Abstract
Purpose: The concept of Pharmacovigilance (PhV) evolved to improve patient safety and the quality of provided healthcare. Community pharmacists are considered to be key players in the process of PhV and reporting adverse drug reactions (ADRs).The aim of this study is to assess the knowledge, attitude, and practice of community pharmacists in relation to pharmacovigilance and adverse drug reactions. Study Design: A cross sectional study. Subjects and Methods: An observational cross-sectional survey was carried out among community pharmacists in Sudan to evaluate their knowledge, attitude and practice (KAP) towards Pharmacovigilance. The study was carried out between March and May 2020, including 201 community pharmacists who were selected through simple random sampling. A self-administered questionnaire was used as a data collection tool. Statistical analysis was carried out using SPSS software version 24. Results: A total of 201 community pharmacists were included in the survey. Females constituted 68.7% of the study participants. Two-thirds of the study population were between 23 and 30 years of age. The majority had a career experience between 1 and 5 years (52.2%). The mean knowledge score among males was 3.48 (± 1.51), and 3.75 (± 1.36) among females. The difference in the mean knowledge score between the two genders was not statistically significant (p-value 0.197). 73.1% showed a positive attitude towards Pharmacovigilance. The mean attitude score was higher among females (2.97 vs 2.90). However, the difference was not statistically significant (p-value 0.662). Conclusion: Community pharmacists may have a prominent role in responding to the increase of ADR reporting if they have enough knowledge about Pharmacovigilance and how to report it. This survey showed that community pharmacists had a positive attitude about ADR but, unfortunately, many of them had insufficient knowledge.
Highlights
The World Health Organisation (WHO) defines adverse drug reaction (ADR) as “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function” (WHO,1972)
A total of 201 community pharmacists were included in the survey with a response rate of 88.2%
When compared to the results obtained in this study, we find that there is a noticeable difference when it comes to understanding the concept of PhV. 26.4% of the enrolled study participants were aware of the WHO definition of PhV
Summary
The World Health Organisation (WHO) defines adverse drug reaction (ADR) as “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function” (WHO,1972). Despite the intense phases of study that a drug goes through to ensure its safety before being registered, ADR continues to be inevitable. This can be attributed to the fact that the pre-marketing studies don’t include all age groups, ethnicities and other unforeseen variables that may play a role in developing ADR (Gautier, 2003). In 2008, Sudan joined the WHO PIDM (Isah, 2012).reporting to the PVC remains to be weak. In Sudan, community pharmacists are considered to be accessible and affordable healthcare providers. This study was carried out with the primary objective to evaluate the knowledge, attitude and practice (KAP) of community pharmacists in Khartoum, the capital city of Sudan, towards PhV and reporting of ADR
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