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Regulation impact statement: International harmonisation of ingredient names
Version 1, November 2015
Ingredient names are a critical piece of information about medicines for doctors, nurses, pharmacists and patients. With a proliferation of trade names and generic medicines in the marketplace, ingredient names help doctors, nurses and pharmacists speak a common language. For patients, the ingredient name is increasingly what is used to inform their treatment regime and to access new supplies, particularly when travelling. Without consistency and surety around ingredient names, there is the risk of confusion about what treatment is being prescribed and medication error, potentially leading to serious risks and poor health outcomes.
Unfortunately, there is lack of consistency and global harmonisation for ingredient names. Aside from the confusion noted above, this also makes it difficult for health practitioners to identify emerging issues in the international medical literature and other communication channels. For example, an article appearing in an American journal about a problem with 'lidocaine' is about 'lignocaine' (in current Australian terminology).
Further, inconsistent naming in different countries creates an additional cost burden on industry stakeholders supplying in a global market. These costs extend further than just the costs of different labels for markets using different names - label requirements often differ across markets for other reasons (related to the public health decisions made by specific regulators). There is also an administrative cost involved in maintaining different sets of documents - dossiers, drug master files etc. - where the only difference is the ingredient name. Such additional costs to manufacturers and suppliers flow on to government health budgets and patients.
This Regulation Impact Statement (RIS) assesses options for the harmonisation of medicine ingredient names with international nomenclature systems, preferring the use of International Nonproprietary names (INNs) where possible. The INN system was developed by the World Health Organization (WHO) and is maintained by a committee of member states that includes Australia. The Therapeutic Goods Administration (TGA) proposes to update Australian ingredient names included in TGA's Business Services Ingredients Table to bring them into line with international nomenclature. Under this proposal, TGA will change a number of Australian ingredient names to their international name, with consequential effects on medicine records, labels and product information.
This will not resolve all of Australia's medicine ingredient name alignment issues. 'Paracetamol', for example, is the INN name already in use in Australia, while 'acetaminophen' is a United States Adopted Name (USAN); 'adrenaline', a name used in Australia is not the INN, which is 'epinephrine', but, as discussed herein, 'adrenaline' is so fixed in the Australian nomenclature that a change may create significant risk of medication error or risks associated with failure to administer medication (for example, an increase in prescribing and dispensing errors1). This harmonisation activity will, however, resolve many of the differences between the naming systems of Australia and other jurisdictions, while improving the current situation in a global marketing system.
This RIS outlines the anticipated impacts of the following options for ingredient name harmonisation:
Option 1: Status quo - No action.
Option 2: Mandatory adoption of harmonisation with international protocols - the full proposal - Adopt all the proposed name changes (478 ingredient names changed). The old ingredient names would be removed from the Ingredients Table and applicants would only be able to use the new ingredient names.
Option 3: Mandatory adoption - a reduced proposal - Reduce the full list of name changes, based on issues raised during consultation. This option removes ingredient name changes that have not been adopted consistently in the international market:
- Maintain status quo for metal containing ingredients - No Latin-to-English name changes would be made to metal-containing ingredients.
- Maintain status quo for sunscreen ingredients - No changes would be made to ingredients that are used as actives in current TGA-regulated sunscreens.
- Maintain status quo for some excipient ingredients - No changes would be made to some excipients where the source reference did not apply this terminology.
- Maintain status quo for macrogol excipient ingredients - No changes would be made to macrogol ingredients that are only used as excipients.
Under this option, 336 ingredient names would change.
Option 4: Mandatory adoption - only those changes based on direct harmonisation of INNs or references plus changes of high clinical significance - This option proposes to further reduce the full list by only implementing name changes where the replacement name has an international reference or an INN that does not require modification, plus a number specific ingredients identified as being of high clinical significance.
Under this option, 160 ingredient names would change.
Option 5: Voluntary name changes - New ingredient name entries would be included in the Ingredients Table and sponsors could voluntarily move to using the new names or continue to use the old ingredient name. Consequently, different products could use different ingredient names on their labels when they are actually referring to the same substance. This voluntary approach can be applied either to the full proposal or to a reduced list.
Two transition period options are presented for the mandatory adoption options (Options 2, 3 and 4):
- Transition Option (i): proposes a three year transition period for changing to the new ingredient names.
- Transition Option (ii): proposes a four year transition period for changing to the new ingredient names.
For both transition options, medicines with ingredients identified as of 'high clinical significance' would be dual-labelled with both the old and new name for an additional three years. Following this period, sponsors could then start using the new ingredient name as the sole name. Adrenaline and noradrenaline products were considered to be an exception to this rule. Both adrenaline and noradrenaline products would be dual-labelled indefinitely, consistent with the United Kingdom approach.
Option 3(ii) is the preferred option, with a transition period of four years. This option would better align Australian ingredient names with widely accepted international terminology, while not imposing harmonisation where the regulatory costs may outweigh the benefits. The four year transition period would minimise the costs associated with name changes as this fits with the business as usual label changes identified by industry stakeholders.
This proposal will result in an estimated cost to industry of $0.13M per annum over 10 years. This net regulatory cost will be offset by other qualitative gains, such reduced risk of incorrect use of medicines, improved access to international medicines information and clarity for patients and healthcare providers. This option will also result in a small reduction in barriers to trade for individual companies, however it is not expected to have a noticeable effect on the market overall.
Due to the qualitative gains from harmonisation, this option is expected to result in an overall net benefit to consumers, healthcare professionals and industry once the name changes are embedded in Australian nomenclature.
In May 2013, TGA consulted on a proposal to change approximately 500 ingredient names. Thirty-one submissions were received from the therapeutic goods industry, and healthcare professional and consumer organisations. TGA also conducted focus groups with some stakeholders to discuss the proposed name changes and seek feedback on implementation strategies.
Consultation responses indicated broad in-principle support for international harmonisation of ingredient names. Healthcare professional and consumer organisations stated that harmonisation would reduce ambiguity and confusion by providing international consistency. With a few exceptions, most stakeholders agreed that the proposed changes would help the pharmaceutical industry provide Australians with medicine products, by making it easier to prepare labels and other documents for the Australian market. The exceptions were based on a perceived lack of international harmonisation with some of the proposed new names (for example, using INN terminology for sunscreen active ingredients).
Stakeholders also provided feedback on implementation, including valuable suggestions for communication and education strategies.
During the transition period, industry and TGA will work together to update ingredient names in:
- The TGA Business Services Ingredients Table
- Formulation details within entries on the Australian Register of Therapeutic Goods (ARTG)
- Product Information and Consumer Medicine Information documents
- Medicine labels.
To minimise the effect of these changes on medicine sponsors, TGA will initiate amendments to affected ARTG entries. There is no fee associated with TGA initiated changes to ARTG entries, labels or supporting product documentation, as long as the only change made is to the ingredient name for the purposes of harmonisation.
TGA will also undertake a range of communication and education activities to minimise potential risks to consumer health and safety from ingredient name changes. TGA will work closely with consumer and healthcare professional organisations to develop and disseminate targeted information about the ingredient name changes. These organisations have expertise in consumer matters and existing resources and networks that extend beyond those currently available to TGA.
- James, H. R. 'Ephedrine/epinephrine drug label confusion', Anaesthesia, 1998, Vol 53, issue 5. <http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2044.1998.04771.x/pdf (pdf,280kb)>