Medication | Wikipedia audio article

Medication | Wikipedia audio article


A medication (also referred to as medicine,
pharmaceutical drug, or simply drug) is a drug used to diagnose, cure, treat, or prevent
disease. Drug therapy (pharmacotherapy) is an important
part of the medical field and relies on the science of pharmacology for continual advancement
and on pharmacy for appropriate management. Drugs are classified in various ways. One of the key divisions is by level of control,
which distinguishes prescription drugs (those that a pharmacist dispenses only on the order
of a physician, physician assistant, or qualified nurse) from over-the-counter drugs (those
that consumers can order for themselves). Another key distinction is between traditional
small-molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals,
which include recombinant proteins, vaccines, blood products used therapeutically (such
as IVIG), gene therapy, monoclonal antibodies and cell therapy (for instance, stem-cell
therapies). Other ways to classify medicines are by mode
of action, route of administration, biological system affected, or therapeutic effects. An elaborate and widely used classification
system is the Anatomical Therapeutic Chemical Classification System (ATC system). The World Health Organization keeps a list
of essential medicines. Drug discovery and drug development are complex
and expensive endeavors undertaken by pharmaceutical companies, academic scientists, and governments. As a result of this complex path from discovery
to commercialization, partnering has become a standard practice for advancing drug candidates
through development pipelines. Governments generally regulate what drugs
can be marketed, how drugs are marketed, and in some jurisdictions, drug pricing. Controversies have arisen over drug pricing
and disposal of used drugs.==Definition==
In Europe, the term is “medicinal product”, and it is defined by EU law as:
“(a) Any substance or combination of substances presented as having properties for treating
or preventing disease in human beings; or (b) Any substance or combination of substances
which may be used in or administered to human beings either with a view to restoring, correcting
or modifying physiological functions by exerting a pharmacological, immunological or metabolic
action, or to making a medical diagnosis.”In the US, a “drug” is: A substance recognized by an official pharmacopoeia
or formulary. A substance intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease. A substance (other than food) intended to
affect the structure or any function of the body. A substance intended for use as a component
of a medicine but not a device or a component, part or accessory of a device. Biological products are included within this
definition and are generally covered by the same laws and regulations, but differences
exist regarding their manufacturing processes (chemical process versus biological process).==Usage==
Drug use among elderly Americans has been studied; in a group of 2377 people with average
age of 71 surveyed between 2005 and 2006, 84% took at least one prescription drug, 44%
took at least one over-the-counter (OTC) drug, and 52% took at least one dietary supplement;
in a group of 2245 elderly Americans (average age of 71) surveyed over the period 2010 – 2011,
those percentages were 88%, 38%, and 64%.==Classification==One of the key classifications is between
traditional small molecule drugs; usually derived from chemical synthesis, and biologic
medical products; which include recombinant proteins, vaccines, blood products used therapeutically
(such as IVIG), gene therapy, and cell therapy (for instance, stem cell therapies). 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 properties,
mode or route of administration, biological system affected, or therapeutic effects. An elaborate and widely used classification
system is the Anatomical Therapeutic Chemical Classification System (ATC system). The World Health Organization keeps a list
of essential medicines. A sampling of classes of medicine includes: Antipyretics: reducing fever (pyrexia/pyresis)
Analgesics: reducing pain (painkillers) Antimalarial drugs: treating malaria
Antibiotics: inhibiting germ growth Antiseptics: prevention of germ growth near
burns, cuts and wounds Mood stabilizers: lithium and valpromide
Hormone replacements: Premarin Oral contraceptives: Enovid, “biphasic” pill,
and “triphasic” pill Stimulants: methylphenidate, amphetamine
Tranquilizers: meprobamate, chlorpromazine, reserpine, chlordiazepoxide, diazepam, and
alprazolam Statins: lovastatin, pravastatin, and simvastatinPharmaceuticals
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.==Types of medicines=====
For the digestive system===Upper digestive tract: antacids, reflux suppressants,
antiflatulents, antidopaminergics, proton pump inhibitors (PPIs), H2-receptor antagonists,
cytoprotectants, prostaglandin analogues Lower digestive tract: laxatives, antispasmodics,
antidiarrhoeals, bile acid sequestrants, opioid===For the cardiovascular system===
General: β-receptor blockers (“beta blockers”), calcium channel blockers, diuretics, cardiac
glycosides, antiarrhythmics, nitrate, antianginals, vasoconstrictors, vasodilators. Affecting blood pressure/(antihypertensive
drugs): ACE inhibitors, angiotensin receptor blockers, beta-blockers, α blockers, calcium
channel blockers, thiazide diuretics, loop diuretics, aldosterone inhibitors
Coagulation: anticoagulants, heparin, antiplatelet drugs, fibrinolytics, anti-hemophilic factors,
haemostatic drugs HMG-CoA reductase inhibitors (statins) for
lowering LDL cholesterol inhibitors: hypolipidaemic agents.===For the central nervous system===
Drugs affecting the central nervous system include: Psychedelics, hypnotics, anaesthetics,
antipsychotics, eugeroics, antidepressants (including tricyclic antidepressants, monoamine
oxidase inhibitors, lithium salts, and selective serotonin reuptake inhibitors (SSRIs)), antiemetics,
Anticonvulsants/antiepileptics, anxiolytics, barbiturates, movement disorder (e.g., Parkinson’s
disease) drugs, stimulants (including amphetamines), benzodiazepines, cyclopyrrolones, dopamine
antagonists, antihistamines, cholinergics, anticholinergics, emetics, cannabinoids, and
5-HT (serotonin) antagonists.===For pain===The main classes of painkillers are NSAIDs,
opioids and Local anesthetics. For consciousness (anesthetic drugs) Some anesthetics include Benzodiazepines and
