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Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, November 2017

Scheduling medicines and poisons

5 February 2018

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1.6. Ibuprofen

Referred scheduling proposal

An application was submitted to amend the Schedule 2 to and Schedule 3 entries in the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – the Poisons Standard.

Scheduling application

This was a general application. The applicant’s proposed amendments to the Poisons Standard are:

Schedule 2 – Amend Entry

IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:

  1. in liquid preparations when sold in the manufacturer’s original pack containing 8 g or less of ibuprofen; or
  2. in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 30 dosage units except when:
    1. as the only therapeutically active constituent (other than phenylephrine or when combined with an effervescent agent);
    2. packed in blister or strip packaging or in a container with a child-resistant closure;
    3. in a primary pack containing not more than 25 dosage units;
    4. compliant with the requirements of the Required Advisory Statements for Medicine Labels;
    5. not labelled for the treatment of children 6 years of age or less; and
    6. not labelled for the treatment of children under 12 years of age when combined with phenylephrine.

Schedule 3 – Amend Entry

IBUPROFEN for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen and not labelled for the treatment of children under 12 years of age:

  1. in divided preparations each containing 200 mg or less of ibuprofen in a primary pack containing not more than 100 dosage units
  2. in divided preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 50 dosage units when labelled:

except when included in or expressly excluded from Schedule 2.

On 29 June 2017, the delegate decided to amend the Schedule 3 entry to include a modified release dosage form of ibuprofen. As a result, the secretariat has amended the proposed entry for consistency with the delegate's decision, which came into effect on 1 October 2017:

Schedule 3 – Amend Entry

IBUPROFEN:

  1. in divided preparations, each containing 200 mg or less of ibuprofen in a primary pack containing not more than 100 dosage units, when labelled:
    1. with a recommended daily dose of 1200 mg or less of ibuprofen; and
    2. not for the treatment of children under 12 years of age; or
  2. in divided preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 50 dosage units, when labelled:
    1. with a recommended daily dose of 1200 mg or less of ibuprofen; and
    2. not for the treatment of children under 12 years of age; or
  3. in a modified release dosage form, each containing 600 mg of ibuprofen in a primary pack containing not more than 32 dosage units, when labelled:
    1. with a recommended daily dose of 1200 mg or less of ibuprofen; and
    2. not for the treatment of children under 12 years of age;

    except when included in or expressly excluded from Schedule 2.

The applicant's reasons for the request are:

  • Over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly used pharmacological agents worldwide to treat mild to moderate pain. Ibuprofen is the most commonly used NSAID.
  • Ibuprofen is currently the only oral NSAID exempt from scheduling that can be sold in general retail with no access to professional advice regarding appropriate use. The current maximum pack size of 100 dosage units is also significantly larger than other type of oral NSAID listed in Schedule 2.
  • Several recent major international studies have highlighted the increased risk of heart failure associated with NSAIDs at OTC doses. Additionally, clearer warnings regarding the use of NSAIDs during preconception and pregnancy have been adopted as per recommendation by the Therapeutic Goods Administration (TGA). Noted in the 2014 TGA safety review of NSAIDs:
  • 'NSAIDs are among the most commonly used pharmacological agents worldwide due to their efficacy as non-addictive analgesics and their anti-inflammatory properties. Hence, even a small absolute risk of serious cardiovascular effects associated with these drugs could produce a significant health burden in a given population.'

