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What Are Over-the-counter (OTC) drugs?

OTC or over-the-counter drugs are certain types of medications which can be sold to a customer without a prescription written from a healthcare provider. All different types of prescription drugs can only be bought in pharmacies with a valid prescription from a healthcare professional. Different countries around the world have various regulatory agencies which are responsible for the selection of OTC drugs according to the safety and effectiveness of the ingredients used in the production of those drugs. The selection takes the active pharmaceutical ingredients of each drug into consideration before declaring it as a valid OTC drug. The regulation of these ingredients is beneficial because the manufacturers are given enough freedom when it comes to mixing and combining different types of ingredients. There are certain types of over the counter drugs which may be legally available but still require an assessment of the patients by a pharmacy employee prior to the purchase. There are also a large number of over the counter drugs which are available in gas stations, supermarkets and general stores. The regulations which deal with the authorization of the dispensing of the drugs, the establishments which may sell the drugs and whether there is a need for prescription may vary greatly in different countries.

Regulation by Country

In the United States, the FDA regulates the sale and the manufacture of all different types of over the counter drugs. An act released by the FDA required all new types of drugs to obtain a New Drug Application, but since there were a large number of OTC drugs already on the market, they had to create the OTC monograph system which would review and categorize all OTC drugs as GRAS/E. GRAS/E stands for generally recognized as safe and effective. These reviews allowed certain OTC drugs to remain on the market only if they conformed to certain guidelines presented by the monograph system. These guidelines effectively addressed the warnings, labeling and doses for each medicament. The outcome of all that is that each OTC drug available on the market of the United States had to conform to the New Drug Application norm, or the norm presented by the monograph system. The most commonly used OTC medications in the United States include anti-dandruff shampoos with coal tar, different topical products with a certain therapeutic effect, eczema topical treatments, psoriasis topical treatments, aspirin, lidocaine, other types of internal and external analgesics, anti fungal products, anti microbial products and sunscreens. The advertising of all different types of over the counter products in the United States is regulated by the Federal Trade Comission. Various restricted over the counter substances need to be mentioned as well. They have a status of an over the counter product but are also associated with certain restrictions on sale. The most common types of restricted over the counter substances are certain products which contain pseudoephedrine. The same can be said for certain types of emergency contraception. These drugs require a prescription for all women younger than 17. The third most common group of restricted over the counter substances are certain Schedule V controlled substances. In the United Kingdom the situation is completely different as there are three main categories for all sorts of medications, and those are prescription only medications or POMs, pharmacy only medications and general sales list or GSL medications. Prescription only medications, as the name suggests, can only be purchased with a prescription from a professional healthcare provider. There are a large number of medications which fit into this category. Pharmacy only medications are the ones which require certain instructions issued by a health pharmacist and further checkups from the pharmacist. General sales list is simple to the list of American over the counter drugs.

Statistical Data

Retail sales of OTC medicines in the United States each year exceed 17 billion dollars. They account for more than 60 percent of all medications used in the United States, while the consumers use them to self treat health problems four times more than prescribed medications. Almost 95 percent of all illnesses are treated simply by using over the counter medications. The medical conditions which are most commonly treated by using various different types of over the counter medicaments include sinus problems, allergy problems, heartburn, skin problems, sore throat, flu, common cold, cough and headaches.

Switches between Prescription and OTC

All different types of over the counter drugs need to be used only for the treatment of certain medical conditions which do not require any supervision from a professional healthcare provider. They also need to be genuinely safe and tolerable. There is a general rule than certain type of prescription drugs can be switched to another class of over the counter drugs once they get proven as appropriate and safe enough over the years. A certain type of antihistamine called diphenhydramine is one of the most common examples of such switches. 

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