What is a Prescription Drug?

Introduction

A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

In North America, ℞, usually printed as “Rx”, is used as an abbreviation of the word “prescription”. It is a contraction of the Latin word “recipe” (an imperative form of “recipere”) meaning “take”. Prescription drugs are often dispensed together with a monograph (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug.

The use of prescription drugs has been increasing since the 1960s.

Regulation

Australia

In Australia, the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) governs the manufacture and supply of drugs with several categories:

  • Schedule 1 – Defunct Drug.
  • Schedule 2 – Pharmacy Medicine.
  • Schedule 3 – Pharmacist-Only Medicine.
  • Schedule 4 – Prescription-Only Medicine/Prescription Animal Remedy.
  • Schedule 5 – Caution/Poison.
  • Schedule 6 – Poison.
  • Schedule 7 – Dangerous Poison.
  • Schedule 8 – Controlled Drug (Possession without authority illegal).
  • Schedule 9 – Prohibited Substance (Possession illegal without a license legal only for research purposes).
  • Schedule 10 – Controlled Poison.
  • Unscheduled Substances.

As in other developed countries, the person requiring a prescription drug attends the clinic of a qualified health practitioner, such as a physician, who may write the prescription for the required drug.

Many prescriptions issued by health practitioners in Australia are covered by the Pharmaceutical Benefits Scheme, a scheme that provides subsidised prescription drugs to residents of Australia to ensure that all Australians have affordable and reliable access to a wide range of necessary medicines. When purchasing a drug under the PBS, the consumer pays no more than the patient co-payment contribution, which, as of 01 January 2022, is A$42.50 for general patients. Those covered by government entitlements (low-income earners, welfare recipients, Health Care Card holders, etc.) and or under the Repatriation Pharmaceutical Benefits Scheme (RPBS) have a reduced co-payment, which is A$6.80 in 2022. The co-payments are compulsory and can be discounted by pharmacies up to a maximum of A$1.00 at cost to the pharmacy.

United Kingdom

In the United Kingdom, the Medicines Act 1968 and the Prescription Only Medicines (Human Use) Order 1997 contain regulations that cover the supply of sale, use, prescribing and production of medicines. There are three categories of medicine:

  • Prescription-only medicines (POM), which may be dispensed (sold in the case of a private prescription) by a pharmacist only to those to whom they have been prescribed.
  • Pharmacy medicines (P), which may be sold by a pharmacist without a prescription.
  • General sales list (GSL) medicines, which may be sold without a prescription in any shop.

The possession of a prescription-only medicine without a prescription is legal unless it is covered by the Misuse of Drugs Act 1971.

A patient visits a medical practitioner or dentist, who may prescribe drugs and certain other medical items, such as blood glucose-testing equipment for diabetics. Also, qualified and experienced nurses and pharmacists may be independent prescribers. Both may prescribe all POMs (including controlled drugs), but may not prescribe Schedule 1 controlled drugs, and 3 listed controlled drugs for the treatment of addiction; which is similar to doctors, who require a special license from the Home Office to prescribe schedule 1 drugs. Schedule 1 drugs have little or no medical benefit, hence their limitations on prescribing. District nurses and health visitors have had limited prescribing rights since the mid-1990s; until then, prescriptions for dressings and simple medicines had to be signed by a doctor. Once issued, a prescription is taken by the patient to a pharmacy, which dispenses the medicine.

Most prescriptions are NHS prescriptions, subject to a standard charge that is unrelated to what is dispensed. The NHS prescription fee was increased to £9.15 per item in England on 01 April 2020; prescriptions are free of charge if prescribed and dispensed in Scotland, Wales and Northern Ireland, and for some patients in England, such as inpatients, children, those over 60s or with certain medical conditions, and claimants of certain benefits. The pharmacy charges the NHS the actual cost of the medicine, which may vary from a few pence to hundreds of pounds. A patient can consolidate prescription charges by using a prescription payment certificate (informally a “season ticket”), effectively capping costs at £29.60 per quarter or £105.90 per year.

Outside the NHS, private prescriptions are issued by private medical practitioner and sometimes under the NHS for medicines that are not covered by the NHS. A patient pays the pharmacy the normal price for medicine prescribed outside the NHS.

Survey results published by Ipsos MORI in 2008 found that around 800,000 people in England were not collecting prescriptions or getting them dispensed because of the cost, the same as in 2001.

United States

In the United States, the Federal Food, Drug, and Cosmetic Act defines what substances require a prescription for them to be dispensed by a pharmacy. The federal government authorises physicians (of any specialty), physician assistants, nurse practitioners and other advanced practice nurses, veterinarians, dentists, and optometrists to prescribe any controlled substance. They are then issued unique DEA numbers; many other mental and physical health technicians, including basic-level registered nurses, medical assistants, emergency medical technicians, most psychologists, and social workers, for example, do not have the authority to prescribe any legend drugs or controlled drugs. Legend drugs are another name for drugs requiring a prescription.

The Controlled Substances Act (CSA) was enacted into law by the US Congress of the United States in 1970. It is the federal drug law that regulates manufacture, importation, possession, use, and distribution of controlled substances. The legislation classes these substances into five schedules, with varying qualifications for each schedule. The schedules are designated schedule I, schedule II, schedule III, schedule IV, and schedule V. Many drugs require a prescription, even though they are not a controlled substance.

The safety and the effectiveness of prescription drugs in the US are regulated by the 1987 Prescription Drug Marketing Act (PDMA). The Food and Drug Administration (FDA) is charged with implementing the law.

Misuse or abuse of prescription drugs can lead to adverse drug events, including those due to dangerous drug interactions.

The package insert for a prescription drug contains information about the intended effect of the drug and how it works in the body. It also contains information about side effects, how a patient should take the drug, and cautions for its use, including warnings about allergies.

As a general rule, over-the-counter drugs (OTC) are used to treat a condition that does not need care from a healthcare professional if have been proven to meet higher safety standards for self-medication by patients. Often, a lower strength of a drug will be approved for OTC use, but higher strengths require a prescription to be obtained; a notable case is ibuprofen, which has been widely available as an OTC pain killer since the mid-1980s, but it is available by prescription in doses up to four times the OTC dose for severe pain that is not adequately controlled by the OTC strength.

Herbal preparations, amino acids, vitamins, minerals, and other food supplements are regulated by the FDA as dietary supplements. Because specific health claims cannot be made, the consumer must make informed decisions when purchasing such products.

By law, American pharmacies operated by “membership clubs” such as Costco and Sam’s Club must allow non-members to use their pharmacy services and may not charge more for these services than they charge as their members.

Physicians may legally prescribe drugs for uses other than those specified in the FDA approval, known as off-label use. Drug companies, however, are prohibited from marketing their drugs for off-label uses.

Large US retailers that operate pharmacies and pharmacy chains use inexpensive generic drugs as a way to attract customers into stores. Several chains, including Walmart, Kroger (including subsidiaries such as Dillons), Target, and others, offer $4 monthly prescriptions on select generic drugs as a customer draw. Publix Supermarkets, which has pharmacies in many of their stores, offered free prescriptions on a few older but still effective medications to their customers, the programme ended in 2022. The maximum supply is for 30 days.

Some prescription drugs are commonly abused, particularly those marketed as analgesics, including fentanyl (Duragesic), hydrocodone (Vicodin), oxycodone (OxyContin), oxymorphone (Opana), propoxyphene (Darvon), hydromorphone (Dilaudid), meperidine (Demerol), and diphenoxylate (Lomotil).

Some prescription painkillers have been found to be addictive, and unintentional poisoning deaths in the United States have skyrocketed since the 1990s according to the National Safety Council. Prescriber education guidelines as well as patient education, prescription drug monitoring programs and regulation of pain clinics are regulatory tactics which have been used to curtail opioid use and misuse.

Expiration Date

The expiration date, required in several countries, specifies the date up to which the manufacturer guarantees the full potency and safety of a drug. In the United States, expiration dates are determined by regulations established by the FDA. The FDA advises consumers not to use products after their expiration dates.

A study conducted by the U.S. Food and Drug Administration covered over 100 drugs, prescription and over-the-counter. The results showed that about 90% of them were safe and effective far past their original expiration date. At least one drug worked 15 years after its expiration date. Joel Davis, a former FDA expiration-date compliance chief, said that with a handful of exceptions – notably nitroglycerin, insulin, some liquid antibiotics; outdated tetracyclines can cause Fanconi syndrome – most expired drugs are probably effective.

