Glossary

A risk factor is a characteristic, condition or habit that increases a person™s chances to develop a particular disease or injury, for example, physical inactivity may, over time, contribute to weight gain, high blood pressure and high cholesterol levels. Risk factors include:

• behavioural (poor diet, smoking, alcohol consumption),
  
• biomedical (high weight, high blood pressure),
  
• environmental (social, economic, cultural),
  
• genetic (chromosomal abnormalities),
  
• demographic (age, gender, ethnicity).
  

Risk management is a process for identifying, assessing, prioritising, and taking the appropriate action to mitigate a risk. The objective of risk management is to continuously try to ensure that the benefits of a particular medicinal product (or a series of medicinal products) exceed the risks by the greatest achievable margin for the individual patient and for the target population as a whole.

A risk management plan provides a detailed description of the activities and interventions in place to prevent or minimise risks of using a medicine. Risk management plans outline how more knowledge about the safety and efficacy of a medicine will be generated, what are the risk factors for developing side effects, and how risk-minimisation measures will be monitored.

Risk management plans must be submitted by companies at the same time they apply for marketing authorisation in the European Union, although they must be continually updated and revised throughout the medicine™s lifetime. Risk management plans can also be requested by the EMA at other times, or whenever there is concern that a risk may be affecting the balance of benefits and risks for a particular medicine.

These are public health interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Risk minimisation measures aim to optimise the safe and effective use of a medicinal product throughout its life cycle. Planning and implementing risk minimisation measures and assessing their effectiveness are key elements of risk management. Routine risk minimisation involves the use of the tools such as the Summary of Product Characteristics (SmPC), the package leaflet, the labelling, the pack size and design, and the legal (prescription) status of the product.

The majority of safety concerns may be adequately addressed by routine risk minimisation measures, but for some risks however, additional risk minimisation measures are necessary to manage risk and/or improve the benefit-risk balance of a medicinal product.

Routine pharmacovigilance activities are generally conducted for any medicine in development, where there are no special safety concerns. Activities might include safety evaluation incorporated into clinical trials, and the monitoring and reporting of adverse events. These activities are specified in European law on pharmacovigilance.