Patient reporting practices of suspected adverse drug reactions to antiretroviral drugs in a tertiary health facility in Nigeria.

To assess the proportion of patients with suspected adverse drug reactions (ADRs) to highly active antiretroviral therapy (HAART) who reported the reactions to their healthcare providers and the factors associated with the reporting.The study was conducted in the US President's Emergency Plan For AIDS Relief (PEPFAR) clinic at the University of Benin Teaching Hospital (UBTH), Benin City. The study population consisted of adult HIV infection patients receiving HAART at the clinic, who had suspected ADRs (SADRs). Using a systematic random sampling technique, patients were selected and interviewed with the aid of a structured questionnaire. The outcome measure was whether or not a SADR was reported to a healthcare provider.The study participants totalled 233, 171 (73.4%) of whom reported SADRs to their healthcare providers. Statistically significant difference was demonstrated with following higher-than-mean proportions of participants that reported SADRs: 100% (13/13) of respondents who experienced a SADR perceived to be life-threatening, (p=0.02; OR=0.00, 95%CI=0.00-0.87); 88.6% (31/35) of those who regarded their SADRs as severe (p=0.01; OR=4.02, 95%CI=1.28-16.63); and 95.2% (20/21) of those who had skin eruptions (p=0.02; OR=0.12, 95%CI=0.00-0.81).The finding that a high proportion of patients reported SADRs suggests that majority of patients contribute to pharmacovigilance and that they constitute opportunities for direct reporting of HAART-related ADRs to pharmacovilance centres. Facility-based pharmacovigilance desks should be set up and access should be created for patients to report SADRs directly. Healthcare providers should educate patients to report SADRs.