Over-the-counter drug
Encyclopedia
Over-the-counter drugs are medicine
s that may be sold directly to a consumer without a prescription
from a healthcare professional, as compared to prescription drugs, which may be sold only 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. OTC drugs are usually regulated by active pharmaceutical ingredients (APIs), not final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.
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 drug
s are almost always 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.
. The Federal Food, Drug, and Cosmetic Act
requires that all "new drugs" 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 that do not fit within a specific monograph. Examples of OTC substances approved 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.
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.
, 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 sold only 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 Illinois Methamphetamine Precursor Control Act and the subsequent Federal Combat Methamphetamine Epidemic Act of 2005
, 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 drug
s for younger women. 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.
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 must be dispensed by a pharmacy
.
, medication is governed by the Medicines Act 1968
. Medication will fall into one of three categories:
Medication available only with a prescription is marked somewhere on the box/container with [POM]. Pharmacy-only products are marked with [P]. A prescription is not required for [P] medicines, and pharmacy sales assistants are required by Royal Pharmaceutical Society
codes to ask certain questions, which varies for what the customer says. If they ask for a specific product, the Pharmacy Assistant must ask "Who is it for," "How long have you had the symptoms," "Are you allergic to any medication," "Are you taking any medication" (WHAM Questions). If a customer asks for a remedy, e.g., hayfever, then the 2WHAM questions must be followed "Who is it for," "What are the symptoms," "How long have you had the symptoms," "Have you taken any action towards your symptoms," and "Are you taking any other medication." It is with this information that the pharmacist can halt the sale, if need be. No [POM] [P] or [GSL] products that are stocked in a pharmacy can be sold, dispensed, or pre-made until a responsible pharmacist is signed in and on the premises. Some medication available in supermarkets and petrol stations is sold 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.
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 3–6 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), 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, after it 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. A substantial minority of the public appears willing to accept considerable risk to gain greater access to pharmaceuticals.
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 would be eligible to buy four tablets after a consultation with a pharmacist
.
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
s that may be sold directly to a consumer without a prescription
Medical prescription
A prescription is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist....
from a healthcare professional, as compared to prescription drugs, which may be sold only 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
Physician
A physician is a health care provider who practices the profession of medicine, which is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury and other physical and mental impairments...
's care. OTC drugs are usually regulated by active pharmaceutical ingredients (APIs), not final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.
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 drug
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
s are almost always 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
Patient education
Patient education is the process by which health professionals and others impart information to patients that will alter their health behaviors or improve their health status...
. In many countries, a number of OTC drugs are available in establishments without a pharmacy
Pharmacy
Pharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs...
, 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.
Canada
An intermediate category - non-prescription items that must be kept behind the counter, in a store room, or on a shelf readily visible by the pharmacist, which includes weak codeine products, muscle relaxants, and some antihistamines - exists.United States
In the United States, the manufacture and sale of OTC substances is regulated by the FDAFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
. The Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
requires that all "new drugs" obtain a New Drug Application
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
("NDA") prior to entering interstate commerce, but the act exempts any drugs generally recognized as safe and effective
Generally recognized as safe and effective
Generally recognized as safe and effective is a legal term used to describe certain old drugs that do not require prior approval from the U.S...
("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
New drug application
The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
(NDA), for products that do not fit within a specific monograph. Examples of OTC substances approved in the USA are sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such as lidocaine
Lidocaine
Lidocaine , Xylocaine, or lignocaine is a common local anesthetic and antiarrhythmic drug. Lidocaine is used topically to relieve itching, burning and pain from skin inflammations, injected as a dental anesthetic or as a local anesthetic for minor surgery.- History :Lidocaine, the first amino...
and aspirin
Aspirin
Aspirin , also known as acetylsalicylic acid , is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. It was discovered by Arthur Eichengrun, a chemist with the German company Bayer...
, psoriasis
Psoriasis
Psoriasis is an autoimmune disease that appears on the skin. It occurs when the immune system mistakes the skin cells as a pathogen, and sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis is not contagious. However, psoriasis has been linked to an increased risk of...
and eczema
Eczema
Eczema is a form of dermatitis, or inflammation of the epidermis . In England, an estimated 5.7 million or about one in every nine people have been diagnosed with the disease by a clinician at some point in their lives.The term eczema is broadly applied to a range of persistent skin conditions...
topical treatments, anti-dandruff
Dandruff
Dandruff is the shedding of dead skin cells from the scalp . Dandruff is sometimes caused by frequent exposure to extreme heat and cold. As it is normal for skin cells to die and flake off, a small amount of flaking is normal and common; about 487,000 cells/cm2 get released normally after...
shampoos containing coal tar
Coal tar
Coal tar is a brown or black liquid of extremely high viscosity, which smells of naphthalene and aromatic hydrocarbons. Coal tar is among the by-products when coal iscarbonized to make coke or gasified to make coal gas...
, and other topical products with a therapeutic effect.
The Federal Trade Commission
Federal Trade Commission
The Federal Trade Commission is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act...
regulates advertising of OTC products. This is in contrast to prescription drug advertising, which is regulated by the FDA.
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)
Active ingredient
An active ingredient is the substance of a pharmaceutical drug or a pharmaceutical ingredient and bulk active in medicine; in pesticide formulations active substance may be used. Some medications and pesticide products may contain more than one active ingredient...
, indications and purpose, safety warnings, directions for use, and inactive ingredients.
Restricted OTC Substances
An ill-defined third category of substances are those products having over-the-counter status from the FDAFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
, 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
Pharmacy
Pharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs...
counter and are sold only in stores employing a registered pharmacist
Pharmacist
Pharmacists are allied health professionals who practice in pharmacy, the field of health sciences focusing on safe and effective medication use...
; 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
Pseudoephedrine
Pseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It is used as a nasal/sinus decongestant and stimulant, or as a wakefulness-promoting agent....
, 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
Methamphetamine
Methamphetamine is a psychostimulant of the phenethylamine and amphetamine class of psychoactive drugs...
production. Since the passage of the Illinois Methamphetamine Precursor Control Act and the subsequent Federal Combat Methamphetamine Epidemic Act of 2005
Combat Methamphetamine Epidemic Act of 2005
The Combat Methamphetamine Epidemic Act of 2005 is federal legislation enacted in the United States on March 9, 2006, to regulate, among other things, retail over-the-counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine products because of their use in the manufacture of illegal...
, the purchase of pseudoephedrine
Pseudoephedrine
Pseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It is used as a nasal/sinus decongestant and stimulant, or as a wakefulness-promoting agent....
in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
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
Medical prescription
A prescription is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist....
is required to purchase any quantity of pseudoephedrine
Pseudoephedrine
Pseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It is used as a nasal/sinus decongestant and stimulant, or as a wakefulness-promoting agent....
). 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
Emergency contraception
Emergency contraception , or emergency postcoital contraception, refers to birth control measures that, if taken after sexual intercourse, may prevent pregnancy.Forms of EC include:...
. The FDA considers these products to be OTC substances for women aged 17 or over, but prescription drug
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
s for younger women. 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.
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 must be dispensed by a pharmacy
Pharmacy
Pharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs...
.
United Kingdom
In the United KingdomUnited Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
, medication is governed by the Medicines Act 1968
Medicines Act 1968
The Medicines Act 1968 is an Act of Parliament of the United Kingdom. It governs the manufacture and supply of medicine.The act defines three categories of medicine: prescription only medicines , which are available only from a pharmacist if prescribed by an appropriate practitioner; pharmacy...
. Medication will fall into one of three categories:
- Prescription Only Medication (POM), which are legally available only with a valid prescription from a doctor. A pharmacistPharmacistPharmacists are allied health professionals who practice in pharmacy, the field of health sciences focusing on safe and effective medication use...
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. Just a small example of these include most Antibiotics, and all Antidepressants or Antidiabetic medications. Drugs also included as POM are high-strength painkillers such as OxycodoneOxycodoneOxycodone is an opioid analgesic medication synthesized from opium-derived thebaine. It was developed in 1916 in Germany, as one of several new semi-synthetic opioids in an attempt to improve on the existing opioids: morphine, diacetylmorphine , and codeine.Oxycodone oral medications are generally...
and TramadolTramadolTramadol hydrochloride is a centrally acting synthetic opioid analgesic used in treating moderate pain. The drug has a wide range of applications, including treatment for restless legs syndrome and fibromyalgia...
, medications such as SildenafilSildenafilSildenafil citrate, sold as Viagra, Revatio and under various other trade names, is a drug used to treat erectile dysfunction and pulmonary arterial hypertension . It was originally developed by British scientists and then brought to market by the US-based pharmaceutical company Pfizer...
