提高制药公司的药监管:在实施之前和之后对电子报告的比较研究
Ghita Meknassi Salime1, Nihal Bhirich1, Abdelghani Asraoui2,3
1Mohammed V University of Rabat, Faculty of Medicine and Pharmacy, Morocco.
Current drug safety
|July 2, 2025
概括
摩洛哥制药公司越来越多地使用电子药物不良反应报告,显示了定量有效性. 然而,采用需要进一步加强和提高认识,以提高报告质量.
科学领域:
- 药物监督 药物监督 药物监督
- 制药行业监管法规 制药行业监管法规
背景情况:
- 自2016年以来,摩洛哥制药公司被要求报告药物不良反应.
- 在2021年从纸质 (CIOMS) 和早期电子 (ICH E2B) 过渡到标准化的在线系统 (vigiflow电子报告).
- 以前的报告方法包括邮件提交和XML文件.
研究的目的:
- 评估制药公司采用和使用电子药物不良反应报告的情况.
- 评估通过不同报告道提交的药物不良反应报告的质量.
- 在CIOMS,ICH E2B和vigiflow电子报告系统中比较报告的完整性.
主要方法:
- 对制药公司在2019年1月1日至2023年12月31日期间提交的个案安全报告的分析.
- 报告量和趋势的定量和定性分析.
- 用于比较分析的VigiGrade完整度评分的计算.
主要成果:
- 电子报告 (vigiflow) 占2021年后报告的50%,超过CIOMS (29%) 和E2B (21%).
- 在2019-2021年期间,观察到CIOMS和E2B提交量的下降,随后电子报告的增加.
- 在三个报告方法 (p=0.094) 中,报告完整性 (VigiGrade分数) 没有发现统计学上显著的差异.
结论:
- 电子报告证明了药物不良反应监测的定量有效性.
- 在不同的报告方式中保持一致的报告质量.
- 电子报告的更广泛采用需要提高对制药公司的认识和持续支持.
相关概念视频
Pharmacovigilance
1.0K
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...
1.0K
Drug Regulation
1.9K
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...
1.9K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
182
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,...
182
Clinical Trials: Overview
3.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.4K
Clinical Trials
8.7K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
8.7K
Drug Control Governance: Regulatory Bodies and Their Impact
257
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
257


