Prescription drug

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.

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Regulation in United States

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.

Unlike most other countries, the United States does not have governmental control of prescription drug prices, and US drug prices are usually viewed as very expensive in comparison to those countries who do. For those with health insurance, many health insurance programs (generally paid partially or in full by the patient's employer) have prescription payment plans where the patient pays only a small copayment and the pharmacy is reimbursed for the remaining cost by the insurance company using the premiums collected from all of the insured individuals and their employers. The uninsured typically must pay whatever higher drug price their local pharmacy charges. Some indigent people can get assistance through publicly funded drug assistance programs such as Medicaid or private support through drug company prescription assistance programs.

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 potentially-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.

Regulation in United Kingdom

In the United Kingdom, a patient visits a general practitioner 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 and Scotland of £6.85 (as of April 2007), 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 and those on certain benefits. However in Wales prescription charges have been abolished - a situation the SNP government of Scotland hopes to emulate within the next four years.

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 four months or a year. 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.

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.

See also

• Regulation of therapeutic goods
• Package insert
• Pill splitting

Further reading

• 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
• Prescription drugs find place in teen culture in USA Today, June 12, 2006