View source for Medication

{{Short description|Substance used to diagnose, cure, treat, or prevent disease}}
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[[File:VariousPills.jpg|thumb|An example of a medication is a [[prescription drug]].]]

'''Medication''' (also called '''medicament''', '''medicine''', '''pharmaceutical drug''', '''medicinal product''', '''medicinal drug''' or simply '''drug''') is a [[drug]] used to [[medical diagnosis|diagnose]], [[cure]], treat, or [[preventive medicine|prevent]] disease.<ref>{{cite web |url-status=dead |url=https://www.fda.gov/opacom/laws/fdcact/fdcact1.htm |website=U.S. Food and Drug Administration |title=Federal Food, Drug, and Cosmetic Act, SEC. 210. |at= (g), (1), (B) |archive-url=https://web.archive.org/web/20090512014151/http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm |archive-date=12 May 2009 |access-date=17 August 2008}}</ref><ref>"[http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004L0027:EN:HTML 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. {{Webarchive|url=https://web.archive.org/web/20210430004857/http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32004L0027:EN:HTML |date=30 April 2021 }}.</ref> Drug therapy ([[pharmacotherapy]]) is an important part of the [[medicine|medical field]] and relies on the science of [[pharmacology]] for continual advancement and on [[pharmacy]] for appropriate management.

Drugs are [[Drug class|classified]] in many ways. One of the key divisions is by level of [[controlled substance|control]], which distinguishes [[prescription drug]]s (those that a pharmacist dispenses only on the [[medical prescription]]) from [[over-the-counter drug]]s (those that consumers can order for themselves). Medicines may be classified by mode of action, [[route of administration]], [[biological system]] affected, or [[therapeutic effect]]s. The [[World Health Organization]] keeps a list of [[essential medicines]].

[[Drug discovery]] and [[drug development]] are complex and expensive endeavors undertaken by [[pharmaceutical industry|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, [[pharmaceutical marketing|how drugs are marketed]], and in some jurisdictions, [[drug pricing]]. Controversies have arisen over drug pricing and disposal of used medications.

==Definition==
Medication is a medicine or a [[chemical compound]] used to [[Therapy|treat]] or [[cure]] illness. According to ''[[Encyclopædia Britannica]]'', medication is "a substance used in treating a disease or relieving [[pain]]".<ref>{{Cite web |title=Medication Definition & Meaning |url=https://www.britannica.com/dictionary/medication |access-date=31 March 2022 |website=Britannica Dictionary |language=en-US |archive-date=31 March 2022 |archive-url=https://web.archive.org/web/20220331172048/https://www.britannica.com/dictionary/medication |url-status=live }}</ref>

As defined by the [[National Cancer Institute]], [[dosage forms]] of medication can include [[Tablet (pharmacy)|tablets]], [[Capsule (pharmacy)|capsules]], liquids, [[Cream (pharmacy)|creams]], and patches. Medications can be administered in different ways, such as [[by mouth]], by [[Intravenous therapy|infusion into a vein]], or by [[Ear drop|drops put into the ear]] or [[Eye drop|eye]]. A medication that does not contain an [[active ingredient]] and is used in research studies is called a [[placebo]].<ref>{{Cite web |date=2 February 2011 |title=Definition of medication |url=https://www.cancer.gov/publications/dictionaries/cancer-terms/def/medication |access-date=24 November 2022 |website=National Cancer Institute |language=en |archive-date=29 November 2022 |archive-url=https://web.archive.org/web/20221129084105/https://www.cancer.gov/publications/dictionaries/cancer-terms/def/medication |url-status=live }}</ref>

In Europe, the term is "medicinal product", and it is defined by EU law as:

* "Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or"
* "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]]."<ref>{{cite web |url-status=dead |url=http://ec.europa.eu/health/files/eudralex/vol-1/dir_2004_27/dir_2004_27_en.pdf |title=Directive 2004/27/EC |work=Official Journal of the European Union. |date=30 April 2004 |at=L136 |archive-url=https://web.archive.org/web/20210429020803/https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/dir_2004_27/dir_2004_27_en.pdf |archive-date=Apr 29, 2021}}</ref>{{rp|36}}

In the US, a "drug" is:
* 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.
* A substance intended for use in the [[diagnosis]], cure, mitigation, treatment, or [[prevention of disease]].
* A substance recognized by an official [[pharmacopeia]] or [[Formulary (pharmacy)|formulary]].
* 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).<ref>FDA, "[https://web.archive.org/web/20090608120918/http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm Drugs@FDA Glossary of Terms]". {{Webarchive|url=https://web.archive.org/web/20230108175048/https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms |date=8 January 2023 }}.</ref>

==Usage==
Drug use among elderly Americans has been studied; in a group of 2,377 people with an 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%.<ref>{{Cite journal|last1=Qato DM|last2=Wilder J|last3=Schumm L|last4=Gillet V|last5=Alexander G|date=1 April 2016|title=Changes in prescription and over-the-counter medication and dietary supplement use among older adults in the united states, 2005 vs 2011|journal=JAMA Internal Medicine|volume=176|issue=4|pages=473–482|doi=10.1001/jamainternmed.2015.8581|pmid=26998708 |pmc=5024734}}</ref>

== Classification ==
{{main|Drug class}}

One of the key classifications is between traditional [[small molecule]] drugs; usually derived from chemical synthesis and [[biologic medical product|biological medical product]]s; which include [[recombinant proteins]], [[vaccines]], [[blood products]] used therapeutically (such as [[IVIG]]), [[gene therapy]], and [[cell therapy]] (for instance, [[stem cell]] therapies).{{cn|date=May 2023}}

