Committees

Published: 15 June 2018
Revised:  24 July 2018
Revised 8 August 2018

Minutes of the 60th meeting of the Medicines Classification Committee held in Wellington on 26 April 2018 at 9:30 am

A valid objection has been received regarding the following recommendation:

6.5 Modified-release paracetamol – proposed reclassification from pharmacy-only medicine to restricted medicine
(Medsafe)

That modified release paracetamol be reclassified from a pharmacy-only medicine to a restricted medicine. 

This item will therefore be added to the agenda of the next meeting as a matter arising for further consideration.

Present:
Dr S Jessamine (Chair)
Mrs A Shirtcliffe (Deputy Chair)
Dr D Burrell
Mrs A Harwood
Professor L Toop
Mrs K Miedema (by teleconference)
Mrs J Lo (Secretary)

In attendance (from Medsafe):
A Cossar (Manager, Product Regulation Branch)
Dr S Scott (Senior Advisor, Product Regulation Branch)
Ms A Kerridge (Senior Advisor, Clinical Risk Management)
Mr M Oldridge (Advisor, Clinical Risk Management)
Mr J Solloway (Advisor, Clinical Risk Management)
Dr G Hill (Senior Medical Advisor, Clinical Risk Management) (for agenda item 6.5 only)

Observers (for specific agenda items only):
Pharmaceutical Society of New Zealand (PSNZ) (for agenda item 6.3)
C King (for agenda item 6.4)

1

Welcome

The Chair opened the 60th meeting at 9:30 am and welcomed members and guests.

2

Apologies

No apologies were received.

3

Confirmation of the minutes of the 59th meeting held on 7 November 2017

The minutes of the 59th meeting were accepted as a true and accurate record. The minutes were signed and dated by the Chair.

4

Declaration of conflicts of interest

Committee members submitted their Conflict of Interest forms to the Secretary.

The following new conflicts of interest were declared:

  1. Mrs Miedema declared that she is a shareholder of Olsen’s Pharmacy (2002) Ltd which operates community pharmacies in Greymouth, and that she is a preceptor to intern pharmacists.

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

The Committee agreed that there were no potential conflicts of interest which were considered likely to influence the discussions or decisions of the Committee at this meeting.

5

Matters arising

5.1

Objections to recommendations made at the 59th meeting

5.1.1

Reclassification of influenza vaccine – Objection to the proposed recommendation to amend the current classification of influenza vaccine to include registered nurses


The submission on the reclassification of influenza vaccine was withdrawn by the submitter prior to the meeting on 2 March 2018.

The Committee discussed the challenges and complexities around nurse vaccinator training and wider accessibility of vaccines. The Committee suggested that a bigger discussion on policy around vaccination is required.

In anticipation of the new therapeutics product regime, the Committee suggested that previous decisions should be reviewed and any inconsistencies identified. A common format should be used for the new legislation that includes standardised terminology for classification statements.

5.2

Update on outstanding agenda items from the 59 th meeting

(Agenda item 5.3 Codeine – proposed reclassification from pharmacy-only and restricted medicines to a more restricted classification)

Background

At the 59th meeting the Committee recommended

  • That Medsafe should write to the professional bodies (ie, New Zealand Medical Association, Royal New Zealand College of General Practitioners, Pharmaceutical Society of New Zealand, Pharmacy Council of New Zealand, Pharmacy Guild of New Zealand, New Zealand Nurses Organisation, Chairs of the District Health Boards, Dental Council and the New Zealand Dental Association) regarding the importance of better education and professional development for health professionals regarding acute and chronic pain management, analgesics with the potential for abuse and a reminder of section 24(1) of the Misuse of Drugs Act 1975.
  • That the Committee should advocate the national monitoring of all codeine-containing medicines which would include restricted and prescription, subsidised and unsubsidised medicines. Medsafe alongside the Ministry of Health should explore how the Committee could advocate for a monitoring system.
  • That, from 31 January 2020, all codeine in combination medicines, both analgesics and those used for cough and colds, should be reclassified to prescription medicines.
  • That, from 31 January 2020, 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 three days’ supply.
  • That Medsafe should liaise with the sector regarding the required labelling to be included on codeine when sold as a restricted medicine.
Discussion

Issues about implementing the recommendation on the reclassification of codeine were discussed. These issues included communication around education and training around the use of codeine in pain management and monitoring the use of codeine-containing medicines.

Letters have been sent to the professional bodies listed by the Committee and Medsafe has published a webpage on the reclassification of codeine ( http://www.medsafe.govt.nz/profs/class/ReclassificationOfCodeine.asp).

The Committee acknowledged the complexities around the implementation of classification changes to codeine and that Medsafe will likely need to seek specialist advice on the implementation of these classification changes, in particular monitoring.

