Abstract

RUIZ MONTERO, A.; DURAN QUINTANA, J. A.; JIMENEZ SAENZ, M.  and  ABADIN DELGADO, J. A.. A strategy to improve the detection of drug-induced hepatotoxicity. Rev. esp. enferm. dig. [online]. 2005, vol.97, n.3, pp.155-160. ISSN 1130-0108.

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.

Keywords : Drug-induced hepatotoxicity; Pharmacovigilance.

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