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药品短缺:对医学毒理学的影响。

Drug shortages: Implications for medical toxicology.

作者信息

Mazer-Amirshahi Maryann, Hawley Kristy L, Zocchi Mark, Fox Erin, Pines Jesse M, Nelson Lewis S

机构信息

Department of Emergency Medicine, MedStar Washington Hospital Center , Washington, DC , USA.

出版信息

Clin Toxicol (Phila). 2015 Jul;53(6):519-24. doi: 10.3109/15563650.2015.1043441. Epub 2015 May 8.

DOI:10.3109/15563650.2015.1043441
PMID:25951876
Abstract

CONTEXT

Drug shortages have significantly increased over the past decade. There are limited data describing how shortages impact medical toxicology of drugs.

OBJECTIVE

To characterize drug shortages affecting the management of poisoned patients.

MATERIALS AND METHODS

Drug shortage data from January 2001 to December 2013 were obtained from the University of Utah Drug Information Service. Shortage data for agents used to treat poisonings were analyzed. Information on drug type, formulation, reason for shortage, shortage duration, marketing, and whether the drug was available from a single source was collected. The availability of a substitute therapy and whether substitutes were in shortage during the study period were also investigated.

RESULTS

Of 1,751 shortages, 141 (8.1%) impacted drugs used to treat poisoned patients, and as of December 2013, 21 (14.9%) remained unresolved. New toxicology shortages increased steadily from the mid-2000s, reaching a high of 26 in 2011. Median shortage duration was 164 days (interquartile range: 76-434). Generic drugs were involved in 85.1% of shortages and 41.1% were single-source products. Parenteral formulations were often involved in shortages (89.4%). The most common medications in shortage were sedative/hypnotics (15.6%). An alternative agent was available for 121 (85.8%) drugs; however, 88 (72.7%) alternatives were also affected by shortages at some point during the study period. When present, the most common reasons reported were manufacturing delays (22.0%) and supply/demand issues (17.0%). Shortage reason was not reported for 48.2% of drugs.

DISCUSSION

Toxicology drug shortages are becoming increasingly prevalent, which can result in both suboptimal treatment and medication errors from using less familiar alternatives.

CONCLUSION

Drug shortages affected a substantial number of critical agents used in the management of poisoned patients. Shortages were often of long duration and for drugs without alternatives. Providers caring for poisoned patients should be aware of current shortages and implement mitigation strategies to safeguard patient care.

摘要

背景

在过去十年中,药品短缺现象显著增加。关于短缺如何影响药物医学毒理学的数据有限。

目的

描述影响中毒患者治疗的药品短缺情况。

材料与方法

从犹他大学药物信息服务中心获取2001年1月至2013年12月的药品短缺数据。分析用于治疗中毒的药物的短缺数据。收集有关药物类型、剂型、短缺原因、短缺持续时间、市场销售情况以及药物是否为单一来源的信息。还调查了替代疗法的可用性以及在研究期间替代药物是否短缺。

结果

在1751起短缺事件中,141起(8.1%)影响了用于治疗中毒患者的药物,截至2013年12月,21起(14.9%)仍未解决。新的毒理学短缺事件自21世纪中期以来稳步增加,2011年达到26起的高峰。短缺持续时间的中位数为164天(四分位间距:76 - 434天)。85.1%的短缺事件涉及仿制药,41.1%为单一来源产品。注射剂剂型常出现短缺(89.4%)。短缺最常见的药物是镇静催眠药(15.6%)。121种(85.8%)药物有替代药物;然而,88种(72.7%)替代药物在研究期间的某个时间点也受到短缺影响。出现短缺时,报告的最常见原因是生产延迟(22.0%)和供应/需求问题(17.0%)。48.2%的药物未报告短缺原因。

讨论

毒理学药品短缺日益普遍,这可能导致治疗效果不佳以及因使用不太熟悉的替代药物而出现用药错误。

结论

药品短缺影响了大量用于中毒患者治疗的关键药物。短缺往往持续时间长且涉及无替代药物的药品。治疗中毒患者的医护人员应了解当前的短缺情况并实施缓解策略以保障患者治疗。

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