5.3

Trimethoprim – usage and resistance following reclassification

Background

This was a Medsafe investigative paper (PDF, 129 KB, 5 pages).

At the 47th meeting, the Committee recommended that trimethoprim should be reclassified from prescription medicine to prescription medicine except when supplied in packs of three tablets to women aged 16 to 65 years for uncomplicated urinary tract infection by a pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections.

The Chair of the Committee requested that Medsafe investigate the use of and resistance to trimethoprim following the reclassification in 2012.

Comments

Two comments were received about the Medsafe investigative paper on trimethoprim following reclassification. Both comments supported Medsafe’s recommendation that a review of the reclassification is not required at the current time.

Discussion

The Committee welcomed the paper and noted no significant impact on the resistance of trimethoprim could be observed, given the limitations of the data available. The Committee recommended that the classification of trimethoprim should remain unchanged. The Committee agreed that they are interested in learning about the impact of reclassification decisions and acknowledged that this may be complex issue to analyse due to the limited data available.

Recommendation

No recommendation was required.

5.4

Manufacturers original pack – information paper

Background

This was a Medsafe information paper (PDF, 397 KB, 9 pages) summarising all medicines in Schedule 1 of the Medicine Regulations 1984 that reference the manufacturer’s original pack and the Committee deliberations behind each reference. This information paper presented the list of medicines in Appendix 1 (PDF, 387 KB, 62 pages).

Comment

One comment was received about the Medsafe information paper on the manufacturers’ original pack. The comment supported the current flexible approach by the Committee where sometimes a manufacturer’s approved pack may be required and provided a description of various scenarios and suggestions.

Discussion

The Committee discussed the use of the term ‘manufacturers’ original pack’ and when the use of this term is appropriate. The Committee discussed the ability for pharmacists to repack medicines for a named individual patient. The Committee discussed various mechanisms for how appropriate information may be communicated to the patient to enable such information to be supplied under the different classifications. The Committee noted that there were several important issues around the balance of information that remains unresolved. The Committee discussed how this may require discussion with other parties when drafting future legislation.

The Committee agreed that this information paper should be used as a reference when considering whether future reclassification decisions require the use of the term ‘manufacturers original pack’.

Recommendation

No recommendation was required.

5.5

Phenibut – proposed classification as a prescription medicine

Purpose

This was a Medsafe submission (PDF, 303 KB, 14 pages) proposing the classification of phenibut as a prescription medicine.

Comments

One comment was received in support of the proposed classification of phenibut as a prescription medicine.

Discussion

The Committee agreed that phenibut should be classified as a prescription medicine.

Recommendation

That phenibut should be classified as a prescription medicine.

5.6

Rilmazafone - proposed classification as a prescription medicine

Purpose

This was a Medsafe submission (PDF, 125 KB, 8 pages) proposing the classification of rilmazafone as a prescription medicine.

Comments

One comment was received in support of the proposed classification of rilmazofone as a prescription medicine.

Discussion

The Committee agreed that rilmazafone should be classified as a prescription medicine.

The Committee recommended that rilmazofone should also be captured under the Misuse of Drugs Act 1975 because it is a benzodiazepine and that it should be referred to the Expert Advisory Committee on Drugs.

Recommendation

That rilmazofone should be classified as a prescription medicine.

That rilmazofone should be referred to the Expert Advisory Committee on Drugs.

6

Submissions for reclassification

6.1

Clotrimazole and hydrocortisone - proposed reclassification from restricted medicine to pharmacy-only medicine (Canesten Plus, Bayer New Zealand Limited)

Purpose

This was a company submission (PDF, 449 KB, 34 pages) proposing the reclassification of Canesten Plus topical cream from restricted medicine to pharmacy-only medicine.

Background

At the 1st meeting on 13 November 1984, the Committee recommended that the classification of hydrocortisone should include the words ‘with no other active ingredient’.

At the 7th meeting on 31 July and 1 August 1990, the Committee confirmed that hydrocortisone and hydrocortisone acetate should be classified as:

  • prescription; except when contained in dermatological medicines containing 1% or less by weight of hydrocortisone base and in a quantity of 15 g or 15 ml or less per container
  • part I pharmacy; in dermatological medicines containing 1% or less by weight of hydrocortisone base and in a quantity of not more than 15 g or 15 ml per container; in rectal medicines in a non-divided dose form containing 1% or less by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of not more than 35 g per container.

At the 9th meeting on 28 May 1992, the Committee acknowledged that the words ‘with no other active ingredient’ recommended at the 1st meeting had been omitted when hydrocortisone was discussed at the 7 th meeting. Following discussion, the Committee therefore recommended that products containing hydrocortisone in combination with antifungals which are currently available over-the-counter should retain their present status. However products in combination with any active ingredient other than an antifungal should be a prescription medicine.

