重要な分類の一つは、従来の[[small molecule/ja|低分子]]医薬品（通常、化学合成から得られる）と[[biologic medical product/ja|生物学的製剤]]（[[recombinant proteins/ja|組み換えタンパク質]]、[[vaccines/ja|ワクチン]]、治療的に用いられる[[blood products/ja|血液製剤]]（[[IVIG/ja|IVIG]]など）、[[gene therappy/ja|遺伝子治療]]、[[cell therapy/ja|細胞治療]]（例えば、[[stem cell/ja|幹細胞]]治療）を含む）との間の分類である。
One of the key classifications is between traditional [[small molecule|small molecule]] drugs; usually derived from chemical synthesis, and [[biologic medical product|biologic medical product]]s; which include [[recombinant proteins|recombinant proteins]], [[vaccines|vaccines]], [[blood products|blood products]] used therapeutically (such as [[IVIG|IVIG]]), [[gene therapy|gene therapy]], and [[cell therapy|cell therapy]] (for instance, [[stem cell|stem cell]] therapies).
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医薬品または薬物は、[[chemical property/ja|化学的性質]]、投与方法または[[route of administration/ja|投与経路]]、影響を受ける[[biological system/ja|生物学的系]]、または[[therapeutic effect/ja|治療効果]]など、作用機序やその薬理作用または活性などの薬理学的特性に基づいて、その起源以外にも様々なグループに分類される。精巧で広く使われている分類システムに、[[Anatomical Therapeutic Chemical Classification System/ja|解剖学的治療化学分類システム]]（ATCシステム）がある。[[World Health Organization/ja|世界保健機関]]（WHO）は、[[essential medicines/ja|必須医薬品]]のリストを作成している。
Pharmaceuticals or drugs or medicines are classified in various other groups besides their origin on the basis of pharmacological properties like mode of action and their pharmacological action or activity, such as by [[chemical property|chemical properties]], mode or [[route of administration|route of administration]], [[biological system|biological system]] affected, or [[therapeutic effect|therapeutic effect]]s. An elaborate and widely used [[classification system|classification system]] is the [[Anatomical Therapeutic Chemical Classification System|Anatomical Therapeutic Chemical Classification System]] (ATC system). The [[World Health Organization|World Health Organization]] keeps a list of [[essential medicines|essential medicines]].
Pharmaceuticals may also be described as "specialty", independent of other classifications, which is an ill-defined class of drugs that might be difficult to administer, require special handling during administration, require patient monitoring during and immediately after administration, have particular regulatory requirements restricting their use, and are generally expensive relative to other drugs.
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==医薬品の種類==
==Types of medicines==
{{Anchor|Types of medicines}}
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{{See also/ja|:Category:Drugs by target organ system/ja}}
{{See also|:Category:Drugs by target organ system}}
[[Emollient/ja|皮膚軟化剤]]、[[antipruritic/ja|かゆみ止め]]、[[Antifungal medication/ja|抗真菌剤]]、[[antiseptic/ja|殺菌剤]]、[[scabicide/ja|抗疥癬薬]]、[[pediculicide/ja|殺シラミ薬]]、[[tar/ja|乾留液]]製品、[[vitamin A derivatives/ja|ビタミンA誘導体]]、[[vitamin D analogue/ja|ビタミンD類似体]]、[[keratolytic/ja|角質溶解薬]]、[[abrasive/ja|研磨材]]、[[systemic antibiotic/ja|全身性抗生物質]]、[[topical/ja|外用]] [[antibiotic/ja|抗生物質]]、[[hormone/ja|ホルモン]]、剥離剤、滲出液吸収剤、 [[fibrinolytic/ja|線維素溶解]]、[[proteolytic/ja|タンパク質分解]]、[[sunscreen/ja|サンスクリーン剤]]、[[antiperspirant/ja|制汗剤]]、[[corticosteroid/ja|副腎皮質ホルモン]]、免疫調整剤
[[Emollient|Emollient]]s, [[antipruritic|anti-pruritics]], [[Antifungal medication|antifungals]], [[antiseptic|antiseptic]]s, [[scabicide|scabicide]]s, [[pediculicide|pediculicide]]s, [[tar|tar]] products, [[vitamin A derivatives|vitamin A derivatives]], [[vitamin D analogue|vitamin D analogue]]s, [[keratolytic|keratolytic]]s, [[abrasive|abrasive]]s, [[systemic antibiotic|systemic antibiotic]]s, [[topical|topical]] [[antibiotic|antibiotic]]s, [[hormone|hormone]]s, desloughing agents, exudate absorbents, [[fibrinolytic|fibrinolytic]]s, [[proteolytic|proteolytic]]s, [[sunscreen|sunscreen]]s, [[antiperspirant|antiperspirant]]s, [[corticosteroid|corticosteroid]]s, immune modulators.
