FAQ

Prescribing to a person not at risk for overdose and who is a caregiver is usually called “3rd party prescribing.” Unless your state explicitly permits 3rd party prescribing, you cannot prescribe a medication to someone for whom it is not indicated. Click here and scroll down to Question #8 “Are prescriptions of naloxone authorized to third parties?”. If you are in a state that does not permit 3rd party prescribing, the prescription should be written for the person potentially at risk for overdose.

We encourage clinicians to consider a paradigm of “risky substances” over “risky patients”. Epidemiologically, certain scenarios are involved in a higher proportion of fatal opioid poisonings, but on a patient level, anyone who uses opioids may be at risk for overdose. As such, we suggest universal application of these broad inclusion criteria to identify those who should be considered for training and a naloxone prescription.

The highest risk patients are people who resume use after a period of abstinence with reduced opioid tolerance, such as people released from incarceration or leaving substance use disorder treatment.

Overdose prevention education can be delivered to patients very briefly and the length of time should be tailored to the patient’s needs. The minimum counseling to accompany naloxone dispensing is to instruct patients to 1) administer naloxone if non-responsive from opioid use, 2) seek emergency medical attention and follow dispatcher’s instructions for resuscitative measures (such as rescue breathing and/or chest compressions), 3) how to assemble naloxone for administration (depending on product), and 4) include family/caregivers in patient counseling or instruct patients to explain to others how to respond to patient’s potential overdose. Evzio and Narcan Nasal Spray present this information in the patient information materials; the other naloxone products do not and additional written instructions are suggested. Click here to go to videos and patient education materials.

For prescribers, training materials directed at pharmacists are available on the Clinician Resource – General page. The two Naloxone trainings are eligible for continuing education credit.

Naloxone is a relatively safe medication that is generally associated with fewer risks than other commonly used injectable rescue medications such as epinephrine for anaphylactic shock and glucagon for hypoglycemia. We are aware of no case in which a provider of naloxone has been subjected to a malpractice case or professional discipline. For a complete discussion of legal issues, see the Legal page.

Take home naloxone is being implemented successfully in a variety of contexts. Project Lazarus and Community Care of North Carolina are rolling out the Chronic Pain Project, with initial results available HERE. A federally-funded research study is underway in Rhode Island to provide overdose prevention education and naloxone to incarcerated people upon release, with an educational video specifically for this population available HERE. CLICK HERE for a presentation about overdose prevention and naloxone at methadone maintenance treatment programs. Naloxone is being made available to people through harm reduction programs. Here are articles on that work in Chicago, Baltimore, Boston, San Francisco, and Pittsburgh.

The promise of naloxone rescue kits has been recognized through endorsements by the United Nations Office on Drugs and Crime (UNODC) jointly with the World Health Organization (WHO), US President’s Emergency Plan For AIDS Relief (PEPFAR), the American Public Health Association (APHA), the American Medical Association (AMA), the Office of National Control Policy (ONDCP), state legislatures, public health departments and national programs.

Prescribing naloxone should be done in addition to discussing rescue breathing and calling 911. Including naloxone in comprehensive overdose education is important because timely naloxone administration may shorten the time that the overdose victim experiences oxygen deprivation, just a few minutes after which hypoxic brain injury begins to occur.

The current AHA guidelines describing “Hands-Only CPR” have received widespread publicity in the media, without mention of the accompanying exceptions for situations involving drug overdose, drowning, or collapse due to breathing problems. People who have received CPR training recently may have been encouraged to discontinue rescue breathing universally, as opposed to the more appropriate context of during sudden collapse or a heart attack.

The exact cost of naloxone depends on the source.

Most insurance, Medicaid and Medicare will pay for naloxone, but coverage varies by state. The nasal adapter is not covered by insurance. Compiling a list of insurance plans in your area that will cover naloxone and collaborating with a pharmacist will be helpful. Because naloxone is not an expensive medication, even patients whose insurance will not cover the medicine may be willing to pay for naloxone. Advocates in some locations have been successful in persuading insurers to cover the cost of naloxone or have it added to local ADAP (AIDS Drug Assistance Program) formularies.

Screening Brief Intervention Referral to Treatment (SBIRT) can be used to bill time for counseling a patient. Complete the DAST-10 and counsel the patient on how to recognize overdose and how to administer naloxone, using the following sheets. Refer to a substance use disorder treatment program if appropriate. For pain patients, the DAST-10 may not be appropriate. Instead, for new pain patients consider using the Screener and Opioid Assessment for Patients with Pain (SOAPP), and for patients already stably on opioid therapy, consider administering the Current Opioid Misuse Measure (COMM).

Prescribing naloxone to opioid users is fully consistent with state and federal laws regulating drug prescribing. CLICK HERE for a more detailed state by state medical-legal analysis.

As with any prescription medication, patients receiving a naloxone prescription should receive verbal and written instructions on how and when to use this drug. Prescribers/staff should not instruct patients to administer naloxone to persons who do not have a valid prescription for the drug; however, both prescribers and patients can educate a potential bystander how to administer the medication to the patient during an overdose emergency.

