Drug Safety and Risk Management in Clinical Practice

Dear Colleagues,

Safety monitoring of drugs throughout their whole life cycle is of paramount importance in order to protect public health and fulfill the whole scope of pharmacovigilance, which is to detect, assess, understand, and prevent adverse effects or any other medicine-/vaccine-related problems. Upon authorization on the market, all medications and vaccines have gone through an extensive clinical trial program to ensure their efficacy and safety. Nevertheless, some adverse effects might not become apparent until after these products have been used for an extended period of time and by a large and diverse population, including those with concurrent illnesses and medications. Therefore, drug safety surveillance through spontaneous reporting systems (SRS) and post-authorization safety studies (PASS) using real-world data will provide information and new insights into the safety profiles of the drugs. Such information must be continuously analyzed, and results should be made available for healthcare professionals and regulatory bodies in case new safety concerns are discovered. If the benefit-risk profile of the drugs is impacted, regulatory authorities can propose risk minimization interventions in order to prevent or reduce adverse effects. This Special Issue welcomes reviews and original papers related to drug safety, such as, but not limited to, studies using active or passive methods for drug/vaccine monitoring (PASS, analysis of data from SRS, including signal detection/disproportionality analysis), studies on risks in special populations, and studies on risk minimization measures, including evaluations of the effectiveness of risk minimization measures.

Dr. Andreea Maria Farcas
Guest Editor

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