ASMI calls for a package of targeted measures for OTC codeine medicines
16 October 2015 –
The Australian Self Medication Industry (ASMI) said proposed changes to the scheduling of over-the-counter (OTC) codeine-containing medicines will not adequately address issues of misuse and addiction.
Instead, a package of targeted measures, including a mandatory real-time monitoring system, could potentially find the correct balance between the risks and benefits of access for the vast majority of consumers who use these medicines safely and effectively. In its supplementary submission to the Federal Government, ASMI argued for the deferment of the decision on the scheduling of OTC codeine medicines for 12 months to allow time for the implementation and impact assessment of a real-time monitoring system in community pharmacy.
Steve Scarff, ASMI Director Regulatory and Scientific Affairs, said:
“A real time monitoring system would help pharmacists to determine if the supply of a medicine is appropriate. The system would assist pharmacists to identify at-risk consumers, facilitate access to education materials and support referral to a pain specialist when necessary.
“The industry, pharmacy and consumer groups have jointly developed a prototype, which could be quickly implemented in community pharmacies nationally.
“ASMI believes the real-time monitoring system should be part of a package of measures, including front-of-pack warnings about the risk of codeine addiction and information/training resources for pharmacists and consumers,” he added.
In its submission ASMI also calls for comprehensive examination of the impacts of the scheduling decision in the form of a Regulation Impact Statement, and reform of the current Scheduling Policy Framework to address its well documented limitations.
New figures reveal significant costs of up-scheduling codeine containing cold/flu products
15 October 2015 –
The Australian Self Medication Industry (ASMI) said the interim decision to up-schedule codeine-containing cold/flu medicines to Schedule 4 does not make public health or economic sense.
New figures1 reveal that up-scheduling codeine-containing cold/flu medicines would cost the Australian economy $257 million annually.
Costs borne by government due to increased doctor visits, Medicare and dispensing costs would be $53 million each year and there would be a further $174 million cost due to productivity losses caused by the restricted access.
The balance of costs would be borne by consumers. ASMI Director Regulatory and Scientific Affairs, Steve Scarff, said:
“There is no evidence that cold/flu medicines are being misused so it does not make sense to up-schedule them.
It represents an inappropriate use of regulation and is not proportionate to the level of risk.
“Up-scheduling cold/flu medicines will make it harder for consumers to access these products, delay treatment, increase out-of-pocket costs and result in more time lost from work due to illness.
“It doesn’t make economic sense either as it will increase government healthcare costs at a time governments are searching for cost savings in the health budget.
“No evidence has been put forward of actual or potential misuse of cold and flu products and so the decision to reschedule from Schedule 2 to Schedule 4 cannot have been made with a proper regard to section 52E of the Therapeutic Goods Act.
“ASMI calls on the Delegate to re-examine the interim decision to up-schedule codeine-containing cold/flu medicines. The current scheduling of these products remains appropriate and there should be no change to the scheduling of them.
“Furthermore, an implementation date of 1 June 2016 is not achievable given long lead times in the supply chain due to the seasonal nature of these medicines. Many manufacturers have already started building cold/flu stock for the 2016 winter season, so a June 2016 transition is not feasible. A sufficient transition period is necessary to allow sponsors to source new ingredients, register, manufacture and distribute alternative products,” he added.
1. Figures calculated using Macquarie University Consumer Fact Book data (March 2015) and publically available data on unit costs
ASMI thanks Martin Cross
13 October 2015 –
The Australian Self Medication Industry today thanked Martin Cross, Chairman of Medicines Australia, for his immense contributions to the pharmaceutical industry. Deon Schoombie, ASMI Chief Executive Officer, said:
“Martin has demonstrated a long-standing commitment and dedication to the pharmaceutical industry in several roles over many years.
“We will remember Martin as a person who could clearly articulate the contributions and issues of the pharmaceutical sector with great clarity and conviction.
“We wish him all the very best for his future,” added Schoombie.