EXPERT ADVISORY COMMITTEE ON DRUGS
Thursday 29 November 2007, 8.30am – 1.30pm
Medsafe Conference Room, Level 6, Deloitte House,
10 Brandon Street, Wel ington
EACD MEMBERS PRESENT
Dr Ashley Bloomfield (Chair)
Adrienne Fruean
Dr Tim Maling
Dr Keith Bedford
Dr Helen Moriarty
Paul Campbell
Professor Doug Sellman
EACD SECRETARIAT PRESENT
Olivia Tuatoko
Martin Woodbridge
Bruce Atmore
Mark Heffernan
Mick Alexander (NDIB)
1 WELCOME AND APOLOGIES
The Chair welcomed members. He welcomed Justine Cornwall from Justice who
attended on behalf of Rajesh Chhana.
Apologies were received from Dr Geoff Robinson, Detective Superintendent Win
Van der Velde, Dr Stewart Jessamine, and Rajesh Chhana.
Paul Campbell apologised for late arrival.
2 CONFIRMATION OF 30 AUGUST 2007 MINUTES
The minutes from the 30 August 2007 meeting were confirmed and are to be
placed on the National Drug Policy website once the Minister has been advised on
salvia divinorum.
3 MATTERS ARISING FROM 30 AUGUST 2007 MEETING
3.1 Ketamine. Item 5
Issue: That the EACD would recommend that the presumption for supply amount
for ketamine be set at 10 grams, whether or not contained in a substance,
preparation or mixture.
Outcome: It has been agreed by Cabinet and is to go through an Order in Council
process.
3.2 Salvia Divinorum. Item 6
Issue: That the EACD would recommend salvia divinorum as a Schedule 4
Restricted Substance in the Misuse of Drugs Amendment Act 2005.
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Outcome: Chair to write a letter to the Minister updating him of the EACD
recommendation.
3.3 Update on Drugs for Review. Item 7
Issue: The Secretariat to follow up, by the next EACD meeting, with the suppliers
of pentazocine, on the impact the possible classification of pentazocine would
have.
Outcome: Pentazocine (Fortral range) has been discontinued. Therefore any
change to the classification of this substance would not affect previous suppliers.
Members requested to look at a previous paper on pentazocine and what their
initial recommendation was for classification.
Discussion: Members advised that the last known use of this substance was
administration by ambulance drivers. Although it is not currently available in New
Zealand, there is concern that is could be imported and members were concerned
with the abuse potential of the substance, therefore discussion around scheduling
the product would stil be necessary. At this stage, it was agreed that this
discussion could be deferred while the MDOA review is underway.
3.4 General Business. Item 8
Issue: The Secretariat to prepare a paper for the next meeting on buprenorphine
and tramadol.
Outcome: Buprenorphine on the Agenda as Item 6. Tramadol is currently being
assessed and wil be available for discussion at the next EACD meeting.
Note: EACD requested that the Secretariat contact several anaesthetists and pain
clinics for a wider spectrum of information when collecting information for this
paper.
4 DECLARATION OF CONFLICTS OF INTEREST
No conflicts of interest were declared.
UPDATE ON BZP
Discussion: Chair updated the Committee on BZP legislation, advising that the
Misuse of Drugs (Classification of BZP) Amendment Bill had been reported back to
the House by the Health Select Committee with no recommended changes. The
Committee discussed new substances that have emerged to possibly replace
BZP. The Secretariat advised that one such product contained a substance
considered to be a controlled drug analogue and the Ministry of Health is actively
monitoring the ‘party pil ’ market for new developments.
The Committee were also advised of current research studies in progress
investigating the use, and effects, of BZP. Members requested that a priority area
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for further research should be to investigate how the pending change in legal
status might influence people’s attitudes towards purchasing and using BZP and
related substances.
The Committee also discussed pil presses and encapsulaters as manufacturers of
‘party pills’ may no longer require them once the classification of BZP and related
substance take effect. The Committee noted that there is a potential for this
equipment to be diverted for il icit purposes such as the manufacture of ‘ecstasy’
pills. The Committee identified a need to monitor where this equipment goes and
who it is sold to. The Committee also agreed they could be used for licit as well as
il icit means, and could potentially drive the importation of substances in their
powdered form.
5 THALIDOMIDE
Reference: Paper provided by EACD Secretariat
Issue: The Commit ee requested that thalidomide be discussed as part of a
possible anomaly in the Misuse of Drugs Act 1975 Schedules.
Outcome: The Committee agreed to inform the Minister on thalidomide with the
possibility to change its classification in the Misuse of Drugs Act.
