Packaging and Labelling Report

Community Quality Use of Medicines and Diagnostics Project Achieving Best Practice in the Packaging and Labelling of Medicines:
Report from the National Consumer Workshop
January 2011
Community Quality Use of Medicines and Diagnostics Project Achieving Best Practice in the Packing and Labelling of Medicines: Report from the National Consumer Workshop Contents Introduction to Medicines Packaging and Labelling: Presentations and Panel Discussion ........................................................................................3 The Role of Packaging and Labelling: A Consumer Perspective .........................................3 Packaging and Labelling: An Industry Perspective..............................................................3 What Seniors Want from Packaging and Labelling .............................................................4 Packaging and Labelling: A Self-Medication Industry Perspective......................................5 How Medicines Packaging and Labelling is Regulated by the TGA ....................................6 Summary of Panel and Group Discussion ...........................................................................6 What Consumers Want from Medicine Information and Labels ..............................................7 What kind of information should be featured on labels of medicines? .................................7 How can we overcome problems with the misinterpretation of directions? ..........................8 How can some of the naming and branding issues in medicines be resolved? ......................8 What Consumers Want from Packaging, Design and Presentation ........................................10 How could the design of labels be used to make medicines instructions clearer? ...............10 How can we overcome access issues in the packaging of medicines? ................................10 Would pictures and/or symbols on labels make medicines easier to use?...........................10 Other Issues ..........................................................................................................................12 Provision of Consumer Medicine Information (CMI) ........................................................12 Reviewing Compliance With Current Legal Requirements and Regulations......................12 Consumer Empowerment and Education...........................................................................12 Summary of Recommendations ............................................................................................13 Conclusion ...........................................................................................................................14 Appendix A: Workshop Program ..........................................................................................15
CHF Achieving Best Practice in the Packing and Labelling of Medicines: Report from the National Consumer Workshop January 2011
Introduction The Consumers Health Forum of Australia (CHF) is the national peak body representing the interests of Australian healthcare consumers. CHF works to achieve safe, quality, timely healthcare for all Australians, supported by accessible health information and systems. CHF began working in collaboration with NPS: Better Choices, Better Health (NPS) in 2000 to provide a consumer perspective on issues relating to the quality use of medicines (QUM). Key objectives of the 2010-11 Community Quality Use of Medicines and Diagnostics (CQUM/D) Project include: Provide strategic advice regarding consumer perspectives on QUM issues Support consumers to contribute and participate in NPS Advisory Groups Develop and build diversity around key topical health areas A key element of the current collaboration between CHF and the NPS involves consumer consultation on the packaging and labelling of medicines, including a national consumer workshop. The aim of the national workshop was: To explore consumer views on current packaging and labelling practices To learn what consumers want from packaging and labelling To attain consumer feedback on best practice recommendations. Prior to the workshop, CHF circulated a consumer information and discussion paper, Achieving Best Practice in the Packing and Labelling of Medicines, providing a snapshot of the current literature, research and policy debate surrounding the packaging and labelling of medicines. The workshop engaged consumers from a range of different backgrounds, including representatives of disease specific groups, networks representing older Australians, and culturally and linguistically diverse consumer organisations. The workshop included 23 consumer participants from across Australia. Held in Sydney on Thursday 2 December 2010, the workshop was formally opened by Ms Carol Bennett, CHF Chief Executive Officer, who provided a brief history of consumer issues in packaging and labelling. CHF Project Officer, Maiy Azize, provided workshop participants with the background to the project and an overview of the research included in the consumer information and discussion paper. The workshop was facilitated by Ms Jennifer Doggett. A copy of the program is provided at Appendix A. This report summarises the discussions, key themes and conclusions of the national workshop.
