Improving monitoring and reporting of adverse drug reactions (ADRs) in HIV positive patients on antiretroviral therapy (ART) in Nigeria

Abstract

Under-reporting of ADR may be associated with poor knowledge, attitudes and practices to pharmacovigilance. This study evaluated knowledge, attitudes and practices of healthcare professionals about ADR monitoring and reporting following interventions. This longitudinal study included 36 healthcare professionals participating in ART program in a tertiary hospital. Interventions included group training on pharmacovigilance (PV) and provision of ADR reporting forms amongst others. Assessments were conducted at months 0 and 6 post-interventions using study-specific Likerttype instruments. Mean attitude scores above midpoint of 3.6 on 5-point scale were regarded as positive and below as negative. P<0.05 used to determine statistical significance. Mean age of participants was 36.6 (95%CI, 34.5-38.7) years; 61.1% males; 44.4% doctors, 13.9% pharmacists, 19.4% nurses, 8.3% laboratory scientists, 8.3% record officers and 5.6% welfare officers. None had received training on PV previously. Mean knowledge test score increased from 53.6% (95%CI, 44.6-63.6) at pre-intervention to 77.1% (95%CI, 72.8-81.4) at post-intervention with a mean change of 146.9% (95%CI, 60.5-233.3; p=0.000). Mean rated attitude scores increased from 3.6 (95%CI, 3.4-3.8) at pre-intervention to 4.2 (95%CI, 4.0-4.4) at post-intervention; the difference was statistically significant (p=0.000). 75.8% reported that ADR reporting forms were not readily available at pre-intervention compared to 18.2% at postintervention; 15.2% had reported ADR previously at pre-intervention compared to 69.7% at post-intervention; 12.1% reported providing information regarding ADRs and its management always at pre-intervention compared to 45.5% at post-intervention; these differences were statistically significant (p<0.05). Lack/inadequate knowledge, unavailability of reporting forms and negative attitudes were barriers identified; and addressing them resulted in significant improvement in this setting. Scaling up these interventions to other hospitals can better the situation of under-reporting of ADRs in Nigeria.

A Prospective Observational Study of Adverse Drug Reactions to Antiretroviral Therapy: Type and Risk Factors in a Tertiary Care Teaching Hospital.

“…10 In our study, incidence of ADRs to ART in males and females did not show any signifi cant difference (males 50.6%, females 49.4%) and CD4 count of <250 cells/μl were affected with more ADRs (65.82%) (Figure 1). A study from Kadapa, India showed the majority of ADRs were observed in males (60%) and CD4 count of <250cells/μl were affected with more ADRs.…”

Interventions to improve adverse drug reaction reporting: A scoping review

“…The most common reason for excluding the records was further publication of relevant studies that suffered from insufficient data (n = 22). Moreover, seven studies were excluded because of their irrelevant outcomes [34][35][36][37][38][39][40] (Figure 1). To identify the published full-text reports of the included abstracts, the databases were searched and three full-text articles were retrieved, 2,24,41 and one paper was received along with a response from the author out of the nine communications made.…”

Knowledge assessment in adverse drug reactions and reporting

“…Under-reporting of ADR may be associated with poor knowledge, attitudes, and practices to pharmacovigilance. [23] In the current study, awareness about pharmacovigilance was created through regular monitoring of patients and their profiles with other HCPs, providing pamphlets, hand outs, and thank you note to the reporter. In phase-II study, most of our participants were aware of pharmacovigilance program when compared with the phase-I study.…”