Over-the-counter (OTC) drugs are medicines that may be sold directly to a consumer without a prescription from a health care professional, as compared to prescription drugs, which may only be sold to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician's care. It is important to note that OTC drugs are regulated as ingredients, not final products. By doing so governments allow manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures. ^[1]

The term over-the-counter may be somewhat counter-intuitive, since, in many countries, these drugs are often located on the shelves of stores like any other packaged product. In contrast, prescription drugs are almost always literally passed over a counter from the pharmacist to the customer. Some drugs may be legally classified as over-the-counter (i.e. no prescription is required), but may only be dispensed by a pharmacy employee after an assessment of the patient's needs and/or the provision of patient education. In many countries, a number of OTC drugs are available in establishments without a pharmacy, such as general stores, supermarkets, gas stations, etc. 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.

Contents 1 Safety 2 Regulation by country 2.1 United States 2.1.1 Restricted OTC Substances 2.2 United Kingdom 3 Switches between prescription and OTC 4 See also 5 References 6 External links

[edit] Safety

This section requires expansion.

OTC drugs pose particular drug safety concerns as they are dispensed and used without the direction of a health care professional. Patients may combine OTC drugs with their prescription medicine, potentially causing drug interactions if the substances are incompatible. Patients may also inadvertently take multiple OTC drugs containing the same active ingredient, which could lead to an overdose or increased side-effects.^[2] In other cases, patients may take more than the recommended dose of a drug, as they may not read or understand the directions or they may choose to ignore them, believing a higher dose to be more effective.^{[citation needed]}

While many OTC drugs have wide therapeutic ranges, some may pose greater risks if not used as directed. For example, acetaminophen (also known as paracetamol) is regulated as an OTC drug in many countries and is widely regarded as safe if used as directed, but it can cause acute liver failure if recommended doses are exceeded and/or when combined with alcohol. This problem is further compounded by the plethora of OTC products containing acetaminophen, as patients may inadvertently overdose by taking multiple drugs (e.g. an individual with a common cold may use two acetaminophen-containing products to treat muscle aches and fever without realizing that they contain the same active ingredient).^[3]

[edit] Regulation by country

[edit] United States

Regulation of therapeutic goods in the United States

Prescription drugs Over-the-counter drugs Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption Government agencies United States Department of Health and Human Services Food and Drug Administration Drug Enforcement Administration Center for Drug Evaluation and Research Process Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs Non-governmental organizations. Institute of Medicine Research on Adverse Drug events And Reports

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In the United States, the manufacture and sale of OTC substances is regulated by the FDA. The Federal Food, Drug, and Cosmetic Act requires that all "new drugs" are required to obtain a New Drug Application ("NDA") prior to entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective ("GRAS/E") from this requirement. In order to deal with the vast number of OTC drugs that were already on the market prior to the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and categorize them as GRAS/E after review by expert panels. This meant that certain classes of OTC drugs were not required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings.

Thus, manufacture must be done either pursuant to an FDA monograph, which specifies types of OTC drugs, active ingredients and labeling requirements, or pursuant to a New Drug Application (NDA), for products which do not fit within a specific monograph. Because an NDA is extremely expensive to complete. Examples of OTC substances approveded in the USA are sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such as lidocaine and aspirin, psoriasis and eczema topical treatments, anti-dandruff shampoos containing coal tar, and other topical products with a therapeutic effect.

The Federal Trade Commission regulates advertising of OTC products. This is in contrast to prescription drug advertising, which is regulated by the FDA.^{[citation needed]}

The FDA requires that OTC products are labeled with an approved Drug Facts label to educate consumers about their medications. These labels comply to a standard format and are intended to be easy for typical consumers to understand. Drug Facts labels include information on the product's active ingredient(s), indications and purpose, safety warnings, directions for use, and inactive ingredients.^[4]

[edit] Restricted OTC Substances

An ill-defined third category of substances are those products having over-the-counter status from the FDA, while being simultaneously subject to other restrictions on sale. While these products are legally classified as OTC drugs, they are typically stored behind the pharmacy counter and are only sold in stores employing a registered pharmacist; such items may be unavailable in convenience or grocery stores that stock other non-restricted OTC medications.

