ASMI has commended the Scheduling Delegate’s interim decision to retain the current scheduling of ibuprofen… but not everyone agrees
In a letter to its members, the Australian Self Medication Industry said that “the decision to retain ibuprofen in grocery outlets aligns with the ASMI position that there is no new evidence to warrant any change to how consumers currently access this medicine”.
The issue was a significant one for ASMI because of potential repercussions for sponsors of other medicines distributed in grocery outlets, the organisation said.
Reasons cited by the Delegate for the decision included minimal risk of misuse or abuse; ibuprofen has a wide therapeutic window and when taken orally, the propensity for toxicity in overdose is low; and there are no new safety concerns.
“The evidence of potential cardiovascular (CV) risk associated with OTC doses of ibuprofen is not substantiated,” the Delegate said.
“Consumers are entitled to the convenience of being able to purchase ibuprofen products when and where it suits them,” says Regulatory and Scientific Affairs Director Steve Scarff.
“Restricting consumer access to ibuprofen would be an inappropriate overregulation of a safe and effective medicine and such a move would be inconsistent with other markets around the world.”
An application to reduce the size of S2 ibuprofen packs was also rejected by the Advisory Committees on Chemicals and Medicines Scheduling.
PSA national president Shane Jackson said the interim was “poor”.
“If we are focused on patient safety then ibuprofen would not be available in supermarkets where unsupervised and unlimited purchases can be made,” he said on Twitter.
“Many pharmacies where advice available open after hours. Ibuprofen contraindicated in many people!”
Yes!Seem to have glossed over some key issues! in our Submission:https://t.co/iqQUhLFW5s combo HT tabs(ACI Inhib/ARB + diuretic ("2/3 of trlple whammy already," 2 .I/A risks with NOACs, and 3. studies reinforce cardiovasc. risks-needs pharm.advice-incl.aft.hrs not just labels!
— ron batagol (@medpregbatagol) February 7, 2018
The final decision is due on 10 April 2018.