在医药护理中使用数字技术的未来系统风险分析
Journal of the American Pharmacists Association : JAPhA
|April 5, 2024
概括
药品中的数字健康存在欺诈和数据错误等风险. 失效模式和影响分析确定了关键风险,导致提出措施,大大降低了对患者安全和药房运营的潜在危害.
科学领域:
- 制药科学 制药科学
- 数字健康数字健康
- 风险管理 风险管理
背景情况:
- 数字技术是制药生命周期的组成部分,从药物设计到患者使用.
- 目前对数字解决方案的监测,评估和风险评估是不够的.
研究的目的:
- 识别数字医药护理技术中的潜在错误.
- 量化和优先考虑与患者安全和护理质量相关的风险.
- 确定针对已识别的数字健康风险的纠正措施.
主要方法:
- 一个由10名成员组成的多学科团队使用了故障模式和效应分析 (FMEA).
- 分析了远程医疗,mHealth,人工智能 (AI) 和软件基础设施.
- 根据严重程度,发生率和可检测性计算的风险优先级号码 (RPN).
主要成果:
- 在四个数字健康组件中确定了42个风险.
- 确定了8个关键风险,其中RPN超过了30的门.
- 互联网/身份欺诈是风险最高的故障模式;其他风险包括数据错误,错误的实施和缺乏透明度.
- 拟议的纠正措施将RPN总额从414减少到156.
结论:
- 药房数字化提供了更高的效率,但需要积极的风险管理.
- 及时识别问题,监测和强大的基础设施对于安全的数字工具实施至关重要.
- 解决已识别的风险对于实现医药护理领域数字创新的全部潜力至关重要.
相关概念视频
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
126
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
126
Issues And Trends In Healthcare Delivery System
5.6K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.6K
Pharmacovigilance
830
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
830
Analysis of Population Pharmacokinetic Data
254
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
254
Drug Regulation
1.4K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.4K
Guidelines and Strategies for Safe Computer Charting
803
The guidelines and strategies provided by the American Nurses Association (ANA) and the Canadian Nurses Association (CNA) offer essential principles for ensuring safe and secure computer charting systems in healthcare settings. Let's break down each recommendation:
Maintain Confidentiality and Security:
Maintain Confidentiality and Security:
803


