Naloxone Resource Guide: Setting up a Naloxone Distribution Program

NALOXONE RESOURCE GUIDE

Harm Reduction and Overdose Prevention Services

February 2024 I Version 2.0

Purpose

This guide is designed for organizations to set up a naloxone distribution program and to facilitate access to prescription naloxone. Overdose prevention work can be feasibly integrated into other community- based services and programs that work with individuals directly or indirectly at risk of an overdose. This guide will provide those organizations with the knowledge and tools on how to integrate overdose prevention education and naloxone distribution into existing community-based programs to reduce the number of deaths related to opioid overdose. Additionally, this guide serves to address how and where specialized populations may access existing life-saving resources, particularly naloxone.

Intended Audience

Los Angeles County Departments, Los Angeles County contracted agencies, and Los Angeles County community-based organizations.

About Substance Use Prevention and Control (SAPC) Harm Reduction Unit

SAPC’s Harm Reduction Unit is focused on expanding access to harm reduction and overdose prevention services throughout the county. This includes Los Angeles County Department of Public Health (DPH) contracted Engagement and Overdose Prevention (EOP) Hubs (known as syringe service providers) to reduce the number of deaths related to opioid overdoses in Los Angeles (LA) County. In an effort to maximize outreach, the Harm Reduction Unit is also focused on expanding harm reduction and overdose prevention services to other community-based organizations.

Email HarmReduction@ph.lacounty.gov for additional questions related to naloxone. Submit a Presentation/Training Request for SAPC Harm Reduction Unit led trainings.

Using Naloxone to Reverse Overdose

Overdose

An overdose occurs when a toxic amount of a drug or mix of substances, either taken intentionally or by accident, overwhelms the body. An opioid overdose occurs when the level of opioids, or combination of opioids and other substances, render an individual unresponsive. Opioids slow down the central nervous system, including breathing. This occurs because opioids occupy the same receptors in the brain that signal the body to breathe. When breathing stops or slows, oxygen levels in the blood decrease and can ultimately lead to unconsciousness, coma and possibly death. Survival entirely depends on restoring

breathing and sustaining adequate oxygen levels. Overdoses are rarely instantaneous, therefore being able to recognize signs of an opioid overdose and having the adequate tools and knowledge to respond is crucial in keeping the person alive.

See Appendix A for tips on recognizing and responding to an opioid overdose.

Naloxone

Naloxone is a medication that works almost immediately to reverse opiate overdose. It is an opioid antagonist, which blocks opioids from binding to receptors in the brain and reverses the respiratory depression caused by an opioid.

Naloxone not a controlled substance. It has few known adverse effects, no potential for abuse, and can be rapidly administered through intramuscular injection or nasal spray. While most professional first responders and emergency departments are equipped with naloxone, emergency service providers may not arrive in time to revive overdose victims. Trained and equipped bystanders such as friends, family and other non-health care providers (lay people) and drug users themselves can effectively respond and reverse an opioid overdose. Given the success of bystander naloxone programs, the CDC and the World Health Organization have recommended expanding the availability of naloxone to lay people (CDPH Injury and Violence Prevention Branch, 2021).

*This guide addresses community access to naloxone in LA County; as additional opioid antagonist medications are FDA-approved to reverse overdose and available via prescription and/or community distribution, the principles described herein may be applicable community access to these additional opioid overdose reversal medications.

Laws and Regulations

In an effort to save lives, many states have implemented laws that support making naloxone more readily available for first responders and the general public. The majority of states have enacted laws to protect laypeople who administer naloxone in an emergency from civil and/or criminal liability.

The following document, provided by the Legislative Analysis and Public Policy Association (LAPPA), outlines the current status of naloxone access laws throughout the United States.

Naloxone Access: Summary of State Laws (LAPPA) 2023

Additional information pertaining to California state laws may be found in Appendix B.

Naloxone Distribution Program (NDP):

The Naloxone Distribution Project (NDP) is administered by the Department of Health Care Services (DHCS) to combat opioid overdose-related deaths throughout California. The NDP aims to reduce opioid overdose deaths through the provision of naloxone at no cost to the receiving organization.

Through the NDP, qualified entities can request naloxone from DHCS and have it directly shipped to their address at no cost.

To learn more about the NDP, please visit the California MAT Expansion website.

To learn more about ordering naloxone through the NDP, please visit the Naloxone Distribution Project website.

