Establishment of the PHARMAC labelling preferences for prescription pharmaceuticals
PHARMAC has established ‘PHARMAC labelling preferences for prescription pharmaceuticals’.
This was the subject of a consultation letter dated 30 June 2015. In summary, the decision is that:
- PHARMAC will have preferences for naming and labelling of pharmaceuticals it is considering for funding.
- These naming and labelling preferences are voluntary, and PHARMAC will use these preferences within the context of its wider decision-making framework when considering medicines for listing in the Pharmaceutical Schedule.
- PHARMAC will continue to consider naming and labelling alongside all other relevant considerations, for example costs and savings, health needs, health benefits, suitability, securing supply, and benefits associated with harmonisation with other jurisdictions.
- PHARMAC does not intend to apply these preferences retrospectively to products that are currently listed. However, should currently listed products be re-evaluated, for example following a new procurement process, the preferences will apply.
PHARMAC labelling preferences for prescription pharmaceuticals [PDF, 267 KB]
Full text of notification - Establishment of the PHARMAC labelling preferences for prescription pharmaceuticals [PDF, 206 KB]
PHARMAC decided on establishing its labelling preference in June 2016. In doing so PHARMAC also decided that these preferences would undergo a review at such a time PHARMAC considers necessary. PHARMAC intends to keep its preferences aligned with the governing legislation. In the event that the governing legislation adopts or conflicts with the PHARMAC preferences, PHARMAC intends to make the appropriate changes.
These preferences are separate from requirements set out in legislation and regulations. We’re confident they are consistent with regulatory requirements. But if inconsistencies arise, then regulatory and legislative requirements (including those that might occur in future) take precedence.
Details of the decision
As part of our Annual Tender evaluation process, PHARMAC seeks advice from the Tender Medical Evaluation Subcommittee (TMESC) of PTAC and other clinical advisers, who review samples and consider whether these pharmaceuticals would be suitable for Sole Subsidised Supply and Hospital Supply Status. During this process the TMESC frequently identifies the same or very similar issues with the suitability of pharmaceutical packaging, naming and labelling for different products every year. As a result of this, PHARMAC considers that the establishment of a labelling guidance document would provide suppliers with clarity on naming and labelling considerations and ensure a consistent approach to reviewing pharmaceuticals.
These preferences would be used in the review of Tender samples as well as other pharmaceuticals being considered for funding. The labelling preferences will be published on the PHARMAC website under the Tools & resources tab and linked in the Information for Pharmaceutical Suppliers section.
Feedback received
We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by PHARMAC were considered in their entirety in making a decision on establishing the preferences. Most responses were supportive of the proposal. Issues raised and PHARMAC comment can be found below.
Clinical responses- refer to those responses submitted by health care professionals, District Health Boards and health care professional representative organisations.
Industry responses- refer to those responses submitted by pharmaceutical suppliers and pharmaceutical supplier representative organisations.
Other responses- any responses which do not fall within the above two categories.
Themes/Preference |
Submission content |
PHARMAC response |
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Support for the establishment of PHARMAC pharmaceutical labelling preferences. |
The majority of supportive responses were from health care professionals and their representative organisations. Responses which supported the initiative:
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We consider the establishment of the PHARMAC labelling preferences for prescription pharmaceuticals would:
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Responses against the establishment of PHARMAC pharmaceutical labelling preferences. |
The majority of responses that were not supportive were from pharmaceutical suppliers and their representative organisations. Responses which did not support the initiative:
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As part of our review processes PHARMAC seeks advice from the Tender Medical Evaluation Subcommittee (TMESC) and other clinical advisers on suitability of pharmaceuticals including naming and labelling. We consider it is important to identify known preferences so pharmaceutical suppliers developing labelling are making an informed decision about labelling of products intended for the New Zealand subsidised market. We will work alongside the Ministry of Health including Medsafe to ensure that our preferences are aligned with current and future legislation. Should there be any inconsistencies between PHARMAC’s preferences and regulatory requirements, the latter will take precedence. The PHARMAC naming and labelling preferences are voluntary. The naming and labelling of pharmaceuticals will not be considered in isolation. We will always consider pharmaceuticals for funding in the context of meeting our statutory objective and all other relevant considerations such as costs and savings, health needs, health benefits, suitability, securing supply, and benefits associated with harmonisation with other jurisdictions. |
Clarification on use of the labelling preferences |
Clarification was sought on
Clarification suggestions
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We have added a preamble to the preferences document to outline how these preferences would fit into PHARMAC decision making.