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,<ref>[https://www.medthority.com/drugs/ https://www.medthority.com] {{Webarchive|url=https://web.archive.org/web/20230108175035/https://auth.medthority.com/login?state=hKFo2SBSR2puZC1ZQ3pZdUQ5UVJGbzlnNElqYktia2c2MXl6d6FupWxvZ2luo3RpZNkgTUptdUZCVTF1bHExdGxRRTBGa2tvZEdBdjlGbU0tREajY2lk2SBxMHRZQk50aEpOM29UTURaM1dmQWF1UHRpdkdGcWd3OA&client=q0tYBNthJN3oTMDZ3WfAauPtivGFqgw8&protocol=wsfed&wtrealm=https%3A%2F%2Fmedthority.com&wctx=WsFedOwinState%3DxcTT6ENAj9wrgjDRMmflf7KNXqenWwGg3b3WlWdkmRTyS2Q3Oj-3SDX_SF_E2rzVEBrKiwDstZtdEDWM0ezH05jm4DBiCGWKGqRZ03AnhHzUPxALAtTi6450_lRP9bYD_bjOurgq0MB9prg4iWRlow&wa=wsignin1.0 |date=8 January 2023 }} database of prescription pharmaceutical products including drug classifications https://www.medthority.com/drugs/ </ref> such as by [[chemical property|chemical properties]], mode or [[route of administration]], [[biological system]] affected, or [[therapeutic effect]]s. 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:
# [[Antipyretic]]s: reducing fever (pyrexia/pyresis)
# [[Analgesic]]s: reducing [[pain]] (painkillers)
# [[Antimalarial drug]]s: treating [[malaria]]
# [[Antibiotic]]s: inhibiting [[Microorganism|germ]] growth
# [[Antiseptic]]s: prevention of germ growth near [[burn]]s, [[Cut (wound)|cuts]], and [[wound]]s
# [[Mood stabilizer]]s: [[Lithium (medication)|lithium]] and [[valproate]]
# [[Hormone replacement]]s: [[Premarin]]
# [[Oral contraceptive]]s: Enovid, "biphasic" pill, and "triphasic" pill
# [[Stimulant]]s: [[methylphenidate]], [[amphetamine]]
# [[Tranquilizer]]s: [[meprobamate]], [[chlorpromazine]], [[reserpine]], [[chlordiazepoxide]], [[diazepam]], and [[alprazolam]]
# [[Statin]]s: [[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.<ref>{{Cite journal|url = http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=103|title = Specialty Pharmaceuticals|date = 25 November 2013|journal = [[Health Aff. (Millwood)|Health Affairs]]|access-date = 28 August 2015|vauthors = Spatz I, McGee N|department = Health Policy Briefs|at = What's The Background?|archive-date = 6 September 2015|archive-url = https://web.archive.org/web/20150906190339/http://www.healthaffairs.org/healthpolicybriefs/brief.php?brief_id=103|url-status = live}}</ref>

==Types of medicines==
{{See also|:Category:Drugs by target organ system}}
{{condensed|section|date=April 2019}}

=== For the digestive system ===
* Lower digestive tract: [[laxative]]s, [[antispasmodic]]s, [[antidiarrhoeal]]s, [[bile acid sequestrant]]s, [[opioid|opioids]].
* Upper [[human gastrointestinal tract|digestive tract]]: [[antacid]]s, [[reflux suppressant]]s, [[antiflatulent]]s, [[dopamine antagonist|antidopaminergics]], [[proton pump inhibitor]]s (PPIs), [[H2 antagonist|H<sub>2</sub>-receptor antagonists]], [[cytoprotectant]]s, [[prostaglandin analogue]]s.

=== For the cardiovascular system ===
* Affecting [[blood pressure]]/([[antihypertensive drug]]s): [[ACE inhibitor]]s, [[Angiotensin II receptor antagonist|angiotensin receptor blockers]], [[beta-blocker]]s, [[alpha blocker|α blockers]], [[calcium channel blocker]]s, thiazide diuretics, loop diuretics, aldosterone inhibitors.
* [[Coagulation]]: [[anticoagulant]]s, [[heparin]], [[antiplatelet drug]]s, [[Fibrinolysis|fibrinolytics]], [[Factor VIII|anti-hemophilic factors]], [[Antihemorrhagic|haemostatic drugs]].
* General: [[beta blocker|β-receptor blockers]] ("beta blockers"), [[calcium channel blocker]]s, [[diuretic]]s, [[cardiac glycoside]]s, [[Antiarrhythmic agent|antiarrhythmics]], [[nitrate]], [[antianginal]]s, [[vasoconstriction|vasoconstrictors]], [[vasodilation|vasodilators]].
* [[HMG-CoA reductase inhibitors]] (statins) for lowering LDL cholesterol inhibitors: [[hypolipidaemic agent]]s.

=== For the central nervous system ===

Drugs affecting the [[central nervous system]] include [[psychedelic drug|psychedelics]], [[hypnotic]]s, [[anaesthetics]], [[antipsychotic]]s, [[eugeroic]]s, [[antidepressant]]s (including [[tricyclic antidepressant]]s, [[monoamine oxidase inhibitor]]s, [[Lithium pharmacology|lithium salts]], and [[selective serotonin reuptake inhibitor]]s (SSRIs)), [[antiemetic]]s, [[anticonvulsant]]s/antiepileptics, [[anxiolytic]]s, [[barbiturate]]s, movement disorder (e.g., [[Parkinson's disease]]) drugs, [[nootropics]], [[stimulant]]s (including [[amphetamine]]s), [[benzodiazepine]]s, [[cyclopyrrolones]], [[dopamine antagonist]]s, [[Histamine antagonist|antihistamines]], [[cholinergic]]s, [[anticholinergic]]s, [[emetic]]s, [[cannabinoid]]s, and [[serotonin antagonist|5-HT (serotonin) antagonists]].

=== For pain ===
{{See also|Analgesic}}
The main classes of painkillers are [[NSAIDs]], [[opioid]]s, and local [[anesthetic]]s.

'''For consciousness (anesthetic drugs)'''

{{See also|Anesthetic}}

Some anesthetics include [[benzodiazepine]]s and [[barbiturate]]s.

=== For musculoskeletal disorders ===
The main categories of drugs for [[musculoskeletal disorders]] are: [[NSAID]]s (including [[COX-2 selective inhibitor]]s), [[muscle relaxant]]s, [[Neuromuscular drug|neuromuscular drugs]], and [[Acetylcholinesterase inhibitor|anticholinesterases]].

=== For the eye ===
* Anti-[[allergy]]: [[mast cell|mast cell inhibitors.]]
* [[Antifungal medication|Anti-fungal]]: [[imidazole]]s, [[polyene]]s.
* Anti-[[glaucoma]]: adrenergic agonists, [[beta-blocker]]s, carbonic anhydrase inhibitors/[[hyperosmotic]]s, [[cholinergic]]s, [[miotic]]s, [[parasympathomimetic]]s, prostaglandin agonists/[[prostaglandin inhibitors]], [[nitroglycerin]].
* [[Anti-inflammatory]]: [[NSAID]]s, [[corticosteroids]].
* [[Antibacterial]]: [[antibiotic]]s, [[topical antibiotic]]s, [[sulfa drugs]], [[aminoglycosides]], [[fluoroquinolones]].
* [[Antiviral drugs]].
* Diagnostic: [[topical anesthetic]]s, [[sympathomimetic]]s, [[parasympatholytic]]s, [[mydriatic]]s, [[cycloplegic]]s.
* General: adrenergic neurone blocker, [[astringent]].

=== For the ear, nose, and oropharynx ===
[[Antibiotics]], [[sympathomimetic]]s, [[antihistamine]]s, [[anticholinergic]]s, [[NSAID]]s, [[corticosteroid]]s, [[antiseptic]]s, [[local anesthetic]]s, [[Antifungal medication|antifungals]], and cerumenolytics.

=== For the respiratory system ===
[[Bronchodilator]]s, [[antitussive]]s, [[mucolytic]]s, [[decongestant]]s, inhaled and systemic [[corticosteroid]]s, [[beta2-adrenergic agonist]]s, [[anticholinergic]]s, [[mast cell stabilizers]], [[leukotriene antagonist]]s.

