Utilización y farmacovigilancia de inmunoglobulina G endovenosa en un hospital pediátrico de alta complejidad / Intravenous immunoglobulin G use and pharmacovigilance in a tertiary care children's hospital

Introducción. La inmunoglobulina G endovenosa (IGEV) es un medicamento hemoderivado de inmunoglobulina G polivalente y policlonal. Posee un amplio espectro de indicaciones como inmunomodulador o como terapia de reemplazo. Asimismo, si bien se considera un tratamiento seguro, la incidencia de reacciones adversas reportadas en la literatura varía del 1 % al 81 %. Este trabajo tuvo como objetivo evaluar la utilización de IGEV y describir los acontecimientos adversos por la medicación en un hospital pediátrico de alta complejidad.Población y métodos. Se realizó un estudio de farmacoepidemiología, observacional y prospectivo. Se evaluaron pacientes que recibieron IGEV durante 7 meses, en 6 áreas de un hospital pediátrico de alta complejidad de la Ciudad Autónoma de Buenos Aires. La unidad de análisis fue cada infusión de IGEV, y la principal variable de estudio fue la presencia de reacciones adversas.Resultados. Se analizaron 305 infusiones en 111 pacientes. El 81,6 % de las indicaciones fueron de tipo supletorio. La dosis máxima utilizada fue 1 g/kg. En el 99,6 % de las infusiones, se indicó algún tipo de premedicación; la difenhidramina fue la droga más utilizada, aunque con diferentes posologías. Se registraron 12 reacciones adversas (el 3,9 % de las infusiones), tres de las cuales se consideraron graves: dos meningitis asépticas y una crisis comicial. Todas se resolvieron ad integrum.Conclusiones. La tasa de reacciones adversas de la IGEV en nuestro medio fue baja, con mayoría de reacciones leves e inmediatas y evolución favorable en todos los pacientes.

Introduction. Intravenous immunoglobulin G (IVIG) is a blood product from polyvalent and polyclonal immunoglobulin G. It covers a broad range of indications as immunomodulator or replacement therapy. In addition, although it is considered a safe therapy, the incidence of adverse reactions reported in the bibliography ranges from 1 % to 81 %. The objective of this study was to assess IVIG use and describe related adverse events in a tertiary care children's hospital.Population and methods. This was a pharmacoepidemiological, observational, and prospective study. Patients receiving IVIG for 7 months in 6 areas of a tertiary care children's hospital in the Autonomous City of Buenos Aires were assessed. The analysis unit was each IVIG infusion, and the main variable was the presence of adverse reactions.Results. A total of 305 infusions in 111 patients were analyzed. In 81.6 % of cases, the indication was for replacement. The maximum dose was 1 g/kg. In 99.6 % of infusions, some type of premedication was indicated; diphenhydramine was the most common drug, with varying dosages. A total of 12 adverse reactions (3.9 % of infusions) were recorded; 3 were severe: aseptic meningitis (2 cases) and seizures (1 case). All resolved to normal.Conclusions. The rate of IVIG adverse reactions in our setting was low; most reactions were mild and immediate and resolved favorably in all patients

Intravenous immunoglobulin G use and pharmacovigilance in a tertiary care children's hospital. / Utilización y farmacovigilancia de inmunoglobulina G endovenosa en un hospital pediátrico de alta complejidad.

INTRODUCTION: Intravenous immunoglobulin G (IVIG) is a blood product from polyvalent and polyclonal immunoglobulin G. It covers a broad range of indications as immunomodulator or replacement therapy. In addition, although it is considered a safe therapy, the incidence of adverse reactions reported in the bibliography ranges from 1 % to 81 %. The objective of this study was to assess IVIG use and describe related adverse events in a tertiary care children's hospital. POPULATION AND METHODS: This was a pharmacoepidemiological, observational, and prospective study. Patients receiving IVIG for 7 months in 6 areas of a tertiary care children's hospital in the Autonomous City of Buenos Aires were assessed. The analysis unit was each IVIG infusion, and the main variable was the presence of adverse reactions. RESULTS: A total of 305 infusions in 111 patients were analyzed. In 81.6 % of cases, the indication was for replacement. The maximum dose was 1 g/kg. In 99.6 % of infusions, some type of premedication was indicated; diphenhydramine was the most common drug, with varying dosages. A total of 12 adverse reactions (3.9 % of infusions) were recorded; 3 were severe: aseptic meningitis (2 cases) and seizures (1 case). All resolved to normal. CONCLUSIONS: The rate of IVIG adverse reactions in our setting was low; most reactions were mild and immediate and resolved favorably in all patients.

