Additional safety protections relating to COVID-19 for faecal microbiota transplant (FMT) products
The Therapeutic Goods Administration (TGA) is providing advice on safety protections to faecal microbiota transplant (FMT) providers since there is the potential to transmit the SARS-CoV-2 virus via FMT through shedding in stool.
This advice follows a recent safety alert from the US FDA that highlighted the additional safety precautions that should be in place for COVID-19 disease screening of potential stool donors for FMT products in order to prevent the spread of the SARS-CoV-2 virus.
The draft FMT donor standards on which we recently consulted included a requirement to notify the TGA of measures put in place to manage such epidemiological situations once they are in effect.
The TGA is advising providers of FMT products that they should introduce the following safety measures:
- Donor screening must include questions directed at identifying stool donors who may be currently or recently infected with the SARS-CoV-2 virus.
- Stool donors may be tested for the SARS-CoV-2 virus, as feasible.
- Criteria for exclusion of stool donors and donor stool based on screening and testing must be developed.
- Informed consent of patients who undergo FMT must include information about the potential for transmission of the SARS-CoV-2 virus via FMT, including FMT prepared from the stool of donors who are asymptomatic for COVID-19 disease.
Providers of FMT products are also expected to regularly monitor the TGA website for safety advice updates relating to the use of FMT during the COVID-19 pandemic. The TGA has a dedicated COVID-19 page and also regularly publishes Medicine Safety Update (MSU) articles and safety alerts.
By definition, FMT products comprise, contain, or are derived from donated human stool and are introduced into a recipient person for a therapeutic use. Human stool is collected from a screened donor by defaecation. This stool is then processed into an FMT product and provided to the recipient via enema, colonoscopy, nasoenteric tube, or orally (e.g. capsules).
The TGA has recently moved to increase oversight of FMT product supply in Australia, with the sector currently subject to a transition period to allow time for current providers to understand how the changes will impact them, allow them time to comply, and ensure ongoing access for Australian patients.
For further information, see TGA regulation of FMT products in Australia.
Reporting adverse events
Consumers and health professionals are encouraged to report adverse events associated with the use of a medicine, vaccine or medical device to the TGA. Adverse events are unintended and sometimes harmful occurrences associated with the use of a therapeutic good and include side effects to medicines and vaccines, and problems or incidents involving medical devices. Your report will contribute to the TGA's monitoring of these products.