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Over-the-counter drug

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"Over-the-counter" redirects here. For the securities trading method, seeOver-the-counter (finance).

OTCBayermedication withchild-resistant packaging(cap) andtamper-resistantcarton and innerseal
Photo of the packaging of four medicines dispensed in the United Kingdom showing theirProduct Licence Numbersand symbols denoting if they are Prescription Only Medicine (POM) or Pharmacy Medicine (P), or lacking either, denoting General Sales List (GSL). From top to bottom:mebendazole(P),amlodipine(POM),diazepam(POM),paracetamol(GSL).

Over-the-counter(OTC)drugsaremedicinessold directly to a consumer without a requirement for aprescriptionfrom a healthcare professional,[1]as opposed toprescription drugs,which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by aregulatory agencyto ensure that they contain ingredients that are safe and effective when used without aphysician's care. OTC drugs are usually regulated according to theiractive pharmaceutical ingredient(API) and strengths of final products.[2]

The termover-the-counter(OTC) refers to a medication that can be purchased without a medical prescription.[3]In contrast,prescription drugsrequire a prescription from a doctor or other health care professional and should only be used by the prescribed individual.[4]Some drugs may be legally classified as over-the-counter (i.e. no prescription is required), but may only be dispensed by apharmacistafter an assessment of the patient's needs or the provision ofpatient 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.

Usage

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As of 2011, around a third of older adults in the U.S. reportedly used OTC drugs, and this number is increasing.[5][6][7][8]By 2018, the prevalence of use by adults in the U.S. as first-line treatment for minor illnesses had reached 81%: however, there is some debate as to whether this figure relates to an actual improvement of health.[9][1][10]

Regulation by country

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Canada

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InCanada,there are four drug schedules:[11]

  • Schedule 1: Requires a prescription for sale and is provided to the public by a licensed pharmacist.
  • Schedule 2: Does not require a prescription but requires an assessment by a pharmacist prior to sale. These drugs are kept in an area of the pharmacy where there is no public access and may also be referred to as "behind-the-counter" drugs.
  • Schedule 3: Does not require a prescription but must be kept in an area under the supervision of a pharmacist. These drugs are kept in an area of the retail outlet where self-selection is possible, but a pharmacist must be available to assist in the self-selection of medication if required.
  • Unscheduled: Does not require a prescription and may be sold in any retail outlet.

All medications other than Schedule 1 may be considered an OTC drug, as they do not require prescriptions for sale. While the National Association of Pharmacy Regulatory Authorities provides recommendations on the scheduling of drugs for sale in Canada, each province may determine its own scheduling.[12]The drugs found in each schedule may vary from province to province.[citation needed]

India

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In November 2016, India's Drug Consultative Committee announced it was embarking on establishing a definition of drugs which could be dispensed without a prescription.[1]Prior to this, the general assumption was that any drug which did not fall into a prescription schedule could be purchased without a prescription.[1]However, the needed definition had not been enacted by early 2018. The lack of a legal definition for OTC drugs has led to thisUS$4 billionmarket segment being effectively unregulated.[1]

Netherlands

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In theNetherlands,there are four categories:[13]

  • UR (Uitsluitend Recept): prescription only
  • UA (Uitsluitend Apotheek): pharmacist only
  • UAD (Uitsluitend Apotheek of Drogist): pharmacist or drugstore only
  • AV (Algemene Verkoop): may be sold in general stores

A drug that is UA may be sold OTC but only by pharmacists. The drug can be on the shelves like any other product. Examples aredomperidone,400 mgibuprofenup to 50 tablets anddextromethorphan.A drug that is UAD can also be sold at drugstores which are stores where no prescription can be filled. The drugs are usually on the shelves, and the store also sells items like toys, gadgets, perfumes and homeopathic products. The drugs in this category have limited risk and addiction potential. Examples arenaproxenanddiclofenacin small amounts,cinnarizine,400 mg ibuprofen up to 20 tablets and also 500 mgparacetamolup to 50 tablets. Drugs in the AV category can be sold atsupermarkets,gas stations, etc. and include only drugs with minimal risk to the public, like paracetamol up to 20 tablets, 200 mg ibuprofen up to 10 tablets,cetirizineandloperamide.

