A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription. Different jurisdictions have different definitions of what constitutes a prescription drug.
"Rx" is often used as a short form for prescription drug in North America. It is in fact an abbreviation for the Latin "recipe," the imperative form of "recipere," meaning "take thus."
Dispensation of prescription drugs often includes a monograph (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug.
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| Regulation of therapeutic goods in the United States |
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| Prescription drugs Over-the-counter drugs |
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Non-governmental organizations
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In the United States, the Federal Food, Drug, and Cosmetic Act defines what requires a prescription. Prescription drugs are generally authorized by veterinarians, dentists, optometrists, medical practitioners, and advanced practice nurses. It is generally required that an MD, DO, PA, OD, DPM, NMD, ND, DVM, DDS, or DMD, some Psychologists (see Medical Psychology), clinical pharmacists, Nurse Practitioners and other APRNs write the prescription; basic-level registered nurses, medical assistants, emergency medical technicians, most psychologists, and social workers as examples, do not have the authority to prescribe drugs.[1]
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.
The safety and effectiveness of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987. The Food and Drug Administration (FDA) is charged with implementing this law.
As a general rule, over-the-counter drugs (OTC) are used to treat conditions not necessarily requiring care from a health care professional and 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, while 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 is still available by prescription in doses up to four times the OTC dose for use in cases of severe pain not adequately controlled by the lower, OTC strength.
Herbal preparations, vitamins, minerals, and food supplements are not regulated by the FDA, so the individual consumer must be aware of the potential negative effects of using these preparations and also the potential interactions with prescription drugs they may be taking.
In the United States, the term "prescription drug" is most commonly used, but they are also called Rx-only drugs or legend drugs, after the Federal and State laws which mandate that all such drugs bear a "legend" prohibiting sale without a prescription; though more complex legends have been used, on most original drug packaging today the legend simply says "Rx only".
Also, pharmacies operated by membership clubs, such as Costco and Sam's Club, by law must allow non-members to use their pharmacy services and must charge the same prices as to members.
Physicians may legally prescribe drugs for uses other than those specified in the FDA approval; this is known as off-label use. Drug companies may not promote or market drugs for off-label uses.
Large U.S. retailers that operate pharmacies and pharmacy chains use inexpensive generic drugs as a way to attract customers into stores. Several chains, including Walmart, Dillons, Target, and others, offer $4 monthly prescriptions on select generic drugs as a customer draw.[2]
In the United Kingdom the Medicines Act 1968 governs the manufacture and supply of three categories of medicine:[3]
Possession of prescription-only medicines without a prescription is not a criminal offence unless it falls under the regulations of the misuse of drugs act.[3]
A patient visits a medical practitioner who is able to prescribe medication and certain other medical items, such as blood glucose testing equipment for diabetics. Similarly, suitably qualified and experienced nurses and pharmacists may be independent prescribers. Both can prescribe all POMs but pharmacists are not allowed to prescribe controlled drugs. District nurses and health visitors have had limited prescribing rights since the mid-nineties, before which prescriptions for dressings and simple medicines would have had to have been signed by a doctor.
Most prescriptions in the UK are NHS prescriptions, which can be taken to a pharmacy to be dispensed. The NHS prescription fee is £7.40 per item in England (as of 1 April 2011),[4] however prescription charges have been completely abolished in Wales, Scotland[5] and Northern Ireland.[6]
Prescription charges are paid entirely to the NHS through the pharmacy, while the pharmacy claims back from the NHS the cost of the medicine dispensed. Many of the prescriptions dispensed on the NHS are exempt from charges. Patients are exempt from the standard per-item charge if they are over 60, under 16 (or under 19 if in full-time education), have certain long-term chronic conditions such as myasthenia gravis, are on certain income-related benefits, or have a low income and qualify for an HC2 certificate.[7] Those requiring regular prescriptions may make a saving by purchasing a pre-payment certificate which covers the cost of all prescriptions required for three months or a year. In 2010, these were £104 for 12 months, or £28.25 for 3 months.
The per-item fee applies regardless of the quantity of each item prescribed by the doctor, and regardless of the underlying cost of the medicine to the NHS. This means that the patients perceived value of the charge can vary enormously - the actual cost of the medicine given out may vary from a few pence to hundreds of pounds. However, medical practitioners can prescribe a maximum three month supply of the medication in order for it to be covered under the NHS. If a medical practitioner wishes to prescribe a supply in excess of three months, the prescriber must write a separate, private prescription for the balance of the medication supply in excess of three months for which the patient must pay the actual price as charged by the pharmacist.[8][9] Private prescriptions are also issued by medical practitioners seen privately or sometimes for medicines not covered on the NHS.[8][9] For these, the patient will pay the pharmacy directly for the cost of the medicine and the pharmacy's dispensing fee.
In Australia the Standard for the Uniform Scheduling of Medicines and Poisons , abbreviated SUSMP, governs the manufacture and supply of drugs:[3]
The categories defined by the SUSMP are:
Similar to the UK, the patient visits a health practitioner, such as a doctor, nurse, dentist, podiatrist, etc., who is able to prescribe the medication.
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 medications. When purchasing a medication under the PBS the maximum price a consumer pays is the patient co-payment contribution which, as of January 1, 2011 is A$34.20 for general patients. Those covered by government entitlements (low-income earners, welfare recipients, Health Care Card holders, etc.) and those covered under the Repatriation Pharmaceutical Benefits Scheme (RPBS) have a reduced co-payment which is $5.60 in 2011. The table below indicates the changes in co-payments over the years. These co-payments are compulsory and cannot be discounted by pharmacies under any circumstances.
Private prescriptions are also issued which are for medicines not covered on the PBS or for medications being used for indications other than that are covered by the PBS. For these prescriptions, the patient will pay the pharmacy directly for the cost of the medicine and the pharmacy's dispensing fee.
The expiration date, required in several countries, specifies the date the manufacturer guarantees the full potency and safety of a drug. Most medications are potent and safe after the expiration date. 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 85% of them were safe and effective as far as 15 years past their expiration date. Joel Davis, a former FDA expiration-date compliance chief, said that with a handful of exceptions - notably nitroglycerin, insulin and some liquid antibiotics - most expired drugs are probably effective.[10]
The American Medical Association (AMA) issued a report and statement on Pharmaceutical Expiration Dates.[11] 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".[12]
Traces of prescription drugs—including antibiotics, anti-convulsants, mood stabilizers and sex hormones—have been detected in drinking water.[13][14]