Contributed by: Mark Garofoli, PharmD, MBA, BCGP, CPE, CTTS Clinical Assistant Professor & Clinical Pain/SUD Pharmacist West Virginia University School of Pharmacy
What are your thoughts on naloxone?
Regardless of your profession, or even beliefs, our opioid overdose crisis is one of the single most discussed and impactful scenarios ever. Naloxone. One word. One medication. So many conversations. In forming one’s “personal facts” (i.e., opinions), it’s best to first review the actual facts with a review of naloxone pharmacology, clinical pearls, and products.
Speaking of pharmacology, can you tell us about naloxone’s pharmacology?
Naloxone’s respective pharmacology includes being highly lipophilic (crossing the blood brain barrier), having low oral bioavailability, and a short duration of action (commonly observed as approximately a half-hour).1
How is naloxone available?
Naloxone opioid overdose reversal medications are generally available via prescription (Rx), over-the-counter (OTC), or harm reduction programs as either injectable or nasal formulations. The injectable formulations doses include 0.4 mg vials (Rx)5, a 5 mg device (Rx)2 , and a 10 mg auto-injector device3 approved only for U.S. military utilization. The nasal formulations doses include a 1 mg assembly-required kit (Rx)5, a 3 mg device (OTC)4, a 4 mg device (Rx & OTC)5, and an 8 mg device (Rx)6. There is also a novel nasal swab formulation 3 mg product under FDA review for OTC status approval.7 Naloxone has been available via prescription through general prescribing, board of pharmacy protocols, and statewide standing orders. The more recent OTC status aimed to increase access and eliminate supply barriers, and although ubiquitous availability beyond pharmacies is a result, cost and administration education remain concerns for many people.
Is there a naloxone “perfect dose”?
Many have debated what the “perfect dose” of naloxone to be within various circular conversations across our country. In 2016, our FDA conveyed a joint advisory committee meeting which concluded that there was simply no “best” or “perfect” naloxone dose since there are several factors that come into play such as the patient’s past and current opioid tolerance, geography relative to a hospital, and dosage of the opioid causing the overdose (yet completely unknown in illegal products), amongst other concerns. Additionally, one must consider the propensity to reverse the opioid overdose (respiratory depression) without precipitating opioid withdrawal.
A recent study illustrated that a higher naloxone nasal spray dose of 8 mg compared to 4 mg results in no additional benefit, yet with potential additional harm in precipitating opioid withdrawal.8
What is the best naloxone product?
Easy. The one that’s closest to you. In order to save lives, our society needs naloxone available at a moment’s notice, thus strategically positioned throughout our communities similar to, if not next to, defibrillators, particularly in rural areas further away from a hospital. That directly means placing naloxone products in malls, libraries, restaurants, and even airplanes.
Can you tell us about recent naloxone expiration date extensions?
Recently, our FDA extended the shelf-life of the brand name naloxone 4 mg nasal spray to four years9, which is appreciably longer than most, if not all, other medications in our country. Once again, emphasizing the importance of this vital medication.
Have you heard of “Narcan Parties” and do they actually exist?
A “Narcan Party” is said to be an event where one would inject heroin with complete disregard for experiencing a deadly overdose since there is naloxone in the vicinity to reverse the opioid overdose respiratory depression and save one’s life.10 Essentially, the reality is that one continually utilizing illicit or diverted opioids or misusing prescribed opioids is aiming to avoid withdrawal (“getting by” rather than “getting high”), and the impending utilization of naloxone to reverse an opioid overdose can precipitate withdrawal, the very thing that one would be looking to stave off in the first place. Illogical, to say the least. Yet, media still sensationalize the concept, even if utilizing headlines that include the word “if ” in reference to these events existing.11 Rather unfortunate.
How many is too many for naloxone reversals for a given person?
Cost and coverage of naloxone in the scenario of potentially saving a human life, once or repeatedly is a tough consternation, as it truly is beyond difficult to put a price tag on a human life. Yet, considering the “relapse rate” of asthma (i.e., having an asthma attack while being actively provided maintenance therapy) is more than that of substance use disorder (addiction)12, one should appreciate that folks may experience “curve balls” in life and end up relapsing in their addiction recovery by experiencing an overdose, more than once. When a patient doesn’t utilize their maintenance asthma medications (inhalers) as prescribed and dispensed, yielding a life-threatening asthma attach, is the rescue inhaler ever withheld? When a person chooses an unhealthy diet due to a myriad of reasonable scenarios (cost, transportation, etc.) and then has a heart attack, is the nitro ever withheld? If your father, mother-in-law, neighbor, best friend, or better yet, if you needed a lifesaving medication more than once, if not 10 times, wouldn’t you want it provided? These answers are best considered for your own point of view right here and right now.
Are there any studies illustrating the lifesaving efforts of pharmacy professionals in respect to providing naloxone?
Naloxone saves lives. Healthcare professionals discussing naloxone education, or even providing naloxone medication products to patients indirectly, if not directly, save lives. One study illustrated that for every eight patients that a community pharmacy provided naloxone and its respective education to, one human heartbeat was saved.13 Considering that many more than eight people a day walk into each and every community pharmacy every day in our country, and certainly an incredible number in each and every hospital, a huge opportunity exists for saving human lives.
Any final thoughts on naloxone?
We are all called to “Do No Harm”. Conflating the pharmacology, societal factors, and stigma, one can easily see that discussions on this one medication really can lead to saving lives by the dozen. One Medication. One heart beat saved. PRN.
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Software: Stewardship Resources (Antibiotic, Opioid, etc)