Preferences would apply to all labelling, innovator and generic. PHARMAC has not taken a position on naming conventions on biologics/biosimilars at this stage. The International Medication Safety Network (IMSN) 2013 Position Statement(external link), that these preferences have largely been adopted from, outlines naming and labelling issues further in its background section. At this stage the preferences cover those factors which most frequently cause concern to us and our clinical advisers, some of which have been fed back from prescribers, dispensers and those administering pharmaceuticals. |
Preference 1- International non-proprietary names (INNs)
1.1. PHARMAC prefers that proprietary (trade) names for pharmaceuticals are derived from INNs (generic names). 1.2. Where the trade name is the INN name in combination with the company name as an identifier, PHARMAC prefers: 1.2.1. The company name to be a suffix 1.2.2. The company name to be written in full to avoid confusion with formulation type. For example, `ibuprofen-companyx’ not ‘ibuprofen-com’
It is expected that with two exceptions (adrenaline and noradrenaline) the INN will be used on medicine labels in the New Zealand market. PHARMAC recommends the New Zealand Universal List of Medicines (NZULM) be consulted when designing a pharmaceutical name. |
Clinical responses
Industry responses
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Preference outlined in 1.1 was the opposite of its intended meaning due to a typographical error that excluded the word ‘not’ in the sentence. This has been amended in the preferences. There is international movement away from country-specific terminology. It is expected that with two exceptions (adrenaline and noradrenaline), the INN will be used on medicine labels in the New Zealand market, this does not exclude the use of AAN but outlines the future direction of pharmaceutical naming. PHARMAC has not taken a particular position on naming conventions on biologics/biosimilars at this stage. We have decided to remove the preference for the company name to appear as suffix as a result of feedback. However, for products where the trade name is the INN name in combination with the company name as an identifier, PHARMAC prefers the company name to be written in full to avoid confusion with formulation type. |
2. Umbrella naming An umbrella segment is a section of a proprietary (trade) name that is used in the name of more than one pharmaceutical to create a brand for a range of products. Current best practice discourages the use of umbrella naming.
2.1. PHARMAC prefers that suppliers develop new proprietary (trade) names or use the full INN name. PHARMAC recommends suppliers familiarise themselves with the approach taken by Medsafe outlined in its guideline. |
Clinical responses
Industry responses
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Our preference is that suppliers develop new trade names or use the full INN name. Suppliers who wish to use umbrella names should follow the Medsafe guideline for these. |
3.1. Pharmaceutical name. The name of the pharmaceutical should include both the generic name and the propriety (trade) name (where applicable).
3.1.1. PHARMAC prefers that the generic name appears prominently alongside the proprietary (trade) name (if any). 3.1.2. PHARMAC prefers that the generic name appears prominently on at least three non-opposing faces of the outer packaging. |
Clinical responses
Industry responses
Other responses:
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We consider that generic names should appear prominently but being too descriptive, such as having a specified font size or a generic name being ‘larger’, does not allow for flexibility where a product could have its overall readability compromised. Examples of this include pharmaceutical products with multiple active pharmaceuticals or products with small containers. Feedback also suggests the importance of the trade name in distinguishing between products. We have decided not to elaborate this preference to the generic name having equal or greater prominence than the trade name as a result of feedback. We consider the addition of a preference for the generic name and trade to be spatially close and not be separated by intervening matter to be appropriate. This has been added to the PHARMAC preferences. We consider that there are numerous design elements that help distinguish between different products. A link to the Health Quality and Safety Commission (HQSC) report on Tall Man lettering has been added. We consider that selection error can occur between different pharmaceutical products, and this can occur regardless of whether there are one or more brands of a particular pharmaceutical in the market. |
3.2.1. PHARMAC prefers that dose strength and pharmaceutical form be given due prominence and be included in all labelling and packaging components where the generic name appears. |
Industry response
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We note that there may be instances where including strength and dose form on all labelling and packaging components where the generic name appears may not always be possible due to space constraints. However, this is still a preference. |
3.2.2 PHARMAC prefers that the pharmacopoeia standard terms be used for pharmaceutical form. These should include standard expression for long acting dose forms.
