Consumers' adverse drug event reporting via community pharmacists: three stakeholder perception.

BACKGROUND: Adverse drug event (ADE) reporting is a significant process to increase consumer care and consumer safety associated with the use of medicines. An in-depth investigation into low ADE reporting by consumers and community pharmacists was undertaken to uncover interventions to improve reporting. METHOD: In-depth interviewing of the three parties; consumers, pharmacists and employees of the Pharmacovigilance Center in Thailand, was used to collect the data. They were interviewed about ADE reporting experiences and contributing factors and problems of ADE reporting. Thematic analysis was used to interpret the results. RESULT: The HPVC received few ADE reports from consumers. Most community pharmacists received ADE reports from consumers; however, the Pharmacovigilance Center received few ADE reports from community pharmacists. ADE reporting of community pharmacists and consumers were influenced by many factors which were categorized into four themes which were (1) "Cognition" (awareness, attitude and responsibility); (2) "Reporting process" (complication, competency, information deficiency, feedback, and resource); (3) "Inducer" (service orientation, acquaintanceship, motivation, severity level, regulatory and reward); and (4) "Obstacle" (doubt, belief and prosecution). CONCLUSION: Health professionals should motivate consumers to report ADEs. Building social responsibility and benefits and increasing knowledge of reporting process, channels, and system to both community pharmacists and consumers were recommended. Providing rewards and making community pharmacists feel comfortable to report ADEs by simplifying the ADE form and providing training, guidelines, and an ADR assessment tool can drive them to report ADEs. Feedback to consumers by confirming whether it was ADE and feedback to pharmacists that the Pharmacovigilance Center received their reports and their reports were utilized were also important.

Factors influencing patient intention to report adverse drug reaction to community pharmacists: A structural equation modeling approach.

BACKGROUND: Under-reporting of adverse drug reactions (ADRs) is the main problem of spontaneous ADR reporting systems, especially reporting from community pharmacists. However, community pharmacists cannot report ADRs if patients do not report them. OBJECTIVE: To investigate factors that can influence patients' intention to report ADRs to community pharmacists and to develop a structural model of influencing factors to report ADRs from patients. METHOD: Self-administered questionnaire via a Google form was used. The study samples were people living in all regions of Thailand. Structural equation modeling (SEM) was used to determine the influencing factors to intention to report ADRs to community pharmacists. RESULTS: A total of 2774 responses were collected. All Pearson correlations among variables were statistically significant. The correlation between intention to report ADR and instrumental attitude was highest. Perceived behavior control had the lowest correlation with intention to report ADRs. The structural equation model was an adequate fit for the data. Intention to report ADRs to community pharmacists was significantly influenced by instrumental attitude, injunctive norm, descriptive norm and self-efficacy. CONCLUSION: Positive attitude of ADR reporting, self-efficacy and their reference person such as physicians, community pharmacists, their families and friends could encourage and motivate their intention to report ADRs to community pharmacists.