Increasing the detection of hepatotoxic response in clinical practice: a quality commitment

M. I. Lucena, R. J. Andrade
2005 Revista Espanola de Enfermedades Digestivas  
Modern drug therapy came of age in the early 19th century, when it abandoned the secondary role it had been relegated to by the more prestigious diagnostic process during the past few decades. The outstanding advances occurred in both cellular and molecular biology, as well as in biotechnology, had a lot to do with this, since they -together with refined diagnostic tests-favored the development of new biologic drugs, and an unprecedented growth of clinical research with the aim of providing a
more » ... im of providing a rigorous scientific assessment of therapeutic benefits and drug-related toxicity. However, a point that has drawn greater attention during the last few years is the safety of patients exposed to drugs. In fact, many drugs exhibit dazzling efficacy but on occasion become double-edged swords, and such safety issues pose a true challenge not only to the scientific community, but to society itself. The fast spread of drugs within a global market determines large-scale exposure of patients to new molecules, with a potential for greater numbers of unexpected adverse effects. The continual commercialization of new drugs, the increasing number of drugs used by the population, and the increasing utilization of pharmacologically active "alternative medications" are all the hallmark of current society and favor the likely development of adverse events. Recent studies contributed to bring to the fore the significance of drug-related adverse events. In 1998 Lazarou et al. (1) reported that their estimated incidence of serious adverse events among inpatients in the U.S. was 6.7% (1 in every 15 inpatients), while adverse events with a fatal outcome amounted to 0.32% and thus involved a total of 106,000 patients, which represents the 4 th to 6 th leading cause of mortality. Even when considered exaggerated, nobody would argue that these figures deserve both attention and active policies by the health systems. Indeed, the true risks of medications only manifest when drugs leave the well-controlled "clinical trial research" setting -where populations at lower risk are commonly examined, the presence of underlying diseases and the concurrent use of other drugs represent exclusion criteria, and exposure length is relatively short-and move on to be administered within a "naturalistic" context, namely standard clinical practice. These considerations are supported by a recent study in the U.S., where drugs that would be eventually withdrawn from the market on safety grounds had already been administered to 20 million subjects (2). The fact that almost 10% of the adult population had already been exposed to non-essential drugs before their harmful effects were properly identified is strong evidence that new systems for the early recogni-Increasing the detection of hepatotoxic response in clinical practice: a quality commitment 1130-0108/2005/97/3/145-153 REVISTA ESPAÑOLA DE ENFERMEDADES DIGESTIVAS
doi:10.4321/s1130-01082005000300001 fatcat:7ptdo2wsxbdglbke4vz6of3n2e