Committees

Minutes for the 72^nd meeting of the Medicines Classification Committee held at 133 Molesworth Street, Wellington on 12 June 2024

Welcome
Apologies
Confirmation of the minutes of the 71^st meeting held on 14 December 2023.
Declaration of conflicts of interest
Matters arising

5.1 Objections to recommendations made at the 71^st meeting

Submissions for reclassification

6.1 Sedating antihistamines – proposed inclusion of age restrictions in classification statements of sedating antihistamines when indicated for insomnia or s edation (Medsafe)
6.2 Respiratory Syncytial Virus vaccine, adjuvanted – proposed classification to allow administration without prescription (GlaxoSmithKline Australia Pty Ltd)

New Chemical Entities
Harmonisation of New Zealand and Australian schedule

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

8.1a Palovarotene
8.1b Nirsevimab

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

8.2.2 Bisacodyl
8.2.2 Olopatadine

Agenda items for the next meeting
General business
Date of the next meeting

Present:

Alison Cossar (Chair)
Dr Tim Hanlon
Dr Ben Hudson
Dr Marcia Walker
Megan Peters
Bronwen Shepherd
Jessica Crockett (Secretariat)

In attendance from Medsafe;

Matthew Spencer (Manager, Product Regulation)
Susan Kenyon (Manager, Clinical Risk)
Leah Russell (Team Leader, Product Regulation)
Lily Chan (Principal Technical Specialist, Clinical Risk)

Observing (from Medsafe):

Karen Fu, Advisor (Science), Product Regulation

1. Welcome

The new Chair of the Medicines Classification Committee (MCC), Alison Cossar, opened the meeting at 9:30am with a karakia.

The Chair introduced the new Ministry of Health member, Dr Tim Hanlon, to the Committee.

2. Apologies

No apologies were received for this meeting.

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

The minutes of the 71^st meeting were accepted as a true and accurate record. The minutes had been signed digitally prior to this meeting.

4. Declaration of conflicts of interest

No members had conflicts of interest which would preclude their participation in the meeting.

5. Matters arising

5.1 Objections to recommendations made at the 71^st meeting

The objection period for the 71^st meeting closed on the 28 March 2024. Information on how to submit an objection to an MCC recommendation can be found on page 11 of the ‘How to change the legal classification of a medicine in New Zealand’ (PDF, 542KB, 19 pages) guidance document.

Three objections were received regarding the MCC’s recommendation for the reclassification of brimonidine, the Minister of Health’s delegate for medicine classification has decided to refer brimonidine to a future MCC meeting for further consideration.

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)

Purpose

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.

Background

The MCC noted that the submission for reclassification of sedating antihistamines includes the following medicines: brompheniramine, chlorpheniramine, cyclizine, dexchlorpheniramine, diphenhydramine, doxylamine, meclozine, mepyramine, pheniramine, promethazine.

The MCC noted that this submission for reclassification is in response to a MARC recommendation that the indication for sedation of children be removed from all OTC sedating antihistamines. The MCC noted that the MARC advised that sedation of children should only occur under the guidance of a medical practitioner.

The MCC noted that there are currently only four approved products containing sedating antihistamines with indications for insomnia or sedation in New Zealand.

The MCC noted that the submission also proposes to remove reference to a ‘sealed container’ in the classification conditions given this statement has no legislative meaning. Any requirement for a ‘sealed container’ is proposed to be replaced with a requirement for a ‘manufacturer’s original pack’.

The MCC noted that the restricted classification conditions for all sedating antihistamines included in this submission (except meclozine) are proposed to be updated to the following:

Restricted; for oral use in medicines for adults or children over 2 years of age other than in medicines used for sedation or the treatment of insomnia; for oral use for the treatment of insomnia in adults and children 12 years of age and older when sold in the manufacturer's original pack containing not more than 10 dosage units; For oral use for sedation in adults only when sold in the manufacturer’s original pack.

The MCC noted that the restricted classification conditions for meclozine are proposed to be updated to the following:

Restricted; for oral use for the treatment of insomnia in adults and children over 12 years of age when sold in the manufacturer’s original pack containing not more than 10 dosage units.

The MCC noted that following the publication of the 72^nd meeting agenda Medsafe published an Alert Communication on the 13 May 2024 for Promethazine (oral): Do not use in children under 6 years of age due to the risk of psychiatric and central nervous system side effects. This Alert Communication states that oral dose form promethazine is now contraindicated in children under 6 years of age due to safety risks.

Comments

Three comments were received regarding the sedating antihistamine agenda item; all comments were in support of the proposal to reclassify sedating antihistamines when used for sedation or insomnia.

Discussion

The MCC considered the Medsafe Alert Communication regarding promethazine and discussed the safety risks associated with the use of sedating antihistamines in children under 6 years of age.

The MCC noted that it would not be within pharmacist’s usual practice to supply sedating antihistamines for use in children under 6 years old. The MCC also considered that there are more appropriate medicines for children under 6 years, for example for indications of allergies there are non-sedating antihistamines.

The MCC acknowledged that this submission only proposed classification changes to restrict use in children for sedating antihistamines when indicated for sedation and insomnia. However, the MCC considered that recent safety information provides evidence that oral sedating antihistamines should be restricted to use in children and adults over 6 years old regardless of the indication and that the classification statements should reflect this. The MCC recommended that any OTC classification conditions for sedating antihistamines in oral-dose forms should be restricted to use in adults and children over 6 years of age.

Recommendation

The MCC recommended that sedating antihistamines be reclassified as follows (changes to the current classification conditions are bolded):

Brompheniramine: