEA regarding the third and fourth recommendations and will update the status of these recommendations at that time.

The GAO also made three recommendations regarding barriers to effective coordination between the DEA and the FDA to prevent future shortages of controlled substances: (1) that the DEA and FDA promptly update the memorandum of understanding (MOU) between the two agencies; (2) that either in the MOU or a separate agreement, the DEA and the FDA specifically outline what information they will share and the time frames for sharing such information in response to a potential or existing drug shortage; and (3) that the DEA expeditiously establish formal policies and procedures to coordinate with the FDA with respect to expediting shortage-related quota applications.

Maurer testified that, in March 2015, the FDA and DEA updated the MOU; however, the second and third recommendations still remain open.

Information to DEA registrants

The GAO reported that the DEA has provided information to its registrants regarding their roles and responsibilities for preventing abuse and diversion through conferences, training, and other initiatives. The GAO also reported that the DEA provided additional resources, such as manuals for specific registrant groups and the DEA’s Know Your Customer guidance for distributors. However, Maurer testified that many registrants are not aware of these resources or they would like additional guidance, information, or communication from the DEA to better understand their roles under the CSA. The GAO recommended three actions to address registrants’ concerns.

First, the GAO recommended the DEA identify and implement means of regular, cost-effective communication with distributor, pharmacy, and practitioner registrants, such as through listservs or web-based training. As of April 2016, the DEA reported that it was in the process of developing web-based training modules for all of its registrant population, and was considering the best way to implement a listserv to disseminate information to its various registrant types. Maurer testified that the GAO plans to continue to monitor the DEA’s efforts in this area, and this recommendation remains open.

Second, to help address the concerns raised by some distributor and pharmacy registrants, the GAO recommended that the DEA solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting. Thirdly, the GAO recommended that the DEA solicit input from pharmacists, or associations representing pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly. With regards to the second and third recommendations, Maurer testified that some efforts have been make by the DEA, however, the GAO plans to continue monitoring the DEA’s efforts in these areas, and these recommendations remain open.

Confidential informants policy

The GAO reported that the DEA’s confidential informants policy required agents to consider most of the factors identified in the Attorney General’s Guidelines for conducting initial suitability reviews prior to using a person as an informant. The GAO also reported that the DEA’s policy was partially consistent with the Guidelines’ requirements to provide written instructions to an informant regarding the parameters of the authorized, but otherwise illegal, activity and to have the informant sign an acknowledgment of these instructions. Additionally, the GAO found that the DEA’s policy was consistent with the provision for revoking authorization in cases where DEA has reason to believe that an informant is not in compliance with the authorization. However, the GAO found that the DEA’s policy did not address circumstances unrelated to the informant’s conduct in which the DEA may, for legitimate reasons, be unable to comply with precautionary measures necessary for overseeing otherwise illegal activity.

In response, DEA officials told the GAO that they did not authorize informants to participate in otherwise illegal activity without agent supervision, and, therefore, this requirement would not be applicable to the DEA. In response, the GAO pointed out that the DEA’s policy did not explicitly state that direct supervision of an agent is required for all instances of an informant’s participation in otherwise illegal activity. Additionally, the GAO noted that the DEA’s policy did not require the informant to sign a written acknowledgment that the authorization had been suspended or revoked.

As a result, the GAO recommended that the DEA, with assistance and oversight from the Department of Justice (DOJ) Criminal Division, update its policy and corresponding monitoring procedures to explicitly address the Guidelines’ provisions on oversight of informants’ illegal activities. According to Maurer, the DOJ Criminal Division has reviewed a revised version of the DEA’s agents manual and has determined that the revised manual is fully consistent with the Guidelines policy regarding confidential informants. Maurer noted in her testimony that the GAO plans to review the updated DEA policy when finalized to determine if the DEA has fully implemented its recommendation.