Therapie
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During the past few decades, it has been stated that a paradigm shift has occurred in the assessment and management of patient related drug safety. Some of these changes have resulted in a significant increase in the importance of pharmacoepidemiology and its use in pharmacovigilance. For European member states, the Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols and results of imposed and non-imposed post-authorization safety studies (PASS). ⋯ The number of imposed PASS was almost constant over time with a mean of 34.3±7.6 imposed protocols per year and 3.5±1.74 imposed results per year. The need for the implementation of PASS for pharmacovigilance regulatory activities is increasing. Nevertheless, conducting such studies remains difficult.
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Pharmacology is often divided in separate branches, such as molecular and cellular pharmacology, pharmacokinetics, pharmacodynamics, experimental and/or preclinical pharmacology, clinical pharmacology (and therapeutics), pharmacogenetics, pharmacogenomics, pharmacovigilance, pharmacoepidemiology, pharmacoeconomics… This enumeration gives a global picture of different scientific areas, which are however dealing with the same question. Another mindset should be a global interactive and continuous approach, which could be designed as "human pharmacology". ⋯ Examples of such analyses investigating the risk of movement disorders, diabetes related to psychoactive drugs, or the risk of adverse cardiac outcomes with different drugs (classical drugs or protein kinase inhibitors) are given. The increasing number of research works investigating this topic underlines the importance of this relatively new approach, which gives significant inputs for the better knowledge of drug safety.