2014 Event Additional studies required to allow continuing availability of HES in the EU market
2017 Event Surviving Sepsis
Guidelines 6
2018 Event Further EMA recommendation for suspension of HES products across EU 7 , 8
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Outcome Post-authorisation commitment for additional studies in surgery and trauma ( TETHYS and PHOENICS ); 4 , 5 continued availability will be dependent on demonstration of an appropriate level of patient safety
Outcome Recommend against using HES for intravascular volume replacement in patients with sepsis or septic shock ( strong recommendation , high quality of evidence )
Outcome PRAC reviewed results of drug utilisation studies , observational studies and clinical trial data on benefits and risks and concluded that the 2013 restrictions had not been sufficiently effective
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References 1 European Medicines Agency . Article 31 referrals document . 20 November 2016 . www . ema . europa . eu / docs / en _ GB / document _ library / Referrals _ document / Solutions _ for _ infusion _ containing _ hydroxyethyl _ starch / Procedure _ started / WC500135590 . pdf ( accessed August 2019 ). 2 European Medicines Agency . PRAC suspension recommendation . 14 June 2013 . www . ema . europa . eu / docs / en _ GB / document _ library / Referrals _ document / Solutions _ for _ infusion _ containing _ hydroxyethyl _ starch / Recommendation _ provided _ by _ Pharmacovigilance _ Risk _ Assessment _ Committee / WC500144448 . pdf ( accessed August 2019 ). 3 European Medicines Agency . Hydroxyethyl starch solutions for infusion . 06 March 2014 . www . ema . europa . eu / ema / index . jsp ? curl = pages / medicines / human / referrals / Hydroxyethyl _ starchcontaining _ solutions / human _ referral _ prac _ 000012 . jsp & mid = WC0b01ac05805c516f ( accessed August 2019 ). 4 Safety and efficacy of a 6 % hydroxyethyl starch ( HES ) solution versus an electrolyte solution in trauma patients ( TETHYS ). https :// clinicaltrials . gov / ct2 / show / NCT03338218 ( accessed August 2019 ). 5 Safety and efficacy of 6 % |
hydroxyethyl starch ( HES ) solution versus an electrolyte solution in patients undergoing elective abdominal surgery ( PHOENICS ). https :// clinicaltrials . gov / ct2 / show / NCT 03278548 ? term = PHOENICS & ra nk = 2 ( accessed August 2019 ). 6 Rhodes A et al . Surviving Sepsis Campaign : International Guidelines for Management of Sepsis and Septic Shock : 2016 . Intensive Care Med 2017 ; 43:304 – 77 . 7 European Medicines Agency . PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market . www . ema . europa . eu / en / news / prac-recommends-suspendinghydroxyethyl-starch-solutionsinfusion-market ( accessed August 2019 ). 8 European Medicines Agency . Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation . www . ema . europa . eu / en / news / hydroxyethyl-starch-solutionsinfusion-be-suspended-cmdhendorses-prac-recommendation ( accessed August 2019 ). 9 European Medicines Agency . Hydroxyethyl starch solutions : CMDh introduces new measures to protect patients . www . ema . europa . eu / en / news / hydroxyethyl-starchsolutions-cmdh-introducesnew-measures-protect-patients ( accessed August 2019 ). |
Implementation of a controlled access programme by MA holders by which only accredited hospitals / centres will be supplied HES . Accreditation requires that relevant healthcare professionals who prescribe or administer HES receive mandatory training on safe and effective use 9
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