133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
S Mil s
By email:
[FYI request #12608 email]
Ref:
H202002284
Dear S Mil s
Response to your request for official information
Thank you for your request on 12 April 2020 under the Official Information Act 1982 (the Act) for
information on the recommendation made by the Medicines Classification Committee (the
Committee) in regard to the reclassifications of Alkyl Nitrites including Amyl Nitrites.
A copy of your ful request and information in response to your queries is outlined below.
“- A synthesis of material presented and/or made available to the committee providing evidence
to support these schedule changes.” –
The document ‘Feedback from consultation (joint feedback from NZAF and the NZ Drug
Foundation)’ was identified within the scope of your request and can also be found available
publicly on the Medsafe website:
https://www.medsafe.govt.nz/profs/class/CommentsOnSubmissionAgen63.html
“- If for some reason this does not exist, instead any communication, correspondence,
documentation, or further discussion given for or against the following resolution made in the
discussion section of 8.2.1: The Committee recommended harmonising the group entry for alkyl
nitrites a prescription medicine.”. -
Documents identified in scope of this part of your request are outlined in Appendix 1 and copies
are enclosed. For your reference, the below documents may be of further interest to you and
these can also be found publicly available on the Medsafe website.
Agenda for the 63rd meeting:
https://www.medsafe.govt.nz/profs/class/Agendas/Agen63/agen63.htm
Minutes from the 63rd meeting: https://www.medsafe.govt.nz/profs/class/Minutes/2016-
2020/mccMin10Oct2019.html
Please also note that the Committee considers recent classification changes in Australia routinely
at each meeting in the interests of harmonisation. This means the Committee wil consider
whether the classification of these substances should be the same in New Zealand as they have
become in Australia.
At the 63rd meeting, the Committee was asked to consider harmonisation of the classification of
amyl nitrite, isoamyl nitrite, butyl nitrite, isobutyl nitrite, octyl nitrite, isopropyl nitrite and n-propyl
nitrite and a group entry for alkyl nitrites, with Australia.
The Committee recommended harmonising the group entry for alkyl nitrites only. The Committee
asked that Medsafe provide further information about the other specific nitrites, in particular amyl
nitrite, for consideration at a future meeting. It should be noted that New Zealand already
classifies amyl nitrite, isobutyl nitrite, butyl nitrite, octyl nitrite, and isoamyl nitrite as prescription
medicines and has done so for many years. Isopropyl nitrite and n-propyl nitrite (which are
associated with higher levels of harm) were unclassified and are now prescription medicines as
they are captured by the new class entry.
There wil be further consideration by the Committee at their 64th meeting to see if lowering the
classification is appropriate for any alkyl nitrites. It is expected that this further information wil be
provided in an information paper that wil be available for consultation before it is presented to the
Committee again.
Once this paper is available, it wil be published for consultation.
“- Any fol ow up communication or correspondence pertaining to the fol owing point in the
discussion section of 8.2.1: The Committee discussed how the indicated population are Men who
have Sex with Men (MSM) and it was not clear to the Committee what the risks were around
these substances.” –
There has been no information identified within the scope of this request and as such your
request is refused under section 18(e) of the Act as the information does not exist.
For your information however a paper is being developed to provide the Committee with this
information.
“- Any fol ow up communication, correspondence, or planning for future engagement pertaining
the fol owing point in the discussion section of 8.2.1: The Committee was also not sure if the
LGBTQI community was aware that these substances were being considered by reclassification
and suggested that feedback from them should be sought.
This final point is of specific importance as it seems that feedback from the LGBTQI community
was not sought prior to the schedule changes coming into effect in February 2020.” –
As mentioned above, a paper on the reclassification of other specific alkyl nitrites (in particular
amyl nitrite) is being prepared for the next Committee meeting and wil be available for
consultation. It is proposed to bring this paper to the attention of the LGBTQI community so they
can provide feedback to the Committee.
There has been no additional information identified within the scope of this request and as such
your request is refused under section 18(e) of the Act as the information does not exist.
I trust this fulfils your request. You have the right, under section 28 of the Act, to ask the
Ombudsman to review any decisions made on this request.
Page 2 of 4
Please note that this response, with your personal details removed, may be published on the
Medsafe website.
Yours sincerely
Chris James
Group Manager
Medsafe
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Appendix One:
#
Date
Title
Decision on release
1
15 July 2019
MCC 63: Harmonisation of the New
Information deemed out of
Zealand and Australian schedules
scope of the request has
been excluded
2
26 April 2019
Notice of final decisions to amend (or
Released in ful
not amend) the current Poisons
Standard
3
6 June 2019
Notice of a final decision to amend (or Released in ful
not amend) the current Poisons
Standard
4
6 September
Products containing ingredient: Amyl
Some information has been
2019
Nitrite
withheld under section
9(2)(b)(i ) of the Act as it
commercial y sensitive.
Page 4 of 4
