No change to pack sizes

paracetamol challenge: blister pack with one tablet separate

Application to reduce Schedule 2 ibuprofen pack sizes knocked back 

An application to reduce the size of S2 ibuprofen packs has been rejected by the Advisory Committees on Chemicals and Medicines Scheduling

The recently released decisions from the ACCS/ACMS November 2017 joint meeting revealed that the application to reduce S2 ibuprofen in divided preparations, each containing 200 mg or less of ibuprofen, to packs of not more than 30 dosage units, down from the current pack size of not more than 200 dosage units, was knocked back.

Of 17 pre-meeting public submissions on this proposal, only three were in support of the change, with fourteen opposed.

This was followed by the TGA delegate’s interim decision that “the current Schedule 2 and Schedule 3 entries for ibuprofen remain appropriate”.

Among a number of reasons given for the decision, the delegate said there was 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.

Meanwhile, a move to downschedule the skeletal muscle relaxant Orphenadrine was also rejected.

This proposal sought to create a new S3 entry for orphenadrine in “oral preparations containing 35 mg or less of orphenadrine when compounded with not more than 500 mg paracetamol for the relief of pain associated with skeletal muscle spasm in adults and children 12 years of age and over; and in a primary pack containing 24 or less dosage units”.

However, the delegate ruled that the “current scheduling of orphenadrine remains appropriate”.

“There is significant abuse potential, increased occurrence of abuse episodes, OD-induced deaths, adverse cardiac events, drug-drug interactions, and incompatible pharmacokinetics with other drugs. There is also a lack of efficacy for certain claims for indications,” the delegate said.

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