Use of herbal products
The use of herbal products, or just extracts resulting from traditional homemade medicine (such as infusions), has been neglected when it comes to monitoring these products and much more when it comes to their interactions with medicines, leaving many sometimes believe that they are devoid of adverse effects. Unfortunately, this is not the reality and, in fact, the increase in the number of reports of cases, including deaths, in which interactions between plants and medicines have occurred has accompanied the recent growth in the consumption of natural products.
It is necessary to educate our populations about consumption and create a critical sense in them. To achieve this, it is absolutely essential that consumers know the different types of products available on the market, what they contain, what they are for, and the risk they may take when consuming them. This is to ensure that you are not fooled into buying something that can often cause serious harm to your health.
There are several types of products on the market that may contain plants, in addition to food. “Food supplements” which have specific legislation and are intended to complement the diet and then we have “Plant-based medicines” and/or “Traditional plant-based medicines” which both contain Medicinal Plants.
“Plant-based medicines” (MBP) are medicines whose application for marketing authorization (AIM) must be accompanied by a dossier with information and documents on the results of physical-chemical, biological or microbiological tests, as well as pharmacological and toxicological and clinical trials of medicines that prove their quality, safety and effectiveness (Directive 2001/83/EC of 6 November 2001). In other words, they have to show the same evidence as other medicines. The requirement is in fact very high and there are not many examples of “Plant-based Medicines” on the Portuguese market.
“Traditional herbal medicines” (MTBP) appear legally, and for the first time, in Directive 2004/24/EC of March 31, 2004. This new “category” of medicine encompasses medicinal plants that demonstrate, through published scientific literature, that the active constituent(s) have a well-established clinical use, recognized efficacy and an acceptable level of safety. In addition to the above, to be considered traditional, these plants must have at least 30 years of therapeutic use in humans, of which at least 15 in the territory of the European Community. Those who meet these requirements will benefit from a special simplified registration that allows them not to present results from pre-clinical and clinical trials. The use of this category of medicine also ensures the quality of the final product that reaches the user (since the quality criteria are the same as those required for other medicines) and also that these products have an information leaflet for the user where they are only proven information and therapeutic claims are not made without there being a basis for them.
Both MBP and MTBP are considered medicines and INFARMED is responsible for their Pharmacovigilance (articles 166 to 175 of Decree-Law no. 176/2006) and supervision, from the marketing authorization process, until and during its commercialization.
“Food Supplements” (FS) are conceptually products that supplement dietary plans that are deficient in some vitamin(s), nutrient(s), mineral salts, etc. But in practice this is not what we see represented on the commercial market: we have formulations that do not supplement dietary plans in any way being sold as such, and furthermore, the range of substances that can be included in these formulations seems to have no limit. This mix and confusion of concepts completely confuses the consumer who, in the end, ends up not understanding the different categories of products on the market or knowing how to distinguish and view each of them. The result is this: we have patients taking supplements to treat illnesses; healthy people taking supplements to prevent unpreventable diseases; people who stop taking conventional medication because it has adverse effects and supplements do not; and patients taking supplements that can harm their health directly, or indirectly, through interactions with conventional medication.
This description is not intended to damage the image of AS, but rather to draw attention to the fact that this category of products includes, in practice, a large number of compounds that are not dietary supplements, but active compounds that have action on the organism and which modify its physiological functions. An example of this are medicinal plants that contain pharmacologically active products, many of which are even lethal.