Experiences of patient reporting in the UK and other countries

1. Experiences of patient reporting in the UKand other countries Andrew Herxheimer UK Cochrane Centre Health Action International DIPEx [www.healthtalkonline.org]

2. Reporting by patients – the context • Pharmacovigilance developed from the 1960s as a specialised technical area related to medicines regulation and regulatory science • For many years only physicians and then other health professionals were asked to report suspected ADRs • That patients themselves might usefully contribute emerged only in 2000, at the first International Conference on Consumer Reports on Medicines organised by Kilen in Sweden Valladolid 1.10.10

3. How it spread 1 • Consumers and patients began to share experiences, and to communicate better with professionals; the media joined in • It became clear that subjective effects can be described only by those who experienced them. When others reported them they often omitted important details • Patients also described the effects on their lives, not just changes in bodily functions, or ‘seriousness’ in a medical sense • Perhaps we should consider it a human right to be taken seriously Valladolid 1.10.10

4. How it spread 2 • Gradually social scientists using qualitative methods have published research on patients’ experiences, adding a fresh dimension to clinical research • This dimension is still largely missing from the work of regulatory agencies and clinical research in industry • Important examples have broadened understanding especially of the effects of psychotropic medicines Valladolid 1.10.10

5. An example In 2002 a BBC TV programme on the antidepressant Seroxat (paroxetine), led to thousands of phone calls and emails from viewers about their experiences. The words that consumers used were much clearer than those in ADR reports from doctors; the regulators’ rigid coding system had also obscured meaning and caused errors. [Medawar C, Herxheimer A. A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine. Int J Risk & Safety in Medicine 2003/2004; 16: 3-17.] Valladolid 1.10.10

6. A 15-country snapshot • In autumn 2009 Health Action International Europe undertook a brief survey, funded by the EU Exec. Agency for Health & Consumers [http://www.haiweb.org/14012010/14Jan2010ReportDirectPatientReportingofADRsFINAL.pdf] Experts in regulatory agencies and NGOs in 15 countries were interviewed by phone, email or in person • 8 countries accept direct patient reporting: NL DK I S UK N B USA • 7 countries don’t accept it: CH D EIR FSF P ES Valladolid 1.10.10

7. Diverse national experiences: NL • Lareb, an independent foundation, does all pharmacovigilance work for the Dutch regulatory authority, collecting patient reports since 2003 • The 2,500 patients’ reports for 3 years were compared with those from professionals. Patients reported more life-threatening ADRs and more disability; they more often noted outcomes and non-recovery. • 70% of cases were followed up • People are altruistic and cooperate willingly • The Lareb board now includes 3 patient representatives Valladolid 1.10.10

8. Diverse national experiences:DK • Patient reporting began in 2003 • The Danish Medicines Agency gets several hundred reports a year from patients • A PhD thesis comparing reports from professionals and patients has noted differences especially in neurological ADRs • Reports published in the media have stimulated consumer reporting • 20 cases of severe kidney toxicity from gadolinium radiological contrast medium led to a national Action Plan in 2009 to reduce barriers to reporting Valladolid 1.10.10

9. Diverse national experiences:Italy • Since 2004 patients can download an ADR reporting form from the regulatory agency website, complete it and send it to their health district’s pharmacovigilance centre • Direct letters too have led to regulatory action, eg on light sensitivity to topical ketoprofen and on the packaging of paracetamol for children • The consumer organisation Altroconsumo says: ‘If adequately stimulated, patients respond in great numbers and provide accurate and detailed reports.’ Valladolid 1.10.10

10. Diverse national experiences:F, D F Patients are not encouraged to report ADRs. People who send a report to their pharmacovigilance centre are asked for medical validation, but few want to discuss a problem with someone who may have caused it. A joint project of the regulatory agency (AFSSAPS) with patient organisations was partly successful but not a satisfactory model. A decree enabling patients to report ADRs should be published by April 2010 D Allowing direct reporting by consumers has not been publicly discussed. The regulators require medical validation. Valladolid 1.10.10

