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Committees

Published: 15 August 2017

Agenda for the 59th meeting of the Medicines Classification Committee to be held in Wellington on Tuesday 7 NOVEMBER 2017 at 9:30 am

1

Welcome

2

Apologies

3

Confirmation of the minutes of the 58th meeting held on 16 may 2017

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 58th meeting

No valid objections have been received.

5.2

Report on standing agenda items from the 58th meeting

5.3

Codeine – proposed reclassification from pharmacy-only and restricted medicines to a more restricted classification

At the 58th meeting, the Committee recommended that the sector would need to answer the following questions to allow codeine to continue to be available without prescription:

  1. what education and continuing professional development would be provided to health professionals regarding the sale and prescription of codeine to minimise the risk of misuse and addiction in consumers?
  2. how will the sector fill the data gap with respect to over-the-counter codeine use?
  3. how will the sector track the sale of codeine in pharmacy in order to better identify consumers with additional needs for pain management and / or addiction problems?

The Committee will consider any information received from the sector before making a recommendation on the reclassification of codeine.

5.4

Principles of harmonisation

At the 58th meeting, the Committee recommended that the principles of harmonisation should be added to the agenda of this meeting.

The Committee considered a number of decisions recommended by the Australian Delegate regarding proton pump inhibitors, fexofenadine and ulipristal. At the 58th meeting the Committee commented that it was difficult to harmonise with Australia when only the minutes of their deliberations were provided.

The principles of harmonisation are available on the Medsafe website and will be considered by the Committee.

5.5

Matters arising for information

5.5.1

Classification of lisdexamfetamine and palbociclib

An out-of-session consultation took place in June 2017 regarding the classification of lisdexamfetamine and palbociclib.

The Committee recommended that lisdexamfetamine and palbociclib should be classified as prescription medicines.

These classification recommendations were gazetted on 22 June 2017.

6

Submissions for reclassification

6.1

Hydrocortisone – proposed reclassification from prescription medicine to restricted medicine
(Zovirax Duo, GlaxoSmithKline Consumer Healthcare New Zealand Limited)

This is a company submission (PDF, 523 KB, 34 pages) requesting the reclassification of hydrocortisone 1% w/w from prescription medicine to restricted medicine when combined with aciclovir 5% w/w in primary packs of not more than 2 g for dermal use in adults or children 12 years of age and older for the treatment of herpes labialis (cold sores).

6.2

Penciclovir – proposed reclassification from pharmacy-only medicine to general sale medicinee
(Vectavir, Orion Laboratories (New Zealand) Limited)

This is a company submission (PDF, 12,038 KB, 20 pages) requesting the reclassification of penciclovir from pharmacy-only medicine to general sale medicine when for external use for the treatment of herpes labialis.

7

New medicines for classification

7.1

Patent blue V – Patent blue V 25 mg/mL solution for injection (TT50-10054)

Patent Blue V is injected subcutaneously under local anaesthesia. The usual injection site is the back of the foot or hand at the level of the first and fourth interdigital spaces. After massage and passive movement of the hand or foot, a skin incision is made transversely, or in the direction of the lymph vessel, and the stained lymph vessel is exposed. Patent Blue V is generally administered once during the lymphographic examination.

Patent Blue V is indicated for diagnostic use only, for marking:

  1. lymph vessels and arterial regions
  2. sentinel nodes before biopsy in patients with operable breast cancer.

At the 23rd meeting on 25 May 2000, the Committee recommended that radiographic contrast media should be reclassified from prescription medicines to general sale medicines. However, Patent Blue V is not a radiographic contrast agent.

A similar product currently marketed, Proveblue 50 mg / 10 mL solution for injection (TT50-9882), is classified as a prescription medicine.

The Committee is asked to consider classifying Patent Blue V as a prescription medicine.

