Narcan Receives Approval for Over-the-Counter Sale

Understanding Naloxone (Narcan)

What is Naloxone?

Naloxone, commonly known by the brand name Narcan, is a medication designed to rapidly reverse opioid overdose. It is an opioid antagonist, which means it binds to opioid receptors in the brain and can block the effects of opioids such as heroin, morphine, and oxycodone. By doing so, naloxone can quickly restore normal respiration to a person whose breathing has slowed or stopped due to opioid use [1].

First approved by the US Food and Drug Administration (FDA) in 1971, naloxone has traditionally been available only via prescription, which has presented potential barriers to access.

Administration of Naloxone

Naloxone can be administered in various ways, including intranasal (nasal spray), intramuscular (injection into a muscle), and intravenous (injection into a vein) routes. The two FDA-approved forms are the injectable form and the prepackaged nasal spray [3].

Regardless of the form used, it is crucial to receive training on how and when to use naloxone. Reading the product instructions and checking the expiration date are also important steps to ensure the medication's effectiveness.

Key Points

• Naloxone acts quickly to reverse opioid overdose effects.
• Available in injectable and nasal spray forms.
• Training and proper usage are critical for effectiveness.

Understanding how naloxone works and how to administer it can save lives, particularly in communities heavily affected by opioid addiction.

Importance of Naloxone in Schools

The rise in opioid overdoses has necessitated the inclusion of naloxone, commonly known as Narcan, in school emergency response plans. Schools play a critical role in safeguarding the health of students, staff, and visitors by being prepared to respond to overdose emergencies.

Naloxone Training in Schools

Training to administer naloxone in schools is essential for staff to effectively respond to probable overdoses. This training is closely aligned with CPR and First Aid, rather than nursing delegation. Key leaders such as the Naloxone Coordinator, School Nurse, and Administrator are crucial in decision-making and program development for a comprehensive naloxone emergency response program.

Schools are recommended to have staff engage in self-assessment of knowledge and skills post-training to ensure confidence and competency in administering naloxone during an opioid incident [4].

Emergency Response Programs

Effective emergency response programs in schools must include naloxone as a staple in their protocols. These programs aim to equip school personnel with the necessary tools and knowledge to act swiftly in case of an opioid overdose. The inclusion of naloxone in emergency response kits, along with clear guidelines and procedures, is imperative.

Implementing these elements ensures that schools are well-prepared to handle opioid-related emergencies, thereby protecting the well-being of their communities.

The approval of Narcan for over-the-counter sale by the FDA (FDA) further enhances the accessibility of this life-saving medication, making it easier for schools to include it in their emergency response programs.

Over-the-Counter Approval

The approval of Narcan for over-the-counter (OTC) sale marks a significant milestone in the fight against opioid overdose. This development aims to increase accessibility and potentially save countless lives.

FDA Approval of OTC Narcan

The U.S. Food and Drug Administration (FDA) approved Narcan, a 4 milligram (mg) naloxone hydrochloride nasal spray, for over-the-counter, nonprescription use. This is the first naloxone product to receive such approval.

The FDA's decision involved a thorough assessment to ensure that Narcan is safe and effective for OTC use. This approval will necessitate changes in the labeling for the currently approved 4 mg naloxone nasal spray products that use Narcan as their reference listed drug product.

Availability and Pricing

The timeline for the availability and pricing of OTC Narcan is determined by the manufacturer. The FDA is collaborating with all stakeholders to facilitate the continued availability of naloxone nasal spray products during the transition from prescription to OTC status, though this may take several months.

The FDA has actively encouraged sponsors to submit applications for OTC naloxone products. In November 2022, the agency released its preliminary assessment indicating that certain naloxone products could be safe and effective for over-the-counter use. As of August 1, 2023, three naloxone products have been approved for OTC use. As of September 2023, naloxone is now available over the counter, further broadening access to this life-saving medication.

Naloxone Access Laws

Increasing Community Access

Naloxone access laws (NALs) have been implemented across all US states to enhance community access to this life-saving medication. These laws primarily allow pharmacists to dispense naloxone without a patient-specific prescription, aiming to reduce barriers to obtaining the drug. Despite these legislative efforts, significant obstacles to naloxone access from pharmacies persist, contributing to ongoing opioid-related overdose deaths [2].