Introduction to Medicines Packaging and Labelling: Presentations and Panel Discussion In the first session, workshop participants were introduced to issues in packaging and labelling. It was explained that packaging refers to the way medicine is stored and dispensed, for example, in blister packs or bottles, while labelling refers to the design and appearance of the medicine, for example, the size of the font and placement of directions. To provide an introduction to the differing perspectives, CHF assembled a panel of presenters to provide an overview of the views of consumers, the medicines industry and the regulator of the industry, the Therapeutic Goods Administration (TGA). Consumers were then invited to ask questions and participate in a group discussion with the presenters. A summary of the presentations and the group discussion is provided below. The Role of Packaging and Labelling: A Consumer Perspective Presentation by Ms Diane Walsh, Consumer Representative Ms Diane Walsh highlighted the importance of medicines packaging and labelling issues for consumers, particularly adverse events associated with medicines packaging and labelling. She described some of her own experiences as a consumer advocate in this area, arguing for improvements in packaging and labelling promoting the quality use of medicines. She presented a number of examples of medicines packaging and labelling and highlighted examples of consumer issues. These included: Storage condition instructions are often too small and cannot be read without glasses. Product names and strengths are not always displayed on the ends of packs, making it more difficult for pharmacists to select the correct medications when they are stacked end-to-end. Brand names are often misleading (for example, Panamax can sound like a stronger dose of paracetamol, but actually has the same strength as standard Panadol). Brand names can bear little relation to medicines or to the active ingredient. The active ingredient is not always clearly identifiable. To address these issues, Ms Walsh made the following recommendations: Mandatory adherence to the Best Practice Guideline on Prescription Medicine Labelling. The Guideline was developed by the TGA, CHF and representatives of industry in 2005, but has remained a voluntary opt-in resource Equal prominence of the name and the active ingredient on the label Provision of sufficient space on prescription medicine labels for the pharmacists dispensing label Mandating certain information, such as storage instructions, that cannot be obscured by the pharmacists dispensing label. Packaging and Labelling: An Industry Perspective Presentation by Dr Brendan Shaw, Chief Executive Officer of Medicines Australia Dr Brendan Shaw welcomed the opportunity to discuss this issue with consumers, and noted that Medicines Australia (MA) was becoming increasingly interested in medicines packaging and labelling issues. Dr Shaw also noted the important role played by packaging and labelling
in consumers use of medicines, and expressed an interest in working with consumers to improve packaging and labelling practices. In order to drive changes in industry practice, Dr Shaw said that any recommendation presented to the industry would need to answer the following four questions: 1. Is this a problem that can be resolved by the industry? 2. Is this a change that most consumers want made? 3. What is the cost of making this change? 4. Where is the evidence to support the need for this change? In response to the naming and labelling issues outlined in the first presentation, Dr Shaw made the following points: There are international conventions on the naming of molecules, which need to be taken into account when naming medicines. There are international trademark and intellectual property issues with which Australia must comply. There are benefits of having multiple identifiable brands of medicines. There are risks associated with undermining branding and standardising packaging. Branding is important to consumers as well as pharmaceutical companies, enabling many consumers to identify medicines. Dr Shaw agreed with the previous speaker that all participants in the supply chain need to be involved in promoting QUM through packaging and labelling, including the manufacturer, the prescriber and the pharmacist. However, he cautioned that any change in the regulation of packaging and labelling would need to be based on evidence that it would tangibly reduce the risk of adverse events. He also noted that different packaging and labelling guidelines for different industry sectors may be the most effective way to regulate (for example, different guidelines for prescription, non-prescription and complementary medicines). What Seniors Want from Packaging and Labelling Presentation by Ms Anne McKenzie, Consumer Advocate at the University of Western Australia In her presentation, Ms Anne McKenzie outlined the findings of research undertaken at the University of Western Australia into seniors use of medicines packages and labels, informed by consultation with consumers. The research identified a number of problems with current labelling and packaging practices as experienced by older Australians, including: Non-specific instructions are often featured on the pharmacists dispensing label (for example, take as directed) causing confusion among consumers. Medications are sometimes prescribed and dispensed without any label. Confusion over the identity of medicines may arise due to different brand names and presentations of generic versions of the same medication. Small font sizing is sometimes used for crucial information on the packaging, rendering it too small for many seniors to read. There may be inadequate dosage instructions on prescription medication (for example, take when required or take twice daily with no reference to the time of day). Important information may be obstructed by the pharmacists dispensing label. Ms McKenzie also discussed the use of stickers or symbols on medicine labels to indicate the body part the medicine targets; for example, a heart sticker or symbol on the label of a heartrelated medication. Many over-the-counter medicines already feature symbols of this kind,
