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Final decisions amending, or not amending, the current Poisons Standard, April 2018

Scheduling medicines and poisons

10 April 2018

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1.6 Ibuprofen

Part A - Final decisions on matters referred to an expert advisory committee (November 2017)

1. Advisory Committee on Medicines Scheduling (ACMS #22)

1.6 Ibuprofen

Delegate's final decision
Final decision:

The delegate’s final decision is not to amend the provisions of the Poisons Standard that relate to ibuprofen on the basis that the current Schedule 2 and Schedule 3 entries for ibuprofen remain appropriate.

Implementation date: N/A

The delegate has reviewed the public submissions on the interim decision for ibuprofen, which both supported and opposed the interim decision. No significant new evidence was received and most public submissions reiterated the submitter’s initial public submissions to the invitation for public comment. In view of this, the delegate finds no reason to alter the interim decision and hence the delegate has confirmed that the final decision and reasons for the final decision are identical to the interim decision.

Additional comment:

The delegate has noted concerns about the labelling of ibuprofen products and will refer it to the appropriate area in TGA for their consideration.

Public submissions on the interim decision

Six (6) public submissions were received. Three (3) supported and three (3) opposed the delegate's interim decision.

The main points in support:
  • The scheduling proposal does not articulate the problems it presumably seeks to address. Any increase in regulation should be based on sound and accurate evidence addressing concerns and scheduling changes are the only mechanism for addressing these concerns. Any regulatory decisions need to be consistent with the principles of best practice regulation.
  • The overall risk benefit of ibuprofen remains positive and the safety profile is well established following the many years of experience with this medicine. There are no new publicly available safety concerns associated with ibuprofen and no evidence of excessive use, purchasing or harm through the current availability.
  • The current Australian scheduling arrangements for ibuprofen are in line with other countries including the UK, Canada, USA and New Zealand. Ibuprofen has been available in Australia as an OTC medication for 30 years and in general retail for approximately 15 years, with limited reported adverse effects.
  • The proposed scheduling change to ibuprofen has limited evidence that consumers would receive any benefit and it would have a significant impact on consumer choice and accessibility. It will also reduce competition and increase cost to consumers with no evidence of any incremental benefit provided. Ibuprofen is currently available from pharmacies in larger pack sizes and if required, allows consumers to obtain advice from pharmacists. There are considerable consumer benefits of retaining 24-hour availability of 24 pack sizes for acute pain, particularly in rural or remote areas or other communities that do not have access to pharmacies that are open after business hours.
  • For consumers, OTC medicine labels provide the single most important source of information. Australian medicines that contain ibuprofen must be labelled in accordance with the RASML, which contains detailed mandatory warning statements in language that consumers are able to understand and act upon. There is a low propensity for toxicity in overdose and current labelling meets the RASML in relation to risks and complications of NSAIDs. Given the strong evidence, small packs of ibuprofen that are currently exempt can be appropriately selected and used by the reasonable consumer with acceptable safety.
  • The TGA (in 2014 and 2016) and the European Medicines Agency (EMA) (in 2015) have both recently conducted safety reviews of NSAIDs (including ibuprofen). These reviews did not identify any new safety concerns or risks and noted that there is minimal cardiovascular risk associated with ibuprofen when used at recommended OTC doses and duration.
The main points opposed:
  • NSAIDs have a number of side effects which are dose related including major upper gastrointestinal bleeding, acute renal injury and cardiovascular effects. The benefits of keeping ibuprofen unscheduled do not outweigh the risks.
  • Whilst ibuprofen is non-addictive there is a risk that consumers may intentionally or inadvertently take more than the recommended OTC dose and for much longer than the 4 day maximum especially if they are living with chronic pain. Studies show that people exceed the daily limit of ibuprofen and this risk could be mitigated by having ibuprofen only available in pharmacies. Further, there are concerns that continued availability of ibuprofen-containing products for self-selection through non-pharmacy settings has the potential to further increase the risk of adverse outcomes and may disadvantage people who are not achieving optimal pain management.
  • Mandatory package labelling requirements do not adequately cover the risks associated with ibuprofen and RASML statements are not always effective. There is a lack of specific cautionary RASML labelling on ibuprofen sold in general stores about the risks of concomitant drug therapy, including the potential of renal "triple whammy" and antithrombotic drugs, increasing the risk of haemorrhage. Further, current labelling does not address the overall renal risks of NSAIDs in adults who are temporarily or otherwise at risk of renal failure caused by dehydration or fluid depletion. Even with the best designed label on the product packaging, pharmacists frequently report of instances where the patient has not read, not understood, misunderstood or disregarded information relevant to them to take the medicine safely or effectively when this information is not reinforced by the intervention of a pharmacist.
  • The input of a health professional with knowledge of significant drug interactions is needed. When consumers are purchasing ibuprofen it is important for them to have access to professional guidance from pharmacists. Pharmacists are the health professionals that understand the well-established safety profile of ibuprofen for short term use and are most accessible to patients. They routinely encounter scenarios where ibuprofen and other NSAIDs are being used inappropriately or sub-optimally by individuals. Up-scheduling ibuprofen would provide the opportunity for pharmacist intervention, support a quality use of medicines approach to the use of ibuprofen, and contribute to enhanced patient care.
  • There are a wide range of community pharmacies throughout Australia that are open for extended evening and public holiday hours. Recent expansion of discount pharmacy groups has also resulted in a very competitive environment regarding price and availability of non-prescription medications.
  • There is accumulating evidence that taking ibuprofen regularly, in any dose, increases the risk of having an acute myocardial infarction.
Interim decision

The interim decision for ibuprofen was published on the TGA website on 5 February 2018 at Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017 - 1.6. Ibuprofen.

Scheduling proposal

The pre-meeting scheduling proposal for ibuprofen was published on the TGA website on 6 September 2017 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, November 2017.

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