了解加拿大的药物特殊接入计划 (DEAPs),以及与之相关的社会和政治问题
Pierre-Marie David1, Kayley Laura Lata2,3, Marie-Eve Bouthillier4,5
1Université de Montréal, Faculty of Pharmacy, 2940 Chem. de Polytechnique, Montréal, QC, H3T 1J4, Canada. pierre-marie.david@umontreal.ca.
BMC medical ethics
|March 27, 2024
概括
加拿大的药物特殊准入计划 (DEAP) 绕过了标准的药物批准程序. 这篇评论探讨了这些制药准入计划所带来的复杂的伦理,经济,社会和政治挑战.
科学领域:
- 卫生政策 卫生政策
- 制药科学 制药科学
- 卫生经济学 卫生经济学
背景情况:
- 在加拿大,药物特殊获取计划 (DEAP) 被用来弥合医药获取差距.
- 这些计划在传统的药物批准途径之外运作.
研究的目的:
- 分析加拿大DEAP的基础上下文和操作程序.
- 为与DEAPs相关的多方面的问题提供见解.
- 为讨论关于药品准入和监管框架的讨论提供信息.
主要方法:
- 这项研究是一种评论,提供了批判性分析.
- 它涉及审查DEAPs的现有格局和程序.
- 重点是确定和讨论DEAPs的影响.
主要成果:
- DEAPs是药物获取的关键但复杂的机制.
- 了解背景和程序对于评估其影响至关重要.
- 这些节目强调了及时访问和既定的监管原则之间的紧张关系.
结论:
- DEAP需要仔细考虑其认识,经济,社会和政治方面的维度.
- 需要进一步审查DEAP框架,以确保公平和合理的药品获取.
- 政策制定应应对绕过标准药物批准流程所带来的挑战.
相关概念视频
Drug Control Governance: Regulatory Bodies and Their Impact
158
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...
158
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
Prescription, Nonprescription and Orphan Drugs
725
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...
725
Factors Affecting Drug Distribution: Physiological Barriers
200
Drug distribution in the body is intricately regulated by various physiological barriers that control the passage of substances. These include the capillary endothelial barrier, the blood-brain, blood-cerebrospinal fluid, blood-placental, and blood-testis barriers.
The capillary endothelial barrier allows only smaller molecules below 600 Da (Daltons) to pass through. It also restricts drugs like heparin that are bound to blood components, limiting their movement within the bloodstream.
The...
The capillary endothelial barrier allows only smaller molecules below 600 Da (Daltons) to pass through. It also restricts drugs like heparin that are bound to blood components, limiting their movement within the bloodstream.
The...
200
Factors Affecting Drug Response: Overview
2.0K
When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
2.0K
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


