“Registers and other real-world data sources for herbal medicinal products” Webinar

On 5 November 2024, the webinar “Registers and other real-world data sources for herbal medicinal products” took place, organized by the Working Group Phytopharmaceuticals of the German Society for Pharmaceutical Medicine (DGPharMed) and moderated by Dr. rer. nat. Juliane Hellhammer.
The speaker, Dr. Simone Breitkopf, gave a comprehensive overview of the possibilities and challenges of collecting so-called real-world data (RWD) and its potential for research, as the real-world evidence (RWE) derived from it plays an increasingly important role in monitoring the entire product life cycle of medicinal products. Accordingly, the aim of Europe-wide harmonization and networking of such health data is to be able to use them for research purposes in the long term.
Different data sources can be linked using the patient’s health insurance number and their electronic patient record (ePA). Detailed product information on herbal medicinal products can then be recorded using the pharmaceutical central number (PZN), although this is not yet routine for non-prescription OTC products, as the PZN is only transferred to the ePA on a voluntary basis. Ideally, information on the course of the disease, symptom severity, patient experience, etc. can be recorded in addition to the ePA and PZN data for the development of a register for herbal medicines.

In summary, registers and other real-world data sources for herbal medicinal products offer many opportunities. However, establishing such structures is challenging and requires the combined efforts of authorities, physicians, pharmacists, professional associations and industry. In addition to the need to disseminate the importance of such data sources and a regulation for recording the PZN of OTC herbal medicinal products, a register should also always be scientifically advised at national or international level to ensure that the resulting data can also be used for regulatory purposes. The topic of RWD and registers requires increased attention, particularly in the area of phytopharmaceuticals. An intensive exchange within the DGPharMed is therefore of great importance. For this reason, a round table on this topic will take place at the DGPharMed annual conference on March 27/28, 2025 in Berlin.