United States

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In theUnited States,the manufacture and sale of OTC substances are regulated by theFood and Drug Administration.The FDA requires that all "new drugs" obtain aNew Drug Application(NDA) before entering interstate commerce, but the act exempts any drugsgenerally recognized as safe and effective(GRAS/E).[14]To deal with the vast number of OTC drugs that were already on the market before the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and to categorize them as GRAS/E after review by expert panels. Certain classes of OTC drugs would not be required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings finalized in theCode of Federal Regulations[15]

Thus, an OTC drug product is allowed to be marketed either (1) pursuant to anFDA monographor (2) pursuant to an NDA for products that do not fit within a specific monograph.[16]There is also the possibility that certain OTC drug products are marketed under the grandfathering provisions of theFederal Food, Drug, and Cosmetic Act,but the FDA has never formally acknowledged that any legitimate grandfathered OTC drug exists.

Examples of OTC substances approved in the United States are sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such aslidocaineandaspirin,psoriasisandeczematopical treatments, anti-dandruffshampoos containingcoal tar,and other topical products with a therapeutic effect.

TheFederal Trade Commissionregulates advertising of OTC products, in contrast to prescription drug advertising, which is regulated by the FDA.[17]

The FDA requires OTC products to be labeled with an approved "Drug Facts" label to educate consumers about their medications. The 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'sactive ingredient(s),indicationsand purpose, safety warnings, directions for use, andinactive ingredients.[18]

The 2020Coronavirus Aid, Relief, and Economic Security Act(CARES Act) includes reforms that modernize the way certain OTC drugs are regulated in the United States.[19][20]Many OTC monographs need to be updated but updating or changing an OTC monograph requires the slow and burdensome notice-and-comment rulemaking process.[19]The CARES Act includes OTC monograph reform provisions that replace the rulemaking process with an administrative order process.[19]

Restricted over-the-counter substances

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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 containingpseudoephedrine,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 reducemethamphetamineproduction. Since the passage of theIllinois Methamphetamine Precursor Control Actand the subsequent federalCombat Methamphetamine Epidemic Act of 2005,the purchase of pseudoephedrine is restricted. Sellers of pseudoephedrine must obtain and record the identity of the purchaser and enforcequantity restrictions.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,Mississippipassed 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 intomethamphetamine,methcathinoneor any active/scheduled analogs ofphenylethylamines/​​amphetamine."[citation needed]However, products containing the substance are still OTC in most states, since no prescription is required.

Plan B One-Step

A similar regulation once applied to some forms ofemergency 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.[21]

Furthermore, someSchedule Vcontrolled 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 apharmacy.[22]Finally, pharmacies frequently require a prescription for Schedule V drugs as a matter of policy, despite their OTC status according to applicable laws and regulations.[citation needed]

United Kingdom

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In the United Kingdom, medication is governed by the Medicines Regulations 2012. Medication falls into one of three categories:[1][23]

  1. Prescription Only Medication (POM), which is legally available only with a valid prescription from a prescriber. Apharmacisthas 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 mostantibioticsand allantidepressantsorantidiabeticmedications. Certain POM medicines are additionally marked Controlled Drug (CD) due to risk of abuse and the possibility of diversion for sale as street drugs. Examples of CDs include allbenzodiazepinesand strong opioids such asheroinandfentanyl.
  2. 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 asparacetamol,ibuprofen,andaspirinas well as a host of other medications such as small pack sizes of someantihistamines,somelaxativemedication, and skin creams. This also includes therecreationalsubstancesalcoholandcaffeine(where they are included in medicinal products), and somenicotinepreparations.
  3. Pharmacy Medicines (P) are medicines that are legally neither a POM or GSL medication. These can be sold from a registered pharmacy but should not be available for self-selection (although directions to discuss a 'P' product may be allocated shelf space with associated GSL items). 'P' medications are reserved from the GSL list as they are either associated with a need for advice on use, or used in conditions which may require referral to a medical prescriber. Suitably trained counter assistants may sell a 'P' medication 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' medicines are available for use in certain situations and doses as 'P' medicines.

If it is not appropriate to sell a 'P' medication – i.e. the condition is not suitable for self-management and requires referral to a medical prescriber – then a sale should not occur and the pharmacist has a legal and professional obligation to refer this on to an appropriate service.