A euthanaticum is used for [[euthanasia|euthanasia]] and [[Assisted suicide|physician-assisted suicide]]. Euthanasia is not permitted by law in many countries, and consequently, medicines will not be licensed for this use in those countries.
[[File:Drawing_by_Marguerite_Martyn_of_a_visiting_nurse_with_medicine_and_four_babies,_1918.jpg|thumb|February 1918 drawing by [[Marguerite Martyn|Marguerite Martyn]] of a visiting nurse in St. Louis, Missouri, with medicine and babies]]
A single drug may contain a single or multiple [[active ingredient|active ingredient]]s.
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投与とは、患者が薬を服用することである。薬物投与には、[[enteral/ja|経腸]]（[[human gastrointestinal tract/ja|消化管]]経由）、体内への[[Injection (medicine)/ja|注射]]、その他の経路（[[Dermis/ja|経皮]]、[[Nasal administration/ja|経鼻]]、[[Ophthalmic drug administration/ja|目]]、[[Ear/ja|耳]]、[[Genitourinary system/ja|泌尿生殖器]]）の3つに大別される。
Administration is the process by which a patient takes a medicine. There are three major categories of drug administration: [[enteral|enteral]] (via the [[human gastrointestinal tract|human gastrointestinal tract]]), [[Injection (medicine)|injection]] into the body, and by other routes ([[Dermis|dermal]], [[Nasal administration|nasal]], [[Ophthalmic drug administration|ophthalmic]], [[Ear|otologic]], and [[Genitourinary system|urogenital]]).
[[Oral administration|Oral administration]], the most common form of enteral administration, can be performed using various [[dosage forms|dosage forms]] including [[Tablet (pharmacy)|tablets]] or [[capsule (pharmacy)|capsules]] and liquid such as a syrup or suspension. Other ways to take medication include [[buccal administration|buccally]] (placed inside cheek), [[Sublingual administration|sublingually]] (placed underneath tongue), [[eye|eye]] and [[ear drop|ear drop]]s (dropped into eye or ear), and transdermally (applied to skin).
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[[bolus (medicine)/ja|ボーラス]]として1回投与することもできる。投与頻度は、''Quaque VIII Hora''からQ8Hと読み、''8時間ごと''など、ラテン語から略されることが多い。薬物の投与頻度は、1日あたりの使用回数（例えば、1日4回）で表されることが多い。これは[指定する]事象に関連した情報（例：食前1時間、朝、就寝時）を含むか、間隔を補完するものであるが、同等の表現でも意味合いが異なる場合がある（例：8時間ごとと1日3回）。
They can be administered in one dose, as a [[bolus (medicine)|bolus]]. Administration frequencies are often abbreviated from Latin, such as ''every 8 hours'' reading Q8H from ''Quaque VIII Hora''. The drug frequencies are often expressed as the number of times a drug is used per day (e.g., four times a day). It{{specify|date=November 2022}} may include event-related information (e.g., 1 hour before meals, in the morning, at bedtime), or complimentary to interval, although equivalent expressions may have different implications (e.g., every 8 hours versus 3 times a day).
In the fields of [[medicine|medicine]], [[biotechnology|biotechnology]] and [[pharmacology|pharmacology]], [[drug discovery|drug discovery]] is the process by which new drugs are discovered.
