MHRA suspends recruitment of further participants to clinical trials using hydroxychloroquine

24 Jun 2020

COVID-19: MHRA has suspended further recruitment of participants to clinical trials using hydroxychloroquine

Data from two clinical trials, including the UK’s RECOVERY trial, was reviewed by the Commission on Humans Medicines (CHM). MHRA was advised that no significant mortality benefits were seen in patients hospitalised with COVID-19. In light of this information, MHRA has announced that no new patients will be recruited into the trials until additional safety measures have been implemented and further evidence becomes available to advocate use of hydroxychloroquine to treat or prevent COVID-19.

Key points for pharmacy teams

  • Hydroxychloroquine and chloroquine are licensed in the UK to treat conditions such as malaria, rheumatoid arthritis, lupus, amoebic hepatitis and abscess and certain dermatological conditions
    • It is important that patients taking these prescribed medicines to treat other health conditions continue to do so under medical advice
  • Hydroxychloroquine and chloroquine are not licensed for the prevention or treatment of COVID-19
  • Suspected side effects from hydroxychloroquine or chloroquine taken by patients with COVID-19, should be reported by either patients or pharmacists via the MHRA Yellow Card COVID-19 reporting site
  • Report suspected side effects from hydroxychloroquine or chloroquine taken to treat other health conditions via the main MHRA Yellow Card site

NPA Professional Indemnity insurance will not cover:

  • OTC sales or supplies of chloroquine intended to be used for prevention/treatment of coronavirus (COVID-19) infection
  • Dispensing of prescriptions for supply of chloroquine and hydroxychloroquine prescribed for prevention/treatment of coronavirus (COVID-19) infection

If the UK Government/NHS advice on the use of chloroquine or hydroxychloroquine for prevention/treatment of coronavirus (COVID-19) infection changes, we will issue updated advice

 

Further reading:

 

Please contact the Pharmacy Services Team for further advice and support:

  • Tel: 01727891800 (Mon-Fri 9am to 6pm, Sat 9am to 1pm)
  • Email: pharmacyservices@npa.co.uk