WHO Drug Information Vol. 18, No. 2, 2004 - World Health ...

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WHO Drug Information Vol 18, No. 2, 2004 are used, the user has to create a modified INN (INNm). For example oxacillin and ibufenac are INNs and their salts are named oxacillin sodium and ibufenac sodium The latter are referred to as modified INNs. The texts of the procedure and of General Principles are regularly published in WHO Drug information as annexes to lists of proposed INNs. The name proposed by a manufacturer for consideration is examined, and the corresponding INN adopted by consensus among all members of the Expert Panel. The name is then published as a proposed INN. For a period of four months, the INN Secretariat receives comments or objections to the proposed name, for example, objections based on similarity with a brand name. If no objections are made to the proposed INN, it is then published as a recommended international nonproprietary name. When INNs are selected for pharmaceutical substances, the following basic principles are to be followed: • An INN must be distinctive in sound and spelling; should not be too long or liable to confusion with other names in common use. • INNs for substances belonging to a pharmacologically related group of substances should as far as possible demonstrate this relationship. Care should be taken to avoid names that might convey to patients an anatomical, physiological, pathological or therapeutic suggestion. In addition to the basic principles, when choosing an INN there are a number of other rules that should be followed in order for them to be suitable for international use. First of all, there are a number of linguistic and phonetic requirements. For example, use of the letters “h” and “k” is to be avoided; it is recommended that “e” should be used instead of “ae” and “oe”, “i” instead of “y”, “f” and “t” instead of “ph” and “th”, etc. When choosing INNs for pharmaceutical substances, specialists should be guided by the following WHO documents: • Procedure for selection of recommended International Nonproprietary Names (INN) for Pharmaceutical Substances; • General Principles for guidance in devising International Nonproprietary Names (INN) for Pharmaceutical Substances. International Nonproprietary Names INN stem system Of particular interest is the INN stem system. Many INNs consist of a common stem, mainly a series of letters — a suffix, prefix, infix or a combination of these — which shows the relationship between the pharmacologically related substance and use in combination with the distinctive part of the name. Table 1 presents examples of widely used stems. Among these are two examples of stems that are placed as prefixises (def- and grado-) wheras others are used mainly as suffixes, or in some cases as infixes. WHO regularly publishes a document on the use of common stems (6). These stems and their definitions have been selected by INN experts and must be used when choosing new INNs for pharmaceutical substances related to an established group (series) of related compounds. For example, the stem - caine” includes 64 INNs classified as local anaesthetics: benzocaine, procaine, lidocaine, tetracaine, etc. In Russia, different preparations based on 12 pharmaceutical substances are registered in this category of compounds; their international nonproprietary names contain the stem -caine. Conclusion The process of selecting INNs becomes increasingly complicated each year. This is due to the constant development of innovative pharmaceutical preparations and biological products, new classes of compounds, and discovery of new mechanisms of action. Specific nomenclature systems are being established for these areas in collaboration with drug regulatory authorities and biological experts. In accordance with World Health Assembly resolution WHA46.19, it is necessary to determine that brand names derived from international nonproprietary names or INN stems are not used as trade marks. The practice of unjustified use of stems in trade marks or brand names for pharmaceutical products undermines the principle whereby INNs are public domain property. Non respect of the INN sytem may impede future rational selection of INNs and ultimately jeopardize the safety of patients by creating confusion in drug nomenclature. The INN system owes its success in great part to the international suitability, flexibility and application of the names. INNs are accessible to specialists dependent on drug nomenclature when 125
International Nonproprietary Names 126 Table 1. Examples of widely used common stems (7) Stem Name of pharmacological group WHO Drug Information Vol 18, No. 2, 2004 ac anti-inflammatory agents, ibufenac derivatives adol analgesics ast anti-asthmatic, anti-allergic substances not acting primarily as antihistaminics astine antihistaminics azepam diazepam derivatives bol steroids, anabolic cain class I antiarrhythmics, procainamide and lidocaine derivatives caine local anaesthetics cef- antibiotics, cefalosporanic acid derivatives cillin antibiotics, 6-aminopenicillanic acid derivatives conazole systemic antifungal agents, miconazole derivatives cort corticosteroids, except prednisolone derivatives coxib selective cyclo-oxygenase inhibitors entan endothelin receptor antagonists gab gabamimetic agents gado- diagnostic agents, gadolinium derivatives gatran thrombin inhibitors, antithrombotic agents gest steroids, progestogens gli antihyperglycaemics io iodine-containing contrast media metacin anti-inflammatory, indometacin derivatives mycin antibiotics, produced by Streptomyces strains nidazole antiprotozoal substances, metronidazole derivatives olol α-adrenoreceptor antagonists oxacin antibacterial agents, nalidixic acid derivatives platin antineoplastic agents, platinum derivatives poetin erythropoietin type blood factors pril(at) angiotensin-converting enzyme inhibitors profen anti-inflammatory substances, ibuprofen derivatives prost prostaglandins relin pituitary hormone release-stimulating peptides sartan angiotensin II receptor antagonists, antihypertensive (non-peptidic) vaptan vasopressin receptor antagonists vin vinca-type alkaloids providing information on the pharmacological and therapeutic action of preparations. INN classification is also used by WHO, particularly for drug evaluation and safety monitoring. References 1. World Health Organization. Guidelines on the use of international nonproprietary nams (INNs) for pharmaceutical substances. WHO/PHARMS/NOM 1570 (1997). 2. World Health Organization. International nonproprietary names (INN) for pharmaceutical substances. Cumulative list No. 10 (CD-ROM) (2002). 3. Art. 1 point 21 of the Directive 2001/83/EC of 6 November 2001 on the Community Code related to medicinal products for human use. 4. EMEA.` Committee for Human Medicinal Products (CHMP). Guideline on the acceptability of invented names for human medicinal products processed through the centralized procedure. CPMP/328/98 Rev. 4. (2004). 5. World Health Organization. The graphic representation of chemical formulae in the publication of international nonproprietary names (INN) for pharmaceutical substances. WHO/PHARM/9.579 (1995) 6. World Health Organization. The use of common stems in the selection of international nonproprietary names for pharmaceutical substances. WHO/EDM/ QSM/2003.2 (2002). 7. World Health Organization. International nonproprietary names for pharmaceutical substances. Names of radicals and groups, comprehensive list. WHO/EDM/ QSM/2003.1 (2002).
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