Medication/ja: Difference between revisions

==定義==  

== 分類 ==  

==医薬品の種類==  

== 投与 ==  

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== Development ==

{{Main|Drug development}}

[[Drug development|Drug development]] is the process of bringing a new drug to the market once a [[lead compound|lead compound]] has been identified through the process of [[drug discovery|drug discovery]]. It includes pre-clinical research (microorganisms/animals) and [[clinical trials|clinical trials]] (on humans) and may include the step of obtaining regulatory approval to market the drug.

'''[https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process Drug Development Process]'''

'''Discovery:''' The Drug Development process starts with Discovery, a process of identifying a new medicine.

'''Development:''' Chemicals extracted from natural products are used to make pills, capsules, or syrups for oral use. Injections for direct infusion into the blood drops for eyes or ear.

'''Preclinical research''' : Drugs go under laboratory or animal testing, to ensure that they can be used on Humans.

'''[[Clinical research|Clinical]] testing:''' The drug is used on people to confirm that it is safe to use.

'''[[FDA|FDA]]''' '''Review:''' drug is sent to FDA before launching the drug into the market.

'''FDA post Market Review:''' The drug is reviewed and monitored by FDA for the safety once it is available to the public

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==Regulation==

{{Main|Regulation of therapeutic goods}}

Depending upon the [[jurisdiction|jurisdiction]], drugs may be divided into [[over-the-counter drug|over-the-counter drug]]s (OTC) which may be available without special restrictions, and [[prescription drug|prescription drug]]s, which must be [[Medical prescription|prescribed]] by a licensed medical practitioner in accordance with [[medical guideline|medical guideline]]s due to the risk of adverse effects and [[contraindication|contraindication]]s. The precise distinction between OTC and prescription depends on the legal jurisdiction. A third category, "behind-the-counter" drugs, is implemented in some jurisdictions. These do not require a prescription, but must be kept in the [[dispensary|dispensary]], not visible to the public, and be sold only by a [[pharmacist|pharmacist]] or [[pharmacy technician|pharmacy technician]]. Doctors may also prescribe prescription drugs for [[off-label use|off-label use]] – purposes which the drugs were not originally approved for by the regulatory agency. The [[Classification of Pharmaco-Therapeutic Referrals|Classification of Pharmaco-Therapeutic Referrals]] helps guide the referral process between pharmacists and doctors.

The [[International Narcotics Control Board|International Narcotics Control Board]] of the [[United Nations|United Nations]] imposes a world law of [[prohibition|prohibition]] of certain drugs. They publish a lengthy list of chemicals and plants whose trade and consumption (where applicable) is forbidden. OTC drugs are sold without restriction as they are considered safe enough that most people will not hurt themselves accidentally by taking it as instructed. Many countries, such as the United Kingdom have a third category of "pharmacy medicines", which can be sold only in registered [[pharmacy|pharmacies]] by or under the supervision of a pharmacist.

[[Medical error|Medical error]]s include over prescription and [[polypharmacy|polypharmacy]], mis-prescription, contraindication and lack of detail in dosage and administrations instructions. In 2000 the definition of a prescription error was studied using a [[Delphi method|Delphi method]] conference; the conference was motivated by ambiguity in the what a prescription error and a need to use a uniform definition in studies.

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==Drug pricing==

{{Main|Prescription costs|Pharmacoeconomics}}

In many jurisdictions [[Prescription costs|drug prices]] are regulated.

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===United Kingdom===

In the UK, the Pharmaceutical Price Regulation Scheme is intended to ensure that the [[National Health Service|National Health Service]] is able to purchase drugs at reasonable prices. The prices are negotiated between the Department of Health, acting with the authority of Northern Ireland and the UK Government, and the representatives of the Pharmaceutical industry brands, the [[Association of the British Pharmaceutical Industry|Association of the British Pharmaceutical Industry]] (ABPI). For 2017 this payment percentage set by the PPRS will be 4,75%.

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===Canada===

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===Brazil===

In Brazil, the prices are regulated through a legislation under the name of ''Medicamento Genérico'' ([[generic drug|generic drug]]s) since 1999.

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=== India ===

In India, drug prices are regulated by the [[National Pharmaceutical Pricing Authority|National Pharmaceutical Pricing Authority]].

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===United States===

{{main|Prescription drug prices in the United States}}

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==Blockbuster drug==

{{Main|List of largest selling pharmaceutical products}}

A blockbuster drug is a drug that generates more than $1 billion in revenue for a pharmaceutical company in a single year. [[Cimetidine|Cimetidine]] was the first drug ever to reach more than $1 billion a year in sales, thus making it the first blockbuster drug.

