Transparency in Europe: patients and doctors Dominic Way a and - - PowerPoint PPT Presentation

Transparency in Europe: patients and doctors

Dominic Waya and Frederic Bouderb

aKing’s Centre for Risk Management, King’s College London bMaastricht University

dominic.way@kcl.ac.uk

Our research (2012-2015)

• What can be learnt from the perspectives of patients

and doctors? What are the policy implications? Empirical research: Experiment(s) (Lofstedt and Way, 2014a, 2014b) General public survey (Bouder et al. 2015; Way et al. 2016) Patients survey (Way et al., 2015) Doctors survey (Lofstedt et al., 2015)

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Online surveys

General public Patients Doctors Dates (year) 2013 2014/2015 2014/2015 Size 5,648 1,010 1,005 Type European adults HIV/AIDS, IPF, MS, Osteoporosis, RA GPs (50%) + Specialists (HIV/AIDS, IPF, MS, Osteoporosis, RA) Countries Fr, De, Sp, UK, Swe, NL Fr, De, Sp, UK Fr, De, Sp, UK Questions 32 30 36 Authors Bouder et al. Way et al. Lofstedt et al. Response rate 12-24% 4.5% 5%

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Patients desire more info

Q10A: Please indicate the extent to which you ‘agree’ or ‘disagree’ with each of the following statements: “Patients receiving more information on the safety of medicines would increase their confidence in taking medicines” (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

HIV/AIDS Idiopathic pulmonary fibrosis (IPF) Multiple Sclerosis Osteoporosis Rheumatoid arthritis All Strongly Agree Agree

• Supports Lofstedt and Way (2014a, b)

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And…how will patients react?

36% 4% 3% 52% 5% 23% 8% 9% 56% 4%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Stop taking your medicine Reduce your dose

• f the medicine

Continue taking your medicine as usual Seek additional advice about the medicine Don't know General public Patients

Q9B If the information you personally receive (via letter, telephone, email etc…) points to safety problems with a [Insert specialty group] medicine you are currently taking, do you think you are more likely to… 5

KEY 5-10% 10-15% 15-20% 20-25% 25-30% 30-35% 35-40% 40-45% 45-50% 50-55%

UK Spain France Germany

Clear regional variations for stop and reduce combined

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Context matters (patients)

Q9B If the information you personally receive (via letter, telephone, email etc…) points to safety problems with a [Insert specialty group] medicine you are currently taking, do you think you are more likely to… (Stop taking your medicine/Reduce your dose of the medicine/ Continue taking your medicine as usual/ Seek additional advice about the medicine/ Don’t Know). 7

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Stop taking your medicine Reduce your dose of the medicine 11% 16% 16% 18% 21% 24% 26% 28% 32% 33% 35% 36% 36% 37% 39% 41% 42% 45% 64% 68%

Patients and Doctors

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Where do patients obtain trusted info?

0% 20% 40% 60% 80% 100%

Very/Somewhat Trustworthy Very/Somewhat Easy To Obtain Info

Patients (1010)

Q5(a): How easy is it for you to find information about medicines from each of the following sources? Q5(b): How trustworthy do you believe the following sources are in providing you with advice on the side effects associated with specific medicines 9

Ps vs. HCPs: when should medicines info be communicated?

• Q9. At what stage do you think information should be conveyed to the public about a possible safety issue of a medicine that they

use or may use? (Please choose one answer only) **All differences between doctors and patients are significant at p < 0.001 (pairwise comparisons in a generalised linear model with a binomial distribution, logit link function, and doctor/patient as a factor variable).

When the problem has been investigated and regulators believe it is related to medicine When the problem has been investigated and pharmaceutical company believes it is related to the medicine When the problem has been investigated; not clear if related to the medicine When there is a possible sign of a safety problem

Doctors (N=1,005) Patients (N=1,010) 24%** 13%** 19%** 44%** 51%** 22%** 13%** 14%** General Public (N=3,587) 58% 10% 11% 12%

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The regulators’ role

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Awareness of regulators

Q11/Q16: Have you heard of the [insert NCA]/EMA/FDA?

80% 33% 94% 44% 16% 98%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

EU Doctors EU Patients EU Doctors EU Patients EU Public US Public EMA NCAs FDA

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Variation across Europe (general public)

UK (MHRA) Sweden (MPS) Netherlands (CBG-MEB) Spain (AEMPS) Germany (BfArM) France (ANSM) Yes 25a 67b 2c 7d 8e 15f

Have you heard of [INSERT relevant national authority]?

a all superscript letters that differ between nations denote a statistically significant

difference (p < 0.05) in the percentage of respondents answering “yes” between those nations (determined by pairwise comparisons in a generalized linear model with logit link, binomial distribution, and Bonferroni corrections for multiple comparisons)

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Do doctors know how regulators assess medicines safety?

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Q15(a)/20(a): I have good knowledge of how [Insert NCA/EMA] assesses the safety of [insert medical speciality] medicines. *Only statistically significant differences between GPs and specialists in treating HIV/AIDS.

N.B.

21% 33% 29% 24% 28% 25% 12% 27% 19% 21% 23% 17%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

General Practitioners HIV/AIDS Idiopathic Pulmonary Fibrosis Multiple Sclerosis Osteoporosis & Rheumatoid Arthritis All

Strong Agree + Agree

National Competent Authority European Medicines Agency

Main findings

• Opportunities
• Ps have a large appetite for more medicines info
• Patients trust HCPs
• Challenges
• Ps nation and condition underpins their reactions to safety info
• Ps don’t know the regulators and trust them moderately
• Ps trust MDs but disagree over when info should be conveyed
• Ps + MDs unfamiliar with the contribution of the regulators
• Ps+ HCPs unlikely to be aware of or understand the regulators’

transparency comms

• Could regulators work through HCPs? MDs are time poor in enabling

empowerment (e.g. BMA 2015 survey of 15,562 GPs)

Our on-going research…

• Transparency deserves effective B-R comm
• Role of patient and doctor groups is essential for

effective medicines transparency How can we improve B-R communication to enhance transparency? Stage One: Interviews with P + MD representatives Stage Two: In-depth patient focus groups

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