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Clinical responses
Industry response
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This preference was originally adapted from the International Medication Safety Network (IMSN) 2013 Position Statement.(external link) However, what constitutes a “standard term” in New Zealand will require further investigation. As such we have removed this preference. |
3.2.3 PHARMAC prefers that the formulation type be written in full on labelling |
Industry response
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The intended purpose of this preference was to encourage suppliers to not use abbreviations for formulation type such as “PR” but instead write this out in full “prolonged-release”. An example has been added to the preferences for clarity.
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3.2.4 PHARMAC prefers that strength is not represented in percentages, e.g. %w/w and %w/v
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Clinical responses
Industry response
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We have amended this preference as a result of concerns raised during consultation. The preference now states: 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. We consider that this provides an element of familiarity with well-established practice of using percentages or ratios to represent strength in some products whilst introducing a more consistent way to display strength in general.
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3.2.5 PHARMAC prefers that the strength of single dose injectable and liquid preparations should be stated as the total quantity of the active pharmaceutical substance per total volume and per mL. If the volume in the container exceeds 1mL, the concentration (quantity of active pharmaceutical substance per one mL) should be indicated immediately below the strength, either in brackets or in less prominent letters.
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Single-dose injectable and liquid products Clinical responses
Other responses
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The PHARMAC preferences are reflective of clinical responses received. We have added in a supplementary sentence: ‘Where space allows use different terminologies for strength as total quantity of active pharmaceutical per total volume (in each container) or total quantity of active pharmaceutical per mL. For example each 5 mL ampoule contains 100 mg (20mg/mL) or 100 mg in 5mL (20 mg/mL).’ to the preferences and has reflected this in the graphic examples. |
Multi-dose injectable products Clinical responses
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We have clarified the preferences for multi-dose injectable products included this in the preferences document We have removed the graphic for multi-dose injectable products from these preferences to reduce the document size. Suppliers can access it via the link to the National Patient Safety Agency (England and Wales) Design for patient safety: a guide to the labelling and packaging of injectable medicines document provided in the labelling preferences. We have included adapted graphics showing other preferences in its place. |
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Multi-dose oral liquids Clinical responses
Other responses
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We have added the following preferences for multi-dose oral liquids: 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. These preferences are reflective of the majority of clinical responses received. However, any significant changes to labelling should be carefully managed |
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Unit of measure Clinical responses
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We agree that where possible strength should be depicted on labelling using the same unit of measure used when prescribed. This has been noted in the PHARMAC preferences. |
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General points Industry responses
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The preferences are intended for general guidance. Any changes to current practice would need to be considered on a case by case basis. The preferences outline that there may also be some instances where the stated preference is not appropriate for some pharmaceuticals. |
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Suggestion- PHARMAC should consider a preference for the expression of the salt and base strengths on the label |
Clinical responses
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We have added a preference which outlines that the expression of salts, hydrates and solvents are represented on the label consistently with what is currently in the market for that pharmaceutical. PHARMAC has recommended the NZULM be consulted in the first instance. |
3.3. Route(s) of administration
3.3.1. PHARMAC prefers that positive messages be used to describe route of administration, such as “give by…”
3.3.2. PHARMAC prefers that negative statements, such as “not for … use”, be avoided. |
Clinical responses
Industry responses
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We have amended preferences for routes of administration as a result of feedback. Instead of avoiding the use of negative statements, PHARMAC prefers, where space allows, that a positive message precedes any negative statement. |
3.4. 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.
