医薬品
Medication/ja
| Medication/ja | |
|---|---|
 Packages of medication | |
| Other names | Medicine, drug, pharmaceutical, pharmaceutical preparation, pharmaceutical product, medicinal product, medicament, remedy |
医薬品(Medication)（medicament、medicine、pharmaceutical drug、medicinal drug、または単にdrugと呼ばれる）とは、診断、治療、病気の予防に用いられる薬物である。 薬物治療（薬物療法）は医療分野の重要な一部であり、継続的な進歩のために薬学の科学に、適切な管理のために薬局に依存するものである。
医薬品は複数の方法で分類されている。重要な区分のひとつは管理レベルによるもので、処方薬（医師、医師助手、看護師の指示によってのみ薬剤師が調剤するもの）と市販薬（消費者が自分で注文できるもの）を区別している。もう一つの重要な区別は、通常化学合成から得られる従来の低分子医薬品と、組み換えタンパク質、ワクチン、治療的に使用される血液製剤（IVIGなど）、遺伝子治療、モノクローナル抗体、細胞治療（幹細胞治療など）を含むバイオ医薬品の区別である。その他、作用機序、投与経路、影響を受ける生物学的システム、治療効果によって医薬品を分類する方法がある。精巧で広く使われている分類システムに、解剖学的治療化学分類システムがある。世界保健機関（WHO）は、必須医薬品のリストを作成している。
創薬と薬物開発は、製薬会社、学術研究者、政府によって行われる、複雑で費用のかかる取り組みである。創薬から商業化までのこのような複雑な道のりの結果、開発パイプラインを通じて薬物候補を前進させるための標準的な手法として、提携が行われるようになった。政府は、一般に、どのような薬を販売できるか、どのように薬を販売するか、また、法域によっては、薬物の価格設定を規制している。薬物の価格設定や使用済み薬物の処分をめぐって、論争が起きている。
定義
医薬品とは、病気の治療や治癒に使用される薬や化合物のことである。ブリタニカ百科事典によると、薬とは病気の治療や痛みを和らげるために使用される物質である。
国立がん研究所の定義によれば、薬の剤形には、錠剤、カプセル、液体、クリーム、パッチが含まれることがある。薬は、口からや、静脈に注入、耳や目に滴下するなど、さまざまな方法で投与することができる。有効成分を含まない薬で、研究調査に使用されるものはプラセボと呼ばれる。
ヨーロッパではMedicinal productと呼ばれ、EU法で次のように定義されている：
- "ヒトの疾病を治療または予防する特性を有するものとして提示された物質または物質の組み合わせ"
- 「薬理学的、免疫学的、代謝学的作用を発揮することによって生理的機能を回復、修正、変更する目的で、または医学的診断を行う目的で、ヒトに使用または投与することができる物質または物質の組合せ」。
米国では、薬物とは:
- 公式の薬局方や処方箋で認められている物質である。
- 病気の診断、治療、緩和、治療、予防に使用することを目的とした物質。
- 身体の構造または機能に影響を与えることを目的とした物質（食品を除く）。
- 医薬品の成分として使用することを意図した物質であって、デバイスまたはデバイスの構成要素、部品、付属品ではない。
- 生物学的製剤はこの定義に含まれ、一般に同じ法規制の対象となるが、その製造工程（化学的工程と生物学的工程）については違いがある。
使用状況
