What determines whether a medication is sold OTC or prescription?


Basically what the title says. Is it because of the cost of the medication? At first I assumed it was because of the potential for abuse for some meds, but Benadryl for instance is sold OTC, and some non-addictive medications are sold through prescription only. I’m from America, for reference, as I suspect it’s different in other countries?

In: 58

In general, the criteria is generally along the lines of “is it a common condition that can be reliably identified and monitored by the patient, is the medicine safe enough at a wide range of doses that careful titration isn’t necessary, and is there any potential for harm/addiction if misused?”.

(And then there’s acetaminophen which is somehow OTC)

While it does depend from country to country, the general idea stays the same. When a manufacturer wants to sell medicaments, they need the approval of the country’s medical authorities (I believe it is the FDA in the USA). They are the one to decide whether or not the medication can be sold over the counter or only through prescription.

As for the criterias, it mostly comes down to risks in case of misuse, abuse potential, and scope of use.

Potassium Chloride in pill is Prescription, in powder it is a supplement.

Potassium Chloride in a pill is $1/750mg, in powder it is $5/345,000mg.

Naproxen, commonly known as Advil, is sold OTC as 200 mg pills, but if you want something to actually kill the pain, you have to pay a doctor to prescribe naproxen 800 mg. I think it’s just a money grab scam if I can just take four Advil, bought OTC instead.

I’m from the UK, so I can break down what we do here. Basically, we have 3 types of meds: general sales (GSL), pharmacy meds (P), and prescription only medicines (POM).

GSL can be sold in any shop, and they don’t need to provide their staff with any sort of medicines information. These meds are used to treat common, short term, conditions, and are, generally safe and easy to use, have very few side effects, or are only sold in small quantities, like paracetamol and ibuprofen are only sold in packs of 16, and you can only buy a maximum of 2 packs.

P meds are also used to treat common conditions, however they can only be sold under the supervision of a pharmacist. This may be because they have addictive qualities, interact with commonly used meds or foods, have odd side effects, or people may need more specific guidance on how to take them.

POM are the most common types of meds, when you start taking these, your doctor wants to monitor your health and how you’re responding to the drugs. There’s a lot that needs to be taken into consideration when you prescribe meds, like: the patient’s height, weight, age, what meds they’re already taking, allergies, diet, amongst other things. For example, people with poor kidney function generally require lower doses of drugs because it stays in their body longer as their kidneys struggle to filter it out and get rid of it.