Barbiturates.===For musculo-skeletal disorders===
The main categories of drugs for musculoskeletal disorders are: NSAIDs (including COX-2 selective
inhibitors), muscle relaxants, neuromuscular drugs, and anticholinesterases.===For the eye===
General: adrenergic neurone blocker, astringent Diagnostic: topical anesthetics, sympathomimetics,
parasympatholytics, mydriatics, cycloplegics Antibacterial: antibiotics, topical antibiotics,
sulfa drugs, aminoglycosides, fluoroquinolones Antiviral drug
Anti-fungal: imidazoles, polyenes Anti-inflammatory: NSAIDs, corticosteroids
Anti-allergy: mast cell inhibitors Anti-glaucoma: adrenergic agonists, beta-blockers,
carbonic anhydrase inhibitors/hyperosmotics, cholinergics, miotics, parasympathomimetics,
prostaglandin agonists/prostaglandin inhibitors. nitroglycerin===For the ear, nose and oropharynx===
Antibiotics, sympathomimetics, antihistamines, anticholinergics, NSAIDs, corticosteroids,
antiseptics, local anesthetics, antifungals, cerumenolytic===
For the respiratory system===bronchodilators, antitussives, mucolytics,
decongestantsinhaled and systemic corticosteroids, Beta2-adrenergic agonists, anticholinergics,
Mast cell stabilizers. Leukotriene antagonists===For endocrine problems===
androgens, antiandrogens, estrogens, gonadotropin, corticosteroids, human growth hormone, insulin,
antidiabetics (sulfonylureas, biguanides/metformin, thiazolidinediones, insulin), thyroid hormones,
antithyroid drugs, calcitonin, diphosponate, vasopressin analogues===
For the reproductive system or urinary system===
antifungal, alkalinizing agents, quinolones, antibiotics, cholinergics, anticholinergics,
antispasmodics, 5-alpha reductase inhibitor, selective alpha-1 blockers, sildenafils, fertility
medications===
For contraception===Hormonal contraception
Ormeloxifene Spermicide===
For obstetrics and gynecology===NSAIDs, anticholinergics, haemostatic drugs,
antifibrinolytics, Hormone Replacement Therapy (HRT), bone regulators, beta-receptor agonists,
follicle stimulating hormone, luteinising hormone, LHRH gamolenic acid, gonadotropin
release inhibitor, progestogen, dopamine agonists, oestrogen, prostaglandins, gonadorelin, clomiphene,
tamoxifen, Diethylstilbestrol===For the skin===
emollients, anti-pruritics, antifungals, disinfectants, scabicides, pediculicides, tar products, vitamin
A derivatives, vitamin D analogues, keratolytics, abrasives, systemic antibiotics, topical antibiotics,
hormones, desloughing agents, exudate absorbents, fibrinolytics, proteolytics, sunscreens, antiperspirants,
corticosteroids, immune modulators===
For infections and infestations===antibiotics, antifungals, antileprotics, antituberculous
drugs, antimalarials, anthelmintics, amoebicides, antivirals, antiprotozoals, probiotics, prebiotics,
antitoxins and antivenoms.===For
the immune system===vaccines, immunoglobulins, immunosuppressants,
interferons, monoclonal antibodies===
For allergic disorders===anti-allergics, antihistamines, NSAIDs, Corticosteroids===
For nutrition===Tonics, electrolytes and mineral preparations
(including iron preparations and magnesium preparations), parenteral nutritions, vitamins,
anti-obesity drugs, anabolic drugs, haematopoietic drugs, food product drugs===
For neoplastic disorders===cytotoxic drugs, therapeutic antibodies, sex
hormones, aromatase inhibitors, somatostatin inhibitors, recombinant interleukins, G-CSF,
erythropoietin===
For diagnostics===contrast media===
For euthanasia===A euthanaticum is used for euthanasia and
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.==Administration==Administration is the process by which a patient
takes a medicine. There are three major categories of drug administration;
enteral (by mouth), parenteral (into the blood stream), and other (which includes giving
a drug through intranasal, topical, inhalation, and rectal means).It can be performed in various
dosage forms such as pills, tablets, or capsules. The drug may contain a single or multiple
active ingredients. There are many variations in the routes of
administration, including intravenous (into the blood through a vein) and oral administration
(through the mouth). They can be administered all at once as a
bolus, at frequent intervals or continuously. Frequencies are often abbreviated from Latin,
such as every 8 hours reading Q8H from Quaque VIII Hora.==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,
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.==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.==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 only be sold 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 only be sold in registered pharmacies
by or under the supervision of a pharmacist. Medical errors include overprescription and
polypharmacy, misprescription, 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 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 and
a lack of ability for organizations to negotiate prices.==Blockbuster drug==A blockbuster drug is a drug generating more
than $1 billion of revenue for the pharmaceutical company that sells it each 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.”Interestingly, despite the enormous advances in science and technology, the number
of new blockbuster drugs has halved roughly every 9 years since 1950. This was ascribed to the fact that every new
drug competes in effectiveness with every other drugs known so far, other economic factors
and ever-tightening regulations.==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 predominately
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 methylphanidate
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 demonstrate the
use of prescriptions 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 2nd 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 5th century BC Greece, refers to the existence of “deadly drugs”, and ancient Greek physicians
imported drugs from Egypt and elsewhere.===Medieval pharmacology===
Al-Kindi’s 9th century AD book, De Gradibus and Ibn Sina (Avicenna)’s The Canon of Medicine
cover a range of drugs known to Medicine in the medieval Islamic world. Medieval medicine saw advances in surgery,
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 tranqulizers 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 in the developed world, and developing 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 India’s 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

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