Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons (EPHOR), University Medical Center Utrecht, Utrecht, The Netherlands.
PLoS One. 2013 Aug 16;8(8):e72060. doi: 10.1371/journal.pone.0072060. eCollection 2013.
The ICH E7 guideline intends to improve the knowledge about medicines in geriatric patients. As a legislative document, it might not reflect the needs of healthcare professionals. This study investigated what information healthcare professionals, regulatory agencies and pharmaceutical industries consider necessary for rational drug prescribing to older individuals.
A 29-item-questionnaire was composed, considering the representation in trials, pharmacokinetics, efficacy, safety, and convenience of use in older individuals, with space for additions. Forty-three European professionals with an interest in medication for older individuals were included. In order to investigate their relevance, five items were included in a second questionnaire, with 11 control items. Median scores, differences between clinical and non-clinical respondents and response consistency were analysed. Consistency was present in 10 control items. Therefore, all items of the first questionnaire and the five additional items were analysed. Thirty-seven (86%) respondents returned the first questionnaire; 31/37 (84%) the second. Information about age-related differences in adverse events, locomotor effects, drug-disease interactions, dosing instructions, and information about the proportion of included 65+ patients was considered necessary by most respondents. Clinicians considered information significantly more important than the non-clinical respondents about the inclusion of 75+, time-until-benefit in older people, anticholinergic effects, drug-disease interactions, and convenience of use. Main study limitations are the focus on information for daily practice, while the ICH E7 guideline is a legislative document focused on market approval of a new medicine. Also, a questionnaire with a Likert scale has its limitations; this was addressed by providing space for comments.
This study reveals that items considered necessary are currently not included in the ICH E7 guideline. Also, clinicians' and non-clinicians' opinions differed significantly in 15% of the items. Therefore, all stakeholders should collaborate to improve the availability of information for the rational prescribing to older individuals.
ICH E7 指南旨在提高老年患者对药物的认识。作为立法文件，它可能无法反映医疗保健专业人员的需求。本研究调查了医疗保健专业人员、监管机构和制药行业认为在为老年人合理开处方时需要哪些信息。
考虑到临床试验中的代表性、药代动力学、疗效、安全性和老年人使用的便利性，我们编写了一份包含 29 个项目的问卷，并留出了添加内容的空间。纳入了 43 名对老年人用药有兴趣的欧洲专业人员。为了调查其相关性，在第二个问卷中纳入了 5 个项目和 11 个对照项目。分析了中位数评分、临床和非临床应答者之间的差异以及应答一致性。在 10 个对照项目中存在一致性。因此，分析了第一个问卷的所有项目和 5 个附加项目。37 名（86%）应答者返回了第一个问卷；31/37（84%）返回了第二个问卷。大多数应答者认为，有关不良事件、运动效应、药物-疾病相互作用、剂量说明以及有关纳入 65+ 岁患者比例的信息，与年龄相关的差异是必要的。与非临床应答者相比，临床医生认为关于纳入 75+岁患者、老年人的获益时间、抗胆碱能作用、药物-疾病相互作用和便利性的信息更重要。主要研究局限性在于关注日常实践中的信息，而 ICH E7 指南是一项侧重于新药市场批准的立法文件。此外，使用李克特量表的问卷有其局限性；通过提供评论空间解决了这个问题。
本研究表明，目前 ICH E7 指南中未包含被认为必要的项目。此外，在 15%的项目中，临床医生和非临床医生的意见存在显著差异。因此，所有利益相关者都应合作，改善为老年人合理开处方提供信息的可获得性。