At the 20th meeting on 19 November 1998, the Committee recommended that there be no increase in the volume limit for 1% hydrocortisone lotions sold as restricted medicines.

At the 24th meeting on 2 November 2000, in order to harmonise with Australia, the Committee recommended that the maximum pack size limit for the sale of dermal hydrocortisone preparations as restricted medicine or pharmacy-only medicines should be increased from 15 g or 15 ml to 30 g or 30 ml.

At the 27th meeting on 23 May 2002, the Secretary reported that Australia had responded to the Committee’s recommendation not to allow steroids more potent than 1 % hydrocortisone to be available over-the-counter. Australia did not adopt the Committee’s recommendation and allowed these products to continue to be sold as Schedule 3 (restricted) medicines. The Committee agreed to review its position in two years.

At the 28th meeting on 19 November 2002, in a discussion considering the classification of clobetasone, the Chair pointed out that the Committee had made a previous policy decision not to allow steroids more potent than 1 % hydrocortisone to be available over-the-counter.

At the 33rd meeting on 9 June 2005, the Committee recommended that the policy statement of November 2000 relating to topical steroids for over-the-counter sale should be revoked.

At the 48th meeting on 30 October 2012, the Committee recommended that hydrocortisone should not be reclassified 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.

At the 54th meeting on 24 November 2015, the Committee deferred making a decision to harmonise with the recommendation from Australia that the Schedule 3 (restricted medicine) entry for hydrocortisone should be amended to allow for 1% or less of hydrocortisone when compounded with aciclovir 5% w/w or less in primary packs of not more than 2 g for dermal use in adults and adolescents (12 years of age and older).

At the 55th meeting on 3 May 2016, the Committee recommended not harmonising and that hydrocortisone when combined with an antifungal should not be reclassified as a pharmacy-only medicine.

At the 59th meeting on 7 November 2017, the Committee recommended t hat hydrocortisone 1% w/w should be reclassified from prescription medicine to restricted medicine when combined with aciclovir 5% w/w in primary packs of not more than 2 g for dermal use in adults or children 12 years of age and older for the treatment of herpes labialis (cold sores).

Comments

The three comments received about this agenda item did not support the proposal.

Discussion

The Committee noted the background information and that similar proposals have been considered in the past.

The Committee discussed how the proposed reclassification may require self-diagnosis by the patient. The Committee discussed how a pharmacist is able to look at the rash, counsel on appropriate action and provide the necessary information for the patient to make an informed decision. The Committee agreed that intervention of a pharmacist in this scenario would contribute towards a positive outcome for the patient.

The Committee identified that off-label use of this product in babies is a safety concern and that pharmacists can advise against use in this population.

Overall, the Committee was concerned about the significant potential for misdiagnosis and how this could delay appropriate diagnosis and treatment. The Committee considered that the appropriate use for this product is best delivered in an environment where a health care professional is involved with diagnosis and treatment. The Committee’s recommendation is supported by the comments received.

The Committee noted that other antifungal and hydrocortisone combinations are classified as restricted medicines. The Committee also considered overseas classifications for this type of product.

Recommendation

That the classification for clotrimazole and hydrocortisone should remain unchanged.

6.2

Loratadine – proposed reclassification from pharmacy-only medicine to general sale medicine (Claratyne, Bayer New Zealand Limited)

Purpose

This was a company submission (PDF, 720 KB, 38 pages) proposing an amendment to the Label Statements Database to change the general sales restriction on age from 12 years and older to six years and older.

Background

At the 5th meeting on 11 November 1986, the Committee reviewed a proposal requesting a pharmacy-only medicine classification of loratadine. The Committee deferred making a decision until the Medicines Assessment Advisory Committee (MAAC) had made a recommendation on an application on loratadine up for consideration.

At the 6th meeting on 10 March 1987, the Committee noted that the MAAC had requested additional information and deferred making a decision.

At the 7th meeting on 31 July and 1 August 1990, loratadine was classified as a pharmacy-only medicine.

At the 10th meeting on 11 November 1992, the decision to recommend loratadine as a general sales medicine was postponed due to the reversal of a recommendation the Committee made on terfenadine; where the general sales medicine classification of terfenadine was reverted back to pharmacy-only medicine due to the information about possible cardiac effects.

At the 11th meeting on 29 June 1993, the Committee decided that non-sedating antihistamines such as loratadine should not be reclassified from pharmacy-only to general sales medicine. The Committee had also received a letter from the Medicines Adverse Reaction Committee (MARC) to consider reclassifying terfenadine, astemizole and loratadine as restricted medicines due to concerns about cardiac effects. As there were no reports of cardiac arrhythmias with loratadine use it was decided not to reclassify loratadine as a restricted medicine.

At the 12th meeting on 25 November 1993, the Committee recommended to keep the pharmacy-only medicine classification of terfenadine, astemizole and loratadine as there was still insufficient evidence for them to consider altering the classification. They recommended that loratadine should be tabled for reclassification when new information became available.

