Sedating antihistamines can be used for a range of indications in both adults and children, depending on the active pharmaceutical ingredient and product. Medicines containing sedating antihistamines may be used for insomnia or sedation.

The Medicines Adverse Reactions Committee (MARC) reviewed sedating antihistamines for sedation at the 182^nd meeting (11 June 2020). The MARC recommended that the indication for sedation of children be removed from all over-the-counter medicines (OTC) containing sedating antihistamines.

Medsafe published a Prescriber Update (41(4):68) on the 3 December 2020 to inform healthcare professionals that oral sedating antihistamines for sedation are for use in adults only and for insomnia are for use in adults and adolescents aged 12 years and over.

Currently, the OTC classification statements for insomnia have no age limit and those for sedation have a lower age limit of over 2 years old. This submission (PDF, 519KB, 18 pages) proposes that the classification statements of sedating antihistamines are updated to align with MARC recommendations.

6.2 Respiratory syncytial virus vaccine, adjuvanted – proposed classification to enable administration without prescription (GlaxoSmithKline Australia Pty Ltd).

This submission (PDF, 193KB, 12 pages) is a proposal for the classification of respiratory syncytial virus (RSV) vaccines to be:

Prescription except when injected by a vaccinator who has successfully completed the Vaccinator Foundation Course (or equivalent course) approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health, but excluding COVID-19 Vaccinators Working Under Supervision, Provisional Vaccinators, Provisional Pharmacist Vaccinators, and Vaccinating Health Workers, or when specified elsewhere in this schedule.

For simplicity, vaccines are frequently group classified by the disease they are indicated for rather than the associated active pharmaceutical ingredient. For example, cholera vaccine, COVID-19 vaccine, influenza vaccine.

Due to their novelty, RSV vaccines are not yet specifically classified in New Zealand. However, it should be noted that all vaccines are included under the group classification for vaccines which is as follows:

Prescription except when specified elsewhere in this schedule.

New medicines for classification

The following new chemical entities were submitted to the Committee for classification.

7. New chemical entities

There are no new medicines applications that have been submitted to Medsafe containing new chemical entities (NCEs) that require classification at the 72^nd meeting.

8. Harmonisation of the New Zealand and Australian schedules

Recent scheduling changes made to the Poisons Standard in Australia are to be considered by the Medicines Classification Committee for their implementation in New Zealand.

Public consultation is an important part of the Medicines Classification Committee process, stakeholders are welcome to provide comment on all agenda items including those being considered for harmonisation.

The Medsafe Medicines Classification Committee- Public Consultation on Agenda Items webpage provides information on how to comment on agenda items.

8.1 New chemical entities which are not yet classified in New Zealand

25 January 2024 Scheduling Final Decisions Public Notice

8.1a Palovarotene

Palovarotene is indicated for reduction in the volume of new heterotopic ossification in adults and children aged 8 years or older for females and 10 years or older for males with fibrodysplasia ossificans progressive (FOP).

From 1 February 2024 palovarotene was classified as a Schedule 4 (prescription medicine) in Australia.

15 December 2023 Scheduling Final Decisions Public Notice

8.1b Nirsevimab

Nirsevimab-alip is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for prevention of RSV lower respiratory tract disease in neonates and infants under certain conditions.

From 1 February 2024 nirsevemab was classified as a Schedule 4 (prescription medicine) in Australia.

8.2 Decisions by the Secretary to Department of Health and Aged Care Australia (or the Secretary’s Delegate).

15 December 2023 Scheduling Final Decisions Public Notice

8.2.1 Bisacodyl

The Australian Government has made the final decision to schedule bisacodyl. Previously, medicines containing bisacodyl have been available unscheduled in Australia. From the 1 February 2025 bisacodyl will be scheduled as:

Schedule 2 (pharmacy-only):

in divided preparations for oral use except in a primary pack containing 20 dosage units or less containing 5 g or less bisacodyl per dosage unit; or
in divided preparations for rectal use except:
in a primary pack containing 12 dosage units or less suppositories containing 10 mg or less of bisacodyl per dosage unit; or
in a primary pack containing 25 dosage units or less enemas containing 10 mg or less of bisacodyl per dosage unit.

Bisacodyl is a stimulant laxative which increases peristalsis through contact with nerve endings in the colonic mucosa and promotes accumulation of water and electrolytes in the colonic lumen, to enhance movement of bowel motions through the colon and rectum.

Bisacodyl is currently classified as a pharmacy-only medicine in New Zealand.

The MCC will consider at the 72^nd meeting whether it would appropriate in a New Zealand context to harmonise the classification of bisacodyl with Australia.

8.2.2 Olopatadine

The Australian Government has made a final decision to reschedule olopatadine from Schedule 4 (prescription only) to:

Schedule 4 (prescription only); except when included in Schedule 2

Schedule 2 (pharmacy-only); in preparations for nasal use delivering 600 micrograms or less of olopatadine per dose when the maximum recommended daily dose is no greater than 4,800 micrograms for the treatment of allergic rhinitis or rhinoconjunctivitis for up to 6 months in adults and children 12 years of age and over.

This scheduling change was implemented on 1 February 2024.

Olopatadine is a relatively selective H-1 receptor histamine antagonist and inhibitor of histamine release from the mast cell. Olopatadine hydrochloride is indicated for seasonal allergic rhinitis, allergic conjunctivitis and perennial allergic rhinitis under certain conditions.

Olopatadine is classified as a prescription medicine in New Zealand.

There are currently only medicines containing olopatadine in ophthalmic dosage forms available in New Zealand. There are no medicines containing olopatadine that are currently available for nasal use in New Zealand.

The MCC will consider at the 72^nd meeting whether it would appropriate in a New Zealand context to harmonise the classification of olopatadine with Australia.

9. Agenda items for the next meeting

10. General business

11. Date of the next meeting

MEDSAFE

New Zealand Medicines and Medical Devices Safety Authority

Committees

Agenda for the 72^nd meeting of the Medicines Classification Committee to be held in Wellington on 12 June 2024.

1. Welcome

2. Apologies

3. Confirmation of the minutes of the 71^st meeting held on 14 December 2023

4. Declaration of conflicts of interest

5. Matters arising

5.1 Objections to recommendations made at the 71^st meeting

6. Submissions for reclassification

6.1 Sedating antihistamines – proposed inclusion of age restrictions in classification statements of sedating antihistamines when indicated for insomnia or sedation (Medsafe)

6.2 Respiratory syncytial virus vaccine, adjuvanted – proposed classification to enable administration without prescription (GlaxoSmithKline Australia Pty Ltd).

New medicines for classification

7. New chemical entities

8. Harmonisation of the New Zealand and Australian schedules