Palleria Caterina, Leporini Christian, Chimirri Serafina, Marrazzo Giuseppina, Sacchetta Sabrina, Bruno Lucrezia, Lista Rosaria M, Staltari Orietta, Scuteri Antonio, Scicchitano Francesca, Russo Emilio
Department of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Azienda Sanitaria Provinciale di Cosenza, Farmacovigilanza Territorio Paola, Italy.
J Pharmacol Pharmacother. 2013 Dec;4(Suppl 1):S66-72. doi: 10.4103/0976-500X.120955.
Nowadays, based on several epidemiological data, iatrogenic disease is an emerging public health problem, especially in industrialized countries. Adverse drugs reactions (ADRs) are extremely common and, therefore, clinically, socially, and economically worthy of attention. Spontaneous reporting system for suspected ADRs represents the cornerstone of the pharmacovigilance, because it allows rapid detection of potential alarm signals related to drugs use. However, spontaneous reporting system shows several limitations, which are mainly related to under-reporting. In this paper, we describe two particular case reports, which emphasize some reasons of under-reporting and other common criticisms of spontaneous reporting systems.
We performed a computer-aided search of Medline, PubMed, Embase, Cochrane library databases, national and international databases of suspected ADRs reports in order to identify previous published case reports and spontaneous reports about the ADRs reviewed in this paper, and to examine the role of suspected drugs in the pathogenesis of the described adverse reactions.
First, we reported a case of tizanidine-induced hemorrhagic cystitis. In the second case report, we presented an episode of asthma exacerbation after taking bimatoprost. Through the review of these two cases, we highlighted some common criticisms of spontaneous reporting systems: under-reporting and false causality attribution.
Healthcare workers sometimes do not report ADRs because it is challenging to establish with certainty the causal relationship between drug and adverse reaction; however, according to a key principle of pharmacovigilance, it is always better to report even a suspicion to generate an alarm in the interest of protecting public health.
如今，基于多项流行病学数据，医源性疾病是一个新出现的公共卫生问题，尤其是在工业化国家。药物不良反应极为常见，因此在临床、社会和经济方面都值得关注。疑似药物不良反应自发报告系统是药物警戒的基石，因为它能快速检测与药物使用相关的潜在警示信号。然而，自发报告系统存在一些局限性，主要与报告不足有关。在本文中，我们描述了两例特殊病例报告，强调了报告不足的一些原因以及对自发报告系统的其他常见批评。
我们对Medline、PubMed、Embase、Cochrane图书馆数据库、国家和国际疑似药物不良反应报告数据库进行了计算机辅助检索，以识别先前发表的与本文所综述的药物不良反应相关的病例报告和自发报告，并研究疑似药物在所描述不良反应发病机制中的作用。
首先，我们报告了一例替扎尼定诱发的出血性膀胱炎病例。在第二例病例报告中，我们呈现了一例使用比马前列素后哮喘加重的情况。通过对这两例病例的回顾，我们强调了对自发报告系统的一些常见批评：报告不足和错误的因果关系归因。
医护人员有时不报告药物不良反应，因为确定药物与不良反应之间的因果关系具有挑战性；然而，根据药物警戒的一项关键原则，即使只是怀疑也最好报告，以便发出警报，保护公众健康。
