Experiences of patient
reporting in the UK
and other countries
Andrew Herxheimer
UK Cochrane Centre
Health Action International
DIPEx [www.healthtalkonline.org]
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
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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
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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
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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.]
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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/14012010/14Jan2010Repo
rtDirectPatientReportingofADRsFINAL.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 F SF P ES
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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
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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
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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.’
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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.
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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
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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 Safety by A. Avery and colleagues
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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
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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
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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,
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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
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Practical aspects of reporting 2
• 93% found the report easy to complete, but 16
noted difficulties – too little space on form, dropdown 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
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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
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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
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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.
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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?
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