Heffernan blasts TGA on codeine

David Heffernan. Image: Twitter
David Heffernan. Image: Twitter

A Guild state president has vowed to continue the fight on codeine and praised the recent NZ downscheduling decision

Pharmacy Guild NSW Branch president David Heffernan has queried the validity of the TGA’s reasoning and the unanimity of state decision-makers over the low-dose codeine upschedule, in the latest edition of the branch’s bulletin to members.

“Once upon a time, when a drug left the warehouse it was out of the TGA’s jurisdiction; scheduling laws are the domain of the states,” Mr Heffernan writes.

“Yet, as a means of cross state and territory harmonisation, the TGA gives its scheduling recommendation which the state and territories will default to – but they don’t have to.

“Further to this, since the RU486 debate, health ministers are petrified of enacting ministerial intervention when it comes to the licensing of therapeutic goods. This gives the TGA a lot of power.

“We all know the TGA was heavily involved with briefing the state and territory Chief Pharmacists and equivalents. However, it is our understanding that the NSW Poisons Advisory Committee was against upscheduling and put in their own submission stating their position.

“The question must be asked: how could the recommendation of all state and territory Chief Pharmacists be unanimous, as stated frequently in the media?

“Did the NSW delegate go against the recommendation of their own advisory committee?”

He also praised the decision of New Zealand’s decision on the scheduling of codeine, and compared its reasoning favourably to that of the TGA.

New Zealand’s Medicines Classification Committee recommended that preparations containing codeine as the single active ingredient be downscheduled to a non-prescription pharmacy schedule (“restricted” medicine).

However, it also recommended low-dose codeine combination products be upscheduled from restricted to Prescription Only.

“This shows that the New Zealand regulator has put patients first and followed the science,” Mr Heffernan writes.

“Furthermore, the decision is devoid of the disingenuous nomenclature residing in the TGA document where ‘codeine related deaths’ is articulated, as opposed to deaths from paracetamol or ibuprofen.

“Any pharmacist could tell you that it is not codeine in combination products that is most likely to kill you – it is paracetamol and ibuprofen.

“From the start, the TGA set out to frame the issue around chronic pain, divert attention away from prescription deaths and paint pharmacists selling OTC codeine containing products as the problem.

“In the process they have prevented a world class real-time monitoring system.

“By framing the issue around chronic pain, they have completely ignored acute pain and have left a big proportion of the population with no choice but to use inferior products or visit a GP.”

He says that once the changes are implemented, including the introduction of a real time monitoring system, New Zealand’s OTC regulations will be among the most robust in the world.

Mr Heffernan also praised the efforts of pharmacists who spoke out about the upschedule in mainstream media in January.

A significant number of pharmacists appeared in state and local media to express concerns about the upschedule, particularly regarding access to analgesics for the treatment of acute pain and in areas where there are limitations on GP access, and regarding a lack of real time monitoring now MedsASSIST is defunct.

“We are heartened by the passion and fortitude of members across our great state, promoting our profession through the codeine debate,” Mr Heffernan writes.

“From Broken Hill to Balmain, in print and airwaves, proud pharmacists have been taking on the absurd reasoning in the TGA decision.

“As one Chief of Staff of a NSW Minister said, ‘I have never seen a decision where the public are so angry, and yet the decision still stands’.”

Mr Heffernan says pharmacists are likely to feel “bitter” about the upschedule and warns that there will be “much anger” to be faced over the coming months and beyond.

He says that “the battle is not over” and that the NSW Branch, together with the NSW Branch of the PSA, will continue to push for the implementation of a “Prescription – except when” protocol.

“We believe the sledgehammer approach by the regulator may present more problems than it may fix, and we will continue to strive for better health policies both in NSW and federally.”

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