Developing a Method for Reporting Patient Harm Due to Antimicrobial Shortages

Developing a Method for Reporting Patient Harm Due to Antimicrobial Shortages
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DOI:
10.1007/s40121-014-0040-z
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发表时间:
2014-12-01
影响因子:
5.4
通讯作者:
Scheetz, Marc H.
Scheetz, Marc H.
中科院分区:
医学3区
文献类型:
--
作者:
McLaughlin, Milena M.;Skoglund, Erik;Scheetz, Marc H.

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导读:近年来,美国药品短缺的数量有所增加。虽然存在一些文献关于导致抗微生物药物短缺的因素,但仍然需要准确衡量由于实现抗微生物药物短缺而造成的患者伤害程度。此外,已知目前报告药物不良事件的方法低估了患者伤害的情况。我们试图开发一种持续和准确的方法来报告由于抗菌药物短缺造成的患者伤害,这种方法方便,匿名,并且允许临床医生估计由于短缺造成的因果关系。方法:我们发布了一个公共SurveyMonkey (R) (SurveyMonkey, Palo Alto, CA, USA)链接,以收集有关机构(用于重复)、患者年龄、性别、短缺抗菌产品、需要治疗或预防的感染类型、不良事件和患者结果的信息。结果:迄今为止,报告了4例感染治疗患者的完整数据,包括嗜麦寡养单胞菌菌血症、乙氏肺囊虫肺炎、病因不明的新生儿败血症和巨细胞病毒结肠炎。患者无法获得的抗菌剂包括磺胺甲恶唑-甲氧苄啶、庆大霉素和氟猩红碱。由于短缺,两个不良事件(治疗延误和由于耐药而无法用其他抗菌素治疗)可能具有因果关系,而其余不良事件(死亡和无法耐受高口服剂量)分别被归因于不太可能和可能由于短缺而具有因果关系。结论:这些方法促进了抗菌药物短缺危害的报道。
Introduction: The number of drug shortages in the United States has increased in recent years. While some literature exists on factors that contribute to antimicrobial shortages, the need remains to accurately gage the level of patient harm incurred as a result of realized antimicrobial shortages. Furthermore, current methods of reporting adverse drug events are known to under-report instances of patient harm. We sought to develop an ongoing and accurate method of reporting patient harm due to antimicrobial shortages, which was convenient, anonymous, and allowed clinicians to estimate the causality due to a shortage.Methods: We distributed a public SurveyMonkey (R) (SurveyMonkey, Palo Alto, CA, USA) link to gather information regarding institution (for de-duplicating purposes), patient age, sex, antimicrobial product on shortage, type of infection requiring treatment or prophylaxis, adverse event, and patient outcome.Results: To date complete data were reported on four patients being treated for infections that included Stenotrophomonas maltophilia bacteremia, Pneumocystis jirovecii pneumonia, neonatal sepsis of unknown etiology, and cytomegalovirus colitis. Antimicrobials that were unavailable to patients included sulfamethoxazole-trimethoprim, gentamicin, and foscarnet. Two adverse events (a delay in treatment and an inability to treat with other antimicrobials due to resistance) were attributed with probable causality due to a shortage, while the remaining adverse events (death and an inability to tolerate high oral doses) were attributed to have unlikely and possible causalities due to a shortage, respectively.Conclusion: These methods encourage reports of antimicrobial shortage harms.