11. Beginnings in the UK • 2003 MHRA started a pilot scheme for patients to report ADRs indirectly to nurses at a telephone call centre – results disappointing • 2004 review of access to the Yellow Card Scheme recommended piloting of systems for direct patient reporting of ADRs • 2005 nationwide scheme launched, but few reports • 2008 re-launch after redesign of paper forms and web site; Nat Inst of Health Research (NIHR) commissions a broad research programme to evaluate patient reporting Valladolid 1.10.10

12. The NIHR evaluation* • Reviewed the relevant published literature • Analysed Yellow Card data for patients and health professionals – describing the characteristics and qualitative features of their reports • Assessed their contribution to pharmacovigilance • Studied the experiences and opinions of patients and on reporting, and public awareness of the Yellow Card scheme *many of the results are published in the Sept 2010 issue of Drug Safetyby A. Avery and colleagues Valladolid 1.10.10

13. Aims - to: • evaluate the pharmacovigilance impact of patient reporting to the yellow card system • report on patient experiences of the yellow card system • assess public awareness of being able to report to the yellow card system • offer recommendations for improvements to patient reporting Valladolid 1.10.10

14. Contribution to ‘pharmacovigilance’ 1 Among reports from 5180 patients & 21,000 from professionals • Word count was greater in patients’ reports than in those from professionals • Patients report a different spectrum of reaction types from professionals, and differ in the types of drugs most often reported • Among professionals’ reports serious ADRs (life-threatening, death, hospitalisation) were more frequent • Patients took longer to report their reactions – median 104 days v 34 for professionals Valladolid 1.10.10

15. Contribution to ‘pharmacovigilance’ 2 • In the pooled reports additional signals followed the inclusion of patient reports; 10% of the signals from professional reports no longer reached the signal threshold in the pooled data • Patients more often reported symptoms, the impact of the ADR, the time relationship between drug and suspected ADR, the intensity/severity of the suspected ADR • In depth qualitative analysis found detailed descriptions of symptoms, their social, emotional & occupational effects, Valladolid 1.10.10

16. Practical aspects of reporting 1 Between March 2008 and Jan 2009 the MHRA sent questionnaires to people soon after they had made a report, asking • How easy they found it to make a report • Any difficulties they met in making a report • Suggestions for improving the reporting system • Median age 57 years, 67% women, 94% white • 68% educated beyond school Valladolid 1.10.10

17. Practical aspects of reporting 2 • 93% found the report easy to complete, but 16 noted difficulties – too little space on form, drop-down menu hard to navigate • 33% expected feedback from the MHRA, and 60% would have liked feedback • 50% had learned about the reporting scheme from pharmacists, 16% from GP, 11% from web Valladolid 1.10.10

18. Suggestions for improvement A sample of questionnaire respondents were interviewed by telephone • they gave their reasons for reporting • Most wanted the scheme more widely advertised • Most would encourage others to report so that more reports would be generated & more side effects known and listed Different subgroups preferred reporting on paper, on the internet and by telephone, so all three methods should be available Valladolid 1.10.10

19. Why do it?Patients’ reports add value • They are more direct and give more and better context than indirect reports from professionals • They commonly describe the impact on people’s lives, which clinicians rarely note • Indirect and direct reports complement each other, generating multicultural knowledge • Knowledge of ADRs and their importance accumulates faster • Patients become active participants in their care • Patients learn how to manage their medicines and to communicate better with professionals Valladolid 1.10.10

20. Conclusions Groups in many countries have been trying to collect ADR reports from patients, but most have done it in isolation from each other and not shared their experience systematically. There is no quick and easy way of doing it. Commitment and adequate resources are needed to undertake systematic studies. Patients and professionals must work together and need feedback to convince them that what they are doing is valuable. Good clear communication is essential between authorities, scientists, health professionals and the public. Valladolid 1.10.10

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23. Suggestions for discussion 1. Does your organisation support direct patient reporting? If not, why? 2. Which initiatives/measures could contribute to raise awareness of direct patient reporting in country, at national level?  3. Which formats should be available for direct patient reporting? 4. How could data retrieved from direct patient reporting feed future activities aimed at consumer/patient health literacy? Valladolid 1.10.10