Over-the-counter ( OTC ) drugs are drugs sold directly to consumers without a prescription from health care professionals, compared with prescription drugs, which can be sold only to consumers who have a valid prescription. In many countries, over-the-counter medicines are selected by regulatory agencies to ensure they are safe and effective when used without medical care. The free drug is usually regulated by an active pharmaceutical ingredient (API), not the end product. By regulating the API in place of specific drug formulations, the government allows independent producers to formulate materials, or combination of ingredients, into a mixture of ownership.
The term over-the-counter may be somewhat counter-positive, because, in many countries, these drugs are often placed on shelves in supermarket areas, like other packaging products. Instead, prescribed drugs almost always pass the counter from the pharmacist to the customer. Some drugs may be legally classified as over-the-counter (ie no prescriptions required), but can only be dispensed by the pharmacist after assessment of the patient's needs or the provision of patient education. In many countries, a number of over-the-counter medicines are available in companies without pharmacies, such as general stores, supermarkets, and gas stations. The rules detailing the companies where drugs are sold, which are authorized to issue them, and whether the required prescriptions vary from country to country.
Video Over-the-counter drug
Usage
In 2011, about one-third of older adults in the US reported using over-the-counter drugs. By 2018, the prevalence of use by adults in the US as first-line treatment for mild disease has reached 81%.
Maps Over-the-counter drug
Rules by country
Canada
In Canada, there are four drug schedules:
- Schedule 1: Require a prescription to be sold and given to the public by a licensed pharmacist.
- Schedule 2: Does not require a prescription but requires assessment by the pharmacist prior to the sale. These drugs are stored in a pharmacy area where there is no public access and can also be referred to as a "behind the counter" drug.
- Schedule 3: Does not require a prescription but should be kept in an area under the supervision of a pharmacist. These medicines are stored in a retail outlet area where self-selection is possible, but a pharmacist should be available to assist in the selection of self-medication if necessary.
- Not scheduled: No recipe required and can be sold at any retail outlet.
All drugs apart from Schedule 1 may be considered OTC drugs, as they do not require a prescription for sale. While the National Association of Pharmaceutical Regulatory Authorities provides recommendations on the scheduling of drugs sold in Canada, each province can determine its own scheduling. The drugs found in each schedule can vary from one province to another.
India
In November 2016, the Indian Drugs Committee announced that they began to define the definition of drugs that could be eliminated without a prescription. Prior to this, the general assumption was that any drug that did not fall into the prescription schedule could be purchased without a prescription. However, the required definition has not been enacted in early 2018. The lack of legal definitions for over-the-counter drugs has resulted in this US $ 4 billion market segment effectively not regulated.
Dutch
In the Netherlands, there are four categories:
- UR (Uitsluitend Recept): only recipes
- UA (Uitsluitend Apotheek): just a pharmacist
- UAD (Uitsluitend Apotheek of Drogist): a pharmacist or drug store only
- AV (Algemene Verkoop): can be sold in general store
Medications that can be sold OTC but only by pharmacists. The drug can be on the shelf like any other product. Examples are domperidone, 400 mg ibuprofen to 50 tablets and dextromethorphan. Drugs that are also UAD can be sold at drug stores, stores where there are no prescriptions available and there are only a selection of popular medicines such as painkillers and relatively few cough remedies. Drugs are usually on the shelf, and the store also sells items such as toys, gadgets, perfumes and homeopathic products. Drugs in this category have limited risks and potential addiction. Examples are naproxen and diclofenac in small amounts, cinnarizine, 400 mg ibuprofen up to 20 tablets and also 500 mg of paracetamol up to 50 tablets. Drugs in the AV category can be sold at supermarkets, gas stations, etc. And it only covers drugs with minimal risk to the public, such as paracetamol up to 20 tablets, 200 mg ibuprofen to 10 tablets, cetirizine and loperamide.
United States
In the United States, manufacture and sale of OTC substances is regulated by the Food and Drug Administration. The FDA requires all "new drugs" to receive a New Drug Application (NDA) prior to entering interstate commerce, but it excludes any medications that are generally recognized as safe and effective (GRAS/E). To deal with the large number of over-the-counter drugs on the market prior to the requirement that all drugs obtain NDA, the FDA creates an OTC monograph system to review drug classes and categorize them as GRAS/E after review by expert panel.. Certain classes of OTC drugs will not be required to obtain NDA and may remain in the market if they are in accordance with monographic guidelines for dosages, labeling and warnings that are resolved in the Federal Regulatory Code.
