Anæstesiudvalget vil gerne gøre opmærksom på følgende afgørelse:
I løbet af 2018 har der været megen diskussion om HES.
Det startede i januar 2018, hvor European Medicines Agency (EMA) sikkerhedskomité PRAC anbefalede, at HES blev suspenderet fra markedet; idet HES forsat blev givet til kritisk syge patienter.
Denne udmelding blev mødt med en del modstand, og der har været flere indlæg i BMJ og Lancet, hvor argumenterne for og imod har været fremført.
I maj 2018 blev det besluttet at revurdere sagen.
I juli 2018 kom den endelige afgørelse. HES suspenderes ikke fra markedet, men kan anvendes med visse forbehold:
- Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients
- Medicines to remain on the market provided that training, controlled access and warnings on the packaging are implemented
The CMDh has decided that hydroxyethyl starch (HES) solutions for infusion should remain on the market provided that a combination of additional measures to protect patients is implemented. This follows further reflection, in consultation with EU Member States, on whether it would be feasible to introduce new measures that would effectively reduce the risks with these medicines.
HES solutions for infusion are used to replace plasma volume following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered sufficient.
In January 2018, EMA’s safety committee PRAC recommended suspending the marketing authorisations of these medicines because they continued to be used in critically ill patients and patients with sepsis despite restrictions introduced in 2013 due to the risk of kidney injury and death in these patients.
The CMDh agreed with the PRAC’s assessment of the serious risks in critically ill patients and patients with sepsis. However, the CMDh gave further consideration to the place of HES in the clinical practice of some countries, noted that previous risk minimisation measures had some effect, and considered that a combination of new risk minimisation measures would effectively ensure that HES solutions are not used in patients at risk.
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.
The CMDh also requested marketing authorisation holders to conduct studies to check that only patients who should be treated with these medicines are receiving them. This is in addition to ongoing studies on the benefits and risks of HES solutions in patients with trauma and those undergoing elective surgery.
As the CMDh position was adopted by majority vote, the CMDh position was sent back to the European Commission, which took an EU-wide legally binding decision on 17 July 2018.
Se også tidligere udmelding her på siden: Link til artiklen.