Urgent action required to avoid ‘Pandora’s box’ as hospitals prepare for novel oral COVID-19 antivirals

Urgent action required to avoid ‘Pandora’s box’ as hospitals prepare for novel oral COVID-19 antivirals

Leading Hospital Pharmacists have called for a consistent and streamlined approach to support the safe prescribing and dispensing of novel oral COVID-19 treatments in clinical care, with supplies of nirmatrelvir/ritonavir (Paxlovid®) and molnupiravir (Lagevrio®) due for imminent use in Australia.

Appearing as an Early View editorial of the Society of Hospital Pharmacists of Australia (SHPA)’s flagship Journal of Pharmacy Practice and Research (JPPR), authors Professor Jason Roberts, Director of the Herston Infectious Diseases Institute and the NHMRC Centre of Research Excellence at the University of Queensland and Alfred Health’s Alison Duncan, Infectious Diseases Pharmacist and Kelly Cairns, Lead Antimicrobial Stewardship Pharmacist, say clinical collaboration between healthcare professionals is crucial to ensure the safe prescribing of the new oral COVID-19 therapies.

Professor Roberts says it is understandable that anticipation around the potentially paradigm-changing treatment of COVID-19 with oral antivirals is building rapidly.

‘Strong clinical data supports use of oral antiviral drugs, including Paxlovid®, which is reported to reduce COVID-19-related hospital admission or death from any cause by 89% in unvaccinated adults with risk factors for disease progression.

‘However, potential drug interactions can be very challenging to interpret, predict and manage. A recent review of COVID-19 positive patients for infusion of sotrovimab, a COVID-19 treatment provisionally approved in 2021, found up to 1 in 3 patients would be potentially at risk of a significant drug interaction if they commenced Paxlovid® therapy.’

The authors of the editorial – ‘Pandora’s box: Paxlovid, Prescribing, Pharmacists and Pandemic’ – say healthcare professionals in Australian hospitals face a further three key challenges regarding Paxlovid®, Lagevrio® and other oral antivirals:

  • changing immunity in the population compared to when clinical trials took place, conferred by vaccinations and booster shots;
  • the potential emergence of new variants against which antivirals may be more or less effective;
  • most importantly, a lack of existing clinical experience, which increases the importance of establishing and adopting nationally consistent guidance on their safe and effective use.

Professor Roberts says the need for nationally consistent guidance on safe and effective use is particularly important as the new antiviral medicines are limited in availability and access.

‘While it is important these novel medicines are imported and distributed quickly, at the same time we must generate a much stronger understanding of their risks and benefits – given limited international experience – and produce practical resources to assist Australian doctors and pharmacists on their safe and effective use in patients.

‘This will involve regular pharmacovigilance activities undertaken by Hospital Pharmacists and other healthcare professionals (including in community-based professionals), supported by robust data collection on effectiveness and safety during early use. More comprehensive data for any COVID-19 therapy would enable more Australians to derive maximum benefit, particularly in traditionally more vulnerable populations such as pregnant and breastfeeding women, children and adolescents, and patients with renal impairment, which adds further weight to expediting standardised, national guidance.’

Download the media release.