What can we learn from developing medicines information for patients?

School of HealthcareFACULTY OF MEDICINE AND HEALTH

Improving health information to promote health literacy

What can we learn from developing

medicines information for patients?

DK Theo RaynorProfessor of Pharmacy Practice, University of Leeds

and Co-founder & Academic Advisor, Luto Research

[email protected]

UK 1970s

‘The Tablets’

‘The Capsules’

‘The Liquid’

UK - 2015

Comprehensive patient leaflet supplied with every medicine

Readability testing of each leaflet through user testing with general public

Patient friendly summaries of: Public assessment report (EPAR) Risk management plan (RMP)

Meaningful consumer input to policy MHRA and EMA patient advisory groups

Background Consumer medicines information research group:

20 year programme, funded by Department of Health, DIA Expert advice to MHRA, EMA and FDA

Focus: Impact of EU legislation & User Testing Expressing risks and benefits to patients US & Australian leaflets – part of World Universities Network

collaboration: Sydney, Wisconsin, Utrecht

University Spin Out: Develops, refines & tests health information >20,000

participant interviews Patient information leaflets & Instructions for use

(IFUs) NHS medicines information e.g. Lithium booklet Health charities e.g. range of condition booklets

Medicine Label Wordings 1978

One to be taken every 6 hours• 53%: every 6 hours for 3 doses only

Complete the prescribed course• 40% misunderstood

Caution: this medicine may cause drowsiness• 33% misunderstood

Raynor &980

Medicine Label Wordings 2011

Patience

1984

Promoting Excellence in Consumer Medicines Information: 1996

European Draft Readability Guideline: 1997

Guideline included: • a prescriptive “model” leaflet

• detailed structure & wording

• proposed 37 headings

pecmi tested model leaflet• performed poorly

• best practice version performed much better

Fred, Mary and Joan go to Brussels

As a result: Model leaflet amended Headings reduced to a manageable 7 Deviation from model allowed if

supported by consumer testing

Need all stakeholders on

board

Expose policy makers to real

people

User Testing

Game Changer

European Directive in 2005  

“The package leaflet shall reflect the results of consultations with target patient groups to ensure

that it is legible, clear and easy to use” No successfully tested leaflet – no licence

Implemented through process called User Testing• Process developed in Australia by Prof David Sless

Performance-based testing• Can potential users find and understand key points of information

for safe and effective use?

Two components:• Quantitative – how many can find & understand key points?• Qualitative – what do people find useful?

Before

User Testing in brief

Select 15 key points

Relevant to safe and effective use

Design & pilot a questionnaire which tests:

Finding each piece of information

Understanding (express in own words)

Recruit 20 people from target group

Interviewed individually

Interview concludes with qualitative questions

What did they like and not like about the leaflet?

Try, Try and Try Again

User Testing is an iterative process

• Test material

• Identify problems the points people struggled with

and their general comments

• Remedy problems using research evidence & good

practice in writing & design

• Test again

A Selection of Materials Tested

Good information needs the input of

real people

What is transparency?

Original Latuda RMP Summary

Be clear about transparency

Rebacsa

Rebastatin

“19 out of 20, I’d say it was a good pill.”

“I found [numerical information] a bit depressing ‘Oh it only improves in 1 in 20 in 5 years’, well, I won’t bother!“

An informed patient is not necessarily an obedient

patient

• Identify patients with lower health literacy and then - develop special materials

or• Develop clear, well written and

designed information to benefit all patients - universal precautions

• Focus on patients is a ‘partial measure’

• ‘Health Literacy Questionnaire’

• Domains related to both individual and health system

Less measuring and more action

What can we learn from medicines information?

School of HealthcareFACULTY OF MEDICINE AND HEALTH

Improving health information to promote health literacy

What can we learn from developing

medicines information for patients?

DK Theo RaynorProfessor of Pharmacy Practice, University of Leeds

and Co-founder & Academic Advisor, Luto Research

[email protected]