Historically, drugs were discovered through identifying the active ingredient from traditional remedies or by [[serendipity|serendipitous]] discovery. Later [[chemical library|chemical libraries]] of synthetic [[small molecule|small molecule]]s, [[natural product|natural product]]s or [[extract|extract]]s were screened in intact cells or whole organisms to identify substances that have a desirable [[therapeutic|therapeutic]] effect in a process known as [[classical pharmacology|classical pharmacology]]. Since [[Human Genome Project|sequencing]] of the [[human genome|human genome]] which allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use [[high throughput screening|high throughput screening]] of large compounds libraries against isolated [[biological target|biological target]]s which are hypothesized to be [[Disease-modifying treatment|disease-modifying]] in a process known as [[reverse pharmacology|reverse pharmacology]]. Hits from these screens are then tested in cells and then in animals for [[efficacy|efficacy]]. Even more recently, scientists have been able to understand the shape of biological molecules at the atomic level, and to use that knowledge to design (see [[drug design|drug design]]) drug candidates.
Modern drug discovery involves the identification of screening hits, [[medicinal chemistry|medicinal chemistry]] and optimization of those hits to increase the [[Affinity (pharmacology)#Protein-ligand binding|affinity]], [[binding selectivity|selectivity]] (to reduce the potential of side effects), efficacy/[[potency (pharmacology)|potency]], [[Metabolism|metabolic]] stability (to increase the [[Biological half-life|half-life]]), and oral [[bioavailability|bioavailability]]. Once a compound that fulfills all of these requirements has been identified, it will begin the process of [[drug development|drug development]] prior to [[clinical trial|clinical trial]]s. One or more of these steps may, but not necessarily, involve [[computer-aided drug design|computer-aided drug design]].
Despite advances in technology and understanding of biological systems, drug discovery is still a lengthy, "expensive, difficult, and inefficient process" with low rate of new therapeutic discovery. In 2010, the research and development cost of each [[new molecular entity|new molecular entity]] (NME) was approximately US$1.8 billion. Drug discovery is done by pharmaceutical companies, sometimes with research assistance from universities. The "final product" of drug discovery is a [[patent|patent]] on the potential drug. The drug requires very expensive Phase I, II and III clinical trials, and most of them fail. Small companies have a critical role, often then selling the rights to larger companies that have the resources to run the clinical trials.
Drug discovery is different from Drug Development. Drug Discovery is often considered the process of identifying new medicine. At the same time, Drug development is delivering a new drug molecule into clinical practice. In its broad definition, this encompasses all steps from the basic research process of finding a suitable molecular target to supporting the drug's commercial launch.
[[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.
'''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.
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'''前臨床試験：'''薬物がヒトに使用できることを確認するため、実験室や動物で試験を行う。
'''Preclinical research''' : Drugs go under laboratory or animal testing, to ensure that they can be used on Humans.
The regulation of drugs varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions, they are regulated at the state level, or at both state and national levels by various bodies, as is the case in Australia. The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be marketed. There is usually some degree of restriction of the availability of certain therapeutic goods depending on their risk to consumers.
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[[:ja:法域|法域]]によっては、薬物は、特別な制限なしに入手可能な[[over-the-counter drug/ja|一般用医薬品]]（OTC）と、副作用や[[contraindication/ja|禁忌]]のリスクがあるため、[[medical guideline/ja|医療ガイドライン]]に従って免許を持つ医師が[[Medical prescription/ja|処方]]しなければならない[[prescription drug/ja|医療用医薬品]]とに分けられる。OTCと処方箋の正確な区別は、法的管轄によって異なる。第3のカテゴリーである「ビハインド・ザ・カウンター」薬物は、一部の法域で実施されている。これらは処方箋を必要としないが、[[dispensary/ja|調剤薬局]]に保管され、公衆の目に触れず、[[pharmacist/ja|薬剤師]]または[[pharmacy technician/ja|薬剤師技師]]によってのみ販売されなければならない。医師はまた、[[off-label use/ja|適応外使用]]、つまり薬物が本来規制当局によって承認されていない目的で処方薬を処方することができる。[[Classification of Pharmaco-Therapeutic Referrals/ja|薬物治療紹介の分類]]は、薬剤師と医師間の紹介プロセスの指針となる。
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.
In many jurisdictions [[Prescription costs|drug prices]] are regulated.
