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Regulation impact statement: Codeine re-scheduling
Version 1.1, December 2016
What is the preferred scenario?
Codeine is a commonly used drug of abuse, both internationally and in Australia. The presence of codeine in OTC combination analgesics and the development of codeine dependence contributes to severe adverse health outcomes associated with the overdose of other active constituents, such as paracetamol or ibuprofen. There is substantial evidence of harm from abuse or misuse of codeine-containing medicines, including deaths.
The medicines scheduling delegate of the Department of Health is considering several options to change the way codeine is made available in Australia by amending the Poisons Standard. Low-dose codeine is currently available OTC in pharmacies in cough and cold medicines (Schedule 2) and in combination with other analgesics (Schedule 3). High dose codeine and other opioids such as morphine and pethidine are either available only by prescription (Schedule 4) or are controlled drugs (Schedule 8). Several options have been considered, and are summarised in Table 1 (p. 37). These options are grouped into four scenarios in Table 2 (p. 38) representing the potential final scheduling decision.
Scenario 4, whereby all Schedule 2 and Schedule 3 codeine-containing medicines will be up-scheduled to Schedule 4, is the preferred option based on both public health considerations and net economic benefits, as discussed below.
Economic and regulatory costs or savings are not necessarily considered by the delegate under the Scheduling Policy Framework (SPF) and the scheduling regulatory framework as specified in Therapeutic Goods legislation. Scheduling decisions are made according to subsection 52D(2) of the Therapeutic Goods Act 1989 (TG Act) taking into account the following matters of public health (where relevant) as set out under section 52E of the TG Act:
- (a) the risks and benefits of the use of a substance;
- (b) the purposes for which a substance is to be used and the extent of use of a substance;
- (c) the toxicity of a substance;
- (d) the dosage, formulation, labelling, packaging and presentation of a substance;
- (e) the potential for abuse of a substance;
- (f) any other matters that the Secretary considers necessary to protect public health.
In addition to considering the above matters prescribed above under subsection 52E of the TG Act, the scheduling delegate must also consider the factors in the SPF.
The specific reasons for the initial recommendation to up-schedule codeine included matters relevent under section 52(E) of the TG Act (see p. 29 'Scheduling of medicines') were outlined and discussed in detail earlier under the following headings:
- Codeine as a prodrug and its metabolism;
- Codeine toxicity and alternative products;
- Codeine use, misuse and abuse;
- Current scheduling inconsistencies; and
- International scheduling considerations.
Furthermore, there is substantial published evidence for the involvement of codeine in cases of drug toxicity, contributing to both accidental and intentional deaths, many of which can be attributed to the misuse of combination codeine medicines. This, in combination with the limited data supporting the incremental effectiveness of codeine associated with codeine combination products, results in a negative risk/benefit analysis.
Due to harm from abuse or misuse of codeine, medicines containing codeine are tightly regulated in many countries. Regulatory controls include limits on pack sizes, label warnings on packaging, warnings in consumer information leaflets, and availability of codeine-containing medicines by prescription only. In Australia, similar regulatory controls are required to protect public health, and in addition, regulatory controls take into consideration restrictions to access. For example, the up-scheduling of codeine will remove codeine-containing medicines from general sale, and limit access. Under these circumstances, limits on pack sizes is not required and label warnings will be provided for by the patients' medical practitioner.
The identified health benefits of Scenario 4 , which involves up-scheduling all OTC codeine products to Schedule 4, include:
- accidental death prevention
- improved quality of life, resulting from the exploration of alternative, more effective treatment options that would not have previously been explored
- prevention of adverse events related to unintentional overdose of paracetamol or ibuprofen, and
- reduced dependence and reduced risk of dependency.
When considering both the scheduling factors in the SPF as well as the matters listed in the TG Act, it is clear that codeine meets the criteria for Schedule 4 (or higher). Therefore the up-scheduling of codeine to Schedule 4 is the preferred option based on the substantial gains in the protection of public health and safety.
This RIS has been completed to better understand the regulatory, social and health impacts of any change to the scheduling of codeine, including the risk to consumer safety if no action is taken.
The regulatory cost estimates and health economics have been informed by feedback from individual consumers, healthcare professionals and the pharmaceutical industry, as well as state and territory jurisdictions. Targeted consultations were held with key stakeholders, including sponsors who currently produce codeine-based products in the OTC market, to document the potential business process impacts and any implementation timeframes to comply with any change in codeine scheduling. These consultations were aimed to minimise the regulatory impact and to address identified issues.
The regulatory and economic costs and benefits are summarised in Table 20. When the regulatory costs, health economic costs, and health economic benefits are all considered, a net benefit to society is only found for Scenario 4 (Options 4 and 6). Scenario 4 yields a net benefit of $5,206.72 million for the ten years from 2017-2026, whereas Scenarios 2 and 3 result in a net cost to society. The economic benefits are driven by gains in quality of life, deaths prevented and a net reduction in out-of-pocket costs to the consumer.
The positive net benefit for Scenario 4 is robust to a wide range of sensitivity analyses. When the assumptions for costs are maximised and benefits are minimised, the net benefit remains positive. The net benefit was most sensitive to the average QALY gain resulting from additional treatment received for pain symptoms and the number of repeat scripts. The result was only moderately sensitive to the discount rate, number of deaths prevented, and the co-payment for GP and specialist consultations. The substantial health benefits are driven by the gain in QALY as patients receive treatment they would otherwise not have accessed that leads to more effective therapy compared to low-dose codeine combination medicines.
Therefore the preferred scenario, Scenario 4, consisting of Options 6 and 4 (remove Schedule 2 and Schedule 3 entries and add a new Schedule 4 entry for codeine), will deliver significant protection to public health and safety as a result of positive changes in consumer purchasing behaviour, raise awareness of codeine dependency through education, and increase exploration of alternative more effective therapeutic and treatment pathways for pain management. Further, Scenario 4 provides a significant net economic benefit to society of $5,206.72 million over a 10-year period from 2017-2026.