Pharmaceutical lobby groups may delay codeine ruling

The Therapeutic Goods Administration's Advisory Committee on Medicines Scheduling in October last year made an interim decision to remove codeine-containing products from over-the-counter sales from June this year, citing growing evidence of codeine-related harm.

Recent research has shown the rate of Australian deaths linked to codeine more than doubled from 2000 to 2009, up from 3.5 per million people to 8.7 per million people, most of which were due to "poly-drug use".

Numerous health experts have said codeine was a weak but addictive drug, while the paracetamol or ibuprofen it is often combined with does relieve pain, but can also cause internal injuries and potentially death in abusers.

While the authority's final decision was originally scheduled to be made last November, it was delayed after an "unusually large" rush of public submissions after the October interim decision.

Several submissions, including those from the industry, argued for reduced pack sizes, new warning labels and a trial of real-time monitoring of sales at pharmacies, which is now under way and is seen by many stakeholders as the middle ground between the current situation and the advisory committee's interim decision.

But the authority has not updated the public on the process since March.

Last November the authority quietly bowed to a push from the Pharmacy Guild, the Pharmaceutical Society of Australia and the Australian Self Medication Industry to complete a "regulation impact statement" (RIS) of the interim decision.

It was the first time the TGA has referred any Advisory Committee on Medicines Scheduling decisions out for such an assessment.

The three lobby groups simultaneously called for the RIS in October last year, arguing the change would have "widespread implications" and claiming it could cost the government more than $300 million, largely in increased GP visits to obtain prescriptions.

"This decision represents unnecessary over-regulation and will result in a huge increase in costs for both consumers and government," the ASMI submission reads.

But several other health sector groups, including the Royal Australian College of General Practitioners and Australian and New Zealand College of Anaesthetists, have argued for the interim decision to be upheld.

The RACGP also argued that "codeine-based over-the-counter medications are "big business" and as a result there is likely to be significant pressure to resist rescheduling these medications".

If approved, the committee's interim decision could affect codeine product sales the industry has estimated was worth about $215 million annually in Australia.

While patient safety, abuse potential and public health were the committee's key considerations, the RIS process focuses on the potential financial costs and demands government agencies justify "why there is a legitimate reason for government to intervene".

Despite the delay, the authority spokeswoman said that "not all aspects of the RIS may be considered by the delegate when making a decision" and once the RIS was completed, "the delegate will make a decision".

"Decisions are made in line with the criteria outlined in the act and broadly take into consideration safety, potential for abuse and any other matters necessary to protect public health," the authority spokeswoman said.

Australian and New Zealand College of Anaesthetists' Dean of the Faculty of Pain Medicine, Dr Chris Hayes, said he supported the real-time monitoring trial and he was concerned that rescheduling could "shift the problem" from pharmacies to doctors surgeries.

But he also said the RIS move was "concerning" and "an odd one", adding it was "a very complicated issue and we know there are a lot of vested interests involved".

Public Health Association of Australia chief executive Michael Moore said the final decision "ought to be about the greatest health benefits for the greatest number of people with the least amount of harm".

"I think there's a fine balance in pharmaceuticals between industry profits and what's the most effective way to deliver pharmaceutical goods to the consumer, it ought not to be just about how that effects industry or jobs," he said.

A Pharmacy Guild spokesman said the guild called for the RIS because there was "a clear need for the government to undertake a formal RIS as that would consider the wider implications of such an up-scheduling on consumers, manufacturers, pharmacies and doctors".

Neither the guild nor ASMI would answer questions on whether the RIS proposal was a coordinated effort. The PSA did not respond to Fairfax Media's questions.

The guild's real-time monitoring trial, MedsAssist, is now operating in more than half the nation's 5500-odd pharmacies, with the guild reporting 53,000 "instances of non-supply" of codeine products as a result.

"The strong evidence emerging is that it is not necessary for the government to re-schedule codeine-containing medicines to prescription only," the guild spokesman said.

ASMI regulatory and legal director Steven Scarff said the RIS process had been used for other authority decisions, including major regulatory changes to medicine labelling and "harmonisation" of laws with overseas agencies.

But he could not identify any other rescheduling decisions that ASMI had urged be subject to an RIS.

The authority spokeswoman said the TGA anticipated the RIS "will be published by the end of this calendar year".

Clarification: The Australian and New Zealand College of Anaesthetists' Faculty of Pain Medicine has clarified that the faculty supports "medical prescription only for codeine". "We note that trials of real-time monitoring are underway and we will be interested to see the results."

Codeine: use and misuse in Australia

Health and addiction experts are most concerned about drugs containing codeine combined with either paracetamol or ibuprofen.

The key concern was that codeine was an addictive but weak analgesic, while the paracetamol oribuprofen was an effective pain reliever, but came with risks of internal injury or potentially death at high doses.

The TGA recommends people take no more than 30 to 60mg codeine every four hours – or up 240mg daily – for no more than three days in a row.

In 2013, 27,780,234 packs of codeine were sold in Australia, or 12,376 kg of raw codeine.

Over the counter sales accounted for 55.8 per cent of those sales – or 15,490,207 packs.

In 2013, sales of unit packs of codeine exceeded that of all other opioids, accounting for almost two-thirds of all opioid packs sold.

Those sales were usually higher in rural and regional areas of the country, likely due to a lack of health services compared to capital cities.

From 2000 to 2009, the overall rate of codeine-related deaths in Australia more than doubled, from 3.5 per million in 2000 to 8.7 per million in 2009.

Of those codeine-related deaths 83.7 per cent were the result of multiple drug toxicity.

In Australia, average consumption of opioid analgesics has risen from about 3250 units per million people per day over the years 2001-03 to 13,440 per million people per day over the years 2011-2013.

Australia was the third highest per capita consumer of opioid analgesics in 2011, after Canada and the US.

Sources: National Drug and Alcohol Research Centre, International Narcotics Control Board, Medical Journal of Australia.