Chapter 35 - Dispensing of Naloxone to First Responders and Community Representatives

3-35.1  INTRODUCTION

1. Purpose.  To establish requirements for the development of local policies and procedures for Indian Health Service (IHS) operated pharmacies to provide naloxone to first responders and community representatives serving in Tribal communities.
2. Background.  Expanded access to naloxone, the opioid overdose reversal agent, is an essential element of the IHS strategy to reduce overdose mortality associated with opioid use disorder. Policies and procedures for training, prescribing, product selection, and dispensing may be tailored to meet specific needs at the local level but must have core elements in place as described in this document.
3. Scope.  This policy pertains to the IHS direct service facilities and to prescribers and dispensers at these facilities. Although naloxone, in this policy, is intended to benefit those eligible for IHS services, it may also be used for the benefit of others in emergency situations and for public health purposes, in accordance with 25 U.S.C. § 1680c(d). The IHS will furnish the non-prescription naloxone formulation where indicated and where appropriate. The dispensing of naloxone will follow the requirements of this chapter.
   
   It is noted that pharmacists acting within the scope of their federal practice are not subject to state laws. However, if a pharmacist holds licensure in a state that prohibits dispensing naloxone to a third party, such as law enforcement officers, the pharmacist may refer to another pharmacist or provider within the facility to dispense.
4. Definitions.
   1. First Responders. . A person who is designated to immediately respond to an emergency and is trained to administer naloxone per product instructions. First responders may include law enforcement officers, fire department and emergency medical workers, community representatives (including community members), or volunteers (including employees who are designated to immediately respond in an emergency in a variety of work settings such as schools, businesses, or other places where people gather).
   2. Medical Control Provider (MCP).  The assigned local licensed medical provider, permitted within the federal scope of practice, to monitor the prescribing and furnishing of naloxone to first responders at each IHS facility. This can be a provider such as the Clinical Director or Area Chief Medical Officer.
   3. Naloxone.  An opioid antagonist that can temporarily reverse the effects of an opioid overdose and prevent death.
   4. Opioid.  A substance with opioid receptor agonist activity, that includes but is not limited to, heroin, morphine, codeine, oxycodone, hydrocodone, fentanyl, hydromorphone, oxymorphone, and methadone.
   5. Opioid Overdose. An acute condition occurs when an excessive amount of opioid is swallowed, inhaled, injected, or absorbed through the skin, intentionally or unintentionally, leading to respiratory depression and possibly death.
   6. Standing Order.  A policy signed by the MCP describing the parameters under which pharmacists may dispense or furnish naloxone to first responders and community representatives for the treatment of suspected opioid overdoses to prevent death. (See Manual Exhibit 3-35-B)

3-35.2 REQUIREMENTS FOR LOCAL POLICIES AND PROCEDURES

1. Standing Order.
   1. All facilities will assign an MCP who will establish a standing order for dispensing prescription formulations of naloxone through the pharmacy to first responders and community representatives.
   2. The approved standing order will be routed to the facility Pharmacy Director where it will be maintained on file at the dispensing pharmacy.
   3. The naloxone standing order will be reviewed, at least annually, to ensure that it meets the local needs and does not require modifications.
   4. Pharmacists will manage and dispense prescription formulations of naloxone to first responders (following above definitions) or community representatives serving in Tribal communities, per the standing order. The IHS facilities may also provide non-prescription formulations of naloxone where indicated and where appropriate, referring to local policy and procedure.
   5. If there is not a pharmacist on site, a licensed independent medical practitioner may fulfill this duty.
   6. Pharmacists may dispense naloxone or supplies to replace used, damaged, or expired products.
2. Training.
   1. Facilities may develop and conduct local training and certification for first responders and community representatives or refer to outside/third-party training, based upon the approval of the MCP.
   2. Pharmacists may conduct training when dispensing naloxone upon end-user request.
   3. Dispensing Naloxone. The facility will maintain a consolidated log identifying transactions resulting in the dispensing of naloxone to first responders and community representatives pursuant to the facility standing order and/or local policies and procedures. The log will include date, training verification, number of naloxone kits provided, lot number of naloxone, and reason code. (See Manual Exhibit 3-35-A).
3. Instructions for First Responders and Community Representatives..  Pharmacists may instruct recipients to:
   1. Store naloxone out of direct light and keep it at room temperature (between 59°F and 86°F) or as directed by FDA-approved labeling;
   2. Complete a visual inspection of naloxone and check for expiration date prior to each shift, as applicable, and immediately before use;
   3. Replace expired or damaged naloxone at an IHS pharmacy; and;
   4. Return to the IHS pharmacy for a refill if the naloxone is used in an incident.
4. Reporting and Data Collection.
   1. The Naloxone Dispensing Log will be collected and stored by the issuing IHS pharmacy for three years.
   2. Sites are encouraged to evaluate logs for continuous quality assurance and to utilize available local metrics to inform public health interventions.