SPECIAL CONTRIBUTION
Emergency Medical Services Naloxone Access: A National Systematic Legal Review Corey S. Davis, JD, MSPH, Jessica K. Southwell, MPH, Virginia Radford Niehaus, JD, MPH, Alexander Y. Walley, MD, MSc, and Michael W. Dailey, MD
Abstract Objectives: Fatal opioid overdose in the United States is at epidemic levels. Naloxone, an effective opioid antidote, is commonly administered by advanced emergency medical services (EMS) personnel in the prehospital setting. While states are rapidly moving to increase access to naloxone for community bystanders, the EMS system remains the primary source for out-of-hospital naloxone access. Many communities have limited advanced EMS response capability and therefore may not have prehospital access to the medication indicated for opioid overdose reversal. The goal of this research was to determine the authority of different levels of EMS personnel to administer naloxone for the reversal of opioid overdose in the United States, Guam, and Puerto Rico. Methods: The authors systematically reviewed the scope of practice of EMS personnel regarding administration of naloxone for the reversal of opioid overdose. All relevant laws, regulations, and policies from the 50 U. S. states, the District of Columbia, Guam, and Puerto Rico in effect in November 2013 were identified, reviewed, and coded to determine the authority of EMS personnel at four levels (in increasing order of training: emergency medical responders [EMRs], emergency medical technicians [EMTs], intermediate/advanced EMTs, and paramedics) to administer naloxone. Where available, protocols governing route and dose of administration were also identified and analyzed. Results: All 53 jurisdictions license or certify EMS personnel at the paramedic level, and all permit paramedics to administer naloxone. Of the 48 jurisdictions with intermediate-level EMS personnel, all but one authorized those personnel to administer naloxone as of November 2013. Twelve jurisdictions explicitly permitted EMTs and two permitted EMRs to administer naloxone. At least five jurisdictions modified law or policy to expand EMT access to naloxone in 2013. There is wide variation between states regarding EMS naloxone dosing protocol and route of administration. Conclusions: Naloxone administration is standard for paramedic and intermediate-level EMS personnel, but most states do not allow basic life support (BLS) personnel to administer this medication. Standards consistent with available medical evidence for naloxone administration, dosing, and route of administration should be implemented at each EMS level of certification. ACADEMIC EMERGENCY MEDICINE 2014;21:1173–1177 © 2014 by the Society for Academic Emergency Medicine
O
pioid overdose is at epidemic levels in the United States.1 The epidemic is largely driven by prescription opioids, which were responsible
for over 16,000 deaths in 2010.2,3 Many opioid-related deaths are the result of polydrug intoxication, and local spikes have been caused by heroin adulterated with or
From the Network for Public Health Law–Southeastern Region (CSD, VRN), Carrboro, NC; the North Carolina Institute for Public Health, Gillings School of Global Public Health, University of North Carolina at Chapel Hill (JKS), Chapel Hill, NC; the Clinical Addiction Research and Education Unit, Boston University School of Medicine (AYW), Boston, MA; and the Department of Emergency Medicine, Albany Medical Center (MWD), Albany, NY. Received March 7, 2014; revision received May 14, 2014; accepted May 29, 2014. Presented at the Society for Academic Emergency Medicine Mid-Atlantic Regional Meeting, Philadelphia, PA, February 2014; and the Society for Academic Emergency Medicine Annual Meeting, Dallas, TX, May 2014. AYW received consulting fees in 2012 from Social Sciences Innovation Corporation as part of a National Institute on Drug Abuse Small Business Innovation Research R43 grant (1R43DA033746–J. Simmons, PI) to develop an electronic overdose training module for first responders. The work of CSD, VRN, and JKS was partially funded by the Robert Wood Johnson Foundation’s Network for Public Health Law program. The rest of the authors have no relevant financial disclosures or conflicts of interest. Supervising Editor: Gary M. Gaddis, MD, PhD. Address for correspondence and reprints: Corey S. Davis, JD, MSPH; e-mail:
[email protected].
