Preventing Medication Errors: A $21 Billion Opportunity

With the majority of hospitalized patients today receiving medications, health systems face a significant risk for harmful medication errors, or preventable adverse drug events (ADEs). According to a 2008estimatefrom the U.S. Department of Health and Human Services, patient harm due to ADEs comprise a sizeable yet impactable portion of safety events:

• Permanent harm from a medical error affects approximately one in seven hospitalized Medicare patients.
• ADEs are associated with 37 percent of medical harm events.
• 50%的ADEs是可以预防的。

Error (medication of other) doesn’t correlate one-to-one with harm. Errors can be near misses, in which a mistake or miscalculation doesn’t make it to the patient; only a small portion filter through to cause harm.

The breadth and depth of ADE impact creates an obvious cost and quality issue for healthcare organizations but also a sizeableopportunity改善方面:可能节省近210亿美元，并对700多万患者产生影响。卫生系统历来没有有效地应对ADEs。然而，今天，随着决策支持软件能够实时监测患者群体，医疗保健在ADE检测、监测和预防方面取得了重大进展。

Patient Data Is a Key Asset in Preventing Medication Errors

Shared interest in drug safety between the FDA and health systems sparked initial research into ways to identify ADEs. In the 1990s, a largehealth systemused its EMR data to identify specific types of patient harm, similarly to how it used the EMR in infectious disease surveillance. The health system started using its EMR data to develop triggers for specific types of patient harm (e.g., sudden medication-stop orders, antidote ordering, and certain abnormal laboratory values). The trigger system generated a daily list of potential ADEs among the patient population, and pharmacists classified risk according to severity and risk type (e.g., dose dependent, predictable, idiosyncratic, or allergic).

Using EMR data and triggers over 18 months, the health system verified 731 ADEs in 648 patients. They compared thedata– and analytics-enabled approach to traditional detection methods, which identified only nine ADEs during the same period.

Therapeutic Advances Make ADEs More Important than Ever

药物安全仍然是医疗保健领域的一个热门话题，特别是在临床试验仅包括来自有限人群的数百或数千名患者后，前沿疗法就会上市。例如，当FDA批准一种新的用于癌症免疫治疗的化学实体时，这种药物可能在临床试验参与者中显得相对安全。然而，上市前临床试验准入标准倾向于排除有显著共病(如心血管或肾脏疾病)的患者。

When the drug reaches the general public, prescribing clinicians don’t have the data or clinical trial experience to know how it affects people with a variety of comorbidities. These blind spots, along with exposing large groups of patients to the agent (often larger numbers than in the original clinical trials), create a risk for ADEs that the premarketing, phase three trials didn’t discover. If the general population outcomes are bad, the FDA removes the drug from the market. Pharmaceutical companies stand to lose up to millions of dollars invested in getting the drug to market, and patients lose the opportunity for a potentially effective therapy.

药品审批过程中的这一空白——从批准到普通公众——为基于数据和分析的上市后监测提供了机会。一个针对新药和设备的重点监控系统，提供严格的、前瞻性的上市后监控，可以使新疗法尽早发布。FDA可以利用这段时间，让更广泛的人群实时了解ADE的风险，并相应地调整指南。扩大的监督可能意味着更多的药物进入公众，对安全性有了更深入的了解。从理论上讲，由于新发现的严重或危及生命的ade，很少有潜在的有希望的疗法会被撤出市场。

Post-Marketing Drug Surveillance Requires a Clinical Workflow Tool

A clinical workflow (decision-support) tool that leverages triggers (e.g., the Health Catalyst® Patient Safety Monitor™ Suite: Surveillance Module) allows drug safety teams to evaluate and take critical action against ADEs:

• 预测并检测ADE。
• 进行干预并降低风险。
• Prevent the ADE.

例如，使用决策支持触发器，该工作流工具将临床医生的注意力集中在接受抗凝剂的患者上，该患者的实验室结果为原因不明的出血，激活的部分凝血酶活时间(aPTT)大于300，收缩压<90 mmHg。这表明病人可能正在经历一次重大的药物性出血事件。该工作流程工具指导临床医生找到可能导致这种严重不良事件的药物，并就如何减轻该事件提供进一步的指导。来自自动化、前瞻性监控的高级分析——结合包括结构性根本原因分析、可能性和严重程度评估的临床评估——为机器学习算法提供了流行病学上可靠的数据。这些算法驱动了先进的决策支持应用程序，旨在防止在未来的患者中使用冒犯性药物或类似药物治疗不良事件。

Figure 1 shows the ADE clinical surveillance workflow, including detection; characterization and analysis; and measurement. The workflow gives clinicians the data they need to understand and make critical decisions about ADE mitigation:

1. Which patients do I need to see?
2. What should I do?
3. 我为什么要这么做?

Four Meaningful Ways Post-Marketing Drug Surveillance Improves Patient Safety

Post-marketing drug surveillance with an ADE clinical surveillance workflow tool helps improvepatient safety对住院患者来说，有四个关键途径:

1. 对不良事件进行远景监测，并在患者人群中识别以前未描述的不良事件。If the drug proves harmful, or harmful to certain patients at certain doses, the FDA removes it from the market.
2. Determines the root cause of many ADEs by drug class.
3. Enables drugs prescribed at appropriate doses for patients with compromised kidney or liver functions (a high risk among patients today).
4. Identifies different types of harm to find causes.

Safer Patients, Billions of Dollars Saved

As healthcare continues to develop and use more, increasingly powerful drugs, risks for ADEs will rise along with the potential for effective treatments. One way that health systems can help manage patient harm due to medication is to adopt a decision support tool that enables real-time surveillance of patient populations and advanced analytics to identify risk for ADEs and suggest preventive action.

Additional Reading

Would you like to learn more about this topic? Here are some articles we suggest:

1. Healthcare Safety Culture: A Seven-Step Success Framework
2. Introducing the Health Catalyst Monitor™ Patient Safety Suite: Surveillance Module
3. Survey Shows the Role of Technology in the Progress of Patient Safety
4. Improving Patient Safety: Machine Learning Targets an Urgent Concern
5. Data-Driven Process Improvement Raises Patient Safety for Highest-Risk Medication

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