Over-the-counter medicines containing codeine will remain OTC until at least 2017

A delegate of the Secretary to the Department of Health gave notice of the deferment of the delegates’ final decision on OTC codeine scheduling. Of 127 public submissions on the interim decision to upschedule codeine-containing analgesics and cold/flu medicines to prescription-only, 113 did not support the proposal.

“The delegate has deferred making a final decision at this time regarding the possible rescheduling of codeine,” the decision reads.

“This is due to the large number of submissions received during the most recent consultation period, and the deferral of a decision will allow the submissions and the subsequent information provided to be thoroughly considered.

“This will also allow the delegate the option available under the legislation to seek further advice, including from the ACMS at its March 2016 meeting, prior to making a final decision, which will not be before 23 June 2016 (the publication date of final decision outcomes of March 2016 meeting).

“Should the decision require an implementation date, it will be announced at the time of publication and will not be before 2017.”

Points made in the submissions on the interim decision in support of retaining the current scheduling include:

• Consumers are able to self-manage pain responsibly.
• Upscheduling seen as prevention of accessing pain relief.
• Issues with access to/Cost associated seeing GPs.
• Alternative medications not seen as effective.
• Cost to Medicare.
• Benefits of codeine outweigh “morbidity, toxicity and dependence”.
• The issue of abuse of prescription codeine verses OTC codeine is not addressed by this scheduling change.
• Not able to take Non-Steroidal Anti-Inflammatory Drugs.
• The issue of abuse of prescription codeine verses OTC codeine is not addressed by this scheduling change.
• There has been no increased demand or change in patterns of use of codeine containing cold and flu products since the up-scheduling of codeine containing analgesics in 2010.
• There is no evidence of harm, abuse or dependency associated with codeine containing cold and flu preparations.
• Pharmacists are accessible and suitably qualified to implement an effective risk mitigation strategy to address concerns of misuse or abuse.
• Introduce system similar to pseudoephedrine.
• Introduce real time monitoring/reporting system.
• Suggest reducing pack size.
• 1 June 2016 implementation is not adequate time and a longer transition period would be required.

Fourteen submissions supported the proposal. Main Points:

• Seen too many addicts and health problems associated with OTC codeine.
• Ease of access to OTC codeine.
• Other effective alternative medication available.
• Arguments regarding increased cost to public purse are disingenuous as there are alternative analgesics on the market.
• Good evidence now demonstrates that under current arrangements (Schedule 3 Pharmacist Medicine) there is a substantial level of harm from the easy and widespread availability of these opioid medicines.
• Personal accounts of family members addicted to codeine, abusing OTC analgesics and cough syrup.

(Source: Australian Journal of Pharmacy)