アメリカの高齢者の薬物使用状況が調査されており、2005年から2006年にかけて調査された平均年齢71歳の2,377人のグループでは、84％が少なくとも1つの処方薬を服用、44％が少なくとも1つの市販薬（OTC）を服用、52％が少なくとも1つの栄養補助食品を服用し、2010年から2011年にかけて調査された平均年齢71歳の2,245人の高齢者のグループでは、その割合は88%、38%、64％となった。
分類
重要な分類の一つは、従来の低分子医薬品（通常、化学合成から得られる）と生物学的製剤（組み換えタンパク質、ワクチン、治療的に用いられる血液製剤（IVIGなど）、遺伝子治療、細胞治療（例えば、幹細胞治療）を含む）との間の分類である。
医薬品または薬物は、化学的性質、投与方法または投与経路、影響を受ける生物学的系、または治療効果など、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、解剖学的治療化学分類システム（ATCシステム）がある。世界保健機関（WHO）は、必須医薬品のリストを作成している。
医薬品のクラスの一例として、以下のものがある：
- 解熱鎮痛剤: 熱を下げる (発汗/発熱)
- 鎮痛剤: 痛みをやわらげる (痛み止め)
- 坑マラリア薬: マラリアの治療
- 抗生物質: 細菌の繁殖阻害
- 殺菌剤: 火傷、切り傷、創傷付近の雑菌の繁殖を防止する
- 気分安定薬: リチウム塩 と バルプロ酸
- ホルモン補充: プレマリン
- 経口避妊薬: エノビッド、二相性 ピル、三相性 ピル
- 覚醒剤: メチルフェニデート, アンフェタミン
- 精神安定剤s: メプロバメート, クロルプロマジン, レセルピン, クロルジアゼポキシド, ジアゼパム, アルプラゾラム
- スタチン: ロバスタチン, プラバスタチン, シンバスタチン
医薬品は、他の分類とは別に「特殊(specialty)」と表現されるものもある。これは、投与が困難である可能性があり、投与中に特別な取り扱いを必要とし、投与中および投与直後に患者のモニタリングを必要とし、その使用を制限する特定の規制要件を持ち、他の薬物と比較して一般的に高価な、定義されていない薬物のクラスである。
医薬品の種類
消化器系用
- 上部腸管: 制酸剤, 逆流防止剤, 鼓腸薬, 坑ドーパミン薬, プロトンポンプ阻害剤 (PPIs), H2-受容体拮抗薬, 細胞保護剤, プロスタグランジン類似体
- 下部腸管: 下剤, 鎮痙薬, 止瀉剤, 胆汁酸隔離剤, オピオイド
循環器用
- 一般: β受容体遮断薬 (βブロッカー)、カルシウム拮抗薬、利尿剤、強心配糖体、坑不整脈薬、硝酸塩、坑狭心症薬、血管収縮薬、血管拡張薬
- 血圧 に影響する／降圧薬: ACE阻害薬、アンジオテンシン受容体拮抗薬、β遮断薬、α遮断薬、カルシウム拮抗薬、サイアザイド系利尿薬、ループ利尿薬、アルドステロン阻害薬
- 凝固: 坑凝固薬、ヘパリン、坑血小板薬、血栓溶解薬、抗血友病因子薬、止血薬
- LDLコレステロールを低下させるHMG-CoA還元酵素阻害薬 (スタチン): 高脂血症治療薬
中枢神経系用
中枢神経系に影響を及ぼす薬物: 向精神薬、睡眠薬、麻酔薬、抗精神病薬、オイゲロイック薬、抗うつ薬（三環系抗うつ薬、モノアミン酸化酵素阻害薬、リチウム塩、選択的セロトニン再取り込み阻害薬（SSRI）を含む）、制吐薬、抗けいれん薬/抗てんかん薬、抗不安薬、バルビツール酸薬、運動障害（パーキンソン病など）治療薬、向精神薬、興奮薬（アンフェタミンを含む）、ベンゾジアゼピン系薬剤、シクロピロロン系薬剤、ドパミン拮抗薬、抗ヒスタミン薬、コリン作動薬、抗コリン薬、催吐薬、カンナビノイド、5-HT（セロトニン）拮抗薬などがある。
痛み用
意識のため (麻酔薬)
筋骨格障害用
筋骨格系障害の薬物の主なカテゴリーは以下の通りである： 非ステロイド性抗炎症薬（COX-2選択的阻害薬を含む）、筋弛緩薬、神経筋薬、抗コリンエステラーゼ薬である。
眼科用
- 一般：アドレナリン作動性神経遮断薬、収斂薬
- 診断薬: 局所麻酔薬、 交感神経刺激薬、 副交感神経溶解薬、 散瞳薬、 調節麻痺剤
