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Non-prescription (“Over-the-Counter”) Naloxone Frequently Asked Questions

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On March 29, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of the first nonprescription naloxone product, Narcan 4 milligram (mg) naloxone hydrochloride nasal spray. Once the transition to nonprescription status is complete, this life-saving medication used to reverse opioid overdose will be available directly to consumers in places like drug stores, convenience stores, grocery stores, and gas stations, as well as online. The following questions and answers provide details about purchasing and using Narcan 4mg naloxone hydrochloride nasal spray specifically, health plan coverage, training resources, other formulations of naloxone available, and federal grant funding aimed toward increasing access to naloxone in communities across the country.

Impact on Consumers Purchasing Nonprescription Naloxone

There are many formulations of naloxone, an opioid overdose-reversal drug. As a result of the FDA’s recent approval action, Narcan 4 milligram (mg) naloxone hydrochloride nasal spray will be available on a nonprescription basis. Other formulations of naloxone will remain available as prescription products.

Shortly after Narcan 4mg becomes available on retail shelves, it will no longer be available by prescription. It will take some time for nonprescription Narcan 4mg naloxone hydrochloride nasal spray to be available on retail shelves. Timing for when this nonprescription product will be available for purchase will be determined largely based on operational logistics of the manufacturer and retailers.

In the interim, remaining stocks of Narcan 4mg naloxone hydrochloride nasal spray, labeled for prescription should continue to be available, including in pharmacies through standing orders that enable individuals to access Narcan without a patient-specific prescription. Such prescription labeled Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray will also continue to be covered by some insurance carriers during this interim time.

Individuals may also want to explore other resources for accessing naloxone, such as community-based programs or public health initiatives, public health departments, threshold to recovery centers, and health centers that offer naloxone at reduced or no cost. Other formulations of naloxone will remain available as prescription products.

It will take some time for nonprescription Narcan to be available on retail shelves. Timing for when nonprescription Narcan will be available for purchase will be determined largely based on operational logistics of the manufacturer and retailers. In the interim, remaining stocks of prescription-labeled Narcan 4mg naloxone hydrochloride nasal spray can be obtained by a prescription or through naloxone access laws, such as standing orders that enable individuals access to prescription forms of naloxone without a patient-specific prescription.

The coverage of nonprescription Narcan 4mg naloxone hydrochloride nasal spray, once it is available, may vary depending on the source of health coverage. As Narcan 4mg transitions to an “over-the-counter” product, some health plans may cover the cost, while others may not. In some cases, a prescription may be required for both prescription and non-prescriptions forms of naloxone to be covered, even if it is available for purchase without a prescription. It is important for individuals to check with their health coverage program, health plan or health insurance issuer regarding coverage for nonprescription “over-the-counter” naloxone and any requirements or restrictions on coverage. State Medicaid programs may or may not cover OTC drugs. States may cover OTC drugs for Medicaid beneficiaries using state-only funds or may choose to cover OTC drugs under Medicaid when prescribed by professionals authorized to do so under state laws and regulations. Individuals may also want to explore other resources for accessing naloxone, such as community-based programs or public health initiatives that offer naloxone at reduced or no cost.

Individuals who are concerned about the risk of an opioid overdose, including people who use prescription or illicit opioids, their family members, friends, caregivers, or concerned members of the public should consider having naloxone on hand. This allows individuals to have naloxone available to administer if they witness someone experiencing an overdose.

There are no federal restrictions on who may purchase nonprescription Narcan, 4mg naloxone hydrochloride nasal spray. Specific state laws may vary.

Yes, naloxone will still be available to 340B covered entities at the 340B price; however, it would need to be prescribed by a physician (or other persons authorized to prescribe such drugs under State law) for it to be eligible under the program.

