Design of a Pharmaceutical Protocol for the Evaluation of Phytotherapeutic Products.

Introduction: The growing use of phytotherapy and the increasing heterogeneity of available formulations require community pharmacists to critically assess marketed products based on criteria of quality, safety, and efficacy. Objectives: To design an operational protocol to support community pharmacists in the evaluation and decision-making process regarding plant-based products. Methods: A consensus process was conducted by the SEFAC Fitoterapia Commission, involving the development and integration of structured checklists and the selection of open-access data sources. A decision tree was defined, starting from the legal classification, and an analytical framework for product evaluation was established. Finally, a rapid reporting template was designed for use in community pharmacy practice. Results: The resulting protocol provides a structured approach to the evaluation of phytotherapeutic products, organized into five sections and a rapid report. It is based on a sequential assessment of legal classification, scientific evidence, quality, safety, and patient information. Its implementation is supported by official, reliable, and openly accessible databases available to community pharmacists. Conclusions: The proposed protocol facilitates consistent and traceable pharmaceutical decision-making by integrating regulatory and scientific information into a practical and applicable tool for community pharmacy.