Affiliations: Global Safety and Pharmacovigilance PharmaNet AG, Küsnacht, Switzerland | Postgraduate Programme in Pharmaceutical Medicine, Université Libre de Bruxelles, Belgium | Psychiatrische Dienste Aargau AG, MediQ, Klinik Königsfelden, Brugg, Switzerland
Note: [] Corresponding author: J.W. van der Velden, MD, FFPM, FISPE, Senior Vice President of Global Safety and Pharmacovigilance, PharmaNet AG, Obere Wiltigasse 52, CH-8700 Küsnacht, Switzerland. E-mail: jwvandervelden@pharmanet.com
Note: [] Jan Willem van der Velden has disclosed that he is an employee of PharmaNet. Eveline Jaquenoud Sirot reports no relationships to disclose.
Abstract: Risk management proactively assesses the potential risks and benefits of health care interventions, including both drugs and medical devices. Risk management systematically identifies safety indications and establishes a risk management strategy for potential adverse events. Professionals trained in risk management have unique expertise in assessing the balance between risk and benefit. They play an important role in clinical study oversight (pre- and postmarketing) and in measuring outcomes of health care interventions. Assessing the risks and benefits of any therapy requires consideration of the complex interactions of multiple variables of the population to treat, including disease state, proposed treatment, and potential risks. Several key factors contribute to the effectiveness and acceptability of any treatment. For example, physician compliance with prescribing guidelines and a patient's ability to tolerate a drug and to understand how to administer medications accurately will affect risk management assessments. Concurrent treatments (drug interactions) and diseases are also important considerations. Other variables include drug treatment ratios (placebo/active) and, increasingly, the use of screening tools to identify pharmacogenetic markers in particular patient populations that correlate with drug metabolism, efficacy, and other outcomes.
