Training & User Populations

OIRD can develop gradually or suddenly into a life-threatening emergency which may be fatal in a matter of minutes. During this situation an individual equipped with naloxone can use the product to quickly deliver a potentially life-saving dose of parenteral naloxone. The naloxone auto-injector includes labeling on the device itself as well as an accompanying User Information leaflet. Moreover, a trainer device is included in each package so that a new user can practice the proper steps for using the auto-injector and train others on how to properly administer the product given that most patients are unresponsive during an opioid emergency requiring intervention from another individual such as a family member or other caregiver. The trainer for practice is similar in look and feel to the actual auto-injector device but does not contain a needle, the drug, or the activation mechanism for drug delivery. However, the trainer allows the user to practice the primary use tasks including removal of the outer case, the red safety guard, actuation of the black base, and become familiar with the audible prompts. In addition, the forces in the trainer were designed to mimic the forces used in the actual device in order to further facilitate correct use (e.g. safety guard removal force). The batteries in the trainer allow for repeated use once per day for several years if required. Of course, it is possible that situations could arise in which an individual with little or no training might have to use the auto-injector. For that reason the device and its user interface were specifically designed, validated, and approved to be used quickly by laypersons even without training.

There are three main types of users of “take-home” naloxone. The first are caregivers to patients at increased risk for an opioid overdose emergency; these caregivers would be most likely to witness an opioid emergency in a home setting. While caregivers should be trained in the use of a naloxone product, it is nevertheless possible that an untrained family member might have to deliver the naloxone dose. A key concern in this scenario is that family members need to be able to locate the naloxone product quickly and use it correctly during an emergency. The next scenario involves a secondary caregiver, such as a coworker or friend. Ideally, secondary caregivers would receive training, but this may not always be the case; secondary caregivers may be more prone to getting flustered or overwhelmed by the emergency situation than primary caregivers. As a result, a product must be readily available and easy to understand, even if the user has not been trained recently or not trained at all. The third scenario involves a layperson who encounters a potential opioid overdose and is able to rapidly assess and respond to the emergency. If the layperson is a peer or drug user, he or she may have naloxone available or know to search for a naloxone product on the person. If the layperson is a random bystander, much depends on his or her ability to interpret the situation and search for the naloxone product. In the latter scenario, the layperson may fail to know about naloxone, and even if finding a product, may panic and not comprehend its use. However, for each of the above scenarios the naloxone auto-injector was specifically designed to be portable so that the product would be available on the patient or readily available for a caregiver in case of an opioid overdose emergency, and intuitive so that even if an untrained person finds the auto-injector, he or she would be able to use it properly and quickly. In addition, each naloxone auto-injector carton comes with two active devices so that multiple doses are available if required. The naloxone auto-injector can be used at most locations including home, work, restaurants, bars, outdoors, schools, on airplanes or other modes of transportation, at public gatherings such as concerts, and in places of entertainment. The naloxone auto-injector is not suitable for use in extreme environments, such as underwater or when exposed to extremely hot or cold temperatures for extended periods of time.