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[e-drug] Stems in International Nonproprietary Names


  • From: stein@lyftingsmo.no
  • Date: Tue, 07 Jun 2005 18:28:31 +0200

E-DRUG: Stems in International Nonproprietary Names
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WHO has issued a document called
The use of stems in the selection of International Nonproprietary Names for
pharmaceutical substances.
http://www.who.int/medicines/library/qsm/stemdoc2004.pdf

The document is a step forward in the international harmonisation and
standardisation process. But it is a paradox that WHO in this connection does not
use the ATC classification system for medicines that WHO itself recommends.
http://www.whocc.no/atcddd/

In the section
'Pharmacological classification with corresponding stems and their definitions'
WHO has used a classification system I have never seen before, a system which
definitively has no potential of becoming an international standard.

The ATC (Anatomical Therapeutic Chemical) classification system for medicines
would have been an excellent tool for this document section. I recommend that WHO
makes an updated ATC classified version available as soon as possible.


Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
www.lyftingsmo.no
stein@lyftingsmo.no

Preface to the WHO document [added by moderator]

WHO?S INN PROGRAMME
WHO has a constitutional responsibility to "develop, establish and promote international standards with respect to biological, pharmaceutical and similar products". This is the basis for many activities within WHO, such as International Nonproprietary Names (INN), WHO Good Manufacturing Practices, the International Pharmacopoeia, the WHO Certification Scheme and many others. The section of the WHO specifically dealing with selection of International Nonproprietary Names for pharmaceutical substances falls under the Department of Essential Drugs and other Medicines.

INN SELECTION PROCEDURE AND CRITERIA
A request for an INN is usually submitted on a form to the World Health Organization. In certain countries, where national nomenclature commissions exist, this is done through the corresponding national nomenclature authority.
Precise information on the chemistry, pharmacological action and use, as well as suggested nonproprietary names, name and address of the manufacturer are to be provided on the form. Each name proposed by the originator of such a request is then examined and a name selected.

All members of the WHO Expert Panel on the International Pharmacopoeia and Pharmaceutical Preparations designated to select nonproprietary names have to agree to the name which is then first published as a proposed INN. During a four-month period, any person can forward comments, or lodge a formal objection to a name, e.g. on grounds of similarity with a trade-name. If no objection is raised the name will be published a second time as recommended INN.

The primary principles for selection are that an INN should be
- distinctive in sound and spelling,
- not too long,
- not liable to confusion with other names in common use.

INNs for substances belonging to a particular group of pharmacologically related substances show their relationship by the use of common stems, which are listed and defined in this document.

In addition to the above rules, certain rules have been established to allow the use of INNs internationally, i.e. in various languages. For example, the letters "h" and "k" should be avoided; "e" should be used instead of "ae" and "oe", "i" instead of "y" and "t", "f" instead of "th" and "ph".

Further information on the selection procedure and general principles in devising INNs may be found in Annex 2 and 3.]