POTENTIAL CHALLENGES AND PROACTIVE APPROACH FOR SAFE HERBAL PRACTICE

Herbal medicinal practice existed either as standard treatment or as adjuvant with conventional medicine since long back. Ayurveda is well known as oldest treatment system ever existing. Safety concerns with toxicological effects and purification of plant product are mentioned in Ayurveda textbook also. Here I’m going to discuss some challenges faced by herbal practitioner, experts as well as global scenario. This article will be  centered around Ayurveda system of medicine, but similar concepts applies for other complementary and  alternative medicines:

Challenges faced during safety monitoring of herbal medicines:

Self-medication: The commonest myth regarding herba medicines s that these medicines are completely safe and can therefore be safely consumed by the patient on his/her own, without a physician's prescription. This belief has led to large-scale self-medication by people all over the world, often leading to disappointing end-results, side-effects, or unwanted after-effects.

     Improper quality control:  A majority of the adverse events related to the use of herbal products and herbal medicines that are reported are attributable either to poor product quality or to improper use. Inadequate regulatory measures, weak quality control systems, and largely uncontrolled distribution channels (including mail order and Internet sales) may have been contributing to the occurrence of such events.

    Complex natural constituents: No any single herbal medicines are synthesized. They are used either as crude or extracted form.  Detail understanding and description of clinical, pharmacological and toxicological effects of Chemical constituents present within every plant used as medicines is ambiguous. Moreover, combined herbal preparation are more in use than single herb.

°   Ambiguous prescription: Mostly herbal medicines are used in conjunction with conventional medicines as adjuvant therapy. Study on interaction of herbal product with synthetic medicine is meagre. Issue can also arise by such interactions between different  potential chemicals present within other medicines or food.

°   Contaminations and adulteration: The herbal based OTC products may be contaminated with excessive or banned pesticides, microbial contaminants, heavy metals, chemical toxins, and for adulterated with orthodox drugs. Excessive or banned pesticides, heavy metals and microbial contaminants may be related to the source of these herbal materials, if they are grown under contaminated environment or during collection of these plant materials. Chemical toxins may come from unfavourable or wrong storage conditions or chemical treatment due to storage. The presence of orthodox drugs can be related to unprofessional practice of manufacturers

°   Improper implementation of pharmacovigilance system: lack of knowledge on pharmacovigilance within practitioner of herbal medicine is another cause of improper reporting of safety issue, which ultimately leading to underreporting and repetition of similar inconveniences. The existing pharmacovigilance system is more based on understanding of synthetic medicines.  Lack of proper terminologies for coding of herbal medicines and adverse effect is causing problems in implementation of pharmacovigilance system.

  

°   Governmental ignorance: Although its being a primary care for health issues in every society, vigorous study couldn’t happen on its safety, potency and efficacy. Without Priority of government and qualified human resource, evidence can’t be collected. That’s why most of the issues and quarries are unresolved yet.  

Proactive approach and Recommendations to overcome safety issue:

°  Quality control and quality assurance: While Overcoming the issues step by step,  quality of final product can be maintained by implementing Quality control system. standard operating procedures (SOP), leading to Good Agricultural Practice (GAP), Good Laboratory Practice (GLP), Good Supply Practice (GSP) and Good Manufacturing Practice (GMP) for manufacturing these medicinal products from herbal or natural sources. The public's belief that herbal and natural products are safer than synthetic medicines can only be ascertained by imposing regulatory standards on these products that should be manufactured using these Good Practices. Government of Nepal also made GMP compulsory for manufacturers of Ayurveda medicines also.  

°  Clinical research: Even small voice with authentic reference is always louder than yelling without facts. Vigorous research activity should be conducted to collect sufficient evidence for crystallization of useful herbs as medicine. Available research methodologies can be used in Ayurveda practice also. Proper data on level of efficacy, safety, dose, dosage and interactions with other medicines will also be known during research process.

°   Use of pharmacovigilance system: The recommended approach is to include herbal medicines in the existing national pharmacovigilance systems or, where such systems have not yet been developed, to establish comprehensive national pharmacovigilance systems, which incorporate coverage of herbal medicines. Regional and national reporting centres are the same, databases used to analyse adverse reaction in herbal medicine is also same, but coding system might be different. Appropriate name for different Ayurveda terminologies are required.

° Professionalism: Clear recommendation of professional competency should be made for herbal medicine practitioner. Those with certified practice license should also be provided knowledge and training on understanding and reporting any expected or unexpected adverse reactions. Ethics of any practitioners comes at the primarily than any law and enforcement.

°  Enhancing reporting system: Report of adverse events is found mainly based on voluntary physician reporting. Other health professional like pharmacist, nurses are normally excluded. This largely led to underreporting. It should be established to report suspected event by all health professional not only for medicinal product but also for nutritional supplements.

°  Consumer consciousness: Consumers are mainly responsible for reporting event to their physician and any practitioner who prescribed medications. Patient and consumer education for prompt reporting will also help to generate signal.

° Use of prescription drug: Prescription based treatment system should be enforced from government level as compulsory in herbal medicine also. It will discourage self-medication and finally controls underreporting.

Member States of the World Health Organization (WHO) including Nepal are therefore encouraged to strengthen their national regulation, registration and quality assurance and control of herbal medicines. In addition, the national health authorities should give greater attention to consumer education and to qualified practice in the provision of herbal medicines.
                                                          thank you!!!