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The HPRA hopes to issue guidance on faecal microbiota transplantation (FMT) “shortly”, this newspaper has learned. Currently, the regulation of FMT is at the discretion of individual EU member states. There is no national regulation in Ireland.
FMT is a procedure in which faecal matter, or stool, is collected from a tested donor. This is then mixed with a solution such as saline. It is strained and placed in a patient by way of a number of procedures, including sigmoidoscopy, colonoscopy, endoscopy and enema, or orally in the form of a capsule.
In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) classified FMT as a medicinal product, not a tissue, thus regulation of FMT changed from the Human Tissue Authority (HTA) to the MHRA.
In Ireland, the Health Products Regulatory Authority (HPRA) is the competent authority for the implementation of the Tissues and Cells Directive (2004/23/EC,) and its associated technical directives. The HPRA is also the competent authority for medicinal products for human use.
“The regulation of FMT is currently at the discretion of individual EU member states, and this matter is under consideration by the HPRA,” a spokesperson for the Authority told the Medical Independent (MI). “The HPRA hopes to be in a position to issue guidance shortly in this area.”
Clostridium difficile Infection
Separately, a recent paper by Irish experts surveyed the various treatments of Clostridium difficile infection (CDI) utilised by Irish clinicians, and in particular the use of FMT (see citation below). Fourteen respondents (14.9 per cent) reported previous FMT use, mostly in the previous year (10/14).
This treatment is recommended in the Irish national guidelines (Surveillance, Diagnosis and Management of Clostridium difficile Infection in Ireland, June 2014) for the second or subsequent recurrence of CDI. FMT is given a Grade A recommendation in these guidelines based on the strength of supporting available evidence.
“Certainly, based on responses received in our survey, a national approach in terms of protocols, in relation to factors such as donor stool selection and how best to administer FMT, would likely be a positive step to help increase utilisation of FMT,” Dr Anna-Rose Prior, Clinical Lecturer in the Department of Microbiology, RCSI, told MI. Dr Prior is one of the authors of the recent article available on the RCSI website and published in print in the Journal of Hospital Infection.
“Availability of prepared stool was also a key factor. However, we did not examine whether respondents felt this should come from a stool bank in Ireland or elsewhere or from individual donors [directed donor model],” said Dr Prior.
“Our results appear to indicate that increased clarity and standardisation of the actual logistics of the procedure, such as protocols, stool availability and access to endoscopy services are likely to be of benefit in increasing FMT use.
“Regulation is a much more complicated area that I have little experience with, however, I am aware that there has been much discussion on both sides of the Atlantic that centres around ensuring a safe service is provided for patients.”
Currently in Ireland there is no nationally agreed FMT policy or guidance should a hospital wish to establish a stool banking service, nor is there a national or regional stool banking service. The ongoing consideration of FMT regulation by the HPRA may change this situation.
“Although FMT is given a Grade A recommendation for the second or subsequent recurrence of CDI, Irish national guidelines do not advise which approach should be taken or which model should be used,” Dr Prior told MI.
“Our group performed this survey to assess use of FMT as per the guideline recommendation, but did not collect information as to what model was used in individual centres.”
Internationally, there are different donor models for FMT.
“There is no universal donor model (ie, stool banking facility) currently in place in Ireland,” according to Dr Prior.
“There are, however, well-established stool banking facilities internationally, such as that provided by the Boston-based organisation OpenBiome. This organisation has an extensive donor screening programme and comprehensive follow-up of patients and has supplied frozen FMT products to Irish facilities for the treatment of recurrent CDI.”
Dr Prior added: “I don’t know if a health economics evaluation has been performed for the establishment of such a service in Ireland. Certainly, regardless of whether a national stool banking service is used or one from another country, the use of a universal donor model rather than directed donor model would likely lead to increased utilisation of FMT for recurrent CDI.
“A universal donor model would facilitate a readily available repository of donor samples which have undergone extensive screening in advance of treatment being required and ensure patients receive a timely and safe service.”
Concerns have been raised over patients possibly doing FMT on a ‘DIY’ basis, not only for CDI but also for other conditions.
Dr Prior made clear the danger involved with this.
“Given this involves transfer of biological material and manipulation of the bowel microbiome, this procedure is not without its potential hazards,” she told MI.
“These risks are minimised by extensive donor screening. Information collected on patient follow-up helps further inform the process. Obviously, there are always concerns that individuals may be performing ‘DIY’ FMT for a range of conditions, evidence-based or not. And easy availability of ‘instructions’ on the Internet certainly makes it possible for individuals to attempt this.
“However, this cannot be recommended and may be associated with adverse outcomes and reduced efficacy.”
She added that the use of FMT for treatment of any condition “should be evidence-based, as it is for CDI, and only ever performed in a safe environment under the guidance of a clinician.”
Authors: Prior AR, Kevans D, McDowell L, Cudmore S, Fitzpatrick F, ‘Treatment of Clostridium difficile infection: a national survey of clinician recommendations and the use of faecal microbiota transplantation’, Journal of Hospital Infection (2016)