Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany.
Br J Clin Pharmacol. 2013 Sep;76 Suppl 1(Suppl 1):37-46. doi: 10.1111/bcp.12188.
We aimed to develop a generic knowledge base with drug administration recommendations which allows the generation of a dynamic and comprehensive medication plan and to evaluate its comprehensibility and potential benefit in a qualitative pilot study with patients and physicians.
Based on a literature search and previously published medication plans, a prototype was developed and iteratively refined through qualitative evaluation (interviews with patients and focus group discussions with physicians). To develop the recommendations for safe administration of specific drugs we screened the summary of product characteristics (SmPC) of different exemplary brands, allocated the generated advice to groups with brands potentially requiring the same advice, and reviewed these allocations regarding applicability and appropriateness of the recommendations.
For the recommendations, 411 SmPCs of 140 different active ingredients including all available galenic formulations, routes of administrations except infusions, and administration devices were screened. Finally, 515 distinct administration recommendations were included in the database. In 926 different generic groups, 29,879 allocations of brands to general advice, food advice, indications, step-by-step instructions, or combinations thereof were made. Thereby, 27,216 of the preselected allocations (91.1%) were confirmed as appropriate. In total, one third of the German drug market was labelled with information.
Generic grouping of brands according to their active ingredient and other drug characteristics and allocation of standardized administration recommendations is feasible for a large drug market and can be integrated in a medication plan.
我们旨在开发一个具有药物管理建议的通用知识库，该知识库可生成动态且全面的药物治疗计划，并通过与患者和医生进行定性试点研究来评估其可理解性和潜在益处。
基于文献检索和已发表的药物治疗计划，开发了一个原型，并通过定性评估（患者访谈和医生焦点小组讨论）进行迭代改进。为了制定特定药物安全给药的建议，我们筛选了不同示例品牌的产品特性摘要（SmPC），将生成的建议分配给可能需要相同建议的品牌组，并根据建议的适用性和适当性对这些分配进行审查。
为了这些建议，我们筛选了 411 份不同活性成分的 SmPC，包括所有可用的剂型、除输注外的给药途径和给药装置。最终，数据库中包含了 515 条不同的给药建议。在 926 个通用组中，对品牌进行了 29879 次分配，包括一般建议、饮食建议、适应证、逐步说明或其组合。其中，27216 次预先选择的分配（91.1%）被确认是适当的。总共，德国药品市场的三分之一被贴上了信息标签。
根据活性成分和其他药物特性对品牌进行通用分组，并分配标准化的给药建议，对于大型药品市场是可行的，并且可以集成到药物治疗计划中。
