RESUMO
During the SARSCoV-2 pandemic many drugs have been used as potential treatments in order to improve the clinical outcome and reduce the mortality. But since it is a currently unknown disease, the evidence about efficacy and safety is built as the drugs are prescribed. In this context, intensive pharmacovigilance allows early detection of adverse events, and thereby infer the safety profile of the indication. We conducted an observational, retrospective, single-center study involving adult patients with severe SARS-CoV-2 infection. All adverse events detected in 23 patients in the Intensive Care Unit between March 15 and June 15, 2020 were registered. We describe type and severity of the adverse events and if treatment suspension was needed. The results show a high rate of adverse events (10/23, 43%) in treatment with lopinavir/ritonavir. In most cases early treatment suspension was required. Even though the limitations of our study derived from the small sample size, these results could help in building evidence about the safety of using lopinavir/ritonavir for severe SARS-CoV-2 infection.
Durante el transcurso de la pandemia causada por el virus SARS-CoV-2 se han utilizado diferentes fármacos como potenciales tratamientos específicos con el objetivo de lograr mejoría clínica y/o disminuir la mortalidad de los afectados, pero al tratarse de una enfermedad hasta ahora desconocida, la evidencia acerca de su seguridad y eficacia se va construyendo a medida que se los prescribe. La farmacovigilancia intensiva en este contexto permite detectar eventos adversos y mediante su reporte y análisis inferir el perfil de seguridad en cada indicación. Se realizó un estudio observacional, retrospectivo, en un único centro, en el cual se relevaron los eventos adversos en 23 pacientes adultos en estado crítico, de los cuales 18 recibieron lopinavir/ritonavir como tratamiento empírico, entre el 15 de marzo y el 15 de junio de 2020, durante su internación en una Unidad de Cuidados Intensivos. Se describe el tipo de eventos adversos, su gravedad y si fueron motivo de suspensión del tratamiento. Los resultados del presente análisis muestran una alta tasa de eventos adversos (10/23, 43%) entre los que recibieron lopinavir/ritonavir, llevando en la mayoría de los casos a la decisión de suspender el mismo antes de completar el tratamiento. Aun con las limitaciones propias del reducido número de casos, la divulgación de dichos resultados aporta evidencia para definir el perfil de seguridad de la combinación lopinavir/ritonavir usado en enfermedad grave por SARS-CoV-2.
Assuntos
Infecções por Coronavirus/tratamento farmacológico , Inibidores do Citocromo P-450 CYP3A/efeitos adversos , Lopinavir/efeitos adversos , Pneumonia Viral/tratamento farmacológico , Ritonavir/efeitos adversos , Adulto , Idoso , Argentina/epidemiologia , Betacoronavirus , COVID-19 , Infecções por Coronavirus/epidemiologia , Estado Terminal , Inibidores do Citocromo P-450 CYP3A/uso terapêutico , Feminino , Humanos , Lopinavir/uso terapêutico , Masculino , Pandemias , Pneumonia Viral/epidemiologia , Estudos Retrospectivos , Ritonavir/uso terapêutico , SARS-CoV-2 , Resultado do Tratamento , Tratamento Farmacológico da COVID-19RESUMO
Resumen Durante el transcurso de la pandemia causada por el virus SARS-CoV-2 se han utilizado diferentes fármacos como potenciales tratamientos específicos con el objetivo de lograr mejoría clínica y/o disminuir la mortalidad de los afectados, pero al tratarse de una enfermedad hasta ahora desconocida, la evidencia acerca de su seguridad y eficacia se va construyendo a medida que se los prescribe. La farmacovigilancia intensiva en este contexto permite detectar eventos adversos y mediante su reporte y análisis inferir el perfil de seguridad en cada indicación. Se realizó un estudio observacional, retrospectivo, en un único centro, en el cual se relevaron los eventos adversos en 23 pacientes adultos en estado crítico, de los cuales 18 recibieron lopinavir/ ritonavir como tratamiento empírico, entre el 15 de marzo y el 15 de junio de 2020, durante su internación en una Unidad de Cuidados Intensivos. Se describe el tipo de eventos adversos, su gravedad y si fueron motivo de suspensión del tratamiento. Los resultados del presente análisis muestran una alta tasa de eventos adversos (10/23, 43%) entre los que recibieron lopinavir/ritonavir, llevando en la mayoría de los casos a la decisión de suspender el mismo antes de completar el tratamiento. Aun con las limitaciones propias del reducido número de casos, la divulgación de dichos resultados aporta evidencia para definir el perfil de seguridad de la combinación lopinavir / ritonavir usado en enfermedad grave por SARS-CoV-2.
Abstract During the SARS-CoV-2 pandemic many drugs have been used as potential treatments in order to improve the clinical outcome and reduce the mortality. But since it is a currently unknown disease, the evidence about efficacy and safety is built as the drugs are prescribed. In this context, intensive pharmacovigilance allows early detection of adverse events, and thereby infer the safety profile of the indication. We conducted an observational, retrospective, single-center study involving adult patients with severe SARS-CoV-2 infection. All adverse events detected in 23 patients in the Intensive Care Unit between March 15 and June 15, 2020 were registered. We describe type and severity of the adverse events and if treatment suspension was needed. The results show a high rate of adverse events (10/23, 43%) in treatment with lopinavir/ritonavir. In most cases early treatment suspension was required. Even though the limitations of our study derived from the small sample size, these results could help in building evidence about the safety of using lopinavir/ritonavir for severe SARS-CoV-2 infection.
Assuntos
Humanos , Masculino , Feminino , Adulto , Idoso , Pneumonia Viral/tratamento farmacológico , Infecções por Coronavirus/tratamento farmacológico , Ritonavir/efeitos adversos , Lopinavir/efeitos adversos , Inibidores do Citocromo P-450 CYP3A/efeitos adversos , Argentina/epidemiologia , Resultado do Tratamento , Estado Terminal , Infecções por Coronavirus/epidemiologia , Pandemias , Lopinavir/uso terapêutico , Inibidores do Citocromo P-450 CYP3A/uso terapêutico , Betacoronavirus , SARS-CoV-2 , COVID-19RESUMO
Adverse drug events are frequent and may be mitigated with the implementation of functionalities within Health Information Systems. We developed a tool that allows Pharmacists to register and communicate to providers potential errors in prescribed drugs in terms of medication omission, unjustified stop of medication or other reasons. We included all interventions performed by Pharmacists for admitted patients between July, 31st 2018 and October, 23rd 2018. During the study period, 193 interventions were carried out by Pharmacists. 117 (60%) were intended for registering medication omission, 7 (4%) for unjustified stop of medication and 69 (36%) for other reasons. 112 interventions lead to the provider performing the suggested action (58%), 77 (40%) were rejected and 4 (2%) required no action. Although there were errors in the use of the tool, a great amount of interventions were accepted, thus representing a better quality of care for patients.
Assuntos
Farmacêuticos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Hospitalização , Humanos , Erros de MedicaçãoRESUMO
While medications can improve the health of patients, the prescription process is complex and prone to errors. The structured medical order entry systems (CPOE) with clinical decision support (CDS) are increasingly implemented to improve patient safety, however the organizations that decide to implement them will have several challenges: understanding which classes of CDS can admit their systems, ensure that clinical knowledge is adequate and design tools for proper monitoring. We share our experience of over ten years of development and implementation of clinical decision support tools during drugs prescription process and tools that have allowed us to monitor them correctly.