Face to face, tutoring, distance learning.

Lecture attendance is not mandatory. Attendance of Clinical Laboratory Practice is mandatory.

Information and Communication Technologies are used to prepare lecture material and provide online information and learning aids to students. Specifically: • Common software (i.e. powerpoint) is used to prepare lecture material and display slides and videos. • The study guide (detailed material & additional literature), and teaching material are electronically available to students through the e-class platform. • Common software (i.e. excel, SPSS) is used for statistical processing of student evaluation.
• Announcements, information, etc. are available online through e-class. Communication between students and teachers also takes place via e-mail.

The Assessment Language of the course is Greek and English.

The Assessment Methods include written Multiple Choice Test, Short Answer Questions, Problem Solving, Written Assignment, Report and/or combination of these methods.

The Clinical Pharmacology course is the application of basic concepts of experimental pharmacology mechanisms in clinical practice. Whereas Pharmacology evolves around the molecular structure and characteristics of drugs, their mechanism of action (targeting molecules and receptors), pharmacogenomics and possible indications/contraindications/adverse reactions, Clinical Pharmacology evolves around the disease, the therapeutic interventions and challenges in drug administration (doses and therapeutic scheme, therapeutic drug monitoring, drug interactions) and moreover challenges in specific patient populations (ie patients suffering from renal or liver disease, pediatric patients etc.).
Upon successful completion of the course, students will be able to:

• make rational decisions on patients’ pharmacotherapy based on the disease(s) and comprehend the value of personalized pharmacotherapy
• comprehend clinically significant drug-drug interactions in patients with multiple diseases
• be able to undertake analytical procedures related to drugs and
• to analyze, process and evaluate the results of clinical-laboratory tests related to the consumption of drugs/substances using the basic equipment of the Clinical Pharmacology Laboratory

General Abilities

The commencement of drug prescription and administration to patients, which is intimately related to the exercise of the profession of a medical doctor, coincides with the nomination day of his/her degree. Therefore, all students should be scientifically qualified to undertake this responsibility (something that does not fall within the scope of the basic pharmacology).
The course aims at training students to search, analyze and subsequently synthesize all the clinical-laboratory pharmacological parameters that ought to be considered for them to be able to individualize these data to each patient (individualized pharmacotherapy) and make the optimal decision regarding drug prescription, thus, avoiding potentially dangerous mistakes. Students will also be able to understand the management of pharmacotherapy in special population/patient groups (i.e. the elderly), considering drug interactions, and to evaluate clinical trial protocols and bioequivalence studies of generic drugs.

A. Indicative topics for discussion, development and study:
Management of pharmacotherapy in special population/patient groups.
• pharmacotherapy in old age
• pharmacotherapy in patients with sepsis, liver or kidney failure
• challenges in the treatment of complex patient cases
Pharmacotherapy of specific diseases (indicative)
• pharmacotherapy of tuberculosis
• pharmacotherapy of sexually transmitted diseases
• pharmacotherapy of eczema and psoriasis
Disorders owed to drug intake (indicative)
• adverse effects of drugs on the liver
• lung disorders due to drugs
• kidney complications from drugs
• allergic reactions from drugs and their further treatment
Clinically Important Drug Interactions
• pharmacokinetic/pharmacodynamic interactions between important drug classes & increased incidence in daily clinical practice
• interactions between drugs and foods or herbal products
• databases of interactions (drug-drug, food-drug, herb-drug interactions)
Design of clinical studies and basic principles of Good Clinical Practice (GCL)
• limitation of risks, rights/safety/good psychophysical condition of participants, adequate information related to the drug, robustness of the scientific protocol
• design of the study & definition of its objectives
• scientific question/hypothesis testing (type I & II error)
• participants (recruitment & inclusion criteria, retention & follow-up of participants, ethical principles in human research – national ethics committee)
• randomization of study participants/study blinding
• clinical trial results (selection & optimization of primary results)
• clinical trial safety & monitoring (defining adverse events & clarifying the role & responsibilities of data monitoring and safety committees)
• data collection, management & sharing/adequacy of data control
• reliability of facilities and laboratory-technological equipment
• statistical analysis & reporting of results
• national & international clinical trial regulations
Pharmacoepidemiology
• reporting of drug effects/interactions in populations – prescribing & consumption of drugs, reporting systems of risks as a result of drug use
• design of pharmacoepidemiological studies (observational studies, interventional studies)
• use of biostatistical methods in Pharmacoepidemiology
Therapeutic Drug Monitoring-TDM – basic principles of good laboratory practice (Good Laboratory Practice, GLP).
• conditions and objectives of TDM in biological patient samples
• analytical methods for the quantitative determination of drugs in biological fluids.
• basic principles of rules and requirements for Good Laboratory Practice
• quality control programs
• certification of analytical instruments and examinations
• book-keeping of sample records, data and results in the clinical laboratory
Prescribing issues & improving patient compliance to treatment
• rational prescribing practices to avoid adverse drug events (prescribing to children/elderly)
• registration and supervision of prescriptions
• drug standards & classification (national prescriptions, pharmacopoeias, monographs, categories of controlled substances)
• pharmaceutical formulations
• use of medicines while driving or operating machinery
• contrast agents in medical imaging
• adherence to treatment – polypharmacy
Principles of Clinical Toxicology
• obtaining patients’ medical history for the rational diagnosis, identification & treatment of poisonings
• toxicological analysis of biological samples – pre-tests for detection of substances
• evaluation of toxicological test results for the investigation of poisoning incidents or court cases
Pharmacological treatment of diseases in combination with alternative therapies
• acupuncture (use in the pain clinic, in the treatment of diseases, in the treatment of obesity, smoking & alcoholism)
• complementary therapies – essential oils & natural products

B. Practical and clinical skills
The acquisition of general knowledge is accompanied by specific practical skills aiming at acquiring competence in specific techniques related to the laboratory of clinical pharmacology, recording and analyzing data, and drawing conclusions from them. In addition, students will be trained in identifying and perceiving the sources of errors in the clinical laboratory. Furthermore, they will be trained to handling basic equipment related to the Clinical Pharmacology laboratory.

Κλινική Φαρμακολογία, Bennett Peter N. & Brown Morris J. & Mir Fraz A. & Sharma Pankaj. Επιμέλεια Ελληνικής Έκδοσης: Κυριάκος Κυπραίος, Γεώργιος Παναγιωτακόπουλος, Νικόλαος Τσοπάνογλου. Εκδοτικός οίκος: Broken Hill Publishers Ltd, 2020 ISBN: 9789925575138.
Κλινική Φαρμακολογία και Θεραπευτική, Lecture Notes (8η έκδοση). Gerard A. McKay, John L. Reid, Matthew. Επιμέλεια Ελληνικής Έκδοσης: Ευαγγελία Παπαδημητρίου. Εκδόσεις Παρισιάνου Α.Ε. ISBN 978-960-394-980-0.
Κλινική φαρμακολογία και φαρμακοθεραπεία. D. G. Graham – Smith, J.K. Aronson. Επιστημονική Επιμέλεια Ελληνικής Έκδοσης: Μάριος Μαρσέλος. Εκδόσεις Τυποθήτω, 2001. ISBN-13: 9789608041660
Literature:
Literature in up-to-date topics related to the syllabus of the course.