(Viagra) and DiazepamDiazepamDiazepam , first marketed as Valium by Hoffmann-La Roche is a benzodiazepine drug. Diazepam is also marketed in Australia as Antenex. It is commonly used for treating anxiety, insomnia, seizures including status epilepticus, muscle spasms , restless legs syndrome, alcohol withdrawal,...
(Valium), and certain topical preparations such as Corticosteroids. These medicines are often sold by drug dealers, especially those marked as "CD POM," which are controlled due to abuse risk such as Diconal, Temazepam, and Methadone. - Pharmacy-Only Medication (P), containing chemicals, strengths, or sizes that are more likely to cause interactions or need basic instruction on use by a health professional. The pharmacist will, in theory, determine whether the medicine is safe for the particular customer based on his/her responses to a set of questions; many pharmacies sell P medicines "no questions asked" instead. Sometimes this is known as "behind-the-counter" medication. These do not require a doctor's prescription, just a discussion with a pharmacist. Examples of these include some sleep aid tablets such as NytolNytolNytol is a brand of sleeping pill produced by GlaxoSmithKline. The active ingredient is diphenhydramine hydrochloride, a sedative antihistamine.GlaxoSmithKline acquired the product in 2001 with the purchase of Block Drug....
, Human de-worming tablets such as MebendazoleMebendazoleMebendazole or MBZ is a benzimidazole drug developed by Janssen Pharmaceutica and marketed as Vermox, Ovex, Antiox, and Pripsen...
, painkillers with small amounts of CodeineCodeineCodeine or 3-methylmorphine is an opiate used for its analgesic, antitussive, and antidiarrheal properties...
(up to 12.8 mg per tablet), and pseudoephedrinePseudoephedrinePseudoephedrine is a sympathomimetic drug of the phenethylamine and amphetamine chemical classes. It is used as a nasal/sinus decongestant and stimulant, or as a wakefulness-promoting agent....
. - General Sales List (GSL), available off the shelf with no pharmacy training required to sell (so they can be sold anywhere, such as supermarkets). In general, they are considered safe for most people when taken correctly. Examples of these include 16-packs (or less) of painkillers such as paracetamolParacetamolParacetamol INN , or acetaminophen USAN , is a widely used over-the-counter analgesic and antipyretic . It is commonly used for the relief of headaches and other minor aches and pains and is a major ingredient in numerous cold and flu remedies...
& ibuprofenIbuprofenIbuprofen is a nonsteroidal anti-inflammatory drug used for relief of symptoms of arthritis, fever, as an analgesic , especially where there is an inflammatory component, and dysmenorrhea....
as well as a host of other safe medications such as small pack sizes of AntiallergyAntihistamineAn H1 antagonist is a histamine antagonist of the H1 receptor that serves to reduce or eliminate effects mediated by histamine, an endogenous chemical mediator released during allergic reactions...
tablets, LaxativeLaxativeLaxatives are foods, compounds, or drugs taken to induce bowel movements or to loosen the stool, most often taken to treat constipation. Certain stimulant, lubricant, and saline laxatives are used to evacuate the colon for rectal and/or bowel examinations, and may be supplemented by enemas under...
medication, and skin creams.
Medication available only with a prescription is marked somewhere on the box/container with [POM]. Pharmacy-only products are marked with [P]. A prescription is not required for [P] medicines, and pharmacy sales assistants are required by Royal Pharmaceutical Society
Royal Pharmaceutical Society
The Royal Pharmaceutical Society is the body responsible for the leadership and support of the pharmacy profession within England, Scotland and Wales...
codes to ask certain questions, which varies for what the customer says. If they ask for a specific product, the Pharmacy Assistant must ask "Who is it for," "How long have you had the symptoms," "Are you allergic to any medication," "Are you taking any medication" (WHAM Questions). If a customer asks for a remedy, e.g., hayfever, then the 2WHAM questions must be followed "Who is it for," "What are the symptoms," "How long have you had the symptoms," "Have you taken any action towards your symptoms," and "Are you taking any other medication." It is with this information that the pharmacist can halt the sale, if need be. No [POM] [P] or [GSL] products that are stocked in a pharmacy can be sold, dispensed, or pre-made until a responsible pharmacist is signed in and on the premises. Some medication available in supermarkets and petrol stations is sold 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.
