Medication
Medication
Medication
Medication
Packages of medication
medicament, remedy
[edit on Wikidata]
A medication (also called medicament, medicine, pharmaceutical
drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat,
or prevent disease.[1][2] 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 multiple 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[edit]
In Europe, the term is "medicinal product", and it is defined by EU law as:
Usage[edit]
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%.[5]
Classification[edit]
Main article: Drug class
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,[6] 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:
1. Antipyretics: reducing fever (pyrexia/pyresis)
2. Analgesics: reducing pain (painkillers)
3. Antimalarial drugs: treating malaria
4. Antibiotics: inhibiting germ growth
5. Antiseptics: prevention of germ growth near burns, cuts and wounds
6. Mood stabilizers: lithium and valpromide
7. Hormone replacements: Premarin
8. Oral contraceptives: Enovid, "biphasic" pill, and "triphasic" pill
9. Stimulants: methylphenidate, amphetamine
10. Tranquilizers: meprobamate, chlorpromazine, reserpine, chlordiazepox
ide, diazepam, and alprazolam
11. Statins: lovastatin, pravastatin, and simvastatin
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. [7]
Types of medicines[edit]
See also: Category:Drugs by target organ system
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Administration[edit]
Main article: Route of administration
February 1918 drawing by Marguerite Martyn of a visiting nurse in St. Louis, Missouri, with medicine and
babies
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, and other (dermal, nasal, ophthalmic, otologic, and urogenital).[8]
Oral administration, the most common form of enteral administration, can be
performed in various dosage forms including pills, tablets, or capsules, and other
routes likewise have various forms.
The drug may contain a single or multiple active ingredients.
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[edit]
Main article: 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.[9] In 2010, the research and development cost of
each new molecular entity (NME) was approximately US$1.8 billion. [10] 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.
Development[edit]
Main article: Drug 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. [11][12]
Regulation[edit]
Main article: Regulation of therapeutic goods
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. [13] 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 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. [14]
Drug pricing[edit]
Main articles: Prescription costs and Pharmacoeconomics
Blockbuster drug[edit]
Main article: 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.[21] Cimetidine was the first drug ever to
reach more than $1 billion a year in sales, thus making it the first blockbuster drug. [22]
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.[23]
History[edit]
Main article: History of pharmacy
Prescription drug history[edit]
Antibiotics first arrived on the medical scene in 1932 thanks to Gerhard Domagk;
[24]
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.[25] 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.[26]
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.[26]
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. [26]
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. [26]
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. [26]
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.[26]
Ancient pharmacology[edit]
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.
[27][28]
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.[29]
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. [30] 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.[31] 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.[32] 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.[33]
Medieval pharmacology[edit]
Al-Kindi's ninth 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)[34] 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[edit]
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".[23]: 21
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".[23]: 22 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.[23]: 23–24 As of 2007, thousands of approved drugs
have been developed. Increasingly, biotechnology is used to
discover biopharmaceuticals. Recently, multi-disciplinary approaches have yielded
[23]
a wealth of new data on the development of novel antibiotics and antibacterials and
on the use of biological agents for antibacterial therapy. [35]
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.[23]: 24–26
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. [23]: 28–29
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. [23]: 30–31
Controversies[edit]
Controversies concerning pharmaceutical drugs include patient access to drugs
under development and not yet approved, pricing, and environmental issues.
Access to unapproved drugs[edit]
Main article: Expanded access
Governments worldwide have created provisions for granting access to drugs prior to
approval for patients who have exhausted all alternative treatment options and do
not match clinical trial entry criteria. Often grouped under the labels of
compassionate use, expanded access, 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. [36]
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. [37]
The Abigail Alliance was established in November 2001 by Frank Burroughs in
memory of his daughter, Abigail. [38] 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. [39][40]
Access to medicines and drug pricing[edit]
Main articles: Essential medicines and Societal views on patents
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." [41] 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.[42] 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. [43]
[44]
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. [43] One study concluded that
marketing expenditures for new drugs often doubled the amount that was allocated
for research and development.[45] 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. [46]
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. [47]
Environmental issues[edit]
Main article: 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 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. [48]