Establishment of PHARMAC labelling preferences

Purpose

PHARMAC is seeking feedback on the development of pharmaceutical labelling preferences (PHARMAC labelling preferences).

By establishing PHARMAC labelling preferences, we aim to:

  • support the Ministry of Health to reduce preventable harm from medication errors and improve patient safety;
  • provide guidance and therefore transparency to suppliers on PHARMAC’s labelling preferences when considering a pharmaceutical for funding;
  • ensure a consistent approach to the assessment of pharmaceutical labelling when reviewing samples, particularly during our tender processes; and
  • align with international best practice.

PHARMAC would work alongside the Ministry of Health, including Medsafe, to ensure its labelling preferences align with any new regulatory requirements. The Ministry is currently developing a new regulatory regime for therapeutic products, following the decision to cease efforts on the Australia New Zealand Therapeutic Products Agency (ANZTPA). This new regime could result in changes to labelling requirements.

PHARMAC considers that labelling developed in accordance to these preferences would be of particular benefit to dispensers and prescribers, who are frequently exposed to the original packaging. The PHARMAC labelling preference would be considered alongside PHARMAC’s other Operating Policies and Procedures and matters for evaluation.

The preferences proposed cover those factors which most frequently cause concern to PHARMAC and its clinical advisors. Additional labelling concerns and preferences would be addressed on a case by case basis.

Establishment of PHARMAC labelling preferences [PDF, 108 KB]

Proposed PHARMAC labelling preferences: draft document for feedback [PDF, 193 KB]

Providing feedback

We are interested in your views on what should be included in the PHARMAC labelling preferences. Please use the following questions to help guide your feedback.

  • Are there any aspects of the proposed preferences which are unclear or could lead to confusion?
  • PHARMAC is considering whether to elaborate on its labelling preference 3.1.1, and state that it would prefer the generic name to have equal or greater prominence than the trade name, for example, by having the generic name appear in a larger and/or bolder font. This would need to be considered with overall readability on a case-by-case basis. Are there any concerns with this elaborated preference?
  • PHARMAC is considering whether to include a preference for the primary strength representation for other liquid formulations. Are there any concerns or exceptions to this being the total quantity of the active pharmaceutical substance per total volume and per ml?
  • Are there other safety warnings not outlined in the Act or Regulations that PHARMAC should consider stating a preference for?
  • Are there other preferences which PHARMAC should consider in developing its labelling preferences for pharmaceuticals?
  • Are there any concerns in this approach or particular situations that should be exceptions to these preferences?

How to give feedback

Please provide feedback by answering the questions that follow, or by providing any other views or information to us. We would prefer this feedback to be in writing.

Give feedback - respond to this consultation online [link no longer available]

Or send your feedback to:

Chloe Dimock
Tender Analyst
PHARMAC
PO Box 10 254
Wellington 6143

Email: consult@pharmac.govt.nz
Fax: 04 460 4995

Your feedback should be provided to PHARMAC by 4 August 2015.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

Background

PHARMAC runs competitive processes whereby one single brand becomes the Sole Subsidised Supply (SSS) brand and/or Hospital Supply Status (HSS) brand.

One of the largest procurement activities PHARMAC runs is the annual Invitation to Tender (Tender). The Tender is released in November every year and pharmaceutical suppliers bid for SSS and/or HSS of around 400-600 pharmaceutical presentations.

As part of its evaluation of the bids received, PHARMAC seeks advice from its Tender Medical Evaluation Subcommittee of The Pharmacology and Therapeutics Advisory Committee (TMESC) and other clinical advisors. TMESC and other clinical advisors review samples and consider whether these pharmaceuticals would be suitable for SSS and HSS. Suitability of a pharmaceutical is the practicality and appropriateness of a pharmaceutical given its use/s in the New Zealand community and/or hospital markets as advised by PHARMAC’s clinical advisors. This includes whether the packaging and presentation is appropriate and whether there are any presentation issues with the pharmaceutical.

Every year, the TMESC identifies similar concerns with the suitability of pharmaceutical packaging and labelling. The most common concerns are:

  • Visibility of the international non-proprietary (generic) name being poor.
  • Expression of formulation type being confusing.
  • Expression of concentration being confusing.
  • Use of error-prone abbreviations, symbols and dose designations in packaging and labelling.
  • Visibility of routes of administration and use of negative statements instead of positive statements to describe these.
  • Poor use of colour to differentiate between strengths of pharmaceuticals due to the use of a similar tone or hue.
  • Visibility and use of warning labels.