The cost of nonprescription Narcan may vary depending on several factors, such as the cost set by the manufacturer, insurance coverage, the state, and the retailer. Some initiatives, such as health officials issuing standing orders, are important avenues for patients to continue accessing prescription naloxone in an affordable way. Other initiatives aim to provide naloxone for free or at reduced cost to individuals who may not otherwise be able to afford it, such as through community-based programs or public health initiatives.

While the cost to purchase nonprescription Narcan may vary, there are significant benefits of increased availability and access to this life-saving medication in the context of preventing opioid overdose deaths and promoting public health.

The nonprescription status of Narcan 4mg naloxone hydrochloride nasal spray should have no impact on prescription injectable forms of naloxone, such as those given through intramuscular, intravenous, or subcutaneous routes. People can continue to obtain injectable forms of naloxone by prescription in pharmacies. Community-based organizations, healthcare settings, and harm reduction organizations are also places where people may be able to get injectable formulations of naloxone, and naloxone nasal spray in dosages above the 4mg dose approved for nonprescription use. Additionally, many states have standing orders that allow different groups or organizations to distribute or dispense naloxone to those who may need it.

There are a variety of resources available for individuals looking for naloxone. One option is to check with local pharmacies to see if they have naloxone in stock. Further, many states have programs that provide naloxone free of charge or at a reduced cost to individuals who are at increased likelihood of experiencing an overdose, or who may be likely to witness an overdose. In addition, harm reduction organizations and community health centers may offer low-cost or free naloxone distribution and training programs. Individuals who are looking to find treatment for substance use disorder can use the Substance Abuse and Mental Health Services Administration (SAMHSA) Behavioral Health Treatment Services Locator to find addiction treatment providers, some of which may also offer naloxone.

Good Samaritan laws exist in many states and may provide legal protections for individuals who administer naloxone in good faith to someone experiencing an overdose. These laws vary by state, but they generally protect individuals from prosecution or arrest for drug possession or use and protect them from certain types of liability resulting from administering naloxone.1

Background on Naloxone

Opioid medications (like Vicodin, Percocet, and Norco) and illicit opioids (like heroin or illicitly manufactured fentanyl) work by binding to mu-opioid receptors in the brain. When this happens, they can cause someone’s breathing to slow down, something known as respiratory depression. Sometimes this respiratory depression can be so significant that it reaches the point where people stop breathing completely. Naloxone is a medication that is not an opioid but can also bind to the same opioid receptors. When it does, it blocks the effects of opioids and rapidly reverses respiratory depression, allowing someone to breathe again.

When given immediately after an overdose, naloxone is a highly effective medication to reverse respiratory depression and it has an excellent safety profile. In fact, naloxone generally only has an effect when someone has taken an opioid. Naloxone has been shown to be a critical tool in preventing opioid overdose deaths. In addition to being used by healthcare professionals, naloxone is increasingly being distributed to first responders, family members, and other bystanders who may witness an opioid overdose. The availability of nonprescription naloxone could help to further increase its distribution and accessibility, potentially saving more lives and reducing the burden of opioid overdose on individuals, families, and communities.

It is advisable to administer naloxone and call 911 immediately if there is any suspicion of opioid overdose, even if the person is believed to be using other drugs, or the drug is unknown. Administering naloxone in these situations can help prevent irreversible harm.

Many non-opioid drugs, such as cocaine and methamphetamine, as well as pills obtained from the illicit drug market, have been found to be contaminated with opioids like illicitly manufactured fentanyl. Additionally, some people may use opioids in conjunction with other substances. This increases the risk of unintentional opioid overdose, particularly for individuals who do not typically use opioids. Therefore, it is essential to recognize that even if a person does not think they are using opioids, they may still be at increased likelihood of experiencing an opioid overdose if the drugs they are using are contaminated with opioids such as illicitly manufactured fentanyl. In such cases, giving naloxone can be lifesaving. It is crucial to note that naloxone is effective in reversing the effects of opioids, but it will generally not harm someone if opioids are not present in their system.

