Updating Australian medicine ingredient names
Ingredient name changes will be published each month in your monthly MIMS Update Newsletter.
A cumulative list of the changes to date can be found here.
The global standard for naming medicine ingredients is the International Nonproprietary Names (INNs) system, which is maintained by the World Health Organization (WHO). It was created to facilitate unique identification of medicinal substances, which is important for the “clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide”.
In Australia, it is a requirement that marketed medicines use the approved ingredient name on their label, referred to in law as the Australian Approved Name (AAN). The AAN is maintained by the Therapeutic Goods Administration (TGA), and is also used in the Australian Register of Therapeutic Goods (ARTG) and supporting documentation, such as Product Information and Consumer Medicine Information documents. Since 2002, the TGA adopted the INN system as a reference for creating AANs for new medicines – in many cases, the AAN is the same as the INN. Where no INN has been created for a substance, other references are used to create the AAN, such as the British Pharmacopoeia.
However, as many healthcare professionals and consumers would know, there is inconsistent use of the INN to express the medicine ingredient name. This is because medicines that were listed prior to 2002 may not be consistent with international naming practices. INNs themselves undergo review, and new INNs can be created for long-existing substances. In addition, there have been instances where an INN is included in the list without removing the old name (generally minor spelling variations).
This can cause confusion in many different situations – customs officers assessing whether a shipment is subject to import restrictions, consumers accessing medicine information over the internet, travellers seeking additional supplies of their medicines, and healthcare professionals trying to keep up-to-date with international literature regarding medicine safety. This also imposes a barrier for supplying a medicine in Australia due to the additional time spent and costs required, e.g. customised marketing material, regulatory documentation.
In light of this, the TGA has announced they will harmonise medicine ingredient names more closely with the INN. These changes affect active ingredients (prescription and non-prescription) and excipients that are required to be included on a label or in information provided to a consumer.
The following includes some of the rules applied for harmonisation:
A complete list of affected names is available on the TGA website.
Some changes are of high clinical significance. For most of these products, medicine labels must use both the old and new ingredient name during the transition period and for an additional three years afterwards. For example, medicines containing lignocaine will need to be dual labelled as ‘lidocaine (lignocaine)’.
The exceptions to this rule are adrenaline and noradrenaline. In these cases, there is no intent to move over to just using epinephrine and norepinephrine as the sole name – adrenaline and noradrenaline will remain as the AANs, and dual labelling will continue indefinitely.
There will be a four year transition period starting in April 2016. Manufacturers may start using the new name on labels and documentation at any point during this time. However, as new labels can take up to a year for approval, and some medicines are supplied infrequently, it is expected that there will be a mix of old and new labels on shelves during this transition period. Products required to display dual labelling will continue to do so until 2023.
As the overall aim is to promote patient safety by eliminating major differences between Australian and international names, MIMS has decided to address the most clinically important name changes first. In the July data release, MIMS users will find that Adrenaline and Noradrenaline medicines will now include their associated international names Epinephrine and Norepinephrine. Further changes will be rolled out over the next few months as MIMS continues to work closely with the TGA to ensure the changes are made on schedule and communication is clear for both healthcare professionals and consumers.
Furthermore, some prescribing and dispensing software systems may require reconfiguration, e.g. to allow for the use of synonyms. These types of changes could take up to 2 years development time and may rely on the user to enable this additional functionality, so some ingredient name changes may not be effective from the 1st of each month.
For further information, please refer to the following links -
