Regulatory Issues
About International Non-proprietary Names (INN) for active ingredients
Reviewed: January 2012
What is an INN?
INN (international non-proprietary names) is a nomenclature system used to
identify active ingredients of medicines. Each INN is a unique name that is
internationally consistent and globally recognised. The INN system began
operating in 1953 and is now administered by the World Health Organisation.
The aim of the INN system is to provide health professionals with a unique and
universally available designated name to identify each pharmaceutical
substance. The existence of such a nomenclature assists in the clear
identification, safe prescription and dispensing of medicines to patients; and
facilitates communication and exchange of information among health
professionals and scientists world-wide.1 [see
www.who.int/medicines/services/inn/en/ for more information about INNs].
Does New Zealand use INNs?
New Zealand legislation requires medicine labels to include certain
information, including specifying the active ingredients. The medicines
legislation does not specify which nomenclature system is to be used to
identify the active ingredients. There is a range of nomenclature systems in
existence world-wide for active ingredients, including the BAN (British
Approved Names), USAN (United States Adopted Names), AAN (Australian Approved
Names) and INN. Medsafe has always accepted medicines and labelling that uses
any of these nomenclature systems. New Zealand is a small market and due to
economy of scale, the medicines supplied here are often batches of product
produced or packaged for a larger or international market. If that other
market is in a country that requires medicines to be labelled as INNs, then NZ
is likely to receive INN-labelled medicines. Globally, medicine manufacturers
are rationalising production and this can limit the range of products
available for supply to New Zealand. Increasingly, countries with large
markets (due to their population size), and thus a critical mass, have
required medicine manufacturers to adopt the INN when labelling their
medicines. As a result, New Zealand is receiving an increasing number of
medicines labelled with INNs. However, the use of INNs is not new in New
Zealand. Thyroxine has been labelled as levothyroxine since January 1998; and
since May 1999, there has been an amoxycillin product labelled by the sponsor
as amoxicillin.
What does it mean for pharmacists?
Pharmacists have a professional and ethical responsibility to accurately
identify the medicine prescribed, whether it be a new active ingredient, a
change of brand name, or a different spelling or nomenclature for an active
ingredient. Lack of familiarity with a medicine name is not an acceptable
reason for dispensing errors to occur. As part of their licensing and
operating requirements, New Zealand pharmacies are required to have access to
reference pharmacopoeias, such as Martindale, which list synonyms for active
ingredients and can be used to check the name of a medicine when in doubt.
Pharmacists also use these reference texts when patients from other countries
need assistance with their medicines, which invariably have different brand
names to those available in New Zealand.
Does the Medsafe web site include INNs?
Medsafe has amended the search function on the Medsafe web site so that data
sheets and Consumer Medicine Information (CMI) can be searched for using any
of the accepted synonyms for active ingredients. For example, while "furosemide"
is the INN, a search using the synonym "frusemide" will also locate any
medicines containing furosemide.
Medsafe is asking New Zealand sponsors to ensure consistent use of nomenclature between the medicine data sheet and the product label, with respect to specifying active ingredients.
Reference
- World Health Organisation. Guidance on INN. Accessed online at www.who.int/medicines/services/inn/en/