and have proven beneficial to consumers from non-English speaking backgrounds or those with impaired vision. Ms McKenzie concurred with the first speaker regarding mandatory adherence to the Best Practice Guideline on Prescription Medicine Labelling. Ms McKenzie also noted that there are many mandatory regulations covering the information that is featured on pharmacy dispensing labels, but these are not enforced. She recommended that all regulations be actively enforced and that penalties be used to promote compliance. Packaging and Labelling: A Self-Medication Industry Perspective Presentation by Dr Deon Schoombie, Chief Executive Officer of the Australian SelfMedication Industry Association Dr Deon Schoombie told the workshop participants that the Australian Self-Medication Industry Association (ASMI) sees medicines packaging and labelling issues as a key issue, particularly as chronic conditions are increasingly managed in the community and greater responsibility is being taken by consumers for their own care. He argued that it is important to distinguish between prescription and over-the-counter medicines in relation to the regulation of packaging and labelling. Many consumers take overthe-counter medicines without the supervision of a health professional, meaning that the labelling needs to provide all the information necessary to use the medication safely. The key issues he asked the workshop to consider were: Any recommendations must be based on evidence that they will impact upon consumer behaviour. Any recommendations must accord with the principle of minimum effective regulation. Preservation of branding is crucial to manufacturers as brands are a key selling factor. Many products are named overseas, making it difficult to change medicine names in Australia. Packaging and labelling are the major components of the cost of over-the-counter medicines, and any change resulting in increased costs in this area will impact upon the price of the product to consumers. The diversity of consumer needs is well understood by ASMI, and approaches that specifically target groups of consumers with special needs would be welcomed. Dr Schoombie highlighted the impact of increasing the font size on packaging by displaying a packet of Panadol with the font size of all the type increased to a 14 point sized font. The packet was three times larger than it is ordinarily, and he argued that this would be impractical.1 He listed all of the mandatory requirements already displayed on medicine labels, pointing out that additional requirements would be difficult to accommodate with many current package sizes. One suggestion made by Dr Schoombie was the use of extended labelling. Extended labelling would see additional information accessed through the barcode and dispensed by pharmacists or accessed by consumers themselves. This information could be targeted to the specific needs of consumers, for example, in different languages, for first-time users or those with specific co-morbidities.
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A number of consumers later made the point that very little information would need to be increased in size, just some of the key information, such as the active ingredient.
How Medicines Packaging and Labelling is Regulated by the TGA Presentation by Dr Rohan Hammett, National Manager of the Therapeutic Goods Administration Dr Rohan Hammett outlined the role of the TGA in medicines packaging and labeling regulation. He emphasised that packaging and labeling issues need to be seen in the context of the TGAs overall role in ensuring that therapeutic goods are safe and of high quality, to a standard equal to that of comparable countries. Dr Hammett provided some background to the TGAs risk management approach to regulation, which is designed to ensure public health and safety while at the same time minimising the burden and cost to industry of unnecessary regulation. He also outlined the main processes by which the TGA regulates medicines as follows: Pre-market evaluation and approval of products intended for supply in Australia Development, maintenance and monitoring of the systems for listing of medicines Licensing of manufacturers in accordance with international standards Post-market monitoring, through sampling, adverse event reporting, surveillance activities, and response to public inquiries Assessment of medicines for export. He also provided an overview of the relevant legislation and regulation in this area, including the Therapeutic Goods Act and supporting Regulations, Orders and Determinations which provide further details of matters covered in the Act. He emphasised that these are the levers through which the Government can effect change in the packaging and labelling of medicines and that there are many issues that lie outside of the Governments control. Summary of Panel and Group Discussion Following the presentations, consumers and panellists participated in a question and answer session and a group discussion on the issues raised in the presentations. A key issue arising from the discussion was that medicines packaging and labelling needed to be seen within the context of the patient journey, rather than as an issue to be addressed in isolation from consumers overall experience of health care. Participants described four stages in the journey for prescription medicines (or three in the case of over-the-counter medication): Prescribing, dispensing, initial use, and ongoing use, with the last two stages involving self-monitoring and, in some cases, medical oversight. Participants also agreed that providing information to consumers was the most important role served by labelling. It was agreed that the key question that needed to be asked when manufacturing and regulating medicine labels is: What is the minimum information needed to use a medicine safely? Within this framework, the packaging and labelling of medicine should be seen in the context of other forms of information provided to consumers about their medicines and other aspects of their health care. Similarly, packaging and labelling practices need to complement and integrate with other consumer health information and education tools.