The American Medical Association (AMA) issued a report and statement on Pharmaceutical Expiration Dates. The Harvard Medical School Family Health Guide notes that, with rare exceptions, “it’s true the effectiveness of a drug may decrease over time, but much of the original potency still remains even a decade after the expiration date”.

The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication. Drug expiration dates exist on most medication labels, including prescription, over-the-counter (OTC) and dietary (herbal) supplements. US pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing. For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date.

Cost

Prices for prescription drugs vary widely around the world. Prescription costs for biosimilar and generic drugs are usually less than brand names, but the cost is different from one pharmacy to another.

Prescription drug prices including generic prices are rising faster than the average rate of inflation. To lower prescription drug costs, some US patients buy medicine in Canada or online.

Generics undergo strict scrutiny to meet the equal efficacy, safety, dosage, strength, stability, and quality of brand name drugs. Generics are developed after the brand name has already been established, and so generic drug approval in many aspects has a shortened approval process because it replicates the brand name drug.

Brand name drugs cost more due to time, money, and resources that drug companies invest in in order to repeat research clinical trials that the FDA requires for the drug to remain in the market. Because drug companies have to invest more in research costs to do this, brand name drug prices are much higher when sold to consumers.

When the patent expires for a brand name drug, generic versions of that drug are produced by other companies and are sold for lower price. By switching to generic prescription drugs, patients can save significant amounts of money: e.g. one study by the FDA showed an example with more than 50% savings of a patient’s overall costs of their prescription drugs.

Drug Cost Containment Strategies in the US

In the United States there are many resources available to patients to lower the costs of medication. These include co-payments, coinsurance, and deductibles. The Medicaid Drug Rebate Programme is another example.

Generic drug programs lower the amount of money patients have to pay when picking up their prescription at the pharmacy. As their name implies, they only cover generic drugs.

Co-pay assistance programmes are programmes that help patients lower the costs of specialty medications; i.e., medications that are on restricted formularies, have limited distribution, and/or have no generic version available. These medications can include drugs for HIV, hepatitis C, and multiple sclerosis. Patient Assistance Programme Centre (RxAssist) has a list of foundations that provide co-pay assistance programmes. It is important to note that co-pay assistance programmes are for under-insured patients. Patients without insurance are not eligible for this resource; however, they may be eligible for patient assistance programmes.

Patient assistance programmes are funded by the manufacturer of the medication. Patients can often apply to these programs through the manufacturer’s website. This type of assistance programme is one of the few options available to uninsured patients.

The out-of-pocket cost for patients enrolled in co-pay assistance or patient assistance programmes is $0. It is a major resource to help lower costs of medications – however, many providers and patients are not aware of these resources.

Environment

Traces of prescription drugs – including antibiotics, anti-convulsants, mood stabilisers and sex hormones – have been detected in drinking water. Pharmaceutically active compounds (PhACs) discarded from human therapy and their metabolites have been found to not be eliminated by sewage treatment plants and have been found at low concentrations in surface waters downstream from those plants. The continuous discarding of incompletely treated water may interact with other environmental chemicals and lead to uncertain ecological effects. Due to most pharmaceuticals being highly soluble, fish and other aquatic organisms are susceptible to their effects. The long term effects of pharmaceuticals in the environment may affect survival and reproduction of such organisms. However, levels of medical drug waste in the water is at a low enough level that it is not a direct concern to human health. However, processes, such as biomagnification, are potential human health concerns.

On the other hand, there is clear evidence of harm to aquatic animals and fauna. Recent advancements in technology have allowed scientists to detect smaller, trace quantities of pharmaceuticals in the ng/ml range. Despite being found such low concentrations, female hormonal contraceptives have been documented to cause feminising effects on male vertebrate species, such as fish, frogs and crocodiles. A promising model has been developed to further study the effects on the aquatic environment. The biological read across model combines the concepts of the mechanism of action (MoA) and adverse outcomes pathway (AOP). In other words, the species being studied needs to have similar mechanisms by which the pharmaceutical acts on the species and reach similar concentrations that would be enough to cause an effect in humans. Studying these relations may give us more quantifiable information on the effects of pharmaceuticals in the environment.

