(2004; 109 pages)
Consumers may need guidance on how to identify quality assured TM/CAM medication therapies. For example, information about quality can be found on the package, label or leaflet that is provided with the medication or given by the provider/retailer. Information that could help the consumer to check the quality of a product include GMP standards, the product registration number and information about the product given by a TM/CAM information centre.
Depending on the regulatory status of TM/CAM medication therapies, the quality of the products may be more or less difficult to assess. In many countries, TM/CAM medication therapies are marketed as food supplements. In such situations no rigorous regulation exists comparable to that of the pharmaceutical sector. As a result, it becomes even more important to empower consumers to make an informed choice in relation to quality.
The following information should always be available when purchasing a quality TM/CAM medication therapy.
(a) Information about the product
Identification of the product/active ingredients is an important step when assuring the quality of most TM/CAM medication products. It involves identification of the plant/animal species (sometimes also including minerals and/or vitamins), when relevant through botanical verification. It is also important to check the quantitative composition of the product. For many Member States it may be relevant to inform consumers of the need to pay attention to the composition and the local and scientific (Latin or equivalent national terminologies) name of all active ingredients (45). Identification of a species both by its local and Latin name may be important since local names are occasionally used for several different species with different biological activities. Latin binomial names are constructed in two parts, the first part identifying the genus and the second part describing the particular species. Since different parts of a species might also have different biological activities, consumers also need to identify the parts of the plant/animal material (e.g.. bark, leaves, blossoms) used for the preparations (25, 26) in order to ensure that the correct part of the species is used. Information about the identity of ingredients can be either presented on labels or explained verbally by the retailer at the time of purchase.
(b) Recognition of quality standards
A product of quality can be identified through recognition of official quality standards. Where available, national or local quality standards and/or registration/licensing systems for TM/CAM medication therapies can guide the consumer to choose quality products by, for instance, labelling quality controlled products with a specific label, such as the licence symbol used by Swissmedic (see Annex IV). Such standards can be based on recommendations in national or international pharmacopoeias, national registration and regulation procedures or according to suggestions from registered TM/CAM providers. Where product quality certifications are not available, certified TM/CAM practitioners or conventional health care providers providing TM/CAM services should be able to provide or recommend products of quality.
It is also important to be able to identify the holder of the market authorization as well as GMP standards and site registration in order to know whom to contact in case of questions about the product, for example. Different rules might apply to nationally produced products and imported products.
With regard to quality standards of raw plant material (or animal and mineral material), it is the responsibility of the registered TM/CAM practitioner or the registered provider of the raw materials to ensure the quality of the material.
(c) Storage and expiry date
Consumers need to pay attention to the manufacturer’s instructions concerning storage and expiry date. Following the storage instructions may be crucial, for example to prevent early ageing and/or destruction of a product. It is also important that consumers are aware that they should not purchase or use a product beyond its expiry date, since the efficacy of TM/CAM medication therapies can be age-related (45).
(d) Quality control of raw materials
Most of the issues cited above also apply to raw materials, which are used by a majority of those who have limited access to high-quality medicines. Good cultivation and preparation are some of the additional areas that need to be addressed in relation to quality assurance of raw materials.