The switching of two products from prescription-only (Rx) to over-the-counter last year hinted that there may be a wave of similar switches on the horizon, and ones in therapeutic categories previously off limits to OTC availability. But without more products accessible without a prescription behind-the-counter, as opposed to off-the-shelf, such switches in the U.S. will continue to be limited in number.
The oral contraceptive Opill (norgestrel) is about to launch as an OTC product. The switch to OTC for Opill was approved by the Food and Drug Administration last summer. As is the case with emergency contraception, at many retailers who stock Opill it may be kept in a locked case on the shelf or behind the pharmacy counter.
Another switched product last year, the opioid antagonist Narcan (naloxone), appears to be more readily available off the shelf, according to the New York Times. But access to the product is characterized by a mishmash of store policies, with some stocking the medication behind the front cash registers, others displaying it behind the pharmacy counter, and others having it available on shelves with or without anti-theft devices.
This doesn’t make either Opill or Narcan behind-the-counter products in the standard sense of the phrase. An exclusively behind-the-counter drug implies that rather than finding the product in one of the pharmacy’s aisles and purchasing it at the main cash register, it is not ever on a regular store shelf that customers can access and must be bought with the assistance of an actual pharmacist employee. The classic example of this is insulin, which has been available without a prescription for decades, but is only stocked behind the pharmacy counter. Another example is any drug containing pseudoephedrine. For safety reasons, such products are invariably kept behind-the-counter because of the possibility of pseudoephedrine being used as a starter chemical for methamphetamine production.
Rx-to-OTC Switch Process
A prescription drug typically becomes a candidate for over‐the‐counter status if it’s used for a condition that can be easily self‐diagnosed. In addition, an OTC product should have low abuse potential under conditions of widespread availability.
For decades, the process of Rx-to-OTC switches has invariably relied heavily on evidence from safety and effectiveness studies concerning the Rx product. But actual use and label comprehension studies have also been prerequisites to evaluate the “OTC-ness” of switch candidates. Here, the pertinent clinical questions include whether the product is safe and effective for consumers under conditions of actual use in the real world, whether there is a need for healthcare provider evaluation or monitoring and the nature and severity of potential adverse effects associated with the product.
Recent History of Switches
The year 2020 marked an end to a long drought in switching of Rx drugs to OTC. In 2020, six products became available OTC, harkening back to the heyday of switches in the mid 1990s. However, all three therapeutic categories in which switches occurred—anti-histamine, analgesic and head lice—already had multiple OTC options. In this respect, these weren’t novel switches.
Moreover, the increased switch activity in 2020 appears to be an anomaly. in the past 15 years the FDA has approved fewer switches on average per year than it did in the 1990s and 2000s.
The more than a decade-long slump in Rx-to-OTC switches has included years with zero switches, like 2010, 2018 and 2019, and several years with only one switch, including 2011, 2015 and 2022.
What’s conspicuous regarding the dearth in switch activity is that with the exception of the two products that went OTC in 2023, almost all recent switches have been in therapeutic categories in which there were already multiple OTC treatment alternatives available to consumers, sometimes as far back as the 1970s, such as hay fever and allergy medicine and cough and pain relief drugs.
Third Class of Drugs May Spur More Novel Switches
The U.S. doesn’t have a formal third class of medicines. And despite there being a few exceptions to the rule, in practice, it’s mostly a binary system of Rx or OTC products. This implies that anyone can enter a pharmacy and get an OTC product off of the shelf without having to interact with a pharmacist.
The situation is quite different in many overseas markets. In Britain, for instance, there is a formal class of behind-the-counter products called “pharmacy,” which are available solely under the supervision of a pharmacist. Then there are “prescription only medicines.” Finally, the U.K. denotes the classification “general sale list” to what would be considered off-the-shelf OTC products in the U.S.
To illustrate just how different the system is, take the case of the switch of low-dose simvastatin nearly 20 years ago in the U.K. to behind-the-counter status. Former colleagues and I explained this process in a British Medical Journal article published in 2005. Patients can obtain low-dose simvastatin without a prescription, but the medications are placed behind the pharmacy counter and distributed after a pharmacist’s consultation. In this context, the pharmacist is consulted as to whether or not a statin is appropriate.
Similarly, since 2018 in the U.K. one can purchase the erectile dysfunction drug sildenafil without a prescription from a pharmacy after a discussion with the pharmacist. The person will be asked questions about his general health to make sure sildenafil is safe to take and the pharmacist will convey which potential side effects to be aware of.
Without a behind-the-counter alternative that involves pharmacist consultations, it’s hard to envision statins or a drug like sildenafil making the switch in the U.S. from Rx to OTC.
Indeed, the history of attempts to bring statin therapy to OTC status in the U.S. dates back more than 25 years, and three attempts—lovastatin, pravastatin and atorvastatin—since then have failed.
In 2015, Pfizer pulled its application to make their cholesterol drug atorvastatin available to patients OTC because in an actual use study patients were not using the drug correctly.
There are therapeutic classes which would seem candidates for Rx-to-OTC switches in the U.S. This includes drugs for erectile dysfunction,* migraine and high cholesterol, among other categories. The introduction by the FDA of the Nonprescription Safe Use Regulatory Expansion or NSURE initiative in 2013 was supposed to spur a new wave of Rx-to-OTC switches, with a focus on facilitating switches in new therapeutic classes. But it hasn’t happened. Perhaps part of the reason is the lack of a formal behind-the-counter classification of drugs.
Read the full article here