- 抗菌薬: 抗生物質、 外用抗生物質、サルファ剤, アミノグリコシド系薬物, フルオロキノロン系薬物
- 抗ウイルス薬
- 抗真菌薬: イミダゾール系、ポリエン系
- 抗炎症薬: 非ステロイド性抗炎症薬、コルチコステロイド
- 抗アレルギー: 肥満細胞阻害剤
- 抗緑内障薬: アドレナリン作動薬、β遮断薬、炭酸脱水酵素阻害薬/高浸透圧薬、コリン作動薬s, ミオティック、副交感神経刺激薬、 プロスタグランジン作動薬/プロスタグランジン阻害薬, ニトログリセリン
耳、鼻、口腔咽頭用
抗生物質, 交感神経刺激薬、抗ヒスタミン薬、抗コリン薬s, 非ステロイド性抗炎症薬、 コルチコステロイド薬、消毒薬、局所麻酔薬、坑真菌薬、角質溶解薬
呼吸器系用
気管支拡張薬、鎮咳薬、鎮咳去痰薬s, 鬱血除去薬、吸入および全身性 コルチコステロイド、β2-アドレナリン作動薬、 坑コリン薬、肥満細胞安定化薬、ロイコトリエン拮抗薬
内分泌疾患用
アンドロゲン、抗アンドロゲン薬、エストロゲン、性腺刺激ホルモン、副腎皮質ホルモン、ヒト成長ホルモン、インスリン、抗糖尿病薬(スルホニル尿素、ビグアナイド/メトホルミン、チアゾリジン薬、 インスリン), 甲状腺ホルモン、抗甲状腺薬物、カルシトニン、ジホスホネート、バソプレシン類似物質
生殖器系または泌尿器系
坑真菌薬、アルカリ化薬、キノロン系抗菌薬、抗生物質、コリン作動薬、坑コリン薬、鎮痙薬、5α還元酵素阻害薬、選択的α1遮断薬、シルデナフィル、不妊治療薬
避妊用
産婦人科用
非ステロイド性抗炎症薬、坑コリン薬、止血薬、坑線溶薬、ホルモン補充療法 (HRT)、骨調整薬、β受容体作動薬、卵胞刺激ホルモン、黄体形成ホルモン、LHRH、ガモレン酸、ゴナドトロピン放出阻害薬、黄体ホルモン、ドーパミン作動薬、エストロゲン、プロスタグラジン、ゴナドレリン、クロミフェン、タモキシフェン、ジエチルスチルベストロール
皮膚用
皮膚軟化剤、かゆみ止め、抗真菌剤、殺菌剤、抗疥癬薬、殺シラミ薬、乾留液製品、ビタミンA誘導体、ビタミンD類似体、角質溶解薬、研磨材、全身性抗生物質、外用 抗生物質、ホルモン、剥離剤、滲出液吸収剤、 線維素溶解、タンパク質分解、サンスクリーン剤、制汗剤、副腎皮質ホルモン、免疫調整剤
感染症と蔓延用
抗生物質、坑真菌薬、坑レプロ薬、坑結核薬、坑マラリア薬、駆虫薬、アメーバ駆除薬、坑ウィルス薬、坑寄生虫薬、プロバイオティクス、プレバイオティクス、坑毒素薬、駆虫薬
免疫系
ワクチン、免疫グロブリン、免疫抑制剤、インターフェロン、モノクローナル抗体
アレルギー疾患用
坑アレルギー剤、坑ヒスタミン剤、NSAIDs、コルチコステロイド剤
栄養
トニック、電解質とミネラル (鉄製剤と マグネシウム製剤を含む)、非経口栄養剤、ビタミン剤、 坑肥満薬、タンパク同化薬、造血薬、食品製剤
腫瘍性疾患用
細胞毒性薬、治療用抗体、性ホルモン、アロマターゼ阻害剤、ソマトスタチン阻害剤、遺伝子組み換えインターロイキン、G-CSF、エリスロポエチン
診断薬
安楽死用
安楽死薬は、安楽死や医師による自殺幇助に用いられる。多くの国では安楽死は法律で認められていないため、そのような国では安楽死のための医薬品は認可されない。
投与
一つの薬物には、単一または複数の有効成分が含まれている。
Administration is the process by which a patient takes a medicine. There are three major categories of drug administration: enteral (via the human gastrointestinal tract), injection into the body, and by other routes (dermal, nasal, ophthalmic, otologic, and urogenital).
