Burden is defined as the additional load that a risk minimisation activity imposes on (1) patients, (2) carers, (3) the healthcare system including health care professionals, (4) others such as regulatory authorities, pharmaceutical companies, the supply chain and those involved in access and supervision of the use of medicines. The burden may impact, for example: Patients by adversely affecting their access to prescribed medicines and/or needed healthcare services, daily activities or routines;

• Healthcare providers by adding steps or services that are normally not required in the day-to-day management of their medical area;
• The health care system by requiring extra human and/or financial resources;
• Other entities of the healthcare system by including additional scientific evaluation of the risk minimization plan, its implementation, and its effectiveness.