Time allows Regulation Impact Statement on codeine: PSA


white pills and tablets: GMiA

The Pharmaceutical Society of Australia has welcomed the deferral of a final decision on the possible rescheduling of codeine.

PSA National President, Joe Demarte says that the extra time allowed by the deferral must be used to prepare a full Regulation Impact Statement on the proposal to reschedule codeine.

Demarte says the PSA in its submission had called for the proposal to be referred to the Office of Best Practice Regulation given the nature of the proposed changes and potential scope of impact.

“This is an opportunity to investigate what the impact of such a decision would be, on consumers and the broader health care sector,” he says.

“The deferral also provides the opportunity to investigate and implement real time recording and reporting which was also suggested by the PSA in its submission,” Demarte says.

A final decision will not now be made before 23 June 2016 (the publication date of final decision outcomes of the March 2016 meeting of the Advisory Committee on Medicines Scheduling). Should the final decision require an implementation date, it will not be before 2017.

“The ACMS’s interim decision would have required consumers to obtain a prescription to access low-dose codeine analgesic, and cold and flu preparations but would not have solved the problem of inappropriate codeine use, given that only 40% of all codeine-related deaths recently analysed were due to over-the-counter (OTC) codeine sales.

“PSA believes that Schedule 3 remains appropriate for codeine-containing analgesics in three day packs and strongly urges the implementation of a national real-time reporting and recording system.

“I have no doubt that a RIS will confirm what PSA has been saying about the impact rescheduling would have on the vast majority of consumers who have been using OTC codeine medicines appropriately.

“The changes would have had significant and costly implications for consumers seeking to access a large range of products for appropriate use and for GPs and hospital emergency departments dealing with the increased burden of consumers seeking prescriptions, and Governments faced with increased healthcare costs.

“PSA was never convinced of the merits of such a substantive regulatory change,” Demarte says.

“Given the problem of inappropriate use also surrounds prescription opioids, it was unlikely that rescheduling would have been effective in addressing the issue of codeine-related harm.”

Demarte says PSA remains concerned about reports of harm associated with the inappropriate use of codeine-containing medicines, and will continue to advocate for a strong, collaborative and multi-faceted approach to assist consumers, and particularly those at risk of misuse, with the quality use of codeine-containing medicines.

“PSA has already developed and implemented resources to support pharmacists in providing solutions to consumers who are seeking to manage pain and addiction.

“It is imperative that these initiatives have adequate time for implementation to take effect,” he says.

“However, alongside current practice support tools, implementation of a national real-time recording and reporting system is needed to provide holistic and comprehensive information to pharmacists and prescribers, to inform decisions regarding the appropriate supply of all medicines, including OTC products with the potential for misuse and abuse. Implementation of such a system must be given absolute priority.”

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