液体药物剂量错误:比较准备使用的维加巴特林溶液与复制的维加巴特林粉末口服溶液的溶液
Raenel Gibson1, Ron Klima2, Jay Van Horn2
1Pyros Pharmaceuticals Incorporated, 2001 Route 46, Suite 310, Parsippany, NJ, 07054, USA. Raenel.Gibson@Upsher-Smith.com.
Advances in therapy
|February 3, 2025
概括
护理人员准确地管理了准备好使用的vigabatrin口服溶液,与需要溶解的vigabatrin粉末不同. 准备好使用的溶液可确保更精确的剂量用于婴儿 (IS) 治疗.
科学领域:
- 儿科神经学 儿科神经学
- 药理学 药理学是指药理学的学科.
- 患者安全 患者安全
背景情况:
- 维加巴特林 (VGB) 是1个月至2岁的婴儿 (IS) 的关键治疗方法.
- 目前的VGB配方要求护理人员将vigabatrin粉末复制,引入潜在的剂量错误.
- 准确的VGB剂量对于管理IS和最大限度地减少不良事件至关重要.
研究的目的:
- 为了比较VGB剂量的准确性和可变性,护理人员使用准备使用 (RTU) 口服溶液与vigabatrin粉末配方.
- 评估护理人员在没有医疗保健专业指导的情况下准备VGB剂量的表现.
主要方法:
- 一项跨越性比较性可用性研究,涉及30名普通用户 (有或没有先前VGB粉末经验的护理人员).
- 参与者将VGB-RTU替代溶液和vigabatrin粉末的单剂量注入收集瓶中.
- 用分析方法测量了剂量准确性,主要终点是在目标剂量1125毫克的±10%以内提供.
主要成果:
- 所有参与者都达到VGB-RTU溶液剂量在目标的5%以内.
- 只有23/30维加巴林粉剂量在±10%的目标范围内.
- 与vigabatrin粉末相比,原始和经验丰富的护理人员在使用VGB-RTU溶液时表现出显著更高的准确性和更低的剂量变化.
结论:
- 与复制的vigabatrin粉末相比,护理人员可以获得更准确,更不变的VGB剂量,与即用口服溶液相比.
- 在复制vigabatrin粉末时,护理人员的错误是剂量不准确的主要原因.
- VGB-RTU解决方案提供了一种更安全,更可靠的方法,用于在家用VGB治疗婴儿.
相关概念视频
Dosage Regimen: Fixed Dose
1.8K
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...
1.8K
Bioequivalence: Overview
913
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
913
Volume of Distribution
93
The apparent volume of distribution (Vd) is a crucial pharmacokinetic parameter representing the hypothetical body fluid volume into which a drug disperses. It is calculated based on the total amount of drug in the body (estimated from the administered dose and bioavailability) divided by the plasma drug concentration. The total amount of drug in the body does not directly refer to the dose given but is derived by accounting for absorption, distribution, metabolism, and excretion processes.
93
Rational Dosage Regimen: Maintenance Dose and Loading Dose
3.8K
A rational dosage regimen considers a drug's pharmacokinetics, including its absorption, distribution, metabolism, and elimination from the body. By understanding these factors, the appropriate dosage can be determined, and the dosing schedule can be designed to achieve and maintain the desired therapeutic effect while minimizing adverse effects.
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady...
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady...
3.8K
Drug Dosage Regimen: Overview
3.4K
A drug dosage regimen describes the specific instructions and schedule for administering a drug to a patient. It considers factors such as drug dosage, frequency, route of administration, and duration of treatment. Designing an appropriate dosage regimen for a patient aims to achieve a target drug concentration at the site of action.
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
Typically, the starting dose and dosing interval are guided by the manufacturer's recommendations based on clinical trials conducted during and after drug...
3.4K
Two-Compartment Open Model: IV Bolus Administration
384
The two-compartment model for intravenous (IV) bolus administration illustrates drug distribution in the body, subdividing it into central and peripheral compartments. This model operates on the concept of two-compartment kinetics. The drug's plasma concentration shows a bi-exponential decline following IV bolus administration, signaling the presence of two disposition processes: distribution and elimination.
The disparity between drug input and the sum of drug transfer rates between...
The disparity between drug input and the sum of drug transfer rates between...
384


