- Can I prescribe naloxone to a caregiver not at risk for overdose?
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. For the current status of your state, CHECK HERE. 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.
- Who should be educated in the use of a naloxone rescue kit? How should they be identified?
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.
- Who should provide the education? How long does it take?
Overdose prevention education can be done by handout, video or in person by the prescriber, support staff or pharmacist. Depending on the number of questions, education can take between 3 and 15 minutes. Naloxone is an emergency response prescription medicine- education on when and how to use it should be similar in length to the same process with other emergency medicines, such as epinephrine for anaphylaxis. Click here to go to videos and patient education materials.
- How should providers/staff be trained?
For prescribers, here is a 60-minute free webinar sponsored by the Prescribers Clinical Support System-Opioids. Training materials directed at pharmacists are available here. Find training materials for substance use disorder treatment staff here.
- What about liabilities and risk following injection or naloxone administration errors?
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 Medical-Legal.
- What are the results of other programs like this/who else is doing this work?
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. See Endorsements and Policy Support tab.
- Why is prescribing naloxone superior to basic life support and calling 911?
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. Download a review of the literature and discussion of the topic from the Harm Reduction Coalition.
- How much does the naloxone cost? Who is paying for the naloxone?
The exact cost of naloxone depends on the source. The Pharmacist tab offers direct links to the manufacturers and pricing through pharmaceutical distribution companies varies on location and they type of organization making the purchase.
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.
- How can I bill for the training time?
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 asubstance 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).
- What is the liability of prescribing naloxone? What if they use it on someone else (medication is not prescribed to them/ use is not as directed)?
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.
- Are there adverse events associated with naloxone administration?
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.
- How do I decide on a naloxone formulation?
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)
• 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)
• 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)
• 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
• Not FDA approved
• No large RCT
• Assembly required, not intuitive
• Subject to breakage
• Cumbersome commercial pharmacy sourcing for MAD 300 nasal adapter from Teleflex
In early 2014, the FDA approved an injectable naloxone product from Mylan and Evzio, a naloxone autoinjector from kaleo. While they have been approved by the FDA, neither of these products are publicly available as of April, 2014.
- Should I be concerned about naloxone storage?
Naloxone should be stored at room temperature and protected from sunlight. People recieving 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.