What Consumers Want from Medicine Information and Labels In this session, workshop participants were divided into groups and asked to consider the content and information featured on medicine labels. The groups were asked to consider the following questions: 1. What kind of information should be featured on the labels of medicines? 2. How can the potential problems with the misinterpretation of directions be overcome? 3. How can some of the naming and branding issues in medicines be resolved? What kind of information should be featured on labels of medicines? The main issue identified by the group focussing on medicines instructions was the instructions on medicine labels, as these are often ambiguous or unclear. This makes it difficult for many consumers, particularly for those from non-English speaking backgrounds, to understand how to take their medicines safely. A specific example mentioned was one which caused difficulty for consumers from non-English speaking backgrounds are instructed to take one tablet twice a day. A clearer instruction suggested was take one tablet in the morning and another one in the evening. Participants also raised the need for explanations to be provided to support instructions to emphasise why the instruction is important. For example, a take with food instruction should be supported by information which explains why taking the medication with food is required (for example, to aid its effectiveness or reduce the risk of nausea) and outlines the consequences if this instruction is not followed. The importance of mentioning Consumer Medicine Information (CMI) on the packaging of medicines was raised as a way of increasing consumer awareness of this resource. This would assist those people wanting more information to find out more about their medicine and support the quality use of medicines. The issue of positive versus negative instructions was discussed, with many participants supporting the use of positive instructions where possible; for example, take on an empty stomach rather than do not take with food. This is based on research showing that positive instructions are more likely to be understood and followed accurately than negative ones.2 Obstruction of medical information by pharmacy dispensing labels was discussed extensively, with some frustration expressed that this issue has been raised repeatedly by consumers for a number of years without resolution. Another issue raised by participants were the problems associated with non-specific instructions; for example, take as directed. A number of consumers reported that the dispensing of medicines with unclear instructions is widespread and has not been addressed, despite clarity being a legal requirement. There was general support for better enforcement of these regulations with penalties for non-compliance. There was some discussion regarding adoption of the British model, which prevents pharmacists from filling prescriptions without clear instructions from the prescribing doctor. However, some participants were concerned that this could adversely affect consumers if they
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Medicines and Healthcare Products Regulatory Agency (2003) Best Practice Guidance on Labelling and Packaging of Medicines. Medicines and Healthcare Products Regulatory Agency: London.
were forced to wait while the pharmacist called the doctor or if they had to return to the doctor for another prescription. Overall, there was general support for penalties for doctors who fail to provide adequate dosage instructions after appropriate education and a lead-in period. To address these issues, consumer made the following recommendations: Critical information should appear in as large a font as possible to maximise legibility, on at least one face of the presentation. It should not be broken up or separated by non-critical information. Where possible, positive statements should appear on medicines labelling to avoid ambiguity of the message. Where possible, space should be included for the placement of the dispensing label. It is recommended that this should be a blank white space in which there is no text of any kind, to aid legibility of the dispensing label. Legal requirements to provide detailed information on the dispensing label should be properly enforced. Dispensing labels should refer to the CMI for the additional information. Where possible, labels or CMI should outline the reasons for specific directions, such as possible adverse events. How can we overcome problems with the misinterpretation of directions? It was noted that no data is currently available on how many adverse events are caused by problems with packaging, labelling, dispensing labels or misinterpretation of directions. Participants in this group argued strongly for a single point of reporting for consumers to access information and report concerns and adverse effects. This should be promoted broadly to the community, and all data should be analysed and reported. Consumers felt that there was no pathway to record and consolidate information about their experiences with medicines. Although group members were aware of phone lines for reporting adverse events, they believed that these are very poorly marketed and that the information fed back to the TGA is not used to measure consumer experience with particular medications. The TGA was nevertheless identified as having a key role in the establishment of any reporting mechanism due to its role in post-market surveillance. The role of local or interest-based networks of consumers in collecting and disseminating information about medicines was also noted. How can some of the naming and branding issues in medicines be resolved? The naming and branding of medicines was discussed extensively, particularly in relation to confusion between generic versions of the same medicine. Many participants provided examples of medicines containing the same active ingredients but having unrelated names. Examples were also provided of medicine names that sound similar but contain unrelated ingredients and have different uses. Participants suggested that this specific problem could be addressed through the review of look alike, sound alike medicines. There was general support for increasing consumer awareness of the active ingredient through a range of strategies, including making this more prominent on packaging and labelling. Following their discussions with the presenters, participants noted that they were not seeking to remove brand names, but simply wanted to increase prominence of the scientific name of the relevant active ingredient so that consumers could identify their medications though both names.
