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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