ASMI fighting to turn around codeine upschedule: Steve Scarff

Upscheduling codeine-containing OTCs to prescription only would cause more problems than it would fix, writes Steve Scarff

ASMI is opposed to the interim decision to up-schedule OTC codeine medicines to Schedule 4 and we are fighting to turn this decision around.

The interim decision represents unnecessary over-regulation and will result in a huge increase in costs for both consumers and government. It will delay treatment and increase the difficulty for consumers of accessing medicines for self-limiting conditions such as cold/flu, migraine and dental pain.

While misuse and addiction are serious problems, the great majority of consumers use codeine containing analgesics appropriately. Furthermore, there is no evidence of misuse of codeine containing cold/flu products.

For the great majority, the interim decision will make these products more expensive and more difficult to obtain or may result in their disappearance from the Australian market.

Macquarie University estimated that up-scheduling OTC codeine-containing analgesics would cost consumers an additional $70 million per annum in out-of-pocket expenses1.

This figure underestimates the true cost to consumers given the interim decision to also up-schedule cold/flu medicines.

We already know that one in 10 people do not go to the doctor because of cost, and many people have difficulty accessing a doctor when they need to, so the decision to up-schedule would deny many people timely access to much needed pain relief and cold/flu medicines2.

Making all codeine containing products prescription only will not solve the problem of misuse and addiction; it will simply transfer it to already overstretched GPs and emergency departments of hospitals.

It will increase the workload of doctors and increase Medicare costs by at least $170 million each year1. This does not take into account additional PBS costs.

Prescription only scheduling is no guarantee against misuse or abuse and there are no mechanisms in place for monitoring of prescription-based purchases.

ASMI believes that a real-time-monitoring system is a high priority and should be put in place nationally. We have been working with pharmacy organisations and consumer organisations to develop a prototype system and believe it could be implemented in community pharmacy in a very short timeframe.

The real-time monitoring system should be part of a sophisticated response to this complex problem.

Such a system should be coupled with mandatory front of pack warning labels about the risk of codeine addiction; and training, guidelines and protocols, to allow healthcare professionals to identify consumers potentially at risk, to prevent medication misadventure and to provide opportunities for more appropriate care.

This system would be more effective and economical in assisting identification of at-risk consumers, facilitating access to educational materials, and supporting appropriate referral to pain specialists when required.

Improved collaboration between pharmacists, doctors and other services is needed to assist people at risk in a holistic manner by providing considered options for pain management or addiction care.

Inter-professional guidance and agreed referral pathways will facilitate identification and early intervention of consumers potentially at risk of harm.

ASMI’s next steps are to continue working with members and other stakeholders to advance ASMI’s position and continue to work with other like-minded organisations to implement a real-time monitoring system for S3 codeine containing analgesics (noting no such option is available for S4 products).

We are preparing a submission in response to the interim decision and are calling for a full and transparent examination of all the regulatory and financial impacts of this decision, before implementation.

Finally, the proposed implementation date of 1 June 2016 is completely unrealistic and ignores the practicalities associated with therapeutic goods supply chains (especially for products sourced overseas).

ASMI is urging the Federal Government to extend this timeframe if the final decision is to proceed with up-scheduling.


  1. Macquarie University. The value of OTC medicines in Australia. March 2014.
  1. Consumers Health Forum. Media statement: Taking codeine off the shelves only hides abuse problem, 2 October 2015.


Steve Scarff is the director, Regulatory and Scientific Affairs, Australian Self Medication Industry

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