R13/272171 VERSION 4

Outcomes of the External Reference Group Meeting 18 February 2013

Location: Conference Room 1 Therapeutic Goods Administration Symonston

Attendees:

Stakeholder organisation / Representative
Council on the Ageing (COTA) / Ms Josephine Root
Generic Medicines Industry Association of Australia (GMiA) / Ms Belinda Wood
Dr Greg Pearce
Pharmacy Guild of Australia (PG) / Ms Anne Develin
Pharmaceutical Society of Australia (PSA) / Ms Kay Sorimachi
Australian Self-Medication Industry (ASMI) / Mr Steve Scarff
Medicines Australia (MA) / Ms Elizabeth de Somer
Ms Kayla Calladine
Royal Australasian College of Physicians (RACP) / Assoc/Prof Shane Carney
Australian Commission on Safety and Quality in Health Care (ACSQHC) / Ms Margaret Duguid
Medsafe / Ms Sarah Reader
National Medicine Policy (NMP) / Prof Andrew McLachlan
Consumers Health Forum (CHF) / Ms Anne McKenzie
Complementary Healthcare Council (CHC) / Ms Emma Burchell
Pharmaceutical Defence Limited (PDL) / Mr Albert Regoli
“Smart Packs” / Mr Steve Cohen
National Prescribing Service (NPS) / Dr Danielle Stowasser
NSW CEC (Clinical Excellence Commission) / Mr Daniel Lalor
NSW PIC (Poisons Information Centre) / Mr Jared Brown
CATAG (Council of Australian Therapeutic Advisory Groups) / Mr Steve Morris
Society of Hospital Pharmacists of Australia (SHPA) / Ms Natalie Bula
TGA National Manager / Dr John Skerritt
Head Market Authorisation Group / Ms Judy Develin
Office head (Office of Medicines Authorisation) / Dr Peter Bird
Project Manager / Ms Suzanne Swensson
Meeting Facilitator (Chair) / Emeritus Professor Lloyd Sansom
Office Head (Office of Scientific Evaluation) / Dr Mark McDonald
Director Committee Support Unit (TGA) / Ms Kylie Barsley
Office Head ( Office of Complementary Medicines) / Ms Trisha Garrett
TGA Chief Medical Officer / Dr Anthony Hobbs
DoHA Assistant Secretary Pharmaceutical Policy Branch PBD / Mr StephenWaldegrave
(morning only)
DoHA Director National medicines Policy / Mr Adrian White
(afternoon only)

Background:

The Labelling and Packaging review is primarily concerned with the presentation of the information on the medicine containers or on the boxes within which they are supplied. Of particular interest are the visual aspects that contribute to the usability of the information provided and facilitate the safe use of the medicine by health care professionals and consumers.

The key issues to be addressed by this review were determined through collation and analysis of previous consultations with key stakeholders on proposed updates to the legal instrument specifying labelling and packaging requirements for medicines in Australia, Therapeutics Goods Order 69 (TGO 69).

The objective of the review of the requirements for medicine labels and packaging is to develop appropriate regulatory solutions that effectively address the consumer safety risks posed by the following issues:

  • information about the active ingredient(s) contained in the medicine is not always easy to find;
  • use of the same brand name for a range of products with different active ingredients resulting in look-alike medicine branding (this is known as brand extension or trade name extension);
  • medicine names that look-alike and sound-alike that can lead to use of the incorrect medicine;
  • medicine containers and packaging that looks like that of another medicine;
  • lack of a standardised format for information included on medicines labels and packaging;
  • dispensing stickers that cover up important information;
  • information provided on blister strips;
  • information included on small containers;
  • information provided in pack inserts.

However, it is recognised that any changes to be implemented must be affordable by industry and not undo positive aspects of product familiarity with names and packaging that patients have (i.e. association of product names with indications and packaging colours). For example, the trade name “Valium” has a long association with being a prescription anxiolytic and “Panadol”, with the accompanying green red and white packaging, an OTC analgesic.

A consultation paper released in May 2012 sought comments on recommendations to change the presentation of information on the labels and packages of medicines. In response to the consultation, 110 submissions from interested stakeholders were received. The submissions were made by individual consumers, consumer representative groups, health care professionals and their organisations, academics and industry. An initial analysis identifying the key issues raised in the submissions as well as the proposed next steps was published on the TGA website. In January 2013, a document “Labelling and packaging practices: A summary of some of the evidence” was also published on the TGA website.

As part of further consultation with stakeholders, a meeting of the External Reference Group was held on 18 February 2013 to discuss possible changes to the labelling and packaging for prescription and non-prescription (registered over-the-counter and registered complementary) medicines. An optionspaper was prepared which formed the basis of the discussion at the External Reference Group meeting. The options,presented below, were based on submissions to the Labelling and Packaging Review for the consultation process from May to August 2012.

A summary of discussions and their outcomes is below. The discussion assisted in clarifying the views of the participants and the organisations they represented and in focussing options for further development from a list of alternatives down to two or three options. The next steps will be to work with relevant stakeholders to further fine tune options and undertake consumer testing of a limited number of shortlisted label options. Any cost impacts to industry would be taken into account when preparing the Regulation Impact Statement (RIS), which must be completed before any change can be implemented.

