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Comparing patients' and healthcare professionals' ADR reports after media attention: the broadcast of a Dutch television programme about the benefits and risks of statins as an example
Author(s) -
Van Hunsel Florence,
Passier Anneke,
Van Grootheest Kees
Publication year - 2009
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2009.03400.x
Subject(s) - pharmacovigilance , seriousness , discontinuation , medicine , adverse drug reaction , family medicine , health professionals , health care , drug reaction , drug , medical emergency , pharmacology , psychiatry , political science , law , economics , economic growth
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • More and more countries accept patient reporting in their spontaneous reporting systems. • Media exposure about drugs can influence patients and health professionals. • Evaluation of patient reporting of adverse drug reactions is needed to provide further evidence of its benefits. WHAT THIS STUDY ADDS • Patient reporting compared with reporting by health professionals after media attention about statins. • Patient reports provide additional insight into impact on daily life, the patient–health professional relationship and general worries next to health professionals' reports. AIMS To compare adverse drug reaction (ADR) reports from patients and health professionals after the broadcast of a Dutch television consumer programme about the benefits and risks of statins. METHODS We performed a quantitative and qualitative analysis on patients' and health professionals' reports of ADRs to statins. These reports were received by the Netherlands Pharmacovigilance Centre Lareb between March 2007 and August 2007. Quantitative data consisted of patient age and gender, number of received reports and characteristics of the report (most frequently reported ADRs, seriousness, drug discontinuation and outcome of the reported reaction). Open text fields in the ADR reporting form were categorized and a content analysis was carried out. RESULTS Media attention led to a peak in patient reporting of ADRs but not in reporting by health professionals. There were no differences between patient and health professional reports in seriousness of the ADRs and drug cessation. Patients reported nonrecovery more often than health professionals. The TV programme is mentioned as a reason for drug discontinuation in almost 30 reports. Patients often felt that they did not receive sufficient information and that their concerns were not adequately addressed by healthcare professionals. CONCLUSIONS Media attention affects drug use and ADR reporting by patients. Patient reports can provide additional information, making them a useful source of information next to health professional reports. Content analysis provides vital insights into the impact of statins on daily life, and patients' concerns about adverse reactions should be recognized in reports to national pharmacovigilance centres.