Discussion: The Commit ee discussed the historical circumstances surrounding
the placement of thalidomide into the Misuse of Drugs Act 1975. All members
agreed that it is an anomaly and that, in retrospect, it should not have been
scheduled in the Act. The Committee agreed that the fear of this substance is
genuine, but there is now very good monitoring of and advice about the use of this
substance and notwithstanding that individuals may ignore this advice, history is
highly unlikely to repeat itself.
During the discussion of scheduling the Committee considered whether there are
any other comparable examples of substances with virtually no abuse potential but
severe, specific adverse effects, and therefore, whether the Misuse of Drugs Act
Class A classification was the most appropriate framework for managing this
situation?
One example came to mind which was MPTP (also Class A). MPTP became
infamous in the 1980s after it was distributed in il icit drug circles in the USA as a
major contaminant in the product from a botched attempt to synthesize MPPP.
MPPP is the "reverse ester" of pethidine meperidine). MPTP is a potent
neurotoxin, selectively damaging the substantia nigra and producing symptoms
closely resembling Parkinson's disease in users. MPPP and pethidine are
scheduled as Class B3 controlled drugs. Unlike thalidomide, MPTP has no
recognised therapeutic use.
The Committee agreed that thalidomide should be removed from the Misuse of
Drugs Act and placed in the Medicines Act 1981; however the availability and
distribution and use of thalidomide requires stringent monitoring. The Committee
agreed that the current Pharmion® registration procedure wil need to continue,
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which was a condition of gazetting during the products registration. Therefore the
rules currently governing access cannot be loosened or removed.
The Commit ee noted that in light of the recommended reclassification of
thalidomide from a controlled drug to a medicine, other terotogens should be also
considered; this would include retenoic acid (high dose vitamin A). In removing
thalidomide from the MODA such that thalidomide is controlled solely under the
Medicines Act 1981, it would be important that an outline of standard requirements
for access and distribution be confirmed. The current limited access requirements
that were gazetted for thalidomide are a suitable and credible benchmark for this
purpose; as such access to other teratogens could also be monitored and
controlled under such arrangements. These access requirements/restrictions
should not go beyond what has already been established for thalidomide as they
would likely become overly restrictive and nonsensical.
Action: The Chair to advise the Minister of the issues surrounding thalidomide and
the recommendation that it should be removed from the MODA, and that this
should be considered during the review of the MODA.
6. DISCUSSION WITH LAW COMMISSION
Initial EACD discussion on the MODA Review
The Committee discussed issues that may come up during the review of the
Misuse of Drugs Act (MODA) with the Law Commissioners. Points of notice that
the Committee wished to bring up were as follows;
• Medicines that are also classified under the MODA
• Psychoactive substances that are not pharmaceutical medicines but are
scheduled in the MODA due to historical reasons
• Assessment of all substances on rational harm assessment criteria, including
the possibility of comparing alcohol and tobacco, and determining appropriate
supply controls
• Possible change to the name of the Act
• Defining the meaning of harm
• The ability to monitor al controlled drugs, not just those in Schedule One.
6.1 Consultation on Guidelines for Drug Offences
The Chair welcomed to the meeting Warren Young, Judge Jeff Ray, Fiona Wright
and Andrea King from the Law Commission.
Reference: Discussion paper provided by the Law Commission
Background: The Law Commission was asked to review the Misuse of Drugs Act
by the Associate Minister of Health during Cabinet discussion on BZP. The
discussion with the Committee arose as part of drafting up guidelines for the
proposed Sentencing Council that is to be established by mid 2008.
Discussion: The Law Commission referred to the list of questions at the back of
the discussion paper outlining issues in sets of questions, including:
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1) Drugs that should be included in the guidelines;
2) Guidelines proposed and relativity between the guidelines;
3) Separate treatment of methamphetamine;
4) Treatment of purity of drugs;
5) Relative seriousness of manufacturing;
6) Sentence levels; and
7) Large scale offending.
The Committee discussed each one of these, raising points that would need to be
developed to help assess the issues covered, such as defining what is meant by
harm. Harm does not just incorporate physical morbidity but social, physical,
mental, and addictive harms.
The Commit ee also outlined that it was not possible to easily compare the
substances within the current Schedule as many were classified due to historical
reasons or consequences, or sometimes ‘mass hysteria’ in other countries.
The Commit ee supported the table that listed the drugs to be covered by the
guidelines. The Commit ee explained why many of the substances were
scheduled as they are, and why some drugs with similar effects have different
classifications. Members also outlined that there were many anomalies within the
MODA and that guidelines for sentencing should take this into consideration.
