Classification and naming of drugs In any science there are two basic requirements — classification and nomenclature (names): + Cassication: drug cannot be cased and named according fa single ration system | Beaute the requiremenc of chemists, pharmacoloistsand doctors dif | « Nomenclaure:nor fc pracccale alway co present each drug under a singe mame Because the formulations in which they are presented a prescrbable medicines may | ‘ary widely an commer consieraons are to offen paramour Generic (nonproprietary) names should be used as far as possible when prescribing except where pharmaceutical bioavailability differences have overriding importance. Classification It is evident from the way this book is organised that there is no homogeneous system for classifying drugs that suits the purpose of every user. Drugs are commonly categorised according to the con- venience of who is discussing them: clinicians, pharmacologists or medicinal chemist. Drugs may be classified by: © Body system, e.g. alimentary, cardiovascular ‘© Therapeutic use, e.g, veceptor blockers, enzyme inhibitors, carrier molecules, ion channels © Moe or site of action — molecular interaction, eg. glucoside, alkaloid, steroid. — cellular site, e.g. loop diuretic, catecholamine uptake inhibitor (imipramine) © Moleculay structure, eg, glycoside, alkaloid, steroid.? ‘Nomenclature (names) ‘Any drug may have names in all three of the following classes: 4. The fil chemscal name 2. Anonproprietary (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 “The ATC Classification System developed by the Nondie «countries and widely used in Europe meets most classification requirements. Drugs ae classified acconding their Anatomical, Therapeutic avd Chemical characteristics into five levels of specific, the fith being tat for the single chemical substance. a HNoliaasSECTION! [6 cunssincarion ao waning on pnves ‘most countries have used! INN for many years. ‘The USA is an exception, but even here most USA National Names are the same as their INN 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. Ina few cases, there is cause for concern that change of name could lead to confusion and constitute a public health risk eg, adrenaline is. the BAN, epinephrine is the rINN name. In such instances, both rINN and BAN must currently appear in the manufacturer’ 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. (UK).Pr In this book proprietary names are distinguished by an initial capital letter. ‘The full chemical name describes the compound for chemists Itis obviously unsuitable for prescribing. ‘A nonproprietary (generic? approved) name is given by an official (pharmacopoeia) agency, eg 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 isnow widely accepted as being synonymous with the nonproprietry name. Strictly “generic! (genus, ace a clas of objects) should refer toa group or class of nig, eg, benzodiazepines, but by common wage the word is now taken to mean the nonproprietary name of individual members ofa group, eg, diazepam, from confusion with existing names, both ;nonproprietary and proprietary, and the desirability of indicating relationships between similar substances? ‘The generic names diazepam, nitrazepam, flur- azepam are all of benzodiazepines, Their pro- prictary 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 uncer patent restriction, in accordance with official pharmacopoeial quality criteria, and may apply to the regulatory authority for a licence #0 ‘market. The task of authority is to ensure that these generic or multisource pharmaceuticals are inter- changeable, ie. they are pharmaceutically and bio- logically 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 fora 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)! The proprietary name is a trade mark applied to particular formulation(S) of a particular substance by a particular manufacturer. Manufacture is con- fined 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 pro- prietary 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 pro- prietaries, When a prescription is writen for a proprietary product, pharmacists under UK law ‘ust dispense that product only. But by agreement SRB hig 1998 Chemical Nomenclature, Kluwer Academic, Dorecechat, pp 208-204. “EU Medicines Evaluation Agency and USA Food and Drug, Agency guidelines are available that give pharmacokinetic limits that ast be met.aire ctarune [6 | 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 pharma- cologically and therapeutically equivalent (therapeutic substitution). NONPROPRIETARY NAMES ‘The principal reasons for advocating the habitual se of nonproprietary (generic) names in prescribing Clarity: because it gives information of the class of drug e.g. nortriptyline and amitriptyline are plainly related, but their proprietary names Allegron and Lentizol are not. It is not unknown for prescribers, when one drug has failed, unwittingly to add or substitute another drug of the same group (or even the same drug) thinking that different proprietary names must mean different classes of drugs. Such ‘occurrences underline the wisdom of prescribing generically, so group similarities are immediately apparent, but point up the requirement of brand names to be as distinct from each other as possible. Relationships cannot and should not be shown by brand names, Economy: drugs sold under nonproprietary names are usually, but not always, cheaper than those sold under proprietary names. Convenience: pharmacists may supply whatever version they stock whereas ifa proprietary name is used they are obliged to supply that preparation alone. They may Rave to buy in the preparation named even though they have an equivalent in stock. Mixtures of drugs are sometimes given non- proprietary names, having the prefix co- to indicate ‘ore than one active ingredient, eg. co-amoxiclav for Augmentin, but many are not because they exist for commercial advantage rather than for therapeutic need.* No prescriber can be expected to write out S"Thiscan result in supply of «formation of appearance diffrent from that previously used. Patients naturally find this disturbing, This isa practice largely confined othe UK Itis unknown, In Europe, and not widely practised inthe USA. the ingredients, so proprietary names are used in ‘many cases, there being no altemative. International travellers with chronic illnesses will be grateful for recommended International Nonproprietary Names (above) as proprietary names often differ from country to country. The reasons are linguistic as well as commercial (see below). PROPRIETARY NAMES ‘The principal noncommercial reason for advocating the use of propritary names in prescribing is consistency of the product, so that problems of quality, especially of bioavailability, are reduced. There is substance in this argument, though it is often exaggerated. It is reasonable to use proprietary names when dosage, and therefore pharmaceutical bioavailability, are critical so that small variations in the amount of rug available for absorption can have big effects on the patient, e.g. drugs with low therapeutic ratio, digoxin, hormone replacement therapy, adreno- cortical steroids (oral), antipileptcs, cardiac anti- archythmies, warfarin. Also, with the introduction of complex formulations, eg. sustained-release, itis important clearly to identify these, and use of proprietary names has a role. ‘The pharmaceutical industry regards freedom to market proprietary names and to advertise or, as it calls the latter, to ‘effectively [bring] to the notice of the medical profession’, as two of the essentials of the ‘process of discovery in a vigorous competitive ‘environment’? ‘The present situation is that industry spends an ‘enormous amount of money promoting, its many names for the same article, and the community, as represented in the UK by the Department of Health, spends a small sum trying to persuade doctors to use nonproprietary names. Ordinary doctors who preseribe for their ordinary patients are the targets ofboth sides. This state of affairs is confusing for prescribers. Generic names are intentionally longer than trade names to minimise the risk of confusion, but the use of accepted prefixes and stems for generic names * nmual Report, 1963-1964, Association of the British Pharmaceutical Industry 5 I NoLD35