Pharmacology and Pharmaceutical Intermediates

Pharmacology and Pharmaceutical Intermediate Products Pharmaceutical terminology, which we have begun hearing more frequently nowadays, originates from the field of chemistry; however, it is now commonly associated with pharmacy and the pharmaceutical industry. When defining its content, we can say that the field of pharmaceutical science encompasses many subjects ranging from the drug preparation process, the stages it goes through within chemistry, its role within the pharmacy profession, to all available information about drug usage methods. Pharmaceutical intermediate products within this scientific discipline are compounds sold in pharmacies that are not evaluated as drugs due to their contents, but are substances tasked with protecting health or assisting in treatment. While Turkey contains intermediate products in considerable proportions, it should be noted that there is information confusion among the relevant public regarding what these products are, their regulations and scope. Indeed, this situation is not unique to our country; in many countries, including EU member states, necessary regulations for "borderline" products that fall between other product categories such as drugs, food and cosmetics have not been fully completed. Looking at the relationship of the aforementioned intermediate products with the Ministry of Health, we see that products evaluated within the intermediate product category are licensed under legislation based on Article 43 of Decree Law No. 181 on Organization and Duties, Article 3/k of Basic Health Services Law No. 3359, and Law No. 1262 on Spice and Medical Preparations. So, what exactly are these intermediate products? The main products evaluated within the pharmaceutical intermediate product category include: herbal products, antiseptics and disinfectants (benzalkonium chloride, hydrogen peroxide, potassium permanganate, merbromin, eosin, ethanol, isopropyl alcohol, povidone iodine, chlorhexidine gluconate, antimicrobial liquid soaps, etc.), fly and tick repellents applied to skin, ear/nasal hygiene preparations (NaCl and sea water), cough and throat lozenges, sweeteners, gargles, vitamin and mineral combinations, oils and vapours, topical cooling gels and sprays, toothpastes (those assisting treatment), corn products, aromatherapy products, nicotine-containing gums, lozenges and patches, and vaginal hygiene preparations. In Turkey, intermediate products are not evaluated as drugs, nor are they examined within the over-the-counter (OTC) medicine category. Prescription and non-prescription medicines are subject to price approval by the Ministry of Health. Pricing of intermediate products has been left to free market conditions. Therefore, there is no price control by the Ministry of Health on these products. Despite this pricing freedom, sales are conducted only in pharmacies. The Ministry of Health does not permit sales outside of pharmacies. As intermediate products are examined as treatment-assisting and health-protective products, limited promotional activities may be conducted in accordance with labelling rules (containing factuality and scientific objectivity) and consistent with information in the instructions for use, to the extent that consumers are not misled. It should also be noted that products approved within the intermediate product category cannot make specific usage recommendations aimed at diagnosing, treating or preventing diseases, and medical claims in instructions for use cannot directly express an indication. Particularly for herbal products, medicinal benefit is based on traditional use and literature. All these products (including herbal products) are treatment-assisting; therefore, definitive expressions exceeding their purpose, such as "Recommended Use" are never used in instructions for use. Of course, it may be stated that they will assist or support in alleviating or eliminating certain health problems. For example; for corn products, "treats and cures corns" should be replaced with "assists in corn treatment". Similarly, for products containing horse chestnut extract, expressions such as "assists in treatment of circulatory disorders like varicose veins", and for products containing echinacea or pelargonium, "assists in alleviating symptoms of upper respiratory tract infections and strengthening body resistance" should be used. Products in this category are expected to have very low risk in terms of safety. Approval procedures are conducted using a more simplified and accelerated procedure compared to prescription and non-prescription medicines. In summary, pharmaceutical intermediate products, which have gained an important place in the primary pharmaceutical science discipline and modern pharmaceutical industry, are referred to as treatment-assisting supplementary products. Although the perception of intermediate products among consumers is sometimes confused with medicines, their relationship with pharmacy and the Ministry of Health is clear in this manner. Prepared by: Dila Taşcı