Literature Review

Answer

Chapter 2:

Literature Review

Introduction

This chapter examines the existing literature on Naloxone accessibility in emergency situations involving opioid overdose. In line with the research objectives and hypothesis, this chapter will evaluate the impacts of training levels, the Scope of Practice, and policies and protocols in accessing and administering Naloxone. Also included in this chapter is the background of the study and the gap which informs the research questions and objectives. To perform a comprehensive literature review, sources were obtained from various databases including PubMed, CINAHL, Cochrane, and EMBASE. Google Scholar was also used to locate relevant materials. A review of the sources was done in relation to the topic. Notably, the studies were published within the last ten years.

Background

The opioid epidemic is a major public health concern globally. According to Cash et al. (2018), opioid overdose has significantly increased since the 2000s. In most analyses, the key focus has been on deaths due to opioids and misuse of opioids. Also, the cooperation between the local and state stakeholders has been a major driver in the development of comprehensive and rapid surveillance systems on opioid use, as well the development and implementation of intervention strategies such as public education on the effects of these drugs to reduce the high mortality rate. The administration of Naloxone is an effective intervention to reduce opioid-related overdose deaths. Documentation of Naloxone administration by emergency medical services in the prehospital care record is an essential source of surveillance data on opioid overdose. These data suggest that Naloxone administration by emergency medical services (EMS) has increased significantly in recent years. In one study, Cash et al. (2018a) point out that in the 2012-2016 period, the EMS Naloxone administrations rose from 573.6 to 1004.4 administrations per 100,000 EMS events Chou et al. (2017) confirm that there is a rise in opioid overdose and administration of Naloxone. According to the Centers for Disease Control and Prevention (CDC) (2018b), there were approximately 70,237 deaths as a result of opioid overdose in 2017. The CDC further documents that the rate of Naloxone administration between 2012 and 2016 has increased by 75%. The use of Naloxone, which can be administered in various ways including intramuscular, intravenous, subcutaneous, and sublingual, was approved by the United States Food and Drug Administration (FDA) in 1971 (Singer, 2018). Notably, the FDA has recently supported the wide access to Naloxone.

Early intervention during an overdose incident is important in preventing complications and deaths. EMS personnel are widely involved in managing opioid overdoses (CDC, 2018a). In a study conducted by Samuels (2014), it was established that EMS professionals employ different approaches during opioid overdose incidents, including managing the airway and continuous monitoring of the vital signs alongside administering Naloxone. Cressman, Mazereeuw, Guan, Jia, Gomes, and Juurlink (2017) outline the use of Naloxone and note that it is an antagonist that functions after a few minutes to reverse the central nervous system depression and respiratory challenges related with the overdose. Different groups are at risk of opioid overdose including those using the drugs illegally and those receiving them as prescriptions for pain management. The common factor regarding both groups is the high risk of overdose and related deaths. The CDC in 2016 developed guidelines on opioid prescribing for intense pain. Among the recommendations was the administration of Naloxone as the co-receipt daily if the patient is taking more than 50 mg of morphine (Cressman et al., 2017). This is aimed at controlling the effects of high opioid dosage among these patients which demonstrates the importance of enhancing access to Naloxone. Despite the demonstrated effectiveness of Naloxone, its administration faces several challenges with the most primary being limited access by prehospital providers.

Access Barriers to Naloxone

                The increase in opioid-related deaths globally has prompted the U.S government to develop effective mitigation strategies. For instance, Faul et al. (2015) noted that in 2011, there were 16,917 deaths related to pain relievers and another 4,397 associated with heroin. The development and implementation of mitigation strategies to address this high mortality are centered on primary strategies which entail the first responder in overdose cases. These interventions include administration of drugs to counter the overdose effect and training the community on the effects of opioids. The augmentation and strengthening of these interventions consider the emergency medical services at the center since they are usually the first to arrive at the scene of an overdose. Other than the support measures which include ensuring sufficient circulation and airway support, the majority of the EMS personnel have antagonist drugs such as Naloxone which can be used to manage the overdose. Faul et al. (2017) argue that in most prehospital settings that involve opioid overdose, Naloxone has been the most common drug used to counter the adverse health effects. The use of this drug in the prehospital setting is not only a routine practice for the authorized personnel such as paramedics, but is preferred due to fewer side effects and the lack of abuse potential as compared to Naltrexone and Nalmefene (Faul et al., 2015; Desert Hope, 2018).

