At the turn of the millennium, guidelines for post-marketing safety reporting of herbal medicines were introduced by the World Health Organization (WHO) in the period between 1999 and 2001. The fact that more than 158 million people in the United States alone spent over 17.6 billion dollars on herbal medicines in the year 2000 is a clear indication of the growing importance of this . The use of herbal medicines is on the rise across the world.
People have used herbal and alternative medicines for centuries to treat health issues and promote well-being. Though they can be helpful, these therapies also come with risks. Many negative events arise from poor product quality or misuse. Inadequate regulation, quality control, and uncontrolled distribution can contribute to these events. Pharmacovigilance plays a crucial role in ensuring the safety and effectiveness of these products.
- 7% of the population used traditional and complementary medicine in the USA in 2000.
- 80% of the developing world’s population use a certain form of traditional medicine.
- In the Southeast Asia Region, 10%–45% of OPD visits in the public health sector were related to traditional medicine services in 2015 .
Evolution of Pharmacovigilance
According to WHO’s ‘Pharmacovigilance for traditional medicine products’, the evolution of pharmacovigilance can be attribute to the following historic events:
- In 1961, many thousands of infants were born with congenital deformities due to prenatal exposure to thalidomide, an unsafe medication that was promoted for use by pregnant women.
- The Sixteenth World Health Assembly agreed on a resolution (WHA 16.36) that reaffirmed the need for early action in disseminating information on ADRs in 1963 (WHA 16.36).
- In 1968, the World Health Organization (WHO) created the First WHO Pilot Research Project for International Drug Monitoring (WHO PIDM) to establish an international system for identifying adverse effects (AEs) of medicines that were previously unknown or poorly understood. This project began collecting reports of international adverse drug reactions (ADRs) and storing them in a central database known as VigiBaseTM. The primary goals of the WHO Programme for International Drug Monitoring (PIDM) are to improve patient care and safety by ensuring the appropriate use of medicines, and to assist public health programs by providing accurate and unbiased information that enables effective assessment of the risk-benefit profile of medicines.
Challenges in Herbal and Alternative Medicine:
The regulation and registration of herbal medicines vary across different countries. This depends on how herbal medicines are classified. For example, in some countries, herbal medicines may be classified as prescription while in others they would be over-the-counter medicines. Below are some potential challenges that are associated with the pharmacovigilance of herbal and alternative medicines:
Standardization of Pharmacovigilance: Herbal and alternative medicinal products are diverse and include traditional remedies, supplements, acupuncture, homeopathy etc which can pose challenges when it comes to standardizing pharmacovigilance standards & global regulations.
Regulation: The regulations and registrations regarding herbal medicines vary from country to country. These medicines are categorized as prescription or OTC medicines, depending on the country’s regulations. In some countries, herbal products may also be classified as something other than medicines. The national regulatory framework usually involves qualified providers and distributors of these substances. The regulatory status determines access to and distribution routes for these products.
Complex Compositions: Herbal remedies often consist of complex mixtures of plant compounds. Identifying the specific ingredient responsible for an adverse event can be challenging.
Self-Administration: Unlike prescription medications, consumers often self-administer herbal and alternative therapies without direct medical supervision. This makes monitoring adverse events more reliant on patient reporting.
Interactions with Conventional Medicine: Herbal and alternative medicines can interact with prescription drugs, potentially leading to adverse effects. These interactions are not always well understood.
Importance of Adverse Event Reporting:
Pharmacovigilance in herbal and alternative medicine heavily relies on the reporting of adverse events by healthcare professionals and consumers. Here’s why it’s :
Early Detection of Safety Concerns: Adverse event reports help identify safety concerns associated with specific products or therapies early on, allowing for timely intervention.
Evaluating Benefit-Risk Balance: Collecting data on adverse events allows regulators and healthcare providers to assess the overall benefit-risk balance of herbal and alternative medicines.
Quality Assurance and Control: Every country that regulates herbal medicines should have quality assurance and control measures in place- national & international quality specifications and standards for herbal materials, GMP for herbal medicines, proper product labelling, and licensing schemes for manufacturing, imports, and marketing. These measures are essential to ensure the safety, efficacy, and effectiveness of herbal medicines. Weak regulation and quality control could lead to low quality herbal products that would cause adverse reactions in consumers and patients. This would result from adulteration with undeclared potent substances or contamination with potentially hazardous substances and residues.
