Mayra Martho Moura de Oliveira

Background: Pharmacovigilance (PV) is a critical science aimed at enhancing patient safety. For a pharmacovigilance system (PVS) to be effective, it must be robust, efficient, and regularly evaluated to ensure ongoing improvement. Key Performance Indicators (KPIs) are essential quantifiable measures that evaluate the performance of companies, processes, and systems, including pharmacovigilance. Aim: This study aimed to implement and evaluate KPIs for the PVS of a public vaccine producer in Brazil, identifying improvement areas and supporting continuous enhancement. Methods: KPI selection for Instituto Butantan’s PVS was guided by a systematic review and benchmarking with pharmaceutical representatives, followed by validation through expert consensus. A dashboard was created for KPI implementation, with goals, measurements, and evaluation frequency detailed in the institution’s Standard Operating Procedure (SOP). Results: The review identified one KPI for a Marketing Authorization Holder (MAH) PV process. Interviews with pharmaceutical company representatives led to 25 additional KPIs, with one overlapping. After expert review, all KPIs were approved after adjustments, and 10 were piloted, including metrics like the number of individual case safety reports (ICSR), ICSR per product, and serious adverse events (SAE) per product. A dashboard tracked these KPIs monthly in 2022 and 2023. Conclusion: Over two years, KPI evaluations proved valuable, prompting improvements in PV processes and tools. Results indicated that expanding to the remaining KPIs would further enhance Instituto Butantan’s PVS. Pharmacovigilance, Key Performance Indicators (KPIs), Quality Improvement

Background On June 8, 2021, a new 20-valent pneumococcal conjugate vaccine (PCV20, PREVNAR 20^®, Pfizer, Inc.) was licensed for use in adults aged ≥ 18 years by the US Food and Drug Administration (FDA). Objective To describe reports to the Vaccine Adverse Event Reporting System (VAERS) after administration of the 20-valent pneumococcal conjugate vaccine in adults. Methods We searched the VAERS for reports of adverse events involving persons aged ≥ 19 years who received PCV20 during October 20, 2021, through December 31, 2023. Our evaluation included automated analysis of reports, clinical review of serious reports and pre-specified events of special interest, empirical Bayesian data mining to assess for disproportionate reporting, and estimation of reporting rates for reports of Guillain-Barré syndrome (GBS). Results The VAERS received 1976 reports after PCV20 administration in persons aged ≥ 19 years (6% of reports involved serious events). The most common adverse events among persons aged 19–64 years (n = 798) were injection-site reactions (231, 29%), pain (134, 17%), erythema (118, 15%), and fever (117, 15%). For persons aged ≥ 65 years (n = 1178), the most common adverse events were injection-site reactions (417, 35%), pain (180, 15%), pain in extremity (162, 14%), and erythema (158, 13%). A data mining alert (EB05 = 3.812) for the MedDRA Preferred Term “Guillain-Barre syndrome” was observed for serious reports. Clinical review verified 11 of 20 GBS reports; 7/11 vaccine recipients were aged ≥ 65 years. Among the 11 verified cases, the median time from vaccination to symptom onset was 14 days. Five persons received another vaccine on the same visit. The reporting rate of GBS after PCV20 receipt was 0.5 cases per million doses distributed. No other safety concern was identified. Conclusions During the period of this post-licensure review of PCV20, we found most reports were non-serious and comprised mostly local and systemic (e.g., fever) reactions consistent with prelicensure studies. In serious reports, we also identified a data mining alert for GBS after receipt of PCV20, which Centers for Disease Control and Prevention and the FDA are investigating further. No other new or unexpected safety concern was identified.

Resumo O objetivo deste artigo é analisar as taxas de coberturas vacinais em crianças menores de um ano durante o período de 2015 a 2020 no estado de Minas Gerais (MG). Estudo ecológico, de série temporal, sobre as coberturas vacinais em crianças menores de 1 ano, considerando-se como unidade de análise as 28 Gerências/Superintendências Regionais de Saúde (GRS/SRS) de MG. Analisaram-se as coberturas vacinais dos seguintes imunobiológicos vacinas: contra o Bacilo de Calmette e Guérin (BCG), contra rotavírus humano, contra pneumococo 10, pentavalente, contra meningococo C, contra febre amarela e contra a poliomielite. Empregou-se o modelo autorregressivo de Prais-Winsten para análise de tendência. Destaca-se o ano de 2020, que apresentou a menor proporção de GRS e SRS que alcançaram as metas preconizadas de cobertura vacinal para os imunobiológicos analisados. Quanto à análise de tendência da cobertura, 8 das 28 GRS/SRS apresentaram tendência decrescente de, pelo menos, 5 dos 7 imunobiológicos avaliados. Observou-se tendência decrescente na cobertura vacinal de pelo menos cinco imunobiológicos em oito das GRS /SRS, com destaque para a vacina Pentavalente, que apresentou tendência decrescente de cobertura vacinal em 60,71% das GRS e SRS.