Current state of pharmacovigilance in the Arab and Eastern Mediterranean region: results of a 2015 survey.

Abstract

This study describes the current state of pharmacovigilance systems in Arab and Eastern Mediterranean countries. A descriptive cross-sectional study was conducted between May and September 2015. Data were gathered from a standardized online survey sent to pharmacovigilance leadership identified as the official national contact for the WHO Programme for International Drug Monitoring. In countries with no specified pharmacovigilance programme or leadership, Ministry of Health officers responsible for drug safety policies were invited to participate in the survey. The survey measured three domains of pharmacovigilance performance using indicators that were defined and assigned scores a priori: 10 structural, 10 process, and seven impact indicators. Total scores were assigned to each domain of indicators, and countries were compared depending on their total performance score. Complete responses were received from 20 countries (of 24 total), representing an 83% response rate. Approximately 20% (n=4) of respondents reported not having any pharmacovigilance programme in their country. In total, across the three primary pharmacovigilance performance domains, the mean score for the 20 countries in the survey was 28.9 [standard deviation(SD): 13.8] with a range from 4 to 48 (maximum possible score: 48). In the structural performance domain, which assessed the existence of key pharmacovigilance structures, systems and policies in each country, the mean score among respondents was 13.1 (SD: 5.7) and the scores ranged from 2 to 19 (maximum possible score: 19). In the process performance domain, which assessed the constellation of activities undertaken by pharmacovigilance programmes (including the collection, collation, analysis and evaluation of adverse drug event reports), the mean score among respondent countries was 9.1 (SD: 5.4) and the scores ranged from 0 to 17 (maximum possible score: 17). Finally, in the impact domain, which measured the scope of national efforts at promoting risk minimization and increasing awareness in use of potentially unsafe pharmaceutical products, the mean score was 6.8 (SD: 3.6) and scores ranged from 0 to 12 (maximum possible score: 12). The findings suggest wide disparities in pharmacovigilance systems in the region, underscoring the need for a multistakeholder effort in bolstering programme development and the necessity to build collaboration regionally and internationally to enhance capacity, improve public and healthcare provider awareness and assist in the development of pharmacovigilance systems still in their nascent stage.