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Design of a Pharmaceutical Protocol for the Evaluation of Phytotherapeutic Products
L Parra-Astorgano1, R Prats Mas2, I Villegas Lama3
1Community Pharmacist (Valladolid, Spain). Assistant Professor of Health Sciences, Faculty of Pharmacy, University of Salamanca. Member of the Pharmaceutical Indication and Medication Use Review Working Groups of SEFAC. Member of the Scientific Committee of SEFAC. Member of the Phytotherapy Commission of SEFAC. España.
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.
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