Why Some Medicine is OTC and Others Only Available by Prescription

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The major difference between over the counter (OTC) and prescription medicine is right there in the language used. OTC drugs are literally available “over the counter” at the drugstore and often even at supermarkets and other retail locations.

This category of drugs includes mild painkillers such as aspirin or ibuprofen, cold medication and allergy relief products, among others.

Other meds are only available by a doctor’s prescription and must be filled by a licensed pharmacist and bought at a drugstore. The pharmacists won’t fill the order unless they have proper authorization from a physician.

Why the difference?

OTC products are generally seen as being safe for most individuals as long as they’re taken according to usage instructions. Most users of OTC drugs are unlikely to be able to abuse them or bring major harm to themselves.

Prescription meds, on the other hand, might be easily abused or addictive. Some could have strong side effects or pose a health risk when taken in combination with other prescribed meds. Others might not be prescribed to individuals with certain medical conditions.

In other words, these drugs can cause more harm than good to certain patients if misused. That’s why it’s important that doctors only prescribe these drugs after diagnosing the patient and reviewing their current medications and medical histories.

Different regulatory environments

Reflecting the difference between the two categories of drugs, OTC drugs are regulated by the Federal Drug Administration (FDA) in the form of drug monographs. These are fairly simple reports on product ingredients, formulations, dosages and labeling information and related issues.

Prescribed medications, on the other hand, are regulated more critically and thoroughly, through the FDA’s New Drug Application process. The FDA obtains much more comprehensive information about the product, including results of animal and human trials, how the drug is manufactured and how it reacts in the body, among other factors.

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