Background and objective : Nowadays, many countries over the world, patients increasingly involve in self-reporting of Adverse Drug Reactions (ADRs) to pharmacovigilance centre. There were limited studies relating to how patients view on this reporting system. Therefore, this study aimed to explore their attitude towards ADR self-reporting system by themselves and other related factors.
Methods : This descriptive study was conducted at university hospitals, Srinagarind hospital and Queen Sirikit Heart Center of the Northeast. The out-patients, aged over 18 years old, had taken statins at least 1 month, received self-administered questionnaires to rate attitude towards patient self-reporting of ADRs. A total of 12 attitudinal questions, consisted of equal numbers of positive and negative statements, were rated on 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Scores were conversely assigned for negative statements before summarizing total score (Min-Max=10-60).
Results : The response rate of valid questionnaire was 51.7%. There were 645-661 patients who gave responses in each statement but 615 patients responded to all 12 statements. Patients mostly had moderate to high scores of attitude towards self-reporting of ADRs (Mean total score±S.D.=42.37±5.54). In positive statement, most patients (89.2%) agreed or strongly agreed that they were prepared for ADR reporting by regularly monitoring themselves. In negative statement, patients frequently disagreed or strongly disagreed that participation in ADR reporting was wasting their time (86.0%). Attitude towards this reporting system was significantly affected by number of comorbid diseases (p=0.030) and experienced ADRs (p=0.022).
Conclusions : Generally, patients had positive attitude towards self-reporting of ADRs. Although they perceived their potentials in making ADR reports, provision of information about comorbid diseases and drugs should also be improved.