At the 17th meeting on 15 May 1997, the Committee noted correspondence from the MARC, that they had produced no further information that would result in them requesting the Committee to reconsider reclassifying loratadine as a restricted medicine.

At the 22nd meeting on 10 November 1999, the Committee decided to harmonise with the Australian Schedule, that loratadine should be classified as a:

  • prescription medicine except when specified elsewhere in the Schedule, and
  • that the pharmacy-only medicine entry classification should be amended to read pharmacy-only medicine; for oral use, except when a prescription medicine.

At the 49th meeting on 19 June 2013, the Committee noted that the Australian Delegate had made the following amendment to the classification of loratadine:

That loratadine should be reclassified from pharmacy-only medicine to general sales medicine when in divided forms for oral use containing 10 mg or less per dose in packs containing no more than 5 days’ supply for the treatment of seasonal allergic rhinitis.

At the 55th meeting on 3 May 2016, the Committee recommended that:

  • the general sales classification of loratadine should be amended to include an increased pack size of 10 days’ supply
  • that Medsafe should not approve applications for 10 days’ supply of loratadine as a general sales medicine, when indicated for the treatment of allergic rhinitis in children under the age of 12.
Comments

The Committee noted that the comments received were mixed. Three comments were received about this agenda item. One comment supported the proposal. Two comments did not support the proposal.

Discussion

The Committee agreed that loratadine is considered safe and that its safety profile is comparable to other medicines that are available as general sale medicines. The Committee noted that the differential diagnosis is considered low risk.

The Committee discussed access of medicines for children under 12 years old and the role of a health care professional when treating this population.

The Committee discussed how medicines for use in children should be accompanied by medical advice, however, they noted that there are already medicines for children available as general sale. The Committee noted that there remains a duty of care by retailers when selling medicines available as general sales because medicines are not ordinary items of commerce.

The Committee also considered the classification of loratadine overseas. In Australia ­­the age restriction for loratadine when sold as a general sales medicine is six years and over.

Recommendation

That the general sales restriction in the Label Statements Database should be changed to children six years and older.

6.3

Influenza vaccine – proposed amendment to ‘prescription except when’ classification (Pharmaceutical Society of New Zealand)

Purpose

This was a submission (PDF, 96 KB, 9 pages) proposing an amendment to the ‘prescription except when’ classification of influenza vaccine to include registered intern pharmacists who have successfully completed a vaccinator training course approved by the Ministry of Health and who are complying with the immunization standards of the Ministry of Health.

Background

At the 47th 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 48th 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 59th 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.

Comments

Three comments were received about the proposed amendment to the ‘prescription except when’ classification for influenza vaccine. All comments supported the proposal.

Discussion

One observer representing PSNZ was requested to join the meeting.

The Committee discussed whether the current classification statement already includes registered intern pharmacists. It was not obvious whether interns are considered ‘registered pharmacists’ and that further clarification is required.

The Committee thanked the observer and they left the meeting.

Recommendation

That the classification for influenza vaccine remain unchanged.

That ‘registered pharmacists’ should be interpreted to include registered intern pharmacists.

Secretary’s note

Medsafe will seek legal advice on this interpretation.

July 2018
Medsafe is of the opinion that the term ‘pharmacist’, as defined in the Medicines Act 1981, is a person formally registered with the Pharmacy Council to practice as a pharmacist, as opposed to an intern pharmacist.

The term ‘pharmacist’ is defined in the Medicines Act 1981 as:

“pharmacist” means health practitioner who is, or is deemed to be, registered with the Pharmacy Council established by the Health Practitioners Competency Assurance Act 2003 as a practitioner of the profession of pharmacy.

The terms ‘registered pharmacist’ or ‘registered intern pharmacist’ are not terms that are defined in the Medicines Act. They are the scopes of practice prescribed by the Pharmacy Council. It is advisable to interpret the term 'pharmacist' as it is defined in the Medicines Act.

The scopes of practice prescribed by the Pharmacy Council suggest that the Council do not consider an intern pharmacist to be 'a practitioner of the profession of pharmacy’ until the intern pharmacist is formally registered to practice as a pharmacist.

Given this, it is advisable to interpret the term 'pharmacist' to be a person formally registered with the Pharmacy Council to practice as a pharmacist (as opposed to an intern pharmacist) for the purposes of the Medicines Act.  

6.4

Melatonin – proposed reclassification from prescription medicine (Individual submission)

Purpose

This was a submission (PDF, 911 KB, 17 pages) proposing the reclassification of melatonin to permit sale as a dietary supplement.

