Codeine upscheduling ‘unnecessary over-regulation’

The Australian Self Medication Industry says it is extremely disappointed with the Federal Government Scheduling Delegate’s interim decision to up-schedule over-the-counter cough/cold medicines and analgesics that contain codeine to Schedule 4 (Prescription Only).

“The vast majority of consumers use OTC codeine containing products appropriately and there is no evidence of misuse of codeine containing cough/cold products,” says ASMI CEO Deon Schoombie.

“ASMI has therefore been advocating for retention of the current classification of OTC codeine-containing products. This interim decision is an example of unnecessary over-regulation.

“Pharmacists are required by law to determine whether it is appropriate to supply over-the-counter analgesics containing codeine and this decision disregards the expertise of pharmacists and their important role in the frontline of primary care.

“We are concerned that restricting access to these medicines will have unintended consequences for consumers, who will now be required to visit a GP or emergency department to access medicines for minor self-limiting conditions instead of being able to get them from a pharmacy.

“It will also increase the workload of doctors and create greater inefficiencies in an already over-strained primary health system.”

Dr Schoombie says ASMI strongly supports the appropriate and responsible use of all medicines and a Schedule 4 entry is no guarantee against misuse or abuse of a medicine.

A Macquarie University study found that if S3 analgesics were up-scheduled to Prescription Only the cost to the economy would be substantial, he says.

“Faced with the scenario of their S3 analgesics no longer being available over-the-counter at their local pharmacy, the research indicated that consumers would go to their doctor to continue to access their preferred medication. Only a quarter of respondents said they would use another OTC alternative.

“Over the counter analgesics containing codeine make up 22% of the volume of analgesics sold in pharmacies and the decision to up-schedule will increase healthcare costs by at least $675 million annually.”

He says the estimated direct cost to Medicare for additional doctor’s visits would be $170 million per annum and consumers would pay an additional $70 million each year. The indirect costs of lost productivity and delayed treatment are over $400 million, says Dr Schoombie.

“This is an under-estimate of the true cost impacts of the interim decision as these figures do not include the costs of up-scheduling cough/cold products.

“This is a huge additional cost for the government at a time when they are evaluating healthcare expenditure and also to consumers.”

The proposed implementation date is 1 June 2016, which Dr Schoombie says is “totally unrealistic”.

“It does not allow industry time to develop accessible alternatives and for consumers to become aware of their market choices,” he says.

“We believe the decision requires a regulatory impact assessment, given the expected depth and breadth of the impacts. Until a final decision is made we will continue to work with stakeholders to ensure they are aware of the need for consumers to access these products appropriately.”

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