Long-term use of pharmacological treatment in Alzheimer’s disease: a retrospective cohort study in real-world clinical practice

Abstract

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Pharmacovigilance and Pharmacoepidemiology as a Guarantee of Patient Safety: The Role of the Clinical Pharmacologist

“…Even though RCTs may be preferred for evaluating the efficacy of a drug or a vaccine, the principal aim of the pharmacoepidemiological method is to estimate drug or vaccine effect in real life (effectiveness), avoiding, as much as possible, any modification caused by the study itself (i.e., presence of biases). From a practical point of view, pharmacoepidemiology relates to descriptive methodologies (i.e., describing the use of a drug in a specific demographic or clinical setting) [ 21 ], as well as to etiologic methodologies (i.e., estimating the association between drug exposure and a specific clinical outcome) [ 22 ]. Researchers operating in the field of pharmacovigilance, first the clinical pharmacologist, can use pharmacoepidemiological studies to identify unexpected or rare safety issues and detect changes in frequency of expected ADRs/AEFIs, making possible a continuous monitoring of the benefit risk ratio of a drug, vaccine or CAM product in the real-world setting [ 5 ].…”