© 2014 by the Society for Academic Emergency Medicine doi: 10.1111/acem.12485
ISSN 1069-6563 PII ISSN 1069-6563583
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replaced by the much stronger opioid fentanyl.2,4–7 Hospital admissions for nonfatal overdose associated with opioids, sedatives, and tranquilizers have also increased substantially over the past decade.8 Opioid overdose is reversible through the administration of the antagonist naloxone.9,10 Efforts to increase layperson access to naloxone are expanding, with nearly 200 community-based naloxone distribution programs and over 10,000 opioid reversals reported as of 2010.11 While evaluations suggest that these programs can reduce overdose death rates in communities in which they are implemented, they cover only a small fraction of the country.11–14 Thus, emergency medical services (EMS) remain a crucial source for emergency rescue, including naloxone. An advisory National EMS Scope of Practice Model promulgated by the National Highway Traffic Safety Administration (NHTSA) in 2007 defines four levels of EMS personnel. By increasing levels of training, these are emergency medical responder (EMR), emergency medical technician (EMT), advanced emergency medical technician (AEMT), and paramedic.16 EMRs and EMTs are commonly referred to as basic life support (BLS), AEMTs or the state equivalent (older EMT-Intermediate levels) are referred to as intermediate life support (ILS), and paramedics are termed advanced life support (ALS) personnel. The national Model, which is not binding but has a strong persuasive effect, lists “minimum psychomotor skills” that personnel practicing at each level should possess. “Administration of a narcotic antagonist” is considered a necessary skill for ALS and ILS personnel, but not for BLS.16 The Model does not contain recommendations regarding route and dose of naloxone administration, but the listed minimum skills for BLS personnel are limited to assisting patients in taking their own prescribed medications and the oral administration of glucose and aspirin.16 Nationwide, BLS personnel outnumber ALS and ILS personnel combined by a factor of approximately three to one.17 In many rural areas, BLS providers may be the only EMS personnel available, leaving opioid overdose patients without access to the medication indicated for their condition until they reach the hospital.16,18 Therefore, in the midst of an opioid overdose epidemic, training and authorizing BLS personnel to administer naloxone is likely to be an efficacious and cost-effective method of reducing opioid overdose deaths. No current compendium of EMS protocols, policies, and procedures in the area of prehospital administration exists. The data presented here may be useful to inform discussion of the Model and state protocols and which might warrant updating and revision. We sought to answer two questions: 1) which levels of EMS personnel, if any, are permitted to administer naloxone and 2) if applicable in a given state, what is the protocol governing route and dose of administration? METHODS Study Design and Setting A public health law research model was used to determine EMS scope of practice regarding nalox-
Davis et al. • EMS NALOXONE ACCESS
one administration as of November 1, 2013, for all 50 states; Washington, DC; Guam; and Puerto Rico.19 The research was deemed exempt by the relevant institutional review board. Study Protocol Sequential searches of the Westlaw state law database and regulatory database were conducted by trained legal researchers (VRN, CSD). Because in most states EMS scope of practice is set at the subregulatory level, each state’s EMS agency website was also searched by a trained public health researcher (JP) for relevant rules, policies, and practice documents. Search terms included “emergency medical,” “scope of practice,” “naloxone,” “overdose,” “opioid antagonist,” and “poisoning.” In two states (Montana and South Dakota), the current scope of practice could not be determined using these methods, and the state EMS agency was contacted to procure relevant documents. Collected data are available in their entirety in Data Supplement S1 (available as supporting information in the online version of this paper). Data Analysis Simple descriptive statistics are reported. RESULTS Authority to Administer Naloxone As of November 1, 2013, all 53 jurisdictions certified EMS personnel at the paramedic level, and all permitted paramedics to administer naloxone. Forty-eight jurisdictions certified ILS personnel, and all but one of these (98%) jurisdictions (Mississippi) authorized ILS personnel to administer naloxone. As of November 1, 2013, a total of 12 of the 53 jurisdictions (23%; California, Colorado, District of Columbia, Massachusetts, Maryland, New Mexico, North Carolina, Ohio, Oklahoma, Rhode Island, Virginia, and Vermont) explicitly permitted EMTs to administer naloxone (Figure 1). Additionally, New York, Wisconsin, and Delaware permitted EMTs participating in approved pilot programs to administer the medication. New York closed its pilot project and modified its scope of practice in December 2013 (outside the scope of this study) to permit all trained EMTs to administer naloxone. At least four other states (Massachusetts, Maryland, Ohio, and Oklahoma) extended naloxone access to EMTs in 2013. As of November 2013, only two states (Maryland and Ohio) explicitly permitted EMRs to administer naloxone (New York added EMRs in December 2013). In most states local EMS medical directors may not authorize EMS personnel to practice beyond the scope set out in state regulation or policy. However, a few states do permit agency medical directors to authorize trained EMS personnel acting under their direction to practice beyond the statewide scope, and at least one agency (Peoria, IL) has used this authority to adopt a protocol that permits EMTs to administer naloxone. Variability in Administration Protocol Some dosing protocols or guidelines are set at the state level, while others are set by regional or local authori-
ACADEMIC EMERGENCY MEDICINE • October 2014, Vol. 21, No. 10 • www.aemj.org
Table 1 Permitted Route of Naloxone Administration by Provider Level in Jurisdictions With Statewide Protocols EMT Total number of jurisdictions Number (%) authorizing IV naloxone Number (%) authorizing IM naloxone Number (%) authorizing IN naloxone
Intermediate
Paramedic
8
28
32
0 (0)
26 (93)
32 (100)
3 (38)
18 (64)
24 (75)
8 (100)
18 (64)
20 (63)
IM = intramuscular; IN = intranasal; IV = intravenous.