NDP Eligible Organizations

DHCS provides naloxone to entities eligible to administer or distribute naloxone through a California Public Health standing order at no cost to the eligible organization. Eligible organizations include:

• Community organizations
• County health agencies
• Community clinics or federally qualified health centers
• Emergency departments or hospitals
• Emergency medical services
• Fire authorities
• First responders
• Law enforcement, courts, and criminal justice partners
• Libraries
• Local city agencies
• Organizations that provide services to unhoused individuals/community
• Religious organizations
• Schools and universities
• Substance use recovery facilities
• Veteran organizations
• Tribal entities

If you have a question about whether your organization is eligible to receive naloxone through the NDP, please contact naloxone@dhcs.ca.gov

The NDP is not intended to distribute directly to individuals. Some community organizations and other entities listed above may offer naloxone at low or no cost to individuals. Naloxone received through the NDP may not be resold.

Obtaining a Standing Order

The standing order was issued by the state Public Health Officer (authorized by California Civil Code Section §1714.22) to: 1) allow community organizations and other entities in California that are not currently working with a physician, to distribute naloxone to a person at risk of an opioid-related overdose or to a family member, friend, or other person in a position to assist; and 2) allow for the administration of naloxone by a family member, friend, or other person to a person experiencing or reasonably suspected of experiencing an opioid overdose.

For more information about naloxone standing orders, review this FAQ document issued by the California Department of Public Health.

A standing order is no longer required to distribute naloxone nasal spray due to the over-the counter status. All formulations and dosages of naloxone not available over-the-counter will remain available by prescription or require a standing order to distribute and administer.

If your organization does not have a standing order, you may apply for one at the California Department of Public Health’s standing order application page.

Obtaining Naloxone Nasal Spray from the CA Naloxone Distribution Program

To request naloxone, complete the online NDP application located on the DHCS website. The application includes instructions, as well as terms and conditions of participating in the NDP. In addition to filling out the application form and agreeing to the terms and conditions, organizations must also provide:

1. A copy of a valid and active business license, FEIN number or tax- exempt letter
2. If the naloxone request is for more than 48 units, the entity must provide a comprehensive summary explaining why the quantity was requested and a document of policies and procedures for naloxone distribution including: inventory and tracking of naloxone received through the program and a distribution plan for naloxone received through the program
3. Any additional supplemental documents required for your organization type (refer to the NDP homepage, or the Eligibility for the NDP section of the FAQ document, for any additional required documentation)

Submit the application and supplemental information via the online application form. Applications that fail to submit all required documentation will be deemed incomplete and may result in application denial.

Any LA County operated clinical program can apply for the DHCS NDP. However, if a clinical program is seeking naloxone, this should be in addition to prescribed naloxone for their registered patents, as to save grant-funded naloxone for communities with more tenuous access to medical care and clinical services.

Obtaining Intramuscular (Injectable) Naloxone through the CA Naloxone Distribution Program

NDP offers intramuscular (injectable) naloxone in addition to naloxone nasal spray at no cost to eligible requesting organization. Please submit separate applications for intramuscular naloxone and naloxone nasal spray formulation.

Before applying for intramuscular naloxone, please email naloxone@dhcs.ca.gov to be added to the list of entities able to receive intramuscular naloxone. This list is updated quarterly, and your organization’s name must be on it before the application can be approved.

Once you have received a confirmation that your organization has been approved to receive intramuscular naloxone, you may apply by submitting the online application form and include the following information:

1. Check intramuscular (injectable) naloxone as the requested formulation. The minimum order is 1000 vials and orders must be made in multiples of 1000. Currently there is no maximum order.
2. Standing order or physician’s prescription for naloxone
3. FEIN, business license, or tax-exempt letter
4. Comprehensive summary justifying your need, and
5. Distribution plan including policies and procedures for distribution, tracking, and inventory.

Entities receiving intramuscular naloxone must store, track, and report reversal information for NDP intramuscular naloxone separately from all other naloxone, including Narcan received through NDP. Include how you will meet this requirement in your distribution and tracking plan.

Naloxone & Overdose Prevention Training for Staff

A required component of a naloxone distribution program is ensuring those who will be potentially administering naloxone know how to use it. According to DHCS, staff distributing naloxone under the NDP are required to receive opioid overdose prevention and treatment training and are required to train individuals who receive naloxone from them. The training must include the following:

• The causes of an opioid overdose
• How to recognize an opioid overdose
• Basic mouth to mouth resuscitation
• How to contact appropriate emergency medical services by calling 911
• How to administer naloxone

The following 11-minute video provided by the California Department of Public Health (CDPH) includes all required material and is suitable training for outreach staff, program managers, and others responsible for the implementation of naloxone distribution: CDPH Administering naloxone Video

Additional trainings may be found on the CDPH naloxone Grant Program website and on the LA County Overdose Education + naloxone Distribution site.

