The proposed rescheduling of OTC codeine: Part I

In this series of posts we will look at the recent proposed changes to the scheduling of codeine containing medicine. In part II we will examine the independent research commissioned by the Guild that highlights the costs of the proposed rescheduling. In the third and final part of this series we will look at industry reactions and plausible alternatives.

PART I: TGA proposed changes to OTC codeine medicines

In October the Therapeutic Goods Administration (TGA) Advisory Committee on Medicines Scheduling announced it was conducting a review into the current scheduling of low-dose codeine based medicine with the view of stopping OTC codeine sales. This would mean that many common cold and flu medicines as well as low dose codeine analgesics would no longer be available without a prescription. The proposed changes drew a huge number of submissions from industry stakeholders, with the vast majority against the proposals.

Since then the TGA has announced that any final decision on the matter would be referred to an expert advisory committee. This delay will allow time for the submissions and other information to be reviewed comprehensively. No ruling will be made before 23 June 2016 and hence any changes would not become effective until 2017. (ref)

While the delay means that there will be no changes in the near future to the way we access OTC codeine containing medicines, it is helpful to understand the background on this matter as well as some of the industry responses.

Current scheduling of OTC codeine medicines

Currently common lower dose codeine containing medicines, such as cold & flu treatment and analgesics are:

– Up to 10mg of anhydrous codeine – Schedule 2: available in pharmacy only; and

– Up to 12mg of anhydrous codeine – Schedule 3: subject to the mandatory oversight of a pharmacy and must be kept in a section of the pharmacy that is not available to the public.

The TGA proposal considers lifting all these low dose, OTC codeine based products to Schedule 4. This would mean patients would need to 1) visit a doctor to receive a script, and 2) take the script to be dispensed at a pharmacy. (ref)

The TGA has proposed that all OTC products should be available as prescription only.

The TGA has proposed that all OTC products should be available as prescription only.

There is currently no requirement for a pharmacist to record sales of OTC codeine containing medicines. There are concerns that this enables patients to obtain medicines unsafely and without the oversight of a healthcare professional.

The TGA review was announced in response to a rise in the number of illnesses, cases of dependency and overdose deaths, as a result of certain medicines. Codeine containing products are often implicated in these statistics. Codeine is a medicine that come with a significant risk of addiction and can also lead to patients turning to stronger prescription medicines and even illicit drugs. Readers that have previously visited the MediSecure DrShop blog will be well aware of the huge escalating prescription medicine addiction and overdose crisis that Australia is facing.

Despite the industry wide concern about the growing rates of prescription medicine and OTC codeine addiction, there has been very mixed responses to the proposal by the TGA. Many experts and industry stakeholders argue that the majority of patients take OTC codeine based medicines responsibly and without risk of addiction.

Concerns with the proposals

One group that has been particularly concerned with the TGA suggestion to require a prescription for OTC codeine medicines is the Pharmacy Guild of Australia. The Guild has expressed worry that limiting medicines available over the counter would not actually help to curb rates of addiction, but would create more work and bring huge costs to the MBS and PBS. To substantiate this view the Guild commissioned independent research to show the costs to taxpayers.

The Guild engaged an independent firm, Cadence Economics, to conduct an economic analysis the results of which show that changing OTC codeine products would bring about significant increases in costs and demands on healthcare professional’s time. The Guild will use this analysis to highlight that real time monitoring would be a far more cost effective way of tackling Australia’s growing medicine abuse and overdose crisis.


In the next section of this post series we will look at the findings in the Cadence Economics report in detail. Keep following us for the next instalment.

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