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Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS, ACCS and Joint ACMS-ACCS meetings, November 2020
Scheduling of chemicals and poisons
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2. Interim decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #32, November 2020)
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2.2 Interim decision in relation to bilastine
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 bilastine as follows:
Schedule 4 - Amend Entry
Schedule 3 - New Entry
Appendix H - New Entry
Index - Amend Entry
In making this interim decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to bilastine;
- The 127 public submissions, including three written 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 #32);
- 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; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.
- 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 advised that bilastine be entered in Schedule 4 and Schedule 3 in the Poisons Standard as follows:
Schedule 4 - New Entry
Schedule 3 - New Entry
Appendix H - New Entry
Index - Amend Entry
cross reference: ASTEMIZOLE, AZELASTINE, DESLORATADINE, FEXOFENADINE, LORATADINE, TERFENADINE, CETIRIZINE
Appendix F, Part 3
The Committee also recommended an implementation date of 1 June 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; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.
The reasons for the advice included:
- the risks and benefits of the use of a substance:
- Potential of substance to mask symptoms of common cold, or more serious dermatological conditions.
- Bilastine is a potent non-sedating antihistamine (second generation) with a high affinity for H1 receptors. It has a strong safety profile having been available internationally for over 10 years and is marketed in around 100 countries around the world, including in NZ where it has been marketed as a pharmacy medicine since 2018.
- Effective symptomatic treatment of allergic rhinitis and urticarial.
- the purposes for which a substance is to be used and the extent of use of a substance:
- Approved for the symptomatic treatment of allergic rhinoconjunctivitis (both seasonal and perennial) and urticarial which are common conditions that are considered to be suitable for self-management by consumers.
- Histamine has been shown to play a central role in most of the symptoms of allergic rhinitis primarily by its action at the H1-receptor site. Urticaria is also primarily mediated by the effects of histamine following degranulation of mast cells. Anti-histamines are first line treatment options for these common conditions. As another 2nd generation antihistamine in addition to those already available in pharmacies to consumers, bilastine offers another similar treatment option.
- the toxicity of a substance:
- Risk profile relatively well understood with overseas safety data, wide therapeutic index.
- Certain drug interactions noted:
Ketoconazole and erythromycin increase bilastine concentration two-three fold.
Diltiazem increases bilastine concentration by 50%.
- Food interactions: interaction with grapefruit juice reduces bioavailability. Food reduces oral bioavailability by up to 30%.
- There are considerable data in support of the safety of bilastine from nonclinical and clinical trials. Clinical studies have demonstrated the safety and tolerability of bilastine with no statistically significant differences in adverse effects between the therapeutic dose (20 mg) and placebo.
- Headache, drowsiness, and lethargy are the most common adverse events reported by patients.
- the dosage, formulation, labelling, packaging and presentation of a substance:
- 20mg immediate release tablet for once daily dosing, to be taken at least 1 hour before or 2 hours after food, grapefruit or other fruit juices.
- Proposed packaging size 4-60 tablets per pack size (blister pack).
- CMI to be included.
- Cautionary labelling in respect to indications, age (not for use in children) and seeking advice if pregnant.
Reasons for the interim decision (including findings on material questions of fact)
I have made an interim decision to amend the Schedule 4 entry for bilastine and create a new Schedule 3 entry for bilastine in the current Poisons Standard. I note that effective 1 February 2021, a decision was made to list bilastine in Schedule 4 of the Poisons Standard. This decision was not published at the time of the November Committee meeting and I have made my decision based on the current listing of bilastine in the Poisons Standard.
My decision is to down-schedule bilastine from Schedule 4 to Schedule 3 when bilastine is divided in oral preparations containing 20 mg or less to adults and adolescents 12 years of age and over. I find that there is sufficient information to support the safety and lower toxicity of bilastine in these preparations. Bilastine has a well-defined safety and tolerability profile, with a wide therapeutic index. The daily dose of 20mg had been determined for adults and adolescents over the age of 12 years of age, noting that 10mg is reported as safe in children (6-11 years) with a body weight of at least 20kg.
Bilastine is a new second generation non-sedating antihistamine (NSAH). Bilastine belongs to the same pharmacological class as other Schedule 2 substances such as fexofenadine, loratadine and cetirizine, which are also used for the symptomatic treatment of allergic rhinitis and urticaria. My decision to down-schedule to Schedule 3, rather than Schedule 2, aims to ensure more appropriate support to Australian consumers, and to facilitate monitoring and reporting of pharmacovigilance factors through pharmacist interactions. As a newly registered product in Australia, bilastine does not have sufficient local experience or data on which to base a Schedule 2 entry. I am not satisfied bilastine can be supplied with reasonable safety without access to health professional advice. Self-selection without pharmacist input could lead to confusion and misuse, including a potential for doubling up on antihistamines. Additionally, drug-drug interactions have been documented, with considerable caution required for consumers with renal impairment using P-glycoprotein inhibitors. Future scheduling consideration may be warranted if further evidence of safety in the Australian context, is made available.
Having considered the matters set out in the Guidelines for advertisements for medicines containing Schedule 3 substances (pdf,166kb), I am satisfied that there are no foreseeable potential impacts on public health that would preclude advertising bilastine directly to consumers through the provision of an Appendix H listing.
I have taken into account all of the public submissions, including those from the Australasian College of Dermatologists (ACD), the Australian Medical Association (AMA) and The Pharmacy Guild of Australia (PGA). Both the ACD and the AMA support the down-scheduling of bilastine to Schedule 2. However, I agree with the submission from the PGA, that bilastine is a new substance on the Australian market and as such, it requires a higher level of health professional input and oversight than is expected under Schedule 2.
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 purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.
Proposed implementation date
1 June 2021