=== For endocrine problems ===
[[Androgen]]s, [[antiandrogen]]s, [[estrogen]]s, [[gonadotropin]], [[corticosteroid]]s, [[human growth hormone]], [[insulin]], [[antidiabetic]]s ([[sulfonylurea]]s, [[biguanide]]s/[[metformin]], [[thiazolidinedione]]s, [[insulin]]), [[thyroid hormone]]s, antithyroid drugs, [[calcitonin]], [[diphosphonate]], [[vasopressin analogue]]s.

=== For the reproductive system or urinary system ===
[[Antifungal medication|Antifungal]], [[alkalinizing agent]]s, [[Quinolone antibiotic|quinolones]], [[antibiotic]]s, [[cholinergic]]s, [[anticholinergic]]s, [[antispasmodic]]s, [[5-alpha reductase inhibitor]], [[selective alpha-1 blocker]]s, [[sildenafil]]s, [[fertility medication]]s.

=== For contraception ===
* [[Hormonal contraception]].
* [[Ormeloxifene]].
* [[Spermicide]].

=== For obstetrics and gynecology ===
[[NSAID]]s, [[anticholinergic]]s, [[haemostatic drug]]s, [[antifibrinolytic]]s, [[Hormone therapy|Hormone Replacement Therapy]] (HRT), bone regulators, [[beta-receptor agonist]]s, [[follicle stimulating hormone]], [[luteinising hormone]], [[LHRH]], [[gamolenic acid]], [[gonadotropin release inhibitor]], [[progestogen]], [[dopamine agonist]]s, [[estrogen|oestrogen]], [[prostaglandin]]s, [[gonadorelin]], [[clomiphene]], [[tamoxifen]], [[diethylstilbestrol]].

=== For the skin ===
[[Emollient]]s, [[antipruritic|anti-pruritics]], [[Antifungal medication|antifungals]], [[antiseptic]]s, [[scabicide]]s, [[pediculicide]]s, [[tar]] products, [[vitamin A derivatives]], [[vitamin D analogue]]s, [[keratolytic]]s, [[abrasive]]s, [[systemic antibiotic]]s, [[topical]] [[antibiotic]]s, [[hormone]]s, desloughing agents, exudate absorbents, [[fibrinolytic]]s, [[proteolytic]]s, [[sunscreen]]s, [[antiperspirant]]s, [[corticosteroid]]s, immune modulators.

=== For infections and infestations ===
[[Antibiotic]]s, [[Antifungal medication|antifungals]], [[antileprotic]]s, [[antituberculous drug]]s, [[antimalarial]]s, [[anthelmintic]]s, [[amoebicide]]s, [[Antiviral drug|antivirals]], [[antiprotozoal agent|antiprotozoals]], probiotics, prebiotics, [[antitoxin]]s, and antivenoms.

=== For the immune system ===
[[Vaccine]]s, [[immunoglobulin]]s, [[immunosuppressant]]s, [[interferon]]s, and [[monoclonal antibody|monoclonal antibodies]].

=== For allergic disorders ===
[[Anti-allergic]]s, [[antihistamine]]s, [[NSAID]]s,{{medical citation needed|date=November 2022}} [[corticosteroid]]s.

=== For nutrition ===
Tonics, [[electrolyte]]s and mineral preparations (including iron preparations and [[Magnesium (pharmaceutical preparation)|magnesium preparations]]), [[parenteral nutrition]], [[vitamin]]s, [[anti-obesity drug]]s, [[anabolic drug]]s, haematopoietic drugs, food product drugs.

=== For neoplastic disorders ===
[[Cytotoxic drug]]s, [[therapeutic antibody|therapeutic antibodies]], [[sex hormone]]s, [[aromatase inhibitor]]s, somatostatin inhibitors, recombinant [[interleukin]]s, [[Granulocyte-colony 0pp0- factor|G-CSF]], [[erythropoietin]].

=== For diagnostics ===
[[Contrast media]].

=== For euthanasia ===
{{See also|Barbiturate}}
A euthanaticum is used for [[euthanasia]] and [[Assisted suicide|physician-assisted suicide]]. Euthanasia is not permitted by law in many countries, and consequently, medicines will not be licensed for this use in those countries.

== Administration == <!--Drug administration redirects here-->
{{Main |Route of administration}}
[[File:Drawing_by_Marguerite_Martyn_of_a_visiting_nurse_with_medicine_and_four_babies,_1918.jpg|thumb|February 1918 drawing by [[Marguerite Martyn]] of a visiting nurse in St. Louis, Missouri, with medicine and babies]]

A single drug may contain single or multiple [[active ingredient]]s.

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 (medicine)|injection]] into the body, and by other routes ([[Dermis|dermal]], [[Nasal administration|nasal]], [[Ophthalmic drug administration|ophthalmic]], [[Ear|otologic]], and [[Genitourinary system|urogenital]]).<ref>{{Cite book | last1=Finkel | first1=Richard | last2=Cubeddu | first2=Luigi | last3=Clark | first3=Michelle | year=2009 | title=Lippencott's Illustrated Reviews: Pharmacology 4th Edition | publisher=Lippencott Williams & Wilkins | pages=1–4 | isbn=978-0-7817-7155-9}}</ref>

[[Oral administration]], the most common form of enteral administration, can be performed using various [[dosage forms]] including [[Tablet (pharmacy)|tablets]] or [[capsule (pharmacy)|capsules]] and liquid such as syrup or suspension. Other ways to take the medication include [[buccal administration|buccally]] (placed inside the cheek), [[Sublingual administration|sublingually]] (placed underneath the tongue), eye and [[ear drop]]s (dropped into the eye or ear), and transdermally (applied to the skin).<ref>{{Cite journal |last1=Zaid Alkilani |first1=Ahlam |last2=McCrudden |first2=Maelíosa T.C. |last3=Donnelly |first3=Ryan F. |date=22 October 2015 |title=Transdermal Drug Delivery: Innovative Pharmaceutical Developments Based on Disruption of the Barrier Properties of the stratum corneum |journal=Pharmaceutics |volume=7 |issue=4 |pages=438–470 |doi=10.3390/pharmaceutics7040438 |issn=1999-4923 |pmc=4695828 |pmid=26506371|doi-access=free }}</ref> 

They can be administered in one dose, as a [[bolus (medicine)|bolus]]. Administration frequencies<ref>{{Cite web |title=USHIK: Medication Frequency |url=https://ushik.ahrq.gov/ViewItemDetails?system=mdr&itemKey=126006000 |access-date=31 March 2022 |website=ushik.ahrq.gov |language=en}}</ref> are often abbreviated from Latin, such as ''every 8 hours'' reading Q8H from ''Quaque VIII Hora''. The drug frequencies are often expressed as the number of times a drug is used per day (e.g., four times a day). It{{specify|date=November 2022}} may include event-related information (e.g., 1 hour before meals, in the morning, at bedtime), or complimentary to an interval, although equivalent expressions may have different implications (e.g., every 8 hours versus 3 times a day).{{cn|date=May 2023}}