  • The proposed amendments to the Schedule 2 listing for ibuprofen are a prudent response to the recent and mounting evidence regarding the risks associated with NSAIDs. The proposed changes will mitigate these risks and facilitate access to these medicines so that patients will gain optimal health outcomes.
  • Low levels of consumer health literacy regarding the safe maximum daily dose of ibuprofen warrants tighter controls on the supply of ibuprofen. This applies particularly to outlets where there are no restrictions on the number of packs that can be purchased by consumers and no access to professional advice or administration under professional health care supervision and guidance.
  • This application should also be viewed in the context of the deletion of Schedule 2 and Schedule 3 entries for codeine, taking effect on 1 February 2018. From this date, many consumers who were previously taking Schedule 3 codeine medicines (specifically combination analgesics containing codeine) will likely seek alternatives that may include ibuprofen either as a single active ingredient or in combination with paracetamol. This will likely lead to increased use of ibuprofen, which will further exacerbate these risks.
  • Providing consumer access to information via hand-outs or labelling is not sufficient to address the concerns raised. Facilitating access to professional advice for the prescribing and supply of medicines is the best way to maintain safe and cost-effective access to medicines. Consumers need advice on the correct and proper way to use medicines. This is best achieved with supply from a pharmacist through a community pharmacy and when necessary, referral to a general practitioner or appropriate health care professional.
  • Large packs of ibuprofen for longer term use should only be available as a Schedule 3 medicine. The mandatory intervention of a pharmacist will determine whether a larger pack size is therapeutically appropriate and will facilitate discussions regarding pain management. Recommendations on potentially more suitable medicines and referral to other health practitioners can be made as required.
Current scheduling status

Ibuprofen is currently listed in Schedules 2, 3 and 4 and Appendix F, Part 3 and Appendix H of the Poisons Standard as follows:

Schedule 2

IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:

  1. in liquid preparations when sold in the manufacturer’s original pack containing 8 g or less of ibuprofen; or
  2. b) in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:
    1. as the only therapeutically active constituent (other than phenylephrine or when combined with an effervescent agent);
    2. packed in blister or strip packaging or in a container with a child-resistant closure;
    3. in a primary pack containing not more than 25 dosage units;
    4. compliant with the requirements of the Required Advisory Statements for Medicine Labels;
    5. not labelled for the treatment of children 6 years of age or less; and
    6. not labelled for the treatment of children under 12 years of age when combined with phenylephrine.

Schedule 3

IBUPROFEN:

  1. in divided preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 50 dosage units, when labelled:
    1. with a recommended daily dose of 1200 mg or less of ibuprofen; and
    2. not for the treatment of children under 12 years of age; or
  2. in a modified release dosage form, each containing 600 mg of ibuprofen in a primary pack containing not more than 32 dosage units, when labelled:
    1. with a recommended daily dose of 1200 mg or less of ibuprofen; and
    2. not for the treatment of children under 12 years of age,

    except when included in or expressly excluded from Schedule 2.

Schedule 4

IBUPROFEN except:

  1. when included in or expressly excluded from Schedule 2 or 3; or
  2. in preparations for dermal use.

Appendix F, Part 3

Warning Statements: 101, 104

Appendix H

IBUPROFEN.

Scheduling history

In November 1985, the National Health and Medical Research Council (NHMRC) considered a request to amend the scheduling of ibuprofen from Schedule 4 to Schedule 2 as ibuprofen was not scheduled in Victoria. It was agreed there were anaphylactic problems with people sensitive to aspirin. It was decided not to alter the scheduling.

In November 1987 the NHMRC considered a request to move ibuprofen from Schedule 4 to Schedule 2 with pack size restrictions. The committee was of the opinion that there was a place for ibuprofen outside Schedule 4. Recommendation for a new Schedule 3 entry with pack size restrictions of less than 50 tablets or capsules (200 mg).

In May 1995, the NDPSC considered proposal for a new Schedule 2 entry for ibuprofen and agreed to a new entry. Schedule 4 entry amended. New Schedule 2 for ibuprofen in divided preparations for oral use containing 200mg or less with a recommended dose of 1200mg or less.

