3 Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)
3.5 Interim decision in relation to ibuprofen
Note
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Interim decision
Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment, made an interim decision to amend the current Poisons Standard in relation to ibuprofen as follows:
Schedule 2 - Amend Entry
IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:
- in liquid preparations when sold in the manufacturer's original pack containing 8 g or less of ibuprofen; or
- in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:
- as the only therapeutically active constituent (other than phenylephrine or when combined with an effervescent agent);
- packed in blister or strip packaging or in a container with a child-resistant closure;
- in a primary pack containing not more than 25 dosage units;
- compliant with the requirements of the Required Advisory Statements for Medicine Labels;
- not labelled for the treatment of children 6 years of age or less; and
- not labelled for the treatment of children under 12 years of age when combined with phenylephrine.
- in divided immediate release preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units, when labelled:
- not for the treatment of children under 12 years of age.
Materials considered
In making this interim decision, the Delegate considered the following material:
- The application to amend to amend the current Poisons Standard with respect to ibuprofen;
- The eight public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
- The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
- Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (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 considered necessary to protect public health;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
- The Scheduling handbook: Guidance for amending the Poisons Standard.
Summary of ACMS advice to the Delegate
The Committee recommended that the current Schedule 2 entry for ibuprofen in the Poisons Standard be amended as follows:
Schedule 2 - Amend Entry
IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:
- in liquid preparations when sold in the manufacturer's original pack containing 8 g or less of ibuprofen; or
- in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:
- as the only therapeutically active constituent (other than phenylephrine or when combined with an effervescent agent);
- packed in blister or strip packaging or in a container with a child-resistant closure;
- in a primary pack containing not more than 25 dosage units;
- compliant with the requirements of the Required Advisory Statements for Medicine Labels;
- not labelled for the treatment of children 6 years of age or less; and
- not labelled for the treatment of children under 12 years of age when combined with phenylephrine.
- in divided immediate release preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units, when labelled:
- not for the treatment of children under 12 years of age.
The Committee also recommended an implementation date of 1 February 2021.
Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (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 considered necessary to protect public health.
The reasons for the advice included:
a - the risks and benefits of the use of a substance:
- Risks
- Increased risk to the elderly, those with cardiovascular disease, renal disease and asthma and a rare incidence of hypersensitivity reactions and liver damage.
- It should not be taken in children younger than 12 years, or by women in the first three months of pregnancy.
- Increased risk of GI bleeding in persons who have a past history of gastric bleeding, stomach ulcers or prolonged use of ibuprofen.
- It should not be taken by those who have an allergy to aspirin or NSAIDs.
- The risks are consistent with other already unscheduled and S2 ibuprofen products.
- Benefits
- Relief of pain and fever.
- Ibuprofen is well tolerated with an excellent safety profile at these dosages.
- Only a single tablet is required to be taken.
b - the purposes for which a substance is to be used and the extent of use of a substance:
- Short term treatment for the relief of mild to moderate pain and fever associated with colds and flu, headaches, back pain, muscular aches and pain, dental related pain, arthritis, primary dysmenorrhoea, and other inflammatory conditions.
c - the toxicity of a substance:
- Minimal toxicity at recommended dosage.
d - the dosage, formulation, labelling, packaging and presentation of a substance:
- 400mg tablets in an immediate release formulation in a pack of 12 dosage units.
- Labelled with 'DOUBLE STRENTH'.
- RASML Warning labelling is appropriate.
- The small size of the pack at 12 tablets is consistent with short-term use and is a significant mitigation for concern around excessive doses.
- Risk around dose confusion mitigated by labelling.
e - the potential for abuse of a substance:
- Low.
f - any other matters considered necessary to protect public health:
- Change the wording of the proposed scheduling entry to exclude the modified release formulation. The experience with modified release products is limited.
- Ibuprofen modified release does not have the same safety profile as immediate release formulations, is designed to manage persistent pain and is not recommended to be included for down scheduling.
- Committee recommends that that the term 'strong pain' would not be appropriate to use in advertising or labelling and that labelling should be closely looked at to mitigate risks.
- The potential for confusion with multiple products makes labelling and education through advertising important for risk mitigation.
- Targeted consumer education campaign around the new dosage regime and need for consumers to read the label is recommended.
Reasons for the interim decision (including findings on material questions of fact)
I have made an interim decision to amend the Schedule 2 entry for ibuprofen in the Poisons Standard. The reasons for my decision are set out below.
It is my view that the net benefits of broadening the availability of immediate release ibuprofen with restrictions placed on age, dosage form and pack size, combined with warning labels, outweighs the potential risks associated with improper use.
I have made the decision to limit the new entry to immediate release formulations, as modified release ibuprofen has limited clinical experience and a very different use profile. Ibuprofen modified release is designed to help manage recurrent or chronic pain and therefore requires pharmacist intervention to ensure the quality use of the medicine. For this reason, modified release ibuprofen should remain in Schedule 3 and has been excluded from this amendment.
I have determined that ibuprofen at this dosage level and pack restriction, meets the Schedule 2 Scheduling Factors outlined in the Scheduling Policy Framework (SPF) 2018. I took into account that ibuprofen has a wide therapeutic index and the risk from harm from overdose is minimal. I consider the risk profile of ibuprofen to be superior to that of other nonsteroidal anti-inflammatory drugs (NSAIDs) and compared to combination paracetamol+ibuprofen formulations currently available in Schedule 2. I have considered that very large doses of ibuprofen are required for moderate to severe toxicity (>/= 400mg/kg or 28 g for a 70 kg person) and that a 400 mg 12-dosage pack contains only 4.8 g ibuprofen. There is unlikely to be any increased safety risk when taken according to directions, noting the availability of 20 g ibuprofen in the 100 pack of 200 mg tabs (with a maximum dose of 1200mg/day) is currently available under Schedule 2.
I have considered the views expressed in the public submissions and acknowledge that there is concerns regarding the established pain relief culture of taking two tablets, which may lead to the risk of double-dosing. However, I am of the view that this risk is not unique to double strength ibuprofen. It is my understanding that products with double strength formulations have been available under Schedule 2 for many years. I also consider that the pack restrictions mitigate any significant risk. If a consumer took double the recommended dose (i.e. 800 mg/day) they would take a non-toxic dose and consume the supply in 1.5 days.
I am satisfied that the Schedule 2 criteria have been met and the quality use of 400 mg ibuprofen immediate release can be achieved through appropriate labelling, packaging and provision of professional advice when necessary, mitigating risks associated with incorrect dosing.
I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the 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 of a substance; (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.
Proposed implementation date
1 February 2021