{{blockquote|In the pharmaceutical industry, a blockbuster drug is one that achieves acceptance by prescribing physicians as a therapeutic standard for, most commonly, a highly prevalent chronic (rather than acute) condition. Patients often take the medicines for long periods.}}

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== History ==

{{Main|History of pharmacy}}

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===Prescription drug history===

Antibiotics first arrived on the medical scene in 1932 thanks to Gerhard Domagk; and were coined the "wonder drugs". The introduction of the sulfa drugs led to the mortality rate from pneumonia in the U.S. to drop from 0.2% each year to 0.05% by 1939. Antibiotics inhibit the growth or the metabolic activities of bacteria and other microorganisms by a chemical substance of microbial origin. Penicillin, introduced a few years later, provided a broader spectrum of activity compared to sulfa drugs and reduced side effects. Streptomycin, found in 1942, proved to be the first drug effective against the cause of tuberculosis and also came to be the best known of a long series of important antibiotics. A second generation of antibiotics was introduced in the 1940s: aureomycin and chloramphenicol. Aureomycin was the best known of the second generation.

The first oral contraceptive, Enovid, was approved by FDA in 1960. Oral contraceptives inhibit ovulation and so prevent conception. Enovid was known to be much more effective than alternatives including the condom and the diaphragm. As early as 1960, oral contraceptives were available in several different strengths by every manufacturer. In the 1980s and 1990s, an increasing number of options arose including, most recently, a new [[drug delivery|delivery system]] for the oral contraceptive via a transdermal patch. In 1982, a new version of the Pill was introduced, known as the "biphasic" pill. By 1985, a new triphasic pill was approved. Physicians began to think of the Pill as an excellent means of birth control for young women.

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===Ancient pharmacology===

Using plants and plant substances to treat all kinds of diseases and medical conditions is believed to date back to [[prehistoric medicine|prehistoric medicine]].

The [[Kahun Gynaecological Papyrus|Kahun Gynaecological Papyrus]], the oldest known medical text of any kind, dates to about 1800 BC and represents the first documented use of any kind of drug. It and other [[medical papyri|medical papyri]] describe [[Ancient Egyptian medicine|Ancient Egyptian medical practices]], such as using [[honey|honey]] to treat infections and the legs of bee-eaters to treat neck pains.

Ancient [[Babylonian medicine|Babylonian medicine]] demonstrated the use of medication in the first half of the [[2nd millennium BC|2nd millennium BC]]. [[Cream (pharmaceutical)|Medicinal creams]] and [[Pill (pharmacy)|pills]] were employed as treatments.

On the Indian subcontinent, the [[Atharvaveda|Atharvaveda]], a sacred text of [[Hinduism|Hinduism]] whose core dates from the second millennium BC, although the hymns recorded in it are believed to be older, is the first Indic text dealing with medicine. It describes plant-based drugs to counter diseases. The earliest foundations of [[ayurveda|ayurveda]] were built on a synthesis of selected ancient herbal practices, together with a massive addition of theoretical conceptualizations, new [[nosology|nosologies]] and new therapies dating from about 400 BC onwards. The student of Āyurveda was expected to know ten arts that were indispensable in the preparation and application of his medicines: distillation, operative skills, cooking, horticulture, metallurgy, sugar manufacture, pharmacy, analysis and separation of minerals, compounding of metals, and preparation of [[alkalis|alkalis]].

The [[Hippocratic Oath|Hippocratic Oath]] for physicians, attributed to fifth century BC Greece, refers to the existence of "deadly drugs", and [[Medicine in ancient Greece|ancient Greek physicians]] imported drugs from Egypt and elsewhere. The [[pharmacopoeia|pharmacopoeia]] ''[[De materia medica|De materia medica]],'' written between 50 and 70 CE by the Greek physician [[Pedanius Dioscorides|Pedanius Dioscorides]], was widely read for more than 1,500 years.

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===Medieval pharmacology===

[[Al-Kindi|Al-Kindi]]'s ninth century AD book, ''[[De Gradibus|De Gradibus]]'' and [[Ibn Sina|Ibn Sina]] (Avicenna)'s ''[[The Canon of Medicine|The Canon of Medicine]]'', covers a range of drugs known to the practice of [[medicine in the medieval Islamic world|medicine in the medieval Islamic world]].

[[Medieval medicine of Western Europe|Medieval medicine of Western Europe]] saw advances in surgery compared to previously, but few truly effective drugs existed, beyond [[opium|opium]] (found in such extremely popular drugs as the "Great Rest" of the [[Antidotarium Nicolai|Antidotarium Nicolai]] at the time) and [[quinine|quinine]]. Folklore cures and potentially poisonous metal-based compounds were popular treatments. [[Theodoric Borgognoni|Theodoric Borgognoni]], (1205–1296), one of the most significant surgeons of the medieval period, responsible for introducing and promoting important surgical advances including basic [[antiseptic|antiseptic]] practice and the use of [[anaesthetic|anaesthetic]]s. [[Garcia de Orta|Garcia de Orta]] described some herbal treatments that were used.