Thus, free drug products are permitted to be marketed (1) in accordance with the FDA monograph or (2) based on NDA for products that are inconsistent with a particular monograph. It is also possible that certain OTC drug products are marketed under the terms of grandparents of the Federal Food, Drug and Cosmetic Act, but the FDA has never officially acknowledged that legitimate OTC OTC drugs exist.
Examples of OTC substances approved in the United States are sunscreen, anti-microbial and anti-fungal products, external and internal analgesics such as lidocaine and aspirin, topical treatment of psoriasis and eczema, anti-dandruff shampoo containing coal tar, and other topical products with effects therapeutic.
The Federal Trade Commission regulates the advertising of OTC products, in contrast to prescription drug advertising, administered by the FDA.
The FDA requires that OTC products be labeled with an approved "Drug Facts" label to educate consumers about their medicines. Labels match the standard format and are intended to be easily understood by the average consumer. The Drug Facts label includes information on the product's active ingredients, indications and objectives, safety alerts, usage instructions, and inactive materials.
Restricted over-the-counter substance
An obscure third category of substances is a product that has over-the-counter status from the FDA while simultaneously subject to other restrictions on sales. Although they are legally classified as over the counter drugs, they are usually kept behind the counter and sold only in listed stores in their country. They may not be available in convenience and grocery stores that stock other non-restricted OTC drugs.
For example, many drugstores have moved products containing pseudoephedrine, OTC products, to locations where customers should ask a pharmacist for them. A prescription is not needed; changes have been made in an attempt to reduce methamphetamine production. Since the issuance of the Methamphetamine Precursor Control Act in Illinois and the federal Combat Methamphetamine Counter Act 2005, the purchase of pseudoephedrine is limited. The pseudoephedrine seller must obtain and record the buyer's identity and impose quantity restrictions. Some states may have more stringent requirements (such as Oregon, where medical prescriptions are required to purchase a certain amount of pseudoephedrine). After initial efforts to control methamphetamine use (by requiring sales documentation with a government-issued ID and a limit to the amount one can buy) failed to realize significant reductions in methamphetamine use and production, Mississippi passed House Bill 512 in the State Senate February 2, 2010 " recipes from licensed medical professionals to purchase over-the-counter medicines with pseudoephedrine, ephedrine, or other precursor chemicals that can be easily and unauthorizedly converted into methamphetamine, Methcathinone or any active/scheduled analogue of Phenylethylamines/amphetamine. "However, products containing such substances are still OTCs in most countries, as there are no prescriptions required.
Similar regulations apply to some forms of emergency contraception. The FDA regards them as OTC substances for 17 or more women but prescription drugs for younger women. To enforce restrictions and to provide counseling and education about proper use, agreements between manufacturers and the FDA require that drugs be stored behind the counter of a pharmacy. Women may obtain over the counter medication after providing proof of age for the pharmacy staff and receive the necessary patient education.
In addition, some substances regulated by Schedule V may be classified as OTC products in certain countries. Such drugs are sold without a prescription but are subject to the rules of recording and the quantity and/or age limit, and the drugs must be excluded by the pharmacy.
United Kingdom
In the United Kingdom, drugs are regulated by the Drug Regulations 2012. Drugs fall into one of three categories:
- Drug Only Prescription (POM), which is legally only available with a valid prescription from the prescriber. A pharmacist should be in place for POM medicines to be distributed, required by law. Medications have been specifically prescribed for patients who hold the prescription, so it is considered safe only for the recipient. Only a small sample of this includes most antibiotics and all antidepressant or antidiabetic drugs. Drugs included as POM are high strength painkillers such as oxycodone and tramadol, drugs such as sildenafil (Viagra) and diazepam (Valium), and certain topical preparations such as corticosteroids. These drugs are often sold by drug dealers, especially those marked as "CD POM," which are controlled for the risk of abuse such as dipipanone, temazepam, and methadone.
- General Sales List (GSL), available on the shelf with no pharmacy training needed to sell (so they can be sold anywhere, like supermarkets). In general, they are considered safe for most people when taken correctly. Examples include 16 packs (or less) painkillers such as paracetamol and ibuprofen as well as a number of other safe medications such as the size of a small anti-allergy tablet, laxative, and skin cream.
