From this month, Australians will need a prescription to buy any medicine containing codeine. This won’t be news to many readers: commentary about the “up-scheduling” of these analgesics from Schedule 2 (pharmacy only) to Schedule 4 (prescription-only) has reached fever pitch over the past few weeks. Despite the furore, though, the need for change was clear.
Late last month, addiction experts Darren Roberts and Suzanne Nielsen summarised what we know about Australians’ use and misuse of over-the-counter codeine-containing medications. “In 2013, more than twenty-seven million packs of codeine-containing analgesic products were supplied by pharmacies, and 56 per cent of these sales were over-the-counter without a prescription,” they wrote in the Australian Prescriber. “National sales data show that over-the-counter codeine-containing analgesics account for 37 per cent of all opioid purchases in the community.”
Back in 2014, 2.7 per cent of Australians sought help for opioid addiction. By 2016 the figure was 4.6 per cent, and there is evidence that low-strength over-the-counter medications have contributed to the rise. A Sydney study reported that codeine was “the sole substance used by 39 per cent of patients with a pharmaceutical opioid dependence,” Roberts and Nielsen write. Of those patients, 83 per cent were using only over-the-counter codeine.
That’s a lot of packets of low-dose codeine and its potentially toxic (if taken to excess) co-formulated ingredients, including paracetamol, aspirin and ibuprofen.
Roberts and Nielsen provide some of the history of the codeine rescheduling, and give advice for identifying and assisting people whose addiction is unmasked by the shift to prescription-only supply. They help explain why the decision of the Therapeutic Goods Administration, or TGA, has been backed by peak medical bodies including the Australian Medical Association, the Royal Australian College of GPs, the Royal Australasian College of Physicians, the Rural Doctors Association of Australia and Painaustralia. Also on board is the Consumers Health Forum of Australia, which has released a set of six storycards to encourage discussion and provide information about pain-relief options under the new rules.
The up-scheduling comes after an eighteen-month consultation by the TGA and a further twelve months’ lead time after the change was announced. Despite the preparations, which include television advertisements explaining the change, the national conversation about the new rule has been dominated by concern about what might happen when consumers find their access to these analgesics blocked.
The Australian’s Sean Parnell reported on Tuesday that NSW health minister Brad Hazzard (who has never been a fan of the up-scheduling) was concerned that people wanting codeine would flock to the state’s overcrowded emergency departments. On the same day, federal health minister Greg Hunt faced a surprisingly confrontational interview on Radio National Breakfast, in which presenter Fran Kelly told him, “People are furious. I’ve never seen such angry texts as on this topic.”
Scattered reports suggest that some people might have been panic buying or stocking up on codeine products ahead of the scheduling change.
The Pharmacy Guild of Australia, which opposed the up-scheduling — citing concerns about access for people with a legitimate need for acute pain relief, and the capacity of the medical system to deal with the increased demand for consultations and prescriptions — closed down its real-time monitoring of over-the counter codeine prescriptions in January. The voluntary database, to which just over 70 per cent of pharmacists submitted codeine purchasing information, had identified potential dependence issues in about 3 per cent of transactions, although the 30 per cent non-participation rate makes this finding difficult to interpret.
Pharmacists also featured in a surprise announcement from federal health minister Greg Hunt that the government would provide $20 million to pilot a Pain MedsCheck scheme, in which pharmacists would “assist patients who are taking medication to deal with on-going chronic pain of three or more months.” The lack of detail about the trial and the lack of consultation with medical bodies guaranteed a hostile response in some quarters, with Australian Medical Association president Michael Gannon describing it as “a slap in the face for GPs.” But the initiative was welcomed in a joint statement from Painaustralia and the Consumers Health Forum of Australia.
Rather than “bracing themselves” for a “stampede” of patients requesting pain medication, as they have reportedly been told to do, the GPs who have spoken publicly are fairly sanguine about the scheduling change, saying that it will provide an opportunity to identify patients with poorly managed chronic pain and associated conditions.
“I don’t think the rescheduling will have a big effect,” one GP told me. “It is an opportunity for doctors to find out what patients are taking. A small group of people who have been self-medicating for chronic pain will get better treatment. Others, who have used over-the-counter codeine preparations occasionally and infrequently, will be inconvenienced.”
Drug abuse has multiple causes, said the GP. “People with entrenched opioid addiction will probably not be deterred by this change. They’ll doctor shop until they find someone who’ll write the script or find somewhere else to get it. Unless we have real-time prescription reporting and better ways to manage addiction, I don’t think much will change.”
So what happens next? Plans for a national electronic prescription-monitoring system, which stalled about five years ago, have been revived. The government announced last year that it would invest $16 million to roll out the system, which both medical and pharmacy peak bodies have repeatedly called for.
Emergency physician David Caldicott told the Guardian that he believed opioid restrictions should apply “across the board,” not just to over-the-counter preparations, but that any changes should be followed up to guard against unexpected consequences. He expressed support for a national real-time monitoring system for patients prescribed opioids and other drugs of addiction.
Caldicott went on to suggest that medicinal cannabis could be a useful analgesic for patients at risk of “falling through the cracks” and turning to other drugs and illicit substances. In the Australian Prescriber, Roberts and Nielsen suggested that training GPs in the use of opioid substitution treatment for patients with addiction could be considered.
Whatever happens next, the rescheduling of codeine to prescription-only feels like a beginning rather than an end. A study that made headlines last year revealed that, in 2012, accidental deaths from prescription opioids far exceeded deaths from heroin overdose in Australia. Australia is undoubtedly part of the global prescription opioid addiction epidemic.
The TGA recently issued a discussion paper outlining a range of options for regulatory responses to strong (Schedule 8) prescription-only opioid use and misuse in Australia. More regulation won’t work on its own, but it’s one tool the government can use to limit the supply side of the equation.
A recent article from the US observed that the prescription opioid epidemic has its origins in the 1990s, when a desire to relieve pain and suffering led to the use of strong opioids for non-cancer pain, with pharmaceutical companies fuelling the market. In Australia in 2018, the up-scheduling of codeine provides a much-needed focus on the dual aims of relieving pain and preventing addiction. •
• A thorough guide to the scheduling changes, for both health professionals and consumers, can be found on the Therapeutic Goods Administration’s website. Of particular interest is the document reviewing the safety and efficacy of over-the-counter codeine combination medicines.
An earler version of this article appeared in Croakey.