==Drug discovery==
{{Main|Drug discovery}}
In the fields of medicine, [[biotechnology]], and [[pharmacology]], [[drug discovery]] is the process by which new drugs are discovered.{{cn|date=May 2023}}

Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by [[serendipity|serendipitous]] discovery. Later [[chemical library|chemical libraries]] of synthetic [[small molecule]]s, [[natural product]]s, or [[extract]]s 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 [[Human Genome Project|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 target]]s which are hypothesized to be [[Disease-modifying treatment|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.{{cn|date=May 2023}}

Modern drug discovery involves the identification of screening hits, [[medicinal chemistry]], and optimization of those hits to increase the [[Affinity (pharmacology)#Protein-ligand binding|affinity]], [[binding selectivity|selectivity]] (to reduce the potential of side effects), efficacy/[[potency (pharmacology)|potency]], [[Metabolism|metabolic]] stability (to increase the [[Biological half-life|half-life]]), and oral [[bioavailability]]. Once a compound that fulfills all of these requirements has been identified, it will begin the process of [[drug development]] prior to [[clinical trial]]s. 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.<ref name=Anson2009>{{Cite news
 |last1=Anson
 |first1=Blake D.
 |last2=Ma
 |first2=Junyi
 |last3=He
 |first3=Jia-Qiang
 |date=1 May 2009
|title=Identifying Cardiotoxic Compounds
 |periodical=Genetic Engineering & Biotechnology News
 |series=TechNote
 |publisher=Mary Ann Liebert
 |volume=29
 |issue=9
 |pages=34–35
 |url=http://www.genengnews.com/articles/chitem_print.aspx?aid=2890&chid=0
 |archive-url=https://web.archive.org/web/20120921025805/http://www.genengnews.com/articles/chitem_print.aspx?aid=2890&chid=0
 |archive-date=21 September 2012
|issn=1935-472X
 |oclc=77706455
 |access-date=25 July 2009
|url-status=dead
}}</ref> In 2010, the research and development cost of each [[new molecular entity]] (NME) was approximately US$1.8 billion.<ref>{{cite journal | volume = 9 | pages = 203–214 | year = 2010 | doi = 10.1038/nrd3078 | title = How to improve R&D productivity: the pharmaceutical industry's grand challenge |author1=Steven M. Paul |author2=Daniel S. Mytelka |author3=Christopher T. Dunwiddie |author4=Charles C. Persinger |author5=Bernard H. Munos |author6=Stacy R. Lindborg |author7=Aaron L. Schacht | journal = Nature Reviews Drug Discovery | pmid = 20168317 | issue = 3| s2cid = 1299234 | doi-access = free }}</ref> Drug discovery is done by pharmaceutical companies, sometimes with research assistance from universities. The "final product" of drug discovery is a patent on the potential drug. The drug requires very expensive Phase I, II, and III clinical trials, and most of them fail. Small companies have a critical role, often then selling the rights to larger companies that have the resources to run the clinical trials.

Drug discovery is different from Drug Development. Drug Discovery is often considered the process of identifying new medicine. At the same time, Drug development is delivering a new drug molecule into clinical practice. In its broad definition, this encompasses all steps from the basic research process of finding a suitable molecular target to supporting the drug's commercial launch.

== Development ==
{{Main|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.<ref>{{cite book|last1=Strovel|first1=Jeffrey|last2=Sittampalam|first2=Sitta|last3=Coussens|first3=Nathan P.|last4=Hughes|first4=Michael|last5=Inglese|first5=James|last6=Kurtz|first6=Andrew|last7=Andalibi|first7=Ali|last8=Patton|first8=Lavonne|last9=Austin|first9=Chris|last10=Baltezor|first10=Michael|last11=Beckloff|first11=Michael|last12=Weingarten|first12=Michael|last13=Weir|first13=Scott|title=Assay Guidance Manual|date=1 July 2016|publisher=Eli Lilly & Company and the National Center for Advancing Translational Sciences|chapter-url=https://www.ncbi.nlm.nih.gov/books/NBK92015/|chapter=Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies|pmid=22553881|access-date=20 May 2017|archive-date=19 April 2020|archive-url=https://web.archive.org/web/20200419043905/https://www.ncbi.nlm.nih.gov/books/NBK92015/|url-status=live}}</ref><ref>{{Cite book|last1=Taylor|first1=David|title=Pharmaceuticals in the Environment|chapter=The Pharmaceutical Industry and the Future of Drug Development|series=Issues in Environmental Science and Technology|date=2015|pages=1–33|doi=10.1039/9781782622345-00001 |doi-access=free |language=en|isbn=978-1-78262-189-8}}</ref>

'''[https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process Drug Development Process]'''

'''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 research|Clinical]] testing:''' The drug is used on people to confirm that it is safe to use.

'''[[FDA]]''' '''Review:''' drug is sent to FDA before launching the drug into the market.

'''FDA post-Market Review:''' The drug is reviewed and monitored by FDA for the safety once it is available to the public.

==Regulation==
{{Main|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 on the availability of certain therapeutic goods depending on their risk to consumers.{{cn|date=May 2023}}

Depending upon the [[jurisdiction]], drugs may be divided into [[over-the-counter drug]]s (OTC) which may be available without special restrictions, and [[prescription drug]]s, which must be [[Medical prescription|prescribed]] by a licensed medical practitioner in accordance with [[medical guideline]]s due to the risk of adverse effects and [[contraindication]]s. The precise distinction between OTC and prescription depends on the legal jurisdiction. A third category, "behind-the-counter" drugs, is implemented in some jurisdictions. These do not require a prescription, but must be kept in the [[dispensary]], 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.<ref>{{cite web|title=Tips for Medication Safety |date=July 21, 2016 |author1=Gina |url=http://www.housefindings.com/tips-for-medication-safety/|website=House Findings|access-date=21 July 2016|archive-url=https://web.archive.org/web/20160914133316/http://www.housefindings.com/tips-for-medication-safety/|archive-date=14 September 2016|url-status=dead}}</ref> Many countries, such as the United Kingdom have a third category of "pharmacy medicines", which can be sold only in registered [[pharmacy|pharmacies]] by or under the supervision of a pharmacist.

