Prescription drug

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A prescription drug is a licensed medicine that is regulated by legislation to require a 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.

Dispensation of prescription drugs often includes a package insert (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug.

1 Regulation in United States
2 Regulation in United Kingdom
3 See also
4 References
5 Further reading

[edit] Regulation in United States

U.S. drug regulation

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
United States Department of Health and Human Services Food and Drug Administration Drug Enforcement Administration National Institutes of Health Center for Drug Evaluation and Research

Process
New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval

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. Prescription drugs are generally authorized by veterinarians, dentists, optometrists, physicians and nurse practitioners, though physician assistants do an increasing amount of drug prescribing under a physician's supervision. It is generally required that an MD, DO, DPM, NP, DVM, DDS, DMD, OD, or PA write the prescription; basic-level registered nurses (as opposed to advanced practice nurses such as a nurse practitioner, clinical nurse specialist, nurse anesthetist, and nurse midwife), emergency medical technicians, psychologists (but not psychiatrists, who are physicians), and social workers as examples, do not have the authority to prescribe drugs.

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 is charged with implementing this law.

As a general rule, over the counter drugs are used to treat conditions not necessarily requiring care from a health care provider and will have been proven to meet higher safety standards for self-medication by patients. Often a lower dosage of a drug will be approved for OTC use, while higher dosages will remain the province of a prescription; a notable case is ibuprofen, which has been widely available as an OTC pain killer since the mid-1980s but is still available in doses up to four times the OTC dose for use in cases of severe orthopedic pain.

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 legend drugs or Rx-only drugs, after the requirements of Federal and state laws 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". In the United Kingdom, they are referred to as Prescription Only Medicine or POM.

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.

Prescription drugs -- including antibiotics, anti-convulsants, mood stabilizers and sex hormones -- have been found in the drinking water supplies of at least 41 million Americans, it was reported on March 10, 2008.^[1]

[edit] Regulation in United Kingdom

In the United Kingdom, a patient visits a general practitioner (GP) who is able to prescribe medicines. If given an NHS prescription, this can be taken to a pharmacy to be dispensed. District nurses and health visitors have had limited prescribing rights since the mid-nineties where prescription for dressings and simple medicines would have had to have been signed by a doctor. Extended prescribing was introduced in late 1999, where appropriately trained nurses could prescribe from a limited list of POMs. From 2006, some nurses and pharmacists will be permitted to prescribe all medicines in the British National Formulary, except controlled drugs directly. Each item on the prescription is liable to a prescription charge in England of £7.10 (as of 1st April 2008)^[2],This charge is paid entirely to the NHS through the pharmacy, while the pharmacy claims the cost of the medicine dispensed. Each "item" can cover any prescribed item in a very large or very small quantity according to the doctor's prescription. This means that the patients perceived "value" of the charge varies enormously - the actual cost of the medicine given out will routinely vary from a few pence to hundreds of pounds.

Although many patients are exempt from this charge, this includes those over 60, under 16 (or under 19 if in full-time education), patients with certain medical conditions, those on certain benefits and those with an HC2 certificate, which is issued if a patient can prove their income is under £8,000 per year. However, in Wales prescription charges have been abolished and in Scotland prescription charges have been reduced to £5 (as of 1st April 2008) as a first phase of abolishing them over the next three years.^[3]

An HC2 certificate can be applied for — although not automatically granted — by those on a low income or in receipt of incapacity benefit. Claimants of "Jobseekers" and "Income support" automatically receive free prescriptions and dentistry.

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. As of 1st April 2008 they cost £27.85 for 3 months and £102.50 for 12 months. (offering a saving to anyone who needs more than 3 items in 3 months or 14 items in 12 months).

The majority of items dispensed on NHS prescription are exempt from charges. This is because of the large number of medicines needed by, for example, the elderly or those with medical exemptions. NHS prescriptions can also be written for certain items by dentists and nurses. Some patients also receive private prescriptions, typically either from a doctor seen privately or for medicine not permitted on the NHS. For these, the patient will pay the pharmacy directly for the cost of the medicine and the pharmacy's markup.