Examples of these include some sleep aid tablets such asdiphenhydramine,humandewormingtablets such asmebendazole,painkillers with small amounts ofcodeine(up to 12.8 mg per tablet), andpseudoephedrine.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 byRoyal Pharmaceutical Societycodes 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., hay fever, then the '2WHAM questions' must be asked "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 asDXM,promethazine, codeine orGee's Linctus) will be queried, due to the possibility of abuse.[24]

Transitions between prescription and OTC

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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.[25]OTC drugs are usually also required to have little or no abuse potential, although in some areas drugs such ascodeineare available OTC (usually in strictly limited formulations or requiring paperwork or identification to be submitted during purchase).[26]

Over time, often 3–6 years, drugs that prove themselves safe and appropriate as prescription medicines may be switched from prescription to OTC.[citation needed]An example of this isdiphenhydramine(Benadryl), an anti-histamine which once required a prescription but now is available OTC nearly everywhere.[citation needed]More recent[when?]examples arecimetidineandloratadinein the United States, andibuprofenin Australia.[citation needed]

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,phenylpropanolaminewas removed from sale in the United States over concern regardingstrokesin young women.[27]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.[28]Ranitidinewas suspended in multiple markets due to concerns over the presence of thecarcinogenN-nitrosodimethylamine(NDMA).[29][30][31][32]

In the United Kingdom, it was announced in February 2007 thatBoots the Chemistwould try over-the-counter sales of Viagra in stores inManchester, England(previous available as prescription only). Men aged between 30 and 65 could buy four tablets after a consultation with apharmacist.[33]

