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

Response 299202759

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Your details

3. Are you providing feedback:

Please select one item
As an individual
Ticked On behalf of an organisation or group

4. Where are you or your organisation based?

Please select one item
Ticked New Zealand
Australia
Other

5. Which of the below options best describes you in the context of this consultation?

Please select one item
Healthcare professional
Member of the public
Sponsor
Ticked Manufacturer
Supplier
Importer
Government organisation
Researcher
Professional body
Industry organisation
Consumer organisation
Institution (eg, university, hospital)
Regulatory affairs consultant
Laboratory professional
Other

Antibiotics

1. Should labels include a warning statement for antibiotics?

Please select one item
Yes
Ticked No
If no, why?
In New Zealand, some antibiotics are sold in bulk packs from which individual prescriptions are dispensed. Warning statements are better placed in data sheets and or CMIs on Medsafe's website with efforts made to promote these as sources of information

2. Do you agree with the proposed conditions for antibiotics?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for antibiotics?

Please select one item
Ticked Yes
No
If no, please suggest an alternative statement
Redacted text agrees with the full statement in this instance since the presence of residual antibiotic in non-antibiotic products would be entirely unexpected so drawing attention to residual antibiotic by use of the word caution is appropriate. In later questions, Redacted text disagrees with use of the word caution providing reasons against each question.

Aspartame

1. Should labels include a warning statement for aspartame?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the proposed conditions for aspartame?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for aspartame?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted textsuggests remove use of the word: "caution" leaving the warning as: "contains aspartame". We consider the word: "caution" is unnecessary since if someone is allergic to aspartame (or phenyalanine) then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Benzoates

1. Should labels include a warning statement for benzoates?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some antibiotics are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Benzoic acid, Sodium benzoate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for benzoates?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for benzoates?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains benzoates". We consider the word: "caution" is unnecessary since if someone is allergic to any benzoate compound then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Crustacea and crustacean products

1. Should labels include a warning statement for crustacea and crustacean products?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some antibiotics are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Crab, Crayfish, Lobster, Prawn, Shrimp)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for crustacea and crustacean products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for crustacea and crustacean products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains crustacea [or] crustacean products". We consider the word: "caution" is unnecessary since if someone is allergic to such products then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Egg products

1. Should labels include a warning statement for egg products?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some antibiotics are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Dried egg yolk, Egg, Egg lecithin, Influenza vaccine, Products manufactured in eggs)?

Please select one item
Ticked Yes
No
If no, please suggest alternative inclusions
Should egg white also be included?

3. Do you agree with the proposed conditions for egg products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement?

Please select one item
Ticked Yes
No
If no, please suggest an alternative statement
In this instance, Redacted text considers inclusion of "caution" is appropriate since it would not be immediately obvious from any composition list that egg might be present.

Ethanol

1. Do you agree with the proposed conditions for ethanol?

Please select one item
Ticked Yes
No

2. Do you agree with the proposed warning statement for ethanol?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Remove the word "caution" from the proposed statement so it reads: "Contains [quantity of ethanol as % v/v] alcohol".

Fish and fish products

1. Should labels include a warning statement for fish and fish products?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Cod, Cod liver oil, Halibut, Shark, Tuna)?

Please select one item
Yes
Ticked No
If no, please suggest alternative inclusions
Fish and fish products
Includes but not limited to:
Cod
Cod liver oil
Halibut
Shark
Tuna

3. Do you agree with the proposed conditions for fish and fish products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for fish and fish products?

If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains fish (or) fish products". We consider the word: "caution" is unnecessary since if someone is allergic to fish (or) fish products then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Galactose

1. Should labels include a warning statement for galactose?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the proposed conditions for galactose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for galactose?

If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains galactose". We consider the word: "caution" is unnecessary since if someone is allergic to glactose then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Gluten

1. Should labels include a warning statement for gluten?

Please select one item
Ticked Yes
No

2. Do you agree with the inclusions (Ingredient derived from gluten-containing grain, Wheat starch)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for gluten?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for gluten?

Please select one item
Ticked Yes
No
If no, please suggest an alternative statement
In our experience, gluten is the topic of the majority of questions we receive on possible allergen presence, therefore we consider it appropriate that this has has a strong statement on inclusion.

Hydroxybenzoic acid esters

1. Should labels include a warning statement for hydroxybenzoic acid esters?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Ethyl hydroxybenzoate, Methyl hydroxybenzoate, Propyl hydroxybenzoate, Sodium ethyl hydroxybenzoate, Sodium methyl hydroxybenzoate, Sodium propyl hydroxybenzoate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for hydroxybenzoic acid esters?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for hydroxybenzoic acid esters?

If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains hydroxybenzoates". We consider the word: "caution" is unnecessary since if someone is allergic to these compounds then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Lactose

1. Should labels include a warning statement for lactose?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the proposed conditions for lactose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for lactose?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains lactose". We consider the word: "caution" is unnecessary since if someone is allergic to lactose then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Milk and milk products

1. Should labels include a warning statement for milk and milk products?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Casein, Hydrolysed milk protein, Non-fat dry milk, Whey powder, Whole dry milk)?

Please select one item
Yes
Ticked No
If no, please suggest alternative inclusions
Casein, Hydrolysed milk protein, Non-fat dry milk, Whey powder, Whole dry milk, lactose from sources other than milk

3. Do you agree with the proposed conditions for milk and milk products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for milk and milk products?

If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains milk [or] milk products". We consider the word: "caution" is unnecessary since if someone is allergic to such products then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Peanuts and peanut products

1. Should labels include a warning statement for peanuts and peanut products?

Please select one item
Ticked Yes
No
If no, why not?
In this instance, since peanut allergy is the most widely reported cause of death from allergy, it is appropriate to have a warning on a product's labelling even if the product is sold in bulk by the manufacturer for dispensing. The warning should also be included in the product's datasheet, CMI and insert (if used)

2. Do you agree with the inclusions (Arachis hypogaea, Arachis (peanut) oil)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for peanuts and peanut products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for peanuts and peanut products?

Please select one item
Ticked Yes
No
If no, please suggest an alternative statement
Peanut allergy is the most widely reported cause of death from exposure, therefore we consider it appropriate that this has has a strong statement on inclusion.

Phenylalanine

1. Should labels include a warning statement for phenylalanine?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the proposed conditions for phenylalanine?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for phenylalanine?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains aspartame". We consider the word: "caution" is unnecessary since if someone is allergic to aspartame then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Pollen

1. Should labels include a warning statement for pollen?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the proposed conditions for pollen?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for pollen?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains pollen". We consider the word: "caution" is unnecessary since if someone is allergic to pollen then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Potassium salts

1. Should labels include a warning statement for potassium salts?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Potassium bicarbonate, Potassium chloride)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for potassium salts?

Please select one item
Yes
Ticked No
If no, please suggest alternative conditions
Should IV use also be specifically included to facilitate use of low potassium intake regimens where needed

4. Do you agree with the proposed statement for potassium salts?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains [mg quantity of elemental potassium per dosage unit or in a stated weight or volume of the medicine]". We consider the word: "caution" is unnecessary.

Propolis

1. Should labels include a warning statement for propolis?

If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the proposed conditions for propolis?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for propolis?

If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains propolis". We consider the word: "caution" is unnecessary.

Royal jelly

1. Should labels include a warning statement for royal jelly?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the proposed conditions for royal jelly?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for royal jelly?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains royal jelly". We consider the word: "caution" is unnecessary since if someone is allergic to royal jelly then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Saccharin

1. Should labels include a warning statement for saccharin?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Saccharin calcium, Saccharin sodium)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for saccharin?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for saccharin?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains aspartame". We consider the word: "caution" is unnecessary.

Sesame and sesame seed products

1. Should labels include a warning statement for sesame and sesame seed products?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Sesame seed, Sesame oil, Sesamum indicum)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sesame and sesame seed products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sesame and sesame seed products?

If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains sesame seeds [or] sesame seed products". We consider the word: "caution" is unnecessary.

Sodium salts

1. Should labels include a warning statement for sodium salts?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Sodium bicarbonate, Sodium chloride)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sodium salts?

Please select one item
Yes
Ticked No
If no, please suggest alternative conditions
Should IV use also be specifically included to facilitate low sodium intake regimens where needed?

4. Do you agree with the proposed statement for sodium salts?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted textsuggests remove use of the word: "caution" leaving the warning as: "contains [mg quantity of elemental sodium per dosage unit or in a stated weight or volume of the medicine]". We consider the word: "caution" is unnecessary

Sorbic acid and sorbic acid salts

1. Should labels include a warning statement for sorbic acid and sorbic acid salts?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusion (Potassium sorbate)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sorbic acid and sorbic acid salts?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sorbic acid and sorbic acid salts?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains sorbates". We consider the word: "caution" is unnecessary.

Soya beans and soya bean products

1. Should labels include a warning statement for soya beans and soya bean products?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Glycine max, Soya bean, Soya oil)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for soya beans and soya bean products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for soya beans and soya bean products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains [soya beans; or soya bean products]". We consider the word: "caution" is unnecessary.

Sucralose

1. Should labels include a warning statement for sucralose?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the proposed conditions for sucralose?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed statement for sucralose?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains aspartame". We consider the word: "caution" is unnecessary.

Sugar alcohols

1. Should labels include a warning statement for sugar alcohols?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Erythritol, Isomalt, Lactitol, Maltitol, Mannitol, Polydextrose, Sorbitol, Xylitol)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sugar alcohols?

Please select one item
Ticked Yes
No
If no, please suggest alternative conditions
But wondering why glycerol has been excluded.

4. Do you agree with the proposed statement for sugar alcohols?

If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains [quantity of sugar alcohols present per recommended maximum daily dose]. Products containing [name of sugar alcohol] may have a laxative effect or cause diarrhoea". We consider the word: "caution" is unnecessary.

Sugars – monosaccharides and disaccharides

1. Should labels include a warning statement for sugars (monosaccharides and disaccharides)?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Fructose, Glucose, Honey, Invert sugar, Lactose, Maltose, Sucrose)?

Please select one item
Ticked Yes
No
If no, please suggest alternative inclusions
Consider adding galactose and tagatose also

3. Do you agree with the proposed conditions for sugars?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sugars?

If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains sugars". We consider the word: "caution" is unnecessary.

Sulfites

1. Should labels include a warning statement for sulfites?

Please select one item
Yes
Ticked No
If no, why?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Potassium metabisulfite, Sodium bisulfite, Sodium metabisulfite, Sodium sulphite, Sulfur dioxide (including residues))?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for sulfites?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for sulfites?

If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains aspartame". We consider the word: "caution" is unnecessary

Tartrazine

1. Do you agree with the proposed conditions for tartrazine?

Please select one item
Ticked Yes
No
If no, why not?
But remove the word "caution" from the proposed statement

Tree nuts and tree nut products

1. Should labels include a warning statement for tree nuts and tree nut products?

Please select one item
Yes
Ticked No
If no, why not?
In New Zealand, some medicines are sold in bulk packs from which individual prescriptions are dispensed meaning any allergen information on the original label is lost on dispensing. Before any label has a warning statement added, it should be determined if the subject of the warning is in the top 10 allergens causing issues in New Zealand. If it is then the warning can be added to the package labelling as well as datasheet, CMI and pack insert (if used). If the subject of the warning isn't in the top 10 allergens causing issues in New Zealand, then the warning need only be in the datasheet, CMI and pack insert (if used).

2. Do you agree with the inclusions (Almond oil, Brazil nut, Cashew, Chestnut, Juglans nigra, Macadamia nut oil, Macadamia ternifolia, Prunus dulcis, Walnut)?

Please select one item
Ticked Yes
No

3. Do you agree with the proposed conditions for tree nuts and tree nut products?

Please select one item
Ticked Yes
No

4. Do you agree with the proposed statement for tree nuts and tree nut products?

Please select one item
Yes
Ticked No
If no, please suggest an alternative statement
Redacted text suggests remove use of the word: "caution" leaving the warning as: "contains contains tree nuts [or] tree nut products". We consider the word: "caution" is unnecessary since if someone is allergic to contains tree nuts [or] tree nut products then they will search for the warning anyway while if not allergic there is no need for that person to consider the warning

Implementation date

1. Do you agree with the proposed implementation date of 1 September 2020 (1/09/2020)?

Please select one item
Yes
Ticked No
If no, please suggest an alternative date
The proposed changes if agreed would be implemented for new products never sold previously in New Zealand when they are first introduced. For products already in New Zealand and if it is required to include warnings on product labels including package inserts where used, then to allow time for products to sell through implementation should be over a 4 year period beginning from date of acceptance of the requirements after completion of the consultation process. If it is agreed that the required statements are to only be included in datasheets and CMI then a 2 year implementation period beginning from date of acceptance of the requirements after completion of the consultation process would be suitable as recently completed for the datasheet formatting change.

Other comments

1. Do you have any other comments about this consultation?

Do you have any other comments?
1. Given the update to the medicines legislation, which is likely to result in many other changes to labelling requirements, Redacted text prefers to postpone significant changes to labelling so all changes can be done in one update. Other product types which are likely to be included in updated legislation, e.g. complementary medicines, dietary supplements or medical devices, may contain higher levels of allergens than both prescription and OTC medicines but currently there is no regulated requirement that allergens have to be declared on labels for these products. It would therefore be advisable to consult on all therapeutic type products at once and implement these changes together.
2. We are concerned that a long list of ingredients on labels will put patients off taking medicines due to creating undue concern. We would also like to suggest that labels could include a website address where information on allergies can be found and this would be easier to update for labels and easier to update in real time if information changes. Sponsors are required to update datasheets and CMIs in a timely fashion thus creating a much more reactive and comprehensive allergen content service than is possible with labelling alone where lead times can usually stretch over a number of years. Instead Redacted text would like Medsafe to consider whether better education of pharmacists and doctors about the availability of excipient information on websites would be beneficial. Direction to websites in accordance with Section 2.2.1 of the Guideline on the Regulation of Therapeutic Products in New Zealand Part 7: could also be included on the labelling, datasheets and CMI as a more useful and direct source of information, especially for doctors who do not have easy access to product labels.