Proposed warning statements for substances (eg, allergens) in medicines that may cause undesirable reactions

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted textproposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Redacted text proposes that the word, “caution” should be omitted from the proposed warning statement. The word “caution” may overtly alarm patients who do not have an intolerance to the ingredient, and patients identified as having adverse reactions to the ingredient should be sufficiently warned by the ingredient appearing clearly on the label – even without the word “caution” preceding it.

Furthermore, the same statement without “caution” is aligned with the new labelling requirements as specified in the TGA Therapeutic Goods Order 91 – Standard for labels of prescription and related medicines (TGO 91), which comes to full effect in Australia on 1 September 2020. As many medicines in New Zealand have shared packs with Australia, Redacted text proposes that the proposed statements be aligned so that the existing shared pack arrangement with Australia can continue.

Whilst Redacted text believes that the warning and advisory statements on labels proposed in this consultation will improve medicine safety, Redacted text does not believe that an implementation timeframe of one year is sufficient taking into account the lead times required for the different activities, ranging from artwork preparation, regulatory submission approval and manufacture of the medicine. Redacted text proposes an implementation period of 3-4 years for the reasons summarised below:
• Artwork generation can take several months and is often staggered by sponsors considering the number of impacted products and resources available.
• Regulatory approval for the revised label could take up to 3 months depending on the submission category.
• Manufacturing lead times can vary from 3 to 6 months, depending on the product type – pharmaceutical or vaccine, and hence label updates (i.e. packaging) incorporating the new warning statements will take considerable time to implement.
• Furthermore, at least 6-12 months may be required from regulatory approval of the revised label for implementation into the market place.
• The proposed 1 year transition period does not take into consideration medicines which have lower turnover and are infrequently manufactured. Such products will require a longer implementation period and potentially the sponsor may have to request a labelling exemption from compliance with the new label requirements to ensure continuity of supply. This will allow existing stock on hand can be supplied until such time that revised labels are available.

Additionally, having a short implementation period of 1 year may have the unintended effect of an increased number of labelling exemption applications from sponsors to Medsafe to ensure uninterrupted supply of medicines, thus resulting in an increased burden on Medsafe resources.

If Medsafe were not to agree with the removal of the word “caution” from the mandatory warning and advisory statements (as suggested in Redacted text preceding responses), an additional TGA application will be required for Australian and New Zealand shared packs to update the Australian approved labelling. This potential additional work required of sponsors and is a further reason as to why a longer transition period is necessary.

In conclusion, to allow sponsors adequate time to update their labelling, prepare Medsafe submissions, implement the changes at the manufacturing site and sell down stock in the existing packs, Redacted text believes a 3-4 year transition period would be more appropriate. This timeframe is similar to the 4 year transition period allowed by the TGA for their TGO 91/2 labelling reform in 2016.

We thank Medsafe for providing Redacted text with the opportunity to participate in this very important consultation process.