Labelling preferences for medicines

2. Umbrella naming

An umbrella segment is a section of a trade name that is used in the name of more than one pharmaceutical to create a brand for a range of products.

2.1. Pharmac prefers that suppliers develop trade names or use the full INN name. Pharmac recommends suppliers familiarise themselves with the approach taken by Medsafe outlined in its guideline.

3. Essential information

This is the information essential for the safe use of the pharmaceutical. The National Patient Safety Agency (England and Wales) has provided a series of useful design examples.

3.1 Pharmaceutical name

The name of the pharmaceutical should include both the generic name and the trade name (where applicable).

3.1.1. Pharmac prefers that the generic name appears prominently alongside the trade name (if any). See examples in figures below.

3.1.2. Pharmac prefers where both a generic name and trade name exists, they should appear spatially close to each other and not be separated by intervening matter such as logos, tagline, dosage form or strength, or other graphics. See examples in figures below.

3.1.3. Pharmac prefers that the generic name appears prominently on at least three non-opposing faces of the outer packaging. See examples in figures below.

Other design features such as the use of ‘Tall Man lettering’ can be utilised to further distinguish between different pharmaceuticals.

3.2. Pharmaceutical dose/strength/concentration

3.2.1. Pharmac prefers that dose strength be given due prominence and be included in all labelling and packaging components where the generic name appears.

3.2.2. Pharmac prefers that on the packaging of single dose injectable and single dose liquid preparations the strength should be stated as the total quantity of the active pharmaceutical substance per total volume (in each container) and per mL. If the volume in the container exceeds 1 mL, the concentration (quantity of active pharmaceutical substance per 1 mL) should be indicated immediately below the strength, either in brackets or in less prominent letters (where space allows). See example in figure 1. Preference for ampoule or vial container labelling is outlined in preference 11 below
Where space allows use different terminologies for strength as total quantity of active pharmaceutical per total volume (in each container) and total quantity of active pharmaceutical per mL. For example: ‘each 5 mL ampoule contains 100 mg (20mg/mL)’ or ‘100 mg in 5 mL (20 mg/mL)’.

3.2.3. Pharmac prefers on the packaging of multi-dose injectable products, such as insulin, the strength should be stated as strength per unit volume only, e.g. units/mL or mg/mL. Preference for ampoule or vial container labelling is outlined in preference 11 below

3.2.4. Pharmac prefers strength in total quantity of active pharmaceutical per total volume (in each container) or total quantity of active pharmaceutical per mL is displayed for injectable or single dose liquid preparations, even if other units of concentration such as percentages and ratios are displayed. See example in figure 1 and 2 below.

3.2.5. Pharmac prefers that for pharmaceuticals already established in New Zealand, that expression of salts, hydrates and solvents are represented on the label consistently with what is currently in the market for that pharmaceutical. For example “terlipressin” is depicted in product labelling and dosing is expressed as terlipressin acetate not the equivalent amount of terlipressin free base (1 mg of terlipressin acetate is equivalent to 0.85 mg of terlipressin). Pharmac recommends the NZULM be consulted in the first instance.

3.2.6. Pharmac prefers for multi-dose oral liquids (excluding controlled drugs) that the strength of liquid oral preparations should be stated as the total quantity of the active pharmaceutical substance per 5 mL volume (where appropriate). The concentration (quantity of the active pharmaceutical substance per one mL) should be indicated in less prominent letters.

3.2.7. Pharmac prefers for multi-dose controlled drug oral liquids, that the strength be expressed as the amount of the active pharmaceutical substance contained per mL.

Where possible strength should be depicted on labelling using the same unit of measure used when prescribed.

3.3. Pharmaceutical form

3.3.1. Pharmac prefers that pharmaceutical form be given due prominence and be included in all labelling and packaging components where the generic name and strength appears (where space allows).

3.3.2. Pharmac prefers that the formulation type be written in full on labelling(where space allows). For example, “Generic Name- Modified Release” instead of “Generic Name- MR”

3.4. Route(s) of administration

3.4.1. Pharmac prefers that positive messages be used to describe route of administration, such as “give by…”

3.4.2. Pharmac prefers, where space allows, a positive message precedes any negative statement. For example “For Infiltration, Nerve Block and Epidural Administration Only. Not for Intravenous Administration”

3.5. Specific warnings

New Zealand legislative requirements for certain pharmaceuticals may require that specific warnings essential for safe use are provided on the front face of the package and/or labelling. The Medsafe Label Statements Database, which provides a list of warning and advisory statements that are required on pharmaceuticals and related products, should be adhered to as required by section 13(1)(i) of the regulations.

