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
Dispensation of prescription drugs often includes a monograph
(in Europe, a Patient Information
Leaflet or PIL) that gives detailed information about the
Regulation in United States
In the United States, the Federal Food, Drug, and
defines what requires a prescription. Prescription
drugs are generally authorized by veterinarians, dentists,
optometrists, and medical practitioners
It is generally required that an MD, DO, PA, OD, DPM, DVM, DDS, or
DMD write the prescription; basic-level registered nurses
, medical assistants
, clinical nurse specialists
, and nurse midwives
, emergency medical technicians,
psychologists, 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
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
charged with implementing this law.
As a general rule, over the counter
(OTC) drugs 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.
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
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". 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
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.
In recent years, large U.S. retailers who operate pharmacies and
pharmacy chains have used inexpensive generic drugs as a way to
lure customers into stores. Several chains, including WalMart,
Target, and several others, offer $4 monthly prescriptions on
select generic drugs as a customer draw.
Regulation in United Kingdom
Kingdom, according to the Home
Office, the Medicines Act
1968 governs the manufacture and supply of three categories of
- Prescription only drugs which can be sold by a pharmacist if
prescribed by a doctor
- Pharmacy medicines which may be sold by a pharmacist without
- General sales list medicines which may be sold without a
prescription in any shop
Again according to the Home Office, possession of prescription only
medicines without a prescription is a serious offence
A patient visits a medical practitioner (GP) who is able to
prescribe medication. If given an NHS
, this can be taken to a pharmacy to be dispensed.
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 medical practitioner
. 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 prescribers' 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. However,
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 over three months which the patient must pay
full-price for.Certain groups of patients are exempt from this
charge, such as 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 1 April 2008) as a first
phase of abolishing them over the next three 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
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 1
April 2008 they cost £27.85 for 3 months and £102.50 for 12 months
(offering savings to anyone who needs more than 3 prescriptions in
3 months or 14 prescriptions in 12 months).
Many of the prescriptions dispensed on NHS are exempt from charges.
This is because of the large number of precription drugs needed by,
for example, the elderly or those with medical exemptions. NHS
prescriptions can also be written for certain items. Some patients
also receive private
, typically either from a medical practitioner
seen privately or for medicine not covered on the NHS. For these,
the patient will pay the pharmacy directly for the cost of the
medicine and the pharmacy's markup.
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 90% 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. The
(AMA) issued a report and statement on
Pharmaceutical Expiration Dates.
Traces of prescription drugs—including antibiotics
, anti-convulsants, mood stabilizers
and sex hormones—have been detected in drinking water. If ingested
these may be harmful to wildlife and humans.
- Drug laws & licensing, Other drug
laws, Home Office website, accessed 16 February 1009
- Patients and Prescribing: Rights and
Responsibilities British Medical Association, September, 2004.
Retrieved on June 27,
- Help with Health Costs NHS. Retrieved on
June 27, 2008.
- Staged end to prescription charge BBC News,
December 5, 2007
- Cancer drugs found in tap water