Who Should Receive Naloxone?

Naloxone should be provided to all individuals at risk of exposure to opioids regardless of the source. The following list is criteria for consideration regarding at higher risk of overdose and who may benefit from receiving overdose prevention education and receiving naloxone.

• Illicit substance use
• Use of prescription opioids
• Treatment for a substance use disorder
• Recently released from incarceration
• Homelessness or risk of homelessness
• Anyone with relationships with individuals who meet above criteria See Appendix C for complete overdose risk checklist.

Educating Individuals at Risk for Overdose About Using Naloxone

Staff who have successfully completed approved naloxone and overdose prevention training should provide individuals overdose prevention education directly or through referral to an Overdose Educator on site.

Education for individuals receiving naloxone includes:

• When to administer naloxone.
• How to administer naloxone.
• Informing others about the medication, how to use it and where it’s kept.

These trainings may be delivered in individual or group settings and delivered live and/or via pre-recorded video which may be conducted in a variety of settings, including on the street or in a congregate setting. Video trainings about naloxone administration are available via http://www.laodprevention.org/od- prevention-videos. For more information, email HarmReducion@ph.lacounty.gov.

See Appendix D for additional information related to a naloxone distribution workflow.

Populations Prioritized for Naloxone

Naloxone for People Experiencing or at Risk for Homelessness or Incarceration (past 12 months)

An individual experiencing or has been at risk for experiencing homelessness or incarceration in the past 12 months can access tailored services at the Overdose Education Naloxone Distribution Program (OEND), operated by Los Angeles County Department of Health Services’ Office of Diversion and Reentry.

OEND has naloxone access points specifically for individuals with multiple structural comorbidities that limit access to pharmacy and health care settings where naloxone can be more appropriately accessed through an individual's Medi-Cal (or other health insurance) benefit.

DPH Programs and DPH-contracted agencies can email OEND (odprevention@dhs.lacounty.gov) to facilitate continuation of care for their individuals.

LA County Community Naloxone Access Points/Refills

To ensure coverage throughout LA County for individuals unable to access naloxone through their primary healthcare provider or via a local pharmacy, each Service Planning Area will have a dedicated Community naloxone Access Point (NAP) with weekly fixed hours where any individual may access overdose education and naloxone.

In the event that individuals use or lose naloxone and need a refill, they should be directed to one of the naloxone Access Points (NAPs), listed on the to-be-provided OEND flyer (email ODPrevention@dhs.lacounty.gov to obtain a flyer). The NAPs have designated drop-in hours during which a individual can meet with a trained community health worker to refill the naloxone supply and/or receive refresher training. If the individual’s naloxone was used to reverse an overdose, the community health worker will conduct a debrief session to discuss events surrounding the overdose reversal attempt, provide supportive counseling, and referrals to community resources as needed.

Individuals Seeking Naloxone for Themselves

For individuals seeking naloxone for themselves, naloxone can be accessed via the following:

• An individual's Medi-Cal (or other health insurance) benefit. To access this benefit, they should first try connecting to a primary care provider and requesting a prescription for naloxone.
• California also allows for third party prescribing, allowing healthcare providers to prescribe or distribute naloxone to an at-risk person’s family member, friend, or other person in a position to assist an at-risk individual in the event of opioid related overdose.
• Via a pharmacy with a pharmacist who can dispense naloxone directly without a prescription, although availability is pharmacy and pharmacist dependent. Individuals are encouraged to call their local pharmacy to confirm they currently furnish naloxone. Albertsons advertises that they will (http://drugstorenews.com/retail-news/albertsons-companies-offers-increased-access-to- naloxone) as does CVS (http://drugpolicy.org/pharmacy-naloxone-access-california).
• Over the Counter (OTC) naloxone was approved July 2023 by the U.S. Food and Drug Administration (FDA) for use without a prescription. Naloxone is available directly to consumers in places like drug stores, convenience stores, grocery stores, and gas stations, as well as online. Visit Where to Buy Narcan Nasal Spray Near Me to locate a retailer in your area.
  • The cost of nonprescription naloxone may vary depending on several factors, such as the wholesale price set by the manufacturer, the retail pricing at the pharmacy or other retail setting where the product is being sold, the state or community where an individual lives, and whether insurance will cover or offset the cost of the product. Currently, OTC naloxone is available at a cost of about $45.

