Background to the Study
Over centuries, the development and mass production of chemically synthesized drugs have revolutionised healthcare in most parts of the world. However, the apparent problems associated with these synthesised drugs in forms of adulteration and potency have resulted in people using herbs as alternative medicine today. The common reasons for using medicinal herbs (otherwise known as herbal medicine, traditional or alternative medicine) are that herbs are affordable, more easily correspond to the patient’s ideology, 3 allays concerns about the adverse effects of chemical medicines, satisfies a desire for more personalised healthcare and allows greater public access to health information (Canter and Ernst, 2004). World Health Organization (2004) defines herb to include crude plant materials, such as leaves, flowers, fruits, seeds, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered. According to WHO (2004), herbal drugs (medicine) include herbs, herbal materials, herbal preparations and finished products. In some countries, herbal medicines may contain, by tradition, natural organic or inorganic active ingredients that are not of plant origin (e.g. animal and mineral materials). For practical purposes, World Health Organisation (2004) classified herbal drugs (medicine) into four categories, based on their origin, evolution and the forms of current usage. While these are not always mutually exclusive, these categories have sufficient distinguishing features for a constructive examination of the ways in which safety and efficacy can be determined and improved. These are: Category 1: Indigenous Herbal Drugs (Medicine): This category of herbal medicines is historically used in a local community and is well known through long usage by the local population in terms of its composition, treatment and dosage. Detailed information on this category of herbal medicine, which also includes folk medicines, may or may not be available. It can be used freely by the local community or in the local region. Common herbal mixtures under this category include 7-Keys Power Mixture or the popular Ogbogboriche mixture. However, for medicines in this category to enter the market or go beyond the local community or region in the country, they have to meet the requirements of safety and efficacy laid down in the national regulations for herbal medicines. Category 2: Herbal Drugs (Medicines) in Systems: Medicines in this category have been used for a long time and are documented with their special theories and concepts and accepted by the countries. 4 Category 3: Modified Herbal Drugs (Medicines): These are herbal medicines that are popular and have been in the market for a long time, except that they have been modified in some way either shape, or form including dose, dosage form, mode of administration, herbal medicinal ingredients, methods of preparation and medical indications. They have to meet the national regulatory requirements of safety and efficacy of herbal medicines. Category 4: Imported Products with Herbal Drugs (Medicine) Base: This category covers all imported herbal medicines including raw materials and products. Imported herbal medicines must be registered and marketed in the countries of origin. The safety and efficacy data have to be submitted to the national authority of the importing country and need to meet the requirements of safety and efficacy of regulation of herbal medicines in the recipient country. Regardless of the importance of herbal drugs as an alternative to modern medicine, herb use has been criticised based on certain factors that inhibit its usefulness. There is health question on the side effects of herbal medicine that range from unregulated preparation procedure, composition and dosage problems. Talalay (2001) and Elvin-Lewis (2001) agree that a number of herbs are thought to be likely to cause adverse effects. Adulteration, inappropriate formulation, or lack of understanding of plant and drug interactions have led to adverse reactions that are sometimes life threatening or lethal. Drug interactions are serious side effects of herbal medicine. Many commonly used medications interact with herbs and sometimes, herbs may amplify the effects of the medication leading to complications or death. Kraft and Hobbs (2004,p.17) state that ‘herbal drugs are often not potent enough to treat severe illnesses by themselves, except sometimes with a long-time course. Diseases may be drawn out unnecessarily when selfprescribed herbal drugs are taken improperly. It is virtually impossible to compare the efficacy of herbal remedies prepared by different manufacturers, even when they are derived from the same plant species, because different companies use different drying, 5 processing and manufacturing processes, and because plants from different populations vary in its constituent levels.’ Unlike the conventional drugs, herbal products are not regulated for purity and potency. Pelletier (2009) states that the herb industry is essentially unregulated. This lack of regulation and organized practice leaves consumers essentially on their own in determining how to use herbal products. The side effects of herbal drugs depend greatly upon the herbal remedy, the dosage and any pharmaceutical modifications taken by the patient.
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