1

Welcome

The Chair opened the 63^rd meeting at 9:39 am with a karakia and welcomed members and guests.

2

Apologies

No apologies were received.

3

Confirmation of the minutes of the 62nd meeting held on 11 April 2019

A typographical error was amended in the Discussion section of agenda item 6.1 (“Aspects of this discussion may also be applicable to agenda item 6.2 and vice versa”).

The remainder of the minutes of the 62^nd meeting was accepted as a true and accurate record. The minutes were signed and dated by the Chair.

4

Declaration of conflicts of interest

Conflict of Interest forms were returned to the Secretary.

The following conflict of interest was declared by Dr Boothman-Burrell:

1. Membership on the Medicinal Cannabis Advisory Group

There are no items on the agenda relating to medicinal cannabis and the Chair concluded that this would not pose a conflict.

All other members declared they had no additional interests which would pose a conflict with any of the items on the agenda.

5

Matters arising

5.1a

Objections to recommendations made at the 62nd meeting

No valid objections were received.

5.1b

Gazette notice to implement recommendations made at the 62^nd and 61^st meeting

5.2

Recommendations implemented from the 62^nd meeting

Medsafe advised the Committee that all recommendations from the 62^nd meeting were accepted and published in the New Zealand Gazette on 12 July 2019.

5.3

Update on outstanding agenda items from the 62^nd meeting

(6.1) Ropivacaine up to 7.5 mg/mL, solution for injection – proposed reclassification from prescription medicine to prescription except when classification

(6.2) Bupivacaine up to 0.5% w/v in combination with adrenaline – proposed reclassification from prescription medicine to prescription except when classification

The Committee had requested further information from the applicant, the Podiatrists Board of New Zealand. This request for further information was sent on 4 June 2019.

No information has been received for this meeting. The Podiatrists Board of New Zealand has indicated that they intend to submit the requested information at a future meeting.

The Committee noted that the Podiatrists Board are exploring the pathway to obtaining prescribing rights and how this may be a better pathway than classification.

5.3a

Reclassification of codeine

An information paper on the classification of codeine (PDF, 592 KB, 24 pages) has been prepared. The purpose of this paper is to summarise the risks and benefits of harmonising the classification of codeine with Australia, and the alternative option recommended by the Committee at the 59^th meeting.

Comments

Seven comments were received about this agenda item. Please see the published comments on the Medsafe website for more detailed information.

Background

In December 2016, Australia decided that from 1 February 2018 medicines containing codeine would no longer be available without a prescription. The Committee considered whether to harmonise the classification of codeine with Australia at the 57^th, 58^th and 59^th meetings.

At the 59^th meeting the Committee recommended an alternative option:

1. that all codeine in combination medicines should be reclassified to prescription medicines and
2. that medicines containing codeine as the only active ingredient should be reclassified from prescription to restricted medicine; for oral use in adults and children over 12 years of age in medicines containing not more than 15 mg per solid dosage unit with a maximum daily dose not exceeding 90 mg of codeine for use as an analgesic and when sold in a pack of not more than three days’ supply.

The Minister’s Delegate had requested further information from Medsafe on this recommendation prior to making a decision. No changes to the classification of codeine have been implemented while awaiting further information.

Medsafe has prepared an information paper (PDF, 592 KB, 24 pages) containing further advice for the Committee’s consideration at this meeting. This advice has been published with the agenda for consultation.

Discussion

The Committee reminded themselves that the classification of codeine was initially brought to the Committee’s attention as a result of a harmonisation with Australia. The Committee agreed that any recommendations should be based on a balanced benefit risk assessment in the New Zealand market, rather than reacting to what has happened in Australia.

The Committee considered the comprehensive feedback received during consultation on the classification of codeine and thanked the submitters for taking the time to provide feedback. All feedback received during consultation is available on the Medsafe website.

