We want to know what you think about the decision to upschedule codeine… have your say here
Over-the-counter medicines containing codeine will be upscheduled from 1 February 2018, the TGA announced this week.
In response to the decision, several readers have voiced their concerns regarding MedsASSIST.
And consumers groups have come out saying that the decision to upschedule codeine medications highlights the need for more effective pain management services.
Meanwhile, the RACGP has said the rescheduling decision will save lives.
But we’d like to hear more from you about what you think. Vote in the poll and let us know your thoughts.
For the first time in my career I disagree with Ron Bagatol; a difficult call. Pharmacists are adequately trained to correctly prescribe and manage the sale of codeine as long as there is a mandatory RTMS in place. I do not believe that doctors/physicians are better qualified to prescribe it & only see enormous costs heaped onto the health care system and thence to patients where their needs are appropriate. While there are alternate analgesics to codeine, they are already prescription only with a safety profile more worrying. I acknowledge that there is a world wide problem with codeine abuse; as with alcohol, tobacco, recreational drugs etc. Perhaps doctors should prescribe all instead of cherry picking. Removing codeine is altruistic and the decision by the TGA demeaning to pharmacists. The referral system for chronic pain between pharmacist and doctor works well & should not be corrupted by codeine removal.
“Correctly prescribe and manage the sale of codeine” ?? The AMH says: “Codeine is not recommended” and “there is no conclusive evidence that products containing 8-15mg of codeine with aspirin, paracetamol or ibuprofen have any benefits over those non-opioids alone.”
That rather strongly implies to me that codeine has little place in pain therapy at all, let alone as an OTC choice. The prodrug codeine is metabolised to morphine. Would the TGA approve a combination morphine analgesic for OTC sale were it to be marketed today? It would be Schedule 8.
Codeine has been grandfathered into today’s health system. There is no inalienable constitutional right to codeine access, as has been implied by many commentators on this issue.
I agree with a few points, and disagree with others.
First, lack of evidence that something doesn’t work isn’t the same as the evidence showing a lack of effect. This is a point ma y lose track of.
While research of the size and quality needed to conclusively provide such evidence is driven by commercial pressures, that research will never happen.
There are many products in AMH and on our shelves with very vague evidentiary backgrounds.
I agree with removing them if they don’t work – the arguments have all been mixed “they cause harm” but “they have no effect”…. How can both be true?
I’m of the opinion these will die out now anyway – while GPs have been happy to recommend them to patients without scripts forever (which doesn’t show up in data of how they are utilised) they won’t prescribe them. Patients who now need a script will pressure their doctors for PBS items.
Interestingly I could vote in this poll and view the results WITHOUT being logged in…. sigh.
Any discussion is a moot point now.
Like many other situations where we have been custodians of scheduled medicines, too many of us have not done the job properly. Too often I witnessed “have you had it before” and “take it after food” as the only input to a sale which was largely handled by non-qualified staff and never refused. Shame; once again we have shot ourselves in our collective feet.
Time to buy shares in maxigesic.
What was disappointing with this decision was the regulatory impact statement, and therefore the economic modelling undertaken by KPMG did not consider a mandatory real-time monitoring system.
In the scenarios considered for the Regulatory Impact Statement that informed the TGA’s decision the following scenarios were considered (these can be accessed from; https://www.tga.gov.au/publication/regulation-impact-statement-codeine-re-scheduling )
Scenario 1: No change to the status quo.
Scenario 2: Schedule 2 and Schedule 3 entries for codeine to be amended to reduce the pack size to not more than 3 days’ supply and include a label warning that codeine can cause addiction.
Scenario 3: The current Schedule 2 entries for codeine in cough and cold preparations to be up-scheduled to Schedule 3. All Schedule 3 entries to be amended to reduce the pack size to not more than 3 days’ supply, and include a label warning that codeine can cause addiction.
Scenario 4: Schedule 2 and Schedule 3 entries for codeine to be up-scheduled to Schedule 4.
The Regulatory Impact Statement supported by the economic modelling found that
“only Scenario 4 (Options 4 and 6) results in a net benefit to society. The economic benefits are driven by gains in quality of life, deaths prevented, and net financial savings to consumers;…. This scenario also delivers a net economic benefit to society significantly greater than any other scenario.”
Neither the Guild, or a number of other stakeholders who opposed the up-scheduling of codeine advocated for any of scenarios 1 through 3 at all or in isolation. The Guild was clear that it supported a mandatory real time monitoring system, and advocated to each State and Territory Department of Health or equivalent for such a system to be mandated for supply of over the counter codeine.
It is extremely disappointing that the TGA did not even have a real-time monitoring system, let alone a mandatory system included in its scenarios for consideration and comparison with the economic modelling and regulatory impact statement to inform its final decision.
Anthony Tassone
President, Pharmacy Guild of Australia (Victoria Branch)
This makes me even more furious, because it is assuming without evidence that option 4 has greater capacity for harm reduction, when it doesn’t.
Ian Carr has hit the nail on the head and put forward the only argument that should matter to an evidence based profession which I assumed (?) pharmacy was………….there is NO evidence that low dose codeine has a therapeutic role and the risk:benefit is not compatible with any method of supply……….the best outcome would have been for TGA to remove codeine from Register of Therapeutic Goods…….as Ian notes such a crappy,unpredictable drug would surely not be approved in 2017!!