Naloxone is a relatively safe medication when used appropriately to reverse opioid overdose. However, it is important to note that naloxone can cause withdrawal symptoms in people who have had an overdose reversed since they may be physically used to having opioids in their system. Opioid withdrawal symptoms include agitation, nausea, vomiting, sweating, and elevated heart rate. These symptoms are typically not life-threatening and can be treated. It is important to recognize the signs of opioid overdose and to administer naloxone quickly and appropriately and to follow up with a health care professional. The benefits of naloxone use in preventing opioid overdose deaths far outweigh the risks.

Administering naloxone to someone who is not experiencing an opioid overdose is safe and generally should not cause harmful health effects. Therefore, if someone is unsure whether an individual is experiencing an opioid overdose or not, it is still recommended to administer naloxone and call 911 immediately. This is because the potential benefits of administering naloxone and potentially saving a life outweigh the risks of not administering it.

The appropriate amount of naloxone to give depends on several factors, including the severity of the opioid overdose, the specific form of naloxone being used, and the individual's response to the medication.3 In cases where the overdose involves illicitly manufactured fentanyl, which is increasingly common, people may need to administer multiple doses of naloxone to effectively reverse the overdose. Illicitly manufactured fentanyl comes in many different forms, each with varying degrees of strength, making it difficult to determine the exact dose of naloxone needed to reverse the overdose in some cases. It is essential to follow the directions on the naloxone medication packaging carefully and to be aware of any specific guidance related to waiting between doses. It is also important to understand that naloxone may not immediately make someone responsive, and it may take a few minutes for the individual to begin breathing normally again. Therefore, it is crucial to continue monitoring the person’s condition and to seek emergency medical attention immediately. While administering naloxone can be lifesaving, it is essential to recognize that overdose reversal with naloxone can be complicated, particularly in cases involving illicitly manufactured fentanyl. Indeed, there are some reports of fentanyl causing chest wall rigidity which requires intervention with naloxone and breathing support.4 For this reason, it is always important to stay with the individual who has overdosed, and to call 911 as soon possible after giving naloxone, to ensure continued safety and well-being.

Yes. While administering naloxone can be a critical step in reversing an opioid overdose and saving a life, it is still important to call 911 in the event of an overdose, even if naloxone has been administered. This is an important step outlined in the Drug Facts Label of Narcan 4mg naloxone hydrochloride nasal spray. Naloxone works to reverse the effects of opioids on the body for a limited period, typically 30 to 90 minutes depending on the specific form and dosage of naloxone used. However, many opioids can last longer than this, and it is still possible to experience the effects of an overdose after naloxone wears off. Additionally, emergency responders can provide additional medical care if the person is experiencing withdrawal symptoms from the naloxone and transport the person to a hospital, if necessary, which may be essential in ensuring their safety and well-being. Calling 911 can also ensure that the individual receives appropriate treatment for other conditions, and follow-up care and support, such as substance use treatment or connection with a peer support specialist, as needed, which can be critical in addressing the underlying causes of drug use and preventing future overdose.

Training on How to Use Naloxone

Many organizations, including community-based groups, public health agencies, local health departments, and harm reduction organizations, offer training programs that are free or low-cost on how to administer various types of naloxone. These programs may also provide different formulations of naloxone at no-cost. In addition, the Centers for Disease Control and Prevention (CDC) also provides information on how to use naloxone.

It is important to ensure that naloxone training programs are accessible to all community members, regardless of income, race, or other factors. This may involve partnering with community-based organizations or healthcare providers to offer free or low-cost training programs in locations that are easily accessible to those who may be at highest risk of opioid overdose.

Ongoing education and support may also be provided to individuals who have naloxone to ensure that they feel confident and empowered to use the medication correctly, in an emergency situation. This might include follow-up calls or reminders, online resources, or peer support groups that can provide ongoing education and support for individuals and families affected by opioid use disorder.