See also

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References

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  1. ^abcdefMillar A (February 2018)."Defining OTC Drugs".Pharma Technology Focus(67).Retrieved3 February2018.
  2. ^"Over-the-Counter Medicines: What's Right for You?".FDA.Retrieved19 May2024.
  3. ^"Understanding Over-the-Counter Medicines".Center for Drug Evaluation and Research.U.S. Food and Drug Administration. 14 August 2019.Retrieved26 August2019.
  4. ^"Prescription Drugs and Over-the-Counter (OTC) Drugs: Questions and Answers".Center for Drug Evaluation and Research.U.S. Food and Drug Administration. 25 April 2019.
  5. ^Saha A, Balakrishnan S, Trivedi N, Abraham GM (1 January 2023)."Hypertension and Severe Hypokalemia Associated With Oral Ingestion of Topical Hydrocortisone Cream".AACE Clinical Case Reports.9(1): 2–4.doi:10.1016/j.aace.2022.10.004.PMC9837079.PMID36654996.
  6. ^Sánchez-Sánchez E, Fernández-Cerezo FL, Díaz-Jimenez J, Rosety-Rodriguez M, Díaz AJ, Ordonez FJ, et al. (May 2021)."Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs".International Journal of Environmental Research and Public Health.18(11): 5530.doi:10.3390/ijerph18115530.PMC8196755.PMID34064096.
  7. ^Qato DM, Wilder J, Schumm LP, Gillet V, Alexander GC (April 2016)."Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011".JAMA Internal Medicine.176(4): 473–482.doi:10.1001/jamainternmed.2015.8581.PMC5024734.PMID26998708.
  8. ^Esher A, Coutinho T (August 2017)."Rational use of medicines, pharmaceuticalization and uses of methylphenidate".Ciencia & Saude Coletiva(in Portuguese).22(8): 2571–2580.doi:10.1590/1413-81232017228.08622017.PMID28793073.
  9. ^Sánchez-Sánchez E, Fernández-Cerezo FL, Díaz-Jimenez J, Rosety-Rodriguez M, Díaz AJ, Ordonez FJ, et al. (May 2021)."Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs".International Journal of Environmental Research and Public Health.18(11): 5530.doi:10.3390/ijerph18115530.PMC8196755.PMID34064096.
  10. ^Saha A, Balakrishnan S, Trivedi N, Abraham GM (1 January 2023)."Hypertension and Severe Hypokalemia Associated With Oral Ingestion of Topical Hydrocortisone Cream".AACE Clinical Case Reports.9(1): 2–4.doi:10.1016/j.aace.2022.10.004.PMC9837079.PMID36654996.
  11. ^"NDS Process and Scheduling Factors".National Association of Pharmacy Regulatory Authorities.Retrieved26 August2019.
  12. ^"Drug Scheduling in Canada".National Association of Pharmacy Regulatory Authorities.Retrieved26 August2019.
  13. ^Geneesmiddelenwet
  14. ^Drug Development and Review Definitions.Fda.gov (2015-08-20). Retrieved on 2019-08-26.
  15. ^Drug Applications for Over-the-Counter (OTC) Drugs.Fda.gov (2015-01-07). Retrieved on 2019-08-26.
  16. ^"Drug Applications for Over-the-Counter (OTC) Drugs".Center for Drug Evaluation and Research.U.S. Food and Drug Administration. 29 May 2019.Retrieved26 August2019.
  17. ^Regulation of Nonprescription Drug ProductsFda.gov. Retrieved on 2014-04-24.
  18. ^OTC Drug Facts Label.Fda.gov (2015-06-05). Retrieved on 2019-08-26.
  19. ^abc"An Exciting New Chapter in OTC Drug History: OTC Monograph Reform".U.S.Food and Drug Administration(FDA).6 August 2020.Retrieved2 September2020.Public DomainThis article incorporates text from this source, which is in thepublic domain.
  20. ^Over-the-Counter Monograph User Fee Program Performance Goals and Procedures - Fiscal Years 2018-2022(PDF)(Report). U.S.Food and Drug Administration(FDA).Retrieved2 September2020.Public DomainThis article incorporates text from this source, which is in thepublic domain.
  21. ^"Princeton University".Archived fromthe originalon 19 April 2021.Retrieved4 February2020.
  22. ^Controlled Substances Listed in Schedules III, IV, and VArchived2021-03-21 at theWayback Machine.US Department of Justice - Drug Enforcement Administration. Retrieved on 2019-08-26.
  23. ^"Medicines information".NHS Choices.Retrieved19 September2017.
  24. ^"Availability of medicines".Archived2010-03-29 at theWayback Machine.MHRA. Retrieved on 2012-07-04.
  25. ^Sánchez-Sánchez E, Fernández-Cerezo FL, Díaz-Jimenez J, Rosety-Rodriguez M, Díaz AJ, Ordonez FJ, et al. (May 2021)."Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs".International Journal of Environmental Research and Public Health.18(11): 5530.doi:10.3390/ijerph18115530.PMC8196755.PMID34064096.
  26. ^Sánchez-Sánchez E, Fernández-Cerezo FL, Díaz-Jimenez J, Rosety-Rodriguez M, Díaz AJ, Ordonez FJ, et al. (May 2021)."Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs".International Journal of Environmental Research and Public Health.18(11): 5530.doi:10.3390/ijerph18115530.PMC8196755.PMID34064096.
  27. ^"Phenylpropanolamine (PPA) Information Page".Center for Drug Evaluation and Research.U.S.Food and Drug Administration.22 December 2005.
  28. ^Alexander GC, Mohajir N, Meltzer DO (2005). "Consumers' perceptions about risk of and access to nonprescription medications".Journal of the American Pharmacists Association.45(3): 363–370.doi:10.1331/1544345054003868.PMID15991758.
  29. ^"Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)".U.S. Food and Drug Administration.11 October 2019.Archivedfrom the original on 24 October 2019.Retrieved23 October2019.Public DomainThis article incorporates text from this source, which is in thepublic domain.
  30. ^"FDA Requests Removal of All Ranitidine Products (Zantac) from the Market".U.S.Food and Drug Administration(FDA)(Press release). 1 April 2020.Retrieved1 April2020.Public DomainThis article incorporates text from this source, which is in thepublic domain.
  31. ^"Suspension of ranitidine medicines in the EU".European Medicines Agency(EMA)(Press release). 30 April 2020.Retrieved2 June2020.
  32. ^"Ranitidine".Therapeutic Goods Administration (TGA).2 April 2020. Archived fromthe originalon 29 August 2021.Retrieved19 July2020.
  33. ^"Over-the-counter Viagra piloted".BBC News Online.11 February 2007.Retrieved10 February2009.
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