In their presentations, Dr Schoombie and Dr Shaw both raised issues in relation to naming conventions for new molecules, particularly those named overseas, making it difficult to change these specifically for the Australian market. They also told participants that the length and complexity of many of these names would be difficult for consumers to read and pronounce. Participants in Group 3 discussed this but concluded that consumers would not need to be able to say the name of the molecule, but simply to be able to compare whether or not it was the same as that featured on another medicine. Tallman lettering3 was also suggested as a strategy to reduce confusion aid both practitioner and aid consumer recognition of long and complex names. To address these issues, consumer made the following recommendations: Name testing for look alike, sound alike medicines should be undertaken for new medicines and should involve consumers. The active ingredient should be displayed in equal size and prominence as the brand name. Information relating to the quantity of active ingredient per dose or unit must be clearly displayed. The name or names of active ingredients should be printed on the ends of the boxes.
Tallman lettering is the practice of writing part of a drugs name in uppercase letters to help distinguish soundalike, look-alike drugs from one another. For example, in Tallman lettering, prednisone and prednisolone would be written predniSONE and prednisoLONE respectively.
What Consumers Want from Packaging, Design and Presentation In this session, participants were asked to again divide into groups and consider the accessibility of packaging, the presentation of medicines and the design of labels. The groups were asked to consider the following questions: 1. How could the design of labels be used to make medicines instructions clearer? 2. How can we overcome access issues in the packaging of medicines? 3. Would pictures and/or symbols on labels make medicines easier to use? How could the design of labels be used to make medicines instructions clearer? The size, colour and other identifying features of medicines have all been cited as difficult design issues for consumers. The size of the font on medicines packaging is often too small, particularly for those with vision impairment. Taking into account the issues raised by the presenters earlier in the day, consumers did not recommend a minimum size but did emphasise that all information should be large enough to read, including for seniors and consumers with reduced vision. As recommended in previous discussions, only key information, such as the active ingredient and the directions for use, should have minimum mandatory font sizes. The lack of visible identification on many medicines was also raised as a problem for many consumers, with the small font of identifiers on the medicines being very difficult for some seniors to read. These issues were discussed in further detail by Group 3. How can we overcome access issues in the packaging of medicines? Physical access to medicines was raised by a number of participants, in particular consumers and advocates for people with arthritis. Medicines with child-safety caps and blister packs often present challenges for seniors and people with arthritis. Recent developments in design systems creating child-proof and senior-friendly packages overseas were also noted, as were developments in software design to allow manufacturers to estimate the percentage of the population able to access particular forms of packaging. It was suggested that manufacturers should undertake pre-market testing of packaging with consumers to ensure they are accessible. The point was also made that reduced access to medicines may contravene the Disability Discrimination Act and that this may be a vehicle for driving change in this area. Consumers also supported the adoption of general standards for access with which medicines would be required to comply. These would need to be developed in conjunction with consumers to ensure they reflected consumer needs. Would pictures and/or symbols on labels make medicines easier to use? The increased use of pictures and symbols was generally supported as a tool to increase consumers understanding of their medicines and how to use them safely. The inclusion of symbols and pictorial information and instructions was identified as particularly important for culturally and linguistically diverse communities and people from Aboriginal and Torres Strait islander backgrounds. Suggested options included the use of symbols to indicate which body part the medicine targeted (for example, the heart); the route of administration (for example, the nose for a nasal spray); and the dosage instructions (for example, a sun for day time and a moon for night
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time). It was noted that a number of over-the-counter medicines, such as Cartia, use symbols of this kind. The use of internationally-recognised symbols was suggested as a way to overcome cultural differences, such as the use of i symbol for information. It was suggested that this could be included on medicines packaging to provide consumers with details of medicines information lines or other sources of medicine information.
