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.
OBJECTIVE
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.
van Hunsel
Florence
F
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands. vanhunsel@lareb.nl
Passier
Anneke
A
van Grootheest
Kees
K
D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D001291:Attitude of Health Personnel; D003146:Communications Media; D016903:Drug Monitoring; D064420:Drug-Related Side Effects and Adverse Reactions; D005069:Evaluation Studies as Topic; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006331:Heart Diseases / Q000188:drug therapy*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D009426:Netherlands; D010817:Physician-Patient Relations; D011788:Quality of Life; D012307:Risk Factors
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors