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OVER-THE-COUNTER DRUGS (or) MEDICINES

OVER-THE-COUNTER DRUGS (or) MEDICINES

Jun 18, 2020
4 min read

📚 Description:-

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription. In contrast, prescription drugs require a prescription from a doctor and should only be used by the prescribed individual. Some drugs may be legally classified as over-the-counter (i.e. no prescription is required), but may only be dispensed by a pharmacist after an assessment of the patient's needs or the provision of patient education. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a prescription is required vary considerably from country to country.

📚 Examples:-

Popular examples include pain relievers like acetaminophen (Tylenol) and ibuprofen (Advil,Motrin), cough suppressants such as dextromethorphan (Robitussin) and antihistamines like loratadine (Claritin24H). These drugs are usually located on shelves in pharmacies, grocery stores, and even in gas stations. OTC medicines treat a variety symptoms due to illness including pain, coughs and colds, diarrhea, heartburn, constipation, acne, and others.

📚 Top 20 OTC Drugs:-

📚 Usage:-

As of 2011, around a third of older adults in the U.S. reportedly used OTC drugs.By 2018, the prevalence of use by adults in the U.S. as first-line treatment for minor illnesses had reached 81%.

OTC drugs
OTC medication with child-resistant packaging (cap) and tamper-resistant carton and innerseal

OTC drugs
Photo of the packaging of four medicines showing their Product Licence Numbers and symbols denoting if they are Prescription Only Medicine (POM) or Pharmacy Medicine (P)

📚 Restricted over-the-counter substances:-

An ill-defined third category of substances is products having over-the-counter status from the FDA while being simultaneously subject to other restrictions on sale. While they are legally classified as OTC drugs, they are typically stored behind the counter and are sold only in stores that are registered with their state. They may be unavailable in convenience and grocery stores that stock other non-restricted OTC medications.

For example, many drugstores have moved products containing pseudoephedrine, an OTC product, into locations where customers must ask a pharmacist for them. A prescription is not required; the change has been made in an effort to reduce methamphetamine production. Since the passage of the Illinois Methamphetamine Precursor Control Act and the subsequent federal Combat Methamphetamine Epidemic Act of 2005, the purchase of pseudoephedrine is restricted. Sellers of pseudoephedrine must obtain and record the identity of the purchaser and enforce quantity restrictions. Some states may have more stringent requirements (such as Oregon, where a medical prescription is required to purchase any quantity of pseudoephedrine). After initial attempts to control methamphetamine use (by requiring documentation of sale with government issued ID as well as limits on the quantity an individual could purchase) failed to realize meaningful reductions in methamphetamine use and production, Mississippi passed House Bill 512 in the State Senate on February 2, 2010 "to require a prescription from a licensed medical professional to purchase over-the-counter medicines with pseudoephedrine, ephedrine, or any other precursor chemical that can readily and illicitly be converted into methamphetamine, Methcathinone or any active/scheduled analogs of Phenylethylamines/ amphetamine."However, products containing the substance are still OTC in most states, since no prescription is required.

Restricted OTC substances
Plan B One-Step

A similar regulation once applied to some forms of emergency contraception. However, on February 25, 2014, the FDA approved generic one-pill emergency contraception products for unrestricted sale on the shelf. There is no age limit or need for ID to purchase.

Furthermore, some Schedule V controlled substances may be classified as OTC products in certain states. Such drugs are sold without a prescription but are subject to record-keeping rules and quantity and/or age restrictions, and they must be dispensed by a pharmacy.

📚 Transitions between Prescription and OTC:-

As a general rule, over-the-counter drugs have to be used primarily to treat a condition that does not require the direct supervision of a doctor and must be proven to be reasonably safe and well tolerated. OTC drugs are usually also required to have little or no abuse potential, although in some areas drugs such as codeine are available OTC (usually in strictly limited formulations or requiring paperwork or identification to be submitted during purchase).

Over time, often 3–6 years, drugs that prove themselves safe and appropriate as prescription medicines may be switched from prescription to OTC. An example of this is diphenhydramine(Benadryl), an anti-histamine which once required a prescription but now is available OTC nearly everywhere. More recent examples are cimetidine and loratadine in the United States, and ibuprofen in Australia.

It is somewhat unusual for an OTC drug to be withdrawn from the market as a result of safety concerns, rather than market forces, though it does happen occasionally. For example, phenylpropanolamine was removed from sale in the United States over concern regarding strokes in young women. A study has been done examining consumer's perceptions about the risk of and access to nonprescription medication. The study concluded that a small percentage of consumers prefer having access to medication over potential risks of taking non-prescribed medication.

In the United Kingdom, it was announced in February 2007 that Boots the Chemist would try over-the-counter sales of Viagra in stores in Manchester, England (previous available as prescription only). Men aged between 30 and 65 could buy four tablets after a consultation with a pharmacist.


 
 
 

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