In November 1998, the NDPSC considered an application for ibuprofen liquid suspension 100 mg/5 mL to be rescheduled from Schedule 4 to Schedule 2. Overall, the committee considered that a Schedule 3 classification was more appropriate for this formulation, and agreed that the Poisons Standard be amended accordingly. The committee agreed that a maximum daily dose should be stipulated, but because the proposed pack size was 200 mL (maximum of 4 g ibuprofen) a restriction on total content was not required for this classification. A new entry for Schedule 3 was agreed in undivided preparations for oral use when labelled with a recommended daily dose of not more than 1200 mg of ibuprofen.

In May 2000, the NDPSC considered a proposal to amend the Schedule 2 entry for ibuprofen to include oral liquid preparations containing more than 20 mg/1 mL. The committee considered the safety profile of ibuprofen and that Schedule 2 is appropriate when used in analgesic dose for minor and temporary ailments for short periods. The committee was seeking consistency with divided dose formulations.

In June 2003, the NDPSC considered a proposal to exempt ibuprofen from scheduling in divided preparations containing 200 mg or less of ibuprofen per dosage unit in packs containing 24 or less dosage units when labelled with a maximum recommended daily dose of 1200 mg of ibuprofen. The NDPSC decided to exempt ibuprofen from scheduling as requested, but with an amended maximum pack size (25 dosage units) and additional restrictions as follows: ibuprofen as the only therapeutically active constituent other than an effervescent agent; and requirements for label warnings (consistent with Appendix F warnings for Schedule 2 ibuprofen). The minutes note that the NDPSC had agreed that the schedule wording should be comparable with that of the current aspirin and paracetamol entries.

In October 2003, following consideration of further public submissions, the NDPSC made some amendments to the label warning statements required for ibuprofen when exempted from scheduling, in particular, by adding warnings not to use the product unless advised by a doctor in children ages 6 years or less, or by people aged 65 years or over.

The NDPSC subsequently made some editorial amendments to the Schedule 2 exemption in June 2004 and February 2005.

In August 2010 the NDPSC considered the scheduling of paracetamol in combination with ibuprofen in June 2010. At that time, divided dose combinations containing up to 200 mg ibuprofen + 500 mg paracetamol were included in Schedule 2 (when labelled with a maximum daily dose of 1200 mg ibuprofen, and in packs of up to 100 dosage units). The NDPSC recommended, and the delegate confirmed, that the scheduling of ibuprofen and paracetamol that was current at that time remained appropriate.

In June 2011 the ACMS considered a proposal from the Advisory Committee on Non-prescription Medicines (ACNM) that the delegate/ACMS consider up-scheduling paracetamol/ibuprofen combinations (containing up to 500 mg paracetamol/200 mg ibuprofen) from Schedule 2 to Schedule 3. The ACNM had also recommended consideration of a maximum pack size for Schedule 3 paracetamol/ibuprofen combinations. The ACNM, in an assessment of an application to register a combination paracetamol/ibuprofen product, had raised concerns that the sponsor had not satisfactorily established the safety of the product, and considered that pharmacist intervention was needed to assist consumers with safe use of the combination.

The ACMS recommended that the combination paracetamol/ibuprofen products that were in Schedule 2 should be rescheduled to Schedule 3, when in packs containing 30 dosage units or less, with larger packs to be included in Schedule 4. The delegate agreed with the ACMS advice.

In February 2013 the ACMS considered proposals to reschedule paracetamol 500 mg when combined with ibuprofen 200 mg from Schedule 3 to Schedule 2 in packs containing 12 dosage units or less, and to also include Schedule 3 paracetamol when combined with ibuprofen in Appendix H. The ACMS recommended that the current scheduling of paracetamol in combination with ibuprofen remained appropriate, and that paracetamol in combination with ibuprofen should not be included in Appendix H. The reasons for opposing rescheduling to Schedule 2 included insufficient data to disprove the safety concerns with the combination, lack of evidence to support rescheduling, lack of long-term evidence of safety of the combination, potential for additive gastrointestinal side effects, potential for inadvertent misuse and no experience with use of paracetamol/ibuprofen combination products in Australia. The ACMS also considered that there were no public health benefits with inclusion of the combination in Appendix H, and that advertising could lead to inappropriate use. The delegate agreed with the ACMS advice.

In June 2012, the ACMS considered a submission to reschedule ibuprofen from Schedule 2 to unscheduled when in divided preparations containing 200 mg or less of ibuprofen in fixed dose combination with 5 mg or less of phenylephrine, in packs containing not more than 25 tablets. ACMS recommended to the delegate that ibuprofen in combination with phenylephrine should be exempt from scheduling, as requested. The delegate decided to also restrict the scheduling exemption to use for the treatment of adults and children aged 12 years of age and over.

In November 2015, the ACMS considered a submission to amend the Schedule 2 entry for paracetamol to include paracetamol when combined with ibuprofen in pack sizes of 12 dosage units or less. The ACMS recommended that paracetamol should be included in Schedule 2 when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a pack of not more than 3 day supply. The delegate agreed with the ACMS and made an interim decision based on the ACMS advice. After deferring their final decision to give consideration to a late submission received during the interim decision consultation period, the delegate decided to vary their decision. In view of the dosage levels of paracetamol and ibuprofen the delegate considers it is more appropriate to limit the Schedule 2 part a) entry to 12 dosage units per pack rather than 3 days' supply packs as this would ensure the total paracetamol available in the pack would not be excessive.

In March 2017, the ACMS considered a proposal to amend the Schedule 3 entry for ibuprofen to include a modified release dosage form of 600 mg of ibuprofen per dosage unit in packs of 32 or less dosage units. ACMS recommended that the Schedule 3 entry should be amended as suggested, allowing consumers greater access to a product for pain relief that is longer-lasting than other products currently available. The delegate's final decision was to amend the Schedule 3 entry for ibuprofen to include the modified release dosage form, with an implementation date of 1 October 2017.

Australian regulatory information

The Australian Register of Therapeutic Goods (ARTG) has 229 entries for products containing ibuprofen. They are approved for treatment of infants, children and adults and come in multiple dosage strengths and forms.

Combination products available include ibuprofen with codeine, ibuprofen with paracetamol and ibuprofen with pseudoephedrine. The ARTG also included entries for ibuprofen lysine 324 mg tablets and capsules and ibuprofen sodium dihydrate 256 mg tablets and capsules.

In the last 30 years there have been 1222 reported cases of adverse events related to ibuprofen in the Database of Adverse Events Notification (DAEN) - Medicines: 813 cases with a single suspected medicine and 35 cases where death was a reported outcome.

According to the TGA Ingredient Database, ibuprofen, ibuprofen lysine and ibuprofen sodium dihydrate are available for use as an:

  • Active Ingredient in: Biologicals, Export Only, Over the Counter, Prescription Medicines; and
  • Excipient Ingredient in: Biologicals, Devices, Prescription Medicines.
International regulations
Canada

Health Canada regulates ibuprofen in strengths of 200 mg, 300 mg and 400 mg as over-the-counter medicines.

New Zealand (NZ)

Medsafe NZ regulates ibuprofen in solid dose forms containing not more than 200 mg in packs of more than 25 and less than 100 tablets as Pharmacy Only.

United States of America (USA)

The USA Food and Drug Administration regulate ibuprofen in varying dose forms as an over-the-counter medicine.

European Union

The European Medicines Authority regulates ibuprofen and dexibuprofen (the dextrorotatory enantiomer of ibuprofen) in varying doses and formulations and these are available on prescription as well as over the counter.

Substance summary
Table 1.6.1: Chemical information of ibuprofen
Property Ibuprofen
CAS name Ibuprofen
CAS number 15687-27-1
IUPAC and/or common and/or other names

2-[4-(2-methylpropyl)phenyl]propanoic acid (IUPAC);

Ibuprofen (INN);

Chemical structure chemical structure of Ibuprofen
Molecular formula C13H18O2
Molecular weight 206.3 g/mol

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used as an analgesic, antipyretic, and anti-inflammatory. It decreases synthesis of pain and inflammation, promoting prostaglandins via non-selective inhibition of both cyclo-oxygenase 1 and 2 (COX-1 and COX-2) enzymes.

