Nomenclature names

Any drug may have names in all three of the following classes:

1. The full chemical name

2. A nonproprietary (official, approved, generic) name used in pharmacopoeias and chosen by official bodies; the World Health Organization (WHO) chooses recommended International Nonproprietary Names (rINN). The harmonisation of names began 50 years ago, and

1 The ATC Classification System developed by the Nordic countries and widely used in Europe meets most classification requirements. Drugs are classified according to their Anatomical, Therapeutic and Chemical characteristics into five levels of specificity, the fifth being that for the single chemical substance.

most countries have used rINNs for many years. The USA is an exception, but even here most USA National Names are the same as their rINN counterparts. In the UK, the British Approved Name (BAN) system is being progressively modified such that the rINN name is adopted; in many cases this involves only a trivial change. In a few cases, there is cause for concern that change of name could lead to confusion and constitute a public health risk, e.g. adrenaline is the BAN, epinephrine is the rINN name. In such instances, both rINN and BAN must currently appear in the manufacturer's literature. In general we use rINNs in this book and aim to minimise some unavoidable differences with, where appropriate, alternative names in the text and index.

3. A proprietary (brand) name that is the commercial property of a pharmaceutical company or companies.

1. 3-{ 10. I I -dihydro-SH-dibenz [b.fl-azepin-5-yl) propyl dimethylami ne

2. imipramine

3. Tofranil (UK), Prodepress, Surplix, Deprinol, etc (various countries)

In this book proprietary names are distinguished by an initial capital letter.

The full chemical name describes the compound for chemists. It is obviously unsuitable for prescribing.

A nonproprietary (generic,2 approved) name is given by an official (pharmacopoeia) agency, e.g. WHO.

Three principles remain supreme and unchallenged in importance: the need for distinction in sound and spelling, especially when the name is handwritten; the need for freedom

2 The generic name is now widely accepted as being synonymous with the nonproprietary name. Strictly 'generic' (L. genus, race, a class of objects) should refer to a group or class of drug, e.g. benzodiazepines, but by common usage the word is now taken to mean the nonproprietary name of individual members of a group, e,g, diazepam.

from confusion with existing names, both nonproprietary and proprietary, and the desirability of indicating relationships between similar substances.3

The generic names diazepam, nitrazepam, flur-azepam are all of benzodiazepines. Their proprietary names are Valium, Mogadon and Dalmane respectively. Names ending in -olol are adrenoceptor blockers; in -pril are ACE-inhibitors; in -floxacin are quinolone antimicrobials.

Any pharmaceutical company may manufacture a drug that has a well-established use and is no longer under patent restriction, in accordance with official pharmacopoeial quality criteria, and may apply to the regulatory authority for a licence to market. The task of authority is to ensure that these generic or multisource pharmaceuticals are interchangeable, i.e. they are pharmaceutically and biologically equivalent, so that a formulation from one source will be absorbed and give the same blood concentrations and have the same therapeutic efficacy as that from another. (Further formal therapeutic trials are not demanded for these well-established drugs.) A prescription for a generic drug formulation may be filled for any officially licensed product that the dispensing pharmacy has chosen to purchase (on economic criteria, see 'generic substitution' below).4

The proprietary name is a trade mark applied to particular formulation(s) of a particular substance by a particular manufacturer. Manufacture is confined to the owner of the trade mark or to others licensed by the owner. It is designed to maximise the difference between the names of similar drugs marketed by rivals for obvious commercial reasons. To add confusion, some companies give their proprietary products the same names as their generic products in an attempt to capture the prescription market, both proprietary and generic, and some market lower-priced generics of their own proprietaries. When a prescription is written for a proprietary product, pharmacists under UK law must dispense that product only. But by agreement

3 R B Trigg 1998 Chemical Nomenclature. Kluwer Academic, Dorerechat, pp 208-234.

4 EU Medicines Evaluation Agency and USA Food and Drug Agency guidelines are available that give pharmacokinetic limits that must be met.

with the prescribing doctor, they may substitute an approved generic product (generic substitution). What is not permitted is the substitution of a different molecular structure deemed to be pharmacologically and therapeutically equivalent (therapeutic substitution).

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