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

8.1.1

Bezlotoxumab (June 2017)


Bezlotoxumab is indicated for the prevention of Clostridium difficile infection (CDI) recurrence in patients 18 years or older receiving antibiotic therapy for CDI.
Bezlotoxumab is already classified in Australia and New Zealand as a prescription medicine under the group entry of monoclonal antibodies.
From 1 October 2017, bezlotoxumab is classified as a prescription medicine in Australia.

8.1.2

Brexpiprazole (May 2017)


Brexpiprazole is indicated for the treatment of schizophrenia in adults.
From 1 June 2017, brexpiprazole is classified as a prescription medicine in Australia.

8.1.3

Ceritinib (March 2017)


Ceritinib is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or who are intolerant of crizotinib.
From 1 June 2017, ceritinib is classified as a prescription medicine in Australia.

8.1.4

Dengue Vaccine (March 2017)


Live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4) is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 through 60 years of age living in endemic areas.
From 1 June 2017, Dengue Vaccine (live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4)) is classified as a prescription medicine in Australia.

8.1.5

Dupilumab (June 2017)


Dupilumab is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupilumab can be used with or without topical therapy.
Dupilumab is already classified in Australia and New Zealand as a prescription medicine under the group entry of monoclonal antibodies.
From 1 October 2017, dupiloumab is classified as a prescription medicine in Australia.

8.1.6

Fosfomycin (June 2017)


The proposed indications for Fosfomycin (with trometamol) is for treatment of acute uncomplicated lower urinary tract infections, caused by pathogens sensitive to fosfomycin, in women above 12 years of age and for prophylaxis of urinary tract infections in surgical or diagnostic procedures involving the lower urinary tract in adult males and females.
From 1 October 2017, fosfomycin is classified as a prescription medicine in Australia.

8.1.7

Guanfacine (March 2017)


Guanfacine hydrochloride is a central alpha2A-adrenergic receptor agonist and is indicated for the treatment of Attention Deficit Hyperactivity Disorder in paediatric patients (children and adolescents 6-17 years old inclusive).
From 1 June 2017, guanfacine is classified as a prescription medicine in Australia.

8.1.8

Meningococcal Group B Vaccine (March 2017)


Meningococcal Group B Vaccine is indicated for individuals ten years and older for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
Meningococcal Group B Vaccine is already classified in Australia and New Zealand as a prescription medicine under the group entry of Meningococcal Vaccine.
From 1 June 2017, Meningococcal Group B Vaccine is classified as a prescription medicine in Australia.

8.1.9

Migalastat (June 2017)


Migalastat is indicated for long-term treatment of adult and adolescent patients 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.
From 1 October 2017, migalastat is classified as a prescription medicine in Australia.

8.1.10

Panobinostat (March 2017)


Panobinostat lactate, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma, who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
From 1 June 2017, panobinostat is classified as a prescription medicine in Australia.

8.1.11

Sebelipase alfa (March 2017)


Sebelipase alfa is indicated for long-term enzyme replacement therapy in patients of all ages with lysosomal acid lipase deficiency.
From 1 June 2017, sebelipase alfa is classified as a prescription medicine in Australia.

8.1.12

Silodosin (March 2017)


Silodosin is indicated for the relief of lower urinary tract associated with benign prostatic hyperplasia in adult men.
From 1 June 2017, silodosin is classified as a prescription medicine in Australia.

8.1.13

Tianeptine (March 2017)


Tianeptine is considered as an anti-depressive agent and is used for the treatment of major depressive disorder.
From 1 June 2017, tianeptine 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 2017

  1. Cetirizine
    Cetirizine hydrochloride should be reclassified from Schedule 2 (pharmacy-only medicine) to unscheduled (general sale medicine) when in preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over, when in a maximum pack size of 10 days’ supply labelled with a recommended daily dose not exceeding 10 mg of cetirizine hydrochloride.

8.2.2

Decisions by the Delegate – June 2017


Decisions included under agenda item 8.1

9

Agenda items for the next meeting

10

General business

11

Date of next meeting

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