Medsafe tabled a recent journal article evaluating the effects of rescheduling in Australia (Cairns, R et al 2019, ‘Codeine use and harms in Australia: evaluating the effects of rescheduling’, Addiction: Society for the study of addiction, https://doi.org/10.1111/add.14798). The following points from this article were summarised:

1. In Australia, codeine re-scheduling was followed by a large and significant drop in poisoning calls. Codeine poisonings began to drop following the announcement, prior to legislative change. This is despite an increase in sales during the “washout” period suggesting stockpiling in anticipation of the rescheduling. Suggested reasons include breaks in the supply chain when pharmacies stopped ordering/stocking the products, widespread education about the addictive potential of codeine and harms from inappropriate use in the lead up to the re-scheduling. The authors assumed that some users began to plan for the change and sought help for pain and/or dependence.
2. Regarding possibly harmful unintended consequences, there is concern that re-scheduling codeine may decrease availability for people who need it, resulting in under-treatment of pain. However, ibuprofen and paracetamol combination products (available OTC) provide superior analgesia to the low strength codeine products.
3. Pre-scheduling concerns included increased burden on GPs as a result of codeine being unavailable OTC. However, the majority of Australian GPs were supportive of the re-scheduling. It is reasonable to assume minimal impact given the lack of significant increase in high strength codeine sales. The Royal Australian College of General Practitioners recently reported the fears of GPs being overwhelmed by requests for codeine products seemed unfounded.

Medsafe advised that the availability of cough and cold medicines containing codeine in New Zealand has been reduced and that products have been withdrawn from the market following the change to the classification of codeine in Australia. The Committee acknowledged that the market for cough and cold products has changed significantly since the reclassification of pseudoephedrine.

The Committee pointed out that the misuse of codeine and opioids around the world is a significant problem.

The Committee noted that the decision in Australia had stemmed from liver toxicity. This is likely because people seeking higher doses of the codeine combination products are seeking more pain relief, rather than for dependency. The Committee agreed that there is a real risk of overdosing of the other ingredients in the combination product (paracetamol or ibuprofen), which could lead to damage to the liver or kidneys.

The Committee commented on how New Zealand has a reputation as being one of the few countries that permit OTC codeine and thereby contributing to small scale manufacturing of illicit drugs. The Committee acknowledged that information on OTC sales of codeine combination products in New Zealand is incomplete as this information is not readily available, particularly in rural contexts.

The Committee discussed how there remains an issue with education around the use of codeine. Neither the patient nor the health care provider are likely to be well informed on the effective use and risks associated with codeine and codeine combination products, and pain management. The Committee acknowledged that there is an issue regarding collaboration between health care providers in this area and that there is a lack of referral pathways for pain management from community pharmacy.

Electronic monitoring was discussed extensively by the Committee. Three years has passed since the Committee considered electronic monitoring as a potential risk mitigating strategy. Although the enablers for electronic monitoring have been developed, national coverage remains incomplete and insufficient to be considered adequate to retaining the status quo classification for codeine.

The Committee shared some of their own experience from working in the South Island where dispensings of prescribed codeine-containing products are recorded electronically using HealthONE, which pharmacists may check prior to making a sale.

The Committee had hoped that there would be a stronger push to make recording of codeine combination medicines consistent across all pharmacies in all regions in New Zealand. The Committee suggested that more than just codeine could be recorded this way and considered that all medicines classified as Restricted medicines should also be recorded electronically so that it can be monitored nationally.

The information paper prepared by Medsafe referred to the Privacy Act restricting the sharing of personal information. The Committee commented that instead it is now an expectation that clinicians should be able to access all relevant information as part of their duty of care.

The Committee reflected on how there has been a significant change in the environment and context since the classification of codeine was first discussed in 2016. There has been development in e-prescribing in localised areas around New Zealand. The Committee remarked that if real-time monitoring was in place nationally, that the discussion on the classification of codeine could have been quite different. The Committee considered that national monitoring, or at least recording, should be a pre-requisite to make the alternative option of reclassifying codeine as a single active ingredient viable.

The concern regarding the lack of access to health care providers was discussed by the Committee. Overall the Committee agreed that the situation around access to health care providers in rural contexts is similar to that of Australia. Both countries experience challenges however, New Zealand may be slightly more favourable in this regard due to geographical differences.

There remains an unmet need to access pain relief in pharmacy especially for people where non-steroidal anti-inflammatories (NSAIDs) were not appropriate. The Committee considered whether codeine is required to satisfy an unmet need (for pain relief) and concluded that this need will remain unmet by retaining the status quo, due to the poor efficacy of low-dose codeine combination products and the variable effect of genetic polymorphism on its metabolism. The Committee discussed that depending on the person, the polymorphism could lead to poor or ultra-rapid metabolism, with quite different outcomes.

