ABSTRACT
Resumo: Desde 1963 que a farmacovigilância foi reconhecida como uma área prioritária na saúde pública a nível global pela Organização Mundial da Saúde, garantindo a monitorização permanente da segurança dos medicamentos. O objetivo deste trabalho foi caracterizar as reações adversas a medicamentos recebidas pela Unidade de Farmacovigilância do Porto (UFPorto), Portugal, ao longo de duas décadas de atividade. Foram consideradas todas as notificações de suspeitas de reações adversas a medicamentos recebidas entre janeiro de 2001 e dezembro de 2019. Foram calculadas as taxas de notificação anuais, assim como a sua distribuição por origem, tipo de notificador e local de exercício da atividade, gravidade, conhecimento prévio e causalidade das reações adversas a medicamentos notificadas. No período em estudo, a UFPorto recebeu 9.711 notificações de suspeitas de reações adversas a medicamentos. As instituições hospitalares são aquelas que mais notificam (n = 6.003; 64%), assim como o médico entre os profissionais de saúde (n = 5.284; 54,4%). Os eventos adversos mais frequentemente reportados são graves (n = 6.275; 72%) e encontram-se descritos no respectivo Resumo das Características do Medicamento (n = 6.978; 72%). À maioria das notificações avaliadas pela UFPorto foi atribuído o grau de causalidade "provável" (n = 7.473; 77%), independentemente do tipo de notificador. Os resultados obtidos são concordantes com outros dados previamente reportados na literatura médica internacional e em relatórios oficiais nacionais. Contudo, continua-se a verificar taxas de subnotificação acentuadas, face ao esperado. Ao longo de aproximadamente 20 anos de atividade da UFPorto, tem-se verificado um aumento da sua atividade nas diversas vertentes da segurança do medicamento.
Abstract: Since 1963, the World Health Organization has acknowledged pharmacovigilance as a priority area in global public health, guaranteeing permanent monitoring of drug safety. This study aimed to characterize the reports of adverse drug reactions received by the Porto Pharmacovigilance Centre (UFPorto), Portugal, in the unit's two decades of work. The analysis included all reports of suspected adverse drug reactions received from January 2001 to December 2019. We calculated the annual reporting rates and distribution by origin, type of notifier and place of work, severity, prior knowledge, and causality of the reported adverse drug reactions. During the study period, UFPorto received 9,711 notifications of suspected adverse drug reactions. Hospital institutions reported the most suspected adverse drug reactions (n = 6,003; 64%), as did physicians among healthcare workers (n = 5,284; 54.4%). The most frequently reported adverse events were severe (n = 6,275; 72%) and are described in the respective Summary of Product Characteristics (n = 6,978; 72%). Most of the reports received by UFPorto were evaluated as having "probable" causality (n = 7,473; 77%), independently of the type of notifier. The results are consistent with other data previously reported in the international medical literature and official national reports. However, the underreporting rates are still higher than expected. In approximately 20 years, UFPorto has experienced an increase in its activity in various areas of drug safety.
Resumen: Desde 1963 la farmacovigilancia fue reconocida por la Organización Mundial de la Salud, como un área prioritaria en la salud pública a nivel global, garantizando la monitorización permanente de la seguridad de los medicamentos. El objetivo de este trabajo fue caracterizar las reacciones adversas a medicamentos recibidas por la Unidad de Farmacovigilancia de Oporto (UFPorto), Portugal, a lo largo de dos décadas de actividad. Se consideraron todas las notificaciones de sospechas de reacciones adversas a medicamentos, recibidas entre enero de 2001 y diciembre de 2019. Se calcularon las tasas de notificación anuales, así como su distribución por origen, tipo de notificador y lugar de ejercicio de la actividad, gravedad, conocimiento previo y causalidad de las reacciones adversas a medicamentos notificadas. En el período de estudio, la UFPorto recibió 9.711 notificaciones de sospechas reacciones adversas a medicamentos. Las instituciones hospitalarias son quienes más notifican (n = 6.003; 64%), así como el médico entre los profesionales de salud (n = 5.284; 54,4%). Los eventos adversos más frecuentemente reportados son graves (n = 6.275; 72%) y se encuentran descritos en lo respectivo Resumen de las Características del Medicamento (n = 6 978; 72%). A la mayoría de las notificaciones evaluadas por la UFPorto se le atribuyó el grado de causalidad "probable" (n = 7.473; 77%), independientemente del tipo de notificador. Los resultados obtenidos son concordantes con otros datos previamente reportados en la literatura médica internacional y en informes oficiales nacionales. No obstante, se continúa verificando tasas de subregistro acentuadas, frente a lo esperado. A lo largo de aproximadamente 20 años de actividad de la UFPorto, se ha verificado un aumento de su actividad en las diversas vertientes de la seguridad del medicamento.
Subject(s)
Humans , Drug-Related Side Effects and Adverse Reactions , Pharmacovigilance , Portugal/epidemiology , Brazil , Adverse Drug Reaction Reporting SystemsABSTRACT
Objective To provide reference for anti-infection treatment and individual pharmaceutical care in patient on peritoneal dialysis. Methods The plasma concentration of vancomycin in patient on peritoneal dialysis was monitored by clinical pharmacists. The anti-infection treatment plan was evaluated and adjusted according to the bacterial culture and drug sensitivity results of the abdominal dialysis fluid. The adverse reactions of pancytopenia induced by vancomycin were documented. Results Infection in the patient on peritoneal dialysis was effectively controlled. The related indicators of pancytopenia were improved. Conclusion A case of pancytopenia induced by vancomycin in the patient on peritoneal dialysis was analyzed to get clinical staff's attention to this adverse reaction and improve the safety of vancomycin administration.
