Prescription drug
Encyclopedia
A prescription medication is a licensed medicine
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...

 that is regulated by legislation to require a medical prescription
Medical prescription
A prescription is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist....

 before it can be obtained. The term is used to distinguish it from over-the-counter drug
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...

s which 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 in fact an abbreviation for the Latin "recipe," the imperative form of "recipere," meaning "take thus."

Dispensation of prescription drugs often includes a monograph
Monograph
A monograph is a work of writing upon a single subject, usually by a single author.It is often a scholarly essay or learned treatise, and may be released in the manner of a book or journal article. It is by definition a single document that forms a complete text in itself...

 (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
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...

 defines what requires a prescription. Prescription drugs are generally authorized by veterinarians, dentists, optometrists, medical practitioners
Physician
A physician is a health care provider who practices the profession of medicine, which is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury and other physical and mental impairments...

, and advanced practice nurse
Advanced practice nurse
An advanced practice registered nurse is a nurse with advanced didactic and clinical education, knowledge, skills, and scope of practice in nursing....

s. It is generally required that an MD
Doctor of Medicine
Doctor of Medicine is a doctoral degree for physicians. The degree is granted by medical schools...

, DO
Doctor of Osteopathic Medicine
Doctor of Osteopathic Medicine is a professional doctoral degree for physicians in the United States. Holders of the MD degree, Doctor of Medicine, have the same rights, privileges and responsibilities as osteopathic physicians in the United States.The American Osteopathic Association’s Commission...

, PA
Physician assistant
A physician assistant/associate ' is a healthcare professional trained and licensed to practice medicine with limited supervision by a physician.-General description:...

, OD
Optometry
Optometry is a health care profession concerned with eyes and related structures, as well as vision, visual systems, and vision information processing in humans. Optometrists, or Doctors of Optometry, are state licensed medical professionals trained to prescribe and fit lenses to improve vision,...

, DPM
Podiatry
Podiatry is a branch of medicine devoted to the study, diagnosis, and treatment of disorders of the foot, ankle, and lower leg. The term podiatry came into use first in the early 20th century United States, where it now denotes a Doctor of Podiatric Medicine , a specialist who is qualified by their...

, NMD, ND
Doctor of Naturopathic Medicine
Doctor of Naturopathic Medicine , in 16 U.S. states and six Canadian provinces refers exclusively to a medical degree granted by an accredited naturopathic medical school...

, DVM
Veterinarian
A veterinary physician, colloquially called a vet, shortened from veterinarian or veterinary surgeon , is a professional who treats disease, disorder and injury in animals....

, DDS
Doctor of Dental Surgery
There are a number of first professional degrees in dentistry offered by schools in various countries around the world. These include the following:* Doctor of Dental Surgery * Doctor of Dental Medicine * Bachelor of Dentistry...

, or DMD, some Psychologists (see Medical Psychology
Medical psychology
Medical psychology is a very broad field and has been defined in various ways. The Academy of Medical Psychology's definition applies to both the practices of consultation and prescribing in Medical Psychology, when allowed by statutes...

), Nurse Practitioner
Nurse practitioner
A Nurse Practitioner is an Advanced practice registered nurse who has completed graduate-level education . Additional APRN roles include the Certified Registered Nurse Anesthetist s, CNMs, and CNSs...

s and other APRNs
Advanced practice nurse
An advanced practice registered nurse is a nurse with advanced didactic and clinical education, knowledge, skills, and scope of practice in nursing....

 write the prescription; basic-level registered nurse
Registered nurse
A registered nurse is a nurse who has graduated from a nursing program at a university or college and has passed a national licensing exam. A registered nurse helps individuals, families, and groups to achieve health and prevent disease...

s, medical assistants, emergency medical technicians, most 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 about allergies.

The safety and effectiveness of prescription drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987
Prescription Drug Marketing Act (PDMA)
The Prescription Drug Marketing Act of 1987 is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals. It's designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent,...

. The Food and Drug Administration (FDA) is charged with implementing this law.

