Theoretical background and practical tasks
LIFELONG STUDY OF PHARMACOLOGY
̶ Research and development of new drugs
̶ Every year, around 40 new medicines get market
authorization worldwide
̶ Most physicians prescribe medications that were not
known at the time of their study/graduation
̶ Misleading information/fake news/hoaxes vs reliable
information
ESSENTIAL INFORMATION SOURCES
̶ SPC/SmPC = Summary of product characteristics
̶ Written by marketing authorization holder (manufacturer),
approved by regulatory authority (e.g. EMA)
̶ UK: Electronic medicines compendium
̶ CZE: SUKL database – english version
In Czech:
̶ Pharmindex Brevíř/Breviary (Medical Tribune)
̶ Information system „AISLP“ (part of Czech IT systems in
hospitals, doctor‘s offices)
̶ Czech Pharmacopoeia (Český lékopis)
PHARMACOPOEIA
̶ Poieo = greek; I prepare
̶ European Pharmacopoeia 10th edition (Ph. Eur. 2020)
̶ Czech Pharmacopoeia
̶ Derived from Ph. Eur. + national specific part
̶ Current version published in 2017
̶ Binding standard (norm) for ensuring safe, effective nad quality
medicines
̶ Quality requirements and specifications of pharmaceutical
substances, excipients, medical preparations and dosage forms
̶ Analytical examinations and evaluations
̶ Requirements for preparation, manufacturing, control, labelling and
storage of drugs
̶ Compounded medication recipes (Czech national part)
CZECH PHARMACOPOEIA – STRUCTURE
European part
̶ General part: analytical examinations and evaluations, analytical
devices, containers and packaging of medicines, general texts (e.g.
about sterility, stability testing), general texts about dosage forms or
specific medicines (radiopharmaceuticals, vaccines, homeopathic
preparations…) etc.
̶ Special part: monographies of pharmaceutical substances
National part
̶ 12 tables (useful mostly for pharmacists)
̶ Table IV and V – Recommended therapeutical doses
for adults and children
̶ Special part (nationally specific substances and preparations)
Examples
in interactive
syllabi
FREE INTERNATIONAL SOURCES
̶ European Medicines Agency (EMA)
http://www.ema.europa.eu/ema/
̶ Drugs.com (incl. drugs interactions checker)
https://www.drugs.com/
̶ PubMed
https://www.ncbi.nlm.nih.gov/pubmed
̶ Medscape
https://www.medscape.com/
PAID INTERNATIONAL SOURCES
̶ Dynamed https://www.dynamed.com/home
̶ Lexicomp https://online.lexi.com/lco/action/login
̶ Micromedex https://www.micromedexsolutions.com
̶ Up-to-date https://www.uptodate.com/home
̶ MUNI sometimes grants short-term „testing access“:
https://ezdroje.muni.cz/prehled/index.php?lang=en&type=abecedne
̶ MUCL Services https://kuk.muni.cz/?page=87&lang=english
ATC DRUG CLASSIFICATION SYSTEM
̶ ATC code = international alphanumerical code for
every individual pharmaceutical substance in defined
indication group – see metformin:
ATC CLASSIFICATION