Another useful resource is: Get Naloxone Now, an online resource to train people to respond effectively to an opioid overdose emergency.

Nonprescription drugs are required to be safe and effective for use without oversight or training by a healthcare professional. Nonprescription naloxone has consumer-friendly labeling that contains all the key information needed for an untrained bystander to administer naloxone. However, administering naloxone can be stressful and confusing for some individuals, particularly if they have not received training or have limited experience in responding to medical emergencies. Therefore, individuals who may witness an opioid overdose, such as family members, friends, or other caregivers, are encouraged to receive some training on how to recognize the signs of opioid overdose and how to administer naloxone correctly. Additionally, specific instructions on administering naloxone are included in the packaging of the nonprescription naloxone, making it easy to follow in an emergency. It is also important to note that training in providing rescue breaths can be an important tool in responding to an opioid overdose, particularly if the individual is not breathing.

Appropriate Settings for Naloxone

Yes. Ensuring ready access to naloxone in schools, including elementary schools, aligns with HHS’ strategic approach to prevent overdose deaths. With naloxone as part of an emergency protocol and readily accessible, a school nurse or other staff members can quickly administer it.5

Including naloxone in the workplace first aid kit is recommended as part of an overall effort to promote workplace safety and protect employees from the risks associated with opioid overdose. In recent years, many employers have recognized the importance of addressing the opioid overdose epidemic in their workplaces, particularly as opioid misuse and addiction continue to have significant impacts on public health and the economy. Including naloxone in the workplace first aid kit is an important step in this effort, as it can help ensure that employees can help their colleagues who may be at increased likelihood of opioid overdose have access to this life-saving medication in the event of an emergency. Additionally, providing training to volunteer staff on how to administer naloxone can help increase the likelihood of a positive outcome and minimize potential complications or risks associated with its use. This is already happening in many workplaces, particularly those in industries where opioid misuse may be more prevalent, such as healthcare, law enforcement, and construction. However, it is important for all employers to consider including naloxone in their workplace first aid kits and to provide appropriate training and support to employees who may need to use it. This can help promote workplace safety and ensure that employees have the resources they need to stay healthy and well.

Grant Funding for Naloxone

Several HHS grant programs, such as SAMHSA’s State Opioid Response (SOR) program, allow for the purchase and distribution of naloxone for states and territories. While these grants are not solely focused on naloxone, they are an important tool in addressing the opioid overdose epidemic and promoting access to life-saving resources for individuals with increased likelihood of overdose. The SOR grant recipients (i.e., states and territories) and sub-awardees are required to use SAMHSA's grant funds primarily to support direct services, which includes the purchase and distribution of naloxone. The Tribal Opioid Response (TOR) grant program similarly allows Tribal grantees to use federal funds for the purchase and distribution of naloxone. Other grant programs, such as FR-CARA, Prescription Drug Overdose, and Harm Reduction, also provide for grantees to purchase and distribute naloxone as part of their efforts to address the opioid overdose epidemic. HRSA-supported health centers and Rural Communities Opioid Response Program (RCORP) grants also allow grant recipients to purchase and distribute naloxone in underserved and HRSA-designated rural areas.

The FDA-approval of nonprescription status for the Narcan 4mg naloxone hydrochloride nasal spray (and other nonprescription naloxone nasal spray products) should have minimal impact on these and other grants in the short-term, as grantees and sub-recipients will be able to continue to purchase and distribute naloxone products as they have done in the past. But while naloxone is a critical tool in preventing opioid overdose deaths, it is just one component of a larger effort to address opioid misuse and addiction. Therefore, SAMHSA and HRSA grants continue to support a comprehensive approach to the overdose crisis, including prevention, harm reduction, treatment, and recovery efforts, while also prioritizing access to naloxone and other life-saving resources.

There are a variety of resources available to support the use of naloxone in the field. These resources are designed to help individuals and organizations implement effective overdose prevention and education programs, and to provide guidance on the safe and effective use of naloxone in emergency situations.