As a general rule, over-the-counter drug
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...

s
(OTC) 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
Ibuprofen
Ibuprofen is a nonsteroidal anti-inflammatory drug used for relief of symptoms of arthritis, fever, as an analgesic , especially where there is an inflammatory component, and dysmenorrhea....

, which has been widely available as an OTC pain killer
Analgesic
An analgesic is any member of the group of drugs used to relieve pain . The word analgesic derives from Greek an- and algos ....

 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, vitamin
Vitamin
A vitamin is an organic compound required as a nutrient in tiny amounts by an organism. In other words, an organic chemical compound is called a vitamin when it cannot be synthesized in sufficient quantities by an organism, and must be obtained from the diet. Thus, the term is conditional both on...

s, mineral
Mineral
A mineral is a naturally occurring solid chemical substance formed through biogeochemical processes, having characteristic chemical composition, highly ordered atomic structure, and specific physical properties. By comparison, a rock is an aggregate of minerals and/or mineraloids and does not...

s, 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
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...

, the term "prescription drug" is most commonly used, but they are also called Rx
Rx
RX is the telegraph and radio abbreviation for "receive" or "receiver".Rx, RX, or rx may also refer to:, medical prescriptions* Rx, the symbol used to describe apparent retrograde motion of planets...

-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".

Also, pharmacies operated by membership clubs, such as Costco
Costco
Costco Wholesale Corporation is the largest membership warehouse club chain in the United States. it is the third largest retailer in the United States, where it originated, and the ninth largest in the world...

 and Sam's Club
Sam's Club
Sam's Club is a chain of membership-only retail warehouse clubs owned and operated by Wal-Mart Stores, Inc., founded in 1983 and named after Wal-Mart founder Sam Walton. , the Sam's Club chain serves more than 47 million U.S. members...

, by 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
Off-label use
Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration...

. 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, Dillons, Target, and others, offer $4 monthly prescriptions on select generic drugs as a customer draw.

Regulation in United Kingdom

In the United Kingdom
United Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...

 the Medicines Act 1968
Medicines Act 1968
The Medicines Act 1968 is an Act of Parliament of the United Kingdom. It governs the manufacture and supply of medicine.The act defines three categories of medicine: prescription only medicines , which are available only from a pharmacist if prescribed by an appropriate practitioner; pharmacy...

 governs the manufacture and supply of three categories of medicine:
  • 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 which 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 regulations of the misuse of drugs act.

A patient visits a medical practitioner
Physician
A physician is a health care provider who practices the profession of medicine, which is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury and other physical and mental impairments...

 who is able to prescribe medication and certain other medical items, such as blood glucose testing equipment for diabetics. Similarly, 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 nurse
District nurse
District Nurses are senior nurses who manage care within the community, leading teams of community nurses and support workers. Typically much of their work involves visiting house-bound patients to provide advice and care, for example, palliative care, wound management, catheter and continence...

s and health visitor
Health visitor
Health visitors are UK community health nurses who have undertaken further training to work as part of a primary health care team. As their name suggests, their role is to promote mental, physical and social well-being in the community by giving advice and support to families in all age groups...

s 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
National Health Service
The National Health Service is the shared name of three of the four publicly funded healthcare systems in the United Kingdom. They provide a comprehensive range of health services, the vast majority of which are free at the point of use to residents of the United Kingdom...

 prescriptions, which can be taken to a pharmacy to be dispensed. The NHS prescription fee is £7.40 per item in England (as of 1 April 2011), however prescription charges have been completely abolished in Wales
Wales
Wales is a country that is part of the United Kingdom and the island of Great Britain, bordered by England to its east and the Atlantic Ocean and Irish Sea to its west. It has a population of three million, and a total area of 20,779 km²...

, Scotland
Scotland
Scotland is a country that is part of the United Kingdom. Occupying the northern third of the island of Great Britain, it shares a border with England to the south and is bounded by the North Sea to the east, the Atlantic Ocean to the north and west, and the North Channel and Irish Sea to the...

 and Northern Ireland
Northern Ireland
Northern Ireland is one of the four countries of the United Kingdom. Situated in the north-east of the island of Ireland, it shares a border with the Republic of Ireland to the south and west...