Ibuprofen is a white or almost white, crystalline powder or colourless crystals. It is practically insoluble in water, freely soluble in acetone, in methanol and in methylene chloride. It dissolves in dilute solutions of alkali hydroxides and carbonates.

Numerous oral non-prescription ibuprofen formulations are available in Australia with various dosage forms, strengths and combinations. These 'immediate release' (IR) non-prescription formulations are indicated for the management of mild to moderate pain and inflammation, including reducing fever, and for the treatment of headache including migraine, period pain, dental pain, musculoskeletal and joint pain and post-operative pain.

Australian therapeutic guidelines recommends that the non-prescription ibuprofen oral dose in people aged more than 12 years of age is 200–400 mg every 4 to 6 hours as needed, with a maximum daily dose of 1200 mg.

Toxic effects are unlikely at doses below 100 mg/kg, but can be severe above 400 mg/kg. Risks noted include increased risk of cardiac arrest, risk of spontaneous abortion, risk of gastrointestinal side effects (including bleeding), as well as renal function changes. Additionally, NSAIDs such as ibuprofen may not be suitable for people with stomach problems such as ulcers or bleeding, people with heart or kidney problems or people with high blood pressure.

Pre-meeting public submissions

Seventeen (17) submissions were received, three (3) in support and fourteen (14) opposed.