Educating Consumers: Transparent reporting of adverse events can educate consumers about potential risks associated with herbal and alternative therapies, empowering them to make informed choices.
Informed Regulatory Decisions: Regulatory agencies use pharmacovigilance data to make informed decisions about product safety, labelling requirements, and market authorization.
Regulatory Considerations: Regulation of herbal and alternative medicines varies widely across different countries. In the United States, for example, dietary supplements are regulated by the FDA, but the standards are not as strict as those for pharmaceuticals. In contrast, some European countries have more stringent regulations for herbal products.
Regulatory considerations in pharmacovigilance for herbal and alternative medicine include:
Product Registration: Some countries require herbal and alternative products to undergo registration and approval processes to ensure their safety and efficacy.
Labelling Requirements: Regulations often stipulate specific labelling requirements, including warnings about potential interactions or adverse effects.
Good Manufacturing Practices (GMP): Compliance with GMP standards is essential to maintain product quality and safety.
Post-Market Surveillance: Regulatory agencies may require companies to continue monitoring their products for adverse events even after they are on the market.
How can pharmacovigilance for herbal and traditional medicine be improved?
Improved pharmacovigilance measures are required to ensure the safety and efficacy of herbal and traditional medicines. These include:
Networking should cover health facilities (traditional medicine practitioners), manufacturers, drug stores (pharmacists), and consumers.
Harmonize regulations for herbal/traditional medicine products among Member States.
Pharmacovigilance should be proactive throughout the product life cycle, with safety data collected before and after marketing.
TRM practitioners should participate in the causality assessment process, and they should be trained on causality assessment.
Integrating PV into the medical education curriculum is crucial. Integrating PV into good pharmacy practices (GPP) is crucial for community pharmacies. Encouraging the use of modern technology and IT facilities, as well as mobile application tools, is important.
The ADR report for herbal medicines should capture as much important data as possible, and include the plant’s scientific name, the plant part used, and the manufacturer’s name.
Regular training programmes for strengthening national capacity in monitoring the safety of traditional medicine products and for promoting awareness should be encouraged.
It would be better to start early with the professional training of healthcare students to create a culture of reporting ADRs.
National quality standards, GMP(sampling, testing, stability, and quality) labelling and licensing should be mandatory for herbal manufacturing.
The Role of Traditional Knowledge:
In many cases, herbal and alternative medicines draw from traditional knowledge passed down through generations. Integrating this knowledge into pharmacovigilance efforts is essential. Traditional healers and communities often hold valuable information about the safety and efficacy of these therapies. Collaboration between traditional and Western medicine can enhance our understanding of these products and improve pharmacovigilance.
The Future of Pharmacovigilance in Herbal and Alternative Medicine:
The field of pharmacovigilance in herbal and alternative medicine is evolving rapidly. Here are some emerging trends and future prospects:
Digital Health Tools: Mobile apps and online platforms can facilitate adverse event reporting and provide information on product safety.
Analytical Techniques: Advances in analytical techniques, such as mass spectrometry and DNA barcoding, can help identify the precise composition of herbal products.
Machine Learning and AI: These technologies can assist in analysing large datasets of adverse event reports, identifying patterns, and predicting potential safety concerns.
Global Collaboration: Enhanced collaboration between countries and regions can harmonize regulations and pharmacovigilance practices.
Consumer Education: Efforts to educate consumers about the importance of reporting adverse events and seeking guidance from healthcare professionals will continue to grow.
Pharmacovigilance in herbal and alternative medicine is essential to ensure the safety and efficacy of these therapies. Despite the unique challenges posed by this diverse field, ongoing efforts in reporting adverse events, regulatory oversight, and the integration of traditional knowledge are paving the way for safer and more reliable herbal and alternative treatments. As the field continues to evolve, collaboration, innovation, and a commitment to consumer safety will remain at the forefront of pharmacovigilance efforts in this area.
References and Further Reading
 Choudhury A, Singh PA, Bajwa N, Dash S, Bisht P. Pharmacovigilance of herbal medicines: Concerns and future prospects. Journal of Ethnopharmacology. 2023 Mar 12:116383.
 WHO. Pharmacovigilance for traditional medicine products: Why and how? World Health Organization. 2017
- Geneva: World Health Organization; 2000. General guidelines for methodologies on research and evaluation of traditional medicine. (WHO/EDM/TRM/2000.1)
- Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance centre. Uppsala, Uppsala Monitoring Centre, 2000 (reproduced in Part II of this publication)