Patterns of adverse drug reaction signals in NAFDAC pharmacovigilance activities from January to June 2015: safety of drug use in Nigeria

Adverse drug reactions (ADRs) are expected to be associated with an economic drain on the healthcare systems. The study was carried out to determine the occurrence of ADRs reported to NAFDAC Pharmacovigilance from January to June 2015, to illustrate the pattern of organ system affected by ADRs, to assess the completeness of ADR report, to determine the relationship between the occurrence of ADRs with suspect drugs and the use of concomitant drugs as well as to generate possible signals from the reported ADRs. A total number of 921 ADR cases reported from January to June 2015 were analyzed using SPSS version 22. A higher percentage of ADR reports were seen in females (65.5%). The highest percentages of reports (45.6%) were from the age range of 21‐40 years, most of the suspected drugs reported had both NAFDAC (50.2%) and batch number identification (65.6%). HIV (56.9%) was the most prevalent indication reported for using the suspected drug; Zidovudine/Lamivudine/Nevirapine combination (16.9%) was reported as the suspected drug with the highest occurrences of ADRs and generalized body itching (6.9%) as the most prevalent ADR. “General disorders” (47.3%) was the most predominant organ system affected by ADRs and Pharmacists were revealed as the highest reporters of ADRs (80.2%). Overall, patients on ARVs should be vigilantly followed up as they are mostly prone to ADRs. Adverse drug reaction reporting systems need to be robust and complete in order to be able to detect new drug alerts, possible signals and improve pharmacovigilance