International Harmonisation of Ingredient Names

The World Health Organization (WHO) is responsible for guardianship of the worldwide benchmark for medicinal ingredient naming, known as the International Nonproprietary Names (INNs) system. This system is used to enable the distinct identification of medicinal constituents which is paramount for the safe prescription and dispensing of medications and to facilitate communication between health professionals and scientists globally.

In Australia, marketed medicines must be labelled with the Australian Approved Name (AAN). The Therapeutic Goods Administration (TGA) is responsible for the maintenance of the AAN, which is used in the Australian Register of Therapeutic Goods (ARTG) and ancillary documentation including Product Information and Consumer Medicine Information documents. The INN system has been used by the TGA to generate AANs for new molecules since 2002. Therefore, the AAN is often the same as the INN. Other references are also used to create the AAN, such as the British Pharmacopoeia if there is no INN already in existence for an ingredient.

However, for medicines listed before 2002, naming may not necessarily be in line with the INN. This has resulted in a number of inconsistencies between Australian and international medicine names. Occasions have arisen whereby the INNs are reassessed, new INNs are developed for historical ingredients, or an INN is listed without firstly eliminating the previous name (e.g. for a minor spelling change). These differences can result in misunderstandings in various scenarios including patients researching medication information online, travellers requiring a subsequent supply of their medication, health professionals accessing worldwide literature, or customs officers evaluating import constraints on incoming shipments. Naming discrepancies can also inflict difficulties due to the added time and money required when marketing a new medicine in Australia in terms of regulatory documentation and tailored promotional material.

Consequently, the TGA decided that medicine ingredient names will be harmonised to align with the INN. These changes will influence active ingredients (prescription and non-prescription) and excipients that are required to be included on a label or in consumer information. This streamlining process has been embarked upon by other nations over the years, including the United Kingdom in 2003 and New Zealand in 2008.

Transition

There will be a four-year transition period for harmonisation commencing in April 2016. For minor changes to spelling or hydration state, manufacturers can cease using the old name on labels and documentation at any point during this period. Name changes for medicines considered to be of high clinical significance will introduce dual labelling during the transition period. For example, medicines containing frusemide will need to be dual labelled as ‘furosemide (frusemide)’. Dual labelling for these medications will be required to continue for three years after the end of the transition period. A notable exception has been made for adrenaline and noradrenaline. The potential risk of patient harm associated with drug errors relating to these critical medications was considered too great. Therefore, adrenaline and noradrenaline will remain the approved names in Australia. The INNs, epinephrine and norepinephrine, will be introduced into labels and information leaflets for products containing adrenaline and noradrenaline, respectively. However, this dual labelling will be continued indefinitely for these products only.

Products with labels depicting the new ingredient names will increasingly begin to present. The medicine itself will remain the same even though the name of the ingredient may have altered. It is expected that there will be a combination of old and new nomenclature on shelves during the transition period since new labels can take up to twelve months for approval, and some medicines do not turn over as frequently. In addition, there may be a requirement for reconfiguration of certain prescribing and dispensing software programs to allow for dual labelling. These modifications could require up to two years to progress, further staggering the appearance of name changes.

Expected changes

A number of changes will be necessary over the four-year transition period. The changes that can be expected to facilitate harmonisation are as follow:

• Avoiding names that are in ‘common’ use and instead using one consistent name to refer to any single ingredient;
• Using a pharmacopoeia reference or INN instead of a non-pharmacopoeia reference;
• Minor spelling amendments, e.g. using ‘e’ instead of ‘oe’;
• Limiting the use of hyphens, isolated numbers or letters (except when needed for chemical structure);
• Inclusion of the hydration state where suitable with a discrete entry for each hydration state;
• Correct word order for salts and other derivatives; and
• Use of ‘macrogol’ terminology for synthetic polymers (rather than ‘PEG’).

The difference in nomenclature will in turn require:

• Dual labelling for affected products considered to be of high clinical significance. Labels for these medicines will need to use both the old and new ingredient name for an additional three-year period at the conclusion of the transition period (until 2023) to aid consumers and health professionals in becoming accustomed to the new nomenclature.
• Revision of Product Information (PI), Product Summary (PS), and Consumer Medicine Information (CMI) documentation.
• Re-submission of pertinent literature and labels for approval by the TGA.

Table 1 provides some examples of name changes. A complete list is available on the TGA website.

Table 1. Summary of medication name changes

For further information or education provision, please contact your HPS Pharmacies Clinical Pharmacist.