Product Code Database
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease." Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use – Article 1". Published 31 March 2004. Accessed 17 August 2008. . Drug therapy (pharmacotherapy) is an important part of the medicine and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.
Drugs are Drug class in many ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the medical prescription) from over-the-counter drugs (those that consumers can order for themselves). Medicines may be classified by mode of action, route of administration, biological system affected, or therapeutic effects. 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 medications.
As defined by the National Cancer Institute, dosage forms of medication can include tablets, capsules, liquids, creams, and patches. Medications can be administered in different ways, such as by mouth, by infusion into a vein, or by Ear drop or Eye drop. A medication that does not contain an active ingredient and is used in research studies is called a placebo.
In Europe, the term is "medicinal product", and it is defined by EU law as:
In the US, a "drug" is:
Pharmaceuticals or drugs or medicines are classified into 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:
For consciousness (anesthetic drugs)
Some anesthetics include and .
The administration is the process by which a patient takes medicine. There are three major categories of drug administration: enteral (via the human gastrointestinal tract), injection into the body, and by other routes (Dermis, nasal, ophthalmic, Ear, and urogenital). (2025). 9780781771559, Lippencott Williams & Wilkins. ISBN 9780781771559
Oral administration, the most common form of enteral administration, can be performed using various dosage forms including tablets or capsules and liquid such as syrup or suspension. Other ways to take the medication include buccally (placed inside the cheek), sublingually (placed underneath the tongue), eye and (dropped into the eye or ear), and transdermally (applied to the 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 may include event-related information (e.g., 1 hour before meals, in the morning, at bedtime), or complimentary to an interval, although equivalent expressions may have different implications (e.g., every 8 hours versus 3 times a day).
Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipity discovery. Later chemical library of synthetic , , or 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 compound 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, Metabolism 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 . 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 a 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.
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 ears.
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.
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 . 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) are forbidden. OTC drugs are sold without restriction as they are considered safe enough that most people will not hurt themselves accidentally by taking it as instructed. Many countries, such as the United Kingdom have a third category of "pharmacy medicines", which can be sold only in registered pharmacy by or under the supervision of a pharmacist.
include over-prescription and polypharmacy, mis-prescription, contraindication and lack of detail in dosage and administration instructions. In 2000 the definition of a prescription error was studied using a Delphi method conference; the conference was motivated by ambiguity in what a prescription error is and a need to use a uniform definition in studies.
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.
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.Tone, Andrea and Elizabeth Watkins, Medicating Modern America: Prescription Drugs in History. New York and London, New York University, 2007. Print.
Premarin (conjugated estrogens, introduced in 1942) and Prempro (a combination estrogen-progestin pill, introduced in 1995) dominated the hormone replacement therapy (HRT) during the 1990s. HRT is not a life-saving drug, nor does it cure any disease. HRT has been prescribed to improve one's quality of life. Doctors prescribe estrogen for their older female patients both to treat short-term menopausal symptoms and to prevent long-term diseases. In the 1960s and early 1970s, more and more physicians began to prescribe estrogen for their female patients. Between 1991 and 1999, Premarin was listed as the most popular prescription and best-selling drug in America.
The first oral contraceptive, Enovid, was approved by FDA in 1960. Oral contraceptives inhibit ovulation and so prevent conception. Enovid was known to be much more effective than alternatives including the condom and the diaphragm. As early as 1960, oral contraceptives were available in several different strengths by every manufacturer. In the 1980s and 1990s, an increasing number of options arose including, most recently, a new drug delivery 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 Methylphenidate (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 was not until some time in the 1980s along with hyperactivity in children that Ritalin came onto the market. Medical use of methylphenidate 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 Chlordiazepoxide and Diazepam, two minor tranquilizers that belonged to a new chemical class of drugs called the . These were drugs that worked chiefly as Anxiolytic and . 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 Alprazolam, introduced in 1981 for the newly created diagnosis of panic disorder, soared.
Lovastatin (lovastatin) is the first and most influential statin in the American market. The 1991 launch of Pravastatin (pravastatin), the second available in the United States, and the release of Simvastatin (simvastatin) made Mevacor no longer the only statin on the market. In 1998, Sildenafil was released as a treatment for erectile dysfunction.
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.H.F.J. Horstmanshoff, Marten Stol, Cornelis Tilburg (2004), Magic and Rationality in Ancient Near Eastern and Graeco-Roman Medicine, p. 99, Brill Publishers, .
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.See Atharvaveda XIX.34.9 The earliest foundations of ayurveda were built on a synthesis of selected ancient herbal practices, together with a massive addition of theoretical conceptualizations, new nosology and new therapies dating from about 400 BC onwards.Kenneth G. Zysk, Asceticism and Healing in Ancient India: Medicine in the Buddhist Monastery, Oxford University Press, rev. ed. (1998) . 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.Heinrich von Staden, Herophilus: The Art of Medicine in Early Alexandria (Cambridge: Cambridge University Press, 1989), pp. 1–26. 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 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 . Garcia de Orta described some herbal treatments that were used.
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; Digoxin, nitroglycerin, and quinine for heart disorders, and insulin for diabetes. Other drugs included , a few biological vaccines, and a few synthetic drugs. In the 1930s, antibiotics emerged: first , 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, for nasal allergies, for asthma, and typical for psychosis. As of 2007, thousands of approved drugs have been drug development. 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 .
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.
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.
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.Charlotte Harrison Patent watch Nature Reviews Drug Discovery 12, 336–337 (2013)
Scientists generally divide environmental impacts of a chemical into three primary categories: persistence, bioaccumulation, and toxicity. Since medications are inherently bio-active, most are naturally degradable in the environment, however they are classified as "pseudopersistent" because they are constantly being replenished from their sources. These Environmentally Persistent Pharmaceutical Pollutants (EPPPs) rarely reach toxic concentrations in the environment, however they have been known to bioaccumulate in some species. Their effects have been observed to compound gradually across Food web, rather than becoming acute, leading to their classification by the US Geological Survey as "Ecological Disrupting Compounds."
(2025). 9781904455899, Caister Academic Press. ISBN 9781904455899
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.
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.
Environmental issues
Pharmaceutical medications are commonly described as "ubiquitous" in nearly every type of environmental medium (i.e. Lake, River, Stream, Estuary, seawater, and soil) worldwide. Their chemical components are typically present at relatively low Concentration in the ng/L to μg/L ranges. The primary avenue for medications reaching the environment are through the effluent of wastewater Water treatment, both from industrial plants during production, and from Sewage treatment after consumption. Agricultural pollution is another significant source derived from the prevalence of antibiotic use in livestock.
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