What determines whether a medication is sold OTC or prescription?

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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?

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10 Answers

Anonymous 0 Comments

Not a pharmacist but per my into to pharmacology class we went over some of the considerations for OTC vs prescription

Tl;dr will small dosages changes kill you, will not being monitored by a medical professional kill you, will you become addicted to this medication, will the side effects frequently be severe enough to kill you, will not understanding how to take this medication kill you, do high quality studies and widespread use of this medication indicate that it will kill you

The big one is therapeutic index which is basically dosage wiggle room. For example, warfarin (blood thinner) and ibuprofen. Ibuprofen can be taken from very small doses to very large doses 100 mg to 1000+ mg without being deadly in the vast majority of people. Warfarin can thin your blood so much you die from hemorrhaging and have severe effects with just a few mg difference in dosing

Monitoring, is this medication something that needs to be monitored for effect on a semi regular basis? Blood pressure meds can have wide ranging effects in different people with different conditions, dosages may need adjusting regularly to find the sweet spot for treatment

Abuse risk, pretty self explanatory, is this medication easily or even semi regularly addictive in the general population?

Side effect severity and how often they occur, does the medication cause mild symptoms like bloating, vomiting, mild drowsiness, headache, when taken inappropriately or will it shut down a major organ or body system like the kidneys? Do these side effects happen regularly in the general population?

It the form the medication comes in able to be easily measured/dosed by those without medical knowledge and able to be safely taken? This is the reason most OTC medications come in pill/tablet form or as a liquid

Has this medication been heavily assessed for safety and side effects, run through comprehensive studies, and used regularly by the general population with a wide variety of health conditions without a high level of risk determined by very clear guidelines

Anonymous 0 Comments

When a drug is new, while it has been thoroughly tested, there is not a lot of real world experience with it. Therefore, prescriptions from doctors are required, so that they can monitor you and adjust as needed. Once the drug has more history of efficacy and safety, a prescription is no longer needed. So, prescription meds are generally a stronger dose as well.

Anonymous 0 Comments

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Anonymous 0 Comments

A proper pharmacist can clarify but In the UK it’s determined by a centralised medical board and drugs are rated. Some are limited OTC purchases to one or two boxes for instance. Anything vaguely like an opiate is a controlled drug so has special restrictions around them so they can be issued via prescription but have additional measures placed on them. Drug classifications can change yearly. Not sure what happens in other countries.

Anonymous 0 Comments

Many prescription drugs are used to treat long term health conditions, such as high blood pressure, high cholesterol, depression, etc. When people are taking these medications, it’s important for them to be monitored regularly and have their dose adjusted as appropriate. Left to their own devices, humans aren’t great at managing their health.

For acute illness, like infection, it’s important to select the appropriate antibiotic and dosage.

I have worked in a pharmacy. The general public should not have access to prescription drugs without seeing a doctor or nurse. People self diagnose all kinds of conditions and can’t even read the ingredients and directions on a bottle of DayQuil properly. They’d buy up antibiotics like candy and take them for every sniffle, and then we’ll end up with antibiotic resistant bacteria and THEN WHAT? 🫠

Anonymous 0 Comments

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.

Anonymous 0 Comments

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.

Anonymous 0 Comments

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.

Anonymous 0 Comments

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.

Anonymous 0 Comments

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)