OVER-THE-COUNTER (OTC) DRUGS are medicines sold directly to a consumer without a prescription from a healthcare professional, as opposed to prescription drugs , which may only be sold 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 counterintuitive , since, in many countries, these drugs are often placed on shelves in self-service areas of stores, like any other packaged products. In contrast, prescription drugs 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 pharmacist after an assessment of the patient's needs 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, and gas stations. 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.
* 1 Usage
* 2 Regulation by country
* 2.3.1 Restricted over-the-counter substances
* 2.4 United Kingdom
* 3 Switches between prescription and OTC * 4 See also * 5 References * 6 External links
As of 2011, around a third of older adults in the U.S. reportedly use OTC drugs.
REGULATION BY COUNTRY
* Schedule 1: Requires a prescription for sale and are 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.
* UR (Uitsluitend Recept): Prescription only
* UA (Uitsluitend Apotheek):
A drug that is UA can 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 .
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
Federal Trade Commission
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 active ingredient(s) , indications and purpose, safety warnings, directions for use, and inactive ingredients .
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
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
A similar regulation applies to some forms of emergency contraception . The FDA considers them to be OTC substances for females 17 or over but prescription drugs for younger women. To enforce the restriction and to provide counseling and education on proper use, an agreement between the manufacturer and the FDA requires the 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 they must be dispensed by a pharmacy .
In the United Kingdom, medication is governed by the Medicines
* Prescription Only
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
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 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. 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
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
* ^ Over-the-Counter Medicines: What\'s Right for You?. Fda.gov (2009-04-30). Retrieved on 2012-07-04. * ^ Qato DM; Wilder J; Schumm L; Gillet V; Alexander G (2016-04-01). "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. ISSN 2168-6106 . PMID 26998708 . doi :10.1001/jamainternmed.2015.8581 . * ^ "National Drug Schedules - Overview". National Association of Pharmacy Regulatory Authorities. Retrieved 16 August 2015. * ^ "National Drug Scheduling Advisory Committee". National Association of Pharmacy Regulatory Authorities. Retrieved 16 August 2015. * ^ Geneesmiddelenwet * ^ CBG-MEB Drug database * ^ Regulation of Nonprescription Drug Products Fda.gov. Retrieved on 2014-04-24. * ^ The New Over-the-Counter Medicine Label: Take a Look. Fda.gov (2012-04-27). Retrieved on 2012-07-04. * ^ FDA Approves Plan B One-Step Emergency Contraceptive; Lowers Age for Obtaining Two-Dose Plan B Emergency Contraceptive without a Prescription. Fda.gov. Retrieved on 2012-07-04. * ^ FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older. Fda.gov (2009-04-30). Retrieved on 2012-07-04. * ^ Availability of medicines. MHRA. Retrieved on 2012-07-04. * ^ 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. PMID 15991758 . doi :10.1331/1544345054003868 . * ^ "Over-the-counter Viagra piloted". BBC News. 2007-02-11. Retrieved 2009-02-10.