Upscheduling of Panadol Osteo confirmed by TGA, but change pushed back till 2020
The TGA’s Advisory Committee on Medicines Scheduling (ACMS) has confirmed its earlier decision to re-schedule modified release Paracetamol to Schedule 3.
However the implementation date has been pushed back to 1 June 2020, due to concerns from industry that the initial date in October 2019 was too soon to ensure compliance.
In addition, the ACMS dismissed concerns that pharmacists were unable to control and restrict S3 purchases of Panadol Osteo, and other products affected by the rescheduling.
“I have made a final decision to confirm my interim decision insofar as it relates to the up-scheduling of paracetamol in modified release (MR) tablets or capsules containing 665 mg or less of paracetamol to Schedule 3 and the reasons for this decision,” said the TGA delegate.
“I have given consideration to the view that Schedule 3 will not provide sufficient control to reduce the frequency of deliberate self-poisoning with MR paracetamol.
Specifically, there was a concern expressed that pharmacists will be unable exert sufficient controls against the purchase of MR paracetamol for suspected problematic or inappropriate use, in view of the experience with codeine and other Schedule 3 products,” the delegate said.
“Notwithstanding the important role of the direct involvement of pharmacists in consumer education, in making my decision, I took into account that up-scheduling to Schedule 3 may also act to reduce some impulsive intentional overdose due to placing additional barriers to sales”.
The amended S3 entry covers paracetamol
- when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or
- in modified release tablets or capsules containing 665mg or less paracetamol.
“I have taken into account the compelling evidence in the public submissions that a 1 October 2019 implementation date provides insufficient time for sponsors of MR paracetamol medicines to carry out all of the regulatory, manufacturing, transportation and distribution steps necessary to comply with the proposed changes,” the delegate said, revealing the decision to hold back the rescheduling till 2020.
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