Pharmacology Science that studies interactions of drugs with organism on different levels (subcellular, cellular, organ, systemic) Studies: - relationship between chemical structure and biologic activity - site of effect localisation - mechanism of action - fate of drug in organism - evaluation of relationship between dose and biologic effect

Clinical pharmacology is the science of drugs and clinical use of drugs branches: - pharmacodynamics - pharmacokinetics - rational prescribing - adverse drug effects - drug interactions - toxicology - drug development

Pharmacogenetics and Pharmacogenomics Pharmacogenetics study of genetic variation which cause different response to drugs is taking into consideration one or only a few genes Pharmacogenomics investigation in variation in DNA and RNA characteristics related to drug response

Genetic variations and pharmacokinetics „Slow-acetylators“ have higher blood concentrations, better response, but greater risk of toxicity to isoniazid than „fast- acetylators“ Many polymorphism in a number of cytochrome P450 isoenzymes Polymorphism in butyrylcholinesterase, alcohol dehydrogenase Polymorphism that alter the elimination pathways

Pharmacovigilance science of collecting, monitoring and evaluating information of the adverse effects of medications, biological products, herbalism and other medicines from Greek pharmacon = drug Latin vigilare = to keep alert

Pharmacoeconomics study that evaluates the cost and effects of a drug or drug therapy examples of pharmacoeconomic evaluation types: - cost – benefit analysis - cost – minimization analysis

Drug discovery Most medicines were botanical or zoological origin (most had dubious therapeutic value) Plant-derived drugs (morphine, cardiac glycosides, acetylsalicylic acid) During 20th century – advances in chemistry allowing the synthesis and purification of small organic molecules (sulphonamides, penicillins) „biologic drugs“(advances in molecular biology) Advantages of modern drugs is their ability to act selectively

Drug discovery Synthesis of novel chemicals not previously synthetised (in vivo, in vitro) Synthesis of chemical analogues and modifications of existing medicines Synthesis of a naturally occuring substance, its precursor or antagonist Development of compounds that can mimic or interfere with the activity of the gene product

Drug approval All medicines licensed for sale have to pass a rigorous evaluation of: SAFETY QUALITY EFFICACY In the European Union (EMA – European Medicines Agency) In the USA (FDA – Food and Drug Administration)

Drug development synthesis of novel chemical compounds preclinical testing (cell cultures, isolated cells, isolated organs  animals) clinical trials phase I (healthy people) clinical trials phase II (selected patients) clinical trials phase III (large group of patients, the drug is compared to conventional treatments, e.g. “double-blind“ study) registration of the drug (a national regulatory body) clinical trials phase IV (surveillance after licence)

Prescription information over-the-counter drugs can be obtained without a prescription (pharmacy medicines (P), which may be sold by a pharmacist without prescription, general sales list (GSL) medicines that may be sold without a prescription in any shop) prescription medication is a drug that requires a medical prescription to be dispensed brand name drug, generic drugs and biosimilars

Prescription – basic terms Prescription Drug Time and Dosage Limit Laws Prescription limitation Indication limitation Co-payment Different in many countries, just know the meaning of these terms

What you should know about the drug? Non-proprietary (generic) drug name (not necessary to know proprietary (trade name)) The class to which the drug belongs Mechanism of action Indications, contraindications adverse drug reactions, interactions Pharmacokinetic parameters (especially the ones characteristic for the drug) Non-pharmacological treatments that are effective alternatives or complementary to pharmacotherapy