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

Transparency in Europe: patients and doctors Dominic Way a and Frederic Bouder b a King’s Centre for Risk Management, King’s College London b Maastricht 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) 2

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, GPs (50%) + Specialists Osteoporosis, RA (HIV/AIDS, IPF, MS, Osteoporosis, RA) Countries Fr, De, Sp, UK, Fr, De, Sp, UK Fr, De, Sp, UK Swe, NL Questions 32 30 36 Authors Bouder et al. Way et al. Lofstedt et al. Response rate 12-24% 4.5% 5% 3

Patients desire more info  Supports Lofstedt and Way (2014a, b) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% HIV/AIDS Idiopathic Multiple Osteoporosis Rheumatoid All pulmonary Sclerosis arthritis fibrosis (IPF) Strongly Agree Agree 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 ” 4 (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).

And…how will patients react? 100% 90% 80% 70% 56% 60% 52% 50% 36% 40% 23% 30% 20% 9% 8% 5% 4% 4% 3% 10% 0% Stop taking your Reduce your dose Continue taking Seek additional Don't know medicine of the medicine your medicine as advice about the usual medicine 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

Clear regional UK France variations for stop and reduce combined KEY 5-10% 10-15% 15-20% 20-25% 25-30% Spain Germany 30-35% 35-40% 40-45% 45-50% 50-55% 6

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

Patients and Doctors 8

Where do patients obtain trusted info? Very/Somewhat Easy To Obtain Info Patients (1010) Very/Somewhat Trustworthy 100% 80% 60% 40% 20% 0% 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 9 with specific medicines

Ps vs. HCPs: when should medicines info be communicated? Patients (N=1,010) Doctors (N=1,005) General Public (N=3,587) When there is a possible 51%** 58% 24%** sign of a safety problem When the problem has 13%** 22%** 10% been investigated; not clear if related to the medicine When the problem has been investigated and 11% 13%** 19%** pharmaceutical company believes it is related to the medicine When the problem has been investigated and 14%** 44%** 12% regulators believe it is related to medicine 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 10 with a binomial distribution, logit link function, and doctor/patient as a factor variable).

The regulators’ role 11

Awareness of regulators 98% 100% 94% 90% 80% 80% 70% 60% 50% 44% 40% 33% 30% 16% 20% 10% 0% EU Doctors EU Patients EU Doctors EU Patients EU Public US Public EMA NCAs FDA Q11/Q16: Have you heard of the [insert NCA]/EMA/FDA? 12

Variation across Europe (general public) UK Sweden Netherlands Spain Germany France (MHRA) (MPS) (CBG-MEB) (AEMPS) (BfArM) (ANSM) Yes 25 a 67 b 2 c 7 d 8 e 15 f 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) 13

Do doctors know how regulators assess medicines safety? Strong Agree + Agree 100% 90% 80% 70% 60% 50% 33% 40% 29% 28% 27% 25% 24% 23% 30% 21% 21% 19% 17% 20% 12% 10% 0% General HIV/AIDS Idiopathic Multiple Osteoporosis & All Practitioners Pulmonary Sclerosis Rheumatoid N.B. Fibrosis Arthritis National Competent Authority European Medicines Agency 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 . 14

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 16