Proposals wil be unlikely to include any guidelines around imprisonment for
possession or use of substances, as the main issues would be around supply and
manufacturing offences.
The Commit ee also discussed precursors and how their ‘weighting’ is misleading,
due to their potential to be made into very harmful final products. The Commit ee
then agreed that a hybrid response is better and agreed with the guidelines that
changed from net quantities to gross quantities of product depending on the
substance.
The Committee discussed the assessment of the guidelines around the separate
treatment of manufacturing. This issue is driven primarily by methamphetamine
and the damages it causes not just to the individual but to society. Sentence levels
proposed are to be based on both the quantity/weight of and the intention for use
of the substance manufactured.
The Committee also discussed the possible introduction of these expectations in
rehabilitation and treatment clinics. A compulsory treatment would be needed not
only for the users but dealers as well, which the current legislation does not allow
for.
6.2 Review of the Misuse of Drugs Act (MODA)
Discussion: A progress report on this review is to be provided to Cabinet by the
end of 2008.
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The Commit ee discussed possible constraints provided by the international
environment and that New Zealand should be taking a more rational approach to
classifying substances.
The Committee emphasised to the Law Commission that any review of the MODA
would impact on the Medicines Act 1981 and possibly the Hazardous Substances
and New Organisms Act 1996 (HASNO). This would incorporate substances that
are not captured under the Medicines Act or Food Act and that have a
psychoactive effect.
The Committee was keen that the review includes consideration of being able to
outline to importers, suppliers and manufacturers that substances should be
deemed to be safe before they are marketed and sold marketing New Zealand.
Such a move effectively ‘reverses the onus of proof’, pacing the responsibility of
proving safety onto the supplier.
Members of the Committee were interested in whether it was possible to ‘plot’ the
drugs currently included in the Misuse of Drugs Act 1975 Schedules and their
relative levels of harm.
Action: Secretariat to invite Val Sim and Warren Young to the next EACD
meeting to continue discussions on the review of the MODA.
7. BUPRENORPHINE
Reference: Paper provided by EACD Secretariat
Issue: Possible reclassification of buprenorphine from Class C to Class B to
provide greater control over its use and provide for increased monitoring
capabilities over its distribution and use. This would also assist in establishing the
effectiveness of treatment regimens and settings, and reduce the potential for
diversion.
Outcome: The Committee agreed to
leave buprenorphine at its current
classification. However, the EACD will re-visit this paper if PHARMAC decide to
fund buprenorphine for opioid addiction treatment, as subsidies generally increase
a product’s use and overall availability (and potential for diversion)..
Reclassification to Class B would then be more relevant. The Committee were
informed that enforcement of the misuse of buprenorphine would not likely change
unless there is a significant change in supply and notified misuse/abuse; the cost
of compliance would be too large to warrant greater enforcement activity.
Discussion: The Commit ee noted that buprenorphine is not being used in New
Zealand currently as PHARMAC does not subsidise it for opioid substitution
treatment. It was noted that buprenorphine is a valuable drug product in this role
and that it is used widely overseas for this purpose.
There is a degree of pressure on PHARMAC by prescribers and consumer groups
to subsidise buprenorphine so that is made available alongside methadone for
substitution programmes.
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8. SATIVEX
Reference: Paper provided by EACD Secretariat
Issue: For the Commit ee to consider if Sativex should be reclassified after further
information on the New Zealand situation is reviewed. The paper was intended to
alert the Committee of the potential for a reclassification so as to ensure future
action is swift and help to guarantee that access to this product is as wide as
possible within the established guidelines.
Outcome: This issue is to be reviewed once the use of Sativex in New Zealand
has been reviewed and assessed.
Discussion: The Committee noted that it was unlikely that dispensing pharmacies
would recover the costs of installing a refrigerated safe if Sativex was required to
be stored in a refrigerated safe, as it wil likely be a low volume product.
7. GENERAL BUSINESS:
Note: Invitations to Beyond 2008 Regional Consultation for Australasia and 2008
Parliamentary Drug Policy Roundtable forum are being sent out to all EACD
members and the next EACD meeting is to be arranged around these.
8. DATE OF NEXT MEETING:
The next meeting is scheduled for Tuesday 19 February 2008, 1pm – 4.30pm,
Ministry of Health Rooms 2.06 & 2.07, 1 The Terrace, Wel ington.
The meeting closed at 1.33pm.
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Document Outline