Background

Melatonin was classified urgently as a prescription medicine at the 16th meeting on 24 April 1996. Before classification a number of supplements had appeared on the New Zealand market bearing therapeutic claims. Melatonin was classified because it is a hormone and at the time there was insufficient data available regarding its effects and safety profile.

At the 47th meeting on 1 May 2012, the Committee considered the submission for 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. The Committee recommended that a revised submission to reclassify 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, would be considered at a future meeting.

At the 48th meeting on 30 October 2012, the Committee recommended that melatonin 2 mg prolonged release tablets should not be reclassified 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. More time on the market with experience in New Zealand with the proposed indication was required.

At the 49th meeting on 17 June 2013, melatonin was discussed again by the Committee. In response to a request from Aspen Pharma Pty Limited, the Committee confirmed what would be required if another submission for reclassification was made at a later meeting. The submission should address the:

  1. risk of use in children
  2. difficulty in diagnosing primary insomnia currently, particularly in the elderly
  3. likelihood and impact of an important diagnosis being missed.

If another submission was received within a year, it was considered appropriate to address the outstanding issues only. However, if a submission for reclassification was made in five years’ time, a full submission would be required.

At the 57th meeting on 1 November 2016, a submission for the reclassification of melatonin was withdrawn before the meeting.

At the 58th meeting on 16 May 2017, a submission for the reclassification of melatonin was withdrawn before the meeting.

Comments

Four comments were received about the proposed reclassification of melatonin from prescription medicine. Three comments opposed the categorisation of melatonin as a dietary supplement and supported the alternative for purchase under the instruction of a pharmacist. One comment supported the reclassification as a dietary supplement.

Discussion

The Committee agreed that melatonin is considered a medicine and not a dietary supplement. The Committee agreed that products containing melatonin meets the definition a therapeutic purpose as defined in the Medicines Act 1981. The uses described in the submission and the currently approved indications for products containing melatonin are for therapeutic purposes and therefore it is considered a medicine. Dietary supplements cannot make therapeutic claims, as described by the Dietary Supplements Regulations 1985.

The Committee compared melatonin to insulin, which is categorised as a medicine. Both melatonin and insulin are naturally occurring hormones that have a therapeutic purpose.

The Committee agreed that melatonin has a good safety profile compared to sedating antihistamines and that the safety profile may support a classification switch.

The Committee also considered the classification of melatonin overseas.

The Committee noted that the published agenda did not accurately reflect the submission. The agenda referred to reclassification as a dietary supplement only and that it did not include the alternative proposal in the submission to reclassify melatonin to allow it to be ‘purchased under the instruction of a chemist, as with doxylamine and diphenhydramine’.

It was not obvious to the Committee whether the alternative proposed in the submission meant a restricted classification or a pharmacy-only classification. The Committee requested to seek further clarification with the observer, C King.

C King joined the meeting. The Chair thanked C King for his submission and introduced the members of the Medicines Classification Committee. The Committee advised C King that melatonin is considered a medicine and explained the rationale for this decision.

The Committee asked C King for further clarification on the alternative proposal for supply ‘under the instruction of a chemist’. C King compared the classification with that for doxylamine. Doxylamine and diphenhydramine are classified as prescription, restricted and pharmacy-only medicines.

The Committee recommended that Medsafe should reconsult on this proposal for reclassification to a restricted medicine because the published agenda did not accurately reflect the submission’s alternative proposal.

C King left the meeting.

The Committee noted that there is already a product containing melatonin that is classified as a prescription medicine. Circadin, 2 mg modified release tablet, was approved in December 2009 for use as ‘monotherapy for the short term treatment (up to 13 weeks) of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over’.

Recommendation

That the classification for melatonin remains unchanged.

That Medsafe should consult again on the reclassification of melatonin to a restricted medicine because the published agenda did not include this submission’s alternative proposal.

6.5

Modified-release paracetamol – proposed reclassification from pharmacy-only medicine to restricted medicine (Medsafe)

Purpose

This was a Medsafe submission (PDF, 916 KB, 9 pages) proposing the reclassification of modified-release paracetamol from pharmacy-only medicine to restricted medicine.

Background

At the 26th meeting on 11 December 2001, the Committee recommended that paracetamol in modified release tablets containing 665 milligrams should maintain its classification as a prescription medicine.

At the 34th meeting on 9 June 2006, the Committee recommended:

  • that medicines containing 665 milligrams or less of paracetamol and more than 500 milligrams should be reclassified as pharmacy-only medicines when in slow release form
  • that the sponsor company for the 665 milligram slow release product should be asked to prepare and promote a protocol for the treatment of paracetamol overdose in emergency rooms that would take into account the treatment required for slow release forms
  • that the NDPSC should be asked to harmonise on the requirement for S2/pharmacy-only medicines over 500 mg and up to 665 mg per tablet or capsule to be in slow release form only.
Comments

Five comments were received about the proposed reclassification of modified-release paracetamol from pharmacy-only medicine to restricted medicine. Two comments supported the proposal. Three comments did not support the proposal.