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.
3.4.1. In addition to these warning statements, PHARMAC prefers that 3.4.1.1. cytotoxic drugs have “cytotoxic” clearly identifiable on packaging 3.4.1.2. neuromuscular blocking agents have “warning: paralysing agent” 3.4.1.3. penicillin products have “contains penicillin”. 3.4.1.4. Oral methotrexate products have “usually taken once a week”. |
Clinical responses
Industry responses
Other response
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We have amended our preference relating to Specific Warnings as a result of feedback. Instead of outlining preferences for specific products PHARMAC has made this preference more general: 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). |
4.1. PHARMAC prefers that mandatory information required on the packaging does not obscure the essential information as noted above.
Medsafe has provided a comprehensive guideline on the minimum requirements for labelling. |
Industry response:
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The intention of this preference was to emphasise that essential information for the safe use of the pharmaceutical should not be obscured by other information, for example manufacturer’s addresses. |
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.
5.1. PHARMAC prefers that the HQSC-preferred term is used in labelling where space allows. |
Clinical response:
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The HQSC document provides an appropriate reference and includes the error-prone abbreviations, symbol and dose designations specifically mentioned in feedback received a long with other less common error prone abbreviations, symbol and dose designations. |
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.
6.1. PHARMAC prefers that when designating different colours between strengths there is no pattern in the colour scheme in the labelling.
6.2. PHARMAC prefers that colour differences between strengths 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.
There are a number of sources of best practice guidelines for colouring on packaging. The National Patient Safety Agency (England and Wales) has provided a series of useful design examples in its graphic design guidelines. |
Clinical responses
Industry responses
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We have the following preferences as a result of this feedback and clinical advice received:
A supplementary sentence outlining colours look different in different lighting conditions; people have different perceptions of colour; and colour blindness means some people see colours differently has been added. An amendment has been made to preference 6.2.3 to outline that the colour difference needs to be clearly identifiable when the product is alongside other pharmaceuticals from the same manufacturer/supplier. We agree that colour difference should not be the only way to distinguish between products and have reflected this in the accompanying paragraphs. The ASTM international standards D4774 ‘Standard Specification for User Applied Drug Labels in Anesthesiology’ relates specifically to the labelling of unlabelled syringes filled by users or their agents to identify drug content. There are a number of organisations that have voiced concerns on the use of this coding system on commercial pharmaceutical products and over relying on colour-classification systems. Creating any shortcut for identifying a pharmaceutical without having to thoroughly read the label can lead to mistakes. The PHARMAC preferences should not reference the ASTM international standards D4774 as the preferences are intended for commercial products. |
7. Braille 7.1. PHARMAC prefers the use of braille on packaging |
Clinical responses
Industry responses
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This preference has been removed as a result of feedback. |
8. Expiry date 8.1. PHARMAC prefers expression of the expiry date as an exact date or otherwise add the words “use before”. |
Clinical responses
Other responses
Industry responses
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As a result of feedback we have removed the preference for the expression of the expiry date. We note there are multiple acceptable ways to express expiry date. Where the expression of expiry date is deemed unacceptable this could be addressed on a case by case basis. We have added a preference for the expiry date to be clearly visible and where printed to be printed in indelible ink. |
9. Space for a dispensing label and machine readable codes 9.1. For packaging designed to be used by the patient, PHARMAC prefers a clearly designated space for affixing a patient label.
9.2. PHARMAC prefers that there are space allowances for machine readable codes and that the information contained within the machine readable code includes: 9.2.1. batch number 9.2.2. expiry date 9.2.3. Global Trade Item Number (GTIN). |
Clinical responses
Industry responders
Other responses
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These preferences are voluntary
Space to put the pharmaceutical label is desirable but not always practical so we have added ‘where space allows’ to this preference. This preference is for packaging designed to be used by the patient. We have added a link to the Health Information Standards Authority (HISO) endorsement for GS1 Standards. |
10. Blister containers 10.1. PHARMAC prefers that each blister pocket include both the generic name, proprietary (trade) name (where applicable), and the strength of the pharmaceutical.