Introducción. La inmunoglobulina G endovenosa (IGEV) es un medicamento hemoderivado de inmunoglobulina G polivalente y policlonal. Posee un amplio espectro de indicaciones como inmunomodulador o como terapia de reemplazo. Asimismo, si bien se considera un tratamiento seguro, la incidencia de reacciones adversas reportadas en la literatura varía del 1 % al 81 %. Este trabajo tuvo como objetivo evaluar la utilización de IGEV y describir los acontecimientos adversos por la medicación en un hospital pediátrico de alta complejidad. Población y métodos. Se realizó un estudio de farmacoepidemiología, observacional y prospectivo. Se evaluaron pacientes que recibieron IGEV durante 7 meses, en 6 áreas de un hospital pediátrico de alta complejidad de la Ciudad Autónoma de Buenos Aires. La unidad de análisis fue cada infusión de IGEV, y la principal variable de estudio fue la presencia de reacciones adversas. Resultados. Se analizaron 305 infusiones en 111 pacientes. El 81,6 % de las indicaciones fueron de tipo supletorio. La dosis máxima utilizada fue 1 g/kg. En el 99,6 % de las infusiones, se indicó algún tipo de premedicación; la difenhidramina fue la droga más utilizada, aunque con diferentes posologías. Se registraron 12 reacciones adversas (el 3,9 % de las infusiones), tres de las cuales se consideraron graves: dos meningitis asépticas y una crisis comicial. Todas se resolvieron ad integrum. Conclusiones. La tasa de reacciones adversas de la IGEV en nuestro medio fue baja, con mayoría de reacciones leves e inmediatas y evolución favorable en todos los pacientes.

Intensive Safety Monitoring of Rituximab (Biosimilar Novex® and the Innovator) in Pediatric Patients With Complex Diseases.

Although rituximab is widely used off-label for complex pediatric diseases, safety reports are limited. We aimed to report evidence of its use in clinical practice, to describe the incidence of adverse drug reactions (ADR) to rituximab biosimilar Novex® and innovator, and to identify risk factors for the development of ADR in a real-life follow-up cohort of pediatric patients with complex diseases. We conducted a prospective, longitudinal, observational, single-centre study in patients that received rituximab for any complex disease, and as part of an intensive pharmacovigilance program. Demographic, pharmacological, clinical, and drug-related data were collected for all patients. ADR-free survival, including infusion-related reactions (IRR) and delayed ADR (dADR), was estimated using Kaplan-Meier curves. Risk factors were evaluated by multivariable Cox regression models. In total, 77 patients (<19 y.o.) received 187 infusions of rituximab Novex® (n = 155) or innovator rituximab (n = 32) for neurologic (Neu), immune-hematologic-rheumatic (IHR), oncologic (O) diseases, and hematopoietic stem-cell transplantation (HSCT) or solid-organ transplantation (SOT). We recorded 29 IRR and 58 dADR that occurred in 27 (35.1%) and 29 (37.7%) patients, respectively. The respiratory tract was the most affected during IRR (29.6%) and hypogammaglobulinemia (37.9 %) was the most frequent dADR. First versus subsequent infusions (HR 5.4, CI95% 2.4-12.1, p<0.05), sex (boys vs. girls, HR 0.3, CI95% 0.1-0.8, and p<0.05), and diagnosis (Neu-IHR diseases vs. O-HSCT-SOT, HR 2.3, CI95% 1.02-5.4, and p < 0.05) were significantly associated with the development of IRR. For dADR, risk factors were diagnosis (Neu-IHR diseases vs. O-HSCT-SOT, HR 0.4, CI95% 0.2-0.9, and p < 0.05) and cumulative body surface area-normalized dosage (HR 1.0003, CI95% 1.0001-1.0006, and p < 0.05). The present is the largest real-world safety assessment of rituximab in Latin-American children with complex diseases supporting its use based on the overall acceptable safety. Identification of risk factors may contribute to optimization of off-label rituximab treatment in pediatrics.