Introduction:

The Chair welcomed participants and opened the meeting by noting that labelling and packaging is primarily a quality use of medicines issue. He provided a summary to the background of the Labelling and Packaging Review (as above) and noted that there were two ways by which individualchangesto labelling and packaging requirements could occur, the first by changes tothe legislative basis of the Therapeutic Goods Order (TGO) and the second by industry participants using best practice guidelines that support the quality use of medicines.

Key initial points made in the introduction included:

  • Labelling and packaging of medicines can be improved, for the benefit of consumers and health professionals, in Australia. But it should also be noted that there are in the marketplace labelling and packaging examples that demonstrate good quality use of medicines principles.
  • Labelling and packaging should be considered through the whole life cycle of the product, starting with being part of the drug development program of a company. For consumers, the point of sale, access and use in the home and, if required,appropriate disposal, are all important considerations.
  • There is genuine concern from health professionals and consumers that without mandating particular requirements, avoidable medicines errors and challenges in identifying the substances involved in accidental poisonings and deliberate overdoses will continue to occur in Australia.
  • International harmonisation should also be a consideration, including the upcoming formation of the Australia and New Zealand Therapeutic Products Agency (ANZTPA), when considering labelling and packaging issues.
  • Labelling and packaging should not be considered in isolation as a tool for improving medicines safety. Consumer education is also very important and education programs should be provided to support any labelling and packaging changes to encourage quality use of medicines by consumers.
  • Timeframes for implementation of any changes is noted to be an important issue for industry, with the need for significant periods to enable transition and avoid the need to discard current packaging inventory and to familiarise consumers with changes.
  • Consumers must be central to the final agreed framework but it is recognised that the proposed solutions must be workable and be able to be implemented by industry in the context of their normal business cycles of refreshing product labels.

At commencement of the meeting a letter was tabled from key organisations (including the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT), Pharmaceutical Society of Australia (PSA), Council of Australian Therapeutic Advisory groups (CATAG), Australian Pharmaceutical Science Association (APSA), Australian Medical Association (AMA), Society of Hospital Pharmacists of Australia (SHPA) and the Royal Australian College of Physicians (RACP)) indicating strong support and commitment to specific proposed labelling and packaging changes. This letter is at Attachment A.

A.Active Ingredient Prominence – Prescription and non-prescription registered medicines

Original options proposed

  1. Introduce specific and mandatory requirements for display of active ingredient names

A. Active ingredient name- font size and style

  • The active ingredient MUST be presented as the same size as the brand name;

or

  • The active ingredient(s) MUST be presented in “due prominence” relative to the brand name, consistent with MHRA requirements in the UK[1]. This may be achieved by means including text size, colour, “white space”, bolding or contrasting font;

or

  • The active ingredient must be displayed in font not less than 50% the size of the brand name with a minimum font size of 2 mm.

B. Active ingredient– lettering case

  • Active ingredient names should be presented in all lower case, consistent with the Australian Medicines Terminology (AMT) (Table 144: Appendix A - Capitalisation rules) but noting the need for use of capitalisation in Latin binomials when organisms are the active ingredient.
  • Active ingredient names should be presented with similar prominence and contrast against the background as brand names.

C. Active ingredient - location

  • The active ingredient(s) is to appear in a standardised location on the main panel of a medicine label, immediately above the brand name;

or

  • The active ingredient(s) is to appear in a standardised location on the main panel of a medicine label, immediately below the brand name. Details regarding justification, font style and colour are at the sponsor’s discretion.
  • Where space permits, the brand name and active ingredient(s) should appear on 3 non-opposing faces of a medicine box.

Discussion

The discussion applied to prescription and non-prescriptionregisteredmedicines.

  • Three issues were identified as problems with regards to the active ingredient: prominence, location and size.
  • Consumers and health professionalrepresentatives proposed that the font size of the active ingredient for both prescription and non-prescription medicines should be at least the same font size as the brand name,particularly if there is one ingredient,and be in a standard location. The active ingredient and brand name should also be displayed on the packet on at least three non-opposing sides for prescription medicines but could remain as is for non-prescription medicines.
  • Industry (ASMI) argued that “due prominence”, which is the MHRA requirement, was sufficient for non-prescription medicines, and that use of the same size lettering would decrease the importance of brand recognition and therapeutic indication, potentially creating confusion.
  • Prescription and non-prescription medicines industry representatives considered that harmonisation with overseas jurisdictions to be important, as a large percentage of packages were manufactured overseas for the Australian market.
  • It was noted that the MHRA UK Guidelines specified that the active ingredient should be given “due prominence” which would be generally determined by the relative size of the text but that other factors such as colour of text, the font used and other graphic elements on the pack would be considered. The MHRA UK Guidelines also specify that the information hierarchy is important and critical information should appear in the order stated.
  • The current TGA guidelines also state that active ingredient should have “due prominence” but that this was often not adhered to by manufacturers. Examples of widely differing interpretation of “due prominence” were discussed. It was noted that the US FDA did prescribe a minimum font size for information on medicine labels, including active ingredient name.
  • It was suggested by industrythat mock ups of various size options for active ingredient/brand be tested although several participants indicated that there is already sufficient evidence in the literature and from clinical practice to support equal size for active ingredient/brand name, particularly for products with single ingredients.
  • However, it was acknowledged that there may need fordifferent requirements for medicines with multiple ingredients. A reduction in font size for each active ingredient for products with multiple ingredientsmay be needed if the total size of the active ingredient and brand name are required to be equal.
  • In late 2012, TGA had undertaken to carry out targeted, independent label testing and discussion of the results with stakeholders prior to proposing specific label changes to government.
  • It was noted that any changes should also be accompanied by education programs for consumers.

