Napchan Berta-Monica, Morales Raquel Pinheiro, Carvalho Marisa Lima, Cunha Keliane Vasconcellos, Figueras Albert
Setor de Farmacovigilância, Centro de Vigilância Sanitária, Secretaria de Estado da Saúde, São Paulo, Brazil.
Pharmacoepidemiol Drug Saf. 2005 Aug;14(8):555-9. doi: 10.1002/pds.1050.
During the 20th century, silver nitrate (SN) eye drops instillation to newborns had been the best prophylaxis against ophthalmia neonatorum (ON) caused by Neisseria gonorrheae, the most frequent cause of ocular infections leading to blindness. At present, this treatment has been questioned because there is a growing prevalence of other pathogens such as Chlamydia trachomatis, and SN is associated with chemical conjunctivitis (ChC). In addition, SN could present some conservation problems in tropical climates. Among other alternative drugs, 2.5% povidone-iodine has a proven efficacy, not only against Neisseria, but also against Chlamydia, has no conservation problems, has not been associated with ChC and is cheap.
The recently created Setor de Farmacovigilãncia (SF) of the São Paulo State in Brazil has created a pharmacovigilance network of 11 big public hospitals. During a periodical signal searching process, the SF found a cluster of 33 ChC reports from one of the network hospitals.
The problem was discussed with the remaining participant hospitals and this signal was used as a way to strengthen the network. Thirteen months later, 622 ChC reports were received from six hospitals.
Thus, this well-known side-effect in the literature was highlighted as a 'real' problem in Brazil, and some participant hospitals began a discussion period together with the delivery and newborn care professionals in order to switch SN by povidone-iodine. This is an example of both, how a simple pharmacovigilance exercise could improve the implication of health professionals with their own therapeutic problems and how a pharmacovigilance network could be strengthened.
在20世纪,向新生儿滴注硝酸银眼药水一直是预防新生儿眼炎(ON)的最佳方法,新生儿眼炎是导致失明的眼部感染的最常见原因,由淋病奈瑟菌引起。目前,这种治疗方法受到了质疑,因为沙眼衣原体等其他病原体的患病率在不断上升,而且硝酸银与化学性结膜炎(ChC)有关。此外,在热带气候下,硝酸银可能存在一些保存问题。在其他替代药物中,2.5%的聚维酮碘已被证明有效,不仅对淋病奈瑟菌有效,而且对衣原体也有效,不存在保存问题,与化学性结膜炎无关且价格便宜。
巴西圣保罗州最近成立的药物警戒部门(SF)创建了一个由11家大型公立医院组成的药物警戒网络。在定期的信号搜索过程中,SF从网络中的一家医院发现了一组共33例化学性结膜炎报告。
与其他参与医院讨论了这个问题,并将这个信号作为加强网络的一种方式。13个月后,从6家医院收到了622例化学性结膜炎报告。
因此,文献中这个众所周知的副作用在巴西被凸显为一个“实际”问题,一些参与医院与分娩及新生儿护理专业人员开始了一个讨论期,以便用聚维酮碘替代硝酸银。这是一个例子,既展示了简单的药物警戒活动如何能改善卫生专业人员对自身治疗问题的关注,也展示了药物警戒网络如何能得到加强。