Overall, the Committee agreed that ideally, a patient should receive specific treatment for the cause of the pain, rather than symptomatic pain relief. If this is not available, there are other pain relief options available over-the-counter.

Feedback received from the New Zealand Dental Association advised that codeine combination products were more beneficial than codeine alone for the management of dental pain. The Committee was not aware of any literature that supported the efficacy of codeine 15 mg in combination products in New Zealand.

One of the overarching concerns the Committee has with codeine combination products is the risk of harm due to the paracetamol or ibuprofen component. The Committee was not aware of any substantial information supporting the use of codeine alone for the management of dental pain pre-op and therefore found it difficult to see a reasonable case for the use of codeine in the situation of access where a patient is waiting to see a dentist.

Therefore, the Committee considered the risk to people using low dose codeine combination products outweighed the benefit of wider access.

The Committee further noted that there were safety concerns such as misuse that were raised in the feedback received, including feedback that was received from experts in the field of pain management.

The Committee discussed how reclassifying all codeine products to prescription medicines would only remove ready access to products available at the pharmacy. There has been a trend of increasing codeine prescriptions in New Zealand and members questioned whether prescribers were aware of the issues around genetic polymorphism (exhibited in the CYP2D6 gene) and the metabolism of codeine. Codeine is a pro-drug for morphine and genetic polymorphism results in uncertainty around the quantity that is metabolised to morphine in the body. The Committee remarked how codeine and morphine both have the same mechanism of action of the same receptors, and the main difference is the dosage. The Committee pointed out the differences in attitudes to codeine compared to morphine, even though codeine is metabolised to morphine.

The Committee acknowledged that even the most restrictive classification (prescription) would be unlikely to impact on codeine in the black market resulting from diversion of prescribed codeine and opioids. A prescription classification would also not be able to address the Committee’s concerns about the over-prescribing of codeine and opioids.

Members came to the conclusion that the balance that needed to be found is between the limited number of incidents of abuse that has resulted in significant harm, compared to a greater number of people who find codeine combination products beneficial.

The Committee discussed the information presented in the information paper on the implementation timeframes of the various options described. In particular, how Option C was complex and required legislative changes. The Committee discussed how this would likely result in a lengthy and cumbersome two stage process. Medsafe confirmed that it was not possible at that point to provide any meaningful estimates for time frames because of the complex nature of the changes.

The Committee agreed that harmonising with Australia would be a pragmatic approach and, in the future, it could be worth re-evaluating the impact of the reclassification of codeine.

In conclusion, a consensus was reached to harmonise with Australia (Option B) so that all medicines containing codeine should be classified as prescription medicines.

From the earlier considerations and each members’ clinical experience and judgement, the Committee determined that there was sufficient concern regarding safety, in particular:

1. the risk of exceeding the maximum dosage of paracetamol and ibuprofen in combination products and
2. the abuse of codeine in New Zealand and globally.

The Committee considered, given the material summarised above, that the recommendation to change the classification of all codeine products to prescription only was appropriate. The Committee was satisfied that the balance of access and risk for codeine and codeine combination products favoured a prescription classification.

The Committee also made the following concluding remarks:

1. The lack of ability to monitor the sale of restricted medicines has made it difficult to estimate the extent that these medicines are used. The Committee considers the ability to monitor the purchase of medicines as essential and felt that this would be considered a pre-requisite in order to support Option C. The Committee felt that all sales of medicines classified as restricted should be recorded in a way that all health care professionals are able to access this information as part of a patients’ medical history.
2. There is an opportunity to improve the management of acute pain, particularly around referral pathways in pharmacy. There is still a problem where there is currently limited support for people who cannot access other health care services. The Committee requested for correspondence to be sent to the Pharmaceutical Society, the Pharmacy Council and other professional organisations to highlight the need to improve pain management pathways.

The Committee agreed to refrain from making a recommendation on the time frame for implementation. Medsafe reassured the Committee that an implementation plan on the proposed recommendation will be developed in consultation with stakeholders and that it will be communicated to the sector to ensure a smooth transition. Medsafe advised that implementation will be carefully planned to ensure that patients and health care professionals will be informed and educated, and industry will be engaged to ensure a smooth transition.