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===Modern pharmacology===

For most of the 19th century, drugs were not highly effective, leading [[Oliver Wendell Holmes, Sr.|Oliver Wendell Holmes, Sr.]] to famously comment in 1842 that "if all medicines in the world were thrown into the sea, it would be all the better for mankind and all the worse for the fishes".

During the [[First World War|First World War]], [[Alexis Carrel|Alexis Carrel]] and [[Henry Drysdale Dakin|Henry Dakin]] developed the Carrel-Dakin method of treating wounds with an irrigation, Dakin's solution, a germicide which helped prevent [[gangrene|gangrene]].

In the inter-war period, the first anti-bacterial agents such as the [[sulpha|sulpha]] antibiotics were developed. The Second World War saw the introduction of widespread and effective antimicrobial therapy with the development and mass production of [[penicillin|penicillin]] antibiotics, made possible by the pressures of the war and the collaboration of British scientists with the American [[pharmaceutical industry|pharmaceutical industry]].

Medicines commonly used by the late 1920s included [[aspirin|aspirin]], [[codeine|codeine]], and [[morphine|morphine]] for pain; [[Digoxin|digitalis]], [[nitroglycerin|nitroglycerin]], and [[quinine|quinine]] for heart disorders, and [[insulin|insulin]] for diabetes. Other drugs included [[antitoxin|antitoxin]]s, a few biological vaccines, and a few synthetic drugs. In the 1930s, antibiotics emerged: first [[sulfa drug|sulfa drug]]s, then [[penicillin|penicillin]] and other antibiotics. Drugs increasingly became "the center of medical practice". In the 1950s, other drugs emerged including [[corticosteroids|corticosteroids]] for [[inflammation|inflammation]], [[Rauvolfia#Chemical constituents|rauvolfia alkaloids]] as tranquilizers and antihypertensives, [[antihistamine|antihistamine]]s for nasal allergies, [[xanthine|xanthine]]s for asthma, and typical [[antipsychotic|antipsychotic]]s for psychosis. As of 2007, thousands of approved drugs have been [[drug development|developed]]. Increasingly, [[biotechnology|biotechnology]] is used to discover [[biopharmaceutical|biopharmaceutical]]s. Recently, multi-disciplinary approaches have yielded a wealth of new data on the development of novel antibiotics and antibacterials and on the use of biological agents for antibacterial therapy.

In the 1950s, new psychiatric drugs, notably the antipsychotic [[chlorpromazine|chlorpromazine]], were designed in laboratories and slowly came into preferred use. Although often accepted as an advance in some ways, there was some opposition, due to serious adverse effects such as [[tardive dyskinesia|tardive dyskinesia]]. Patients often opposed psychiatry and refused or stopped taking the drugs when not subject to psychiatric control.

Governments have been heavily involved in the regulation of drug development and drug sales. In the U.S., the [[Elixir Sulfanilamide disaster|Elixir Sulfanilamide disaster]] led to the establishment of the [[Food and Drug Administration|Food and Drug Administration]], and the 1938 Federal Food, Drug, and Cosmetic Act required manufacturers to file new drugs with the FDA. The 1951 Humphrey-Durham Amendment required certain drugs to be sold by prescription. In 1962, a subsequent amendment required new drugs to be tested for efficacy and safety in [[clinical trial|clinical trial]]s.

Until the 1970s, drug prices were not a major concern for doctors and patients. As more drugs became prescribed for chronic illnesses, however, costs became burdensome, and by the 1970s nearly every U.S. state required or encouraged the substitution of [[generic drugs|generic drugs]] for higher-priced brand names. This also led to the 2006 U.S. law, [[Medicare Part D|Medicare Part D]], which offers Medicare coverage for drugs.

As of 2008, the United States is the leader in [[medical research|medical research]], including pharmaceutical development. U.S. drug prices are among the highest in the world, and drug innovation is correspondingly high. In 2000, U.S.-based firms developed 29 of the 75 top-selling drugs; firms from the second-largest market, Japan, developed eight, and the United Kingdom contributed 10. France, which imposes price controls, developed three. Throughout the 1990s, outcomes were similar.