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===イギリス===
===United Kingdom===
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イギリスでは、薬価規制制度は[[:ja:国民保健サービス|国民保健サービス]]が適正価格で薬物を購入できるようにすることを目的としている。薬価は、北アイルランドと英国政府の権限で行動する保健省と、製薬業界ブランドの代表者である[[:en:Association of the British Pharmaceutical Industry|英国製薬団体連合会]]（ABPI）との間で交渉される。2017年、PPRSによって設定されたこの支払い割合は4,75％となる。
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%.
In Canada, the Patented Medicine Prices Review Board examines drug pricing and determines if a price is excessive or not. In these circumstances, drug manufacturers must submit a proposed price to the appropriate regulatory agency. Furthermore, "the International Therapeutic Class Comparison Test is responsible for comparing the National Average Transaction Price of the patented drug product under review" different countries that the prices are being compared to are the following: France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States
High prices have been attributed to monopolies given to manufacturers by the government. New drug development costs continue to rise as well. Despite the enormous advances in science and technology, the number of new blockbuster drugs approved by the government per billion dollars spent has halved every 9 years since 1950.
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==ブロックバスター医薬品==
==Blockbuster drug==
{{Anchor|Blockbuster drug}}
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{{Main|/jaList of largest selling pharmaceutical products/ja}}
{{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.}}
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.
Lithium was discovered in the 19th century for nervous disorders and its possible mood-stabilizing or prophylactic effect; it was cheap and easily produced. As lithium fell out of favor in France, valpromide came into play. This antibiotic was the origin of the drug that eventually created the mood stabilizer category. Valpromide had distinct psychotrophic effects that were of benefit in both the treatment of acute manic states and in the maintenance treatment of manic depression illness. Psychotropics can either be sedative or stimulant; sedatives aim at damping down the extremes of behavior. Stimulants aim at restoring normality by increasing tone. Soon arose the notion of a tranquilizer which was quite different from any sedative or stimulant. The term tranquilizer took over the notions of sedatives and became the dominant term in the West through the 1980s. In Japan, during this time, the term tranquilizer produced the notion of a psyche-stabilizer and the term mood stabilizer vanished.
Premarin (conjugated estrogens, introduced in 1942) and Prempro (a combination estrogen-progestin pill, introduced in 1995) dominated the hormone replacement therapy (HRT) during the 1990s. HRT is not a life-saving drug, nor does it cure any disease. HRT has been prescribed to improve one's quality of life. Doctors prescribe estrogen for their older female patients both to treat short-term menopausal symptoms and to prevent long-term diseases. In the 1960s and early 1970s, more and more physicians began to prescribe estrogen for their female patients. between 1991 and 1999, Premarin was listed as the most popular prescription and best-selling drug in America.
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.
Stimulants such as Ritalin (methylphenidate) came to be pervasive tools for behavior management and modification in young children. Ritalin was first marketed in 1955 for narcolepsy; its potential users were middle-aged and the elderly. It wasn't until some time in the 1980s along with hyperactivity in children that Ritalin came onto the market. Medical use of methlyphenidate is predominantly for symptoms of attention deficit/hyperactivity disorder (ADHD). Consumption of methylphenidate in the U.S. out-paced all other countries between 1991 and 1999. Significant growth in consumption was also evident in Canada, New Zealand, Australia, and Norway. Currently, 85% of the world's methylphenidate is consumed in America.
The first minor tranquilizer was Meprobamate. Only fourteen months after it was made available, meprobamate had become the country's largest-selling prescription drug. By 1957, meprobamate had become the fastest-growing drug in history. The popularity of meprobamate paved the way for Librium and Valium, two minor tranquilizers that belonged to a new chemical class of drugs called the benzodiazepines. These were drugs that worked chiefly as anti-anxiety agents and muscle relaxants. The first benzodiazepine was Librium. Three months after it was approved, Librium had become the most prescribed tranquilizer in the nation. Three years later, Valium hit the shelves and was ten times more effective as a muscle relaxant and anti-convulsant. Valium was the most versatile of the minor tranquilizers. Later came the widespread adoption of major tranquilizers such as chlorpromazine and the drug reserpine. In 1970, sales began to decline for Valium and Librium, but sales of new and improved tranquilizers, such as Xanax, introduced in 1981 for the newly created diagnosis of panic disorder, soared.