.

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. Many of the prescriptions dispensed on the NHS are exempt from charges. Patients are exempt from the standard per-item charge if they are over 60, under 16 (or under 19 if in full-time education), have certain long-term chronic conditions such as myasthenia gravis
Myasthenia gravis
Myasthenia gravis is an autoimmune neuromuscular disease leading to fluctuating muscle weakness and fatiguability...

, are on certain income-related benefits, or have a low income and qualify for an HC2 certificate. 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. In 2010, these were £104 for 12 months, or £28.25 for 3 months.

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 patients perceived value of the charge 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 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
Private prescription
A private prescription is a United Kingdom Medical term that refers to a prescription funded by the patient, rather than the National Health Service....

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

Regulation in Australia

In Australia
Australia
Australia , officially the Commonwealth of Australia, is a country in the Southern Hemisphere comprising the mainland of the Australian continent, the island of Tasmania, and numerous smaller islands in the Indian and Pacific Oceans. It is the world's sixth-largest country by total area...

 the Standard for the Uniform Scheduling of Medicines and Poisons , abbreviated SUSMP, governs the manufacture and supply of drugs:

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 medication.
Many prescriptions issued by health practitioners in Australia are covered by the Pharmaceutical Benefits Scheme
Pharmaceutical Benefits Scheme
The Pharmaceutical Benefits Scheme or PBS is a program of the Australian Government that provides subsidised prescription drugs to residents of Australia. The PBS ensures that all Australians have affordable and reliable access to a wide range of necessary medicines.-History:The PBS was established...

 ; 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 medications. When purchasing a medication under the PBS the maximum price a consumer pays is the patient co-payment contribution which, as of January 1, 2011 is A$
Australian dollar
The Australian dollar is the currency of the Commonwealth of Australia, including Christmas Island, Cocos Islands, and Norfolk Island, as well as the independent Pacific Island states of Kiribati, Nauru and Tuvalu...

34.20 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 $5.60 in 2011. 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 are also issued which are for medicines not covered on the PBS or for medications being used for indications other than that are covered by the PBS. 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 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 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 - notably nitroglycerin, insulin and some liquid antibiotics - most expired drugs are probably effective.

The American Medical Association
American Medical Association
The American Medical Association , founded in 1847 and incorporated in 1897, is the largest association of medical doctors and medical students in the United States.-Scope and operations:...

 (AMA) issued a report and statement on Pharmaceutical Expiration Dates. The Harvard Medical School
Harvard Medical School
Harvard Medical School is the graduate medical school of Harvard University. It is located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts....

 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".

Environmental problems

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

See also

  • Classification of Pharmaco-Therapeutic Referrals
    Classification of Pharmaco-Therapeutic Referrals
    The Classification of Pharmaco-Therapeutic Referrals is a taxonomy focused to define and group together situations requiring a referral from pharmacists to physicians regarding the pharmacotherapy used by the patients. It has been published in 2008...

  • Inverse benefit law
    Inverse benefit law
    The Inverse Benefit Law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed...

  • List of pharmaceutical companies
  • Package insert
    Package insert
    A package insert or prescribing information is a document provided along with a prescription medication to provide additional information about that drug.-Responsible agencies:In the United States, the Food and Drug Administration determines the requirements...

  • Pill splitting
  • Pharmacy Automation - The Tablet Counter
  • Prescription drug prices in the United States
    Prescription drug prices in the United States
    Prescription drug prices in the United States are the highest in the world. "The prices Americans pay for prescription drugs, which are far higher than those paid by citizens of any other developed country, help explain why the pharmaceutical industry is — and has been for years — the most...

  • Regulation of therapeutic goods
    Regulation of therapeutic goods
    The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency...



Further reading

The source of this article is wikipedia, the free encyclopedia.  The text of this article is licensed under the GFDL.
 
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