Oral administration, the most common form of enteral administration, can be performed using various dosage forms including tablets or capsules and liquid such as a syrup or suspension. Other ways to take medication include buccally (placed inside cheek), sublingually (placed underneath tongue), eye and ear drops (dropped into eye or ear), and transdermally (applied to skin).
They can be administered in one dose, as a 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] 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).
Drug discovery
In the fields of medicine, biotechnology and pharmacology, 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 serendipitous discovery. Later chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology. Since sequencing of the human genome which allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease-modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for 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 candidates.
Modern drug discovery involves the identification of screening hits, medicinal chemistry and optimization of those hits to increase the affinity, selectivity (to reduce the potential of side effects), efficacy/potency, metabolic stability (to increase the half-life), and oral bioavailability. Once a compound that fulfills all of these requirements has been identified, it will begin the process of drug development prior to clinical trials. One or more of these steps may, but not necessarily, involve 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 (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 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.
Development
Drug development is the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery. It includes pre-clinical research (microorganisms/animals) and clinical trials (on humans) and may include the step of obtaining regulatory approval to market the drug.
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 testing: The drug is used on people to confirm that it is safe to use.
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
Regulation
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.
Depending upon the jurisdiction, drugs may be divided into over-the-counter drugs (OTC) which may be available without special restrictions, and prescription drugs, which must be prescribed by a licensed medical practitioner in accordance with medical guidelines due to the risk of adverse effects and contraindications. 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, not visible to the public, and be sold only by a pharmacist or pharmacy technician. Doctors may also prescribe prescription drugs for off-label use – purposes which the drugs were not originally approved for by the regulatory agency. The Classification of Pharmaco-Therapeutic Referrals helps guide the referral process between pharmacists and doctors.
The International Narcotics Control Board of the United Nations imposes a world law of 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 pharmacies by or under the supervision of a pharmacist.
Medical errors include over prescription and 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 conference; the conference was motivated by ambiguity in the what a prescription error and a need to use a uniform definition in studies.
Drug pricing
In many jurisdictions drug prices are regulated.
United Kingdom
In the UK, the Pharmaceutical Price Regulation Scheme is intended to ensure that the 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 (ABPI). For 2017 this payment percentage set by the PPRS will be 4,75%.
Canada
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
Brazil
In Brazil, the prices are regulated through a legislation under the name of Medicamento Genérico (generic drugs) since 1999.
India
In India, drug prices are regulated by the National Pharmaceutical Pricing Authority.
United States
In the United States, drug costs are partially unregulated, but instead are the result of negotiations between drug companies and insurance companies.
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.
Blockbuster drug
A blockbuster drug is a drug that generates more than $1 billion in revenue for a pharmaceutical company in a single year. Cimetidine was the first drug ever to reach more than $1 billion a year in sales, thus making it the first blockbuster drug.
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.
History
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.
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 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.
Ancient pharmacology
Using plants and plant substances to treat all kinds of diseases and medical conditions is believed to date back to prehistoric medicine.
The 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 describe Ancient Egyptian medical practices, such as using honey to treat infections and the legs of bee-eaters to treat neck pains.
