Pharmaceutical industry voices concerns over codeine rescheduling

05 October, 2015

According to the Pharmaceutical Society of Australia (PSA), the interim decision to reschedule codeine-containing medicines will have a major impact on consumers needing to purchase the products for legitimate health reasons.

Acting National President of PSA, Michelle Lynch, said the interim decision based on the recommendation of the Advisory Committee on Medicines Scheduling (ACMS) on the schedule of codeine is to delete the current Schedule 2 and 3 entries and to amend the current Schedule 4 and 8 entries to reflect this change, with a proposed implementation date of 1 June 2016.

"This change will have an overwhelming impact on consumers, pharmacists, medical practitioners and industry given codeine is a widely used ingredient and contained in many over-the-counter medicines for pain management and treatment of coughs and colds," Lynch said.

"There will be considerable impact on professional pharmacy practice and potentially changes to the education, support and management advice provided to patients and carers.

"While PSA is concerned with the rising levels of harm associated with the inappropriate use of codeine-containing analgesics, we have stressed that a holistic, multifaceted approach is necessary to achieve consumer-focussed outcomes."

Lynch said that while a more restrictive schedule may, in the short term, lead to less codeine use, including misuse, it was unlikely to fundamentally address the underlying problems leading to misuse, nor provide a long-term health solution.

"It is not clear to PSA whether justification for the proposal of such a substantive regulatory change has been clearly demonstrated," Lynch said.

"Profession-wide initiatives being implemented by PSA and other quality-use-of-medicines partners do not appear to have been taken into account.

"In the published reasons for decisions, it is noted that currently real-time monitoring is not available across Australia except in Tasmania where it is restricted to Schedule 8 medicines. Further it suggests that it is uncertain whether the implementation of a monitoring system would ever cover S3 medicines.

"Since 2010, PSA has been calling for the implementation of a national real-time recording and reporting system and for such a system to be able to capture all drugs of dependence, including OTC analgesics, in accordance with relevant state and territory legislation.

"PSA strongly suggests this remains a core priority for the Australian healthcare sector."

Lynch said PSA would submit further comments before the 15 October 2015 closing date. The final decision is expected on 19 November 2015.