What determines whether a medication is sold OTC or prescription?

324 views

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

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

You are viewing 1 out of 10 answers, click here to view all answers.