ABSTRACT
AIMS: To report a new strategy for the detection of hepatotoxic adverse drug reactions (ADRs) in hospitalized patients improving the results obtained with other methods. DESIGN: The model is based on the identification of a single alert signal in various target clinical departments over a 12-month period. Each patient was later interviewed following a set protocol. The main results analyzed were the drugs suspected of ADR; causal relationship between suspected drugs and ADRs; ADR severity, and incidence of hepatotoxic ADR/100,000 inhabitants. SUBJECTS: Population served by a university-affiliated urban teaching hospital (519,381 inhabitants). RESULTS: The overall ratio of confirmed/suspected ADRs was high (35/80). The most commonly reported drug was amoxicillin-clavulanic acid (4 cases). With regard to causality, 2 suspected cases were classified as definite and 14 as probable. The distribution according to the severity of hepatotoxicity was 6 severe and 29 mild cases. The incidence of hepatotoxic ADRs/100,000 inhabitants as revealed by our method was much higher versus voluntary report (6.74 and 1.79, respectively). CONCLUSIONS: Our method has proven effective for improving the detection of hepatotoxic ADRs, and may be extended to other types of adverse reactions.
Subject(s)
Adverse Drug Reaction Reporting Systems , Chemical and Drug Induced Liver Injury/diagnosis , Medication Systems, Hospital/standards , Adult , Aged , Chemical and Drug Induced Liver Injury/prevention & control , Female , Hospitals, Teaching , Hospitals, Urban , Humans , Male , Middle Aged , Pilot Projects , Quality Assurance, Health Care , SpainABSTRACT
Objetivos: comunicar una nueva estrategia para la detecciónde reacciones hepatotóxicas por medicamentos que mejora los resultadosobtenidos con otros métodos utilizados.Diseño: el modelo se basa en la identificación de una señal dealerta simple en los pacientes de varios servicios diana, durante12 meses. Cada paciente fue posteriormente entrevistado siguiendoun protocolo específico. Se analizaron: los fármacos sospechososde producir hepatotoxicidad, la relación de causalidad entre elfármaco sospechoso y la hepatotoxicidad, la gravedad y la incidenciade hepatotoxicidad medicamentosa/100.000 habitantes.Pacientes: la población del área de influencia de nuestro hospital(519.381 habitantes).Resultados: se encontraron 80 sospechas de reacciones hepatotóxicasa medicamentos. La relación de reacciones confirmadas/sospechadas fue de 35/80. El fármaco imputado con mayorfrecuencia fue amoxicilina/clavulánico (4 casos). En relación algrado de imputabilidad, 2 sospechas fueron calificadas como definitivasy 14 como probables. Según la gravedad, se encontraron6 reacciones graves y 29 leves. La incidencia de reacciones hepatotóxicaspor medicamentos/100.000 habitantes (6,74) fue muchomayor que las obtenidas con otros métodos.Conclusiones: la aplicación de este método mejora la detecciónde reacciones hepatotóxicas por medicamentos y podría serempleado en otros tipos de reacciones adversas
Aims: to report a new strategy for the detection of hepatotoxicadverse drug reactions (ADRs) in hospitalized patients improvingthe results obtained with other methods.Design: the model is based on the identification of a singlealert signal in various target clinical departments over a 12-monthperiod. Each patient was later interviewed following a set protocol.The main results analyzed were the drugs suspected of ADR;causal relationship between suspected drugs and ADRs; ADRseverity, and incidence of hepatotoxic ADR/100,000 inhabitants.Subjects: population served by a university-affiliated urbanteaching hospital (519,381 inhabitants).Results: The overall ratio of confirmed/suspected ADRs washigh (35/80). The most commonly reported drug was amoxicillinclavulanicacid (4 cases). With regard to causality, 2 suspected caseswere classified as definite and 14 as probable. The distributionaccording to the severity of hepatotoxicity was 6 severe and 29mild cases. The incidence of hepatotoxic ADRs/100,000 inhabitantsas revealed by our method was much higher versus voluntaryreport (6.74 and 1.79, respectively).Conclusions: our method has proven effective for improvingthe detection of hepatotoxic ADRs, and may be extended to othertypes of adverse reactions
Subject(s)
Adult , Aged , Humans , Adverse Drug Reaction Reporting Systems , Chemical and Drug Induced Liver Injury/diagnosis , Medication Systems, Hospital/standards , Chemical and Drug Induced Liver Injury/prevention & control , Hospitals, Teaching , Hospitals, Urban , Pilot Projects , Quality Assurance, Health Care , Spain/epidemiologyABSTRACT
Objetivo. Analizar las características de la hepatotoxicidad por ticlopidina. Pacientes y métodos. Describimos todos los casos de hepatotoxicidad atribuidos a ticlopidina y remitidos al Registro de Hepatopatías asociadas a medicamentos e identificamos por MEDLINE e Índice Médico Español los casos publicados durante el período 1982-2001. Resultados. Se remitieron 12 casos de alteración hepática relacionada con ticlopidina, que constituyeron un 5 por ciento del total de casos de hepatotoxicidad notificados al Registro. El 83 por ciento de los pacientes eran varones con una edad media de 68 años. El 66 por ciento de éstos precisó ingreso hospitalario. El período de latencia varió de 2 a 13 semanas. El patrón de lesión hepática fue de tipo colestásico en el 75 por ciento de los casos, hepatocelular en el 16,6 por ciento y mixto en el 8,3 por ciento. El 25 por ciento de los pacientes recibió una dosis subterapéutica. Conclusiones. Ticlopidina se relaciona frecuentemente con hepatotoxicidad, que parece obedecer a un mecanismo idiosincrásico y es predominantemente de carácter colestásico. La utilización de dosis menores a la recomendadas, además de carecer del efecto terapéutico esperado, no protege del desarrollo de hepatotoxicidad. Los médicos que prescriben este medicamento deben estar informados de este potencial para establecer una correcta relación beneficio-riesgo (AU)
Subject(s)
Middle Aged , Aged , Aged, 80 and over , Male , Female , Humans , Chemical and Drug Induced Liver Injury , Ticlopidine , Platelet Aggregation Inhibitors , Blood Chemical AnalysisABSTRACT
OBJECTIVE: To analyze the characteristics of hepatotoxicity due to ticlopidine. PATIENTS AND METHODS: We describe all the case of hepatotoxicity attributed to ticlopidine and reported to the Register of drug associated hepatopathies. We also obtained data from MEDLINE and the Spanish Medical Index regarding cases reported during the period 1982 2001. RESULTS: We reported twelve cases of hepatopathy related to the use of ticlopidine. These made up 5% of all the cases notified to the Register. Eighty three percent of the patients were male, and of an average age of 68 years. Sixty six percent required hospital admission. The latent period varied between 2 and 13 weeks. The liver lesion was of cholestatic type in 75% of the cases, hepatocellular in 16.6% and mixed in 8.3%. Twenty five percent of the patients had received sub therapeutic doses. CONCLUSIONS: Ticlopidine is often related to hepatotoxicity. This seems to be due to an idiosyncratic mechanism and is mainly cholestatic. The use of lower dosage than that recommended means that the desired therapeutic effect is not attained but does not protect against the development of hepatotoxicity. Doctors who use this drug should be aware of this so as to establish the true risk benefit relation.