Location Barrier

                One of the main challenges is access to the drug in rural settings. During the 1999-2004 period, there was an increase in overdose mortality, especially in the non-metropolitan rural areas (Faul et al., 2017). With rural emergency medical services covering more than 20% of the total population and more than 80% of the US land mass, the primary intervention of using Naloxone faces a major challenge related to the response time and shortage of authorized EMS personnel to administer Naloxone (Zhang, Marchand, Sullivan, Klass, & Wagner, 2018). This often results in delayed administration of Naloxone causing opioid-related complications, or in worst cases, death. Also, Naloxone administration in rural settings may be challenged by poor public access to emergency services and lack of regionalized systems such as trauma (Chou et al., 2017). As noted by Zhang et al. (2018), besides the limited number of EMS providers who can administer Naloxone, there may be geographic barriers and/or inadequate medical facilities and equipment to address emergency situations. The accessibility issue is further explained by the communication and transport challenges. In rural areas, poor communication emanating from lack of developed information and communication technology (ICT) infrastructure is a major hindrance for an opioid overdose individual to contact the EMS personnel. Considering the transport issue, it is reflected in poor roads and long distances that the EMS professionals have to cover to access the overdosed individual.

Level of Training and Scope of Practice

The established Scope of Practice guides the EMS administration of drugs and other pharmaceutical agents. Faul et al. (2017) note that every county is allowed to develop their own protocols and guidance although most states will follow a standard model where there are limits to the Scope of Practice at every credential level. Also, the certification to provide emergency medical attention to overdose patients is limited according to the level of training. For instance, the emergency medical technical-basic (EMT-basic) is limited to providing aspirin and glucose orally and assisting the patients to take their prescribed medication (Cressman et al., 2017). The administration of Naloxone, on the other hand, is allowed according to the state’s medical policies and regulations. According to the Agency for Healthcare Research and Quality (AHRQ), the administration of Naloxone is not within the EMS National Scope of Practice for the Emergency Medical Responders (EMRs) and EMTs (ANRQ, 2017). However, all states permit paramedics while 48 states permit the administration of Naloxone by intermediate life support personnel. The impact of this issue in mitigating opioid-related deaths is centred on the basic life support personnel being the first responders to the opioid overdose situation. This scenario is adverse in the rural setting as fewer EMS personnel receive advanced training. In addition, inadequate resources and equipment such as airway support also challenge effective overdose management (Goldberg et al., 2018). Coupled with the event location, the limited resources and personnel shortage in rural settings have significant impact on the administration of the drug.

The Scope of Practice model which is widely used across the different states contributes to the hindrance of Naloxone administration. In a systematic review by Davis et al. (2014) aimed at determining the authority of various EMS personnel levels in administering Naloxone in cases of opioid overdose, it was established that in most states, the basic life support (BLS) professionals are not allowed to administer the drug. This impedes the emergency response in addressing the overdose condition. These authors further noted that opioid-related emergency situations could be addressed effectively through providing the antagonist within the right time. The advisory EMS Scope of Practice model which was promulgated in 2007 outlines the different levels of practice which determine their permission to administer Naloxone (Cressman et al., 2017). This Scope of Practice was updated in 2018 by the National Association of State EMS Officials (NASEMO), the Health Resources & Services Administration (HRSA) and the National Highway Traffic Safety Administration (NHTSA). Notably, there are four main levels of EMS professionals based on their degree of training. These include the paramedic, advanced emergency medical technicians (AEMT), emergency medical technician (EMT), and emergency medical responder (EMR).

Training varies by level, and each has a distinct permission and roles during an opioid overdose situation. The EMRs and EMTs are classified as basic life support (BLS) while the AEMTs are described as intermediate life support (ILS). The paramedics are defined as advanced life support (ALS) professionals who are authorized to provide the most specialized care and administer different medications including Naloxone (Cressman et al., 2017). For the EMR who has successfully completed the accredited EMR training program, s/he is permitted to deliver lifesaving care to patients who are in critical condition through basic interventions that use minimal equipment (EMS NHTSA, 2007). The EMT is permitted to provide basic interventions while using equipment typically found in an ambulance. This category of EMS personnel ensures the patient is delivered to the emergency healthcare unit for further services. The AEMT provides advanced emergency medical care for critical patients. They are also involved in patient transportation for advanced medical care. Paramedics are described as allied healthcare professionals whose focus is to provide advanced medical care in emergency situations. These professionals are part of the comprehensive EMS system. Their education is from an accredited program for paramedics at the associates, certificate, or bachelor’s degree level (EMS NHTSA, 2007).

