Improving the Quality of Patient Information

1
Improving
the Quality
of Patient Information

• Professor DK Theo Raynor
• University of Leeds, UK and LUTO Research Ltd
• theo_at_luto.co.uk

2
Much consumer medicines information is poor

• Too small folded and in the box
• You throw them away dont you?
• They dont inspire you
• Things we want to know
  dont come first
• Priorities are those who
  wrote it, not patients
• People who suffer should help write leaflets
• Raynor, Savage, Knapp Henley. Patient Education
  Counselling 2004

3
Regulations increasing worldwide

• Australia
• 1991 Baume Report
• 1993 Mandatory leaflets
• 1998 User Testing
• Europe
• 1999 Mandatory leaflets
• 2005 User Testing
• USA
• 2000 Targets set
• 2005 FDA consultation

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Improving Quality of Patient Information
Overview

• What information do people want?
• Users definition of quality information
• What do they get?
• UK, US Australia
• Risky business
• How common is common?
• Current EU legislation
• What is User Testing?
• Insights into the method
• Web-based information

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Working Group on Patient Information

• Chaired by Melinda Letts
• All stakeholders represented
• Reflects new vigour of MHRA for patient
  information
• First report to be launched on July 19th
• Key areas of work
• Risk communication
• Readability guidance
• Meeting needs of special groups

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University of Leeds

• Research in consumer
  medicines information
• 10 year programme
• Funded by the DH, NHS, National Lottery
• Focus on
• Impact of EU legislation User Testing
• Expressing risk
• International comparison
• Needs of people with sight loss
• NHS Systematic Review underway
• University company LUTO Research Ltd
• Leaflet testing service for pharma companies
• www.luto.co.uk

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What information do people want?

• Improving the Quality of Patient Information
• theo_at_luto.co.uk

8
What do people want?

• Broad range of preferences
• Different people want different things
• Individual people want different
  information at different times
• Key criteria
• Individualised information
• Linked to information about conditions
• Available in advance
• Information about benefits as well as risks
• Accessible to people with special needs
• Combination of oral written information

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Limitation of oral

• 1st priority
• Face-to-face oral information from health
  professionals
• However
• Insufficient time
• Insufficient memory
• Patients need a take-away option
• Written medicines information

10
What do people get?

• Two UK studies since law enacted (99 03)
• Do patients see, read
  and retain the leaflets?
• Based in community
  pharmacies
• What we found
• 88 (83) noticed the leaflet
• 49 (40) had read some
• 36 (21) had read all
• Raynor Knapp. Pharmaceutical Journal 2000

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United States

• Third-party provision
• Computer generated leaflets in the pharmacy
• No manufacturer involvement
• Quality
• Over a third were hard to read
• On average contained 50 of
  expected information
• FDA activity
• Arms length approach
• Target for 2006 95 of new
  prescriptions to get a useful leaflet
• June 2005 consultation suggest more proactive
  approach
• Use PI / SPC as source document
• Will transform US provision

12
Australia

• Computer generated in the pharmacy
• Written by the manufacturers
• Collaborative approach
• Communications Research
  Institute of Australia
• User testing in place
  since late 1990s
• 2003 study
• 79 read the CMI
• 70 said read all sections
• Side effects, instructions for taking
  indication most popular sections

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Getting it wrong

• Avoid pantyhose and tight underwear

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What should I do if I
forget a dose?

• If your next scheduled dose is more than four
  hours away, take the missed dose as soon as you
  remember it. If you are scheduled to take another
  dose in less than four hours, take the missed
  dose when you remember it but do not take the
  next dose at the scheduled time. Instead, wait
  four hours until you take the next dose. Take any
  remaining doses for that day at least four hours
  apart. If you miss two or more doses in a row,
  take only one dose when you remember them. Do not
  take more than one dose at a time.

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Risky Business?

• Improving the Quality of Patient Information
• theo_at_luto.co.uk

16
Communication of side effect risk

• Side effect information is very important for
  most patients
• But we fail to meet
  patientsneeds
• Give complicated
  description
  of side-effects
• Give little indication
  of how likely to happen
• Give little guidance
  on what to do if they do happen

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(No Transcript)
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Describing risk

• EU Guideline suggests terms to describe risk
• Very common
• Common
• Uncommon
• Rare
• Very rare
• What do you think?

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Describing risk

• EU People
• Very common
• gt10 54
• Common
• 1-10 34
• Uncommon
• 0.1-1 11
• Rare
• 0.01-0.1 8
• Very rare
• lt0.01 4
• Knapp, Raynor, Berry. The Lancet 2002

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The way forward?

