Prescription drug

A prescription drug (also prescription medication or prescription medicine) 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 that 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 an abbreviation for the Latin "recipe", an imperative form of "recipere", meaning "take". ^[1]

Prescription drugs are often dispensed together with a monograph (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug.

Regulation in United States

Regulation of therapeutic goods in the United States
Prescription drugs Over-the-counter drugs
Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption
Government agencies Department of Health and Human Services -Food and Drug Administration- Department of Justice -Drug Enforcement Administration-
Process Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs
Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports
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In the United States, the Federal Food, Drug, and Cosmetic Act defines what requires a prescription. In general, prescription drugs are authorized by veterinarians, dentists, optometrists, medical practitioners, and advanced practice nurses. In general, it is 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.^[2]

The Controlled Substances Act (CSA) was enacted into law by the Congress of the United States in 1970. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain substances is regulated. The legislation created five Schedules (classifications), with varying qualifications for a substance to be included in each.

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.

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 conditions not necessarily requiring care from a healthcare 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, whereas 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, 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.^[3] In June 2007, the FDA issued the Dietary Supplement Current Good Manufacturing Practice (cGMP) Final Rule FDA 21 CFR Part 111. In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations.^[4]

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 that 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 states "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.^{[citation needed]}

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, Kroger (including subsidiaries such as Dillons), Target, and others, offer $4 monthly prescriptions on select generic drugs as a customer draw.^[5] Publix Supermarkets, which has pharmacies in many of their stores, offers free prescriptions on a few older but still effective medications to their customers. The maximum supply is for 30 days.

Regulation in United Kingdom

In the United Kingdom the Medicines Act 1968 governs the manufacture and supply of three categories of medicine:^[6]

• Prescription-only medicines (POM), which can be sold by a pharmacist if prescribed by a prescriber
• Pharmacy medicines (P), which may be sold by a pharmacist without prescription
• General sales list (GSL) medicines that may be sold without a prescription in any shop

Possession of prescription-only medicines without a prescription is not a criminal offence unless it falls under the Misuse of Drugs Act.^[6]

A patient visits a medical practitioner authorised to prescribe drugs and certain other medical items, such as blood glucose-testing equipment for diabetics. Also, 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 £7.85 per item in England (as of 1 April 2013),^[7] however prescription charges have been completely abolished in Scotland,^[8] Wales and Northern Ireland.^[9]

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. Most of the prescriptions dispensed on the NHS are exempt from charges.

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 financial impact on the patient of this system of fees 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 months supply of the medicine 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 medicine supply in excess of three months, for which the patient must pay the actual price as charged by the pharmacist.^[10][11] Private prescriptions are also issued by medical practitioners seen privately or sometimes for medicines not covered on the NHS.^[10][11] For these, the patient will pay the pharmacy directly for the cost of the medicine and the pharmacy's dispensing fee.

In 2007, a survey conducted by Ipsos Mori found that 800,000 people failed to collect a prescription during 2007 due to the cost.^[12]

Regulation in Australia

In Australia the Standard for the Uniform Scheduling of Medicines and Poisons, abbreviated SUSMP, governs the manufacture and supply of drugs:^[6]

The categories defined by the SUSMP are:

• Schedule 1 - Defunct
• Schedule 2 - Pharmacy Medicine
• Schedule 3 - Pharmacist-Only Medicine
• Schedule 4 - Prescription-Only Medicine/Prescription Animal Remedy
• Schedule 5 - Caution
• Schedule 6 - Poison
• Schedule 7 - Dangerous Poison
• Schedule 8 - Controlled Drug (Possession without authority illegal)
• Schedule 9 - Prohibited Substance
• Unscheduled Substances

Similar to the UK, the patient visits a health practitioner, such as a doctor, nurse, dentist, podiatrist, etc., who is able to prescribe the 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 maximum price a consumer pays is the patient co-payment contribution, which, as of January 1, 2013, is A$36.10 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 $5.90 in 2013. 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 that are for medicines not covered on the PBS or for medicines being used for indications other than that are covered by the PBS are also issued. For these prescriptions, the patient will pay the pharmacy directly for the cost of the medicine and the pharmacy's dispensing fee.

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. Most drugs are potent and safe for some time 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 - notable ones being nitroglycerin, insulin, and some liquid antibiotics - most expired drugs are probably effective.^[13]

The American Medical Association (AMA) issued a report and statement on Pharmaceutical Expiration Dates.^[14] 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".^[15]

Environmental problems

Traces of prescription drugs—including antibiotics, anti-convulsants, mood stabilizers and sex hormones—have been detected in drinking water.^[16][17]

See also

1a ^[18]

References

Further reading

Wikinews has related news: Partnership for a Drug-Free America study finds 1 in 5 teens abused prescription drugs

• The Optimal Level of Regulation in the Pharmaceutical Industry (Yale Economic Review)
• Jerry Avorn, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, Random House (2004), hardcover, 448 pages, ISBN 0-375-41483-5

• Donna Leinwand (June 13, 2006). "Prescription drugs find place in teen culture". USA Today.