Mevacor (lovastatin) is the first and most influential statin in the American market. The 1991 launch of Pravachol (pravastatin), the second available in the United States, and the release of Zocor (simvastatin) made Mevacor no longer the only statin on the market.
In 1998, Viagra was released as a treatment for erectile dysfunction.
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]].
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紀元前5世紀のギリシアの[[:ja:ヒポクラテスの誓い|ヒポクラテスの誓い]]には「劇薬」の存在が記されており、[[Medicine in ancient Greece/ja|古代ギリシアの医師]]はエジプトなどから薬物を輸入していた。ギリシャの医師[[:ja:ペダニウス・ディオスコリデス|ペダニウス・ディオスコリデス]]が紀元50年から70年にかけて著した[[pharmacopoeia/ja|薬局方]]『[[Wikipedia:De materia medica|De materia medica]]』は、1500年以上にわたって広く読まれてきた。
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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===中世の薬理学===
===Medieval pharmacology===
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[[:en:Al-Kindi|アル＝キンディ]]の西暦9世紀の著書『[[Wikipedia:De Gradibus|De Gradibus]]』と[[:en:Ibn Sina|イブン・シーナ]]（アヴィセンナ）の『[[Wikipedia:The Canon of Medicine|The Canon of Medicine]]』には、[[medicine in the medieval Islamic world/ja|中世イスラム世界における医学]]の実践で知られているさまざまな薬物が網羅されている。
[[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]].
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[[Medieval medicine of Western Europe/ja|西ヨーロッパの中世医学]]では、外科手術は以前に比べて進歩していたが、[[opium/ja|アヘン]]（当時、『[[:en:Antidotarium Nicolai|アンチドタリウム・ニコライ]]』の「大休息」など、非常に人気のあった薬物に含まれていた）や[[quinine/ja|キニーネ]]以外に、真に有効な薬物はほとんど存在しなかった。民間伝承の治療薬や、毒になる可能性のある金属化合物が人気の治療法だった。[[:en:Theodoric Borgognoni|テオドリック・ボルゴニョーニ]]（1205-1296）は、中世の最も重要な外科医の一人で、基本的な[[antisepti/ja|殺菌剤]]の使用や[[anaesthetic/ja|麻酔薬]]の使用など、外科手術の重要な進歩の導入と促進に貢献した。ガ[[:en:Garcia de Orta|ルシア・デ・オルタ]]は、使用されたいくつかの薬草療法について述べている。
[[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.
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.
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政府は医薬品開発や薬物販売の規制に大きく関与してきた。米国では、[[Elixir Sulfanilamide disaster/ja|エリキシル・スルファニルアミドの事故]]が[[Food and Drug Administration/ja|食品医薬品局]]の設立につながり、1938年の連邦食品医薬品化粧品法によって、製造業者は新薬をFDAに申請することが義務づけられた。1951年のハンフリー・ダーラム修正案は、特定の薬物を処方箋によって販売することを義務付けた。1962年の改正では、新薬の有効性と安全性を[[clinical trial/ja|臨床試験]]で確認することが義務づけられた。
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.
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1970年代までは、薬物の価格は医師や患者にとって大きな関心事ではなかった。しかし、慢性疾患で処方される薬物が増えるにつれて、そのコストは負担となり、1970年代までには、米国のほぼすべての州が、高価な先発医薬品から[[generic drugs/ja|ジェネリック医薬品]]への切り替えを義務付け、あるいは奨励するようになった。このことが、2006年に米国で制定された[[Medicare Part D/ja|メディケアパートD]]という法律にもつながっている。
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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==論争==
==Controversies==
{{Anchor|Controversies}}
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薬物に関する論争には、開発中および未承認薬への患者のアクセス、価格設定、環境問題などがある。
Controversies concerning pharmaceutical drugs include patient access to drugs under development and not yet approved, pricing, and environmental issues.