One such resource is the CDC's Guide to Developing and Managing Overdose Prevention and Take-Home Naloxone Projects, which provides practical guidance on how to design and implement effective naloxone distribution programs. The guide includes information on key components of successful programs, such as identifying target populations, developing training protocols, and implementing quality assurance measures.

Additionally, the CDC and SAMHSA National Harm Reduction Technical Assistance Center (NHRTAC), provides direct technical assistance to organizations seeking to develop and implement overdose prevention and education programs. This resource provides expert guidance on a variety of topics related to overdose prevention and naloxone distribution, including program design, training protocols, and quality assurance measures.

Overall, these resources can be valuable tools for individuals and organizations seeking to support the safe and effective use of naloxone. By promoting best practices in overdose prevention and education, and by providing expert guidance on the use of naloxone in emergency situations, these resources can help reduce the risk of opioid overdose and save lives.

Additional Questions

Making naloxone available through a nonprescription, “over-the-counter” mechanism is a critical step in addressing the overdose crisis and reducing opioid overdose deaths.

Research tells us that increased access to naloxone is associated with a significant reduction in opioid overdose deaths in communities that implemented such policies.6 Additionally, other studies have found that increased access to naloxone through community-based programs, such as distribution through syringe service programs, can also help reduce opioid overdose deaths and improve access to addiction treatment and other healthcare services.7

The goal is to improve access to this life-saving medication in non-healthcare sites, such as in homes, schools, workplaces, and other community settings. This would likely be appealing for family members and people who use drugs, who are often at increased likelihood for opioid-related overdoses and may be wary of engaging with conventional healthcare professionals due to past experiences of discrimination and judgment. Additionally, it could help reduce healthcare costs associated with opioid overdoses.

By promoting improved access to naloxone in non-healthcare settings, we can all help ensure that individuals at increased likelihood of opioid overdose have access to life-saving resources and support, while also promoting safer and healthier communities for all.

Studies have shown that naloxone access and distribution does not lead to more drug use or riskier drug use.8 In fact, some studies have shown that naloxone availability results in a decreased use of opioids.9 The mechanisms by which naloxone may reduce opioid use are not entirely clear, but it is thought that the availability of naloxone may promote safer opioid use practices, such as using opioids in smaller amounts or in the presence of others who can administer naloxone in the event of an overdose.

It is important to note that substance use disorders are complex conditions that often require treatment for people to achieve and sustain recovery. People not yet ready to seek treatment may experience an overdose, and naloxone can keep them alive until they are able to engage in care. Naloxone is a vital tool for use in concert with comprehensive prevention, treatment, and recovery efforts. By pairing naloxone distribution with evidence-based addiction treatment and harm reduction strategies, we can help reduce the risk of opioid misuse and addiction while also promoting health, well-being, and recovery for individuals and communities affected by this crisis.

Naloxone can play an important role in addressing the opioid overdose epidemic and reducing opioid overdose deaths. However, naloxone is just one component of a comprehensive approach to the opioid overdose epidemic, and additional efforts are needed to address opioid misuse and addiction and promote health, well-being, and recovery for all.

Ensuring that naloxone is available in communities with the highest risk of opioid overdose, including rural and underserved areas, is an important priority for public health officials and community organizations. There are several strategies that can be used to help promote access to naloxone in these communities. Strategies can include stocking nonprescription naloxone products in pharmacies and other retail settings, healthcare providers prescribing naloxone to patients who are at risk for opioid overdose, community-based programs such as harm reduction programs that distribute naloxone, and distributing naloxone at treatment facilities and emergency departments.

It is important for Federal agencies to work with community-based organizations, departments of public health, healthcare providers, and other stakeholders to identify individuals and groups who are at highest risk of opioid overdose, and to ensure that they have access to naloxone and training on how to use it. That way, those who are most likely to witness or respond to an overdose, including people who use drugs, their friends and family members, and first responders, will have access to this medication.

