Yorkshire Quality and Safety Research Group, Bradford Institute for Health Research, Temple Bank House, Bradford Royal Infirmary, Bradford, UK.
BMJ Qual Saf. 2011 Jan;20(1):52-9. doi: 10.1136/bmjqs.2009.034512.
To examine the safety and acceptability of providing antiretroviral therapy (ART) in a resource poor setting.
Two-stage observational and qualitative study.
Rural hospital in Southern Africa.
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.
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.
研究在资源匮乏环境下提供抗逆转录病毒疗法（ART）的安全性和可接受性。
两阶段观察性和定性研究。
南部非洲农村医院。
使用失效模式和影响分析（FMEA）对药物供应、配药、处方和给药过程进行结构化观察。FMEA 的结果通过对参与提供 ART 的 8 名卫生专业人员进行定性访谈进一步探讨。为了获得患者的观点，还对接受 ART 治疗的 14 名患者进行了分层抽样访谈。
ART 提供过程中的关键脆弱性包括供应问题、包装和标签不良、员工知识不足以及人员短缺。成功患者依从性的主要障碍包括供应的运输不一致和个人经济困难。然而，有强有力的证据表明患者有承诺和依从性。
药物安全性在发展中国家相对未得到充分探索。本研究揭示了在提供复杂的 ART 方面，卫生系统和患者的依从性具有令人鼓舞的弹性。然而，确定的脆弱性破坏了患者的安全和 ART 的有效性。这对药物制造商、为 ART 提供资金和供应的国际援助机构以及当地从业者都有影响。FMEA 可以帮助识别潜在的脆弱性，并为安全改进干预措施提供信息。