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==Controversies==

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===Access to unapproved drugs===

{{Main|Expanded access}}

Governments worldwide have created provisions for granting access to drugs prior to approval for patients who have exhausted all alternative treatment options and do not match clinical trial entry criteria. Often grouped under the labels of compassionate use, [[expanded access|expanded access]], or named patient supply, these programs are governed by rules which vary by country defining access criteria, data collection, promotion, and control of drug distribution.

Within the United States, pre-approval demand is generally met through [[treatment IND|treatment IND]] (investigational new drug) applications (INDs), or single-patient INDs. These mechanisms, which fall under the label of expanded access programs, provide access to drugs for groups of patients or individuals residing in the US. Outside the US, Named Patient Programs provide controlled, pre-approval access to drugs in response to requests by physicians on behalf of specific, or "named", patients before those medicines are licensed in the patient's home country.  Through these programs, patients are able to access drugs in late-stage clinical trials or approved in other countries for a genuine, unmet medical need, before those drugs have been licensed in the patient's home country.

Patients who have not been able to get access to drugs in development have organized and advocated for greater access.  In the United States, [[ACT UP|ACT UP]] formed in the 1980s, and eventually formed its [[Treatment Action Group|Treatment Action Group]] in part to pressure the US government to put more resources into discovering treatments for [[AIDS|AIDS]] and then to speed release of drugs that were under development.

The [[Abigail Alliance|Abigail Alliance]] was established in November 2001 by Frank Burroughs in memory of his daughter, Abigail. The Alliance seeks broader availability of investigational drugs on behalf of terminally ill patients.

In 2013, [[BioMarin Pharmaceutical|BioMarin Pharmaceutical]] was at the center of a high-profile debate regarding expanded access of cancer patients to experimental drugs.

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===Access to medicines and drug pricing===

{{Main|Essential medicines|Societal views on patents}}

Essential medicines, as defined by the [[World Health Organization|World Health Organization]] (WHO), are "those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the community can afford."  Recent studies have found that most of the medicines on the WHO essential medicines list, outside of the field of HIV drugs, are not patented in the developing world, and that lack of widespread [[Access to medicines|access to these medicines]] arise from issues fundamental to economic development – lack of infrastructure and poverty. [[Médecins Sans Frontières|Médecins Sans Frontières]] also runs a [[Campaign for Access to Essential Medicines|Campaign for Access to Essential Medicines]] campaign, which includes advocacy for greater resources to be devoted to currently untreatable diseases that primarily occur in the developing world. The [[Access to Medicine Index|Access to Medicine Index]] tracks how well pharmaceutical companies make their products available in the developing world.

[[World Trade Organization|World Trade Organization]] negotiations in the 1990s, including the [[TRIPS Agreement|TRIPS Agreement]] and the [[Doha Declaration|Doha Declaration]], have centered on issues at the intersection of international trade in pharmaceuticals and [[intellectual property rights|intellectual property rights]], with developed world nations seeking strong intellectual property rights to protect investments made to develop new drugs, and developing world nations seeking to promote their generic pharmaceuticals industries and their ability to make medicine available to their people via [[compulsory licenses|compulsory licenses]].

[[Novartis|Novartis]] fought a protracted battle with the government of India over the patenting of its drug, [[Gleevec|Gleevec]], in India, which ended up in a Supreme Court in a case known as [[Novartis v. Union of India & Others|Novartis v. Union of India & Others]].  The Supreme Court ruled narrowly against Novartis, but opponents of patenting drugs claimed it as a major victory.

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===Environmental issues===

{{Main|Environmental impact of pharmaceuticals and personal care products}}

The environmental impact of pharmaceuticals and personal care products is controversial. PPCPs are substances used by individuals for personal health or [[cosmetics|cosmetic]] reasons and the products used by [[agribusiness|agribusiness]] to boost growth or health of livestock.  PPCPs comprise a diverse collection of thousands of chemical substances, including prescription and over-the-counter therapeutic drugs, veterinary drugs, fragrances, and cosmetics. PPCPs have been detected in water bodies throughout the world and ones that persist in the environment are called [[Environmental Persistent Pharmaceutical Pollutant|Environmental Persistent Pharmaceutical Pollutant]]s.  The effects of these chemicals on humans and the environment are not yet known, but to date there is no scientific evidence that they affect human health.

* [[Adherence (medicine)|Adherence]]

* [[Deprescribing|Deprescribing]]

* [[Drug nomenclature|Drug nomenclature]]

* [[List of drugs|List of drugs]]

* [[List of pharmaceutical companies|List of pharmaceutical companies]]

* [[Orphan drug|Orphan drug]]

* [[Overmedication|Overmedication]]

* [[Pharmaceutical code|Pharmaceutical code]]

* [[Pharmacy|Pharmacy]]

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== External links ==

{{Major Drug Groups}}

{{Pharmacy}}

{{二次利用}}