Factors associated with underreporting of adverse drug reactions by healthcare professionals in Rwanda

Abstract

Background: Adverse Events (AE) place a substantial financial burden on the healthcare system and significantly increase patient morbidity and mortality. Spontaneous or voluntary reporting is a Valuable method in Adverse Events surveillance and provides information on medication errors, drug interactions, and risk factors. It is a suitable passive surveillance method of detecting new, uncommon, or serious adverse events and so enhancing patient safety. The majority of safety alerts are based on evidence gathered from collection and collating numerous independent cases reports.

Under-reporting, or the situation where all instances of adverse events (AE) are not reported through the established system, is a well-known issue for different pharmacovigilance center. Under reporting of adverse events (AE) hinders efforts to detect and assess the severity of drug-associated risks, as well as the setting up of necessary preventive action. The purpose of this study is to identify the possible factors that slow down the reporting of Adverse Events by healthcare professionals in Rwanda.

Method: A cross-sectional research involving 169 healthcare professionals from various hospitals around the country was conducted using a questionnaire. A series of ten questions were utilized to obtain information on participants' socio-demographic characteristics as well as personal and health system-related factors of healthcare professionals that may influence AE reporting. Respondents were asked to select an answer from a list of predefined possibilities and were allowed to remark or comment for clarification. The Chi-square test and logistic regression models were utilized to determine the relationship between the independent variables and AE reporting.

Results: Overall, 74.56% (n=126) of the 169 participants had observed a patient with an Adverse Event; however, only, 41.91% (n= 57) of them had ever reported detected AE to the responsible unit or individual. Receiving training in pharmacovigilance (OR = 4.61; CI = 2.02–10.54) and being experienced (OR = 3.56; CI = 1.12–11.32) had higher odds of reporting AE. Additionally, Those with the conviction that “Reporting AE is a part of pharmacist duty only” (AOR= 0.06; 95CI= 0.01-0.28) had 94% less odds of reporting AE, Healthcare professionals who believe that “It is not necessary to report AE because they are already known when the vi drugs are authorized to the market” (AOR = 0.11;95CI= 0.02-0.55), had 89% less odds of reporting AE compared to their counterpart. Respondents who said yes “the reporting forms are not available and easily accessible” (AOR = 0.12;95CI= 0.02-0.68), “lack of knowledge on how to report AEs” (AOR = 0.11;95CI=0.01- 0.88), and "having insufficient knowledge in detecting AE (AOR = 0.17;95CI= 0.03-0.89), had less odd of reporting AE. Paradoxically, “lack or delayed feedback after reporting AE from relevant authorities” (AOR = 9.78;95CI= 1.55-61.56), and two personal factors namely "the claim that reporting process is time-consuming (AOR = 11.59, CI= 2.14 - 462.8) and the conviction that patient confidentiality may be lost by reporting AEs (AOR = 16.89;95CI= 1.30-220.30) had higher odds of AE reporting

Conclusion: The study identifies several factors contributing to underreporting of Adverse Events (AE) in Rwanda. Health system-related factors include the belief that only pharmacists are responsible for reporting, knowledge in AE detection, availability of reporting tools, and lack of feedback from responsible units. Personal factors like time constraints and patient confidentiality issues also play a role. Addressing these issues is crucial for improving the AE surveillance system in Rwanda.