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 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. Authorities.
   1. Indian Health Care Improvement Act, 25 United States Code (U.S.C.) § 1601 et seq., as amended
   2. Snyder Act, 25 U.S.C. § 13
   3. Transfer Act, 42 U.S.C. § 2001 et seq.
4. Scope.  This policy pertains to the IHS direct service 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 appropriate. The dispensing of prescription 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.
5. 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, monitors 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. Pharmacy Staff.  Includes all licensed pharmacists and pharmacy technicians working under such a position description (0660, 0661 series) as specified by the Office of Personnel Management.
   4. Naloxone.  An opioid antagonist that can temporarily reverse the effects of an opioid overdose and prevent death.
   5. 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.
   6. 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.
   7. Over-the-Counter.  Products that do not require a prescription or license for purchase or dispensing.
   8. Standing Order.  A policy signed by the MCP describing the parameters under which pharmacy staff 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  RESPONSIBILITIES

1. Director, IHS.  The Director, IHS, will support and promote the implementation of this policy.
2. Chief Medical Officer, IHS.  The Chief Medical Officer (CMO), IHS, is administratively responsible for the oversight of this policy.
3. Deputy Director(s) for Field Operations, IHS.  The Deputy Director(s) for Field Operations (DDFO), IHS, are responsible for ensuring this policy is supported and implemented.
4. Area Director.  Each Area Director is responsible for:
   1. Ensuring that administrative support and necessary resources are available at IHS pharmacies in his/her respective Areas to implement this policy.
   2. Ensuring that this policy is fully implemented; and
   3. Ensuring all policies must be developed and maintained consistent with the requirements listed in the Indian Health Manual (IHM) 1-1. The intent here is to ensure that policies developed at the Service Unit (SU) are developed consistent with requirements listed in IHM 1-1.
5. Chief Executive Officer.  The Chief Executive Officer will ensure:
   1. Naloxone is available to patients and first responders through the pharmacy.
   2. Staff are available to distribute naloxone on behalf of any employee who objects pursuant to applicable Federal conscience requirements; and
   3. Ensure policies developed within their respective SU regarding naloxone will be consistent with IHM 3-7, “Pharmacy.”
6. Clinical Director.  The Clinical Director will ensure:
   1. Naloxone is included on local formularies; and
   2. Policies or procedures developed in the SUs support the distribution of naloxone.
7. Pharmacy Director.  The Pharmacy Director is responsible for developing and updating local policies and procedures regarding naloxone distribution at least annually.
8. Pharmacy Staff.  The pharmacy staff will ensure patients are provided with naloxone and training when requested.

3-35.3 REQUIREMENTS FOR LOCAL POLICIES AND PROCEDURES

1. Standing Order: Prescription Products..
   1. All IHS 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's 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. Pharmacy staff will manage and dispense formulations of naloxone to first responders (following the above definitions) or community representatives serving in Tribal communities, per the standing order.
   5. Pharmacy staff are permitted to dispense naloxone or supplies to replace used, damaged, or expired products.
2. Over-the-Counter Products.  IHS facilities are permitted to provide non-prescription formulations of naloxone as consistent with local policy and procedure.
3. Training.
   1. Facilities may develop and conduct local training and certification for first responders and community representatives or refer to outside/third-party training.
   2. Pharmacy staff may conduct training when providing naloxone upon end-user request.
   3. Distributing Naloxone. The facility will maintain a consolidated log identifying transactions resulting in the provision of naloxone to first responders and community representatives pursuant to the facility's 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).
4. Instructions for First Responders and Community Representatives .
   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 the 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 replacement if the naloxone is used in an incident.
5. Reporting and Data Collection.
   1. The Naloxone Consolidated Log will be collected and stored by the issuing IHS pharmacy for three years and follow the IHS record retention schedule.
   2. Sites are encouraged to evaluate logs for continuous quality assurance and to utilize available local metrics to inform public health interventions.