[[Medical error]]s 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.<ref>{{cite journal|vauthors=Dean B, Barber N, Schachter M |date=December 2000 |title=What is a prescribing error? |journal=Qual Health Care |volume=9 |issue=4 |pages=232–7 |doi=10.1136/qhc.9.4.232 |pmc=1743540 |pmid=11101708 }}</ref>

==Drug pricing==
{{Main|Prescription costs|Pharmacoeconomics}}
In many jurisdictions, [[Prescription costs|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%.<ref>{{cite web|title=PPRS: payment percentage 2017 – Details|url=https://www.gov.uk/government/publications/pprs-payment-percentage-2017|date=23 December 2016|website=GOV.UK|access-date=16 March 2017|archive-date=17 March 2017|archive-url=https://web.archive.org/web/20170317055827/https://www.gov.uk/government/publications/pprs-payment-percentage-2017|url-status=live}}</ref>

===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"<ref name=price-comparison>{{cite web|title=Schedule 7 – International Therapeutic Class Comparison Test|url=http://www.pmprb-cepmb.gc.ca/view.asp?ccid=492&lang=en|date=30 April 2014|access-date=16 March 2017|archive-date=17 April 2018|archive-url=https://web.archive.org/web/20180417225251/http://www.pmprb-cepmb.gc.ca/view.asp?ccid=492&lang=en|url-status=live}}</ref> different countries that the prices are being compared to are the following: France, Germany, Italy, Sweden, Switzerland, the United Kingdom, and the United States<ref name=price-comparison />

===Brazil===
In Brazil, the prices are regulated through legislation under the name of ''Medicamento Genérico'' ([[generic drug]]s) since 1999.<ref>{{Cite journal|last1=Fonseca|first1=Massard da|last2=Shadlen|first2=Kenneth C.|date=20 April 2017|title=Promoting and regulating generic medicines: Brazil in comparative perspective|journal=Revista Panamericana de Salud Pública|volume=41 (e5)|pages=2|pmid=28444005|pmc=6612747}}</ref>

=== India ===
In India, drug prices are regulated by the [[National Pharmaceutical Pricing Authority]].

===United States===
{{main|Prescription drug prices in the United States}}
In the United States, drug costs are partially unregulated, but instead are the result of negotiations between drug companies and insurance companies.<ref>{{Cite book|title=Social welfare policy for a sustainable future : the U.S. in global context|first1=Katherine S.|last1=van Wormer |last2=Link |first2=Rosemary J.|isbn=978-1-4522-4031-2|location=Los Angeles|oclc=899880624|date = 18 March 2015 |publisher=SAGE}}</ref>

High prices have been attributed to monopolies given to manufacturers by the government.<ref>{{cite journal|last1=Kesselheim|first1=Aaron S.|last2=Avorn|first2=Jerry|last3=Sarpatwari|first3=Ameet|title=The High Cost of Prescription Drugs in the United States|journal=JAMA|date=23 August 2016|volume=316|issue=8|pages=858–71|doi=10.1001/jama.2016.11237|pmid=27552619|s2cid=19317308}}</ref> 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.<ref>{{Cite journal|last1=Scannell|first1=Jack W.|last2=Blanckley|first2=Alex|last3=Boldon|first3=Helen|last4=Warrington |first4=Brian|date=1 March 2012 |title=Diagnosing the decline in pharmaceutical R&D efficiency|journal=Nature Reviews Drug Discovery|language=En|volume=11 |issue=3|pages=191–200|doi=10.1038/nrd3681|pmid=22378269|s2cid=3344476|issn=1474-1776}}</ref>

==Blockbuster drug== <!--Blockbuster drug redirects here-->
{{Main|List of largest selling pharmaceutical products}}
A blockbuster drug is a drug that generates more than $1 billion in revenue for a pharmaceutical company in a single year.<ref>{{"'}}Blockbuster medicine' is defined as being one which achieves annual revenues of over US$1&nbsp;billion at global level." in European Commission, [http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf ''Pharmaceutical Sector Inquiry, Preliminary Report'' (DG Competition Staff Working Paper)] {{Webarchive|url=https://web.archive.org/web/20200826223336/https://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf |date=26 August 2020 }}, 28 November 2008, page 17 (pdf, 1.95 MB).</ref> [[Cimetidine]] was the first drug ever to reach more than $1 billion a year in sales, thus making it the first blockbuster drug.<ref>{{cite news |url=http://www.guernicamag.com/features/111/me_too_drugs/ |title=Pharmaceutical Sales 101: Me-Too Drugs |author=Whitney, Jake |work=[[Guernica Magazine|Guernica]] |date=February 2006 |access-date=31 July 2008 |url-status=dead |archive-url=https://web.archive.org/web/20080807114344/http://www.guernicamag.com/features/111/me_too_drugs/ |archive-date=7 August 2008 }}</ref>

{{blockquote|In the pharmaceutical industry, a blockbuster drug is one that achieves acceptance by prescribing physicians as a therapeutic standard for, most commonly, a highly prevalent chronic (rather than acute) condition. Patients often take the medicines for long periods.<ref name="Reasonable" />}}

== History ==
{{Main|History of pharmacy}}

===Prescription drug history===

[[Antibiotic]]s first arrived on the medical scene in 1932 thanks to [[Gerhard Domagk]];<ref>{{cite magazine|url= http://pubs.acs.org/cen/coverstory/83/8325/8325prontosil.html|magazine= Chemical & Engineering News|title= Top Pharmaceuticals: Prontosil|first= William|last= Stork|volume= 83|issue= 25|date= 20 June 2005|access-date= 30 May 2014|archive-date= 13 October 2008|archive-url= https://web.archive.org/web/20081013182359/http://pubs.acs.org/cen/coverstory/83/8325/8325prontosil.html|url-status= live}}</ref> and were coined the "wonder drugs". The introduction of the [[Sulfonamide (medicine)|sulfa drugs]] led to the mortality rate from [[pneumonia]] in the U.S. to drop from 0.2% each year to 0.05% ({{em|i.e.}}, {{frac|4}} as much) by 1939.<ref>{{cite journal |author= Dowling HF |title=Frustration and foundation. Management of pneumonia before antibiotics |journal=JAMA |volume=220 |issue=10 |pages=1341–5 |date=June 1972  |pmid=4553966 |doi= 10.1001/jama.1972.03200100053011 }}</ref> 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: [[Chlortetracycline|aureomycin]] and [[chloramphenicol]]. Aureomycin was the best known of the second generation.{{cn|date=May 2023}}

[[Lithium (medication)|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. [[Psychoactive drug|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.<ref name="ToneAndrea">Tone, Andrea and Elizabeth Watkins, ''Medicating Modern America: Prescription Drugs in History''. New York and London, New York University, 2007. Print.</ref>

[[Conjugated estrogens|Premarin]] (conjugated estrogens, introduced in 1942) and [[Conjugated estrogens/medroxyprogesterone acetate|Prempro]] (a combination estrogen-progestin pill, introduced in 1995) dominated [[hormone replacement therapy]] (HRT) regimens during the 1990s. Though not designed to cure any disease, HRT is prescribed to improve quality of life and as a preventative measure, such as treating post-menopausal symptoms. In the 1960s and early 1970s, 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.<ref name="ToneAndrea" />

The first oral contraceptive, [[Mestranol/noretynodrel|Enovid]], was approved by FDA in 1960. Oral contraceptives inhibit ovulation and so prevent conception. Enovid was known to be much more effective than alternatives including the condom and the diaphragm. As early as 1960, oral contraceptives were available in several different strengths by every manufacturer. In the 1980s and 1990s, an increasing number of options arose including, most recently, a new [[drug delivery|delivery system]] for the oral contraceptive via a [[transdermal patch]]. In 1982, a new version of [[Combined oral contraceptive pill|"the pill"]] was introduced, known as the [[Birth control pill formulations|biphasic pill]]. By 1985, a new [[Birth control pill formulations|triphasic pill]] was approved. Physicians began to think of "the pill" as an excellent means of birth control for young women.<ref name="ToneAndrea" />

