Talking about medicines to patients: the good the bad and the ugly

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1 School of Healthcare FACULTY OF MEDICINE AND HEALTH Talking about medicines to patients: the good the bad and the ugly Improving the way we inform patients MUSN Meeting London, May 2016 DK Theo Raynor Professor of Pharmacy Practice, University of Leeds & Co-founder & Academic Advisor, Luto Research

2 1970s

3 1970s The Tablets The Capsules The Liquid

4 2010s Comprehensive patient leaflet supplied with every medicine Readability of each leaflet assured through user testing with real patients Meaningful expert patient and consumer input into labelling policy Patient friendly summaries of: Public assessment report (EPAR) Risk management plan (RMP) Clinical trial public summaries

5 Over-view 1. Improving medicines information Last 40 years in 5 slides Some questions and principles 2. Where is the benefit? Step change in quality of information But still nothing about benefit 3. False promise of lay summaries in EU Are they fit-for-purpose Do they meet patients needs? 4. What is the way forward?

6 Background Consumer medicines information research group Professor of Pharmacy Practice 25 year programme, funded by Department of Health, EU, DIA, TGA Expert advice to MHRA, EMA and FDA Leader of a World Universities Network collaboration University Spin Out company Co-founder and academic advisor to Luto Research, Develops, refines & tests health information >20,000 participant interviews Patient information leaflets / package leaflets Variety of other information for HCPs & patients

7 School of Healthcare FACULTY OF MEDICINE AND HEALTH Improving Medicines Information : the last 40 years

8 1978 Medicine label wordings Nottingham City Hospital One to be taken every 6 hours 53%: every 6 hours for 3 doses only Caution: this medicine may cause drowsiness 33% misunderstood

9 1984

10 1990

11 Systematic Review of Research Evidence: Key findings Patients do not want written information as substitute for spoken information Patients value information that contains a balance of benefit & harm information Concern about complex language & poor visual presentation of information Most patients wanted sufficient detail... to know about any possible side-effects Raynor DK et al Systematic review of research on role & effectiveness of written medicines information. Health Technology Assessment

12 Key findings Patients would like written information to help decision-making in 2 ways: 1. Initial decisions about whether to take medicine or not Need information about the range of treatments available (needed before prescribing decision). 2. Ongoing decisions about the management of medicines and interpreting symptoms Patients do not see improving compliance as a function of information provision An informed decision not to take a medicine is an acceptable outcome Some health professionals thought otherwise

13 What do patients think about medicine leaflets? You throw them away don t you? They don t inspire you Things we want to know don t come first Priorities are those who wrote it, not patients People who suffer should help write leaflets Raynor DK et al. We are the experts patients talk about their medicines information. Patient Education and Counseling

14 User Testing of Package Leaflets: the Game Changer European Directive 2005 Leaflet to reflect results of consultations with target patient groups to ensure legible, clear and easy to use Implemented through User Testing Developed in Australia by David Sless Performance-based testing Can potential users find and understand key points of information for safe and effective use?

15 What is User Testing? Select key points of information Recruit 10 people from target group Interviewed individually (a) Quantitative aspect Design & pilot a questionnaire which tests: Finding each piece of information Understanding (express in own words) (b) Qualitative aspect Interview then moves to qualitative questions What did they like and not like about the document?

16 Testing on real people Job Title 1 Fundraising Assistant 2 Administrator Retired Primary School Teacher Retired Air Traffic Controller Christmas Grotto Manager Unemployed Forklift Driver 7 Retired Bus Driver 8 Warehouseman 9 Cleaner 10 Stand-up comedian

17 User Testing is 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 Raynor DK. User testing in developing medication information in Europe. Research in Social and Administrative Pharmacy 2013

18 School of Healthcare FACULTY OF MEDICINE AND HEALTH Some questions and principles

19 A question Which is the most likely cause of information failing a user test: People not finding? People not understanding?

20 Another question Is long information bad and short information good? No

21

22

23 What are principles of good information writing & design? 1. Short familiar words and short sentences 2. Short headings that stand out 3. Type as large as possible 4. Leave white space 5. Use bullets for lists 6. Be conversational 7. Use the active voice 8. Use non-justified text 9. Use bold lower case for emphasis 10. Pictures and graphs do not necessarily help Raynor & Dickinson. Annals of Pharmacotherapy 2009

24 Health Authority Patient Materials Smiley Faces? Knapp, Wanklyn, Raynor et al. Developing and testing a patient information booklet for thrombolysis. Int Journal of Pharmacy Practice 2010

25 So near, yet so far..

26

27

28 Medicine Label Wordings Warning: May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink. Warning: This medicine may make you sleepy. If this happens, do not drive or use tools or machines. Do not drink alcohol.

