Pharmacology, Clinical Pharmacology and Pharmacoepidemiology in Drug Surveillance Studies

Jiří Vlček¹, Zdeněk Fendrich² (fendrich@faf.cuni.cz)

¹Department of Social & Clinical Pharmacy
²Department of Pharmacology & Toxicology, Faculty of Pharmacy, Charles University, Hradec Králové, Czech Republic

Summary

The choice of a drug for therapeutic intervention is a rather sensitive matter. In most cases it is not always possible to make the drug be effective only in the sense of healing the disease for which it was administered, but it may concomitantly influence other physiological or pathological processes in the organism. Therefore, it is often necessary to choose a compromise between the required and adverse effects of any drug may depend on many factors, such as the actual state of the organism for wich the drug was aimed, the choice of the correct dosage regimen, environmental factors, taking other drugs, and others. All these factors should always be taken into account. All the factors therefore form the content of the information, which arises mostly in pharmacological and pharmacoepidemiological research. The present authors tried to establish the boundaries of the individual disciplines and the reliability of information. Pharmacology is a fundamental discipline examining the effect of a drug, its mechanisms of action, and relationship to the drug dose. Pharmacoepidemiology is a new science which is based on the knowledge of pharmacology. However, pharmacoepidemiolgy advances further and triesto proceeds from the models used in pharmacology to the analysis of data which arise directly in the therapeutic process. This advantage is, however, balanced by the disadvantage in the sense of higher sensitivity in the development of false conclusions. It is therefore necessary to regularly analyse these faults as an integral part of epidemiological research. Only statistical grounding, or collaboration with a statistician is not sufficient for pharmacoepidemiological analyses, but the application of the fundamental principles of pharmacology, physiology and sociology are also absolutely essential.