1

Welcome

2

Apologies

3

Confirmation of the minutes of the 57^th meeting held on 1 November 2016

4

Declaration of conflicts of interest

5

Matters arising

5.1

Report on standing agenda items from the 57^th meeting

5.2

Objections to recommendations made at the 57^th meeting

5.3

Update on the classification of nicotine and the regulation of e-cigarettes

In 2016, the Ministry of Health released a consultation document seeking feedback on proposed updates to the regulation of nicotine e-cigarettes in New Zealand.
The Committee will be requested to consider whether and when a reclassification of nicotine may be required to take place to align with any updated regulations

5.4

Final version of the document titled ‘How to change the legal classification of a medicine in New Zealand’

The final version of the document titled ‘How to change the legal classification of a medicine in New Zealand’ will be provided to the Committee for its consideration, prior to the release of the document for consultation following the meeting.

5.5

Medicine reclassification - Proposed additional process when considering the reclassification of prescription medicine to restricted medicine (Pharmacy Council)

The Pharmacy Council (the Council) provided an amended version of their proposed additional process to the medicine reclassification process (PDF 90 KB, 1 page).

The process is intended to provide the MCC with information regarding pharmacist competence to safely and effectively supply a particular medicine to a patient as a restricted medicine. The framework is currently being developed in collaboration with the Pharmaceutical Society of New Zealand and is designed to provide the MCC with assurance regarding Pharmacist Competence Standards, current guidelines or protocols and relevant codes (e.g. Code of Ethics). The process will also enable the Council to provide a recommendation as to whether any formal training or upskilling is required or whether it is within a pharmacist's current competence and knowledge. Advice around screening tools and documentation will also be provided in the report to the MCC.

The original submission can be viewed here.

5.6

Amendments to classification wording

5.6.1

Articaine, lignocaine and prilocaine with or without felypressin – proposed amendment of the classification wording (Dental Council)

This is a submission (PDF 784 KB, 22 pages) that proposes the amendment to the classification wording of articaine, lignocaine and prilocaine with or without felypressin, to include use by oral health therapists.

The appendices (PDF 3 MB, 103 pages) relating to this submission can be found here.

5.6.2

Diphtheria, tetanus and pertussis (acellular, component) vaccine – proposed amendment to the prescription medicine except classification (Green Cross Healthcare Ltd and Natalie Gauld Ltd)

This is a submission (PDF 920 KB, 23 pages) that proposes an amendment to the classification wording of diphtheria, tetanus and pertussis (acellular, component) vaccine by pharmacists to include pregnant women aged 13 years and over. The age limit of non-pregnant women would remain as 18 years and over.  

The appendices (PDF 7.3 MB, 783 pages) relating to this submission can be found here.

5.6.3

Sildenafil – proposed amendment to the prescription medicine except classification (Individual submission)

This is a submission (PDF 69 KB, 8 pages) that proposes two amendments to the restricted medicine entry of sildenafil.

The proposed amendments are:

1. to remove the requirement that it must be supplied in an original manufacturer’s pack
2. to amend the age limit from 35 – 70 years in the classification text to 25 – 70 years.

6

Submissions for reclassification

6.1

Codeine – proposed reclassification of the pharmacy only medicine entry to a more restricted medicine classification
(Medsafe)

This is a Medsafe submission (PDF 281 KB, 16 pages) that proposes the reclassification of codeine currently classified as a pharmacy medicine to a more restrictive classification.

The submission is made following the recommendation made at the 57th meeting, that;

1. an item to consider the reclassification of codeine should be added to the agenda for the 58th meeting for the possible harmonisation with Australia of all pharmacy only entries of codeine to be amended to restricted medicine.
2. Medsafe should review the relationships between the Australian and New Zealand markets, the role of codeine in cough and cold products and whether the benefit of its use outweighs the risk of harm.

6.2

Sedating antihistamines – proposed amendment and reclassification of non-prescription medicine entries to prescription medicine
(Medsafe)

This is a Medsafe submission (PDF 609 KB, 28 pages) to amend and reclassify the non-prescription medicine entries of the following sedating antihistamines to prescription medicines when used in children under 6 years of age for the treatment of nausea, vomiting and travel sickness

1. brompheniramine
2. chlorpheniramine
3. cyclizine
4. dexchlorpheniramine
5. diphenhydramine
6. doxylamine
7. meclozine
8. promethazine
9. trimeprazine

7

New medicines for classification

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

1. Carfilzomib

   Carfilzomib is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy.
   
   Carfilzomib is classified as a prescription medicine in Australia.