Recommendation

That all medicines containing codeine should be classified as prescription medicines.

6

Submissions for reclassification

6.1

Influenza vaccine – proposed change to the Prescription classification statement
(Pharmaceutical Society of New Zealand )

Purpose

This is a submission (PDF, 100 KB, 8 pages) from the Pharmaceutical Society of New Zealand to change the Prescription classification statement for influenza vaccine to include registered intern pharmacists.

Background

At the 47^th meeting on 1 May 2012, 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 course and is complying with the immunisation standards of the Ministry of Health.

At the 48^th meeting on 30 October 2012, the Committee recommended that the classification statement for influenza vaccine be changed to clarify the adult age (to '18 years of age or over'), to remove the words 'in a pharmacy' and to reword the provider requirements for the vaccinator course (to 'has successfully completed a vaccinator training course approved by the Ministry of Health').

At the 59^th meeting on 7 November 2017, the Committee recommended that the current classification of influenza vaccine should be amended to include registered nurses. A valid objection was received for this recommendation. This proposal was withdrawn on 23 March 2018.

At the 60^th meeting on 26 April 2018, the Committee considered an application to amend the classification statement for influenza vaccine to include registered intern pharmacists. The Committee recommended that the classification should remain unchanged and that ‘registered pharmacists’ should be interpreted to include registered intern pharmacists. Following the meeting, the Committee was advised by Medsafe that the term ‘pharmacist’, as defined in the Medicines Act 1981, is a person formally registered with the Pharmacy Council to practise as a pharmacist, as opposed to an intern pharmacist.

Comments

Three comments were received about this agenda item. Two comments supported the proposal. One comment opposed the proposal.

Discussion

The Committee discussed the working environment and the level of competency expected of a pharmacy intern. The Committee agreed that from their perspective, the pharmacy intern was part of the pharmacy team and supported increasing the number of trained vaccinators. The Committee understood that there are tight controls around cold-chain accreditation of the pharmacy, and sector controls to ensure vaccines go to where they are required.

Overall the Committee supported reducing regulatory barriers to increasing the number of vaccinators. The Committee expressed support for any health practitioner (in particular registered nurses) that has completed vaccination training to be able to administer vaccines.

The Committee discussed the need for co-ordinated efforts to improve immunisation coverage and asked how this can be addressed by something like an immunisation strategy. The Committee considered regulatory barriers, what they are and how they can be addressed. The Committee requested that this be further discussed at a future meeting and to extend an invitation to the relevant teams at the Ministry of Health to attend (the immunisation team, primary care team and public health team).

Recommendation

That registered intern pharmacists should be included in the prescription except statement for influenza vaccine.

6.2

Bilastine– proposed change to the Pharmacy Only classification statement
(Menarini New Zealand Pty Ltd)

Purpose

This is a submission (PDF, 247 KB, 14 pages) from Menarini New Zealand Pty Ltd to change the Pharmacy Only classification statement for bilastine by removing the maximum pack size.

The current classification of bilastine is:

Prescription; except when specified elsewhere in this schedule.

Pharmacy Only; in divided solid dosage forms for oral use containing 20 milligrams or less for the treatment of the symptoms of allergic rhinoconjuctivitis (seasonal and perennial) and urticaria when sold in a pack containing not more than 30 dosage units

There is currently one medicine that is approved in New Zealand containing the active ingredient bilastine, Labixten 20 mg tablets. The sponsor company of Labixten is Menarini New Zealand Pty Ltd.

Background

Bilastine was classified following the 53^rd meeting of the Medicines Classification Committee. The Committee recommended:

That bilastine should be classified as a prescription medicine, except when specified elsewhere in this Schedule.

That bilastine should be classified as a pharmacy-only medicine in tablets containing 20 mg or less, when sold in a pack containing not more than 30 tablets, for the treatment of the symptoms of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria.

Comments

Two comments were received about this agenda item. Both comments supported the proposal.

Discussion

The Committee briefly discussed the proposal and was satisfied with the overall good safety data supporting bilastine. The Committee pointed out that the proposed classification would be consistent with the classification of other antihistamines.

Recommendation

That the maximum pack size limit should be removed from the pharmacy-only classification statement for bilastine.

7

New medicines for classification

The following new chemical entities were submitted to the Committee for classification.

7.1

New chemical entities

New medicine applications have been received for the following new chemical entities that require classification.

7.1a

Esketamine
Spravato nasal spray solution, 28 milligrams (TT50-10559)

Esketamine, the S-enantiomer of racemic ketamine, is an antidepressant with a novel mechanism of action. It is a non-competitive, subtype non-selective, activity dependent glutamate receptor modulator.

Discussion

The Committee noted that esketamine is the s-isomer of ketamine, which is a Class C4 controlled drug. For this reason, the Committee also recommended referring this to the Expert Advisory Committee on Drugs (EACD) for consideration.

Recommendation

That esketamine should be classified as a prescription medicine.

That esketamine should be referred to the EACD for consideration.

7.1b

Upadacitnib
TRADENAME film coated tablet, 15 milligrams (TT50-10565)

Upadacitinib is a selective and reversible inhibitor of Janus Kinase 1 (JAK1). Upadacitinib more potently inhibits JAK1 compared to JAK2 and JAK3. Upadacitinib has been indicated for the treatment of adults with moderate to severe active rheumatoid arthritis.

Recommendation

That upadacitnib should be classified as a prescription medicine.

7.1c

Avibactam sodium
Zavicefta powder for infusion, 2000 milligram / 500 milligram (TT50-10637)

Avibactam is a non β-lactam, β-lactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis.

Recommendation

That avibactam should be classified as a prescription medicine.

7.1d

Polatuzumab vedotin
Polivy powder for injection, 140 milligram (TT50-10616)

Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially binds with high affinity and selectivity to CD79b, a cell surface component of the B-cell receptor.

Recommendation

That polatuzumab vedotin should be classified as a prescription medicine.

7.1e

Entrectinib
TRADE NAME capsule, 100 milligram and 200 milligram (TT50-10652,a)

Entrectinib is an inhibitor of the tropomyosin receptor tyrosine kinases (TRK) TRKA, TRKB, and TRKC, proto-oncogene tyrosine-protein kinase ROS1 (ROS1), and anaplastic lymphoma kinase (ALK). Entrectinib also inhibits JAK2 and TNK2. Entrectinib inhibits cancer cell lines derived from multiple tumor types harboring NTRK, ROS1, and ALK fusion genes thus inhibiting tumorigenic potential through hyperactivation of downstream signaling pathways and uncontrolled cell proliferation caused by fusion proteins

Recommendation

That entrectinib should be classified as a prescription medicine.

7.1f

Lanadelumab

TAKHZYRO solution for injection, 300 milligram/ 2 millilitre (TT50-10654)

Lanadelumab is a fully human, monoclonal antibody produced indicated for routine prevention of recurrent attacks of hereditary angioedema (c1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

Recommendation

That lanadelumab should be classified as a prescription medicine.

7.2

New chemical entities identified by Medsafe

7.2a

Metamizole (aka dipyrone)

Metamizole has analgesic, anti-inflammatory and antipyretic properties. It is currently unscheduled in New Zealand. Metamizole was withdrawn from the US and Canada over 40 years ago due to safety concerns (agranulocytosis). Metamizole is no longer for sale in Australia and importation requires a TGA-issued import permit.

Recommendation

That metamizole (aka dipyrone) should be classified as a prescription medicine.

7.2b

Meldonium

Meldonium is an inhibitor of carnitine synthesis and is reported to have cardio protective and anti-ischaemic effects. It has been used in the management of ischaemic heart disease and ischaemic cerebrovascular disturbances.

Meldonium is currently unscheduled in New Zealand and there are no approved products.

Recommendation

That meldonium should be classified as a prescription medicine.

7.2c

Octodrine (synonyms include 1,5 – dimethylhexylamine, DMHA and 2,-amino-6-methylheptane)

Medsafe had prepared an information paper on this New Chemical Entity (PDF, 530 KB, 3 pages)

Comments

One comment was received about this agenda item that was not in support of classifying octodrine.

Discussion

The Committee discussed the information paper, the feedback received and the additional advice provided by Medsafe. The Committee noted the nuances in the nomenclature and how this related to the chemical structure. The Committee agreed that the terminology used in the classification should be clear and inclusive of these different isomers.

The Committee was advised that although there is no evidence of abuse, that DMHA is structurally similar to DMAA and DMBA. DMAA is classified as a prescription medicine, while DMBA is not currently classified. Medsafe provided expert advice to the Committee that the compounds are structurally similar and are expected to have similar pharmacological properties.

The Committee compared the classification of these substances and confirmed that neither of these substances have been scheduled as Controlled Drugs under the Misuse of Drugs Act. For this reason, the Committee agreed that DMHA does not need to be referred to the EACD for consideration as a controlled drug.

It was noted that these substances are classified as a Schedule 10 of the Poisons Standard in Australia, which means that these substances are banned. Unfortunately, New Zealand legislation does not contain a provision similar to Schedule 10 in Australia. In contrast, these substances are currently unscheduled in New Zealand and it was agreed that this was not risk appropriate.

The Committee confirmed that there are currently no approved medicines containing DMHA. It was considered unlikely that prescribers would be getting requests for prescriptions containing DMHA.

Note: The Committee later discussed their concerns about how the classification of substances as prescription medicine could mislead the public (see discussion for agenda item 7.2e).

Recommendation

That DMHA and the isomers 2-amino-6-methylheptane (also known as 1,5-dimethylhexylamine, and octodrine) and 2-amino-5-methylheptane (also known as 1,4-dimethylhexamine) should be classified as a prescription medicine.

7.2d

Voglibose

Voglibose is an alpha-glucosidase inhibitor with general properties similar to those of acarbose. It is used in the treatment of diabetes mellitus in oral doses of 200 to 300 micrograms three times daily, immediately before meals.

Recommendation

That voglibose should be classified as a prescription medicine.

7.2e

Artemisia annua

Medsafe had prepared an information paper on this New Chemical Entity (PDF, 514KB, 18 pages)

Comments

Four comments were received about this agenda item that were not in support of classifying Artemisia annua.

Discussion

The Committee discussed the information paper and the feedback received during consultation.

The Committee agreed that Artemisia annua has a therapeutic purpose and stated that the precedent for any new chemical entities that have a therapeutic purpose is to be classified as prescription medicines. This is to address any potential safety concerns for new medicines. Safety signals have been associated with Artemisia annua, including hepatic cirrhosis which has resulted in two safety alerts by Medsafe and referral to the Medicines Adverse Reactions Committee (MARC). The Committee also acknowledged the opposing opinions received from stakeholders on the benefits of Artemisia annua and their concerns around manufacturing processes. The Committee was satisfied that the potential harm identified would adequately justify controlling the access by classifying it as a prescription medicine.

The Committee was also advised that Arthrem (containing Artemisia annua) has since been withdrawn from the Australian market due to adverse reaction reports. In addition, a retail level recall in Australia was undertaken to address the safety concerns with the risk of harm to the liver. It is noted that Arthrem capsules are a complementary medicine listed on the Australian Register of Therapeutic Goods and are marketed as a natural dietary supplement. Arthrem capsules contain the substance Artemisia annua extract as the only active ingredient. Further information about Arthrem capsules and actions taken in Australia are available on the TGA website (https://www.tga.gov.au/alert/arthrem-capsules).

The Committee discussed how this is a product derived from an herb and considerations would be required in the terminology used in the classification wording as “Artemisia” includes many different species.

Existing products on the market would be considered as unapproved prescription medicines. The Committee recommended that Medsafe communicate this to prescribers should patients approach their family doctor to request a prescription for these medicines.

The Committee was also concerned that classifying these substances as prescription medicines could mislead the public that these were approved prescription medicines and emphasized that it should be clearly communicated that these products are unapproved and therefore have not been assessed for their pharmaceutical quality and safety. This same concern would also apply for octodrine (agenda item 7.2c).

Recommendation

That Artemisia annua should be classified 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

Final decisions for NCEs and medicines and chemicals referred to the November 2018 scheduling meetings

8.1.1

Racetams

Racetams are a group of compounds that are associated with cognitive enhancing effects and nootropic claims.

The Advisory Committee on Chemicals Scheduling/ Advisory Committee on Medicines Scheduling considered a new group entry for racetams and new specific entries for aniracetam, coluracetam, dimiracetam, fasoracetam, methylphenylpiracetam, nebracetam, nefiracetam, omberacetam, oxiracetam, phenylpiracetam, pramiracetam, rolziracetam, seletracetam, sunifiram and unifiram.

