TGA’s independent ruling on codeine is the right one
AMA President Dr Michael Gannon has strongly condemned the Pharmacy Guild of Australia for its “irresponsible and unprincipled lobbying of State and Territory Governments” aimed at undermining the independent Therapeutic Goods Administration (TGA).
The TGA has ruled that codeine will become a prescription-only medicine from February next year.
The AMA has welcomed that decision, saying codeine can be a harmful drug if misused.
But the Guild, which represents pharmacy owners, is against the TGA ruling and has lobbied State and Territory governments, calling for codeine to continue to be available over the counter.
Patient advocacy groups such as the Consumers’ Health Forum and Pain Australia support the decision; other groups publicly supporting the TGA include the Rural Doctors’ Association, the Royal Australian College of Physicians, the Royal Australian College of General Practitioners, and the Australasian Chapter of Addiction Medicine.
State Governments appear to have buckled to the Guild’s strong-arm lobbying.
Dr Gannon said any such move to “get around” the TGA – an independent federal body – would put patients’ health at risk.
“It is essential for public safety that the TGA makes evidence-based decisions about medicines, free from political interference and sectional interests,” Dr Gannon said.
“As doctors, we rely on the independence and expertise of the TGA to ensure Australians have access to safe, effective, and high quality medicines.
“There is compelling evidence to support the decision to make codeine prescription-only. Deaths and illness from codeine use have increased in Australia.
“A 2016 survey showed that 75 per cent of recent painkiller or opioid misusers reported misusing an over-the-counter codeine product in the previous 12 months. Tragically, the survey showed these products were even more likely to be misused by teenagers.
“Under the new arrangements, patients who have short-term pain will still have access to alternative over-the-counter painkillers, which are more effective than low-dose codeine, but without codeine-associated health risks.
“It is better for patients with chronic pain to manage it with doctors’ advice on appropriate medicines and non-medicine treatments. Self-treating long-term with codeine is dangerous.”
When the TGA announced its decision, the AMA warned that some groups would put self-interest ahead of patients’ best interests by using highly-paid lobbyists to influence or coerce State Governments to change, delay, or dilute the impact of the TGA decision.
Dr Gannon said that fear was realised when the Guild announced in early October that it had won support from the NSW Nationals, and then most other State and Territory Governments wrote to the Federal Minister expressing concern about the upscheduling.
The AMA fully supports the independence of the TGA in making decisions about medicines scheduling and will actively support the TGA codeine decision by intensifying its efforts to work with all governments to respect and uphold the evidence-based rulings of the highly-respected independent regulator.
“We will be urging the Pharmacy Guild and others groups who seek to undermine the TGA to reconsider their actions and put the health of Australians first,” Dr Gannon said.
“The AMA supported the independent scientific advice of the TGA – the authority that’s responsible for determining which medications come in, how they come in, and how they’re made available.
“They looked at the science, looked at the increasing understanding of the risks of codeine use, made a determination, and gave that advice to Federal Health Minister Greg Hunt, who agreed, with the full support of the AMA.
“And, we thought, with the support of the Pharmacy Guild, the Pharmaceutical Society, and certainly other medical bodies like the College of GPs, and the College of Physicians.
“Australia would join the situation in roughly 25 other countries that you need a script to get codeine.
“But we have now seen the Guild going out and doing what they’re good at – lobbying politicians hard. They’re very well resourced, but they’re wrong on this.
“The AMA will continue to make the case that the TGA has made the right decision. It’s long overdue. Codeine is a harmful drug. And do you know what? It’s not even that good a painkiller. There are better alternatives.”
The Committee who reached the decision was comprised of medicines experts – including pharmacists.
The Guild claims that it is not seeking to overturn or disregard the TGA decision, yet it has taken every opportunity to criticise the ruling to upschedule codeine to prescription-only.
The Guild alleges it is only wanting a “part reversal” of the decision, but its lobbying suggests otherwise, and has sought to link the decision to upschedule with prescription monitoring.
Dr Gannon said that the Guild was being “a bit too cute” for his liking.
“I’d like to know exactly what they mean by a part reversal,” he said.
“We should be reassuring the public that they can buy more effective and safer over-the-counter medicines at their local pharmacy. Their short-term acute pain will be eased without codeine. Instead, the Guild is claiming that people in rural areas without easy access to GPs will suffer. This is simply not true.”
“People with chronic pain should not be using over-the-counter codeine at all. People with chronic pain can be helped to manage it with doctors’ advice on appropriate medicines and non-medicine treatments. Self-treating with codeine is dangerous.”
Dr Gannon said if codeine was invented next week, it might struggle to get listed. When the harms it causes and its ineffectiveness at low doses are looked at, it might struggle to get on the formulary today.
“At low doses it’s no better than the standalone agents like paracetamol and anti-inflammatory, and at high doses it is increasingly a drug of abuse,” he said.
“So there’s no argument here. I’m not interested in GPs, other specialists, prescribing yet more and more codeine. The more we know about this drug, the more we realise that we should be looking for more effective and safer alternatives.
“I’ve written up codeine prescription for patients for a long time, up until about three or four years ago when I started to become apprised of the evidence. I’ve had to change my practice. That’s true of many, many other doctors and look, that’s what we do in the medical profession: we look to new robust evidence and we change our practice.
“Codeine is a drug that’s found in too many people’s systems. We’ve seen the Victorian Coroner’s report. Too many people are found with codeine in their body at post mortem examinations.
“This is a harmful drug. It’s hurting people, it’s killing people.”