Discussion

The Committee discussed the difficulties of managing overdose with modified release paracetamol. There is a risk that paracetamol overdose may not be appropriately treated due to its slow release profile over time.

The Committee also discussed the risk of unintended misuse resulting in chronic overdose of modified release paracetamol which may result in long term liver damage. The Committee discussed the role of a pharmacist in counselling the patient on the appropriate use of modified release paracetamol, including dosage frequency.

The Committee considered the classification of this product overseas and the situation in Europe. Modified release paracetamol products have been suspended in Europe until a harmonised guideline on managing overdose can be established.

The Committee noted that in New Zealand immediate release paracetamol is more widely available than modified release paracetamol and that the incidence of paracetamol overdose due to modified release paracetamol in New Zealand is low compared to Europe. However, the Committee also discussed that reclassification may pre-emptively prevent higher incidence rates that have been observed elsewhere.

The MARC recommended at the 172nd meeting that the MCC consider reclassifying modified release paracetamol from pharmacy-only medicines to restricted medicines, and that guidelines for the treatment of modified release paracetamol overdose be updated.

The Committee discussed classifications for paracetamol, ibuprofen, diclofenac and aspirin, and how these varied by strength and dosage form.

The Committee arrived at a consensus decision.

Recommendation

That modified release paracetamol be reclassified from a pharmacy-only medicine to a restricted medicine.

6.6

Sedating antihistamines – proposed amendment to restricted medicine classification (Medsafe)

Purpose

This was a Medsafe submission (PDF, 155 KB, 14 pages) proposing that ‘for the treatment of anxiety’ should be removed from the restricted medicine classification statements of sedating antihistamines.

Background

At the 19th meeting on 20 May 1998, the Committee considered a submission from the National Toxicology Group for the reclassification from pharmacy-only to restricted medicine of sedating anti-histamines when sold as sleeping aids. The submission provided evidence of increasing intentional abuse of products marketed in this way.

At the 19th meeting the Committee recommended that:

  1. a sedating anti-histamine or any other over-the-counter product indicated for sedation or anxiety should be classified as a restricted medicine when in packs sufficient for five days' supply or less; those containing more than five days' supply should be classified as prescription medicines
  2. the Ministry be asked to review the classification of all oral sedating antihistamine products where the anti-histamine is not combined with another active ingredient
  3. the Ministry compose guidelines for all over-the-counter products indicated for insomnia or anxiety.

At the 20th meeting on 19 November 1998 an update was provided to the Committee on their recommendations at the last meeting. Medsafe had not supported the recommendation on the grounds that most products on the market would become prescription medicines rather than restricted medicines. This would cause them to be removed from the market as they would not be prescribed. Companies had not been consulted on the possibility of their products being changed to prescription medicines. Nor did the recommendation harmonise with the Australian classification for these medicines.

The matter was resolved by means of a postal consultation held in October 1998. The five respondents agreed to limit the maximum pack size for sale as restricted medicine to 10 doses rather that to five days’ supply. This would bring the pack size limits into line with those of Australia. Medsafe wrote guidelines for medicines marketed for sedation or anxiety which harmonised with the proposed Australian guidelines for sedating antihistamines. The New Zealand guidelines were already on the website and would be incorporated into the new edition of The New Zealand Regulatory Guideline for Medicines which was currently under preparation.

Comments

Two comments were received about the proposed amendment to the restricted classification for sedating antihistamines. Both comments supported the proposal.

Discussion

The Committee considered the submission and the recommendation from the MARC at the 166th meeting that ‘for the treatment of anxiety’ should be removed from the restricted medicine classification statements for sedating antihistamines because there is little evidence supporting the use of sedating antihistamines for anxiety.

The Committee discussed how sedating antihistamines are not commonly used for anxiety and that there is currently no product containing sedating antihistamines that is approved for treatment of anxiety.

The Committee agreed that ‘for the treatment of anxiety’ should be removed from the restricted medicine classifications statements for sedating antihistamines and that the use of sedating antihistamines for treatment of insomnia should remain unchanged.

Recommendation

That ‘for the treatment of anxiety’ should be removed from the restricted medicine classification statements of sedating antihistamines.

That Medsafe should inform prescribers and pharmacists about this recommendation by publishing an article in a future edition of Prescriber Update.

7

New medicines for classification

7.1

Spinraza – nusinersen solution for injection 12 mg/5 mL (TT50-10323)

The active ingredient nusinersen is an antisense oligonucleotide.

