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Introduction Pharmacovigilance plays a crucial role in evaluating and monitoring the safety of medicines, which is essential for preventing harm to patients and improving public health. This study aims to compare the pharmacovigilance systems of Costa Rica and Italy and assess the safety profile of coronavirus disease 2019 (COVID-19) vaccines in both countries. Methods Data were collected from the official pharmacovigilance platforms in Costa Rica and Italy. Adverse events following immunization (AEFIs) were categorized by system organ class. Reports of suspected AEFIs associated with COVID-19 vaccines were analyzed for the period from January 1, 2021, to December 31, 2022. Results Both countries achieved high vaccination rates, with 84.9% in Italy and 92.9% in Costa Rica. A higher proportion of AEFIs occurred in females in both countries, with 53% and 65% in Naples and Costa Rica, respectively. Most AEFIs were observed in individuals aged 18-64 years. The rate of serious adverse reactions was lower in both countries than the international average. However, Naples reported a higher incidence of serious events per 100,000 inhabitants. Discussion The study sheds light on the importance of vaccine safety profiling and the significance of a comprehensive understanding of vaccine safety and effectiveness, specific population data, and collaborative strategies to mitigate and improve safety. Additionally, the study highlighted the significance of considering sex and gender when evaluating vaccine safety and efficacy, as sex-specific differences may impact vaccine outcomes. Conclusion Continuous pharmacovigilance efforts, collaborative approaches, and comprehensive data analysis are critical in ensuring vaccine safety and efficacy and safeguarding global public health. Lessons learned from the COVID-19 pandemic highlight the importance of proactive measures in addressing emerging challenges in vaccine safety and rollout programs worldwide.
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BACKGROUND AND OBJECTIVE: The increasing emergence and spread of drug-resistant pathogens resulting from inappropriate antibiotic usage have become more evident in recent years, particularly with the rising incidence of methicillin-resistant Staphylococcus aureus (MRSA) infections. Since joining the Organization for Economic Cooperation and Development (OECD), Costa Rica can now compare its healthcare system with other countries, and similarities have been noted with Italy regarding health indicators. Both nations have universal healthcare systems, covering their entire populations, and hold similar positions in the Human Development Index (HDI). Consequently, the goal is to compare antibiotic prescribing and consumption patterns to collaboratively develop strategies against bacterial resistance. METHODS: In order to compare antibiotic consumption between regions, a standardized contrast was utilized, specifically using the defined daily dose (DDD). An Orthogonal Contrast test was performed to test the means, followed by the application of the Student's t-test on these contrasts. This analysis aimed to assess the potential influence of regions on DDD values. Antibiotic consumption data were collected between January 2021 and December 2022 from the Local Health Authority of Naples 3 South (LHANS) in Italy and IMS Health, Q Quintiles, and VIA by way of (IQVIA) reports in Costa Rica. RESULTS: LHANS shows a considerable disparity in gross expenditure compared to Italy's overall expenditure, while the private sector of Costa Rica exhibits even lower gross expenditure than Italy. Antibiotic consumption in Italy exceeds that of Costa Rica, with Costa Rica's consumption amounting to 47.70% of Italy's total consumption. Additionally, LHANS exhibited a 22.43% higher gross expenditure compared to the Campania region, emphasizing the variability in antibiotic usage within the same country The results indicated no statistically significant differences in antibiotic consumption between the regions, as none of the null hypotheses were rejected. CONCLUSIONS: The study provides valuable insights into expenditure patterns and antibiotic consumption, highlighting the need for improved prescribing practices and awareness campaigns to address the issue of antibiotic resistance. The findings emphasize the importance of implementing international guidelines to combat the growing threat of antibiotic resistance and ensure the effective management of infectious diseases.