Pharmacovigilance Consideration for Ayurvedic Medicines in Pediatric Practice: Developing Protocols for Documenting Clinical Safety

ABSTRACT

Background: The rising global trend of traditional medicine and complementary and alternative medicine use necessitates a structured approach to ensure patient safety and efficacy. Due to its unique theoretical framework, directly applying modern pharmacovigilance principles to Ayurveda may be insufficient. Purpose: This study aims to highlight the need for a collaborative approach that integrates traditional Ayurvedic knowledge with modern safety and efficacy evaluation methods. It critiques the limitations of current pharmacovigilance practices, especially in the context of Ayurveda, and proposes improvements to better capture the complexities of traditional medicine. Methodology: An analysis of the “AyushSuraksha” program, a key initiative for the pharmacovigilance of Ayurveda, Siddha, Unani, and homoeopathy (ASU&H) medicines in India, was conducted. The program’s focus areas, including monitoring medications, specific materials, and procedure-based therapies, were reviewed in light of their efficacy and safety reporting mechanisms. Additionally, the applicability of current pharmacovigilance methodologies, particularly in the context of personalized Ayurveda treatments, was evaluated through case studies and literature reviews. Results: The “AyushSuraksha” program, while focused on medication and therapy monitoring, overlooks the safety of food items used in Ayurveda. Current pharmacovigilance systems, designed for standardized medications, may be inadequate for Ayurveda, as demonstrated by positive outcomes in autism treatment despite the presence of microbiologically harmful products. Furthermore, existing pharmacovigilance proformas lack a distinction between physicians' and end-users perspectives, limiting the reporting scope. Conclusion: A transition to a holistic, evidence-based pharmacovigilance approach that incorporates Ayurvedic assessments and nonlinear herbal interactions is crucial. Separate proformas for physicians and end-users, along with diseasespecific questions, are recommended to improve reporting accuracy. Expanding the scope of pharmacovigilance beyond standardized medication monitoring is essential for the evolution and refinement of Ayurvedic science.

KEYWORDS

• Pharmacovigilance
• Ayurveda
• pediatric
• adverse drug reaction

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• DOI10.1177/0976500X241276311Copy