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

Part 3 - Professional Services

Chapter 35 – DISPENSING OF NALOXONE TO FIRST RESPONDERS AND COMMUNITY REPRESENTATIVES

Title Section
Introduction 3-35.1
Purpose 3-35.1A
Background 3-35.1B
Scope 3-35.1C
Definitions 3-35.1D
Requirements for Local Policies and Procedures 3-35.2
Standing Order 3-35.2A
Training 3-35.2B
Instructions for First Responders 3-35.2C
Reporting and Data Collection 3-35.2D
Exhibit Description
Manual Exhibit 3-35-A First Responder Naloxone Program Acquisition Form
Manual Exhibit 3-35-B First Responder Naloxone Program Standing Order

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 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, 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 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 national agreement between BIA and IHS applies to the dispensing of naloxone to BIA first responders.
  4. It will be 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.
  5. Definitions.
    1. First Responders. A person who is designated to immediately respond to an emergency and may include law enforcement officers, fire department and Emergency Medical Workers, community representatives, or volunteers.
    2. Medical Control Provider (MCP).  The assigned local licensed medical provider, permitted within the federal scope of practice, to monitor the prescribing 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.  A prescription 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 (Oxycontin®), hydrocodone (Vicodin®), fentanyl (Duragesic®), hydromorphone (Dilaudid®), oxymorphone (Opana®), and methadone.
    5. Opioid Overdose.  An acute condition 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. Opioid Overdose Toolkit.  A kit that includes two doses of a naloxone product indicated for reversal of opioid overdose with instructions.
    7. Standing Order.  A policy signed by the MCP describing the parameters under which pharmacists may dispense naloxone to first responders 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 naloxone through the pharmacy to first responders.
    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 Opioid Overdose Toolkits to trained first responders serving in tribal communities, per the standing order.
    5. If there is not a pharmacist on site, a designated licensed independent medical practitioner may fulfill this duty.
    6. Pharmacists may dispense naloxone or supplies to replace used, damaged, or expired materials to maintain the Opioid Overdose Kits per the standing order.
  2. Training.
    1. Facilities may develop local training and certification for first responders or refer to outside/third party training, based upon the approval of the MCP.
    2. Pharmacists will ensure that each first responder receiving an Opioid Overdose Kit has completed naloxone and opioid overdose assessment training prior to dispensing naloxone.
    3. Dispensing Naloxone. The first responder and pharmacist will sign the Naloxone Acquisition Form acknowledging the pharmacist is dispensing naloxone under the standing order for initial and reissuance prescriptions. A paper copy of the form will be kept on file at the pharmacy for three years. (See Manual Exhibit 3-35-A).
  3. Instructions for First Responders.  Pharmacists will instruct first responders to:
    1. Store naloxone out of direct light and keep at room temperature (between 59°F and 86°F) or as directed by FDA-approved labeling;
    2. Complete a visual inspection of the Opioid Overdose kit and check for expiration date prior to each shift;
    3. Replace expired or damaged naloxone at an IHS pharmacy; and;
    4. Return to the pharmacy for a refill if the Opioid Overdose Kit is used in an incident.
  4. Reporting and Data Collection.
    1. The Naloxone Acquisition Forms will be collected and stored by the issuing IHS pharmacy for three years.
    2. Sites are encouraged to evaluate acquisition forms for continuous quality assurance and to utilize available local metrics to inform public health interventions.