Microsoft powerpoint - andrewherxheimer_patientreporting.ppt
• 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
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 Netherlands
• 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- recovery.
• 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 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
• 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 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.’
• 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. United Kingdom
• 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 shortly.
• 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 France, Germany
• 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. Conclusion
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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