The Medicines and Poisons Regulation opened a public consultation in relation to the proposed amendment to include pregabalin, gabapentin and tramadol in SafeScript.
The Regulatory Impact Statement (RIS) in relation to the proposed Drugs, Poisons and Controlled Substances Amendment Regulations 2023 (proposed Regulations) has been prepared in accordance with section 11 of the Subordinate Legislation Act 1994. The RIS presents the cost to prescribers and pharmacists implementing the proposed Regulations and the expected health, social and financial benefits.
The RIS draws on the findings of the Austin Health updated literature review with regards to the evidence of harms caused by pregabalin, gabapentin and tramadol. You can find the full report here - https://www.health.vic.gov.au/drugs-and-poisons/medicines-monitored-in-safescript.
Links below to consultation documents and the response submitted by VicTAG
Regulatory Impact Statement - Schedule 5 & Schedule 6 of the DPCS Regulations 2017
Exposure draft - DPCS Amendment Regulations 2023
VicTAG Response to proposed amendement
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strategies to deal with the lack of development into agents targeting microbial infections was held. The current business model for drug development does not work with antimicrobials and consequently almost all large pharma are no long involved in drug development in this space.
The meeting was to discuss different options with various players and the slides are available below.
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