The study of completeness and quality of adverse drug reaction reports at Health Development Centre in Mongolia

Abstract

Background: Mongolia has listed as 149th full membership of Uppsala Monitoring Centre, WHO collaborating centre. Aim of this study was to analyse completeness and quality of information of ADRs reporting forms gathered in 2015-2020 at Health Development Centre. Aim: As a result, adverse drug reactions reported in Mongolia were available to be submitted into the WHO global database and an opportunity was set for medicines safety information sharing promptly. Materials and Methods: A total of 438 ADRs forms which were registered in period 2015-2020 were analysed. A minimum requirement for completeness and quality data of ADRs reporting forms developed by UMC was used in the study. Results: Among total of registered cases with ADR 32.6% of them were male and 67.4% of them were female patients. In the regard of filling out required fields of ADR reporting form, 98.6% of age, 99.5% of gender and 88.4% of body weight in patient information section and 95.2% of drug name, 99.5% of drug dosage form and 81.3% of drug dose in drug with ADR information section were filled out properly. In contrary ADR ending, information section of ADR reporter and reporting hospital fields were insufÏciently filled out. Conclusion: Although the ADRs reporting has been improving in recent years, this study had some limitation because of incomplete data or poor-quality forms. Thus, continuous training on the importance of submitting ADRs reporting form with well-completed is necessary for healthcare professionals.