From 1 June 2019, a group entry for racetams and the specific substances aniracetam, coluracetam, dimiracetam, fasoracetam, methylphenylpiracetam, nebracetam, nefiracetam, omberacetam, oxiracetam, phenylpiracetam, pramiracetam, rolziracetam, seletracetam, sunifiram and unifiram are classified as a prescription medicine in Australia.

Racetams were considered by the Committee at the 53rd meeting in May 2015 and the Committee recommended that they should be classified individually as prescription medicines and that a class entry for racetams would not be suitable.

The Committee considered the Scheduling delegate’s final decisions published on the Therapeutic Goods Administration website.

Recommendation

That a new group entry for racetams and new specific entries for aniracetam, coluracetam, dimiracetam, fasoracetam, methylphenylpiracetam, nebracetam, nefiracetam, omberacetam, oxiracetam, phenylpiracetam, pramiracetam, rolziracetam, seletracetam, sunifiram and unifiram should added to the New Zealand Schedule as prescription medicines.

8.1.2

Galcanezumab

Galcanezumab is indicated for migraine prophylaxis that requires medical assessment and monitoring.

From 1 June 2019, galcanezumab was classified as a prescription medicine in Australia.

Galcanezumab is not specifically scheduled in the Medicines Regulations, but as a monoclonal antibody, it is captured by the entry for monoclonal antibodies as a prescription medicine.The Committee considered the Scheduling delegate’s final decisions published on the Therapeutic Goods Administration website.

Recommendation

That galcanezumab should be added to the New Zealand Schedule as a prescription medicine.

8.1.3

Doravirine

Doravirine is a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). Doravirine is indicated for the treatment of a serious infection (HIV) requiring specialised medical oversight and monitoring.

From 1 June 2019, doravirine was classified as a prescription medicine in Australia.

The Committee considered the Scheduling delegate’s final decisions published on the Therapeutic Goods Administration website.

Recommendation

That doravirine should be added to the New Zealand Schedule as a prescription medicine.

8.1.4

Abemaciclib

Abemaciclib is indicated for the treatment of women with hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy (MONARCH-2,3).

From 1 June 2019, abemaciclib was classified as a prescription medicine in Australia.

The Committee considered the Scheduling delegate’s final decisions published on the Therapeutic Goods Administration website.

Recommendation

That abemaciclib should be added to the New Zealand Schedule as a prescription medicine.

8.1.5

Plitidepsin

Plitidepsin is used for the treatment of patients with relapsed or refractory multiple myeloma who have received at least three prior treatment regimens, including both a proteasome inhibitor and an immunomodulator.

From 1 June 2019, plitidepsin was classified as a prescription medicine in Australia.

The Committee considered the Scheduling delegate’s final decisions published on the Therapeutic Goods Administration website.

Recommendation

That plitidepsin should be added to the New Zealand Schedule as a prescription medicine.

8.1.6

Isavuconazole

Isavuconazole is used for the treatment of invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate.

From 1 June 2019, isavuconazole was classified as a prescription medicine in Australia.

The Committee considered the Scheduling delegate’s final decisions published on the Therapeutic Goods Administration website.

Recommendation

That isavuconazole should be added to the New Zealand Schedule as a prescription medicine.

8.1.7

Semaglutide

Semaglutide is used for the treatment of adults with insufficiently controlled type 2 diabetes mellitus. Semaglutide is a long-acting glucagon like peptide-1 (GLP-1) receptor agonist (GLP=1RA).

From 1 June 2019, semaglutide was classified as a prescription medicine in Australia.

The Committee considered the Scheduling delegate’s final decisions published on the Therapeutic Goods Administration website.

Recommendation

That semaglutide should be added to the New Zealand Schedule as a prescription medicine.

8.1.8

Cenegermin

Cenegermin is a new biological medicine indicated for the treatment of neurotrophic keratitis. The diagnosis of neurotrophic keratitis requires a detailed clinical assessment and ongoing assessment by an opthamologist.

From 1 June 2019, cenegermin was classified as a prescription medicine in Australia.

The Committee considered the Scheduling delegate’s final decisions published on the Therapeutic Goods Administration website.