Outcome of discussions

For prescription and non-prescription medicines:

  • The majority view was that any changes agreed to by government should be specified in the TGO, rather than as guidelines.
  • The majority view was that for products containing a single ingredient,the brand name and the active ingredient must be at least equal in font size and prominence.
  • The majority view but not unanimous was that for products containingtwo or three active ingredients the space shared by the active ingredients should be the same size as the brand name.
  • The majority but not unanimous view was that these practices should apply for both prescription and registered over-the-counter (OTC) medicines.
  • Several issues remain to be resolved:
  • Font styles for active ingredients in OTC non-prescription medicines should be in black sans serif font, lower case, consistent with Australian Medical Terminology (AMT) and consistent with the current TGA Best Practice Guideline on Prescription Medicine Labelling.
  • Font styles for trade names could incorporate colours and designs and not have limitations on font style of capitalisation, to provide continued brand recognition.
  • Achievement of equal prominence.
  • For products containing more than three active ingredients, the current TGO requirements should apply i.e. the names can be included on a side or rear panel or side or rear label of the primary pack.
  • There should be a consistent approach to the location of the active ingredient with respect to the brand name i.e. above or below the brand name.(The active ingredient name is currently placedunder the brand name for prescription medicines).
  • It was felt that a consistent approach should be applied to registered OTC medicines, with the active ingredient name appearing close to the trade name and in a consistent position. There was the need to determine the hierarchy for display of the information including symptoms/ indications for non-prescription medicines. It is recognised that the symptoms/indications was an important part of the process of consumer self-medication choice.
  • Consumer testing will be required to assess the impact of these options.
  1. Introduction of specific requirements for generic medicines

Original options proposed

  • New generic medicines be marketed only by the active ingredient, i.e. no brand name. Product differentiation will be achieved using the sponsor’s name. For example:“amoxycillin- Chemist Brand”;

or

  • Maintain the ability for brand names to be nominated by generic sponsors, but require that the sponsor name MUST NOT be included as a prefix before the active ingredient to create a brand name. (Rationale: Due to the use of drop down menus for electronic prescribing and the way medicines are stacked on pharmacists’ shelves, this practice creates a heightened risk of medicine confusion).

Discussion

The discussion applied only to prescription medicines.

  • It was noted that the UK does not allow brand names for generic medicines. On the packaging, the active ingredient is followed by the strength then the manufacturer’s name.It was also noted that doctors prescribe generically in the UK.
  • Generic medicines industry representatives requested that sponsors have the option of choosing a brand name. However it was acknowledged that choosing a brand name for generic products wassometimes difficult and was often rejected by the TGA because the name was considered inappropriate or unsuitable. Industry thought that in time the naming of generics may decrease due to this difficulty. Generic industry considered that by having the choice of brand name that this would allow a more level playing field for generic companies with innovator companies.
  • There was discussion about removing the brand name of innovator medicines once a generic medicinebecame available, but this was not considered practical as both patients and doctors recognise their medicines by brand, and generic prescribing is not as widely embraced in Australia as it is in the UK, particularly in private GP practice. It was also noted by industry that sponsors of innovator medicines consider a brand name to be an important factor in product recognition and use, and that this was agreed by many at the meeting.
  • There was also discussion about how the potential removal of brand names for generics would affect electronic prescribing and dispensing software and whether this may provide difficulties in choosing the right product and also create problems with respect to brand substitution. It was noted that some patients may be prescribed a particular brand of medicine (e.g. for the treatment of epilepsy), which may be either an innovator or generic medicine, and if there was no brand name, this may result in another brand being substituted,which might not be appropriate for some patients.
  • The issue of placement of active ingredient either above or below the brand name was not a big issue for consumers,so long as placement was consistent.
  • There was discussion whether the size of the lettering for the active ingredient should be larger than the brand name for generic medicines but the group considered that the preferred option should be that the active ingredient name be “at least” the same size as the brand name and specified as such in the TGO.
  • There was general agreement that company acronyms such as prefixes and suffixes should not be used as it confuses patients and prescribers and may potentially cause errors when using electronic prescribing. However, this is integral to some generic companies’ long-established branding practices and further discussion may be required.
  • It was noted that the UK had an accepted list of suffix abbreviations, such as those used for longer acting medications e.g. controlled release, sustained release, and the group considered that any list available in Australia should be consistent with international requirements.

Outcome of discussions

For prescription medicines only: