A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators.
Ther Innov Regul Sci
; 56(5): 717-743, 2022 09.
Article
in En
| MEDLINE
| ID: mdl-35657484
ABSTRACT
BACKGROUND:
In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries' PV systems' performance.METHODS:
EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries' PV performance.RESULTS:
Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range 0-26). Higher average scores were obtained in the 'Core' (9.27/27) compared to 'Complementary' (5.59/36) indicators. Overall performance for 'Process' and 'Outcome' indicators was lower than that of 'Structural'.CONCLUSION:
This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Developing Countries
/
Pharmacovigilance
Type of study:
Systematic_reviews
Aspects:
Determinantes_sociais_saude
Language:
En
Journal:
Ther Innov Regul Sci
Year:
2022
Document type:
Article
Affiliation country:
United kingdom