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  • Review Article
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Assessing cardiovascular drug safety for clinical decision-making

Nature Reviews Cardiology volume 10, pages 330–337 (2013)Cite this article

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Abstract

Optimal therapeutic decision-making requires integration of patient-specific and therapy-specific information at the point of care, particularly when treating patients with complex cardiovascular conditions. The formidable task for the prescriber is to synthesize information about all therapeutic options and match the best treatment with the characteristics of the individual patient. Computerized decision support systems have been developed with the goal of integrating such information and presenting the acceptable therapeutic options on the basis of their effectiveness, often with limited consideration of their safety for a specific patient. Assessing the safety of therapies relative to each patient is difficult, and sometimes impossible, because the evidence required to make such an assessment is either imperfect or does not exist. In addition, many of the alerts sent to prescribers by decision-support systems are not perceived as credible, and 'alert fatigue' causes warnings to be ignored putting patients at risk of harm. The CredibleMeds.org and BrugadaDrugs.org websites are prototypes for evidence-based sources of safety information that rank drugs for their risk of a specific form of drug toxicity—in these cases, drug-induced arrhythmias. Broad incorporation of this type of information in electronic prescribing algorithms and clinical decision support could speed the evolution of safe personalized medicine.

Key Points

  • For prescribers attempting to assess the benefit and risk potential of therapies, the large and rapidly changing knowledge base for adverse drug reactions represents a major challenge

  • Most automated decision-support systems designed to promote safe use of medicines do not provide evidence-based, actionable information about a specific patient's relative risk of harm from available therapeutic options

  • Independent resources, in which the huge amount of rapidly changing information on the relative safety of medications are continuously assessed, are needed to inform modern decision-support systems

  • Excessive QT prolongation on the electrocardiogram is a preventable drug reaction associated with >50 medications and drug interactions that can result in life-threatening ventricular arrhythmias (i.e. torsades de pointes), and death

  • Websites are available that provide independent information on the relative risk of drugs that can induce QT prolongation and torsades de pointes in various clinical settings

  • These resources provide a model for causality analysis that can be incorporated into decision-support systems to inform physicians about the relative risks of drug-induced adverse events

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Figure 1: Schematic for the causality analysis of relative drug safety for CredibleMeds.org.62
Figure 2: Hypothetical drug safety clinical decision support system.

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Authors and Affiliations

  1. AZCERT, Inc., 1822 East Innovation Park Drive, Oro Valley, 85755, AZ, USA

    Raymond L. Woosley

  2. Critical Path Institute, 1730 East River Road, Tucson, 85718, AZ, USA

    Klaus Romero

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Both authors researched data for the article, contributed to the discussion of content, wrote the manuscript, and reviewed/edited the article before submission.

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Correspondence to Raymond L. Woosley.

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The authors declare that they are uncompensated officers of the nonprofit organization AZCERT.org, which sponsors the website www.CredibleMeds.org that is mentioned in this Review. The authors declare no other competing interests.

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Woosley, R., Romero, K. Assessing cardiovascular drug safety for clinical decision-making. Nat Rev Cardiol 10, 330–337 (2013). https://doi.org/10.1038/nrcardio.2013.57

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