The Scope of Practice model outlines the least psychomotor skills which every level of personnel should possess. For ALS and ILS personnel, administering the narcotic antagonist is a fundamental competency, but not for BLS. Notably, the model does not outline the route of administration of the opioid antagonist for the ALS and ILS (Mitchell et al., 2017). However, the minimum skills for the BLS personnel are aiding patients in taking prescribed medication and oral intake of aspirin and glucose although this depends on the state. They are also permitted to carry Cardiopulmonary Resuscitation (CPR) or Automated External Defibrillator (AED), backboards, and oxygen. The relationship between the level of practice and barriers to administering Naloxone is further manifested in the distribution of EMS professionals by the level of certification. According to Samuels et al. (2014), the number of BLS providers is higher than that of the ILS and ALS combined. Davis et al. (2014) note the ratio of BLS with ALS and ILS combined is 3:1. In rural settings, BLS providers are usually the most available. This is based on the high volunteering rate in the rural settings which March and Ferguson (2013) approximate as 75%. However, the level of volunteering varies in different states. The opioid overdose patients in this regard are left without specialized care until they reach the hospital.

The accessibility of Naloxone is a major challenge even to pharmacies. In North America, the high mortality rate from opioid overdose is partly attributed to the liberal prescribing of drugs for pain management (Fischer, Rehm, & Tyndall, 2016). Previous strategies to address this issue have focused on training and educating the public regarding the drugs and the use of Naloxone. In a survey conducted in Canada by Cressman et al. (2017) on the availability and access to Naloxone in pharmacies, it was established that majority of the pharmacies do not stock the antagonist, and in those that may have accessibility to it, failed to assure on its accessibility within one week. This was due to uncertainty on when they would next stock the pharmacy with the drug. In this study, among the main recommendations was that the accessibility and administration of Naloxone should be emphasized not only to the pharmacists, but also among the emergency services providers. In relation to the CDC recommendation of Naloxone accompanying the administration of morphine that is higher than 50 mg, it is apparent that the accessibility of the drug is important enough that it should be advocated for within the community, pharmacies, and among all the emergency services providers (Cressman et al., 2017).

The accessibility and administration of Naloxone to overdose individuals during an emergency situation should not be limited to the paramedics, but extended to law enforcement (Davis et al., 2014). These authors examined the expanded access to Naloxone and noted that in the United States, the rise in opioid-related deaths could be attributed to the legally prescribed analgesic medications and increasing the number of EMS professionals who access and administer Naloxone can reduce the high mortality rate associated with opioid overdose. According to these authors, the mortality rate from prescribed opioids is high as compared to cocaine and heroin combined. A major barrier to the administration of the Naloxone is the smaller number of providers authorized to access and administer it. Essentially, emergency first responders do not have access to strategies which can be used to reverse the effects of the opioids among other sedatives (Fischer et al., 2016). In other instances, the law enforcers are the first to arrive at the emergency scene. However, this population has not undergone any training to address the situation, and thus the emergency may transform into adverse such as death (Zhang et al., 2018). Over the years, most states have moved to increase community access to Naloxone. As of 2010, approximately 200 community-based prevention programs had been dispensed (Davis et al., 2014). The impact of such extensive training is that the participants are able to reverse most of the overdose cases as noted by Rzasa Lynn and Galinkin (2018).

Policy and Protocols Related Barriers

The accessibility and administration of Naloxone are also affected by laws and policies. In 2014, approximately 160,000 Naloxone doses were administered by EMS personnel. However, Chou et al. (2017) argue that the regulations related to the administration of the drug vary by state. The laws establish whether EMS is authorized and/or mandated to administer the drug (Lutz, 2018; AHRQ, 2017). As noted by Davis et al. (2014), by November 2013, only 12 out of 53 states permitted the administration of Naloxone by EMTs while all the jurisdictions permitted the paramedic level to administer Naloxone. Cash et al. (2018), while examining the Naloxone administration frequency, noted that although there are several evidence-based practice guidelines on the administration of Naloxone, the protocols and recommendations are not clear. For instance, the administration route, dosing strategies, and required training levels for those permitted to administer the antagonist are not outlined. The systematic review by Chou et al. (2017) further revealed that not all emergency service providers are allowed to administer the drug which is a key challenge. Not only did this study recommend the expansion of EMS authorization to administer the drug but also a review of the Scope of Practice model for the necessary updates such as administration routes, dosing strategies, and level of training.