Presente y futuro de la farmacia hospitalaria en Latinoamérica / The present and future of hospital pharmacy in Latin America

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Therapeutic monitoring of pediatric renal transplant patients with conversion to generic cyclosporin.

BACKGROUND: Cyclosporin is a calcineurin inhibitor widely used in renal transplant patients to prevent organ rejection. Several position papers have been published but no reports on the practical experience in pediatric patients undergoing conversion between cyclosporin innovator and generic products are available. OBJECTIVE: To evaluate the pharmacokinetics and safety as part of therapeutic monitoring of cyclosporin in renal transplant pediatric patients who switch from the innovator to the generic formulation in Argentina. SETTING: Hospital de Pediatría JP Garrahan, Buenos Aires, Argentina. METHODS: Stable pediatric renal transplant patients (6 months post-transplant) switched from the innovator to the generic formulation of cyclosporin microemulsion capsule. Cyclosporin pharmacokinetic parameters were obtained while taking the innovator and after starting with the generic formulation. Blood samples were drawn before and 1, 2, and 3 h after drug administration and subsequently quantified. Pharmacokinetic parameters were obtained by means of a Bayesian approach. MAIN OUTCOMES MEASURE: Cyclosporin pharmacokinetic parameters (area under the curve, AUC; Blood concentration after 2 h, C2), adverse events and graft rejection. RESULTS: A total of 12 patients were included. Median (range) age and time post-transplant were 10.7 years (6.5-17.7) and 8.3 years (3.4-14.0), respectively. Two patients or their parents did not consent to the switch. Median (range) dose normalized cyclosporin AUC and C2 were 1.15 (mg*h/L)/mg/kg (0.72-3.0) and 265.5 (ng/ml)/mg/kg (120.8-725.7), respectively, on the innovator therapy and 1.05 (mg*h/L)/mg/kg (0.54-2.22) and 317.1 (ng/ml)/mg/kg (116.7-564.7) for the generic drug after the switch. The median (range) percentage of change in the AUC and C2 when switching between formulations were 16.7 % (0.7-56.7) and 13.1 % (3.7-68.6), respectively. No significant changes in serum creatinine levels were registered when comparing before and after substitution of products. Adverse events (number of events) recorded 5 months before and after the switch included hirsutism (2), hypertension (2), and gingival hyperplasia (1). CONCLUSION: Conversion of cyclosporin from innovator brand to generic in pediatric renal transplant patients needs to be closely monitored.

[Health care team and parents' opinion about pediatric patients identification]. / Evaluación de la opinión del equipo de salud y padres sobre la identificación de los pacientes pediátricos.

INTRODUCTION: Patient misidentification continues to be a quality and safety significant issue. The Joint Commission International listed patient identification as the first of ten life-saving patient-safety solutions. Identification wrist bands are the goal in the identification strategy. At the Hospital Nacional de Pediatría "Prof. Dr. J.P. Garrahan" we inquired about perception and agreement of this practice within hospital staff and parents. METHOD: A short questionnaire was used with; in the first part a four point Lickert scale, and in the second one an open unstructured response. The questionnaire was distributed among health care workers and parent's patients. For families, the third question was not administrated. The survey explored about purpose and opportunity regarding the use of wrist band identification. A one day cutoff was made to obtain baseline data for properly use of identification bands. RESULTS: A total of 300 questionnaires were analyzed, 100 for each cluster (physicians, nurses, and parents); 82% responded that the wrist band should stay along the whole hospitalizing period. A range of 64% to 74% within the groups responded that it is helpful to prevent errors. There was no statistical difference between parents and physicians. Overall, percentage of patient with correct identification band in the hospital was 34%. CONCLUSIONS: We concluded that the wrist band identification is not a health care workers priority behavior yet. Initiatives on safety patient identifications, including families and healthcare workers, must be developed in the near future.