PHARMAC considers that the establishment of PHARMAC labelling preferences would provide suppliers with clarity on labelling considerations and ensure a consistent approach to reviewing pharmaceuticals. This would also enable suppliers to pre-empt these particular issues when designing labelling and packaging.

These preferences would be used in the review of tender samples as well as other pharmaceuticals being considered for funding.

Context

The primary purpose of pharmaceutical labelling and packaging is to provide clear unambiguous identification of the pharmaceutical and the conditions for its safe use. Safe use of pharmaceuticals depends on end users interpreting labelling and packaging accurately and being able to assimilate and act on the information presented.

PHARMAC considers the guidelines described in the International Medication Safety Network (IMSN) 2013 Position Statement (external PDF)(external link) should largely be adopted. This document has collated published documents on guidance for safe design of pharmaceutical labels and packaging from around the world, including guidelines developed by the Medicines and Healthcare products Regulatory Agency (MHRA-UK), National Patient Safety Agency (NHS) and the United States Food and Drug Administration (FDA).

PHARMAC appreciates the New Zealand market is small on a global scale and considers the use of harmonised packaging with other global markets is desirable. PHARMAC would continue to take a pragmatic approach when considering products for funding.

The proposed preferences have not adopted the IMSN document in its entirety as not all of the guidelines can/should be applied to all pharmaceuticals all of the time.

These preferences have been primarily developed for medicines. At this stage these preferences do not extend to medical devices being considered by PHARMAC for funding.

Proposed PHARMAC labelling preferences

This document provides guidance on the naming and labelling preferences of PHARMAC and its clinical advisors when reviewing a pharmaceutical for funding. The preferences in this document address the issues with labelling that cause the most concern to PHARMAC, and PHARMAC’s preferred approach to these.

These preferences are in addition to, and intended to be consistent with, labelling requirements set out in the Medicines Act 1981, the Medicines Regulations 1984 and Medsafe’s guideline below. In the unlikely event of an inconsistency between PHARMAC’s preferences and regulatory requirements, the latter takes precedence.

PHARMAC recommends applying best practice concepts when designing labelling.

Legislation relating to the labelling of pharmaceuticals

The following legislation currently governs the labelling of pharmaceuticals (medicines, including controlled drugs used as medicines) and related products supplied in New Zealand:

  • Medicines Act 1981
  • Medicines Regulations 1984
  • Misuse of Drugs Regulations 1977

Pharmaceutical labelling must comply with the Guideline on the Regulation of Therapeutic Products in New Zealand: Part 5: Labelling of Medicines and Related Products(external link).

Naming

Particular care must be taken when designing a pharmaceutical name. Failure to do so can lead to communication and selection error which could cause harm.

  1. International non-proprietary names (INNs)

    PHARMAC supports the World Health Organization’s initiative to protect INNs(external link).
    The use of the INN should be in accordance with the WHO INN guidance(external link).
    1. PHARMAC prefers that proprietary (trade) names for pharmaceuticals are derived from INNs (generic names).
    2. Where the trade name is the INN name in combination with the company name as an identifier, PHARMAC prefers:

      1. The company name to be a suffix

      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)(external link) be consulted when designing a pharmaceutical name.

  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.
    1. 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(external link)

