1
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Welcome
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2
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Apologies
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3
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Confirmation of the Minutes of the 47th
Meeting Held on Tuesday 1 May 2012
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4
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Declaration of conflicts of interest
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5
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Matters Arising
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5.1
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Objections to recommendations made at
the 47th meeting
No objections have been received.
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5.2
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Classification criteria
As suggested by a member at the 47th meeting, the
Committee will review the factors when considering a medicine for
reclassification for non-prescription sale.
The classification criteria currently used by the Committee can
be found on the Medsafe website at
www.medsafe.govt.nz/download/How_to_change_medicine_classification.pdf.
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5.3
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Bifonazole
(Caneston Once Daily Bifonazole Athlete's Foot and Caneston Once
Daily Bifonazole Body, Bayer New Zealand Limited)
At the 46th meeting on 15 November 2011, the Committee
recommended that a number of medicines, used by Podiatrists and
currently classified as pharmacy-only medicines, should include
the wording 'except when sold in practice by a podiatrist registered
with the Podiatrists Board'.
This is a submission from Bayer New Zealand Limited for the reclassification
of bifonazole so that the pharmacy-only classification includes
the wording 'except when sold in practice by a podiatrist registered
with the Podiatrists Board'.
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5.4
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Influenza vaccine
(Pharmacybrands Limited)
At the 47th meeting, the Committee recommended that influenza
vaccine should be reclassified from prescription medicine to prescription
medicine except when administered to an adult by a pharmacist who
has successfully completed the New Zealand Qualifications Authority
approved vaccinator's training course and is complying with the
immunisation standards of the Ministry of Health. On 12 July 2012
the classification of influenza vaccine was gazetted as a prescription
medicine; except when administered to an adult in a pharmacy by
a registered pharmacist who has successfully completed the New Zealand
Qualifications Authority approved vaccinator training course and
is complying with the immunisation standards of the Ministry of
Health.
Following the gazette notice, Pharmacybrands Limited have requested
that the classification wording for the influenza vaccine be reviewed
to clarify the adult age (to '18 years of age or over'), to consider
whether the words 'in a pharmacy' are necessary and to reword the
provider requirements for the vaccinator course (to 'has successfully
completed the Immunisation Advisory Centre vaccinator training course').
The Committee will consider this request.
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6
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Submission for Reclassification
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6.1
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Diphtheria, tetanus and pertussis (acellular,
component) vaccine
(Pharmacybrands Limited)
This is a submission (Adobe
PDF file 660kb) from Pharmacybrands Limited (the parent company
for Life, Unichem, Amcal, Radius and Care Pharmacies in New Zealand)
for the reclassification of diphtheria, tetanus and pertussis (acellular,
component) vaccine in a single dose from prescription medicine to
prescription medicine except when administered to a person aged
16 years or over by a pharmacist who has successfully completed
the Immunisation Advisory Centre vaccinator course and is complying
with the immunisation standards of the Ministry of Health.
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6.2
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Hydrocortisone topical preparations
(Caneston Plus, Bayer New Zealand Limited)
This is a company submission
(Adobe PDF File 938kb) from Bayer New Zealand Limited for
the reclassification of hydrocortisone from restricted medicine
to pharmacy-only medicine when for dermal use in medicines containing
1% or less by weight of hydrocortisone base in combination with
an antifungal and in a quantity of 30 g or less or 30 mL or less
per container.
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6.3
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Ibuprofen in liquid sachet unit dose
forms
(Reckitt Benckiser (New Zealand) Limited)
This is a company submission
(Adobe PDF file 667b) from Reckitt Benckiser (New Zealand)
Limited for the reclassification of ibuprofen, when in liquid oral
suspension in sachets each containing 200 mg or less of ibuprofen
for use in adults or children 12 years of age and older, from pharmacy-only
medicine to general sale medicine.
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6.4
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Melatonin 2 mg prolonged release tablet
(Circadin, Aspen Pharma Pty Limited c/o Pharmacy Retailing (NZ)
Limited trading as Health Care Logistics
This is a company submission
(Adobe PDF file 656kb) for the reclassification of melatonin
2 mg prolonged release tablets from prescription medicine to restricted
medicine, in a pack of up to 30 tablets, when used as monotherapy
for the short term treatment of primary insomnia characterised by
poor quality of sleep in patients who are aged 55 and over.
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6.5
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Oseltamivir 75 mg powder filled capsules
(Tamiflu, Roche Products (New Zealand) Limited
This is a company submission
(Adobe PDF file 1008kb) for the reclassification of oseltamivir
in 75 mg powder filled capsules (Tamiflu) from prescription medicine
to restricted medicine, in a pack of up to 10 capsules, for the
treatment or prophylaxis of influenza in adults and children aged
13 years and older.
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7
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New Medicines for classification
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8
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Harmonisation of New Zealand and Australian
schedules
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8.1
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New chemical entities which are not yet
classified in New Zealand
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8.2
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Decisions by the Secretary to the Department
of Health and Aging in Australia, or the Secretary's Delegate
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8.2.1
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Decisions by the Delegate - May 2012
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| |
- Adrenaline
Preparations for injection should be excluded from the current
exemption from scheduling for preparations containing 0.02 per
cent or less of adrenaline.
- Ciclopirox
Ciclopirox, in preparations for application to the nail containing
8% or less of ciclopirox, should be rescheduled from Schedule
3 (restricted medicine) to Schedule 2 (pharmacy-only medicine).
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8.2.2
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Decisions by the Delegate - June 2012
No harmonisation decisions relevant to the Committee were made
by the Delegate.
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8.2.3
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Decisions by the Delegate - August 2012
No harmonisation decisions relevant to the Committee were made
by the Delegate.
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9
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For the next meeting
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10
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General business
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11
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Date of Next Meeting
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