Over-the-counter drug

Over-the-counter (OTC) drugs are

The term over-the-counter (OTC) refers to a medication that can be purchased without a medical prescription.[3] In contrast, prescription drugs require 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 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.

Usage

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

Canada

In Canada, 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

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 this US$4 billion market segment being effectively unregulated.^[1]

Netherlands

In the Netherlands, 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 are

In the United States, the manufacture and sale of OTC substances are regulated by the Food and Drug Administration. The FDA requires that all "new drugs" obtain a New Drug Application (NDA) before entering interstate commerce, but the act exempts any drugs generally 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 the Code of Federal Regulations^[15]

Thus, an OTC drug product is allowed to be marketed either (1) pursuant to an FDA monograph or (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 the Federal 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 as

The Federal Trade Commission regulates 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's

The 2020 Coronavirus 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

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

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.^[21]

Furthermore, some

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. A
   benzodiazepines and strong opioids such as heroin and fentanyl
   .
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 as
   recreational substances alcohol and caffeine (where they are included in medicinal products), and some nicotine
   preparations.
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.

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 as codeine are 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 is diphenhydramine (Benadryl), an anti-histamine which once required a prescription but now is available OTC nearly everywhere.^{[citation needed]} More recent^[when?] examples are cimetidine and loratadine in the United States, and ibuprofen in 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,

References