Switches 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 codeineCodeine
Codeine or 3-methylmorphine is an opiate used for its analgesic, antitussive, and antidiarrheal properties...
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
Aspirin
Aspirin , also known as acetylsalicylic acid , is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. It was discovered by Arthur Eichengrun, a chemist with the German company Bayer...
.
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
Diphenhydramine
Diphenhydramine hydrochloride is a first-generation antihistamine possessing anticholinergic, antitussive, antiemetic, and sedative properties which is mainly used to treat allergies. Like most other first-generation antihistamines, the drug also has a powerful hypnotic effect, and for this reason...
(Benadryl), which once required a prescription but now is available OTC nearly everywhere. Diphenhydramine is an anti-histamine. More recent examples are cimetidine
Cimetidine
Cimetidine INN is a histamine H2-receptor antagonist that inhibits the production of acid in the stomach. It is largely used in the treatment of heartburn and peptic ulcers. It is marketed by GlaxoSmithKline under the trade name Tagamet...
and loratadine
Loratadine
Loratadine is a second-generation H1 histamine antagonist drug used to treat allergies. Structurally, it is closely related to tricyclic antidepressants such as imipramine, and distantly related to the atypical antipsychotic quetiapine. It is marketed by Schering-Plough under several trade names...
in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, and ibuprofen
Ibuprofen
Ibuprofen is a nonsteroidal anti-inflammatory drug used for relief of symptoms of arthritis, fever, as an analgesic , especially where there is an inflammatory component, and dysmenorrhea....
(Herron Blue/Nurofen) in Australia
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...
.
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
Phenylpropanolamine
Phenylpropanolamine , also known as the stereoisomers norephedrine and norpseudoephedrine, is a psychoactive drug of the phenethylamine and amphetamine chemical classes which is used as a stimulant, decongestant, and anorectic agent. It is commonly used in prescription and over-the-counter cough...
is one such example, after it was removed from sale in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
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. A substantial minority of the public appears willing to accept considerable risk to gain greater access to pharmaceuticals.
In the United Kingdom
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
, it was announced In February 2007, that Boots the Chemist would try over-the-counter sales of Viagra in stores in Manchester
Manchester
Manchester is a city and metropolitan borough in Greater Manchester, England. According to the Office for National Statistics, the 2010 mid-year population estimate for Manchester was 498,800. Manchester lies within one of the UK's largest metropolitan areas, the metropolitan county of Greater...
, England
England
England is a country that is part of the United Kingdom. It shares land borders with Scotland to the north and Wales to the west; the Irish Sea is to the north west, the Celtic Sea to the south west, with the North Sea to the east and the English Channel to the south separating it from continental...
(previous available as prescription only). Men aged between 30 and 65 would be eligible to buy four tablets after a consultation with a pharmacist
Pharmacist
Pharmacists are allied health professionals who practice in pharmacy, the field of health sciences focusing on safe and effective medication use...
.
See also
- Child-resistant packagingChild-resistant packagingChild-resistant packaging or C-R packaging is special packaging used to reduce the risk of children ingesting dangerous items. This is often accomplished by the use of a special safety cap. It is required by regulation for prescription drugs, over-the-counter medications, pesticides, and household...
- Generic drugGeneric drugA generic drug is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its...
- Generally recognized as safe and effectiveGenerally recognized as safe and effectiveGenerally recognized as safe and effective is a legal term used to describe certain old drugs that do not require prior approval from the U.S...
- Inverse benefit lawInverse benefit lawThe Inverse Benefit Law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed...
- List of drug interactions
- Medical prescriptionMedical prescriptionA prescription is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist....
- PharmacyPharmacyPharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs...
- Regulation of therapeutic goodsRegulation of therapeutic goodsThe regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency...
External links
- http://www.medilyzer.com FREE software to better understand OTC drug and drug interaction. Consumer can freely download software in smart phone or use web widget to check drug-drug interaction.;
- http://www.windhover.com/toc/toc_xml.asp?magID=12 The Tan Sheet is the weekly source of OTC industry news in the US;
- http://www.otcproductnews.com 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 PhysiciansAmerican Academy of Family PhysiciansThe American Academy of Family Physicians was founded in 1947 to promote the science and art of family medicine. It is one of the largest medical organizations in the United States, with over 100,000 members...
. 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.