美国食品和药物管理局对超粘膜即释放芬太尼产品的风险评估和缓解策略的评估
Jeffrey Eric Rollman1, James Heyward1, Lily Olson1
1Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
JAMA
|February 20, 2019
概括
尽管人们对TIRF的适当使用有很高的了解,但仍有大量的非标签处方. 美国食品和药物管理局没有强制对风险评估和减轻战略 (REMS) 计划进行重大改变.
科学领域:
- 药理学
- 药物安全
- 监管科学
背景情况:
- 超粘膜即释放芬太尼 (TIRF) 仅用于阿片类耐药患者的突破性癌症疼痛.
- 美国食品和药物管理局 (FDA) 实施了风险评估和缓解策略 (REMS),以防止不适当的TIRF处方.
研究的目的:
- 评估药剂师,处方者和患者关于适当使用TIRF的知识评估.
- 通过使用索赔数据来评估REMS计划是否达到了目标.
- 为了描述FDA对REMS评估的反应.
主要方法:
- 美国食品和药物管理局的4877页文件 (2012-2017年) 的定性分析.
- 包括REMS评估报告,FDA评估以及FDA赞助商的信件.
- 使用了"信息自由法" (FOIA) 的要求.
主要成果:
- 通过索赔数据和调查发现了大量不合适的TIRF使用率.
- 处方者和患者经常误解或错误报告适当的TIRF适用情况.
- 尽管发现了一些问题,但对REMS计划的实质性变化很少.
结论:
- 调查显示,人们对TIRF的正确处方知识普遍很高.
- 基于索赔的分析揭示了大量不适当使用TIRF的情况.
- 美国食品和药物管理局没有要求对TIRF REMS计划进行重大修改.
相关概念视频
Strategies for Assessing and Addressing Confounding
384
Confounding is a critical issue in epidemiological studies, often leading to misleading conclusions about associations between exposures and outcomes. It occurs when the relationship between the exposure and the outcome is mixed with the effects of other factors that influence the outcome. Given that, addressing confounding is of high importance for drawing accurate inferences in research.
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
384
Design Example: Analyzing Capacity Contours for Flood Risk Assessment
304
Flood risk assessment involves careful planning and analysis to ensure the safety of communities near water retention structures. Capacity contours are a vital tool in this process, as they illustrate the potential spread of water at specific levels in a given area. In the context of building a bund across a small valley, these contours play a critical role in evaluating the safety of nearby residential areas.In this example, the bund is intended to store stormwater in the valley. The engineers...
304
FDA Approved Drugs: Changes to Approved Drugs
257
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
257
Relative Risk
2.1K
Relative risk (RR) is a statistical measure commonly used in epidemiology to compare the likelihood of a particular event occurring between two groups. This metric is important for evaluating the relationship between exposure to a specific risk factor and the probability of a particular outcome. It plays a crucial role in medical research, public health studies, and risk assessment. Relative risk quantifies how much more (or less) likely an event is to occur in an exposed group compared to an...
2.1K
Energy-releasing Steps of Glycolysis
146.7K
Glycolysis is divided into two phases based on whether energy is utilized or released. While the first phase consumes ATP, the second phase produces energy in the form of ATP and NADH. The energy is released over a sequence of reactions that turns G3P into pyruvate. The energy-releasing phase—steps 6-10 of glycolysis—occurs twice, once for each of the two 3-carbon sugars produced during steps 1-5 of the first phase.
The first energy-releasing step—the 6th step of glycolysis...
The first energy-releasing step—the 6th step of glycolysis...
146.7K
Persuasion Strategies
43.5K
Researchers have tested many persuasion strategies, including the foot-in-the door and the door-in-the-face techniques, in a variety of contexts. Ultimately, the principles are effective in selling products and changing people’s attitude, ideas, and behaviors (Cialdini & Goldstein, 2004).
43.5K


