Update 10 May 2021
On this page
- Access to Non-formulary and/or Off-Label Medicines in Hospital
- Clinical trials
- Document information
This guidance applies only to patients with COVID-19 who are managed as an inpatient in a physical hospital. It includes evidence-based recommendations, as well as guidance and resources supporting therapeutic decision-making, drug access, governance and utilisation in hospital.
As evidence emerges from clinical trials, recommendations regarding the use of some disease-modifying medicines in COVID-19 can now be made, while the use of other disease-modifying medicines remains best limited to a clinical trial setting. Recommendations can also be made where the use of some medicines should not occur. The Australian guidelines for the clinical care of people with COVID-19, updated weekly, is the nationally recognised source for specific, patient-focused recommendations on management and care of people with suspected or confirmed COVID-19.
The tables below summarise the recommendations regarding specific disease-modifying medicines, as of May 10, 2021, with guidance on access, governance and resources to support use in hospital.
||Recommended for use in adults, including pregnant and breastfeeding women, receiving oxygen (including mechanically ventilated patients). Conditional recommendation for children and adolescents receiving oxygen (including those mechanically ventilated).
||NSW tag drug guidance (requires local DTC|
||Conditional recommendation for use in adults including pregnant or breastfeeding women who require oxygen but not ventilation. Note criteria and exceptions^
||Via formulary (restricted access); or IPU*
||NSW TAG drug guidance (requires local DTC endorsement); patient information; patient consent form; Prescribing Declaration/IPU* application form#;outcomes reporting form.|
- Interferon Beta-1a
Do not use for the
¥ Other corticosteroids (prednisolone, hydrocortisone) are also considered appropriate if dexamethasone is not available- refer to Australian Guidelines
for further information.
Efficacy and safety of tocilizumab has not been established for children and adolescents with COVID-19 or non-COVID-19 conditions. Recommendations for use in pregnant and breastfeeding women are evolving and based on short-term observational data and theoretical assumptions. Refer to Australian Guidelines
for further information.
* IPU = Individual Patient Use – see below.
# check with Infectious Diseases/Pharmacy departments for access information and documentation’
^ Conditional recommendation against use of remdesivir in children or adolescents with COVID-19 - refer to Australian Guidelines
for further information.
@ applies to COVID-19 treatment or for pre- or post-exposure prophylaxis.
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NSW Health does not endorse any specific antiviral or immunomodulatory therapy for patients with COVID-19, outside those treatments recommended by the national COVID-19 clinical guidelines. Currently there are few circumstances where this might be considered (e.g. remdesivir slightly outside current criteria). In these rare circumstances, the following process should be followed.
Access to Non-formulary and/or Off-Label Medicines in Hospital
Clinical decision making must align with the criteria for Off-Label Use of Medicines for “Exceptional/Individual Use” and “Conditional Use, with Evidence Development”, outlined in the Council of Australian Therapeutic Advisory Groups’ (CATAG)
Guiding principles. Institutional governance is through the Individual Patient Use procedure, with shared decision making and informed consent involving the patient or carer, and entry of patient data into a registry for evidence development. Rigorous monitoring for adverse drug events and reporting of these is essential. Use of a registry will inform safer future use of treatments for COVID-19. Currently local sites are responsible for their own registry with collated information regarding IPUs reported through the usual process – refer to Approval process of Medicines for Use in NSW Hospitals. State-wide registries are being established to facilitate the collection of information on use and outcomes for all NSW patients with COVID-19 who are given specific COVID-19 medicines outside a clinical trial. Further information is available at NSW TAG COVID-19 resources.
There are at least three clinical trials of specific medications for patients in hospital with COVID-19 with ethics approval in NSW, supported by NSW Health:
- REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial which has randomised more than 11,000 ICU patients with suspected or proven COVID-19. (see REMAP-CAP). A wide range of antiviral, immunomodulatory therapies and other therapies are being evaluated. The study can adapt over time as the pandemic and other evidence develops: the antiviral domain is entering a dormant state, and the immune modulation domain will no longer be randomising patients to a placebo arm.
- Australasian COVID-19 Trial (ASCOT). A multicentre, adaptive, randomised clinical trial to assess patients with SARS-CoV-2 infection (COVID-19) treated in hospital outside of ICU. ASCOT enrols each patient into two domains: (i) antibody (convalescent plasma) vs standard of care and (ii) antiviral (nafamostat vs standard of care). See Australasian COVID-19 Trial
- Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease (CLARITY) is a pragmatic prospective, open-label, randomised controlled trial investigating the effectiveness of angiotensin II receptor blockers (ARBs) on improving the outcomes of hospital- and home-based adults who have tested positive for COVID-19 disease.
There are other approved studies of therapies for prevention of COVID-19 as well as studies of other therapies for treatment, currently under ethics review and applications for funding.
This guidance will be updated regularly as new information becomes available.
- Evidence on management is summarised in Australia with the Living Guidelines.
- The recommended process to guide clinical decision making and governance of off-label use of medicines in Australia is described in the Council of Australian Therapeutic Advisory Groups (CATAG) Guiding principles.
- Resources regarding use of specific COVID-19 therapies in hospitalised patients (patient/carer information and consent forms, drug guidelines and IPU/outcomes forms) and a summary of clinical trials approved in NSW are available from NSW TAG.
- Worldwide clinical trials are listed at: Global Coronavirus COVID-19 Clinical Trial Tracker.
- Australia and NZ clinical trials are listed at: Australian New Zealand Clinical Trials Registry (ANZCTR) (search COVID studies).
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Drug and therapeutics Advisory Community of Practice.
- Antiviral Expert Advisory Group chaired by Prof Tania Sorrell
- NSW Health communities of practice for:
Dr Nigel Lyons, Deputy Secretary, Health System Strategy and Planning, NSW Ministry of Health.
10 May 2021.
For use by
All communities of practice.