The product Spinraza is indicated for the treatment of 5q spinal muscular atrophy, an autosomal recessive progressive neuromuscular disease caused by the mutation or deletion of the survivor motor neuron 1 (SMN1) gene on the q arm of chromosome 5. This results in a deficiency of SMN protein. The SMN2 gene, also present on the same chromosome, transcribes a similar but generally truncated SMN protein that is unstable and defective. Fully functioning SMN protein is essential for the normal function of the anterior horn cell. Its deficiency results in progressive loss of skeletal muscle. Nusinersen promotes the transcription of a full length SMN protein from the SMN2 gene.

International regulations

Nusinersen is classified in Australia and Canada as a prescription medicine.

Spinraza is authorised centrally by the EMA as a prescription medicine.

The product Spinraza is classified by the FDA as a prescription medicine

Recommendation

That nusinersen is added to the New Zealand Schedule as a prescription medicine

7.2

Etomidate – proposed classification as prescription medicine (section 29)

The active ingredient etomidate is an intravenous anaesthetic used for the induction of general anaesthesia. Anaesthesia is rapidly induced and may last for 6 to 10 minutes with a single usual dose. Recovery is usually rapid without hangover effect. Etomidate has no analgesic activity.

Recommendation

That etomidate is added to the New Zealand Schedule 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

8.1.1

Guselkumab (October 2017)

Guselkumab is indicated for the treatment of moderate to severe plaque psoriasis, scalp, nail, and hand and foot psoriasis and improvement of health related quality of life in adult patients who are candidates for systemic therapy or phototherapy.

From 1 October 2017, guselkumab is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That guselkumab is added to the New Zealand Schedule as a prescription medicine.

8.1.2

Apalutamide (January 2018)

Apalutamide is intended to be indicated for the treatment of patients with castration-resistant prostate cancer at risk of developing metastases.

From 1 February 2018, apalutamide is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That apalutamide is added to the New Zealand Schedule as a prescription medicine.

8.1.3

Bictegravir (January 2018)

Bictegravir is indicated for the treatment of HIV-1 infection in adults without any known mutations associated with resistance to the individual components of the fixed dose combination and for the treatment of chronic hepatitis B in adults coinfected with HIV-1.

From 1 February 2018, bictegravir is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That bictegravir is added to the New Zealand Schedule as a prescription medicine.

8.1.4

Binimetinib (January 2018)

Binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma, with NRAS Q61 mutation.

From 1 February 2018, binimetinib is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That binimetinib is added to the New Zealand Schedule as a prescription medicine.

8.1.5

Cabozantinib (January 2018)

Cabozantinib is indicated for the treatment of advanced renal cell carcinoma in adults following prior therapy.

From 1 February 2018, cabozantinib is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That cabozantinib is added to the New Zealand Schedule as a prescription medicine.

8.1.6

Cinnarizine (January 2018)

Cinnarizine is used in a fixed dose combination product with dimenhydrinate and is intended for the short term treatment of vertigo in adults.

From 1 February 2018, cinnarizine is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That cinnarizine is added to the New Zealand Schedule as a prescription medicine.

8.1.7

Encorafenib (January 2018)

Encorafenib is indicated for use in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma, with BRAF V600 mutation.

From 1 February 2018, encorafenib is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That encorafenib is added to the New Zealand Schedule as a prescription medicine.

8.1.8

Erenumab (January 2018)

Erenumab is indicated for the prophylaxis of migraine in adults.

From 1 February 2018, erenumab is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That erenumab is added to the New Zealand Schedule as a prescription medicine.

8.1.9

Ertugliflozin (January 2018)

Ertugliflozin is indicated for the treatment of type 2 diabetes.

From 1 February 2018, ertugliflozin is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That ertugliflozin is added to the New Zealand Schedule as a prescription medicine.

8.1.10

Ferric derisomaltose (January 2018)

Ferric derisomaltose is indicated for the treatment of iron deficiency in adults, under the following conditions:

  • when oral preparations are ineffective or cannot be used; and
  • when there is a clinical need to deliver iron rapidly.

From 1 February 2018, ferric derisomaltose is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That ferric derisomaltose is added to the New Zealand Schedule as a prescription medicine.

8.1.11

Insulin deglude (January 2018)

Insulin degludec is indicated to improve glycaemic control in adult patients with diabetes mellitus.

From 1 February 2018, insulin deglude is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That insulin deglude is added to the New Zealand Schedule as a prescription medicine.

8.1.12

Letermovir (January 2018)

Letermovir has been requested for the indication of prophylaxis of cytomegalovirus (CMV) infection or disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.

From 1 February 2018, letermovir is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That letermovir is added to the New Zealand Schedule as a prescription medicine.

8.1.13

Patiromer sorbitex calcium (January 2018)

Patiromer sorbitex calcium is indicated for the treatment of hyperkalaemia in adults.

From 1 February 2018, patiromer sorbitex calcium is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That patiromer sorbitex calcium is added to the New Zealand Schedule as a prescription medicine.