10.2. Where blisters are small, PHARMAC prefers repetitive diagonal use of generic name and strength over the blister covers with expiry date and batch number on the side to assist with identification of partly used packs. |
Clinical responses
Industry responses
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As a result of feedback we have amended this preference, to have the information outlined over every two blister pockets rather than every pocket. We have also outlined a preference for the expiry date and batch number to appear at both ends or on the side of each blister. |
11. Other considerations
PHARMAC takes a pragmatic approach when considering a pharmaceutical for funding. PHARMAC and its clinical advisers may have additional preferences not covered in this document, however these would be advised on a case by case basis. |
Industry response
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A preamble has been included in the preferences which outlines where these preferences sit in PHARMAC decision making. The naming and labelling preferences are voluntary, and we will use these preferences within the context of our wider decision making framework when considering medicines for listing in the Pharmaceutical Schedule. The preferences aim to provide guidance and transparency on PHARMAC’s naming and labelling preferences. Some preferences are only identified on a case by case basis and there are also instances where the preference may not be suitable for some pharmaceuticals. The preferences address the most common naming and labelling issues that PHARMAC encounters, and PHARMAC’s preferred approach. |
Suggestion - PHARMAC should consider a preference for Storage Conditions |
Clinical response
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Preferences have been added relating to storage conditions as a result of feedback. |
Suggestion - PHARMAC should clarify which of the labelling preferences apply to external packaging and which apply to containers such as ampoules or vials |
Responses noted that:
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We have added preferences for ampoules and vials along with a graphic example adapted from the National Patient Safety Agency (England and Wales) Helen Hamlyn Research Centre. Design for patient safety: A guide to the labelling and packaging of injectable medicines (2008). |
Suggestion - Packaging should have a tick box to use when a pack has been opened |
Clinical response
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This may be useful, however this has not be raised by the TMESC or other clinical advisers. We consider the focus should remain on the things that would most improve patient safety. |
Suggestion - Preference for accurate labelling of products which contain common allergens |
Clinical response
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Patients with severe allergies to any excipient should be consulting their healthcare professional prior to using any medication and should not be relying solely on the labelling of products, particularly as a number of products are not dispensed in original packaging.
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Suggestion - Further thought should be given to ensuring a balance between plain language for consumers/public and clinical language for clinicians. |
Clinical responses
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There is always a balance between providing the information which enable health care professionals to prescribe, dispense and administer to patients accurately and safety and what a patient would want to see on labelling. We consider that a lot of the issues raised regarding consumer information is much broader than the scope intended for these preferences and while important, does not consider these should or can be addressed through these PHARMAC preferences. |
Suggestion - Addition of more consistent information on the packaging regarding the condition/s a particular drug is indicated for. |
Clinical response
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Healthcare professionals who prescribe and administer pharmaceuticals are best placed to inform patients about the pharmaceuticals’ therapeutic purpose for them personally. A number of products have multiple indications and often patients do not receive their medicines in the commercial pack. We consider that the labelling of pharmaceuticals should not be the primary source of this information for patients. |
Feedback received outside of the Scope of this consultation
Themes/Preference |
Submission content |
PHARMAC staff consideration and view |
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Pack sizes |
Clinical response
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Pack size is one of a number of important factors that are considered when assessing the suitability of pharmaceuticals. For the purpose of these preferences we do not consider pack size to be within the scope. |
The preferences should be added to the requirements for vendors of pharmacy IT programmes (Lots & Toniq) to have this built into the IT system |
Clinical responses
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This sits outside of the scope of this consultation. |
Product specific feedback |
Clinical responses
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The preferences are intended as a more general guide. PHARMAC has noted the feedback. |
More information
If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.