Belleudi Valeria, Fortinguerra Filomena, Poggi Francesca R, Perna Serena, Bortolus Renata, Donati Serena, Clavenna Antonio, Locatelli Anna, Davoli Marina, Addis Antonio, Trotta Francesco
Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Italian Medicines Agency (AIFA), Rome, Italy.
Front Pharmacol. 2021 Jun 23;12:699062. doi: 10.3389/fphar.2021.699062. eCollection 2021.
There is an acute need for research to acquire high-quality information on the use of medicines in pregnancy, both in terms of appropriateness and safety. For this purpose, the Italian Medicines Agency established a Network for Monitoring Medication use in pregnancy (MoM-Net) through the conduction of population-based studies using administrative data available at regional level. This paper aimed to describe the experiences and challenges within the network. MoM-Net currently involves eight regions and several experts from public and academic institutions. The first study conducted aimed to identify drug use before, during and after pregnancy investigating specific therapeutic categories, analysing regional variability and monitoring drug use in specific subpopulations (i.e. foreign women/multiple pregnancies). Aggregated demographic, clinical, and prescription data were analysed using a distributed network approach based on common data model. The study population included all women delivering during 2016-2018 in the participating regions ( = 449,012), and corresponding to 59% of deliveries in Italy. Seventy-three per cent of the cohort had at least one drug prescription during pregnancy, compared to 57% before and 59% after pregnancy. In general, a good adherence to guidelines for pregnant women was found although some drug categories at risk of inappropriateness, such as progestins and antibiotics, were prescribed. A strong variability in the use of drugs among regions and in specific subpopulations was observed. The MoM-Net represents a valuable surveillance system on the use of medicines in pregnancy, available to monitor drug categories at high risk of inappropriateness and to investigate health needs in specific regions or subpopulations.
迫切需要开展研究，以获取有关孕期用药在合理性和安全性方面的高质量信息。为此，意大利药品管理局通过利用区域层面现有的行政数据开展基于人群的研究，建立了一个孕期用药监测网络（MoM-Net）。本文旨在描述该网络内部的经验和挑战。MoM-Net目前涵盖八个地区以及来自公共和学术机构的若干专家。开展的第一项研究旨在确定孕期前后的用药情况，调查特定治疗类别，分析区域差异，并监测特定亚人群（即外国女性/多胎妊娠）的用药情况。使用基于通用数据模型的分布式网络方法对汇总的人口统计学、临床和处方数据进行分析。研究人群包括2016年至2018年在参与地区分娩的所有女性（n = 449,012），占意大利分娩总数的59%。该队列中有73%的女性在孕期至少有一次药物处方，而孕期前和孕期后的这一比例分别为57%和59%。总体而言，发现对孕妇指南的依从性良好，尽管存在一些有不合理用药风险的药物类别被开具，如孕激素和抗生素。观察到各地区以及特定亚人群之间在药物使用方面存在很大差异。MoM-Net是一个关于孕期用药的宝贵监测系统，可用于监测有不合理用药高风险的药物类别，并调查特定地区或亚人群的健康需求。