Youth and Naloxone

Naloxone is FDA approved for all ages and there are no distribution restrictions based upon age. Depending on the circumstances, the youth can get naloxone prescribed to them and dispensed through a pharmacy, or contact a pharmacy where the pharmacist can dispense without a prescription (see https://drugpolicy.org/california/cvs-pharmacies-california-selling-naloxone), or visit a naloxone distribution site.

Appendix

Appendix A: Recognizing and Responding to Opioid Overdose

Step 1: Evaluate for Signs of Overdose

Look for signs of an overdose which may include:

• Discolored skin (especially in lips and/or nails)
• Small, constricted pupils
• Falling asleep or losing consciousness
• Slow, weak or no breathing
• Choking or gurgling sounds
• Cold and/or clammy skin

If an opioid overdose is suspected, stimulate the person by:

• Provide a “Sternal Rub”: Vigorously rub knuckles up and down on victim’s breastbone. This introduces a painful stimulus that will not cause damage to the person and helps assess whether the person is conscious or not.

Step 2: Call 911

Call 911 and inform emergency personnel that someone is not breathing or is unresponsive.

Step 3: Administer Naloxone

It’s important to know that naloxone has no effects if opioids are not present. If unsure, air on the side of safety and administer naloxone.

Intranasal Administration

• Tilt the victims head back
• Spray into one nostril until all the medication has been dispensed

Step 4: Provide Rescue Breathing

Rescue breathing can sustain someone until emergency personnel arrive:

• Clear the person’s airway.
• Tilt the head to open the airway by lifting the neck or chin.
• Pinch the nose shut.
• Make a seal over the mouth with your mouth.
• Give 2 rescue breaths and continue one breath every 5 seconds.

Step 5: Monitor the Person’s Response

Most individuals respond by returning to spontaneous breathing. This generally occurs within 2-3 minutes of administering naloxone. If the person is not responding give a second dose of naloxone and continue rescue breathing.

After an Overdose Reversal:

Once naloxone begins working, an individual may show signs of opioid withdrawal. These symptoms are uncomfortable, but not life threatening. After an overdose, a person should be monitored closely.

• Don’t leave the person alone, as sedation may return.
• Wait for emergency personnel to arrive.
• If possible, encourage the person to refrain from using additional opioids as the naloxone can wear off and they can experience another overdose.

Additional Resources for Responding to an Opioid Overdose

• National Harm Reduction Coalition: Responding to Opioid Overdose
• CDC The National Institute for Occupational Safety and Health (NIOSH): Responding to a Suspected Opioid Overdose

Appendix B: California Naloxone Access Laws

Naloxone Access Law

Cal. Civ. Code § 1714.22; Cal. Bus. & Prof. Code § 4052.01; 16 CCR § 1746.3

Prescribers may prescribe and give out naloxone, either directly or by standing order, to a person at risk of overdose or a family member, friend, or other person in a position to help.

If a person receives naloxone via standing order, they must complete training from an opioid overdose prevention and treatment training program.

Pharmacists may give naloxone to persons with a history of use of opioids or persons in contact with someone with a history of use of opioids without that person first getting a prescription for it as long as they follow a statewide protocol. The protocol requires the pharmacist to be trained. Before giving out naloxone, a pharmacist must provide a consultation outlined in the law.

A health care provider acting with reasonable care has civil and criminal immunity for issuing a prescription for naloxone and cannot be professionally sanctioned.

A person who gives out naloxone under a prescription or standing order is not subject to civil action, criminal prosecution, or professional review.

A person who administers naloxone and has received proper training who acts with reasonable care, in good faith, and without payment is not subject to civil action, criminal prosecution, or professional review.

Good Samaritan Law

Ark. Code. Ann. § 20-13-1701 et. seq.

A person who acts in good faith and calls for help for a drug overdose, whether for themselves or others, may not be arrested, charged, or prosecuted for possession of a controlled substance, if evidence for the offense was found as a result of calling for help.

A person who acts in good faith and calls for help for a drug overdose, whether for themselves or others, may not be penalized for a violation of restraining or protective order, pretrial release, probation, or parole, if evidence for the violation was found as a result of calling for help. These protections apply for violations based on possession of a controlled substance only.

Syringe Possession & Distribution

Cal. Health & Saf. Code 11364

Syringes are defined as paraphernalia if designed or marketed for injected substances into the body.

Cal. Health & Saf. Code 11014.5. Possession of paraphernalia is generally illegal. However, the possession of a syringe solely for personal use, if the syringe was given by a doctor, pharmacist, syringe exchange program, or any other source authorized by law, is not illegal. Beginning January 1, 2021, possession of a syringe is not a crime regardless of the source.

