在处方药推广中定义生物类似产品的认知和偏好
Mihaela Johnson1, Jessica E Thompson2, Avery A Tilley2
1From the RTI International, Research Triangle Park, NC (MJ, JET, AAT); U.S. Food and Drug Administration, Office of Prescription Drug Promotion, Silver Spring, MD (KJA, ACO). mjohnson@rti.org.
Journal of the American Board of Family Medicine : JABFM
|April 29, 2025
概括
消费者和医疗保健专业人员对处方生物类似药的理解有限,这表明需要更清晰的沟通和教育,以提高对这些重要药物的认识和接受.
科学领域:
- 制药科学 制药科学
- 卫生沟通健康沟通
- 监管科学 监管科学
背景情况:
- 处方生物类似药是FDA批准的,在治疗上相当于参考产品.
- 消费者和医疗保健专业人员 (HCP) 对生物类似药的认识有限.
- 这项研究评估了对生物类似药物披露声明的理解和偏好.
研究的目的:
- 评估生物类似药物披露声明的理解和看法.
- 确定生物类似信息的最佳沟通策略.
- 确定影响消费者和医疗人员接受生物类似药物的因素.
主要方法:
- 消费者 (n=379) 和医疗保健人员 (n=368) 查看了一个模拟广告,随机选择了生物类似药的披露定义.
- 调查评估了理解,感知,态度,意图和偏好.
- 披露变化包括将产品确定为生物类似物,定义内容,并命名参考产品.
主要成果:
- 对于消费者 (48.5%-62.0%) 和医疗人员 (68.4%-88.4%) 来说,生物类药物披露的理解程度都不够理想.
- 扩展定义改善了HCP的态度和处方意图;这两组都更喜欢扩展定义.
- 医疗保健专家表示他们更喜欢命名的参考产品,并同意可互换性.
结论:
- 关于生物类似药的知识差距和不确定性在消费者和医疗人员中仍然存在.
- 有针对性的教育和经过仔细测试的沟通对于有效推广生物类似药物至关重要.
- 需要更清晰的信息来确保理解和防止负面看法.
相关概念视频
Bioequivalence: Overview
887
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,...
887
Drug Nomenclature
1.5K
During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
1.5K
Biopharmaceutics and Pharmacokinetics: Overview
1.8K
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
1.8K
Prodrugs
2.3K
Prodrugs are a class of pharmaceutical compounds that undergo a biotransformation process within the body to be converted into a pharmacologically active drug. Prodrugs are designed to improve the therapeutic properties of the parent drug, such as enhancing bioavailability, increasing stability, or reducing toxicity. The concept of prodrugs revolves around modifying the chemical structure of the original drug to make it more effective or convenient for administration.
Prodrugs help overcome...
Prodrugs help overcome...
2.3K
Drug Biotransformation: Overview
2.2K
Pharmaceutical substances known as xenobiotics are predominantly lipophilic and nonionized. This enables them to permeate lipid bilayers, such as cell membranes, and interact with intracellular target receptors. Lipophilic drugs have an advantage in crossing biological barriers and reaching their intended sites of action. However, lipophilic drugs often have a restricted capacity for renal expulsion or elimination from the body. When these drugs enter the kidneys and undergo glomerular...
2.2K
Prescription, Nonprescription and Orphan Drugs
663
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...
663


