塔潘塔多尔:应对滥用,患者安全和监管措施的复杂性
Jaishree Suresh1, Shatrunajay Shukla1, Kalaiselvan Vivekanandan1
1Public Health, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Ghaziabad, India.
Current medical research and opinion
|November 8, 2024
概括
滥用塔潘塔多尔是一种越来越令人担忧的问题,主要报告在印度,东南亚地区. 加强警和监管行动对于防止滥用和确保患者安全至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 药物滥用流行病学 药物滥用流行病学
- 监管科学 监管科学
背景情况:
- 塔达尔是一种阿片类止痛药,因其滥用和依赖的潜力而越来越受认可.
- 现实世界的数据分析对于了解药物滥用模式和报告不足至关重要.
- 由于不同的监管框架,东南亚地区 (SEAR) 为监测药物安全提供了一个独特的景观.
研究的目的:
- 用现实世界的数据来评估塔潘塔多尔滥用案例.
- 为了在SEAR中识别出有关塔潘塔多尔滥用的报告不足的国家.
- 加强该地区的塔潘塔多尔药物监测.
主要方法:
- 使用了回顾性,观察性研究设计.
- 从VigiBase收集了从2013年到2024年3月的数据.
- 使用"监管活动医学词典" (MedDRA) 系统分析了塔潘塔多尔滥用病例.
主要成果:
- 药物滥用案例属于精神病,神经系统障碍和中毒等类别.
- 印度是唯一报告TAPENTADOL滥用病例的SEAR国家;其他国家没有提交个人病例安全报告 (ICSR).
- 在印度的127个ICSR中,有20个涉及TAPENTADOL滥用,其中药物依赖/戒断综合征 (35%) 和药物滥用 (20%) 是最常见的.
结论:
- 需要采取严格的监管行动,包括将塔达尔重新安排到印度的X日程表.
- 在其他SEAR国家,由于潜在的依赖性,建议密切监测TAPENTADOL.
- 为了采取强有力的监管措施,鼓励更多来自SEAR国家的药物不良反应 (ADR) 报告至关重要.
相关概念视频
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 Abuse and Addiction: Pharmacological Phenomena
444
Drug dependence, abuse, and addiction are complex phenomena that can precipitate various abnormal states. Physical dependence refers to a state of pharmacological adaptation to a drug. This adaptation often results in tolerance—a reduced response to the drug after repeated administrations. When the drug use is abruptly stopped, withdrawal symptoms occur due to the body's need to readjust from the pharmacologically induced imbalance. However, tolerance and withdrawal symptoms do not...
444
Analgesia and Pain Management
518
Pain is critical to various clinical pathologies, provoking an urgent need for effective management. Pain, whether acute or chronic, is a complex neurochemical process. Its alleviation depends on the type, with nonopioid analgesics effective for mild to moderate pain, such as musculoskeletal or inflammatory pain, while neuropathic pain responds best to anticonvulsants, tricyclic antidepressants, or serotonin/norepinephrine reuptake inhibitors. For severe acute or chronic pain, opioids may be...
518
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
Opioid Analgesics: Synthetic and Semisynthetic Opioids
230
Synthetic and semisynthetic opioids are pivotal in pain management and tackling opioid addiction. Semisynthetic opioids, including morphinans (morphine derivatives), oxycodone, oxymorphone, hydrocodone, and hydromorphone, have improved pharmacokinetic profiles compared to morphine. Additionally, heroin and 6-MAM (6-Monoacetylmorphine) show better CNS penetration than morphine due to heightened lipid solubility. Hydromorphone, a potent opioid, undergoes hepatic metabolism to form the active...
230
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