  3. Labelling
    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.

    1. Pharmaceutical name
      The name of the pharmaceutical should include both the generic name and the propriety (trade) name (where applicable).
      1. PHARMAC prefers that the generic name appears prominently alongside the proprietary (trade) name (if any).
      2. PHARMAC prefers that the generic name appears prominently on at least three non-opposing faces of the outer packaging.
    2. Pharmaceutical form and dose/strength/concentration
      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.
      2. PHARMAC prefers that the pharmacopeia standard terms be used for pharmaceutical form. These should include standard expression for long acting dose forms.
      3. PHARMAC prefers that the formulation type be written in full on labelling.
      4. PHARMAC prefers that strength is not represented in percentages, eg %w/w and %w/v.
      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.
    3. Route(s) of administration
      1. PHARMAC prefers that positive messages be used to describe route of administration, such as “give by…”
      2. PHARMAC prefers that negative statements, such as “not for … use”, be avoided.
    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(external link), 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.
      1. In addition to these warning statements, PHARMAC prefers that
        1. cytotoxic drugs have “cytotoxic” clearly identifiable on packaging
        2. neuromuscular blocking agents have “warning: paralyzing agent”
        3. penicillin products have “contains penicillin”.
        4. Oral methotrexate products have “usually taken once a week”.
  4. Other information required by regulation
    1. PHARMAC prefers that mandatory information required on the packaging does not obscure the essential information as noted above. Medsafe have provided a comprehensive guideline(external link) 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(external link) should be considered when designing labelling.

    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.
    1. PHARMAC prefers that when designating different colours between strengths there is no pattern in the colour scheme in the labelling.
    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:
      1. in isolation
      2. in different lighting conditions
      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.
  7. Braille
    1. PHARMAC prefers the use of braille on packaging.
  8. Expiry date
    1. PHARMAC prefers expression of the expiry date as an exact date or otherwise add the words “use before”.
  9. Space for a dispensing label and machine readable codes
    1. For packaging designed to be used by the patient, PHARMAC prefers a clearly designated space for affixing a patient label.
    2. PHARMAC prefers that there are space allowances for machine readable codes and that the information contained within the machine readable code includes:
      1. batch number
      2. expiry date
      3. Global Trade Item Number (GTIN).
  10. Blister containers
    1. PHARMAC prefers that each blister pocket include both the generic name, proprietary (trade) name (where applicable), and the strength of the pharmaceutical.
    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.
  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, however these would be advised on a case by case basis.

Figure 1. Adapted from Recommended best practice design (National Patient Safety Agency, 2008)

Resources used in the development of these preferences

The following resources have been used in the development of the PHARMAC labelling preferences and go into further detail on best practice:

  1. International Medication Safety Network. Position Statement Making Medicine Naming, Labelling and Packaging Safer. Available at: http://english.prescrire.org/Docu/Images/IMSN/IMSN_MakingMedicinesNamingLabelingAndPackagingSafer2013.pdf(external link)
  2. Medsafe New Zealand Medicines and Medical Devices Safety Authority. Guideline on the Regulation of Therapeutic Products in New Zealand Part 5 Labelling of medicines and related products. Edition 1.4 February 2015(external link). 
  3. World Health Organisation. Essential medicines and health products, Guidance on INN. Available at http://www.who.int/medicines/services/inn/innguidance/en/(external link)
  4. World Health Organisation. Essential medicines and health products, Publications: Publishing INN Lists. Available at http://www.who.int/medicines/services/inn/innguidance/en/(external link)
  5. New Zealand Universal List of Medicines. Available at http://www.nzulm.org.nz/(external link)
  6. Medicines and Healthcare Products Regulatory Agency (UK). Best Practice Guidance On The Labelling and Packaging Of Medicines. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/328404/Best_practice_guidance_on_the_labelling_and_packaging_of_medicines.pdf
  7. National Patient Safety Agency (England and Wales) Helen Hamlyn Research Centre. Design for patient safety: A guide to the graphic design of medication packaging. London (2007). Available at: www.nrls.npsa.nhs.uk/resources/collections/design-for-patient-safety/?entryid45=63053
  8. 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. London. 2008. Available at: http://www.nrls.npsa.nhs.uk/resources/collections/design-for-patient-safety/?entryid45=59831
  9. Health Quality and Safety Commission New Zealand. Error-prone abbreviations, symbols and dose designations, May 2012. Available at: http://www.hqsc.govt.nz/assets/Medication-Safety/Alerts-PR/Poster-error-prone-abbreviations-not-to-use.pdf(external link)
  10. Best practice guideline on prescription medicine labelling (published by the Australian Therapeutic Goods Administration November 2005) http://www.tga.gov.au/industry/labelling-pm-best-practice.htm
  11. Guideline on the readability of the labelling and package leaflet of medicinal products for human use (Revision 1 published by the European Commission 12 January 2009) http://ec.europa.eu/health/files/eudralex/vol-2/c/2009_01_12_readability_guideline_final_en.pdf