印度固定剂量组合精神药物的销售和监管状况:一项追溯纵向研究
Paul Bogowicz1, Aashna Mehta2, Shruti Choudhary2
1Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
Journal of pharmaceutical policy and practice
|November 19, 2024
概括
印度的固定剂量组合 (FDC) 精神药物销售和配方增加,尽管有监管行动. 未经批准的FDC在市场上占主导地位,由于未经验证的安全性和有效性,可能会造成公共卫生风险.
科学领域:
- 药理学 药理学是指药理学的学科.
- 公共卫生 公共卫生
- 卫生政策 卫生政策
背景情况:
- 有限的证据支持固定剂量组合 (FDC) 药物用于精神疾病.
- 印度的精神药物FDC在政府监管计划中面临审查.
研究的目的:
- 分析印度心理药物FDC的销售趋势和监管状况.
- 评估监管举措对心理药物FDC市场的影响.
主要方法:
- 搜索了针对心理药物FDC的监管倡议和措施的官方文件.
- 2008年至2020年的综合私营市场数据.
- 使用描述性统计数据分析FDC数量,配方和销售量变化.
主要成果:
- 心理药物FDC的销售量从2008年的80亿美元 (18.4%的市场份额) 增加到2020年的14亿美元 (20.1%)
- FDC配方的数量从2008年的28 (101) 增加到2020年的33 (143).
- 未经批准的FDC占销售额的很大一部分 (2008年为69.3%,2020年为60.3%).
- 2020年,三种被禁止的精神药物FDC中的两种仍然在市场上.
结论:
- 未经批准的精神药物FDC继续主导销售,引发了安全性和有效性的担忧.
- 监管举措在制未经批准的FDC市场方面取得了有限的成功.
- 由于缺乏评估的安全性和有效性,未经批准的FDC的流行对公众健康构成潜在风险.
更多相关视频
相关概念视频
Pharmacovigilance
774
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...
774
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
Dosage Regimen: Fixed Dose
1.9K
Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
1.9K
Nonlinear Pharmacokinetics: Dependence of Elimination Half-Life and Dose Clearance
87
The elimination half-life and drug clearance of drugs following nonlinear kinetics can vary with dosage. The Michaelis-Menten parameters and drug concentration influence these factors. As the dose increases, the elimination half-life tends to lengthen, resulting in a reduction in clearance and a disproportionately larger area under the curve. The total clearance can be derived from the Michaelis-Menten equation for drugs following a one-compartment model.
A study on guinea pigs examined the...
A study on guinea pigs examined the...
87
Drug Therapy
39
The advent of drug therapy has profoundly shaped modern mental health care, providing targeted treatments for a range of psychological disorders. Psychotherapeutic drugs, classified into antianxiety, antidepressant, and antipsychotic medications, address symptoms across anxiety disorders, mood disorders, and schizophrenia. While these medications have transformed patient outcomes, they require careful management due to their potential side effects and limitations.
Antianxiety Medications
Antianxiety Medications
39
Drug Control Governance: Regulatory Bodies and Their Impact
142
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...
142


