Quality assessment of individual case safety reports in pharmacovigilance in Burkina Faso

Abstract

Pharmacovigilance is based on individual case safety reports. Our study is intended to be a contribution to good practices by the quality assessment of individual case safety reports sent to the National Center for Vigilance in Burkina Faso. We carried out a cross-sectional study which concerned individual case safety reports sent to the Center between 2009 and 2014. 302 individual case safety reports forms were identified and the rate of notifications per year and per million inhabitants was 2,9. The sex ratio was 0,83 in favor of women and the average age was 14,3. 320 drugs were listed with a predominance of antimalarials (37.8%) and antibiotics (19%). Adverse reactions were mostly cutaneous-allergic (37.9%) and general (25.2%). More than half of individual case safety reports were sent by pharmacists (58.6%) followed by nurses (29.5%) then doctors (6.6%). An analysis of the quality of the files according to WHO criteria gave 25.8% for grade A, 67.2% for grade B and 7% for grade C. The files were transmitted within 15 days in 54% cases. The description of the adverse drug reactions was in accordance with WHO ART terminology in 93.5%. Underreporting is a reality and special attention should be paid to collecting information on adverse drug events.

Keywords

• adverse effects
• drugs
• who grade
• pharmacovigilance
• burkina faso