It is also necessary to focus naloxone distribution efforts on locations where opioid overdoses are most likely to occur. This involves working with local law enforcement agencies, healthcare providers, and other stakeholders to identify high-risk areas and ensure that naloxone is available in these locations. To help communities plan for naloxone distribution, all 50 states and 8 territories that received SOR grant funding were required to submit a Naloxone Saturation Plan in their FY22 grant applications. As part of this plan, applicants were required to describe a focused distribution and communication strategy to get the appropriate type of naloxone into the hands of those most likely to witness an overdose and in the locations where they are most likely to occur. SAMHSA is working closely with States as they continue to refine their plans to address gaps and get naloxone into the hands where it is most needed, and the National Institutes of Health funds research on how implementation of naloxone availability and other tools can help prevent fatal overdoses.

In addition to the recent action to approve Narcan 4mg naloxone hydrochloride nasal spray as a nonprescription drug and maintaining standing orders for prescription formulations of naloxone, there are many other policies and strategies that have been implemented to prevent opioid misuse and overdose. A highly effective strategy is increasing access to substance use disorder treatment, such as medications for opioid use disorder, and accompanying behavioral therapies. These interventions have been shown to improve retention in treatment, reduce opioid use, and decrease the risk of overdose. Additionally, increasing access to harm reduction services such as syringe services programs, fentanyl testing strips, and overdose prevention education can reduce the risk of overdose and promote safer drug use practices. These services can also provide opportunities to connect individuals with other support services, such as housing and employment assistance, which can help address underlying issues contributing to substance use.

Other policies that can be implemented to prevent opioid misuse and overdose include increasing funding for research on pain management and non-opioid pain treatments, implementing prescription drug monitoring programs to track prescribing patterns and identify potential misuse, and improving access to mental health services for individuals with substance use disorders. Additionally, policies that address the social determinants of health, such as poverty and housing insecurity, can help reduce the risk of substance use by addressing risk factors for addiction. Ultimately, a multifaceted approach that addresses the complex factors contributing to opioid misuse and overdose is necessary to effectively prevent and address this public health crisis.

Footnotes


Please note that this FAQ document does not constitute legal advice. Individuals and grantees should consult their counsel regarding specific legal protections that may apply.

2Strang J. (2022). Take-Home Naloxone and the Prevention of Deaths from Heroin Overdose: Pursuing Strong Science, Fuller Understanding, Greater Impact. European addiction research, 28(3), 161–175.

3Çoruh, B., Tonelli, M. R., & Park, D. R. (2013). Fentanyl-induced chest wall rigidity. Chest, 143(4), 1145–1146.

Please note that this FAQ document does not constitute legal advice. It is essential that schools consult at the state level to determine the legality and associated policies pertaining to naloxone availability and administration in schools.

Walley A Y, Xuan Z, Hackman H H, Quinn E, Doe-Simkins M, Sorensen-Alawad A et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: interrupted time series analysis BMJ 2013; 346: f174 doi:10.1136/bmj. f174

Lambdin, B. H., Bluthenthal, R. N., Wenger, L. D., Wheeler, E., Garner, B., Lakosky, P., & Kral, A. H. (2020). Overdose Education and Naloxone Distribution Within Syringe Service Programs - United States, 2019. MMWR. Morbidity and mortality weekly report, 69(33), 1117–1121.

Jones, J. D., et al. “No Evidence of Compensatory Drug Use Risk Behavior among Heroin Users after Receiving Take-Home Naloxone.” Addictive Behaviors, vol. 71, 2017, pp. 104–106. 2.

Wagner, K. D., et al. “Evaluation of an Overdose Prevention and Response Training Programme for Injection Drug Users in the Skid Row Area of Los Angeles, CA.” International Journal of Drug Policy, vol. 21, no. 3, 2010, pp. 186–193.

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Last Updated: 04/24/2023

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