Table 2 Initial Adult IV Naloxone Dosage in Jurisdictions With Statewide Protocols (n = 32)
0.4–2
1
the intranasal (IN) route, and three via the intramuscular (IM) route (since most states permit administration by more than one route, these numbers are nonexclusive). At the intermediate level, 26 states permit intravenous (IV) administration, while 18 states permit both IM and IN administration. At the paramedic level, 32 states permit administration via the IV route, while 24 states permit IM administration, and 20 states permit IN administration (Table 1). For adult IV administration of naloxone for opioid overdose, 17 states (53%) permit the responding EMS provider to select the appropriate initial dose in the range of 0.4 to 2 mg. One state (3%) specifies an initial IV dose of 1 mg, 12 states (38%) specify an initial dose of 2 mg, and one state (3%) specifies an initial IV dose of 2 to 4 mg (Table 2). Some state protocols vary dosage based on patient presentation or mode of administration, while others specify a single dose for all indications and routes of administration. DISCUSSION
Dosage (mg) 0.1–2
1175
2
2–4
Number 1 (3%) 17 (53%) 1 (3%) 12 (38%) 1 (3%) % of jurisdictions
ties. We found 32 states that maintain statewide protocols or guidelines governing EMS naloxone dosing. Our research confirmed the wide variability in naloxone dosing protocols that has previously been reported.20 We also discovered wide variation in the route by which naloxone is permitted to be administered between states and provider levels. At the EMT level, eight of 32 states with statewide protocols permit EMTs to administer the medication via
This research shows that, despite extensive practice evidence that laypersons and BLS personnel can successfully administer IM and IN naloxone, only 13 states permit EMTs and only three permit EMRs to administer the medication. This disconnect may reflect a gap in knowledge translation, as states and NHTSA have been slow to update regulations and the EMS Scope of Practice Model16 as the evidence base that BLS providers can administer naloxone has grown.21–25 Nineteen states and the District of Columbia have moved to increase community naloxone access by modifying state laws to permit lay people with little or no training to administer naloxone to overdose victims,26,27 and the FDA has recently approved a naloxone autoinjector explicitly for use by laypeople.15 The Centers for Disease Control and Prevention recently reported that
Figure 1. EMS personnel authorized to administer naloxone, by state.
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as of 2010, laypeople had successfully used naloxone to reverse overdose in more than 10,000 cases.11,28 Law enforcement officers in at least 10 states (Massachusetts, Michigan, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Rhode Island, and Vermont) carry or have announced plans to carry naloxone for emergency prehospital administration (unpublished data on file with the authors), with promising initial results.29 This practice evidence, combined with the fact that 12 states permit EMTs to administer naloxone, strongly suggests that naloxone administration is well within the capability of trained BLS personnel. We also discovered wide variations in naloxone dosing protocols and permitted routes of administration between jurisdictions. IN naloxone has been shown to be similarly efficacious as IV administration in the prehospital setting, but there is little consensus among states regarding route of administration.24,30,31 It is possible that some jurisdictions may currently recommend or require initial naloxone doses that are likely to precipitate withdrawal, and some protocols may be insufficient to counteract the effects of high dose extended release prescription analgesics.32,33 The wide variations in both dosing and route of administration suggest the need for evidence-based research on naloxone dosing in real-world settings. The National Highway Traffic Safety Administration is currently developing a set of evidence-based practices to inform changes in the voluntary national Scope of Practice Model, and many states are adapting their protocols to conform to the Model.34 The ongoing opioid overdose epidemic, coupled with increasing evidence that naloxone can be successfully administered by laypeople, nonmedical first responders, and BLS providers suggests that the revised Model should address this gap in knowledge translation by including administration of naloxone as a minimum psychomotor skill for BLS providers and that states should modify regulations or policies to permit such administration. LIMITATIONS This study was limited to a review of statutes, regulations, and published subregulatory documents of jurisdiction-level policies and procedures. Many states permit local or regional EMS medical directors to adopt policies that are more restrictive than that authorized at the state level, and a few permit medical directors to exceed that scope in certain instances. Therefore, it is possible that in an unquantified number of jurisdictions, the practice of naloxone administration may deviate from that contained in the documents analyzed in this study. CONCLUSIONS While naloxone is the standard care for advanced life support and intermediate life support EMS personnel, few states permit its use at the basic life support level. We recommend that National Highway Traffic Safety Administration update the national Model Scope of Practice to include the administration of naloxone as a minimum psychomotor skill for basic life support
Davis et al. • EMS NALOXONE ACCESS
personnel and that all states, territories, and the District of Columbia permit all properly trained EMS personnel to administer the drug under medical oversight. We also recommend research to determine appropriate standard EMS naloxone dosing and administration protocols. The authors thank Colleen Healy, JD, and Christine Kearsley, JD, MSPH, for research assistance.
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