There are now two drug utilisation studies on the effectiveness of the risk minimisation measures implemented in the Marketing Approval for starches. The results are humiliating for anaesthetists and critical care clinicians in Europe.
Every year up to 1.5 million patients in the EU are give hydroxyethyl starch.
Up to 34% of Starch prescriptions are to patients with contraindications.
Prescriber non-adherence to revised product information is up to 77%.
You may recall that the UK MHRA withdrew marketing authorisations for starches, but were overruled by the European Medicines Agency after pleas from… well, I don’t need to name the exalted Professors who have been protecting Fresenius, Braun and Serumwerk from loss of this market.
Sweden now formally initiates an urgent union procedure under Article 107i of Directive 2001/83/EC and refers the matter to the Pharmacovigilence and Risk Assessment Committee of the EMA.
I can’t tell you how angry it makes me that colleagues could behave so badly. If you can’t practice without a so-called plasma substitute you should not be doing Anaesthesia or Intensive Care Medicine. If you are reading this, I am probably preaching to the converted. Time to get out there Starling Ambassadors and challenge your colleagues who are responsible for this stain on our profession.