Pharmacoépidémiologie, Faculté de Médecine, UMR 1027 INSERM-Université Toulouse III, 37, Allées Jules Guesde, 31000, Toulouse, France.
Infectious Diseases Data Observatory-WorldWide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, Churchill Hospital, CCVTM, University of Oxford, Oxford, UK.
Drug Saf. 2017 Sep;40(9):809-821. doi: 10.1007/s40264-017-0544-z.
The health dangers of medicines of unknown identity (MUIs) [loose pharmaceutical units repackaged in individual bags without labelling of their identity] have been suspected in L/MICs. Using visual and analytical tools to identify MUIs, we investigated the frequency of, and factors associated with, adverse drug reaction (ADR)-related hospitalizations in a central hospital in Vientiane Capital, Lao People's Democratic Republic (PDR).
All unplanned admissions, except for acute trauma and intentional overdose, were prospectively recorded during a 7-week period in 2013, leading to include 453 adults hospitalized for ≥24 h. The patients or their relatives were interviewed to complete the study questionnaire. MUIs suspected of being involved in ADR(s) were identified through comparison of visual characteristics of tablets/capsules with that of reference medicines (photograph tool), and by proton nuclear magnetic resonance and mass spectrometry analyses. Factors associated with ADRs were identified by multivariate logistic regression.
The frequency of hospitalizations related to an ADR was 5.1% (23/453, 95% confidence interval [CI] 3.1-7.1). Forty-eight (12.8%) patients used MUI(s) in the last 2 weeks preceding hospitalization. They were more likely to be hospitalized because of an ADR (adjusted odds ratio 4.5, 95% CI 1.7-11.5) than patients using medicines of known identity. MUIs were mainly involved in bleeding gastroduodenal ulcers. The photograph tool led to the misidentifications because of look-alike pharmaceutical units in the medicines photograph collection.
According to the results of this study, there is a need to ensure appropriate labelling of medicines at dispensing and to provide well-suited tools to identify MUIs in clinical settings to improve drug safety and patients' care in developing countries with limited capacities for drug analysis.
在中低收入国家（LMICs），人们怀疑身份不明药品（MUIs）[未经标签、重新包装在单独袋子中的散装药品]对健康存在危害。本研究使用视觉和分析工具，调查了老挝万象首都中心医院因药物不良反应（ADR）相关住院的频率和相关因素。
2013 年，在为期 7 周的时间里，前瞻性地记录了所有非计划入院的情况，除急性创伤和故意过量外，共纳入 453 名住院时间≥24 小时的成年人。通过访谈患者或其亲属完成研究问卷。通过比较片剂/胶囊的视觉特征与参考药物（照片工具），并通过质子核磁共振和质谱分析，鉴定出疑似与 ADR 相关的 MUIs。通过多变量逻辑回归确定与 ADR 相关的因素。
ADR 相关住院的频率为 5.1%（23/453，95%置信区间 3.1-7.1）。48 名（12.8%）患者在住院前 2 周内使用了 MUIs。与使用已知身份药物的患者相比，他们因 ADR 住院的可能性更高（调整后的优势比 4.5，95%置信区间 1.7-11.5）。MUIs 主要与胃十二指肠出血性溃疡有关。照片工具导致错误识别，原因是药品照片库中存在外观相似的药品单位。
根据本研究结果，有必要确保在配药时对药品进行适当的标签，并在临床环境中提供合适的工具来识别 MUIs，以提高药物安全性并改善发展中国家有限的药物分析能力下患者的护理。
