不推列入世卫组织基本药物清单的药物:一项追溯观察性研究
Enrico Costa1, Vittorio Del Grosso2, Bernadette Cappello3
1Utrecht World Health Organization Collaborating Centre for Pharmaceutical Policy and Regulation, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, Netherlands.
Frontiers in medicine
|April 1, 2025
概括
许多新药不建议加入世卫组织基本药物清单 (EML). 临床证据质量差和经济因素是拒绝的主要原因,随着时间的推移,可行性问题越来越严重.
科学领域:
- 药物经济学 药物经济学
- 卫生政策 卫生政策
- 基于证据的医学基于证据的医学.
背景情况:
- 世界卫生组织基本药物模型清单 (EML) 指导国家基本药物政策.
- 了解为什么不建议使用药物治疗EML对于有效制定政策至关重要.
- 本研究审查了世卫组织EML不推的应用程序.
研究的目的:
- 分析不建议将药物列入世卫组织基本药物清单 (EML) 的特征,频率和原因.
- 确定预测新药负面推的因素.
- 随着时间的推移,追踪非推原因的趋势.
主要方法:
- 专家委员会关于2002-2023年基本药物的审查报告.
- 收集关于提交申请的数据,包括治疗指示,申请人,以及负面推的原因.
- 利用后勤回归来分析负面建议的预测特征.
主要成果:
- 在359个申请中,有148个 (41.2%) 不被推.
- 不推的主要原因是临床证据质量差 (62.1%) 和经济标准 (33.1%).
- 随着时间的推移,对实施能力和专业专业知识的担忧越来越大;制药公司和学术界更有可能收到负面建议.
结论:
- 很大一部分新药申请并没有被添加到世卫组织EML.
- 临床证据质量有限仍然是不推的持续原因.
- 经济因素和实施可行性是EML纳入越来越重要的考虑因素.
相关概念视频
Pharmacovigilance
755
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...
755
Prescription, Nonprescription and Orphan Drugs
666
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
666
Drug Regulation
1.3K
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...
1.3K
Drug Classes and Categories
1.8K
Drugs can be classified according to their chemical composition or their intended therapeutic application. For instance, anti-infective agents that possess the ability to eliminate pathogens or suppress their growth and reproduction can be grouped based on the organisms they target or their chemical structure. Furthermore, drugs can be divided into prescription, nonprescription, or controlled substances. Prescription medications, such as antibiotics, require oversight from a licensed healthcare...
1.8K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
106
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,...
106
Sedatives and Hypnotics Drugs: Miscellaneous Agents
132
Sedatives and hypnotics encompass a wide range of substances, each with its unique mechanism of action, uses, and potential adverse effects.
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...
132


