Dhanani Trusha C, Mantovani Emily H, Turner J Rick
CVS Health, Raleigh, NC, USA.
Rutgers Ernest Mario School of Pharmacy, Piscataway, NJ, USA.
Int J Pharm Pract. 2017 Apr;25(2):176-179. doi: 10.1111/ijpp.12303. Epub 2016 Sep 28.
All biologically active agents carry the potential to lead to adverse reactions in certain individuals, including serious cardiac adverse reactions. Since 2005, there has been an international regulatory landscape governing the investigation of a new drug's propensity to lead to the polymorphic ventricular tachycardia Torsades de Pointes (Torsades), a rare but potentially fatal occurrence. When a regulatory agency considers it appropriate, warning information is placed in a medicine's patient information leaflet (label) concerning drug-induced QT interval prolongation, a phenomenon associated with Torsades. In busy hospital settings, however, prescribers, including cardiologists, make injudicious prescribing decisions that put patients at risk. The science of cardiac safety, including the clinical trials that generate the information about QT prolongation in patient information leaflets, is frequently not part of the curriculum at Schools of Pharmacy. Given that medication-induced cardiotoxicity is extremely serious, we advocate that schools integrate the science of cardiac safety into existing therapeutics/therapeutic medication monitoring courses. Given their expert knowledge of pharmacology, pharmacists working as part of a hospital's clinical team would then be even better placed to review prescribing decisions concerning medications that prolong the QT interval, and alert prescribers in cases where reassessing their decisions seems prudent. National pharmacy societies or other pertinent professional societies could create practice guidelines to support graduates once employed as clinical pharmacists. Clinical pharmacists are well placed to be influential arbiters of safer prescribing decisions. Cardiac safety education during their pharmacy training and practice guideline support from professional societies during their careers can optimize this role.
所有生物活性药物都有可能在某些个体中引发不良反应,包括严重的心脏不良反应。自2005年以来,国际上已形成一套监管框架,用于调查新药引发多形性室性心动过速(尖端扭转型室速,一种罕见但可能致命的情况)的倾向。当监管机构认为合适时,会在药品的患者信息说明书(标签)中加入有关药物诱发QT间期延长的警示信息,QT间期延长是一种与尖端扭转型室速相关的现象。然而,在繁忙的医院环境中,包括心脏病专家在内的开处方者会做出不明智的处方决定,使患者面临风险。心脏安全性科学,包括那些在患者信息说明书中生成有关QT间期延长信息的临床试验,在药学院的课程中常常并不涉及。鉴于药物引起的心脏毒性极其严重,我们主张各药学院将心脏安全性科学纳入现有的治疗学/治疗药物监测课程。鉴于医院临床团队中的药剂师具备药理学专业知识,他们将更有能力审查有关延长QT间期药物的处方决定,并在重新评估这些决定似乎审慎时提醒开处方者。国家药学协会或其他相关专业协会可以制定实践指南,以支持毕业后成为临床药剂师的人员。临床药剂师完全有能力成为更安全处方决定的有影响力的仲裁者。在他们接受药学培训期间进行心脏安全性教育,以及在其职业生涯中获得专业协会的实践指南支持,可以优化这一角色。