Rescheduling of codeine: a Tasmanian perspective

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Background Paper for the Codeine Rescheduling Implementation Group

Rationale for TGA decision

Extent of prescribed opioids and related harms in Tasmania


1. Background

The Therapeutic Goods Administration (TGA) announced on 20 December 2016 that from 1 February 2018 combination analgesics containing codeine (CACC) currently available over the counter (OTC) in community pharmacies will be rescheduled from Schedule 2 (Pharmacy Medicine) and Schedule 3 (Pharmacist Only Medicine) to Schedule 4 (Prescription Only Medicine) (1).

This decision will mean that low-dose codeine will only be available by prescription from February 2018.

Such medications include analgesics (eg Panadeine paracetamol-codeine, Nurofen Plus ibuprofen-codeine) used for temporary relief of pain, and cold and flu medications used for treatment of coughs and colds.

These medications contain a low-dose of codeine (up to 15g per tablet) and are presently restricted to five-day pack sizes. High-dose codeine (over 15mg per tablet) is currently only available by prescription (Schedule 4).

In making this decision the TGA considered the evidence of harms related to overuse and abuse of these medications such as codeine dependency, liver damage, gastrointestinal perforations, renal damage, respiratory depression and death; the limited evidence of additional efficacy of including low-dose codeine in a combination product; the availability of safer and effective management for temporary relief of pain; the extent of use of these medications to self-treat chronic pain; and the modelling of social and economic benefit to society from rescheduling resulting in reduced deaths from accidental or deliberate codeine overdose, improved quality of life, reduced codeine dependence and risk of dependency, and reduced healthcare costs. (2)

Requiring a prescription for all codeine medicines will bring Australia into alignment with international regulators such as the US, most of Europe, Hong Kong, Japan, the United Arab Emirates and several other countries.

International evidence supports regulation of codeine availability to reduce abuse and misuse of low-dose OTC codeine. (3-5)

Despite the previous decision by the TGA to reschedule some OTC CACCs from Schedule 2 to Schedule 3 in 2010, there is evidence of increasing misuse in Australia (6).

The decision by the TGA will have implications in Tasmania for consumers, pharmacists, GPs, other medical specialists, hospital EDs, specialist alcohol and drug services, and persistent pain services.

2. Codeine

Codeine is an opioid drug closely related to morphine and is derived from opium poppies. It is a prodrug, which is metabolised by the liver into morphine. This is must have a therapeutic effect. There is significant genetic variation across the community in terms of an individual’s ability to metabolise of codeine.

Up to 10 per cent of the population are poor metabolisers who experience very little therapeutic benefit from codeine. Around 10% of the population have ultrarapid metabolism and a higher risk of toxicity at recommended doses. (2, 3)

Codeine is available in low dose (up to 15mg per tablet) OTC CACCs used for temporary relief of pain and for treatment of coughs and colds; and in high dose (over 15mg per tablet) prescription only medications, either alone (Schedule 8) or in combination with paracetamol (Schedule 4).

High dose codeine containing analgesics are prescribed for the treatment of pain including cancer related pain, post-operative pain and other acute pain conditions.

While opioids are effective in the temporary treatment of strong pain and treatment of cancer pain, evidence to support ongoing use in chronic non-cancer pain is lacking (7-10).

There is also a lack of evidence to support the effectiveness of low-dose codeine in a combination with other analgesics for the relief of pain while there is evidence of significant harms (11).

The Australian Therapeutic Guidelines for acute pain do not include the use of codeine for mild acute pain and when it is introduced in the treatment of moderate pain it is at a dosage of “30 to 60mg orally, six-hourly as necessary”.

The guidelines also note “there is evidence that a lower dose of codeine, less than 30 mg six-hourly, is no more effective than simple analgesia”. (7)

Opioid analgesics are not considered suitable first-line therapy to treat chronic non-cancer pain, nor are they appropriate for long-term use.

Clinical therapeutic guidelines for analgesia state that the management of chronic non-cancer pain is better achieved via medical practitioner evaluation and advice with regards to both appropriate non-opioid pharmacological and non-pharmacological treatments. (7-9)

The Australian Therapeutic Guidelines for chronic non-cancer pain states “opioids work well in acute pain, but their role in chronic non-malignant pain management is limited … evidence for long-term benefit is lacking.” These guidelines include all opioids of which the majority are more potent than low dose codeine. (7)

The Faculty of Pain Medicine (Australian and New Zealand College of Anaesthetists) and the US Centers for Disease Control and Prevention recognise the lack of definitive evidence to support the long-term effectiveness of opioid analgesics in people experiencing chronic non-cancer pain and the substantial evidence of harm (8, 9).