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Regulation impact statement: International harmonisation of ingredient names
Version 1, November 2015
In May 2013, TGA consulted34 on a proposal to change 473 ingredient names. Thirty-one submissions were received35 from the therapeutic goods industry, and healthcare professional and consumer organisations (see Appendix C). The TGA also held focus groups with some stakeholders to discuss the proposed name changes and seek feedback on implementation strategies.
Overall, consultation responses supported international harmonisation of ingredient names, in principle. 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 medicines. Some industry stakeholders asserted that the proposed changes would enhance and improve patient safety when selecting over-the-counter medicines (with the exception of issues outlined below).
The issues raised in the submissions are grouped into two main themes:
- the potential lack of harmonisation with international naming and
- the implementation of ingredient name changes.
6.1 Potential lack of harmonisation
6.1.1 Unique names
Some stakeholders raised concerns that TGA was changing existing harmonised ingredient names to non-harmonised names. The consultation paper provided a table of 473 existing names and included the proposed new name and the old and new references. In 113 cases (24%), the new reference column was blank (see Table 4 for an example).
|ID||Current Name||Current Ref||Proposed Name||New Ref|
Some stakeholders interpreted this blank space to mean that the new ingredient name was unique and did not have an international reference. This blank space instead meant that the current reference had updated the old name and TGA was proposing to align with this update (hence a change to the current reference was not needed). In the cholecalciferol example above, the BP would remain as the ingredient name reference.
6.1.2 Hydration states and modified names
Many stakeholders raised concerns about including the hydration state in an ingredient name. Some stakeholders claimed that including a hydration state would result in unique Australian names. Option 4 has been included in this RIS in response to these concerns.
Mostly, these concerns were related to whether this hydration state would have to be included on a label, and the difficulties in fitting the extended name on the label. Some stakeholders claimed that this information would not help consumers or healthcare professionals and would instead cause confusion. The majority of current approved ingredient names include the accurate hydration status in the name. This proposal only changes those ingredients that did not have this accurate information.
Some submissions were specifically concerned about the change from 'lactose' to 'lactose monohydrate', and whether label statements like 'lactose free' would be affected. Although the ingredient 'lactose' will be changed to include its hydration state on the Ingredients Table, the word 'lactose' would still be used on a label. A product contains 'lactose' regardless of whether it contains 'lactose monohydrate' or 'lactose anhydrous'. The exact amount of lactose (as an excipient) is rarely disclosed on the label of a medicine. Therefore, a label statement of 'contains lactose' or 'lactose free' would remain the same.
6.1.3 Metal naming (English names and oxidation state)
Some industry stakeholders raised concerns that changing metal-containing ingredient names to English would create unique Australian names. Stakeholders asserted that there would be no advantage to changing metal names as the existing names did not pose a health concern and current labelling requirements ensured that the English name of the metal was included on the label. Industry and healthcare professional stakeholders also asserted that there was no benefit to the consumer or practitioner from including the metal oxidation state in the name. Option 3 has been included in this RIS in response to these concerns.
6.1.4 Use of INN terminology for sunscreen active ingredients
Industry stakeholders raised concerns that changing sunscreen active ingredient names to INN or pharmacopoeia nomenclature would result in a lack of international harmonisation with most countries. Stakeholders also raised concerns about the potential lack of consistency within Australia, as NICNAS would continue to use INCI naming for secondary sunscreen products. Stakeholders asserted that some sunscreen ingredients are associated with allergies and this inconsistency could increase risks to Australian consumer health. Option 3 has been included in this RIS in response to these concerns.
6.1.5 Use of INN terminology for excipient ingredients
Industry stakeholders raised concerns about using INN spelling conventions for excipient ingredient names. These stakeholders asserted that INNM naming guidelines should not be used for excipients where there is a more authoritative reference that can be used as the naming reference (such as a pharmacopoeia). These comments were specific to ingredients such as 'cyclomethicone', or 'sodium lauryl sulfate'. It was asserted that such pre-emptive action would result in a lack of harmonisation for no benefit.
Stakeholders also noted that excipients like cyclomethicone are present in many cosmetics and included on cosmetics labels. Stakeholders asserted that where these excipients are included in medicine labels (i.e. injections), such INN spelling changes may result in consumer confusion.
Option 3 has been included in this RIS in response to these concerns.
6.1.6 Macrogol terminology
Some industry stakeholders raised concerns that changing all synthetic polymeric substance names to macrogol terminology would pre-empt INN action in some cases. Some stakeholders noted that not all of these substances had INN stems.
One submission supported changing pure polyethylene glycols to macrogol terminology. However, this stakeholder asserted that using this naming for other synthetic polymeric derivatives (usually used as excipients) would result in a lack of harmonisation with cosmetic products. This stakeholder asserted that the active use of an ingredient should be prioritised over the excipient use, as it will appear on the label and needs to be meaningful to consumers.
Industry stakeholders also noted that there was a lack of consistency between how international standards define macrogol terminology (i.e. the average molecular mass of the polyethylene glycol portion).
Option 3 has been included in this RIS in response to these concerns. An updated numbering method has been applied for these changes.
6.1.7 Specific ingredients where INNs may not be appropriate
Adrenaline and noradrenaline
Adrenaline and noradrenaline are historic BP names. The consultation paper proposed to change these names to their INN counterparts (epinephrine and norepinephrine). The paper also proposed to dual-label adrenaline and noradrenaline products with both the new and old names for a total transition time of five years before moving to the INN as the sole name.
