Risk Management

All medicines have risks. Risk management is used to ensure that the potential benefits of a medicine exceed its potential risks, and to minimize those risks. The traditional tools used to manage the risks of prescription medicines have been the prescription status itself, labeling for healthcare professionals, and the requirement that manufacturers monitor and report to regulatory authorities adverse events that occur with use of the medicine. In the past decades, additional steps have been taken to manage more actively the risks of certain marketed medicinal products. These measures have included increased communication to patients and healthcare professionals, and measures to restrict the usage, in various ways, of certain medicines. Risk management systems are ideally scientifically driven, functional throughout a product's life cycle, proactive in nature, and inclusive of all stakeholders. The principal current challenges center on advancing the science of risk management in terms of developing systems-based approaches to minimizing the risk of medicines and developing strategies and evidence of the effectiveness of risk minimization strategies. In addition, in the EU, developing a more focused approach to risk management is an ongoing challenge, with the aim of rationalizing resources to where they can have the most impact.