The new measures are:
- the implementation of a controlled access programme by the companies holding the marketing authorisations to ensure that only accredited hospitals will be supplied with these medicines. The accreditation would require that relevant healthcare professionals receive training on the safe use of HES solutions for infusion. Further details about the training and the controlled access programme will be provided to hospitals and healthcare professionals in due time;
- warnings in the medicines’ packaging and at the top of the summaries of product characteristics (SmPCs) reminding healthcare professionals that these medicines must not be used in patients with sepsis or kidney impairment or in critically ill patients;
- writing directly to healthcare professionals to ensure that they are fully aware of the conditions of use of the medicines and the groups of patients that must not receive them due to an increased risk of kidney injury and death.