• Alternatives to verbal descriptors
• Percentages 1
• Natural frequencies less than 1 in 100
• Graphical representations
• Analogies
• Preferred option
• Combination of verbal frequency
• Rare Affects less than 1 in 10,000 people

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Current EU Legislation

• Improving the Quality of Patient Information
• theo_at_luto.co.uk

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Pharma Review 2001

• Council Directive 2004/27/EC
• (Pharmaceuticals Legislation 2001Review)
• The package leaflet shall reflect the
• results of consultations with target patient
• groups to ensure that it is legible, clear
• and easy to use
• Such consultations to be conducted documented
• Results submitted with other mandatory regulatory
  information necessary for licensing
• Applies to branded and generic products, PI and
  herbals
• Usually interpreted as User Testing (as described
  in 1998 Readability Guideline)

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Regulation timeline
2001
Jul 2005
Jul 2008
2004
1999
Oct 2005
Review of Medicines legislation (2001) and EC
Directive 2004/27/EC The package leaflet
shall reflect the results of consultations with
target patient groups to ensure that it is
legible, clear and easy to use
UKs early adoption of EC Directive
2004/27/EC Any submission for a licence
covering a new drug after 07/05 has to be
accompanied by user testing documentation with
the relevant PIL
EU adopts EC Directive 2004/27/EC
All licensed drugs will need to have had their
PILs user tested
EC Directive 1992/92/27 Directive implemented
across member states Guideline on readability
published by EC
Period of time allowed by MHRA to ensure all
currently marketed products have had their PILs
user tested
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What is User Testing?

• User testing is a form of diagnostic testing
• Also known as performance based testing
• Contrasts with content-based testing
• Evaluates 2 aspects of the document under test
• Whether potential users can find and understand a
  number of key pieces of information
• Method developed in Australia
• Prof David Sless, Communications Research
  Institute
• User testing conducted on PILs since late 1990s
• Best practice based on
• Australian process
• EU derivative (Recommended since 98 Guideline)

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Readability Formulae

• Use word and sentence length
• Examples FOG, SMOG, Flesch
• Increasing in popularity
• available on Word Processing packages
• Do not take into account
• layout or design of leaflet
• size of text
• typeface
• sequence of words used
• Guide a only are they.

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User Testing in a Nutshell

• Select 12-15 key points of information
  in the leaflet
• Essential for the safe and
  effective use of the
  medicine
• Recruit 20 people who could imagine
  needing to use the medicine concerned
• From the general population, unless the illness
  is rare
• Must not be taking the medicine concerned
• Interview each participant individually
• Hand them the leaflet
• Ask them to find, and then express in their own
  words, each of the key points
• The aim is to get 90 who can find,
  of whom 90 can understand the information

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User Testing in Context

• MHRA Guidance describes one method of testing
• Based on Australian method and EU guideline
• However, any performance based method will be
  considered if it
• Clearly defines the most important information
  in the leaflet
• Clearly defines the appropriate test participants
• Provides credible evidence that participants can
  find and appropriately use the information

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Insights from LUTO

• Many PILs submitted by companies for testing are
  unlikely to meet the 90 of 90 threshold
• Audience Design Step maximises chances of passing
• Early patient input adds value
• Expert patients see things
  that we
  do not
• MHRA patient input
  at all stages
• Importance of format layout
• If cant find the information, then wording is
  irrelevant
• Experience of interviewers
• Most participants are older people
• Need interviewers with experience of dealing with
  vulnerable older people
• www.luto.co.uk

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Meeting the needs of special groups

• Improving the Quality of Patient Information
• theo_at_luto.co.uk

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MINOPS Project

• Collaboration with RNIB
• Funded by the National Lottery
• Key findings
• Large print is the preferred format for medicines
  information.
• Information on audio-cassette is also desired,
  but could present problems for some.
• Very little need for Braille.
• Growing awareness for technology as a vehicle for
  medicines information

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EU Legislation

• The name of the medicinal product .must also
  be expressed in Braille format on the packaging.
• Marketing authorisation holder shall ensure that
  the PIL is made available on request from
  patients organisations in formats appropriate for
  blind partially sighted.
• Must be implemented by 30 October 2005
• 19,000 people in UK who can read Braille

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Information Options

• Large print
• Audiotape/CD
• Braille
• Electronic version
• Help-lines

Is this leaflet hard to read or see? Phone 0123
456789 for help
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Web-based information and the future

• Improving the Quality of Patient Information
• theo_at_luto.co.uk

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Web-based leaflets are the future

• Advantages
• Up-to-date
• Personalised / individualised
• Accessible in advance
• Video clips etc
• Counter-arguments
• Low level of access?
• Need to nanny health on net?

35
Barefoot Doctor
I read with interest your recent piece about
the value of the gall bladder in decision-making.
Mine has been removed - what advice can you
give me about decision-making without a gall
bladder? Rachel Parkes
The Taoists divided the body into orbs one
contained the gall bladder and the liver. When
the gall bladder is removed the decision-making
functions are taken up by the liver
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FDA web-based information sheets

• June 2005 announcement
• New Drug Safety Board
• A new Drug Watch web-site
• Development of web-based Patient Information
  Sheets
• Ultimate objective is sheets for all approved
  drugs

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Medicine Guides
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Improving the Quality of Patient Information
Summary

• Many current leaflets are rated poor in quality
  by people who take medicines
• Risk of side effects best expressed using
  combination of words frequency
• Audience Design Step adds value to User Testing
• 5 key options for meeting special needs
• Web-based leaflets growing in importance

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Thanks

• Medicines Management Research Group,
  University of Leeds
• www.leeds.ac.uk/healthcare

• LUTO Research Ltd
• www.luto.co.uk