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Microsoft powerpoint - andrewherxheimer_patientreporting.ppt
• They are more direct
and give more and better
than indirect reports from professionals
• They commonly describe the impact on
which clinicians rarely note
• Indirect and direct reports complement
other, generating multicultural
of ADRs and their importance
• Patients become active
participants in their care
• Patients learn how to manage their medicines
and to communicate better
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 regulatory agency’s 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.
• In autumn 2009 Health Action International
Europe undertook a brief survey, funded by
the EU Exec Agency for Health & Consumers
• Experts in regulatory agencies and NGOs in
7 countries accept direct patient reporting:
NL DK I S UK B USA
AUS CH D EIR F
• Lareb, an independent foundation, does all
pharmacovigilance work for the Dutch regulatory
authority. Since 2003 it collects patient reports
• The 2,500 patients’ reports during 3 years were
compared with those from professionals. Patients
reported more life-threatening ADRs and more
disability; they more often noted outcomes and non-
• Follow up was possible in 70% of cases where needed
• People are altruistic and cooperate willingly
• The Lareb board now includes 3 patient representatives
• Patient reporting began in 2003 when the law allowed it
• The Danish Medicines Agency gets several hundred
reports a year from patients
• Several PhD theses have compared reports from
professionals and patients, with differences noted
especially in neurological ADRs
• Reports published in the media have stimulated
• 20 cases of severe kidney toxicity from gadolinium
radiological contrast medium led to a national Action
Plan in 2009 to reduce barriers to reporting
• Since 2004 patients can download an ADR reporting
form from the AIFA (regulatory agency) website,
complete it and send it to their health district’s
• 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.’
• KILEN, a voluntary organisation, has worked on
issues of dependence, side effects and injuries
related to medicines, particularly psychotropic
drugs. In 1997 it established a database to enable
consumers to share such experiences. In 2000 it
held the 1st International conference on Consumer
Reports on Medicines.
• In 2008 the Medical Products Agency added an
interactive section to its website for people to report
ADRs on the site.
• The first 400 reports received were compared with
those from professionals; more of them concerned
psychiatric disorders and drugs.
• In 2005 the MHRA launched a small pilot scheme for
patient reporting of ADRs. The response was
disappointing and a broad evaluation of patient
reporting was commissioned. It will be completed
• In 2008 greater efforts were made to make people
aware of patient reporting and to increase the
number of reports. In late 2009 the MHRA receives
about 100 reports a month.
• The reports have contributed some useful signals,
insights and quality of life experiences
• 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
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
The European Commission’s initiative to
allow and encourage spontaneous patient reporting is welcome.
Reporting should be possible not only via
a web portal but also by e-mail, telephone and letter.
This research arises from the
Developing Rational Use of Medicines in Europe project,
which has received funding from the European Union
in the framework of the Health programme.
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