According to a systematic review conducted by Davis et al. (2014), extensive practice evidence shows that BLS and laypersons can administer Intranasal (IN) and Intramuscular (IM) Naloxone successfully. These authors further note that the differences in the allowed EMS personnel to administer Naloxone in various states reflects on the knowledge translation gap since NHTSA and states are reluctant in updating the regulations. In addition, advanced trained professionals across different realms including physicians and nurses fear losing scope by letting others in their Scope of Practice. The importance of training and permitting more EMTs to access and administer Naloxone is as described by Zhang et al. (2018) who note that this will yield more positive outcomes. These authors further note that presently, most states are passing legislation to broaden access to Naloxone by first responders which will reduce the high mortality rate related to opioids overdose. A research gap at this point is whether the access and administration of Naloxone by BLS is viable and whether excluding them will have a significant effect in addressing the opioid overdose challenge. In addition, it is important to examine how training and allowing first responders to access Naloxone will distinguish the different categories of EMS providers.

                Over the years, intervention programs aimed at reducing opioid-related deaths have focused on training family members and friends on the administration of Naloxone (Faul et al., 2017). A major concern in this case, is the understanding that Naloxone does not treat opioid addiction and that it is a motivation for individuals to continue abusing the drugs and other illegal substances (Weiner, Baker, Bernson, & Walley, 2017). Despite its credit for saving lives and reducing the mortality rate, Naloxone use has come under scrutiny for not addressing the core challenge which is an addiction. According to Faul et al. (2015), healthcare organizations and legislators are exploring steps to address this concern while improving the accessibility of Naloxone to the bystanders, friends, and families. The administration of the antagonist drug has traditionally been intramuscularly or intravenously although recent studies have shown that the nasal administration is as effective as intravenous (Zhang et al., 2018). The increased recognition of Intranasal (IN) administration route is based on its effectiveness in countering the opioid adverse effects and reducing the use of needles. IN entails giving the medication into the nose through spray or pump. In other studies, as noted by Goldberg et al. (2018), it was established that there is a significant difference in Naloxone action time to reverse opioid overdose effects during nasal and intravenous administration of Naloxone. With intramuscular injection demonstrating a high response rate of approximately 89% as espoused by Goldberg et al. (2018), it is not clear on the specific approach or administration guidelines that should be included in the legislation on the administration and accessibility of the drug.

Research Gap

                Over the last two decades, the use of prescription opioids has increased globally for pain management. However, there is a downside to this increased use which is the high mortality rate associated with abuse and overdose. Since 2000, there has been a rise in the misuse of legal opioids (Davis et al., 2014). Notably, the focus of this study is on legal drugs. Since 2010, numerous interventions have been developed and implemented such as education programs for families and bystanders on the administration of emergency services and drugs such as Naloxone to manage the respiratory depression associated with opioids abuse. A number of aspects have faulted these approaches including the level of training and Scope of Practice which outline the access and administration of Naloxone. According to Weiner et al. (2017), most case studies have proven Naloxone to be effective in reversing the effects of opioid overdose if the administration is done quickly.

Despite these interventions, the access and administration of Naloxone remain a challenge to EMS professionals resulting in high mortality rates from opioids overdose. Moreover, although families and bystanders are presently trained in the administration of Naloxone, most basic providers are not allowed to administer the drug. In addition, there is confusion on the specific policies and protocols on the administration of Naloxone such as the route and dosing strategies. Further, the approval policies and practice guidelines on the access and administration of the antagonist remains unclear in different states (Fischer et al., 2016). This study, therefore, aims at examining the barriers related to the administration of Naloxone in emergency situations. Notably, these barriers are categorized into the level of training, the Scope of Practice, policies, and protocols. In the level of training and Scope of Practice, this research will focus on reasons why BLS are not allowed to administer Naloxone, whether they can be allowed to access and administer the drug, and the level of training that they should undergo. With first responders being allowed to access and administer Naloxone, this research will also evaluate the differences between the different categories of EMS professionals.  

                In summary, this chapter examines the literature on factors hindering the access and administration of Naloxone in opioids abuse situations. Drawing from the background and discussion, it is apparent that despite Naloxone being the best antagonist for opioids overdose, its access and administration by EMS professionals is still a challenge. The Scope of Practice model for EMS professionals reveals that there are different levels of training and credentialing on the access and administration of Naloxone. The above literature analysis shows that that the BLS personnel are the highest in number, but are prohibited from accessing and administering Naloxone. Besides the location barriers where most EMS face infrastructure-based challenges, this study aims at examining the level of training, the scope of practice, policies, and protocols based hinderances in access and administration of the drug.