29 School of Healthcare FACULTY OF MEDICINE AND HEALTH Where is the benefit? (and what is risk?)

30 Risk or harm? The two words: risk and benefit are not comparable The appropriate phrasing is: The chance of benefit The risk of harm So we should be talking about: harm / benefit benefit / harm

31 How common is very common? Very common EMA: 10% or more Public: 54% Common 1-10% 34% Uncommon 0.1-1% 11% Rare % 8% Very rare less than 0.01% 4% Berry, Raynor, Knapp. Provision of information about drug side effects. Lancet 2002

32 Where is the benefit? For informed choice, the patient needs both benefit and harm information Research shows patients want this information Current information focus mainly on the harm notably patient leaflets: Common - may affect up to 1 in 10 people Recent PhD research tested benefit information for people taking statins

33 Negative I found [numerical information] a bit depressing Oh it only improves in 1 in 20 in 5 years, well, I won t bother! 19 out of 20, I d say it was a good pill. Positive [I want to know] my chance and if the information was there.. I would feel the information leaflet was treating me with respect I quite like the facts being there because it will make me think

34 If 17 people take Rebastatin over the next 5 years, 1 of them will be prevented from having a heart attack or stroke. Lottery It s a bit like saying a lottery, we ve got 17 people, one might be lucky and 16 won t be lucky More emphasis on benefit There s I want too know much my emphasis chance on and the if bad the side benefit effects. information but I want was to be there drawn I would into what s feel that good the.i want benefits to scream out at me information leaflet was treating me with respect Textual information preferred, but numerical can help "I'd like to see that [textual statement] but I'd be looking for something more quantified benefits to back that up" Reality check? It's brought it home to me

35 Number Needed to Treat

36 School of Healthcare FACULTY OF MEDICINE AND HEALTH Public or Lay Summaries in the EU: EPAR Summaries

37 EPAR: European Public Assessment Report EMA publish a full EPAR for all medicines which describes: potential benefits and risks of a medicine how regulators came to view that benefits outweigh the risks. Lengthy report, written for professionals Also produce short lay version: an EPAR Summary Written in manner understandable to public To give public information to understand basis for approval

38

39 User Testing Findings EPAR Summary on Paper Original 5 / 19 Revised after User Testing 14 / 19 Not very clear.this is a summary for the public and it s not good. It needs re-designing Its not user friendly from the start its more like something from a lecture

40 School of Healthcare FACULTY OF MEDICINE AND HEALTH Risk Management Plan Summaries

41

42

43

44 Clinical Trial Public Summaries EU Clinical Trial Regulation May Sponsors must provide results of clinical trials Having a summary read that, is I d go for X understandable to lay persons - Available not earlier than May 2016 It would make me think ooh excuse me - No guidance on format, length, structure of summary doctor, is there any chance of me trying this? - Elements listed briefly in Annex V of regulation

45 Information Dumping? Straightforward translation of sections of full documents does not work: same headings, same sequence, same content Is this approach a form of information dumping rather than transparency? Need to start from scratch with a structure and content that works for lay people not that devised for professionals Is it cost-effective? would the time & money be better spent on other approaches to transparency

46 School of Healthcare FACULTY OF MEDICINE AND HEALTH Key Points d..

47 Key points Patients do not want written information as substitute for spoken information Patients want medicines information for two purposes: for the question whether? and then how? Expert patients & real patients have equally important but separate roles in development There is no substitute for involving real patients in testing written information More likely not to find or not understand? Design and layout equally important Without numerical benefit information, a patient cannot be truly informed An informed patient is not necessarily an obedient patient

48 Patient empowerment means what it says Patient empowerment means what it says, giving power to patients. With that power, an informed patient may decide to do what they see as right for them - and not to follow professional advice An informed patient is not necessarily an obedient patient. Raynor DK. Health Literacy is it time to shift our focus from patient to provider? BMJ 2013

49 School of Healthcare FACULTY OF MEDICINE AND HEALTH Talking about medicines to patients: the good the bad and the ugly Medicines Use and Safety Network Meeting London, May 2016 DK Theo Raynor Professor of Pharmacy Practice, University of Leeds & Co-founder & Academic Advisor, Luto Research

50

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