The long-awaited decision on the rescheduling of codeine-containing medicines may not be revealed anytime soon.
In response to questions from AJP Daily, a Department of Health spokesperson said: “The TGA is still considering the numerous submissions and advice from the March 2016 meeting of the Advisory Committee on Medicines Scheduling.
As such we are not able to advise a date for any announcement”.
The most recent advice from the Department was that a decision was expected by the middle of this year.
At the time this decision is made the delegate will also announce the timetable for any implementation, which will not be before 2017, the spokesperson said.
A decision on the controversial rescheduling of codeine to S4 was previously expected by May, following a safety review, Department of Health officials had said.
Appearing before the Senate Community Affairs Committee in February, 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.
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.”
I response to the latest news, a spokesperson for the Pharmacy Guild of Australia said “the guild has made clear its position on how up scheduling medicines containing codeine will adversely affect patients and the TGA has a large number of submissions to examine before announcing its final decision”.
The spokesperson added that the strong uptake of the Guild’s MedsASSIST program by community pharmacies – and its wide acceptance by consumers – showed that this real time reporting and recording program helped to “identify at risk patients whole ensuring patients who need codeine based medicines to treat medical conditions have safe access to these medicines.”