Evaluación de la opinión del equipo de salud y padres sobre la identificación delos pacientes pediátricos / Health care team and parents opinion about pediatric patients identification

Introducción. La correcta identificación del paciente es esencial para la seguridad de la atención:la pulsera identificadora del paciente internado es una estrategia en la prevención del error médico.Sin embargo, en la realidad, la identificación de la totalidad de los pacientes es un tema pendiente.Objetivo. Conocer la opinión del equipo de salud y los padres respecto al procedimiento de identificaciónde los pacientes en el Hospital Nacionalde Pediatría ¶Prof. Dr. Juan P. Garrahan÷ y medir la adhesión a esta práctica.Método. Se realizó una encuesta al equipo de salud en una semana, autoadministrada y anónima, de tres preguntas sencillas con respuesta cerrada (4 ítems con escala de Likert), acerca de la opinión sobre la identificación de los pacientes, conun espacio abierto para observaciones. El mismo cuestionario, con excepción de la tercera pregunta, fue administrado a los padres de los pacientes. Serealizó un corte de un día evaluando porcentaje de pacientes correctamente identificados.Resultados. Se realizaron 300 encuestas a médicos (100), enfermeros (100) y padres (100). El 82 por cientocontestó que los pacientes debían tener pulsera identificadora en todo momento durante la internación.Un 64-74 por ciento contestó que era útil para prevenir errores. No se encontraron diferencias significativas entre padres y médicos. Sin embargo,sólo el 34 por ciento de los pacientes se encontraban correctamente dentificados. Conclusiones. La discrepancia entre la opinión y la práctica indica que la identificación de los pacientes no representa aún un eslabón prioritarioen la seguridad y la calidad de la atención.Por lo tanto, es necesario desarrollar estrategias para mejorar la cultura de la seguridad.(AU)

Introduction. Patient misidentification continues to be a quality and safety significant issue. The Joint Commission International listed patient identification as the first of ten life-saving patient-safety solutions. Identification wrist bands are the goal in the identification strategy. At the Hospital Nacional de Pediatría "Prof. Dr. J.P. Garrahan" we inquired about perception and agreement of this practice within hospital staff and parents.Method. A short questionnaire was used with; in the first part a four point Lickert scale, and in the second one an open unstructured response. The questionnaire was distributed among health care workers and parents patients. For families, the third question was not administrated. The survey explored about purpose and opportunity regarding the use of wrist band identification. A one day cutoff was made to obtain baseline data for properly use of identification bands.Results. A total of 300 questionnaires were analyzed, 100 for each cluster (physicians, nurses, and parents); 82% responded that the wrist band should stay along the whole hospitalizing period. A range of 64% to 74% within the groups responded that it is helpful to prevent errors. There was not statistical difference between parents and physicians. Overall, percentage of patient with correct identification band in the hospital was 34%.Conclusions. We concluded that the wrist band identification is not a health care workers priority behavior yet. Initiatives on safety patient identifications, including families and health care workers, must be developed in the near future.(AU)

Evaluación de la opinión del equipo de salud y padres sobre la identificación delos pacientes pediátricos / Health care team and parents opinion about pediatric patients identification