A study revealed that the dispensing of naloxone from US pharmacies increased eight-fold between the fourth quarter of 2015 and the second quarter of 2017, correlating with the implementation of NALs in various states. This surge underscores the potential of these laws to improve access, yet highlights that more work is needed to ensure widespread availability.

Impact on Opioid Overdose Deaths

The rise in naloxone accessibility is part of a broader strategy to combat the opioid crisis. Since 1999, opioid-related overdose (ORO) mortality in the United States has surged more than six-fold, prompting initiatives to distribute naloxone widely.

The US Department of Health and Human Services has outlined a 5-point strategy to reduce ORO mortality, which includes the extensive distribution of naloxone. This opioid antagonist can rapidly reverse an overdose, offering a critical intervention during emergencies [2].

Moreover, there is a push among clinicians and policymakers to reclassify naloxone as an over-the-counter (OTC) medication to further increase its accessibility. This reclassification could potentially result in a net benefit through increased access, making it easier for individuals to obtain naloxone without needing a prescription.

These efforts, combined with the FDA's proactive development of a Drug Facts Label (DFL) for naloxone, aim to support the creation of an OTC version of the drug. This unprecedented step could significantly boost the availability of naloxone, offering a vital tool in the fight against the opioid epidemic.

Naloxone Usage and Effects

Understanding the effects and appropriate usage of Naloxone, particularly after its approval for over-the-counter sale, is crucial for those involved in addiction recovery.

Withdrawal Symptoms

Administering Naloxone (Narcan) to individuals with physical dependence on opioids can trigger withdrawal symptoms within minutes. These symptoms include:

• Headaches
• Changes in blood pressure
• Rapid heart rate
• Sweating
• Nausea
• Vomiting
• Tremors

While these symptoms are uncomfortable, they are generally not life-threatening.

Co-Prescription Recommendations

Research indicates that clinicians prescribing Naloxone along with prescription opioids may reduce the risk of opioid-related emergency room visits and prescription opioid-involved overdose deaths. The U.S. Centers for Disease Control and Prevention recommends co-prescription of Naloxone for some patients who take opioids.

Understanding these aspects of Naloxone usage can greatly aid in managing and mitigating the risks associated with opioid use.

FDA Initiatives for Naloxone

Model Drug Facts Label (DFL)

The FDA has taken proactive measures to support the development of over-the-counter (OTC) naloxone by creating and testing a Model Drug Facts Label (DFL). This initiative aims to simplify the usage instructions for naloxone, making the information accessible and easily understandable for a broad audience.

The FDA developed two versions of the Model DFL: one for a nasal spray and another for an auto-injector. These labels include easy-to-understand pictograms that guide users on how to administer the life-saving drug [7].

To ensure the effectiveness of these labels, the FDA conducted comprehensive label comprehension testing involving over 700 participants from various user groups. The results indicated that the information was well-understood by consumers, supporting the development of OTC naloxone products.

Efforts to Increase Availability

The FDA has implemented several initiatives to increase the availability of naloxone products, addressing the urgent need for wider access to this critical medication. These efforts include:

• Approval of injectable naloxone for use in healthcare settings.
• Approval of prescription auto-injector and intranasal forms of naloxone.
• Release of draft guidance to advance the development of generic naloxone hydrochloride nasal spray.

These initiatives aim to ensure that naloxone is readily accessible to those who need it, particularly in emergency situations involving opioid overdoses. By promoting the development and availability of both branded and generic naloxone products, the FDA is working to make this life-saving drug more affordable and widely available to the public.

References

[1]: https://nida.nih.gov/publications/drugfacts/naloxone

‍[2]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7894851/

‍[3]: https://www.mass.gov/info-details/naloxone-facts-and-formulations

‍[4]: https://www.health.state.mn.us/people/childrenyouth/schoolhealth/training.html

‍[5]: https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray

‍[6]: https://www.health.pa.gov/topics/disease/Opioids/Pages/Naloxone.aspx

‍[7]: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-unprecedented-new-efforts-support-development-over