How the decision was reached
The TGA’s announcement that all codeine products will be upscheduled from 1 February 2018, comes nearly two years after the TGA first began considering a proposal to shift all schedule 2 (over-the-counter) and 3 (pharmacist only) codeine preparations to prescription only (schedule 4 and S8).
The Advisory Committee on Medicines Scheduling (ACMS), an independent committee of experts, including several pharmacists, appointed by the Minister to advise the TGA on scheduling matters, invited public submissions on this proposal.
The AMA made a submission noting that it did not have the information to form a definitive view but raising a range of issues that should be considered.
The TGA delegate responsible for medicines scheduling decisions subsequently issued an “interim decision” supporting a recommendation by ACMS to remove codeine from schedules 2 and 3. The interim decision included a summary of all the information and issues considered by ACMS in making the recommendation.
A two-week consultation period was provided following the delegate’s interim decision, to allow any further comments to be made.
The AMA made another submission, this time supporting the decision on the basis that it was informed by advice from an independent, expert committee (ACMS), and based on best available evidence.
About 120 submissions were lodged in response to the interim decision. Of those opposing the upscheduling, more than 70 were from individuals opposing limits to codeine access (usually citing personal experience with migraine or musculoskeletalconditions); a handful from individual pharmacists; eight from pharmacy related organisations; five from consumer organisations. Those supporting included: the Society for Hospital Pharmacists; five medical related organisations; and seven individuals (again citing personal/close experiences such as harm and death resulting from over-the-counter codeine).
In addition, the Pharmacy Guild mounted a strong public campaign opposing the removal of non-prescription codeine from pharmacies.
Subsequently, in early 2016 the TGA announced that the delegate had deferred making a final decision … due to the large number of submissions.
The TGA then issued alternative proposals for public comment, which included options such as continuing to allow S2 and S3 codeine but in smaller pack sizes.
In 2016, the TGA commissioned KPMG to undertake a regulation impact analysis to quantify the impact of various scheduling options. Dr Richard Kidd, Chair of the AMA Council of General Practice, was interviewed by KPMG to provide a general practice perspective on the impact of any codeine scheduling changes. The report conclusively found that the social and economic benefits would outweigh the regulatory costs of upscheduling codeine.
The TGA subsequently announced its final decision to upschedule all codeine products to ‘prescription only’ in late 2016.
The AMA continues to advocate for the implementation of the Electronic Recording and Reporting of Controlled Drugs system in each State and Territory. This system would allow doctors and pharmacists to monitor in real time the prescribing and dispensing of a range of medicines with the potential for misuse and harm, not only Schedule 8 medicines.
However, the implementation of this system is unlikely for several more years. Victoria and WA are the only States so far to announce a timeframe for implementation – sometime in 2018.