Introducción. La correcta identificación del paciente es esencial para la seguridad de la atención:la pulsera identificadora del paciente internado es una estrategia en la prevención del error médico.Sin embargo, en la realidad, la identificación de la totalidad de los pacientes es un tema pendiente.Objetivo. Conocer la opinión del equipo de salud y los padres respecto al procedimiento de identificaciónde los pacientes en el Hospital Nacionalde Pediatría “Prof. Dr. Juan P. Garrahan” y medir la adhesión a esta práctica.Método. Se realizó una encuesta al equipo de salud en una semana, autoadministrada y anónima, de tres preguntas sencillas con respuesta cerrada (4 ítems con escala de Likert), acerca de la opinión sobre la identificación de los pacientes, conun espacio abierto para observaciones. El mismo cuestionario, con excepción de la tercera pregunta, fue administrado a los padres de los pacientes. Serealizó un corte de un día evaluando porcentaje de pacientes correctamente identificados.Resultados. Se realizaron 300 encuestas a médicos (100), enfermeros (100) y padres (100). El 82 por cientocontestó que los pacientes debían tener pulsera identificadora en todo momento durante la internación.Un 64-74 por ciento contestó que era útil para prevenir errores. No se encontraron diferencias significativas entre padres y médicos. Sin embargo,sólo el 34 por ciento de los pacientes se encontraban correctamente dentificados. Conclusiones. La discrepancia entre la opinión y la práctica indica que la identificación de los pacientes no representa aún un eslabón prioritarioen la seguridad y la calidad de la atención.Por lo tanto, es necesario desarrollar estrategias para mejorar la cultura de la seguridad.

Introduction. Patient misidentification continues to be a quality and safety significant issue. The Joint Commission International listed patient identification as the first of ten life-saving patient-safety solutions. Identification wrist bands are the goal in the identification strategy. At the Hospital Nacional de Pediatría "Prof. Dr. J.P. Garrahan" we inquired about perception and agreement of this practice within hospital staff and parents.Method. A short questionnaire was used with; in the first part a four point Lickert scale, and in the second one an open unstructured response. The questionnaire was distributed among health care workers and parent's patients. For families, the third question was not administrated. The survey explored about purpose and opportunity regarding the use of wrist band identification. A one day cutoff was made to obtain baseline data for properly use of identification bands.Results. A total of 300 questionnaires were analyzed, 100 for each cluster (physicians, nurses, and parents); 82% responded that the wrist band should stay along the whole hospitalizing period. A range of 64% to 74% within the groups responded that it is helpful to prevent errors. There was not statistical difference between parents and physicians. Overall, percentage of patient with correct identification band in the hospital was 34%.Conclusions. We concluded that the wrist band identification is not a health care workers priority behavior yet. Initiatives on safety patient identifications, including families and health care workers, must be developed in the near future.

Detección, análisis y prevención en el uso de medicamentos con similitud fonética, ortográfica o de envasado en Argentina / Detection, analysis and prevention of look alike and sound alike drugs in Argentina

RESUMEN. INTRODUCCIÓN: existe una gran cantidad de medicamentos con similitud visual, fonética u ortográfica en sus nombres comerciales y/o principios activos, lo cual genera errores operativos de medicación y ocasionan daños a los pacientes. Este problema se conoce con la sigla LASA (en inglés: Look-Alike, Sound-Alike). OBJETIVO: Identificar productos medicinales comercialesy/o sus principios activos con características LASA en el mercado farmacéutico argentino. MÉTODO: se realizó una revisión bibliográfica sobre antecedentes LASA internacionales y nacionales. Los nombres comerciales y genéricos de medicamentos se relevaron en las páginas Web de Alfabeta®, Kairos ®y Manual Farmacéutico® durante julio de 2008, y el criterio de búsqueda fue el de raíz y terminación de nombres comerciales y principios activos. Se relevaron además las similitudes visuales de los medicamentos en los lugares de trabajo de los investigadores y se generó un archivo fotográfico. Se implementó un registro de reporte voluntario de error cuyos datos se analizaron para caracterizar los factores determinantes de los errores detectados. RESULTADOS: Se hallaron 927 conjuntos de medicamentos LASA sobre un total de 20.517 evaluados. A través del registro voluntario se reportaron 80 errores LASA. CONCLUSIÓN: los medicamentos LASA son un problema de salud pública en Argentina. Es necesario detectarlos, difundirlos y prevenirlos para evitar consecuencias negativas en los pacientes.

