Abstract
Risk communication associated with drug use is a critical point in post-marketing surveillance. Therefore, validation of strategies to minimize under-reporting of adverse drug events (ADE) are needed in order to contribute towards good pharmacovigilance practices. The present study aims to validate a multi-faceted educational intervention (MEI) in pharmacovigilance for Mercosur countries and assess its impact on particular attitudes, knowledge, and skills to correctly complete the ADE form to ensure quality of reports. The MEI was developed during four one-hour meetings. The following activities were carried out: a lecture regarding landscape; importance and concepts related to pharmacovigilance; classroom practice for elucidating the correct completion of ADE reports; distribution of an educational manual and completion of a questionnaire to assess knowledge, attitudes, and skills in pharmacovigilance. The answers of the questionnaire were analyzed using a content analysis technique. Definitions from the World Health Organization and the minimum and desired criteria to fill the ADE form, according to the Pan American Health Organization, were considered gold-standard answers. The impact of the MEI was analyzed by a Wilcoxon statistical test. 82 subjects were enrolled and sixteen returned questionnaires. Since after the methodology there were also fifteen reports of medication error, the MEI did contribute to the improvement of knowledge (p<0.002), skills (p=0.002) and attitude in pharmacovigilance. The proposed MEI may contribute to risk management, as it enhanced the quantity and quality of the reports. Furthermore, it can be used to effectively harmonize pharmacovigilance practices in Latin American countries. Key words: Adverse drug reaction reporting systems, drug-related side effects and adverse reactions, pharmacovigilance, attitude of health personnel, risk management.
Highlights
The tradition of pharmacovigilance in Latin America is relatively recent, since most countries have initiated postmarketing drug surveillance systems in the 1990s (Pérez-Garcia and Figueiras, 2011)
The major cause of poor adherence of Latin American health professionals (Venezuela) in spontaneous reporting is the lack of knowledge; there is a need for development of interventions that clarify the concepts related to pharmacovigilance, and can be used to improve the adverse drug events (ADE) reporting rate (Pérez-Garcia and Figueiras, 2011)
A multi-centric, longitudinal, prospective, uncontrolled, and noblinded study was performed in six institutions in order to validate educational intervention for health professionals who act in tertiary levels of health care for Mercosur members
Summary
The major cause of poor adherence of Latin American health professionals (Venezuela) in spontaneous reporting is the lack of knowledge; there is a need for development of interventions that clarify the concepts related to pharmacovigilance, and can be used to improve the ADE reporting rate (Pérez-Garcia and Figueiras, 2011). Studies performed in European countries show that continuing education in pharmacovigilance contributes to the increase of ADR reporting rates, and improves the quality of reports (López-González et al, 2015; González-González et al, 2013; Biagi et al, 2013; Herdeiro et al, 2012; Cereza et al, 2010; Pedrós et al, 2009; Herdeiro et al, 2008; Herdeiro et al, 2006; Figueiras et a., 2006; Herdeiro et al, 2005; Bäckström et al, 2002). This study promotes signals detections, assessment of ADR causal association, analysis of quality of pharmaceutical products, prevention of medication errors, and in the risk management associated with drug use for market regulation
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