Prescription Only Medicine
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.
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 and physicians, though physician assistants and nurse
practitioners do an increasing amount of drug prescribing under a physician's
supervision, . It is generally required that an MD, DO, DVM, DDS, DMD, PA or NP
write the prescription; nurses (other than nurse practitioners), emergency
medical technicians, psychologists (but not psychiatrists, who are MDs), as
examples, do not generally have the authority to prescribe drugs. Unlike most
other countries, the United States does not have price controls for prescription
drugs, and US drug prices are usually viewed as very expensive in comparison to
those countries. 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. For the
uninsured, they typically must pay whatever higher drug price their local
pharmacy charges. In 2005, there were nearly 45 million uninsured Americans,
according to the U.S. Census.
The safety and effectiveness of prescription drugs in the U.S. is regulated by
the federal Prescription Drug Marketing Act of 1987.
As a general rule, over the counter drugs are used to treat conditions not
necessarily requiring a doctor's care 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
doctor's 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.
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 are free for all.
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.
The devolved legislature in Wales has decided to phase out prescription charges
altogether; this process is expected to be completed during 2007. In January
2006, similar proposals were made by the health committee of the Scottish
Parliament; however, these were rejected by Health Minister Andy Kerr on the
grounds that "Executive policy remains that it is right that patients who can
afford to should continue to contribute towards NHS dispensing costs".