Currently, research is being done on various methods of reducing chemical waste in the environment. In addition, FDA established guidelines in 2007 to inform consumers should dispose of prescription drugs. When medications do not include specific disposal instructions, patients should not flush medications in the toilet, but instead use medication take-back programmes. This aims to reduce the amount of pharmaceutical waste that gets into sewage and landfills. If no take-back programs are available, prescription drugs can be discarded in household trash after they are crushed and/or dissolved and then mixed in a separate container or sealable bag with undesirable substances like cat litter or other unappealing material (to discourage consumption).

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What is an Over-the-Counter Drug?

Introduction

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription.

In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician’s care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

The term OTC refers to a medication that can be purchased without a medical prescription. In contrast, prescription drugs require a prescription from a doctor and should only be used by the prescribed individual. Some drugs may be legally classified as OTC (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 authorised 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 US reportedly used OTC drugs. By 2018, the prevalence of use by adults in the US as first-line treatment for minor illnesses had reached 81%.

Regulation by Country

Canada

In Canada, there are four drug schedules:

  • 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. The drugs found in each schedule may vary from province to province.

Indonesia or 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. Prior to this, the general assumption was that any drug which did not fall into a prescription schedule could be purchased without a prescription. 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.

Netherlands

In the Netherlands, there are four categories:

  • 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 domperidone, 400 mg ibuprofen up to 50 tablets and dextromethorphan. A drug that is UAD can also be sold at drugstores, stores where no prescription can be filed and there is only a relatively small selection of popular drugs like painkillers and cough medicine. 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 are naproxen and diclofenac in small amounts, cinnarizine, 400 mg ibuprofen up to 20 tablets and also 500 mg paracetamol up to 50 tablets. Drugs in the AV category can be sold at supermarkets, 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, cetirizine and loperamide.

United States

In the United States, the manufacture and sale of OTC substances are regulated by the Food and Drug Administration (FDA). The FDA requires that all “new drugs” obtain a New Drug Application (NDA) before entering interstate commerce, but the act exempts any drugs generally recognised as safe and effective (GRAS/E). 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 categorise 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, labelling, and warnings finalized in the Code of Federal Regulations.

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. 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 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, in contrast to prescription drug advertising, which is regulated by the FDA.

The FDA requires OTC products to be labelled 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 active ingredient(s), indications and purpose, safety warnings, directions for use, and inactive ingredients.

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

Restricted Over-the-Counter Substances (US)

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 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 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 (such as Oregon, where a medical prescription is required to purchase any quantity of pseudoephedrine). 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 realise meaningful reductions in methamphetamine use and production, Mississippi passed 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 into methamphetamine, Methcathinone or any active/scheduled analogues of Phenylethylamines/ amphetamine.” However, products containing the substance are still OTC in most states, since no prescription is required.

A similar regulation once applied to some forms of emergency contraception. However, on 25 February 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.

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 they must be dispensed by a pharmacy. 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.

United Kingdom

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

  • Prescription Only Medication (POM), which are legally available only with a valid prescription from a prescriber.
    • 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.
    • Just a small example of these include most antibiotics and all antidepressants or antidiabetic medications.
    • Drugs included as POM are high-strength painkillers such as oxycodone and tramadol, medications such as Zolpidem (Ambien), diazepam (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 dipipanone, temazepam, and methadone.
  • 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 paracetamol and ibuprofen as well as a host of other safe medications such as small pack sizes of antiallergy tablets, laxative medication, and skin creams.
  • 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.
    • Suitable 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 as Nytol, human deworming tablets such as Mebendazole, painkillers with small amounts of codeine (up to 12.8 mg per tablet), and pseudoephedrine. 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. hay fever, then the two WHAM 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.

Transitions 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 codeine are available OTC (usually in strictly limited formulations or requiring paperwork or identification to be submitted during purchase).

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. More recent examples are cimetidine and loratadine in the United States, and ibuprofen 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. For example, phenylpropanolamine 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 non-prescription medication. The study concluded that a small percentage of consumers prefer having access to medication over potential risks of taking non-prescribed medication. Ranitidine was withdrawn from multiple markets due to concerns over the carcinogen N-nitrosodimethylamine (NDMA).

In the United Kingdom, it was announced in February 2007 that Boots the Chemist would try OTC sales of Viagra in stores in Manchester, England (previous available as prescription only). Men aged between 30 and 65 could buy four tablets after a consultation with a pharmacist.