Main points in support:
  • Rescheduling of codeine is likely to increase the use of ibuprofen.
  • Guidance and counselling from a pharmacist should be readily available to avoid medication misuse, and to confirm baseline risk factors, comorbidities and medication use to provide individualised treatment.
  • Co-administration of ibuprofen with combination tablets of angiotensin-converting-enzyme inhibitor (ACE inhibitor) or Angiotensin II Receptor Blockers (ARBs) with a diuretic for treating hypertension can increase the potential for renal adverse medication events.
  • Co-administration of NSAIDs with antithrombotic drugs could result in a major bleeding event.
  • Rescheduling ibuprofen would reduce the incidence of self-selection of ibuprofen to treat pain or muscular inflammation.
  • Two comprehensive reviews of NSAIDs conducted by the TGA in recent years acknowledged the cardiovascular, hepatotoxicity and pregnancy risks associated with these medicines. Thus it is appropriate that access to these medicines is restricted further to ensure appropriate review by a pharmacist.
  • Ibuprofen has a good safety profile for use at over-the-counter doses and short term therapy.
  • NSAIDs are potent substances particularly for individuals with risk factors such as asthma, hypertension, renal impairment or heart failure. The wide availability of NSAIDs both OTC and prescription ultimately pose a risk to consumers who may inadvertently take different NSAIDs concurrently or continue therapy for a longer period than clinically necessary.
  • At least 50% of all patients, and at least 60% of patients diagnosed with a musculoskeletal disorder had at least one NSAID-relevant coexisting medical condition as identified in a recent study. The frequency of NSAID-relevant coexisting medical conditions also increased with age.[37]
  • Some consumers are known to increase their OTC dose when analgesia is suboptimal.
  • Ibuprofen should be considered in the context of scheduling of similar substances such as naproxen given the similar safety profiles.
Main points opposed:
  • A previous proposal to reschedule ibuprofen to restrict sale to pharmacies was considered in 2014/15 and was rejected on the grounds that there was insufficient evidence. There have been no new safety alerts or concerns raised since that time to warrant a further review or a change in the scheduling of ibuprofen.
  • 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 have stated that there is minimal cardiovascular risk associated with ibuprofen when used at recommended OTC doses and duration
  • The reviews did not recommend that any changes to access are warranted and proposed new labelling warning statements to improve consumer awareness of risks associated with use by people who have risk factors or use for prolonged periods of time
  • Since the reviews were published there has been no evidence of any significant public health concern that could have altered the risk vs benefit profile of ibuprofen, to warrant a departure from the current scheduling arrangements.
  • In many international markets, ibuprofen is available through general retail stores. Ibuprofen scheduling in Australia is in line with all major international countries, including the UK, Canada, the USA and New Zealand.
  • Ibuprofen (200 mg in small packs and up to 25 dosage units) has been available through retail stores as an unscheduled medicine since 2003 and as a pharmacy medicine (Schedule 2) for over 2 decades. There is no apparent reason why ibuprofen in small pack sizes should be restricted in a way that sees consumers purchasing from a pharmacy instead of a general retail store.
  • Ibuprofen is currently available from pharmacies in larger pack sizes, allowing consumers to obtain advice when required.
  • Up-scheduling ibuprofen will not provide any significant additional health care professional supervision, with interaction typically provided by a pharmacy assistant, and will only result in reduced access to general pain relief to consumers.
  • Rescheduling would reduce the consumer’s ability to self-select pain medication when pharmacies are closed, especially in rural/remote Australia.
  • Restricting the sale of ibuprofen to pharmacies only would deny Australian consumers appropriate and timely access to a safe and effective analgesic, thereby limiting their ability to effectively treat or manage sudden symptoms or minor ailments. As such, this would have a negative impact on public health.
  • Ibuprofen has an excellent, well known safety profile and the use of labelling and safety warnings facilitates appropriate use by the consumer.
  • Access to ibuprofen is currently similar to that of other products used for short term pain relief such as paracetamol and aspirin.
  • Ibuprofen continues to demonstrate a favourable benefit versus risk profile.
  • Ibuprofen has a wide therapeutic window and when taken orally, the propensity for toxicity in overdose is low. The consequences of misuse of paracetamol are substantially worse than with ibuprofen. There is a low incidence of adverse events relating to the consumption of ibuprofen given the large number of dosage units that are sold unscheduled in Australia.
  • The proposed changes to the scheduling will have a significant impact on consumer choice and convenience, reduce competition and increase cost to consumers.
  • Limiting options and accessibility will not deliver any health benefits to the community. It may result in possible public health consequences such as those arising from increased consumption of paracetamol.
  • Education of at risk patients and improved product labelling would be more effective measures with a greater impact than reduced convenience and impeded access.
  • 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 Required Advisory Statements for Medicine Labelling (RASML), which contains detailed mandatory warning statements in language that consumers are able to understand and act upon.
  • Any increase in regulation should be based on sound evidence that (i) the concerns are based on accurate evidence and (ii) that scheduling changes are the only mechanism for addressing these concerns.
  • Small packs of ibuprofen that are currently exempt (i.e. 25 dosage units / approximately 4 days' supply) can be appropriately selected and used by the reasonable consumer with acceptable safety.
  • A thorough and transparent public examination of the evidence behind this scheduling proposal is required and any regulatory decisions should be consistent with the principles of best practice regulation.

The public submissions will be made available on the TGA website.

Summary of ACMS advice to the delegates

The committee recommended that the current Schedule 2 and Schedule 3 entries for ibuprofen remain appropriate.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (a) risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the advice comprised the following:

