Drug Safety
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To analyse and compare the adverse drug reactions (ADRs) associated with the use of nimesulide with those associated with diclofenac, ketoprofen, and piroxicam, reported spontaneously in a northern Italian area (Veneto and Trentino). ⋯ Nimesulide is the most frequently used NSAID in Italy. Spontaneous reporting data suggest that nimesulide has the most favourable GI tolerability profile of the NSAIDs investigated, with few reports of severe GI reactions. A few reports of hepatic and renal impairment associated with nimesulide suggest caution in patients at risk. Age-related reporting analysis suggests a higher toxicity for diclofenac and piroxicam in the elderly compared with nimesulide and ketoprofen. This analysis of the Veneto-Trentino database on spontaneous reporting confirms that NSAIDs differ in their tolerability profile, and this fact should be taken into account in the choice of drugs in relation to patient characteristics.
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Adverse events and medical errors affecting patient care are recognised internationally as major problems in medicine. The failure of health care professionals and health institutes to address this problem has threatened to undermine public confidence in the health care system as a whole. Less focus has been directed at the ethical issues raised by negative outcomes of care, specifically the issue of disclosure. ⋯ Healthcare institutions should provide training for the clinicians in this area, if necessary. As a general rule, patients should be informed of unexpected adverse incidents as soon as possible. Medical staff should be rewarded for adverse event reporting and protected from institutional retaliation on account of errors made in health care.
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The extent to which the medical device manufacturers are responsible for actively monitoring the performance of their products after they have successfully passed the rigorous pre-market approval process has always been a matter of diverse opinion. Within Europe, the law is unhelpfully vague on this point. While there are some comparatively clear obligations for reporting incidents to the authorities (known as the 'vigilance system'), little detail is given on how diligently the manufacturer should try to find out about such incidents. ⋯ This article discuses both the vigilance and PMS processes and outlines the currently available European, and particularly UK, guidance documents which are aimed at promoting a more level playing field across industry where these activities are concerned. In particular, it explains the principle differences between vigilance and post-marketing surveillance: the former being the reporting of adverse incidents by manufacturers to the regulatory authorities and their subsequent sharing of key incident data between each other; the latter being the process by which information on overall devise performance is captured, analysed and acted upon. Nevertheless, it is still a struggle to gain widespread appreciation that these two activities are not in fact one and the same.