Rescheduling review announced by department as May decision date looms
A decision on the controversial rescheduling of codeine is expected by May 2016, following a safety review, Department of Health officials have revealed.
Appearing before the Senate Community Affairs Committee earlier this month, Adjunct Professor John Skerritt, deputy secretary of the department’s Regulatory Services Group said “we would expect a decision to be made by about May” when quizzed about the postponed rescheduling of codeine containing medicines.
Such was the controversy over the initial recommendation to reschedule these products that an independent review has been commissioned “over the next six to eight weeks” to look at codeine safety and efficacy, especially at lower doses, he said.
The Department officials noted the “sheer number of submissions “ received in the consultation process since the rescheduling decision was deferred in November 2015 was “unusual”.
The majority of these were not in favour of reclassification Prof Skerrit said, although both the AMA and the Royal Australian College of General Practitioners supported the upscheduling process.
When asked by Senator Katy Gallagher (ALP, ACT) if the feedback was split into “doctors versus pharmacists”, Prof Skerritt said it was “very broad….. the range of views was highly polarised.”
The next meeting of the TGA Advisory Committee on Medicines Scheduling would be held in mid to late March to “review the state of play, including further safety studies, and then a recommendation will be made”, with an interim decision by the department’s delegate in May.
Regardless of the final decision, any change would not take place until 2017 “at least 12 months” after the decision due to the existing levels of stock in the supply chain, and the need to relabel a “significant number of products,” he said.
Prof Skerritt said the upcoming review will examine whether OTC codeine is any more efficacious for pain relief that other products – such as a paracetamol and ibuprofen combination, or paracetamol alone.
A number of submission had argued for splitting the decision, with low-risk cough and cold codeine-containing medicines to remain OTC, he said.
The Pharmacy Guild of Australia recently kicked-off trials of real-time recording and monitoring of codeine-containing medicines, with the hope that the resultant data would feed into a case for the safety of these products.