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Navigating the Terrain of Pharmacovigilance in Herbal and Traditional Medicines

Herbal and traditional medicines have been integral to healthcare systems worldwide for centuries, offering natural remedies for various ailments. The roots of herbal and traditional medicine stretch back to the dawn of civilization. Ancient civilizations like the Egyptians, Greeks, Chinese, and indigenous cultures across the globe cultivated an intimate understanding of the plants around them. They discovered the therapeutic properties of various herbs and developed intricate systems of medicine based on their observations and experiences. These traditions were not only about treating ailments but also about maintaining harmony between the body, mind, and spirit—a holistic approach that still resonates today. Fast forward to the modern era, and herbal and traditional medicine continues to thrive, embraced by millions seeking natural alternatives and cultural connections. Yet, as the world becomes more interconnected and scientific advancements reshape healthcare, the need for pharmacovigilance becomes increasingly apparent.

A large portion of world population relies on traditional and herbal medicines as a part of their normal healthcare. Thousands of products available worldwide even in countries with highly regulated safety monitoring has these products being sold outside regulatory framework. Most of the time patient may be oblivious of the fact that these may have little or no formal efficacy and safety testing during product development. In last few years, herbal and traditional medicines market has increased worldwide. Herbal medicines typically encompass a range of dose forms from relatively crude preparations such as tinctures and extracts that are supplied by herbal medical practitioners to manufactured or finished products usually formulated as tablets or capsules. Patients worldwide are vulnerable to the adverse effects of herbal and traditional medicines, which may range from mild or moderate reactions to life-threatening or fatal events. Some populations have increased susceptibility, mainly women using herbal medicines during pregnancy and labour, or elderly people with other coexisting medical conditions. Risk assessment of herbal and traditional medicines is always challenging in these groups populations. However, as their popularity continues to grow globally, so do concerns about their safety and efficacy.

Pharmacovigilance of pharmaceutical products is equally applicable to herbal and traditional medicines. Unlike synthetic pharmaceuticals, herbal and traditional medicines often consist of complex mixtures of botanicals, minerals, and animal-derived substances. The variability in composition, potency, and quality of these products poses significant challenges for pharmacovigilance efforts. Moreover, cultural and traditional practices influence the use of herbal remedies, leading to variations in dosing regimens, administration routes, and therapeutic expectations. One of the primary challenges in pharmacovigilance of herbal and traditional medicines is the underreporting of adverse reactions. Cultural factors, lack of awareness among healthcare professionals, and informal channels of medicine distribution contribute to the underestimation of adverse events associated with these products. Additionally, the absence of standardized terminology and classification systems for herbal medicines complicates data collection, analysis, and signal detection. Despite these challenges, several methodologies can be employed to enhance pharmacovigilance of herbal and traditional medicines such as signal detection, Post-Marketing Surveillance, Quality Assurance, Pharmacovigilance education and awareness.

Ensuring the safety of herbal and traditional medicines is essential for protecting public health and promoting rational medicine use. Adverse reactions to herbal remedies can range from mild allergic reactions to severe toxicity and interactions with conventional medications. By implementing robust pharmacovigilance practices, regulators, healthcare providers, and consumers can make informed decisions about the safety and efficacy of herbal and traditional medicines.


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