8.1.14

Peramivir (January 2018)

Peramivir is indicated for the treatment of infections due to influenza A and B viruses in adults and children 2 years and older. Treatment should commence as soon as possible, but no later than 2 days after the onset of the initial symptoms of infection.

From 1 February 2018, peramivir is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That peramivir is added to the New Zealand Schedule as a prescription medicine.

8.1.15

Recombinant varicella zoster virus glycoprotein E antigen (January 2018)

Recombinant varicella zoster virus glycoprotein E antigen is a varicella zoster virus antigen based on recombinant technology. Recombinant varicella zoster virus glycoprotein E antigen is indicated for the prevention of herpes zoster and herpes zoster-related complications, such as post-herpetic neuralgia, in adults 50 years of age or older.

From 1 February 2018, recombinant varicella zoster virus glycoprotein E antigen is classified as a prescription medicine in Australia.

The Committee noted the Schedule entry for varicella vaccine. The Committee agreed to harmonise and that it should be added as a separate entry and that this approach is consistent with other similar products such as insulin and blood clotting agents. The Committee agreed that this approach recognises that new active ingredients may have different safety and risk profiles and that there are opportunities for these new active ingredients to be classified under the product entry in the future following post market experience.

The Committee requested that Medsafe prepare an information paper on New Biological Entities and vaccine product classifications for consideration at a future meeting.

Recommendation

That recombinant varicella zoster virus glycoprotein E antigen is added to the New Zealand Schedule as a prescription medicine.

That Medsafe write an information paper for the Committee on the classification process for New Biological Entities and vaccine product classifications.

8.1.16

Reslizumab (January 2018)

Reslizumab is indicated as an add-on treatment in adult patients with severe eosinophilic asthma.

From 1 February 2018, reslizumab is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That reslizumab is added to the New Zealand Schedule as a prescription medicine.

8.1.17

Ribociclib (January 2018)

Ribociclib is indicated for advanced breast cancer.

From 1 February 2018, ribociclib is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That ribociclib is added to the New Zealand Schedule as a prescription medicine.

8.1.18

Tafenoquine succinate (January 2018)

Tafenoquine succinate is indicated for radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older.

From 1 February 2018, tafenoquine succinate is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That tafenoquine succinate is added to the New Zealand Schedule as a prescription medicine.

8.1.19

Telotristat ethyl (January 2018)

Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome.

From 1 February 2018, telotristat ethyl is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That telotristat ethyl is added to the New Zealand Schedule as a prescription medicine.

8.1.20

Tipiracil (January 2018)

Tipiracil (as tipiracil hydrochloride), in combination with trifluridine, is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vascular endothelial growth factor agents, and anti-epidermal growth factor receptor agents.

From 1 February 2018, tipiracil is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That tipiracil is added to the New Zealand Schedule as a prescription medicine.

8.1.21

Trifluridine (January 2018)

Trifluridine, in combination with tipiracil hydrochloride, is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vascular endothelial growth factor agents, and anti-epidermal growth factor receptor agents.

From 1 February 2018, trifluridine is classified as a prescription medicine in Australia.

The Committee agreed to harmonise.

Recommendation

That trifluridine is added to the New Zealand Schedule as a prescription medicine.

8.2

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

8.2.1

Decisions by the Delegate – October 2017

8.2.1a

Esomeprazole

Purpose

Esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply should be reclassified from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy-only medicine).

Discussion

The Committee noted the proposed change in pack size and the absence of the age restriction. The Committee noted that this aligns with other similar products.

The Committee agreed to harmonise.

Recommendation

That New Zealand should harmonise with Australia and esomeprazole in oral preparations containing 20 mg or less per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease in packs containing not more than 14 days’ supply should be classified to pharmacy-only medicine in the New Zealand Schedule.

9

Agenda items for the next meeting

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

  1. Further information about the Committee under the new therapeutics products regime including work programme

10

General business

10.1

The function of the MCC under the future therapeutic products regime

The Committee discussed the future of the Committee and how it will function under the new therapeutic products regulatory regime. The following points were raised at the 59th meeting:

  1. continuing with the transparency of the Committee
  2. increasing engagement with the health sector
  3. concerns that the number of submissions will reduce due to the commercial sensitivity of publishing training tools and references

Medsafe gave some background information and an update on the progress of the new therapeutics products regulatory regime.

The Committee discussed the suitability of the current classifications described in the current legislation and what the future model might look like.

The Committee discussed the process for submitting proposals for reclassification, who typically submits proposals and the reactive nature of the Committee.

11

Date of next meeting

The Committee suggested that the next meeting will be held in November 2018. The Secretary will email members for their availability.

There being no further business, the Chair thanked members and guests for their attendance and closed the meeting at 2:15 pm.

This document was prepared and written by
Jessica Lo
Secretary of the Medicines Classification Committee