Behind the Counter Availability of Naloxone

Medicare Set-Aside Blog, Medicare Set-Asides, Opioids, Rx/Pharmacy on October 2, 2019
Posted by Leah King, PharmD, JD, Independent Pharmacy Consultant

One component of the FDA’s drug approval process is a designation of the drug as prescription only or over-the-counter (OTC). If a drug is initially approved as a prescription only medication, this doesn’t mean that the drug cannot later be approved for over-the-counter status. In order to facilitate this change, the drug manufacturer files a switch application with the FDA. When considering switch applications, the FDA evaluates four factors: (1) the ability of patients to properly self-diagnose without professional guidance; (2) whether or not the drug has an acceptable safety margin, meaning that the benefits of the drug outweigh its risks; (3) whether or not the drug has low abuse and misuse potential; and (4) whether the product labeling can be easily understood by a layperson. Traditionally, the therapeutic categories represented by OTC products have been relatively limited. These include such categories as allergy, cough and cold, pain, heartburn relief (acid reducers), skincare/acne, red eye and smoking cessation. More recently, the FDA has granted OTC status for drugs in new therapeutic categories such as overactive bladder and nasal corticosteroids. Drug manufacturers are incentivized to initiate the Rx-to-OTC switch process by a three-year award of exclusivity following the approval of OTC status.

As you may recall from previous blog posts, the federal government has communicated a five-part strategy to combat the opioid crisis. One element of the five-part strategy is to increase the availability of naloxone, which is a drug that quickly reverses the effects of an opioid overdose. Naloxone is a potentially life-saving drug during an opioid emergency. You can read more about naloxone here. Currently, all formulations of naloxone (nasal spray, injection and auto-injector) are available by prescription only. One way to increase the availability of naloxone is to convert its status to OTC. In order for that to happen as part of the switch NDA process discussed above, a drug manufacturer would need to develop product labeling that is easily understood by a layperson. In January, the FDA announced that it created these consumer-friendly labels in the form of Drug Fact Labels, or DFLs. At that time, the FDA Commissioner stated that this was the first time in the agency’s history that it had created the labels itself. This announcement certainly demonstrated a commitment on the part of the FDA to support the Rx-to-OTC switch of naloxone. Despite these efforts, the Rx-to-OTC switch has not yet occurred. 

In the absence of FDA approval for a Rx-to-OTC switch, certain states have taken action to nonetheless facilitate the availability of certain products without a prescription, including insulin, flu vaccine . . . and now, naloxone. The mechanism by which this is accomplished is a collaborative practice agreement. A collaborative practice agreement, sometimes called a CPA or a standing order, is a legal agreement between a physician and a pharmacist which allows the pharmacist to participate in activities that exceed the scope of practice which is granted to the pharmacist by state statute. A collaborative practice agreement sets forth the terms and conditions under which a pharmacist can manage drug therapy problems with the supervision of a physician. The physician is expected to oversee the pharmacist’s activities, but the physician does not necessarily need to have physical presence in order to have adequate oversight of the pharmacist.   

The phrase “over the counter” may be misplaced in the case of naloxone, since consumers cannot actually find it on the shelves. Rather, the drug is stored behind the pharmacy counter. Both the nasal spray and auto-injector formulations are available from certain retail pharmacy locations. In order to obtain a supply, patients must speak to the pharmacist on duty. Naloxone is available from CVS pharmacy locations in forty-eight states and the District of Columbia.[1] In addition, naloxone is available from Walgreens pharmacy locations in forty-four states and the District of Columbia.[2]  

You may be wondering what effect all of this has on the inclusion of naloxone in a Workers’ Compensation Medicare Set-Aside (WCMSA). The short answer is that it has not had any effect at all- yet. The approval of a switch application, on the other hand, would grant true OTC status to naloxone and would likely produce significant changes. OTC products are non-Medicare covered and as a result, these products are typically excluded from WCMSAs. We will continue to follow the FDA’s activity relative to naloxone formulations, and post updates here.   

[1] Naloxone is not available in Wyoming or Hawaii. 

[2] Naloxone is not available in Delaware, Hawaii, Kansas, Michigan, North Dakota or Wyoming.