3.5.1. Pharmac prefers specific warnings to be clearly identifiable from other information on labelling. For example the use of red font, or within a border to distinguish the warning from other information.

3.5.2. Pharmac prefers specific warning statements be included on both packaging and container labels (where space allows).

3.6. Storage conditions

3.6.1. Pharmac prefers that product specific storage conditions are easily distinguishable from other information on labelling, particularly when the pharmaceutical requires refrigeration. For example, with the use of bold font.

3.6.2. Pharmac prefers the use of positive statements to give direction. For example “For long term storage, store in a refrigerator at 2-8°C”.

4. Other information required by regulation

4.1. Pharmac prefers that mandatory information required on the labelling and/or packaging does not obscure the essential information as noted above. For example, the name and address of the manufacturer is mandatory but not essential for the safe selection/use of the pharmaceutical. Medsafe have provided a comprehensive guideline on the minimum requirements for labelling.

5. Error-prone abbreviations, symbol and dose designations

The use of abbreviations and acronyms may save time but can increase the potential for medication errors. The Health Quality and Safety Commission New Zealand (HQSC)’s error-prone abbreviations, symbols and dose designations should be considered when designing labelling.

Error-prone abbreviations, symbols and dose designations not to use – HQSC website(external link)

5.1. Pharmac prefers that the HQSC-preferred term is used in labelling, where space allows.

6. Colour used in labelling

Colour can help correctly identify, classify, and differentiate between pharmaceuticals. However, relying totally on colour to do this can lead to mistakes. Additional graphic elements should be used to improve differentiation between pharmaceuticals.

6.1. Pharmac prefers written information to be written in colours that strongly contrast with its background.

6.2. Pharmac prefers that colour differences between strengths and presentations of a pharmaceutical are clearly distinguishable from one another. The same tone or hue should be avoided. This colour difference also needs to be clearly identifiable when the product is:

6.2.1. in isolation

6.2.2. in different lighting conditions

6.2.3. alongside other pharmaceuticals from the same manufacturer/supplier.

6.3. Pharmac prefers packaging and primary container colouring of a pharmaceutical to be consistent.

6.4. Pharmac prefers for tablet and capsule pharmaceuticals which are different colours between strengths within the manufacturer’s range (of that pharmaceutical form), that the colour of the physical tablet or capsule be reflected in the labelling of that strength.

Colours look different in different lighting conditions; people have different perceptions of colour; and colour blindness means some people see colours differently. There are a number of sources of best practice guidelines for colouring on packaging. The National Patient Safety Agency (England and Wales) had provided a series of useful design examples in its graphic design guidelines. 

7. Expiry date

7.1. Pharmac prefers the expiry date to be clearly visible and where printed to be printed in indelible ink.

8. Space for a dispensing label and machine readable codes

8.1. For packaging designed to be used by the patient, Pharmac prefers a clearly designated space for affixing a patient label (where space allows).

8.2. Pharmac prefers that there are space allowances for machine readable codes and that the information contained within the machine readable code includes:

8.2.1. product information

8.2.2. batch number

8.2.3. expiry date

8.2.4. GTIN

Please note the Health Information Standards Authority (HISO) has endorsed the use of GS1 Standards for machine readable codes for pharmaceuticals(external link).

9. Blister containers

9.1. Pharmac prefers that every two blister pockets include the generic name, trade name (if any), pharmaceutical form and the strength of the pharmaceutical.

9.2. Where blisters are small, Pharmac prefers generic name, trade name (if any), pharmaceutical form and the strength of the pharmaceutical appear in repetitive diagonals.

9.3. Pharmac prefers that the expiry date and batch number appear at both ends or on the side of each blister.

10. Ampoule or vial containers

10.1. Pharmac prefers labelling on containers of single dose injectable preparations to have the strength appear prominently as total quantity of the active pharmaceutical substance per total volume in container. The concentration (quantity of active pharmaceutical substance per one mL) should be indicated immediately below the strength less prominently (where space allows). See example, figure 2, below.

10.2. Pharmac prefers that labelling on containers of multi-dose injectable products, such as insulin, express strength as strength per unit volume only, e.g. units/mL or mg/mL.

10.3. Pharmac prefers that labelling of ampoules and small vials to have information presented longitudinally along the length of the container.

10.4. Pharmac prefers where glass or clear plastic labelling is used key information needs to be clearly distinguishable. For example by inverting the text colour of this information to provide greater contrast.

11. Other considerations

Pharmac takes a pragmatic approach when considering a pharmaceutical for funding. Pharmac and its clinical advisors may have additional preferences not covered in this document and there may also be some instances where the stated preference is not appropriate for some pharmaceuticals.