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Other Issues Throughout the course of the day, a number of issues were continually revisited by consumers. These are outlined below. Provision of Consumer Medicine Information (CMI) Consumers noted a study cited by CHF in its recent consumer information paper, Achieving Best Practice in the Packing and Labelling of Medicines.4 The study reported that only 6.4 per cent of consumers leaving community pharmacies received written instructions such as CMI. Consumers reported that they are rarely provided with CMI, and are frustrated that it is difficult to pinpoint who is responsible for this. While pharmaceutical companies are obliged to produce CMI, the responsibility for providing them to consumers rests elsewhere. Medical practitioners are not obliged to dispense CMI, and, while pharmacists are, there is no monitoring of compliance. As part of a compliance audit, consumers want mandatory penalties to apply to pharmacists who do not dispense the CMI or provide equivalent oral advice to consumers filling a prescription for the first time. One unresolved issue amongst participants was whether CMI should be automatically included in medicine packages. Some felt strongly that this should occur, while others felt it would reduce discussion with the pharmacist. Reviewing Compliance With Current Legal Requirements and Regulations Over the course of the day, it was noted that a number of the issues raised by consumers were already regulated, such as the provision of ambiguous information on pharmacy dispensing labels and the lack of provision of CMI. Consumers called for more effective monitoring of current regulations applying to packaging, labelling and dispensing of medicines. As an initial step, consumers recommended that an independent audit of compliance be carried out. This would cover Commonwealth legislation and regulation applying to packaging, dispensing labels, instructions given by the prescribing doctor and the role of the TGA in overseeing the regulatory process. Consumer Empowerment and Education The need for ongoing consumer education in relation to medicine use was raised by a number of participants in the workshop, specifically in relation to education around interpreting the information provided on medicine labels. This was seen as the responsibility of all stakeholders in this area, including Government, consumer groups, industry and professional groups.
Consumers Health Forum of Australia (2010) Achieving Best Practice in the Packing and Labelling of Medicines. Canberra: Consumers Health Forum of Australia
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Summary of Recommendations Key elements of the recommendations put forward by CHF in the consumer information paper Achieving Best Practice in the Packing and Labelling of Medicines were revisited by consumers in their discussions. From the suggestions made by consumers on the packaging and labelling of medicines, the following key recommendations were identified: 1. The full name of the medicine should appear on at least three non-opposing faces of the pack to aid accurate identification of the drug. 2. Where the common name appears after the brand name, it should be given due prominence. Generally this will be determined by the relative size of the text, but other factors may be relevant, such as colour of text and the font used. 3. The critical information, such as directions for use, should appear in as large a font as possible to maximise legibility, on at least one face of the presentation. It should not be broken up or separated by non-critical information. 4. Adoption of innovative pack design incorporating the use of colours or symbols to = help identify medicine and its intended use should be encouraged. 5. Where possible, packs should include space for the placement of the dispensing label. It is recommended that this should be a blank white space in which there is no text of any kind, to aid legibility of the dispensing label. 6. Where possible, positive statements should appear on medicines labelling to avoid ambiguity of the message. 7. Undertaking a user test to ensure the maximum clarity of the critical information is desirable and recognised as best practice. 8. Colour for the text and the font style on blister packs should be chosen carefully, as the legibility of the text on the foil is already impaired. 9. The active ingredient should be displayed in equal size and prominence as the brand name. 10. Information relating to the quantity of active ingredient per dose or unit must be displayed clearly on the packaging. From the suggestions made by consumers on monitoring and compliance, the following key recommendations were identified: 11. An independent audit of compliance with all Commonwealth legislation and regulation should be undertaken. 12. A single point of reporting for consumers to access information, report concerns and adverse effects should be established. Alternatively, the existing Adverse Medicine Event Line operated by NPS could be better promoted and used to collect data on adverse events attributable to packaging and labelling.