ABSTRACT. INTRODUCTION: there is a large amount of drugs with visual, phonetic or spelling similarities in their trade names and/or active ingredients that create operational and medication errors and could cause harm to patients. This problem is known by the acronym LASA (Look-Alike, Sound-Alike). OBJECTIVE: to identify LASA medicines and/oractive ingredients in the Argentine pharmaceutical market. METHOD: the international and national literature on LASA was reviewed. Then a search of trade name and generic medicines in the Alfabeta®, Kairos® and Manual Farmacéutico® internet databases was conducted during July 2008. The researchers surveyed the visual aspect of medicines in their premises work and generated a photographic archive. In addition, a LASA error voluntary report system was implemented and subjected to analysis in order to characterize the factors involved in LASA problem. RESULTS: 927 sets of LASA medications were found among 20.517 medicines assessed and 80 LASA errors were reported through the report system. CONCLUSION: LASA medicines are a public health problem in Argentina. Their detection, communication and prevention are needed to avoid negative consequences for patients.

Detección, análisis y prevención en el uso de medicamentos con similitud fonética, ortográfica o de envasado, en Argentina: uso de medicamentos con similitud visual, fonética u ortográfica / Detection, analyze and use prevention in look alike and sound alike drugs, in Argentina

Introducción: La literatura describe gran cantidad de medicamentos generadores de errores de medicación, por similitud visual, fonética u ortográfica -en inglés- Look-Alike, Sound-Alike (LASA). Objetivos: 1) Identificar productos comerciales y/o principios activos tipo LASA; 2) Diseñar e implementar un registro voluntario; 3) Analizar los factores intervinientes; 4) Elaborar y difundir alertas. Metodologia: Revisión de nombres comerciales y principios activos de los medicamentos del mercado farmacéutico actual. Para relevar similitudes visuales, se realizó detección intensiva sobre stock / existencias de medicamentos utilizados. Se realizó una búsqueda bibliográfica exhaustiva. Resultados: Se identificaron 927 conjuntos de medicamentos LASA, clasificados por categorías, y se elaboró un documento fotográfico para similitudes de envasado. Sobre estos resultados se sugirieron estrategias para minimizar riesgos de confusión por clase. Se reportaron 80 registros de errores y se analizaron los factores intervinientes. Se elaboraron alertas de medicación: generales, de diferentes grupos terapéuticos y dirigidos a población especial. Se diseñó e implementó un sitio WEB como plataforma de expansión del tema LASA: www.errorenmedicina.anm.edu.ar/LASA. Conclusiones: En Argentina LASA alcanza una dimensión importante. Su conocimiento, difusión y la generación de estrategias, tanto desde Laboratorios productores como de las autoridades sanitarias, constituirán los primeros pasos para evitar sus consecuencias negativas en los pacientes.

Introduction: There are a lot of drug names that look or sound like (LASA) other drug names described worldwide that could potentially result in medication errors (ME). Objectives: 1) To identify brand or generic names that generate confusion and error phonetic-orthographic similarity. 2) To design and to implement a voluntary ME LASA report. 3) To analyze contributing factors. 4) To make and spread alerts on reported ME, LASA type. Methods: brand or generic names were review in Argentine pharmaceutical market. The label and package drugs were review from stocks to find look-alike drugs. An exhaustive bibliographic search was made. ME were analyzed and recommendations given. Results: 927 LASA drugs pairs were identified and were classified by categories. Look-alike drugs were photographed. Prevention strategies were made to different classes. Eighty ME were reported and contributing factors were analyzed. Alerts were made such us: LASA drugs, different therapeutic groups and target population alerts. A web site was designed as a LASA expansion platform: www.errorenmedicina.anm.edu.ar/LASA. Conclusion: LASA is a main issue in Argentina and it is necessary to be known. Dissemination and prevention strategies from pharmaceutical industry and national authorities must be made. These are the first steps to avoid patient's negative outcomes.