Making medicine information work: a new approach to improving adherence to therapy Jerome Reinstein PhD, Co-facilitator

2 Yong Sook Kwok, Co-Facilitator Medicines Labelling Group

3 In this Presentation The role of medicine information Information needs What is the problem with labelling? What is the solution? How do we get from the problem to the solution? What have we done so far? How we would like you to help

4 The role of medicine information Providing appropriate and useful information is in the interests of society for both social and economic reasons Usable information assists comparison of similar products, appropriate selection and encourages appropriate use Appropriate use leads to improved health outcomes MEDICINES ARE INFORMATION DEPENDENT PRODUCTS

5 FDA says labelling changes a must for OTC Prilosec “US: The FDA has sent an "approvable" letter to Procter & Gamble for Prilosec (omeprazole), which confirms that the company must create a new label – and prove patients can understand it by carrying out a label Comprehension study – before the proton pump inhibitor can be granted OTC status.” 23 August 2002

6 Information needs Without information, medicines cannot be used safely or effectively Information sources must be reliable and accessible Quality of information must be consistent Information must be usable MEDICINES ARE INFORMATION DEPENDENT PRODUCTS

7 What is the problem with labelling? Labelling = labels + leaflets Wrong emphasis: mandatory versus usable information Poor layout and design Poor comprehensibility

8 Example of ‘problem’ label Problems: small type, poor design, difficult to find the information

9 Example of ‘problem’ label Poor design of information. Sticker covers label

10 What is the problem with labelling? Labelling = labels + leaflets Wrong emphasis: mandatory versus usable information Poor layout and design Poor comprehensibility Resulting in: Labels not always meeting consumers’ needs Possible inappropriate use Potential for good health outcomes jeopardised

11 While labels alone cannot stop all cases of inappropriate use, evidence suggests that they could do much more to help

12 Learning from the research Label elements cannot be treated in isolation How information is arranged and presented affects label usability Disregarding design performance significantly reduces label effectiveness

13 What is the solution? Good information design practice can improve labelling Identify and apply good research evidence Build on established benchmark standards

14 Task Current Design % New Design* % Comparison of Mean Success on Current and New Designs % Finding information87 97 Using information72 96 * New design was based on Information Design Principles

15 Can the consumer/patient perform the appropriate actions by following the information provided on labels and leaflets?

16 How do we get from the problem to the solution? Five suggested steps: Make effective labelling a higher priority Develop stakeholder collaboration Improve regulation of labelling Fund research, development and training Train medicine manufacturers, regulators and other information providers

17 Make Effective Labelling a Higher Priority Medicines are information dependent products Labelling is a critical component in appropriate use of medicines Strengthen the last link in the chain Ingredient  Product  Supply  USE

18 Develop Stakeholder Collaboration Sharing the vision Agreeing goals Working in partnership

19 Improve Regulation Shift the emphasis – information out  information used – content-based  performance-based Make the content deliver the outcome – that is, PERFORMANCE-BASED

20 Funding Research, Development & Training Making the investment Collaboration and partnership is the key Combined effort to meet the needs Training is key

21 Training the Partners Acknowledge the ‘new’ science of information design Provide the opportunity for learning Make skills training available and accessible

22 What have we done so far? Formed the Medicines Labelling Group – Group of individuals with a range of experience and expertise – Shared concerns about how people use medicines and want to help them to use medicines better – Collaborative approach

23 Medicines Labelling Group Success to date – Support for performance-based approaches growing – Australian willingness to shift paradigm – Publication of literature review – Usable Medicines Information – and its generalised principles – Training program developed

24 Medicines Labelling Group Future plans – Spreading the word – Developing specific skills – Training in label/leaflet writing in several cultural contexts to demonstrate applicability of generalised principles

25 How we would like you to help Help create the paradigm shift Promote change within your constituency Become involved in the project Assist with resources