- Pharmaceutical Medicines (P) are drugs that are not legally POM or GSL drugs. These can be sold from registered pharmacies but should not be available for self-selection (although the instructions for discussing 'P' products can be allocated to shelf space with related GSL items). Drug 'P' is protected from the GSL list because they are related to the need for advice on use, or are used under conditions that may require referral to the medical prespriber. A suitable trained counter assistant can sell the drug 'P' under the supervision of a pharmacist and will ask questions to determine if the customer needs to be referred for a discussion with a pharmacist. Some 'POM' drugs are available for use in certain situations and doses as 'P' drugs.
If it is not appropriate to sell 'P' drugs - ie conditions unsuitable for self-management and require referrals to the medical prespriber - sales should not occur and pharmacists have legal and professional obligations to refer these to appropriate services.
Examples include some sleep-aid tablets such as Nytol, human deworming tablets such as Mebendazole, painkillers with a small amount of codeine (up to 12.8 mg per tablet), and pseudoephedrine. Drugs only available by prescription are marked somewhere in the box/container with [POM]. Pharmaceutical specialty products are indicated by [P]. A prescription is not required for drugs [P], and pharmaceutical sales assistants are required by the Royal Pharmaceutical Society code to ask a specific question, which varies to what the customer says. If they ask for a specific product, the pharmacy assistant should ask "For whom," "How long have you had the symptoms," "Are you allergic to any medication," "Did you take any medication" ('WHAM' question). If a customer asks for a drug, for example, a fever, then two WHAM questions should be followed. "For whom," "What are the symptoms," "How long have you had symptoms?" "Have you taken action on your symptoms," and "Did you take other drugs. "With this information, pharmacists can stop selling, if necessary. There are no [POM], [P] or [GSL] products stored in pharmacies that can be sold, distributed or pre-made until the responsible pharmacist enters and is on site. Some of the drugs available in supermarkets and gas stations are sold only in smaller package sizes. Often, larger packages will be marked as [P] and available only from pharmacies. Often, customers who purchase doses of larger [P] drugs than usual (such as DXM, promethazine, codeine or Gee's linctus) will be asked, because of possible abuse.
Switch between recipes and OTC
As a general rule, over-the-counter medications should be used primarily to treat conditions that do not require direct supervision of a doctor and should prove to be quite safe and well-tolerated. Over the counter drugs are usually also required to have little or no potential abuse, although in some areas drugs such as codeine are available OTC (usually in very limited formulations or require documents or identification to be submitted at purchase).
Over time, often 3-6 years, drugs that prove themselves safe and appropriate as prescription drugs can be transferred from prescription to OTC. An example is diphenhydramine (Benadryl), an anti-histamine that once needed a prescription but is now available almost everywhere OTC. More recent examples are cimetidine and loratadine in the United States, and ibuprofen in Australia.
It is rather unusual for a drug to be withdrawn from the market as a result of security concerns, rather than market forces, although that sometimes happens. For example, phenylpropanolamine has been removed from sales in the United States for concerns about stroke in young women. A study has been conducted examining consumer perceptions about the risks and access to nonprescription drugs. Most people seem willing to accept a big risk to get greater access to drugs.
In the United Kingdom, it was announced in February 2007 that Boots the Chemist would try the sale of free Viagra in stores in Manchester, England (previously only available as a recipe). Men aged between 30 and 65 can buy four tablets after consultation with pharmacists.
See also
- Child-resistant packaging
- Drug interactions
- Generally known as safe and effective
- Generic drugs
- The benefit law is reversed
- Medical prescriptions
- Over-the-counter counseling
- Pharmacy
- Therapeutic goods regulation
References
External links
- List of complete OTC drugs
- "Drug Free Drug Guides", Toolbox at ConsumerMedSafety.org
- "The Tan Sheet", OTC industry weekly news source in the US
- OTC Product News, comments on news and events affecting the OTC industry
- Over-the-counter medicines (OTC) at FamilyDoctor.org, managed by the American Academy of Family Physicians. Contains a wealth of information about over-the-counter and responsible use, including specific guidelines on several classes of drugs in question and answer format and information on general drug interactions.
- English Pharmaceuticals and Regulatory Agency List of Health Care Products on substances on the general sales list
- National Institute on Drug Abuse: "NIDA for Teens: Cough and Cold Drugs (DXM and Codeine Syrup)"
Source of the article : Wikipedia
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