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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===医薬品へのアクセスと薬物価格===
===Access to medicines and drug pricing===
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{{Main/ja|Essential medicines/ja|Societal views on patents/ja}}
{{Main|Essential medicines|Societal views on patents}}
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[[World Health Organization/ja|世界保健機関]]（WHO）が定義する必須医薬品とは、「人口の大多数の医療ニーズを満たす薬物であり、それゆえ、適切な量、適切な剤形、地域社会が購入可能な価格で、いつでも入手可能であるべきである。最近の研究によると、HIV治療薬以外のWHOの必須医薬品リストに掲載されている医薬品のほとんどは、開発途上国では特許を取得しておらず、これらの[[access to medicines/ja|医薬品へのアクセス]]が普及していないのは、経済発展の基本的な問題、すなわちインフラの欠如と貧困から生じていることがわかった。[[Médecins Sans Frontières/ja|国境なき医師団]]はまた、「[[Campaign for Access to Essential Medicines/ja|必須医薬品へのアクセスキャンペーン]]」を実施しており、主に開発途上国で発生している現在治療不可能な病気により多くのリソースを割くよう提唱している。[[Access to Medicine Index/ja|医薬品アクセス指数]]（Access to Medicine Index）は、製薬会社が開発途上国で自社製品をどの程度利用可能にしているかを追跡するものである。
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]].
Some have raised ethical objections specifically with respect to pharmaceutical patents and the high prices for drugs that they enable their proprietors to charge, which poor people around the world, cannot afford. Critics also question the rationale that exclusive patent rights and the resulting high prices are required for pharmaceutical companies to recoup the large investments needed for research and development. One study concluded that marketing expenditures for new drugs often doubled the amount that was allocated for research and development. Other critics claim that patent settlements would be costly for consumers, the health care system, and state and federal governments because it would result in delaying access to lower cost generic medicines.
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[[Novartis]]は、インドにおける薬物[[Gleevec/ja|グリベック]]の特許をめぐってインド政府と長期にわたる争いを繰り広げ、[[:en:Novartis v. Union of India & Others|Novartis対インド連合＆その他]]として知られる訴訟で最高裁に持ち込まれた。最高裁は僅差でNovartisに不利な判決を下したが、薬物特許反対派はこれを大きな勝利と主張した。
[[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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===環境問題===
===Environmental issues===
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{{Main/ja|Environmental impact of pharmaceuticals and personal care products/ja}}
{{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.
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== こちらも参照 ==
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== See also ==
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* [[Adherence (medicine)|Adherence]]
* [[Adherence (medicine)/ja|アドヒアランス]]
* [[Deprescribing|Deprescribing]]
* [[Deprescribing/ja|デ・プレスクライビング]]
* [[Drug nomenclature|Drug nomenclature]]
* [[Drug nomenclature/ja|薬物の命名法]]
* [[List of drugs|List of drugs]]
* [[List of drugs/ja|薬物のリスト]]
* [[List of pharmaceutical companies|List of pharmaceutical companies]]
* [[List of pharmaceutical companies/ja|製薬会社のリスト]]
ボーラスとして1回投与することもできる。投与頻度は、Quaque VIII HoraからQ8Hと読み、8時間ごとなど、ラテン語から略されることが多い。薬物の投与頻度は、1日あたりの使用回数（例えば、1日4回）で表されることが多い。これは[指定する]事象に関連した情報（例：食前1時間、朝、就寝時）を含むか、間隔を補完するものであるが、同等の表現でも意味合いが異なる場合がある（例：8時間ごとと1日3回）。
世界保健機関（WHO）が定義する必須医薬品とは、「人口の大多数の医療ニーズを満たす薬物であり、それゆえ、適切な量、適切な剤形、地域社会が購入可能な価格で、いつでも入手可能であるべきである。最近の研究によると、HIV治療薬以外のWHOの必須医薬品リストに掲載されている医薬品のほとんどは、開発途上国では特許を取得しておらず、これらの医薬品へのアクセスが普及していないのは、経済発展の基本的な問題、すなわちインフラの欠如と貧困から生じていることがわかった。国境なき医師団はまた、「必須医薬品へのアクセスキャンペーン」を実施しており、主に開発途上国で発生している現在治療不可能な病気により多くのリソースを割くよう提唱している。医薬品アクセス指数（Access to Medicine Index）は、製薬会社が開発途上国で自社製品をどの程度利用可能にしているかを追跡するものである。
