News in brief: IBD medication non-adherence; New rules for FMT; Latitude and Primary biliary cholangitis

19 May 2021

IBD medication non-adherence is ‘alarming’

Patients with more severe IBD have been stopping or reducing their medication because of fears of COVID-19 infection, a study from South Australia has found.

A survey of 262 patients with IBD found that one in 20 (5%) had self-initiated missed or reduced doses of IBD medication as a results of the onset of the pandemic in 2019.  Patients  who were non-adherent tended to have more severe disease and be taking steroids – and about half were taking biologics, according to gastroenterologists from Flinders Medical Centre and the Inflammatory Bowel Disease Service at the Royal Adelaide Hospital.

“These findings are alarming, in that most patients did not discuss their concerns or medication changes with their IBD physician, despite this being in a cohort with more severe disease,” they wrote in the Journal of Gastroenterology and Hepatology.

Tougher FMT regulation begins in July

Providers of faecal microbiota transplant products are on notice that the TGA’s new regulatory model will come into force on July 1, following a 12-month transition period.

The new regulations mean that all FMT products must conform to a set of rules including inclusion in the Australian Register of Therapeutic Goods (ARTG), advertising prohibitions and requirements, and reporting of adverse events, as well as meeting relevant product standards. FMT products are mostly regulated as Class 1 or Class 2 biologicals, depending on the level of clinical governance, such as whether they are produced in a hospital, and the degree of manipulation.

Outside the ARTG listing, the TGA may grant approval of supply under “unapproved” product pathways such as clinical trials and special access.

Primary biliary cholangitis more common in lower latitudes

Primary biliary cholangitis is more common in southern latitudes of Australia, according to new research that suggests it shares a similar underlying cause as other autoimmune diseases  such as multiple sclerosis.

A study based on pathology results and prescription data found the prevalence of PBC to be significantly positively associated with latitude, with Tasmania having up to 2.5  higher rates than Queensland. Further studies are needed to determine whether factors such as variations in ultraviolet radiation exposure and/or vitamin D levels are responsible for this observation, said researchers from the Department of Gastroenterology, Austin Hospital, Melbourne.

Their findings are published in Clinical and Translational Gastroenterology..

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