Ancient Babylonian medicine demonstrated the use of medication in the first half of the 2nd millennium BC. Medicinal creams and pills were employed as treatments.
On the Indian subcontinent, the Atharvaveda, a sacred text of 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 were built on a synthesis of selected ancient herbal practices, together with a massive addition of theoretical conceptualizations, new 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.
The Hippocratic Oath for physicians, attributed to fifth century BC Greece, refers to the existence of "deadly drugs", and ancient Greek physicians imported drugs from Egypt and elsewhere. The pharmacopoeia De materia medica, written between 50 and 70 CE by the Greek physician Pedanius Dioscorides, was widely read for more than 1,500 years.
Medieval pharmacology
Al-Kindi's ninth century AD book, De Gradibus and Ibn Sina (Avicenna)'s The Canon of Medicine, covers a range of drugs known to the practice of medicine in the medieval Islamic world.
Medieval medicine of Western Europe saw advances in surgery compared to previously, but few truly effective drugs existed, beyond opium (found in such extremely popular drugs as the "Great Rest" of the Antidotarium Nicolai at the time) and quinine. Folklore cures and potentially poisonous metal-based compounds were popular treatments. 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 practice and the use of anaesthetics. Garcia de Orta described some herbal treatments that were used.
Modern pharmacology
For most of the 19th century, drugs were not highly effective, leading 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, Alexis Carrel and Henry Dakin developed the Carrel-Dakin method of treating wounds with an irrigation, Dakin's solution, a germicide which helped prevent gangrene.
In the inter-war period, the first anti-bacterial agents such as the 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 antibiotics, made possible by the pressures of the war and the collaboration of British scientists with the American pharmaceutical industry.
Medicines commonly used by the late 1920s included aspirin, codeine, and morphine for pain; digitalis, nitroglycerin, and quinine for heart disorders, and insulin for diabetes. Other drugs included antitoxins, a few biological vaccines, and a few synthetic drugs. In the 1930s, antibiotics emerged: first sulfa drugs, then penicillin and other antibiotics. Drugs increasingly became "the center of medical practice". In the 1950s, other drugs emerged including corticosteroids for inflammation, rauvolfia alkaloids as tranquilizers and antihypertensives, antihistamines for nasal allergies, xanthines for asthma, and typical antipsychotics for psychosis. As of 2007, thousands of approved drugs have been developed. Increasingly, biotechnology is used to discover biopharmaceuticals. 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, 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. 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 led to the establishment of the 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 trials.
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 for higher-priced brand names. This also led to the 2006 U.S. law, Medicare Part D, which offers Medicare coverage for drugs.
As of 2008, the United States is the leader in 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.
Controversies
Controversies concerning pharmaceutical drugs include patient access to drugs under development and not yet approved, pricing, and environmental issues.
Access to unapproved drugs
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, 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 (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 formed in the 1980s, and eventually formed its Treatment Action Group in part to pressure the US government to put more resources into discovering treatments for AIDS and then to speed release of drugs that were under development.
The 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 was at the center of a high-profile debate regarding expanded access of cancer patients to experimental drugs.
Access to medicines and drug pricing
Essential medicines, as defined by the 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 these medicines arise from issues fundamental to economic development – lack of infrastructure and poverty. Médecins Sans Frontières also runs a 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 tracks how well pharmaceutical companies make their products available in the developing world.
World Trade Organization negotiations in the 1990s, including the TRIPS Agreement and the Doha Declaration, have centered on issues at the intersection of international trade in pharmaceuticals and 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.
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.
Novartis fought a protracted battle with the government of India over the patenting of its drug, Gleevec, in India, which ended up in a Supreme Court in a case known as Novartis v. Union of India & Others. The Supreme Court ruled narrowly against Novartis, but opponents of patenting drugs claimed it as a major victory.
Environmental issues
The environmental impact of pharmaceuticals and personal care products is controversial. PPCPs are substances used by individuals for personal health or cosmetic reasons and the products used by 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 Pollutants. 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.
See also
External links
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