ABSTRACT
BACKGROUND/AIMS: To describe the toxicity profile of anti-neoplastic agents from real clinical settings, we analyzed spontaneously reported adverse events (AEs) using data from the adverse drug reaction (ADR) reporting system of the Korean Food and Drug Administration (KFDA). METHODS: Data were extracted from the nationwide spontaneous ADR reporting system of KFDA from July 2009 to December 2010. We extracted and analyzed data related to chemotherapy and identified unlabeled ADR that were not described in the package insert of the products. RESULTS: In total, 5,867 cases of antineoplastic agent-related AE reports were identified after excluding cases for duplication and cases assessed as 'unlikely' and 'unclassifiable', based on expert opinion. Of the patients with AEs, 52.4% were males and the median age was 56 years. In total, 460 AEs (7.8%) from 267 patients were reported as 'serious' AEs. The most common causative anti-cancer drug class was pyrimidine analogs (31.5%), followed by platinum compounds (19.9%), protein kinase inhibitors (10.8%), and taxanes (8.8%). The most common clinical manifestation of AEs was gastrointestinal toxicities (25.5%), followed by skin disorders (25.3%), and generalized reactions (14.3%). In total, 168 cases (2.9%) of unlabeled AEs were identified. Among these, 10 were reported as serious AEs. CONCLUSIONS: The most common causative class of antineoplastic agents was that of pyrimidine analogs. Gastrointestinal and dermatological toxicities were the most common clinical chemotherapy-related adverse events. Further investigation and monitoring to evaluate causality associated with unlabeled AEs identified in this analysis are needed.
Subject(s)
Humans , Male , Antineoplastic Agents , Drug-Related Side Effects and Adverse Reactions , Expert Testimony , Pharmacovigilance , Platinum Compounds , Product Labeling , Protein Kinase Inhibitors , Pyrimidines , Skin , Statistics as Topic , Taxoids , United States Food and Drug AdministrationABSTRACT
BACKGROUND/AIMS: To describe the toxicity profile of anti-neoplastic agents from real clinical settings, we analyzed spontaneously reported adverse events (AEs) using data from the adverse drug reaction (ADR) reporting system of the Korean Food and Drug Administration (KFDA). METHODS: Data were extracted from the nationwide spontaneous ADR reporting system of KFDA from July 2009 to December 2010. We extracted and analyzed data related to chemotherapy and identified unlabeled ADR that were not described in the package insert of the products. RESULTS: In total, 5,867 cases of antineoplastic agent-related AE reports were identified after excluding cases for duplication and cases assessed as 'unlikely' and 'unclassifiable', based on expert opinion. Of the patients with AEs, 52.4% were males and the median age was 56 years. In total, 460 AEs (7.8%) from 267 patients were reported as 'serious' AEs. The most common causative anti-cancer drug class was pyrimidine analogs (31.5%), followed by platinum compounds (19.9%), protein kinase inhibitors (10.8%), and taxanes (8.8%). The most common clinical manifestation of AEs was gastrointestinal toxicities (25.5%), followed by skin disorders (25.3%), and generalized reactions (14.3%). In total, 168 cases (2.9%) of unlabeled AEs were identified. Among these, 10 were reported as serious AEs. CONCLUSIONS: The most common causative class of antineoplastic agents was that of pyrimidine analogs. Gastrointestinal and dermatological toxicities were the most common clinical chemotherapy-related adverse events. Further investigation and monitoring to evaluate causality associated with unlabeled AEs identified in this analysis are needed.
Subject(s)
Humans , Male , Antineoplastic Agents , Drug-Related Side Effects and Adverse Reactions , Expert Testimony , Pharmacovigilance , Platinum Compounds , Product Labeling , Protein Kinase Inhibitors , Pyrimidines , Skin , Statistics as Topic , Taxoids , United States Food and Drug AdministrationABSTRACT
Background: During 2005, the surveillance system of the Chilean Immunization Program detected an increased number of adverse reaction notifications associated to diphtheria, pertussis and tetanus whole-cell vaccine (DPT), coincidentiy with a change in the vaccine manufacturer. Aim: To compare the reactogenicity of two DPT formulations (vaccines 1 and 2) in 18-month-old infants and 4-year-old children. Material and methods: Severe adverse reactions to DPT were studied at the emergency room of two hospitals of Santiago in a case-control study (110 cases and 171 controls, who consulted for other causes). Simultaneously the incidence of total adverse reactions (mild and severe) for vaccine 1 and 2 was estimated in a cohort of 1,017 children vaccinated in an ambulatory health center of the same área. The formulation of DPT received by all participants was verífied, as well as the temporal relation with consultation or symptoms referred by their caregivers. Results: There was a greater probability of consulting at the emergency rooms for severe adverse reactions among children who received vaccine 1 (odds ratio (OR) =7.1; p <0.001), being greater among 4-year-old children (OR =18.9; p <0.001). Coincidentiy, in the cohort of vaccinated children, those who received vaccine 1 had a higher risk of presenting adverse reactions (RR =2.9; p <0.001), being high fever the commonest. Conclusions: We confirmed that vaccine 1 was associated to a higher risk of adverse reactions, especially among 4-year-old children. These results allowed the sanitary authority to adopt an informed decisión. The usefulness of observational studies in vaccine adverse reactions is confirmed.