2. Dermatophagoides pteronyssinus and Dermatophagoides farinae extract

   Dermatophagoides pteronyssinus and Dermatophagoides farinae extract (American & European HDM extract) is a standardised allergen extract (50%) of the American HDM and the European HDM species, Dermatophagoides pteronyssinus and Dermatophagoides farinae.
   
   In patients with a positive test of house dust mite sensitisation (skin prick test and/or specific IgE), Dermatophagoides pteronyssinus and Dermatophagoides farinae extract is indicated for the treatment of moderate to severe HDM-allergic rhinitis despite use of symptom-relieving medication, and HDM-allergic asthma not responsive to inhaled corticosteroids in adults.
   
   Dermatophagoides pteronyssinus and Dermatophagoides farinae extract are classified as prescription medicines in Australia.

3. Elotuzumab

   Elotuzumab is indicated as a combination therapy for the treatment of multiple myeloma in adult patients who have received one or more prior therapies.
   
   Elotuzumab is classified as a prescription medicine in Australia.

4. Eluxadoline

   Eluxadoline is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D).
   
   Eluxadoline is classified as a prescription medicine in Australia.

5. Ixazomib

   Ixazomib is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy.
   
   Ixazomib is classified as a prescription medicine in Australia.

6. Lenvatinib

   Lenvatinib is indicated for the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer.
   
   Lenvatinib is classified as a prescription medicine in Australia.

7. Lipegfilgrastim

   Lipegfilgrastim is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.
   
   Lipegfilgrastim is classified as a prescription medicine in Australia.

8. Lumacaftor

   Lumacaftor is a component of the FDC product ORKAMBI (lumacaftor/ivacaftor), which is indicated for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene.
   
   Lumacaftor is classified as prescription medicine in Australia.

9. Nintedanib

   Nintedanib esilate is indicated, in combination with docetaxel, for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after failure of first line chemotherapy. OFEV is also indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
   
   Nintedanib is classified as a prescription medicine in Australia.

10. Sarilumab

    Sarilumab, in combination with non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), is indicated for the treatment of moderate to severe Rheumatoid Arthritis in adult patients who have had an inadequate response or intolerance to one or more DMARDs.
    
    Sarilumab is classified as a prescription medicine in Australia.

11. Sodium zirconium cyclosilicate

    Sodium zirconium cyclosilicate is indicated for the treatment of hyperkalaemia in adult patients.
    
    Sodium zirconium cyclosilicate is classified as a prescription medicine in Australia.

12. Sonidegib

    Sonidegib diphosphate is indicated for the treatment of adult patients with:
    Locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
    Metastatic BCC.
    
    Sonidegib is classified as a prescription medicine in Australia.

13. Talimogene laherparepvec

    Talimogene laherparepvec is indicated for the treatment of melanoma that is regionally or distantly metastatic.
    
    Talimogene laherparepvec is classified as a prescription medicine in Australia.

14. Venetoclax

    Venetoclax is indicated for patients with relapsed/refractory chronic lymphocytic leukaemia with 17p deletion and for patients without 17p deletion who have no other suitable treatment options.
    
    Venetoclax is classified as a prescription medicine in Australia.

8.2

Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary's Delegate)

8.2.1

Decisions by the Delegate – March 2016

1. Performance and image enhancing drugs

   The Australian Delegate recommended that a new Schedule 4 (prescription medicine) entries should be created for Thymosin Beta 4, TB-500 fibroblast growth factors.

2. Proton pump inhibitors

   The Australian Delegate recommended that the Schedule 3 (restricted medicine) entry of lansoprazole, omeprazole and rabeprazole should be down-scheduled to Schedule 2 (pharmacy only medicine) as follows:

   1. lansoprazole in oral preparations containing 15 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply, be down-scheduled from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy only medicine)
   2. omeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply, be down-scheduled from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy only medicine)
   3. rabeprazole in oral preparations containing 10 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days' supply, be down-scheduled from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy only medicine).

8.2.2

Decisions by the Delegate – July 2016

1. Fexofenadine

   The Australian Delegate recommended that the unscheduled entry of fexofenadine should be amended to when in divided preparations for the treatment of seasonal allergic rhinitis (SAR) in adults and children 12 years of age and over when labelled with a recommended daily dose not exceeding 120 mg of fexofenadine from not more than 5 days' supply to not more than 10 days' supply.

2. Ulipristal

   The Australian Delegate recommended that a new Schedule 3 (restricted medicine) entry should be created for ulipristal for emergency post-coital contraception.

9

Agenda items for the next meeting

10

General business

10.1

Update to the Members’ Handbook

11

Date of next meeting