Coronavirus: Temporary “Off-label” Derogation for Rivotril® Rescinded

In France, the official decree issued on March 29, 2020, which authorized Rivotril® to be prescribed “off-label, in the context of the COVID-19 outbreak” was rescinded on May 12, (decree n° 2020-548, Art. 28, dated May 11, 2020).

The exceptional derogation for using Rivotril ® was intended to provide relief for COVID-19 patients with acute respiratory distress (asphyxia) and who were not to be resuscitated. Due to the shortage of sedative drugs during the outbreak, the decree authorized Rivotril ® to be prescribed off-label during the initial confinement period until April 15, and was later extended until May 11th.

Alliance VITA previously warned in its April 3, 2020 article, that although off-label dispensation of Rivotril® was sometimes a necessity for exceptional cases of COVID-19 patients who are not to be resuscitated, its use in private practice or in nursing homes and medico-social establishments should nevertheless be supervised and several previous conditions should be met:

  • seek the patient’s recovery with curative attempts prior to any palliative measures;
  • respect the patient’s will;
  • dispense appropriate training for caregivers;
  • ensure a minimum of traceable collegial decision-making;
  • offer appropriate support to patients and their families;
  • provide support and follow-up to the healthcare team.

Rivotril® should only be prescribed to relieve the patient’s suffering and never with the intention of shortening his life. Rescinding the temporary derogation for off-label prescriptions of Rivotril® is a reassuring sign and indicates that hospital services are currently able to manage COVID-19 patients.

 

 

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