Recommendation

That cenegermin should be added to the New Zealand Schedule as a prescription medicine.

8.2

Decisions by the Secretary to the Department of Health and Aging in Australia (or the Secretary’s Delegate)

The Committee noted that the Delegate had also made the following amendments to the Standard for the Uniform Scheduling of Medicines and Poisons.

8.2.1

Decisions by the Delegate – 6 June 2019

a.     Alkyl nitrites

A new group entry for alkyl nitrites was created in Schedule 4 (prescription) except when specified elsewhere in the schedules.

The Schedule 4 (prescription) entry for amyl nitrite was down-scheduled to Schedule 3 (Restricted) when in preparations for human therapeutic use and packaged in containers with child-resistant closures.

The Schedule 4 (prescription) entries for isoamyl nitrite, butyl nitrite, isobutyl nitrite and octyl nitrite remained unchanged.

New Schedule 10 (prohibited) entries were created for isopropyl nitrite and n-propyl nitrite.

The implementation date for the delegate’s decision is 1 February 2020, since there are new Schedule 10 entries and the incorporation of a group alkyl nitrite entry in Schedule 4 which captures previously unscheduled substances.

Schedule 1 of the Medicines Regulations currently does not contain a group entry for alkyl nitrites.

Amyl nitrite is currently classified as a prescription medicine except when sold to a person who holds a controlled substances licence (issued under section 95B of the Hazardous Substances and New Organisms Act 1996) authorising the person to possess cyanide; except when sold to an exempt laboratory covered by a Hazardous Substances and New Organisms Act 1996 approved code of practice.

Isoamyl nitrite, butyl nitrite, isobutyl nitrite and octyl nitrite are currently classified as prescription medicines.

Comments

One comment was received about this agenda item.

Discussion

The Committee noted that this item has been presented due to harmonisation with Australia.

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. The Committee also wished to know about potential drug interactions, including with medicines such as sildenafil.

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.

The Committee resolved to make a recommendation regarding the group entry only and asked that Medsafe provide further information about the specific nitrites, in particular amyl nitrite. The Committee was satisfied that there was value in a group entry so that alkyl nitrites will not remain unscheduled due to the potential dangers associated with this group of substances.

The Committee recommended harmonising the group entry for alkyl nitrites a prescription medicine.

Recommendation

That a group entry for alkyl nitrites should be added to the New Zealand Schedule as a prescription medicine.

9

Agenda items for the next meeting

The following items will be added to the agenda of the next meeting:

1. explore opportunities to optimise access to vaccines (as discussed in agenda item 6.1)
2. lkyl nitrites (as discussed in agenda item 8.2.1.a)
3. an information paper to update the Committee on CBD products and the medicinal cannabis scheme.

10

General business

10.1

Pharmacy Council and the Pharmaceutical Society of New Zealand to present on the new Appendix B from the Guideline on How to Change the Classification of a medicine

The Pharmacy Council and the Pharmaceutical Society of New Zealand presented to the Committee on the reclassification framework described in Appendix B and gave the Committee feedback on how this worked for the recent reclassification of melatonin.

The framework is intended to provide the Committee with advice on reclassification proposals that include pharmacist intervention on what training aspects and competencies may be required. The benefit of this advice is to give the Committee assurance that the regulatory authority and the professional society has considered training requirements. The Committee reserves the right to not agree with a reclassification proposal despite the outcome of this framework assessment.

Following receipt of a reclassification application, the Chair will consider whether Council and Society input on the training requirements are required and will refer as necessary for assessment against this framework.

The Council and Society explained that a training package may not be ready in time for implementation but the initial process for it would have begun. It is expected that there may be a delay from the time of implementation (ie publication in the Gazette) and the delivery of the required training.

The Committee thanked the Council and the Society for their collaboration and that it has been most helpful in the work around reclassification of medicines.

10.2

Membership

This meeting is the last meeting for Professor Les Toop after six years of service. Members of the Committee thanked Les for his valuable insights, pragmatism and commitment to this Committee.

The Secretary will write to the Minister to appoint a new member.

10.3

Letter from the Medicines Adverse Reactions Committee about the reclassification of dextromethorphan

A letter was received from the MARC expressing support for the recent reclassification of dextromethorphan.

11

Date of next meeting

A date in April 2020 will be confirmed.