Stimulants such as [[Methylphenidate|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 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.<ref name="ToneAndrea" />

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|Librium]] and [[Diazepam|Valium]], two minor tranquilizers that belonged to a new chemical class of drugs called the [[benzodiazepine]]s. These were drugs that worked chiefly as [[Anxiolytic|anti-anxiety agents]] and [[muscle relaxant]]s. 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|Xanax]], introduced in 1981 for the newly created diagnosis of panic disorder, soared.<ref name="ToneAndrea" />

[[Lovastatin|Mevacor]] (lovastatin) is the first and most influential [[statin]] in the American market. The 1991 launch of [[Pravastatin|Pravachol]] (pravastatin), the second available in the United States, and the release of [[Simvastatin|Zocor]] (simvastatin) made Mevacor no longer the only statin on the market.
In 1998, [[Sildenafil|Viagra]] was released as a treatment for erectile dysfunction.<ref name="ToneAndrea" />

===Ancient pharmacology===
Using plants and plant substances to treat all kinds of diseases and medical conditions is believed to date back to [[prehistoric medicine]].{{cn|date=May 2023}}

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.<ref>{{cite book|last = Griffith|first = F. Ll.|title =The Petrie Papyri: Hieratic Papyri from Kahun and Gurob|location = London|publisher = B. Quaritch|date = 1898}}</ref><ref>{{cite web |url=http://www.reshafim.org.il/ad/egypt/timelines/topics/kahunpapyrus.htm|title=Ancient Egypt: The Kahun medical papyrus|website=www.reshafim.org.il|archive-url = https://web.archive.org/web/20190113044320/http://www.reshafim.org.il/ad/egypt/timelines/topics/kahunpapyrus.htm|archive-date = 13 January 2019}}</ref> It and other [[medical papyri]] describe [[Ancient Egyptian medicine|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]]. [[Cream (pharmaceutical)|Medicinal creams]] and [[Pill (pharmacy)|pills]] were employed as treatments.<ref name=Stol-99>H.F.J. Horstmanshoff, Marten Stol, Cornelis Tilburg (2004), ''Magic and Rationality in Ancient Near Eastern and Graeco-Roman Medicine'', p. 99, [[Brill Publishers]], {{ISBN|90-04-13666-5}}.</ref>

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.<ref>See Atharvaveda XIX.34.9</ref> 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|nosologies]] and new therapies dating from about 400 BC onwards.<ref>Kenneth G. Zysk, ''Asceticism and Healing in Ancient India: Medicine in the Buddhist Monastery,'' Oxford University Press, rev. ed. (1998) {{ISBN|0-19-505956-5}}.</ref> 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 [[Medicine in ancient Greece|ancient Greek physicians]] imported drugs from Egypt and elsewhere.<ref>[[Heinrich von Staden (historian)|Heinrich von Staden]], ''Herophilus: The Art of Medicine in Early Alexandria'' (Cambridge: Cambridge University Press, 1989), pp. 1–26.</ref> The [[pharmacopoeia]] {{Lang|la|[[De materia medica]]}}, written between 50 and 70 CE by the Greek physician [[Pedanius Dioscorides]], was widely read for more than 1,500 years.<ref>{{Cite web|title=Greek Medicine – Dioscorides|url=https://www.nlm.nih.gov/hmd/greek/greek_dioscorides.html|access-date=16 February 2021|website=www.nlm.nih.gov|archive-date=9 November 2013|archive-url=https://web.archive.org/web/20131109193334/https://www.nlm.nih.gov/hmd/greek/greek_dioscorides.html|url-status=live}}</ref>

===Medieval pharmacology===
[[Al-Kindi]]'s ninth century AD book, ''[[De Gradibus]]'' and [[Ibn Sina]] (Avicenna)'s ''[[The Canon of Medicine]]'', covers a range of drugs known to the practice of [[medicine in the medieval Islamic world]].

[[Medieval medicine of Western Europe]] saw advances in surgery compared to previously, but few truly effective drugs existed, beyond [[opium]] (found in such extremely popular drugs as the "Great Rest" of the [[Antidotarium Nicolai]] at the time)<ref>{{Cite journal|title = The pharmacology of medieval sedatives: the "Great Rest" of the Antidotarium Nicolai|journal = Journal of Ethnopharmacology|date = 8 August 2014|issn = 1872-7573|pmid = 24905867|pages = 443–449|volume = 155|issue = 1|doi = 10.1016/j.jep.2014.05.048|first1 = Nicholas|last1 = Everett|first2 = Martino|last2 = Gabra}}</ref> 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 [[anaesthetic]]s. [[Garcia de Orta]] described some herbal treatments that were used.{{vague|date=November 2022}}

===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".<ref name=Reasonable/>{{rp|21}}

During the [[First World War]], [[Alexis Carrel]] and [[Henry Drysdale Dakin|Henry Dakin]] developed the Carrel-Dakin method of treating wounds with an irrigation, Dakin's solution, a germicide which helped prevent [[gangrene]].

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|digitalis]], [[nitroglycerin]], and [[quinine]] for heart disorders, and [[insulin]] for diabetes. Other drugs included [[antitoxin]]s, a few biological vaccines, and a few synthetic drugs. In the 1930s, antibiotics emerged: first [[sulfa drug]]s, then [[penicillin]] and other antibiotics. Drugs increasingly became "the center of medical practice".<ref name=Reasonable>{{cite book | year = 2008 | title = Reasonable Rx: Solving the drug price crisis | publisher = FT Press |vauthors=Finkelstein S, Temin P }}</ref>{{rp|22}} In the 1950s, other drugs emerged including [[corticosteroids]] for [[inflammation]], [[Rauvolfia#Chemical constituents|rauvolfia alkaloids]] as tranquilizers and antihypertensives, [[antihistamine]]s for nasal allergies, [[xanthine]]s for asthma, and typical [[antipsychotic]]s for psychosis.<ref name=Reasonable/>{{rp|23–24}} As of 2007, thousands of approved drugs have been [[drug development|developed]]. Increasingly, [[biotechnology]] is used to discover [[biopharmaceutical]]s.<ref name=Reasonable/> 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.<ref name= MillerAAMillerPF>{{cite book | vauthors= Miller AA, Miller PF | year=2011 | title=Emerging Trends in Antibacterial Discovery: Answering the Call to Arms | publisher=[[Caister Academic Press]] | isbn= 978-1-904455-89-9}}</ref>

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 trial]]s.<ref name=Reasonable/>{{rp|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.<ref name=Reasonable/>{{rp|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.<ref name=Reasonable/>{{rp|30–31}}

==Controversies==

Controversies concerning pharmaceutical drugs include patient access to drugs under development and not yet approved, pricing, and environmental issues.

===Access to unapproved drugs===
{{Main|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.<ref>{{cite journal |author=Helene S |title=EU Compassionate Use Programmes (CUPs): Regulatory Framework and Points to Consider before CUP Implementation |journal=Pharm Med |volume=24 |issue=4 |pages=223–229 |year=2010 |doi=10.1007/bf03256820 |s2cid=31439802 |doi-access=free }}</ref>

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.{{cn|date=May 2023}}

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.<ref>{{cite news |first=Gina |last=Kolata |work=The New York Times |date=12 September 1994 |url=https://www.nytimes.com/1994/09/12/us/fda-debate-on-speedy-access-to-aids-drugs-is-reopening.html |title=F.D.A. Debate on Speedy Access to AIDS Drugs Is Reopening |archive-url=https://web.archive.org/web/20170701041550/http://www.nytimes.com/1994/09/12/us/fda-debate-on-speedy-access-to-aids-drugs-is-reopening.html |archive-date=1 July 2017 |url-status=dead }}</ref>

The [[Abigail Alliance]] was established in November 2001 by Frank Burroughs in memory of his daughter, Abigail.<ref>{{cite journal
 |last=Phillips |first=Lisa |date=4 September 2008 |title=Contract Law and Ethical Issues Underscore the Latest Lawsuit About Access to Experimental Drugs for Duchenne Muscular Dystrophy |journal=Neurology Today |volume=8 |issue=17 |pages=20–21 |doi= 10.1097/01.nt.0000337676.20893.50}}</ref> 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.<ref>{{cite news | title = Andrea Sloan Faces Pharma Firm With History of Indifference | date = 26 September 2013 | url = http://www.huffingtonpost.com/2013/09/26/andrea-sloan-biomarin_n_3997527.html | work = Huffington Post | access-date = 24 December 2013 | archive-date = 25 December 2013 | archive-url = https://web.archive.org/web/20131225134640/http://www.huffingtonpost.com/2013/09/26/andrea-sloan-biomarin_n_3997527.html | url-status = live }}</ref><ref>{{cite news | title = In cancer drug battle, both sides appeal to ethics | date = 20 September 2013 | url = http://www.cnn.com/2013/09/28/health/compassionate-drug-use/ | work = CNN | access-date = 24 December 2013 | archive-date = 25 December 2013 | archive-url = https://web.archive.org/web/20131225100423/http://www.cnn.com/2013/09/28/health/compassionate-drug-use/ | url-status = live }}</ref>

===Access to medicines and drug pricing===
{{Main|Essential medicines|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."<ref>{{cite web|url=http://apps.who.int/medicinedocs/en/d/Js4875e/5.2.html |archive-url=https://web.archive.org/web/20140201194528/http://apps.who.int/medicinedocs/en/d/Js4875e/5.2.html |url-status=dead |archive-date=1 February 2014 |title=The Selection and Use of Essential Medicines – WHO Technical Report Series, No. 914: 4. Other outstanding technical issues: 4.2 Description of essential medicines |publisher=Apps.who.int |date=14 April 2016 |access-date=25 June 2016}}</ref>  Recent studies have found that most of the medicines on the WHO essential medicines list, outside of the field of HIV drugs, are not patented in the developing world, and that lack of widespread [[Access to medicines|access to these medicines]] arise from issues fundamental to economic development – lack of infrastructure and poverty.<ref>{{cite web |first=Stanley P |last=Kowalksy |date=2013 |url=http://www.accesstopharmaceuticals.org/wp-content/uploads/2013/02/Kowalski.pdf |title=Patent Landscape Analysis of Healthcare Innovations |archive-url=https://web.archive.org/web/20160304025500/http://www.accesstopharmaceuticals.org/wp-content/uploads/2013/02/Kowalski.pdf |archive-date=4 March 2016 |url-status=dead |work=The Franklin Pierce Center for Intellectual Property |publisher=University of New Hampshire School of Law }}</ref> [[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.{{cn|date=May 2023}}

[[World Trade Organization]] negotiations in the 1990s, including the [[TRIPS Agreement]] and the [[Doha Declaration on the TRIPS agreement and public health|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.<ref name="Banta, D.H. 2001">{{cite journal | author = Banta D.H. | year = 2001 | title = Worldwide Interest in Global Access to Drugs | journal = Journal of the American Medical Association | volume = 285 | issue = 22| pages = 2844–46 | pmid = 11401589 | doi=10.1001/jama.285.22.2844-JMN0613-3-1}}</ref><ref>{{cite journal | author = Ferreira L | year = 2002 | title = Access to Affordable HIV/AIDS Drugs: The Human Rights Obligations of Multinational Pharmaceutical Corporations | url = http://ir.lawnet.fordham.edu/cgi/viewcontent.cgi?article=3874&context=flr&sei-redir=1& | journal = Fordham Law Review | volume = 71 | issue = 3 | pages = 1133–79 | pmid = 12523370 | access-date = 20 January 2014 | archive-date = 1 April 2014 | archive-url = https://web.archive.org/web/20140401205420/http://ir.lawnet.fordham.edu/cgi/viewcontent.cgi?article=3874&context=flr&sei-redir=1& | url-status = live }}</ref> 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.<ref name="Banta, D.H. 2001"/> One study concluded that marketing expenditures for new drugs often doubled the amount that was allocated for research and development.<ref>{{cite journal | author1 = Barton J.H. | author2 = Emanuel E.J. | year = 2005 | title = The Patents-Based Pharmaceutical Development Process: Rationale, Problems and Potential Reforms | journal = Journal of the American Medical Association | volume = 294 | issue = 16 | pages = 2075–82 | pmid = 16249422 | doi = 10.1001/jama.294.16.2075 | s2cid = 10277752 }}</ref> 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.<ref>{{cite web|title = Misguided Policy on Patents|url = http://www.gphaonline.org/gpha-media/press/gpha-ftc-misguided-policy-on-patentsettlements|publisher = Generic Pharmaceutical Association (GPhA)|access-date = 8 October 2015|archive-date = 28 September 2015|archive-url = https://web.archive.org/web/20150928124131/http://www.gphaonline.org/gpha-media/press/gpha-ftc-misguided-policy-on-patentsettlements|url-status = live}}</ref>

[[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.<ref>Charlotte Harrison [http://www.nature.com/nrd/journal/v12/n5/pdf/nrd4007.pdf?WT.ec_id=NRD-201305 Patent watch] Nature Reviews Drug Discovery 12, 336–337 (2013)</ref>

===Environmental issues===
{{Main|Environmental impact of pharmaceuticals and personal care products}}

Pharmaceutical medications are commonly described as "ubiquitous" in nearly every type of environmental medium (i.e. [[Lake|lakes]], [[River|rivers]], [[Stream|streams]], [[Estuary|estuaries]], [[seawater]], and [[soil]]) worldwide.<ref name=":0">{{Cite journal |last1=Richmond |first1=Erinn K. |last2=Grace |first2=Michael R. |last3=Kelly |first3=John J. |last4=Reisinger |first4=Alexander J. |last5=Rosi |first5=Emma J. |last6=Walters |first6=David M. |date=2017-01-01 |title=Pharmaceuticals and personal care products (PPCPs) are ecological disrupting compounds (EcoDC) |url=https://doi.org/10.1525/elementa.252 |journal=Elementa: Science of the Anthropocene |volume=5 |page=66 |doi=10.1525/elementa.252 |bibcode=2017EleSA...5Q..66R |issn=2325-1026}}</ref><ref name=":1">{{Cite journal |last1=Ebele |first1=Anekwe Jennifer |last2=Abou-Elwafa Abdallah |first2=Mohamed |last3=Harrad |first3=Stuart |date=2017-03-01 |title=Pharmaceuticals and personal care products (PPCPs) in the freshwater aquatic environment |url=https://www.sciencedirect.com/science/article/pii/S2405665016300488 |journal=Emerging Contaminants |volume=3 |issue=1 |pages=1–16 |doi=10.1016/j.emcon.2016.12.004 |issn=2405-6650}}</ref><ref name=":2">{{Cite journal |last1=Patel |first1=Manvendra |last2=Kumar |first2=Rahul |last3=Kishor |first3=Kamal |last4=Mlsna |first4=Todd |last5=Pittman |first5=Charles U. |last6=Mohan |first6=Dinesh |date=2019-03-27 |title=Pharmaceuticals of Emerging Concern in Aquatic Systems: Chemistry, Occurrence, Effects, and Removal Methods |journal=Chemical Reviews |language=en |volume=119 |issue=6 |pages=3510–3673 |doi=10.1021/acs.chemrev.8b00299 |pmid=30830758 |issn=0009-2665|doi-access=free }}</ref><ref>{{Cite web |last=Environment |first=U. N. |date=2020-09-17 |title=Environmentally Persistent Pharmaceutical Pollutants (EPPPs) |url=http://www.unep.org/explore-topics/chemicals-waste/what-we-do/emerging-issues/environmentally-persistent-pharmaceutical |access-date=2024-01-07 |website=UNEP – UN Environment Programme |language=en}}</ref> Their chemical components are typically present at relatively low [[Concentration|concentrations]] in the ng/L to μg/L ranges.<ref name=":3">{{Cite journal |last1=Liu |first1=Jin-Lin |last2=Wong |first2=Ming-Hung |date=2013-09-01 |title=Pharmaceuticals and personal care products (PPCPs): A review on environmental contamination in China |journal=Environment International |volume=59 |pages=208–224 |doi=10.1016/j.envint.2013.06.012 |issn=0160-4120|doi-access=free |pmid=23838081 |bibcode=2013EnInt..59..208L }}</ref><ref name=":2" /> The primary avenue for medications reaching the environment are through the [[effluent]] of wastewater [[Water treatment|treatment plants]], both from [[Industrial water treatment|industrial plants]] during production, and from [[Sewage treatment|municipal plants]] after consumption.<ref>{{Cite journal |last1=Gadipelly |first1=Chandrakanth |last2=Pérez-González |first2=Antía |last3=Yadav |first3=Ganapati D. |last4=Ortiz |first4=Inmaculada |last5=Ibáñez |first5=Raquel |last6=Rathod |first6=Virendra K. |last7=Marathe |first7=Kumudini V. |date=2014-07-23 |title=Pharmaceutical Industry Wastewater: Review of the Technologies for Water Treatment and Reuse |url=https://pubs.acs.org/doi/10.1021/ie501210j |journal=Industrial & Engineering Chemistry Research |language=en |volume=53 |issue=29 |pages=11571–11592 |doi=10.1021/ie501210j |issn=0888-5885|url-access=subscription }}</ref> [[Agricultural pollution]] is another significant source derived from the prevalence of [[antibiotic use in livestock]].<ref name=":3" />

Scientists generally divide environmental impacts of a chemical into three primary categories: persistence, [[bioaccumulation]], and [[toxicity]].<ref name=":1" /> 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.<ref name=":0" /> These [[Environmental persistent pharmaceutical pollutant|Environmentally Persistent Pharmaceutical Pollutants]] (EPPPs) rarely reach toxic concentrations in the environment, however they have been known to bioaccumulate in some species.<ref>{{Cite journal |last1=Anand |first1=Uttpal |last2=Adelodun |first2=Bashir |last3=Cabreros |first3=Carlo |last4=Kumar |first4=Pankaj |last5=Suresh |first5=S. |last6=Dey |first6=Abhijit |last7=Ballesteros |first7=Florencio |last8=Bontempi |first8=Elza |date=2022-12-01 |title=Occurrence, transformation, bioaccumulation, risk and analysis of pharmaceutical and personal care products from wastewater: a review |url=https://doi.org/10.1007/s10311-022-01498-7 |journal=Environmental Chemistry Letters |language=en |volume=20 |issue=6 |pages=3883–3904 |doi=10.1007/s10311-022-01498-7 |issn=1610-3661 |pmc=9385088 |pmid=35996725|bibcode=2022EnvCL..20.3883A }}</ref> Their effects have been observed to compound gradually across [[Food web|food webs]], rather than becoming acute, leading to their classification by the [[United States Geological Survey|US Geological Survey]] as "Ecological Disrupting Compounds."<ref name=":0" /> 

== See also ==
{{div col|colwidth=30em}}
* [[Adherence (medicine)|Adherence]]
* [[Deprescribing]]
* [[Drug nomenclature]]
* [[List of drugs]]
* [[List of pharmaceutical companies]]
* [[Orphan drug]]
* [[Overmedication]]
* [[Pharmaceutical code]]
* [[Pharmacy]]
{{div col end}}

==References==
{{reflist}}

== External links ==
{{sisterlinks|d=Q12140|c=Category:Pharmaceutical drugs|n=no|q=no|b=no|v=no|voy=Medication|m=no|mw=no|s=no|wikt=no|species=no}}
* [https://openmd.com/directory/drugs Drug Reference Site Directory] – OpenMD
* [http://curlie.org/en/Health/Pharmacy/Drugs_and_Medications Drugs & Medications Directory] – Curlie
* [https://www.ema.europa.eu/en/medicines European Medicines Agency]
* [https://www.nhs.uk/medicines/ NHS Medicines A–Z]
* [https://web.archive.org/web/20090720031417/http://www.fda.gov/Drugs/ U.S. Food & Drug Administration: Drugs]
* [https://www.who.int/medicines/publications/essentialmedicines/en/ WHO Model List of Essential Medicines]

{{Major Drug Groups}}
{{Pharmacy}}

{{Authority control}}

[[Category:Drugs| ]]
[[Category:Chemicals in medicine]]
[[Category:Pharmaceutical industry]]
[[Category:Products of chemical industry]]