Česky
2.2.2009
Medicines, medicinal substances and preparations, food supplements... everyone has come across these terms in their lives. But few know for sure what the difference between them is. And is there any difference at all? And which of these are used for allergy sufferers?
Medicines
Medicinal products are medicinal substances or mixtures thereof or medicinal preparations intended for administration to humans or animals, unless they are additives.
Medicinal substances are any substances intended to be part of a medicinal product and which produce its effect. Medicinal substances are most often pure chemical substances with a well-defined structure (chemical individuals), but may also be complex mixtures of different substances whose structure may not be well-defined. These may be, for example, raw materials of natural origin (dried parts of plants, essential oils, extracts, etc.) treated in a prescribed way.
Medicinal product means any substance or combination of substances intended to cure or prevent disease in humans or animals. A medicinal product is also defined as any substance or combination of substances which can be administered to humans or animals for the purpose of making a medical diagnosis or restoring, modifying or affecting their physiological functions.
Usual form of medicine sold
As the medicinal substance itself cannot usually be administered to the patient for practical reasons, it must be incorporated into a medicinal product. This is done by the addition of various amounts of excipients, which usually form the bulk of the preparation, and a subsequent technological process which results in a finished product which is finally filled into a container and ready for administration to the patient. The medicinal product may take a variety of forms (e.g. tablets, drops, suppositories, injections, etc.) based on the way in which the product will be used. The final form of the medicinal product is referred to as the dosage form.
Thus, if we have a medicine in a particular dosage form, it is ready for its use - administration to the patient. If it is administered in the correct way, as intended by the manufacturer, it becomes a medicine at that point. Medicines are medicinal substances and medicinal preparations adapted to the final form in which they are used and administered to the patient.
The registration of medicines in the Czech Republic is decided by the State Institute for Drug Control (SÚKL).
Food supplements
Dietary supplements are products that look similar to medicines (sold in pharmacies and outside) but are a special category of food. They contain so-called food supplements as active ingredients. Dietary supplements are intended to supply the body with nutrients it needs but does not get enough of in the normal diet, or other substances that have a beneficial effect on health. They are distinguished from foods for normal consumption by their high content of vitamins, minerals or substances having a nutritional or physiological effect, and have been produced to supplement the consumer's normal diet to a level that favours his or her health.
The manufacturer of a food supplement shall first ask the State Institute of Health (SHA) to issue an opinion assessing the health safety of the product and the way it is to be used (dosage, suitability for pregnant and lactating women, suitability for children, etc.). On the basis of this opinion, the Chief Sanitary Officer of the Ministry of Health issues a decision authorising the placing on the market of the product. The decision contains the recommended dosage and restrictions according to the opinion of the HSE, which must be indicated on the packaging. The efficacy of the product and quality assurance are not considered in the approval of food supplements. However, the manufacturer must not make false claims about the effect of the product (prohibition of misleading the consumer). It must be able to substantiate the claimed effects at any time. Food supplements must comply with all applicable food standards. Compliance with them is controlled by the State Agricultural and Food Inspection Authority (SZPI).
Borderline preparations
Food supplements are in many ways similar to medicinal products. Not only in their external form, but also in the content of often the same substances. However, the difference is usually (but not always) in the doses used and the intended use. In the case of so-called borderline products, we often find virtually similar compositions in the categories of food supplements and medicinal products (typically, e.g. multivitamins, chondroitin sulphate, etc.). The method of registration or approval in such cases is usually determined by the decision of the manufacturer. According to Act No. 79/1997 Coll. on Medicinal Products, the State Institute for Drug Control (SÚKL) is the competent authority to decide whether or not a disputed case is a medicinal product.
Labelling and promotion of food supplements
Dietary supplements may not be labelled with a therapeutic indication on the packaging (nor may they imply a cure or prevention of diseases), this is reserved for medicines only. However, beneficial effects on the health of the user may be claimed - so-called health claims. The same applies to advertising. Nor may it be stated or implied that a balanced and varied diet cannot provide sufficient nutrients. The above definitions show the difference between food supplements and medicines. Medicines are held to a much higher standard and must be proven to be effective in treating a particular disease, while at the same time being proven to be safe to administer. Food supplements must be safe, but their efficacy no longer needs to be proven, but the consumer should not be misled by the manufacturer. Food supplements, unlike medicines, do not undergo such rigorous studies and are therefore much less costly and time-consuming for manufacturers to bring to market.
Allergy and dietary supplements
If for some reason an allergy sufferer is not getting enough of important vitamins or minerals, for example, they can certainly take an over-the-counter product - but it is always best to consult a specialist about this too. However, where an allergy sufferer requires medication such as corticosteroids or antihistamines, dietary supplements are unlikely to be sufficient.
Source:
U Lékaře.cz