For example, many U.S. 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 Methamphetamine Precursor Control Act, the purchase of pseudoephedrine in the United States 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 (e.g. Oregon, where a medical prescription is required to purchase any quantity of pseudoephedrine). Despite these restrictions, products containing the substance are still considered OTC in all states except Oregon, since no prescription is required.

A similar regulation applies to various forms of Emergency Contraception. The FDA considers these products to be OTC substances for women aged 17 or over, but prescription drugs for younger women. ^[5] To enforce this restriction and to provide counseling and education on proper use, an agreement between the manufacturer and the FDA requires that these drugs are stored behind the pharmacy counter. Women may obtain the medication without a prescription after providing proof of age to pharmacy staff and receiving any necessary patient education.^[6]

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, quantity and/or age restrictions, and must be dispensed by a pharmacy.

[edit] United Kingdom

In the United Kingdom, medication will fall into one of three categories

1. Prescription Only Medication (POM), which is usually only available with a valid prescription from a doctor or via internet suppliers: some POMs including Viagra, Xenical, Valium, Physeptone, DF 118, Dexedrine, Concerta XL, Ritalin, Diconal, MST Continus and anabolic steroids are also sold by street drug dealers and other completely illegal sources. A pharmacist has to be on the premises for POM medicines to be dispensed, required by law. The medicine has been specifically prescribed for the patient holding the prescription, so it is considered safe for only the recipient to take. Examples of these include most Antibiotics and all Antidepressants and Antidiabetic drugs.
2. Pharmacy Only Medication (P), containing chemicals, strengths or sizes which require more information, personal to the person taking the medication. The pharmacist will determine whether the medicine is safe for the particular customer based on their responses to a set of questions. Sometimes this is known as "behind-the-counter" medication. Examples of these include some sleep aid tablets such as Nytol and the emergency contraceptive pill to patients over 16.
3. General Sales List (GSL), available off the shelf with no pharmacy training required to sell. Generally considered safe for most people when taken correctly. Examples of these include 16-packs (or less) of painkillers such as Paracetamol & Nurofen as well as a host of other safe medications such as small pack sizes of Antiallergy tablets, Laxative medication and skin creams.

Medication available only with a prescription is marked somewhere on the box/container with [POM]. Over-the-counter medicines are marked with [P]. A prescription is not required for [P] medicines and pharmacy sales assistants are required by RSPGB codes to ask certain questions, most of all, whether the patient is taking other medication, before selling these; in fact many pharmacies sell [P] medication "no questions asked". It is with this information that the pharmacist can halt the sale, if need be. Some medication available in supermarkets and petrol stations is sold there only in smaller packet sizes. Often, larger packs will be marked as [P] and available only from a pharmacy. Frequently, customers buying larger than usual doses of [P] medicines (such as DXM, promethazine, codeine or Gee's linctus) will be queried, due to the possibility of abuse.

[edit] Switches between prescription and OTC

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As a general rule, over-the-counter drugs have to be primarily used 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). One of the oldest OTC drugs is aspirin.

Over time, often 3-5 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) which once required a prescription but now is available OTC nearly everywhere. Diphenhydramine is an anti-histamine. More recent examples are cimetidine and loratadine in the United States, and ibuprofen (Herron Blue/Nurofen) 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, phenylpropanolamine is one such example.

[edit] See also

• Pharmacy
• Medical prescription
• Regulation of therapeutic goods
• Generic drug
• Child-resistant packaging
• Generally recognized as safe and effective
• List of drug interactions

[edit] References

[edit] External links

• [1] The Tan Sheet is the weekly source of OTC industry news in the US;
• [2] OTC Product News comments on news and events effecting the OTC industry;
• Over-the-counter (OTC) Medicines at FamilyDoctor.org, maintained by the American Academy of Family Physicians. Contains extensive information on over-the counter drugs and their responsible use, including specific guidance on several drug classes in question-and-answer format and information on common drug interactions.