Most stakeholders (industry, government and healthcare professional) raised concerns about this proposed change. These concerns focussed on potential risks to patient safety because of the substance's high clinical significance and possible confusion between epinephrine and ephedrine. Some stakeholders stated that an intense education program and five year dual-labelling requirement would not be sufficient to mitigate these risks. Some stakeholders also noted that the current BP entries for adrenaline and noradrenaline include both the old names and the new INNs (epinephrine and norepinephrine).
In response, adrenaline and noradrenaline are proposed to be dual-labelled (dual-named) with no end date, consistent with the UK approach.
The original proposal in the consultation paper was to change the ingredient name 'menthol' (a USP name) to 'racementhol' (INN). Stakeholders also noted that if 'racementhol' was adopted, a new entry would need to be created for 'levomenthol' since the USP definition of 'menthol' covers both physical states of the substance (racementhol and levomenthol).
Menthol is an ingredient common both to food and medicines. Stakeholders therefore raised concerns that the name change may result in consumer confusion and a lack of harmonisation between regulators. Stakeholders asserted that 'menthol' was the name used in therapeutic products internationally and there was limited benefit in knowing which menthol stereoisomer was used in a product (racementhol versus levomenthol).
In response, menthol was removed from the full proposal.
The consultation paper proposed to change 'docosahexaenoic acid' (DHA) (a Martindale name) to 'doconexent' (INN). The paper also proposed to change 'eicosapentaenoic acid' (EPA) (a Merck Index name) to 'icosapent' (INN). EPA and DHA are fatty acids (present as triglycerides) in fish oils and other oils derived from natural sources.
Stakeholders raised concerns that these changes would result in a lack of harmonisation as EPA and DHA terminology is commonly used in the literature internationally. Stakeholders also asserted that the proposed change would result in consumer confusion for little benefit.
Further consideration revealed that EPA and DHA are components of ingredients (fish oils), not ingredients themselves. TGA policy does not apply INN naming to components of ingredients. Therefore INN nomenclature may not be appropriate for EPA and DHA.
As EPA and DHA are technically not ingredients, they have been removed from the full proposal.
Stakeholders provided extensive feedback on implementation strategies. Much of this feedback has been incorporated into the proposed implementation process (see Section 8 - Implementation and review). The main themes are outlined below.
6.2.1 Fee waivers
Several stakeholders noted the costs associated with label changes and requested that TGA provide fee waivers for any required updates to ingredients databases, the ARTG, PIs and CMIs.
In response, it will be clarified that changes to ARTG entries initiated by TGA are not fee based. Therefore updating the ARTG entry and the resulting updates to labels, PIs and CMIs will not incur a fee if the only change is the harmonisation of the ingredient name. Alternatively, to reduce the impact on businesses, the use of a transition period is intended to minimise the costs of ingredient name updates by allowing the incorporation of changes to the ARTG/PIs/CMIs as part of business-as-usual processes.
The consultation paper proposed a two year transition period for ARTG/label/CMI/PI changes. For substances proposed to be dual-labelled, an additional three years was suggested for a total dual-labelling period of five years.
Most industry stakeholders stated that a two year transition period was insufficient to update labels and supporting documentation and to allow the use of excess stock. Industry stakeholders proposed alternative transition periods ranging between three to five years. The majority of consultation responses agreed that timeframes should align with other TGA activities that are expected to affect sponsors and the community (such as the labelling review).
Some stakeholders noted that an extended transition period may increase risks to patient safety, especially if name changes are implemented on prescribing software before labels are changed (and vice versa). Risks of consumers inadvertently double-dosing may arise where multiple brand products are available for the same ingredient and some sponsors update their labels before other sponsors.
In response, two transition options have been developed (three years and four years) and a communication program is proposed to reduce the risks associated with the transition (see Section 8 - Implementation and review).
The consultation paper proposed that substances be dual-labelled with the old name first, followed by the new name. Most stakeholders preferred the opposite order for labelling - that the new ingredient name be listed first, followed by the old name in brackets. For example, 'lignocaine hydrochloride' would be dual-labelled as 'lidocaine (lignocaine) hydrochloride'. Stakeholders asserted that this approach would assist with consumers' and healthcare professionals' transition to the new name.
This revised order of names has been included as the preferred approach in this RIS for most dual-labelled ingredients. As discussed earlier, adrenaline and noradrenaline products will be dual-labelled in the opposite order (adrenaline (epinephrine)) to harmonise with the UK example.
Stakeholders also nominated a number of additional ingredients for dual-labelling (for example sunscreens or ingredients where the first couple of letters have changed). Currently, sponsors can include additional information on labels to clarify the active ingredient (for example including a common name for a herbal preparation). TGA can also require that specific products include both names on their labels, case by case.
6.2.4 Communication and education
Many stakeholders (industry, healthcare professional and consumer) raised concerns about the risks of changing existing medicine names. Stakeholders noted the risks of medication errors if adequate education and resources were not provided to support the changes, particularly for substances of 'high clinical significance', anaesthetics or medicines used to treat chronic diseases.
Most stakeholders proposed a targeted communication and education strategy. Focussed communication activities were proposed for the following areas:
- Substances of high clinical significance
- Sunscreen active ingredients
- Common over-the-counter active ingredients
- Ingredients associated with allergies (both cause and treatment)
- Where an existing ingredient on the Ingredients Table has changed its meaning (i.e. 'carbidopa' to 'carbidopa monohydrate').
Stakeholders recommended that communication and education activities be implemented in close collaboration with government, industry and consumer and healthcare professional organisations. It was recommended that communication activities start before the ingredient name changes are implemented and continue throughout the transition period. See Section 8 - Implementation and review for more information on the proposed communication activities.