Raffaella’s Literature Update
Dear Friends,
in the attached Synthesis Report issued from the World Bank Group, Wang, Marquez, Figueras and Bieliaieva discusses the importance of Pharmacovigilance in contributing to building up resilient systems. Please share it with any potentially interested colleagues.
Pharmacovigilance (PV) is an essential component of a health (pharmaceutical) system, particularly in the first decade after the marketing authorization of a new medicine, when you need to complete the limited safety information from clinical trials with safety information from clinical practice. Unfortunately, PV is often overlooked, under-resourced or under-funded. This report, based on a literature review and on relevant case-studies, suggests that successful PV programs are built on three essential pillars: statutory provisions that establish standards for PV centers and programs; well-trained health professionals and associated stakeholders; and engaged PV reporters using effective reporting systems.
If these pre-requisites are in place, a PV programs will be effective in three core activities: reporting adverse drug events (ADEs) and identifying safety signals; determining threats through a benefit-risk balance analysis; and taking appropriate actions. Furthermore, an efficient PV programme can also be able to identify substandard/falsified medicines, as well as medication errors.
The report also lists the different methods used in pharmacovigilance, and their respective strengths and weaknesses (Table 2); and, important, the areas of PV Interventions and Contribution in Health System (Table 4). Among the latter, I wish to underline the new concept of eco-pharmacovigilance, that is the surveillance of the effects of drug residues in the environment, such as antibiotics, psychoactive drugs, and hormones, on human health and livestock.
Have a nice reading,
Raffaella