The most common adverse event is opioid withdrawal symptoms. In a person who has a tolerance to opioids, naloxone may cause a withdrawal reaction which can make the person feel physically ill, agitated and frustrated. Our experience is that lower injected doses and intranasal naloxone do not result in a withdrawal reaction. More severe adverse events are considerably less common and, even when severe, less dangerous than an untreated opioid overdose or poisoning. Studies by Kerr, 2009, Belz, 2006, Kelly, 2005, Buajordet, 2004, Vilke, 2003, and Sporer, 1996 describe these events in more detail.

Recently, the stronger naloxone formulation adapted for IN use has seen higher uptake among newer bystander overdose prevention programs than injected naloxone. This is largely due to resistance to needle delivery as opposed to IN-delivered naloxone being clearly objectively advantageous. Based on our collective experience providing naloxone to tens of thousands of people, we have observed that both formulations/routes of administrations have advantages and disadvantages:

0.4/mL naloxone for intramuscular (IM) injection only is available in two forms from Hospira (NDC 0409-1219-01 for 10mL multidose vial and NDC 00409-1215-01 for 1mL single dose vial)

Advantages:
• First line for paramedics & emergency departments
• Most commonly used formulation
• Comparatively intuitive assembly and administration
• Manufacturer more accessible for strategizing, negotiating, planning
• FDA approved (IMS/Amphastar product is also FDA approved, but not for IN administration & we discourage IM/IV administration of that stronger formulation by laypersons because it requires dosing decisions)
Disadvantages:
• Needle use seems to cause generic anxiety in many groups (though people are consistently able to effectively use the needles in emergencies)
• Needle disposal requirements

2mg/2mL naloxone is available from IMS/Amphastar (NDC 76329-3369-1) is modifiable post market to be useable intranasally (IN)

Advantages:
• First line for some local EMS
• Randomized Control Trials (RCT): slower onset of action but milder withdrawal
• Acceptable to needle-adverse groups
• No needle stick risk
• No needle disposal concerns
Disadvantages:
• Not FDA approved
• No large RCT
• Assembly required, not intuitive
• Subject to breakage
• Cumbersome commercial pharmacy sourcing for MAD 300 nasal adapter from Teleflex

Products approved by FDA in 2014– PrescribeToPrevent.org does not have sufficient experience with either product to comment on advantages and disadvantages:

0.4/mL naloxone generic from Mylan (NDC 67457-292-02 for 1mL single dose vial)- no image available
0.4/mL naloxone auto-injector called Evzio® is available from kaléo (NDC 60842-030-01 for 2 auto-injectors + 1 trainer)

Naloxone should be stored at room temperature and protected from sunlight. People receiving naloxone should be discouraged from storing the naloxone in places that could expose naloxone to heat (for ex- a car glove compartment), cold (for ex- a refrigerator), or sunlight (for ex- in a window).

Extreme and repeated temperature fluctuations have been shown in a simulation study to degrade the concentration of the medicine over time. The study by Gammon and colleagues was done in the context of existing EMS, so this issue is one that is unresolved in the EMS context as well as in the expanded context of police, fire or laypersons. The degradation weakens concentration, but has not shown toxic byproducts, etc. This means that a person may, in the scenario with extreme temperature changes, receive a lower dose, but would still be receiving naloxone. Layperson naloxone administration is proposed in addition to current status quo, not instead of it. As such, even in the worst case scenario, an overdose victim would receive a slightly weaker dose earlier on than they would have otherwise, thus moving the continuum of care more forward. Ultimately, even if the medicine were less concentrated than at the time of manufacture due to improper storage (which is a ubiquitous concern), that scenario is still likely more of a benefit than not having an equipped first responder of layperson present to administer the medicine.

For the context of deploying naloxone among police and fire first responders, we have compiled a summary of practices among existing pilots and recommendations.

There is not consensus on the “correct” naloxone product. We created this comparison chart, which has many considerations. Prescribe To Prevent does not systematically endorse any particular product, but you can contact us for technical assistance with this and other important programmatic decisions.

There is not currently consensus about the correct measure to instruct laypeople to use in responding to an opioid overdose. Instruction on resuscitative measures is usually included in most community-based take-home naloxone initiatives. Opioid overdose prevention programs in the United States generally teach rescue breathing following naloxone administration. The World Health Organization recommends rescue breathing as a priority during layperson opioid overdose response. The American Heart Association’s 2015 guidelines have been updated to include naloxone administration in the setting of suspected overdose and a new algorithm for “Opioid-Associated Life-Threatening Emergency” that calls for responders to administer CPR for the victim who is unresponsive with no breathing or only gasping. CPR technique should be based on the rescuer’s level of training. Rescuers are instructed to administer naloxone as soon as it is available. Some overdose prevention programs in Canada and the United Kingdom recommend chest compressions only or chest compressions with rescue breathing. Rescue breathing training may be done briefly in person, using a short video, or by including a hard copy set of instructions. An alternative to including training on resuscitative measures is to encourage overdose responders to follow dispatcher instructions upon seeking emergency medical services for help for the overdose victim. The New York State Technical Working Group on Opioid Overdose Resuscitation summarizes the current practices and existing knowledge base nicely.

The order of action had been to deliver rescue breathing prior to naloxone administration, as opioid-induced respiratory depression may be treated with oxygen alone, but some programs are moving toward delivering naloxone before resuscitative measures, based on program data and feedback from overdose rescuers. Both Evzio and Narcan Nasal Spray patient information materials instruct to administer naloxone as early as possible. In the absence of rigorous research, it is unknown which order of actions yields the most beneficial results.