An investigation into the value of a standardised global pharmacovigilance reporting system

Schurer, Maximillian Juan ; Bam, Louzanne ; De Kock, Imke (2017)

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.

The original publication is available at http://sajie.journals.ac.za

Article

Pharmacovigilance (PV) is based on the medical assessment of adverse medical events or drug-related problems, collected within organised health programmes. The large number of different PV systems, the equally large number of stakeholders within such systems (pharmaceutical companies, government regulatory bodies, national and international clinical regulatory bodies, healthcare workers, etc.), and the significant number of dimensions along which the effectiveness and efficiency could be measured, adds to this complexity. Furthermore, the lack of a standardised reporting protocol across the various PV systems hinders efforts to manage PV coherently on a global scale. 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.

ENGLISH ABSTRACT: Pharmacovigilance (PV) is based on the medical assessment of adverse medical events or drug-related problems, collected within organised health programmes. The large number of different PV systems, the equally large number of stakeholders within such systems (pharmaceutical companies, government regulatory bodies, national and international clinical regulatory bodies, healthcare workers, etc.), and the significant number of dimensions along which the effectiveness and efficiency could be measured, adds to this complexity. Furthermore, the lack of a standardised reporting protocol across the various PV systems hinders efforts to manage PV coherently on a global scale. 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.

AFRIKAANSE OPSOMMING: Farmakologiese waaksaamheid (PV) is gebaseer op die mediese assessering van nadelige mediese gebeure of dwelmverwante probleme wat deur georganiseerde gesondheidsprogramme versamel word. Die groot aantal verskillende PV-sisteme, die ewe groot aantal belanghebbendes in sulke stelsels (farmaseutiese maatskappye, regerings, nasionale en internasionale kliniese reguleringsliggame, gesondheidswerkers, ens.), en die aansienlike aantal dimensies waarvolgens die effektiwiteit en doeltreffendheid gemeet kan word, dra by tot hierdie kompleksiteit. Verder belemmer die gebrek aan ’n gestandaardiseerde rapporterings-protokol wat oor die verskillende PV-sisteme strek die pogings om PV op ’n wêreldwye skaal konsekwent te bestuur. Hierdie artikel stel die waarde van ’n gestandaardiseerde globale PV rapporteringsprotokol voor deur die sistematiese gevolge van die gebrek aan so ’n gestandaardiseerde stelsel te evalueer.

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