Delivery of paraphernalia is illegal, except as provided by law. Cal. Health & Safety Code § 11364.7. Syringe exchange is explicitly allowed by Cal. Health & Saf. § 121349(b).

Physicians and pharmacists are also allowed to give out syringes to people 18 and over without a prescription. Cal. Bus. & Prof. Code § 4145.5(b).

California Assembly Bill 635

An act to amend Section 1714.22 of the Civil Code, relating to drug overdose treatment.

Appendix C: Overdose Risk Checklist

During the last 12 months, has the individual:

• Been incarcerated?
• Used illicit substances/or non-prescribed prescription opioids?
• Used prescription opioids as directed?
• Received treatment for a substance use disorder?
• Experienced homelessness or been at risk of homelessness?

If YES to either of first two bullets and YES to at least one of the remaining bullets: Individual is at risk for opioid overdose and is potentially facing a structural barrier to medical services. Individual should may email odprevention@dhs.lacounty.gov for information on where to access naloxone.

If YES at least one of the last three bullets and NO to both of the first two bullets: Individual is at risk for opioid overdose. Individual may be provided naloxone via pharmacy, medical provider and/or via an available syringe service program. Individuals may email harmreduction@ph.lacounty.gov for further information.

If NO to all of the above: Individual is not currently at risk for opioid overdose. Referral to SAPC program is not required. However, provider may still refer to SAPC program if provider deems referral is appropriate based on other factors.

If Not sure/unknown: Individual’s risk is unknown at this time. Provider may use professional judgment to connect individual with appropriate resources, including but not limited to referral to SAPC program.

Does the individual have family members, friends, partners, neighbors or other relationships with individuals who have, in the last 12 months:

• Been incarcerated?
• Experienced homelessness or been at risk of homelessness?
• Used illicit substances/or nonprescribed prescription opioids?
• Used prescription opioids as directed?
• Received treatment for a substance use disorder?

If YES to either of first two bullets and YES to at least one of the remaining bullets: Individual is likely to be able to assist a person at-risk of experiencing an overdose and potentially facing a structural barrier to medical services. Individual should email odprevention@dhs.lacounty.gov for information on how to access overdose education and naloxone.

If YES at least one of the last three bullets and NO to both of the first two bullets: Individual is likely to be able to assist a person at-risk of experiencing an overdose. Individual may be provided naloxone via

pharmacy and/or medical provider via third party prescription written to friends or family of at-risk users, or to other laypersons who may have contact with at-risk users. Additionally, individuals may access naloxone via syringe service programs. For additional information email harmreduction@ph.lacounty.gov. If NO to all of the above: Individual does not know someone that is not currently at risk for opioid overdose. Referral to SAPC program is not required. However, provider may still refer to SAPC program if provider deems referral is appropriate based on other factors.

If Not sure/unknown: The risk is unknown at this time. Provider may use professional judgment to connect individual with appropriate resources, including but not limited to referral to SAPC program.

Appendix D: Workflow for Naloxone Distribution

Naloxone formulations:

There are various types of FDA-approved naloxone, a life-saving medication that can temporarily stop or reverse the effects of an opioid overdose. Per the DHS standing order for OEND, the following types may be dispensed through the OEND program:

• naloxone hydrochloride 0.4mg/ml vials
• Evzio® (naloxone HCl) 2mg/1ml auto-injectors
• NARCAN® (naloxone HCl) 4 mg/0.1ml Nasal Spray

Individuals should be given a naloxone kit upon successful completion of the training. Each nasal naloxone kit includes one package of two (4 mg/0.1 ml) FDA-approved Narcan® (naloxone HCl) Nasal Spray, step-by-step instructions for administration on the packaging, and other program materials. Each intramuscular (IM) naloxone kit includes two (2) vials of 1ml (0.4mg/ml)

naloxone, two IM syringes, step-by-step instructions for administration, and other program materials.

Example Workflow for Naloxone Distribution

For Participants

• A participant requests naloxone via a fixed based site or via community outreach. They do not need to register as a participant and should remain anonymous to minimize barriers to access. A participant may also be a concerned friend or family member seeking naloxone for a loved one.
• An overdose prevention education or volunteer who has received naloxone training retrieves the requested naloxone. It should be stored in a readily accessible place and unlocked so that staff may easily distribute to participants.
• The educator educates and confirms the participants understanding in how to use naloxone and knows how to effectively respond in the event of an overdose. Educator documents naloxone distribution and distributes naloxone to participant.