Naloxone
PHARMACIST ROLE AND BENEFITS
Per the CDC, the number of opioid overdoses continues to increase. Deaths due to opioid overdose have quadrupled since 1999. An average of 91 people in the United States die every day due to opioid overdose from both prescription opioids and heroin.2 The most common prescription opioids are oxycodone, methadone and hydrocodone. Therefore, the need for pharmacists to become more aware of these situations and to learn to manage patients with potential risk factors for overdose is becoming increasingly important.
SPECIFIC INFORMATION/TREATMENT
Naloxone is a safe and highly effective medication indicated for the diagnosis of suspected or known acute opioid overdose or for the complete or partial reversal of narcotic depression. It is specifically used to reverse the effects of life-threatening depression of the central nervous system and respiratory system, allowing an overdose victim to breathe normally.3,4
Opioid overdose requires naloxone to be administered in a timely manner.
- Traditionally, naloxone has been administered by emergency personnel such as paramedics or emergency room professionals.
- However, with many states increasing the scope of practice for pharmacists, this potentially lifesaving medication can be more easily accessed in the community.
- Naloxone use can have an impact on reversing overdoses and decreasing the number of deaths due to opioid overdose.
In the United States, the main preparations for naloxone available to the “layperson” or in the community setting is by injection or nasal route.
- Injection preparations are administered via an auto-injector (Evzio®) or a standard injection supplied in a naloxone kit.
- The nasal preparation is a single use nasal spray (Narcan®). For specific dosing and product information, as well as information regarding administration and storage, Pharmacist’s Letter has created a naloxone
- Additionally, a chart outlining the differences in naloxone products most commonly used in the community setting and important ordering information can be found at PrescribeToPrevent.org
REGULATORY GUIDELINES
Patients can acquire naloxone in various ways.
- Naloxone can be prescribed by a prescriber (MD, DO, NP, PA) during normal medical care.
- Patients can also receive naloxone through their pharmacists.
In at least 4 states, pharmacists are allowed to prescribe naloxone to patients without prescriber intervention or collaboration. New Mexico was the first state to do so. However, these pharmacists have undergone specific advanced training and are aware of the specific regulations in their state.
Patients can also access naloxone through a pharmacist if the pharmacist has a collaborative practice agreement (CPA) with a prescriber in at least 11 states.
The majority of patients access naloxone through pharmacists via a standing order.
- As of April, 2017: 40 states have authorized pharmacists to dispense naloxone under standing orders issued by licensed healthcare providers authorized by law to prescribe an opioid antagonist, or by the states’ top medical officials.5
Some states also allow a prescription to be written or dispensed to a “third party”. A third party is someone that has not necessarily been prescribed the drug, but will have it available if needed to be given to someone else.
- This is usually a friend, family member or caregiver. This law allows the prescriber to prescribe naloxone without having had to evaluate the patient. The naloxone prescription will be written in the third party’s name.
- To increase patients’ access to naloxone and its life saving effects, 42 states have modified their laws to allow third party prescribing. These modifications may also apply to a state’s standing order.7,8
Additionally, some prescribers, pharmacists and bystanders are concerned with legal liability concerning the dispensing and administration of naloxone. Many states have also amended their Good Samaritan laws to combat this process. The Network for Public Health laws have created information detailing laws aimed at increasing lay access to naloxone by reducing barriers to prescription and administration by state and laws that address criminal concerns for Good Samaritans who summon aid in overdose situations.9
State laws and regulations vary regarding pharmacist dispensing of naloxone. With the increased need for better access, these laws are quickly changing. A resource to determine specific state’s naloxone regulations for prescribing, dispensing, and liability laws and also to compare state laws is the Prescription Drug Abuse Policy System.
NALOXONE OTC
Although a patient can obtain naloxone in many states without a “prescription”, it is important to keep in mind that naloxone is not an over-the-counter product. Naloxone requires a prescription in all 50 states and the District of Columbia.
As part of the Opioid Initiative launched by the U.S. Department of Health and Human Services (HHS) in March 2015, the Food and Drug Administration has created an opioid action plan in response to the growing opioid epidemic. One of the proposed actions in the plan is to support better treatment for opioid overdose, including the over-the-counter availability of naloxone to increase its accessibility to the public. According to the FDA, a new drug application would need to be submitted by a manufacturer for an over-the-counter version of naloxone. Additionally, a more consumer friendly label would need to be created and testing of this label would need to be performed to ensure that consumers can understand the information.10
CERTIFICATIONS/TRAININGS
Pharmacist's Letter: Naloxone Rescue Therapy for Opioid Overdose
Dispensing Naloxone via a Non-Patient Specific Prescription: The Role of the Community Pharmacist
Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists
Expanding Access to Naloxone: Role of the Pharmacist
Wear your cape to work: Pharmacist-initiated naloxone dispensing
Additional Information
Naloxone Access: A Practical Guide for Pharmacists
PDAPS Prescription Drug Abuse Policy System
The information provided here is for reference use only and does not constitute the rendering of clinical, legal or other professional advice by Health Mart. Health Mart is not responsible for, nor will it bear any liability for, the accuracy, efficacy or reliability of the content provided herein and is not advocating any particular program or approach herein. Readers should consult appropriate professionals for advice and assistance prior to making important decisions regarding their business.
