LECTURE 1 – Introduction – definition, legislative status, basic terms. Dr. Ivana Daňková Dept. of Natural Drugs, Faculty of Pharmacy, VFU Brno PHYTOPHARMACEUTICALS academic year 2018/19 PHYTOPHARMACEUTICALS 2  The aim of the course is to provide the basic knowledge about phytopharmaceuticals and discuss the position of phytotherapy in the self-treatment. The course deals with the most commonly used groups of phytopharmaceuticals according to their pharmacological effect, provides the information about the most frequently used drugs in each group. Discuss the role of a pharmacist in phytotherapy.  optional course, 2 credits  time requirements: lectures – 1/0/0 a week (= 2 hours lecture/week in first 7 weeks of summer semester)  recommended year of study – 3rd  guarantor/lecturer  Dr. Ivana Daňková  dankovai@vfu.cz, office No 247  the course will be available on Moodle - presentations of lectures (pdf) What is necessary to know for studying PHYTOPHARMACEUTICALS? 3  good knowledge of:  Botany – plant systematics, Latin names of plants and plant families, plant morphology  Pharmacognosy – basic terminology, chemical constituents of plants (secondary metabolites) – their properties, effects…, which plant part is used  basic knowledge of:  Human Physiology, Pathology  Pharmacology  Pharmaceutical technology PHYTOPHARMACEUTICALS 4  „Medicines that are exclusively or predominantly composed of plants, plant parts, chemical constituents of plants.“  „herbal drug“ = a plant or a plant part that is used for the treatment or prevention of diseases or for influencing of physiological state PHYTOTHERAPY 5  known also as a herbalism  the use of plants and plant products for medicinal purposes. Herbal medicine usually refers to plants that are not part of the normal diet.  part of traditional medicine, nowadays regarded as alternative therapy  Herbal medicines for therapeutic purposes have been explicitly used since the dawn of human civilization to maintain health and to treat diseases. WHO estimates that about three-quarters of the world's population currently uses herbs and other forms of traditional medicines. PHYTOPHARMACEUTICALS 6  complicated legislative status – the most of phytopharmaceuticals are not included into official medical care  according to the WHO: „Phytopharmaceuticals don´t belong to the essential medicine.“ PHYTOPHARMACEUTICALS 7  1) some of them are approved as medicines by the state medicines authority (in the Czech Republic: SÚKL = State Institute for Drug Control)  exactly defined composition (standardised, quantified extracts), proven efficiency, safety…  the preparations have „SÚKL code“  these phytopharmaceuticals can be sold only in a pharmacy ! http://www.sukl.eu/modules/medication/search.php8 http://www.sukl.eu/modules/medication/search.php ATC Groups 9  Anatomical Therapeutic Chemical Classification System – defined by the WHO, see www.whocc.no.  A: Alimentary tract and metabolism  B: Blood and blood forming organs  C: Cardiovascular system  D: Dermatologicals  G: Genito-urinary system and sex hormones  H: Systemic hormonal preparations, excl. sex hormones and insulins  J: Antiinfectives for systemic use  L: Antineoplastic and immunomodulating agents  M: Musculo-skeletal system  N: Nervous system  P: Antiparasitic products, insecticides and repellents  Q: Veterinary products  R: Respiratory system  S: Sensory organs  V: Various preparations → V11 = Phytopharmaceuticals and animal products http://www.sukl.eu/modules/medication/search.php10 PHYTOPHARMACEUTICALS 11  2) some phytopharmaceuticals are included into group „food supplements“ (= „dietary supplements“)  using of these products is controlled by state institutions that are covered by the Ministry of Agriculture (SZPI = CAFIA, Czech Agriculture and Food Inspection Authority) and the Ministry of Health (Health Officer of the CR)  these products can be sold in a pharmacy or in herb shops and natural food stores http://www.szpi.gov.cz/en/ 12 PLANT DRUGS IN PHARMACOPOEIAS 13  ČESKÝ LÉKOPIS 2017 (PHARMACOPOEIA BOHEMICA MMXVII, Ph.B. MMXVII)  EUROPEAN PHARMACOPOEIA 9th Edition (2016) PhEur 9th Edition 2016 (9.0)  http://www.edqm.eu/en/european- pharmacopoeia-9th-edition 14 HERBAL PHARMACOPOEIAS e.g.  Deutsches Arzneibuch (German Pharmacopoeia)  British Herbal Pharmacopoeia  American Herbal Pharmacopoeia and Therapeutic Compendium  U.S. Food and Drug Administration (FDA)  Indian Herbal Pharmacopoeia, Ayurvedic Pharmacopoeia of India  Japanese Herbal Medicine Codex,  etc.  European Scientific Cooperative on Phytotherapy (ESCOP)  British Herbal Medicine Association (BHMA) 15 PHYTOTHERAPY – Risks 16  „The natural products are always healthy and harmless.“ – is it true?  self-medication - difficult determination of exact diagnosis  wide range of therapeutic use  the active constituents of herbal drugs are not well established  mixture of many constituents, unknown exact composition  not exact dosage  presence of toxic compounds, allergens, unwanted components – e.g. pesticides, heavy metals PHYTOTHERAPY – Risks 17  chemical composition variability  natural variation/biodiversity  influence of harvest, drying, storage…  microbial contamination  standardization, stability and quality control testing are relatively time consuming, tedious and highly priced  selective analytical methods may not exist  reference compounds may not be available commercially General information for using phytomedicines  Do not use longer than a few days/weeks without consulting your physician  If the symptoms do not improve, or even deteriorate, or if undesirable effects or an unusual reaction occur, consult your doctor.  In the event of overdose or accidental usage by a child, consult your doctor.  Caution in pregnancy, nursing, for children (see the recommendation of producer)  Contraindication in case of hypersensitivity to any constituent! Recommended literature 19 http://books.google.cz/books/about/Herbal_Drugs_and_Phytopharmaceuticals.html?id= 7PRyMWo5e28C&redir_esc=y Herbal teas – important producers on Czech market 20  LEROS http://leros.cz/  MEGAFYT Pharma http://www.megafyt-pharma.cz/  APOTHEKE http://www.apotheke.cz/  Dr. POPOV http://www.drpopov.cz/  GREŠÍK Valdemar http://www.gresik.cz/  Pavel Váňa http://www.ipavelvana.eu/  TEEKANNE, HIPP, HERBEX, FYTOPHARMA, etc. http://leros.cz/en/produkty-dle-druhu/teas-by-kind21 Phytomedicines – important producers on Czech market 22  ZENTIVA, IVAX/TEVA – pharmaceutical companies  WALMARK https://www.walmarkgroup.com/en/brands  Dr. MÜLLER http://www.muller-pharma.cz/  AROMATICA http://www.aromatica.cz/  GREŠÍK http://www.gresik.cz/  TEREZIA Company https://www.terezia.eu/en  MedPharma http://www.medpharma.info/  PharmaSuisse Laboratories, Angelini Pharma, Jamieson, GS, Naturevia (Swiss)…  Dr. THEISS, KNEIPP, HerbalMed Dr. WEISS, etc. 23 https://www.walmarkgroup.com/en/files/Walmark-Product-Catalogue-2018.pdf