Abstract
CITATION: Schurer, M. J., Bam, L. & De Kock, I. 2017. An investigation into the value of a standardised global pharmacovigilance reporting system. An investigation into the value of a standardised global pharmacovigilance reporting system. South African Journal of Industrial Engineering, 28(3):78-88, doi:10.7166/28-3-1841.
Highlights
No medication is inherently safe: each treatment situation is unique, and each patient can respond differently to a specific treatment
This paper proposes the value of a standardised global PV reporting system by evaluating the systemic effects of the lack of such a standardised system
This paper aims to connect the potential benefits of a standardised reporting system with the challenges brought about by the fragmented nature of the current global PV context
Summary
No medication is inherently safe: each treatment situation is unique, and each patient can respond differently to a specific treatment. The topic of drug safety was brought to the world’s attention when, in the late 1950s, thousands of babies in the United Kingdom were born with congenital deformities (phocomelia) after in utero exposure to the seemingly safe drug Thalidomide. The World Health Organization (WHO) established the International Drug Monitoring Programme (IDMP) in 1968, in direct response to the Thalidomide tragedy [1]. Pharmacovigilance (PV) is based on the medical assessment of adverse medical events or drugrelated problems, collected within organised health programmes. Within these programmes it is vital to be able consistently to identify the nature of events, their severity, and their likelihood of occurrence, and to assess causality in connection with the suspected drug(s) or medicine(s). PV is a responsibility that is shared by all stakeholders in the health system, from pharmaceutical multinationals and regulatory agencies to healthcare professionals (HCPs) and the patients themselves
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