Aim: To examine the safety and acceptability of providing antiretroviral therapy (ART) in a resource poor setting.
Design: Two-stage observational and qualitative study.
Setting: Rural hospital in Southern Africa.
Methods: Structured observation using failure modes and effects analysis (FMEA) of the drug supply, dispensing, prescribing and administration processes. The findings from the FMEA were explored further in qualitative interviews with eight health professionals involved in the delivery of ART. To obtain a patient perspective, a stratified sample of 14 patients receiving ART was also interviewed.
Results: Key vulnerabilities in the process of ART provision include supply problems, poor packaging and labelling, inadequate knowledge among staff and lack of staff. Key barriers to successful patient adherence include transport inconsistency in supply and personal financial difficulties. There is, however, strong evidence of patient commitment and adherence. IMPLICATIONS AND CONCLUSION: Medication safety is relatively unexplored in the developing world. This study reveals an encouraging resilience in the health system and adherence among patients in the delivery of complex ART. The vulnerabilities identified, however, undermine patient safety and effectiveness of ART. There are implications for drug manufacturers; international aid agencies funding and supplying ART; and local practitioners. FMEA can help identify potential vulnerabilities and inform safety improvement interventions.