  1. the risks and benefits of the use of a substance:
  • Risks:
    • Increased incidence of NSAID (ibuprofen) cardiovascular (CV) effects especially (but not exclusively) in people at risk at high doses and longer duration than OTC doses.
    • There are no new safety concerns. The evidence of potential CV risk associated with OTC doses of ibuprofen is not substantiated (Bally M et al., BMJ 2017).
  • Benefits: 24 hour availability of 24 pack sizes as exempt for acute pain.
  • the purposes for which a substance is to be used and the extent of use of a substance:
    • OTC Indication is for acute pain (1200 mg/day for short term of not more than 4 days).the toxicity of a substance:
  • the toxicity of a substance:
    • Cardiovascular disease and other complications of NSAID use (gastrointestinal, blood pressure, renal impairment); confusion in elderly.
    • Covered by RASML statement.
  • the dosage, formulation, labelling, packaging and presentation of a substance:
    • Covered by RASML statement.
  • the potential for abuse of a substance:
    • Ibuprofen is non-addictive.
    • Minimal risk of misuse or abuse.
  • any other matters that the Secretary considers necessary to protect public health
    • Ibuprofen (200 mg in small packs and up to 25 dosage units) has been available through retail stores as an unscheduled medicine since 2003 and as a Pharmacy Medicine (Schedule 2) for over 2 decades.
    • No evidence provided of excessive use, purchasing or harm through general sale or Schedule 2 availability.
    Delegate's considerations

    The delegate considered the following in regards to this proposal:

    • Scheduling proposal
    • ACMS advice
    • Public submissions received
    • Section 52E of the Therapeutic Goods Act 1989
    • Scheduling Policy Framework (SPF 2015)
    Delegate's interim decision

    The delegate's interim decision is that the current Schedule 2 and Schedule 3 entries for ibuprofen remain appropriate.

    The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: (a) the risks and benefits of the use of the substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of the substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

    The reasons for the recommendation comprised the following:

    1. the risks and benefits of the use of a substance:
    • The October 2014 TGA ‘Review of cardiovascular safety of non-steroidal anti-inflammatory drugs’ stated:
    • Based on the current evidence, there are no major changes required to the availability and warnings on labels for over-the-counter (OTC) diclofenac, ibuprofen and naproxen. These drugs provide effective pain relief when used according to the label at recommended doses for short durations.

    • EMA advice in May 2015 following a review was:
    • No increase in cardiovascular risk is seen with ibuprofen at doses of up to 1,200 mg per day, which is the highest dose generally used for over-the-counter (OTC) preparations taken by mouth in the European Union (EU).
    • There are no new safety concerns. The evidence of potential cardiovascular (CV) risk associated with OTC doses of ibuprofen is not substantiated (Bally M et al., BMJ 2017).
    • Risks: increased incidence of NSAID (ibuprofen) CV effects are especially (but not exclusively) seen in people at risk, at high doses and at longer duration, rather than OTC doses.
    • Benefits
      • 24 hour availability of 24 pack sizes as exempt for acute pain.
      • Ibuprofen has a good safety profile for use at over-the-counter doses and short term therapy.
  • the purposes for which a substance is to be used and the extent of use of a substance:
    • Indication is for acute pain (1200 mg/day for short term of not more than 4 days).
  • the toxicity of a substance:
    • Although there are cardiovascular disease and other complications of NSAID use (gastrointestinal, blood pressure, renal impairment) and confusion in the elderly these are well covered in the labelling as per the RASML statement.
    • Ibuprofen has a wide therapeutic window and when taken orally, the propensity for toxicity in overdose is low.
  • the dosage, formulation, labelling, packaging and presentation of a substance:
    • RASML statement and hence the labelling mitigate any risk.
    • Ibuprofen scheduling in Australia is in line with major international countries including the UK, Canada, the USA and New Zealand.
    • There is 24 hour availability of exempt pack sizes for acute pain as well as easy accessibility in rural/remote areas.
  • the potential for abuse of a substance:
    • Minimal risk of misuse or abuse.
  • any other matters that the Secretary considers necessary to protect public health
    • No evidence provided of excessive use, purchasing or harm through general sale or Schedule 2 availability.
    • Ibuprofen scheduling in Australia is in line with major international countries including the UK, Canada, the USA and New Zealand.

    Footnotes

    1. Bloom L, Blacketer M, Boyle K et al. Aging and the frequency of NSAID-relevant coexisting medical conditions in the primary care setting. Innovation in Aging 2017;1(suppl_1):875.

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