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Conclusion Packages and labels make an important contribution to the safe and effective use of medicines, and the presentation of medicines is intended to be the first line of communication with medicine users. Consumers underlined the importance of achieving a best practice approach to packaging and labelling, based on meeting their needs and promoting the quality use of medicine. Consumers considered the key question that needed to be asked when manufacturing and regulating medicine labels need to be: What is the minimum data set needed to use a medicine safely? The active ingredient, directions for use and text featured on the dispensing label were continually cited as crucial pieces of patient information. Consumers want the packaging and labelling of medicine to be considered in the context of the patient journey, and called for packaging and labelling practices to complement and integrate with other consumer health information and education tools. Further Information Further information about CHFs Community Quality Use of Medicines and Diagnostics project can be found on the CHF website www.chf.org.au. Alternatively, interested persons can contact Maiy Azize, Project Officer at m.azize@chf.org.au or (02) 6273 5444 (STD calls will be returned). Consumers Health Forum of Australia Inc PO Box 3099 Manuka ACT 2603 Telephone (02) 6273 5444 Fax (02) 6273 5888 Email info@chf.org.au www.chf.org.au
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Appendix A: Workshop Program
Community Quality Use of Medicines and Diagnostics Project Medicines Packaging and Labelling Holiday Inn Potts Point, 203 Victoria Street, Potts Point NSW 9.30am-3.00pm, Thursday 2 December 2010 Facilitator: Ms Jennifer Doggett Program Timing 9:00 Session Registration (coffee and tea available) Introduction to Medicines Packaging and Labelling 9:30 9:35 Welcome to participants Introduction to the Panel Presentations The Role of Packaging and Labelling: A Consumer Perspective Packaging and Labelling: An Industry Perspective What Seniors Want from Packaging and Labelling Packaging and Labelling: A Self-Medication Industry Perspective How Medicines Packaging and Labelling is Regulated by the TGA
Ms Carol Bennett Chief Executive Officer Consumers Health Forum Dr Jennifer Doggett Panellists:
Ms Diane Walsh Consumer Representative
Dr Brendan Shaw Chief Executive Officer Medicines Australia Ms Anne McKenzie Consumer Researcher University of Western Australia Dr Deon Schoombie Chief Executive Officer Australian Self Medication Industry Association Dr Rohan Hammett National Manager Therapeutic Goods Administration Facilitator: Dr Jennifer Doggett
9:40
Panel Discussion and Participant Questions and Answers 11:30 Morning tea
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Session 1 The Role of Packaging and Labelling 11:45 Introduction to the CQUM/D Project Small group work: What consumers want from medicine information and labels 4. What kind of information should be featured on the packages and labels of medicines? 5. How can we overcome problems with the misinterpretation of directions? 6. How can some of the naming and branding issues in medicines be resolved? Discussion of Session 1 Lunch
Group work Ms Maiy Azize Project Officer Consumers Health Forum
11.50
12.20 12.40
Group discussion
Session 2 Consumer-Friendly Design Small group work: What consumers want from packaging, design and presentation 4. How could the design of labels be used to make medicines instructions clearer? Group work 5. How can we overcome access issues in the packaging of medicines? 6. Would pictures and/or symbols on labels make medicines easier to use? Discussion of Session 2 Wrap Up: Major Issues and Priorities Next steps and Evaluation Close and afternoon tea
1.20
1.50 2.20 3.15 3.30
Group discussion
Session 3 Packaging and Labelling Recommendations

Group discussion Ms Maiy Azize
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The Consumers Health Forum of Australia (CHF) is the national peak body representing the interests of Australian healthcare consumers. CHF works to achieve safe, quality, timely healthcare for all Australians, supported by accessible health information and systems. CHF does this by: 1. advocating for appropriate and equitable healthcare 2. undertaking consumer-based research and developing a strong consumer knowledge base 3. identifying key issues in safety and quality of health services for consumers 4. raising the health literacy of consumers, health professionals and stakeholders 5. providing a strong national voice for health consumers and supporting consumer participation in health policy and program decision making CHF values: our members knowledge, experience and involvement development of an integrated healthcare system that values the consumer experience prevention and early intervention collaborative integrated healthcare working in partnership
CHF member organisations reach millions of Australian health consumers across a wide range of health interests and health system experiences. CHF policy is developed through consultation with members, ensuring that CHF maintains a broad, representative, health consumer perspective. CHF is committed to being an active advocate in the ongoing development of Australian health policy and practice.

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Community Quality Use of Medicines and Diagnostics Project Achieving Best Practice in the Packaging and Labelling of Medicines:

Report from the National Consumer Workshop

Appendix A: Workshop Program

Ms Diane Walsh Consumer Representative

1.50 2.20 3.15 3.30

Session 3 Packaging and Labelling Recommendations

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