Drug nomenclature

Regulation of therapeutic goods in the United States
Prescription drugs Over-the-counter drugs
Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption
Government agencies Department of Health and Human Services Food and Drug Administration Department of Justice Drug Enforcement Administration
Process Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs
Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports

Drug nomenclature is the nomenclature of drugs, especially pharmaceutical drugs. Drugs, in the majority of circumstances, have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are the International Nonproprietary Names (INNs); and trade names, which are brand names.^[1] Generic names for drugs are nowadays constructed out of affixes and stems that classify the drugs into different categories and also separate drugs within categories.^[2] A marketed drug might also have a company code or compound code.^[3]

Types

The chemical name is the scientific name, based on the molecular structure of the drug. These names are typically very long and too complex to be commonly used in referring to a drug.^[1] When a drug is approved by the U.S. Food and Drug Administration (FDA), it is given a generic name, or United States Adopted Name (USAN), the shorthand version of the chemical name.^[4] The pharmaceutical company then gives it a brand name, what the drug is sold as. For example, Lipitor is Pfizer's brand name for atorvastatin, a cholesterol-lowering medication. Sometimes, a company that is developing a drug might give the drug a company code,^[3] which is used by people within the company to identify the drug while it is in development. For example, CDP870 is UCB’s company code for Cimzia.^[1] Many of these codes, although not all, have prefixes that correspond to the company name.

Generic names and affixes

The earliest roots of standardization of generic names for drugs began with city pharmacopoeias, such as the London, Edinburgh, Dublin, Hamburg, and Berlin Pharmacopoeias. The fundamental advances in chemistry during the 19th century made that era the first time in which what we now call chemical nomenclature, a huge profusion of names based on atoms, functional groups, and molecules, was necessary or conceivable. In the second half of the 19th century and the early 20th, city pharmacopoeias were unified into national pharmacopoeias (such as the British Pharmacopoeia, United States Pharmacopeia, Pharmacopoeia Germanica (PhG or PG), Italian Pharmacopeia, and Japanese Pharmacopoeia) and national formularies (such as the British National Formulary, the Australian Pharmaceutical Formulary, and the National Formulary of India). International pharmacopeias, such as the European Pharmacopoeia and the International Pharmacopoeia of the World Health Organization (WHO), have been the next level.

In 1953 the WHO created the International Nonproprietary Name (INN) system, which issues INNs in various languages, including Latin, English, French, Spanish, Russian, Chinese, and Arabic. Several countries also have national-level systems for creating generic drug names, including the British Approved Name (BAN) system, the Australian Approved Name (AAN) system, the United States Adopted Name (USAN) system (which is mostly the same as the United States Pharmacopeia (USP) system), and the Japanese Accepted Name (JAN) system. At least several of these national-level Approved Name/Adopted Name/Accepted Name systems were not created until the 1960s, after the INN system already existed. In the 21st century, increasing globalization is encouraging maximal rationalization for new generic names for drugs, and there is an increasing expectation that new USANs, BANs, and JANs will not differ from new INNs without especial justification.

During the first half of the 20th century, generic names for drugs were often coined by contracting the chemical names into fewer syllables. Such contraction was partially, informally, locally standardized, but it was not universally consistent. In the second half of the 20th century, the nomenclatural systems moved away from such contraction toward the present system of stems and affixes that show chemical relationships.

Generic names are used for a variety of reasons. They provide a clear and unique identifier for active chemical substances, appearing on all drug labels, advertising and other information about the substance. They are used in New Drug Applications for the US Food and Drug Administration, in scientific descriptions of the chemical, in discussions of the chemical in the scientific literature and descriptions of clinical trials.^[2] The prefixes and infixes have no pharmacological significance and are used to separate the drug from others in the same class. Suffixes or stems may be found in the middle or more often the end of the drug name, and normally suggest the action of the drug. Generic names often have suffixes that define what class the drug is.^[2]

See also Time release technology > List of abbreviations for formulation suffixes.

List of drug name stems and affixes

More comprehensive lists can be found at the National Library of Medicine^[5] or in Appendix VII of the USP Dictionary.

Example breakdown of a drug name

If name of the drug solanezumab were to be broken down, it would be divided into two parts like this: solane-zumab. -Zumab is the suffix for humanized monoclonal antibody.^[7] Monoclonal antibodies by definition contain only a single antibody clone and have binding specificity for one particular epitope.^[8] In the case of solanezumab, the antibody is designed to bond to the amyloid-β peptides which make up protein plaques on the neurons of people with Alzheimer's disease. These plaques keep neurons from communicating, so the antibody is designed to destroy them.

Pronunciation

Most commonly, a nonproprietary drug name has one widely agreed pronunciation in each language. For example, doxorubicin is consistently /ˌdɒksɵˈruːbɨsɪn/.^[9][10] Trade names almost always have one accepted pronunciation, because the sponsoring company who coined the name has an intended pronunciation for it.

However, it is also common for a nonproprietary drug name to have two pronunciation variants, or sometimes three. For example, for paracetamol, both /ˌpærəˈsiːtəmɒl/ and /ˌpærəˈsɛtəmɒl/^[10] are common, and one medical dictionary gives /pærˌæsɨˈtæmɒl/.^[11]

Some of the variation comes from the fact that some stems and affixes have pronunciation variants. For example, the aforementioned third (and least common) pronunciation for paracetamol reflects the treatment of the acet affix as /ˈæsɨt/ rather than /əˈsiːt/ (both are accepted for acetyl^[11][9]). Other variations arise from the degree to which spelling pronunciation plays a role in individuals' use of the words. When variations interact in speech, it sometimes produces the familiar reaction of "You say /təˈmeɪtoʊ/, I say /təˈmɑːtoʊ/." Nevertheless, accepted variants for drug names reflect plausibility regarding chemistry and pharmacy. For example, just as /ˈtɒmətoʊ/ is not an accepted third option for tomato, /fəˈnɒθiəˌziːn/ is an implausible guess for phenothiazine, given that pheno- and thiazine are predictable (thus /ˌfiːnəˈθaɪəziːn/).

The World Health Organization does not give suggested pronunciations for its INNs, but familiarity with the typical sounds and spellings of the stems and affixes often points to the widely accepted pronunciation of any given INN. For example, abciximab is predictably /æbˈsɪksɨmæb/, because for INNs ending in -ciximab, the /ˈsɪksɨmæb/ sound is familiar. The United States Pharmacopeia gives suggested pronunciations for most USANs in its USP Dictionary, which is published in annual editions. Medical dictionaries give pronunciations of many drugs that are both commonly used and have been commercially available for a decade or more, although many newer drugs or less common drugs are not entered. Pharmacists also have access to pronunciations from various clinical decision support systems such as Lexi-comp.

See also

• Drug development
• Generic brand
• Regulation of therapeutic goods

References