1

Welcome

The Chair opened the 50^th meeting at 9:30 am and welcomed members and guests.

2

Apologies

Professor Leslie Toop was unable to attend the meeting.
Dr Mark Peterson was only available to attend on Wednesday 13 November 2013. Dr Peterson confirmed that there were no items on the Tuesday that were of concern to the New Zealand Medical Association.

3

Confirmation of the minutes of the 49^th meeting held on Monday 17 June 2013

The last two sentences in the final paragraph of agenda item 8.2.3 Decisions by the Delegate - November 2013 were revised from "Ibuprofen in combination with phenylephrine was already available over-the-counter in a pharmacy in New Zealand. Therefore no recommendation was required" to "As ibuprofen and phenylephrine are already classified as general sale medicines, no recommendation was required".
All other sections of the minutes of the 49^th meeting were accepted as a true and accurate record. The minutes were signed and dated by the Chair.

4

Declaration of conflicts of interest

The Conflict of Interest forms were returned to the Secretary.

The following conflicts of interest were declared:

1. Dr Yousuf declared that he worked as a Medical Advisor for Pfizer Limited on sildenafil from 2001 to 2003, and as a Clinical Research Physician at Eli Lilly and Company on tadalafil in 2003. The Committee agreed that as Dr Yousuf has no financial interest in either company, and that his work as an Advisor was over a decade ago, he could participate fully in the discussion.
2. Mr Orange declared that he received funding from the NZ College of Pharmacists to assist with training when omeprazole was reclassified from prescription medicine to restricted medicine; however the Committee agreed that as sufficient time had elapsed, Mr Orange could participate fully in the discussion.

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

5

Matters arising

5.1

Objections to recommendations made at the 49^th meeting

5.1.1

Further data to support the reclassification of diphtheria, tetanus and pertussis (acellular, component) vaccine
(Pharmacybrands Limited)

At the 49^th meeting held on 17 June 2013, the Committee recommended that diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap), should be reclassified from prescription medicine to prescription medicine except when administered in a single dose to a person aged 18 years or over by a pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health. Subject to the minor amendments being made to the pre-vaccination checklist and consent form.

A valid objection was received to the following amendment suggested by the Committee to Pharmacybrands regarding the proposed pre-vaccination checklist and consent form: "remove the sentence on page four 'this vaccine should be used during every pregnancy to protect each baby' - if two pregnancies are close together two vaccinations would not be necessary".

The objection stated that the proposed amendment was contrary to current evidence-based Ministry of Health advice. The objector pointed out that to maximise the protection provided to new-born infants, Tdap immunisation should be offered every pregnancy within the period of 28 to 38 weeks (with immunisation between 28 to 32 weeks being optimal). This allows time for the woman's immune system to produce protection against whooping cough, reducing the risk that she will have the disease when the baby is born, and for the subsequent year when the infant's risk of developing complications from whooping cough is highest. The objector referenced the Halperin study, which demonstrated little or no antibody protection to infants from breast milk. The objector stated that the aim of pertussis vaccination is to prevent severe disease in infants, as this group is most at risk of death or long term sequelae as a result of pertussis. The Halperin study also noted that the antibody response to pertussis vaccination reached a peak 14 days after vaccination, which may not be rapid enough to protect infants in the first weeks of life if the vaccine is delivered post-partum.

The Committee agreed that the suggested amendment to Pharmacybrands' pre-vaccination checklist should be retracted so that the advice provided aligns with current Ministry of Health recommendations.

Recommendation

That the Committee should retract the suggested amendment to Pharmacybrands' pre-vaccination checklist so that the advice provided reflects the advice of the Ministry of Health Immunisation Handbook.

5.1.2

6.1 Meningococcal vaccine - proposed reclassification from prescription medicine to prescription medicine except when…(Pharmacybrands Limited)

At the 49^th meeting held on 17 June 2013, the Committee recommended that meningococcal vaccine should be reclassified from prescription medicine to prescription medicine except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

That the reclassification should be subject to Medsafe reviewing and being satisfied with the documentation used by pharmacists.

An objection was received stating that the age requirement for which Meningococcal vaccine is to be made available in pharmacies should be changed from 16 to 18 years of age.

The Committee commented that the submission stated one of the targets was to make this vaccination available to teenagers who are entering new environments such as college, university, the armed forces or any other group activity where the risk of meningococcal disease is higher, by offering the vaccine through pharmacies.

The Committee concluded that the meningococcal vaccine wasn't funded for those under the age of 18 and the option to make the vaccine more available to patients moving into higher risk communities was appropriate. The Committee had no additional safety concerns about the use of this vaccine in those between the ages of 16 and 18.

Recommendation

That the Committee confirm its earlier recommendation to reclassify meningococcal vaccine from prescription medicine to prescription medicine except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

That the reclassification should be subject to Medsafe reviewing and being satisfied with the documentation used by pharmacists.

5.1.3

Training for pharmacist vaccinators

At the 49^th meeting held on 17 June 2013, the Committee recommended that the Chair should write to the Pharmacy Council of New Zealand, asking them to liaise with the appropriate bodies, to define the appropriate level of training that is required for a pharmacist vaccinator to resuscitate a patient who has gone into anaphylactic shock.

The Pharmacy Council of New Zealand responded, declaring that the current guidance states that pharmacists must comply with the Ministry of Health's immunisation standards, which include being able to deal with anaphylaxis. The guidance also states that they must hold a current CPR certificate consistent with Competence Standard 3 of the competence standards for pharmacists (ie, Level 2 of the New Zealand Resuscitation Council's [NZRC] competencies). The Council acknowledged that Level 2 is not sufficient for vaccinators, and stated that it would advise the profession that pharmacists who are vaccinators require training to NZRC Level 3.

An objection was received that stated:

1. the proposed governance mechanism for the creation of pharmacists as authorised vaccinators to deliver these reclassified vaccines has no basis in the current legislation
2. it is unclear as to how the Committee sees that 'authorised vaccinator' status is achieved for pharmacists by the reclassification of an individual vaccine
3. it is noted that the Pharmacy Council does not consider that an individual practising as a vaccinator is operating within the scope of practice of a pharmacist
4. there is currently no mechanism to provide assurance that the Immunisation Handbook requirements are being fulfilled by pharmacist vaccinators. The Pharmacy Council does not consider vaccination within its remit to regulate.

The advice the Committee has received is that by reclassifying vaccines, such that in certain defined circumstances the vaccines are no longer prescription medicines, is sufficient to mean that persons meeting the schedule entry can vaccinate without having to become an authorised vaccinator. As the standard that has been set for pharmacists is the equivalent of the training required for people who become authorised vaccinators, the Committee considered that reclassification and administration of a vaccine by persons meeting the defined criteria would not expose a consumer to any level of increased risk of harm.

The Committee agreed that it is satisfied that the Pharmacy Council mechanisms for clinical governance, support, and training are sufficient. The Committee has been advised that while vaccination is not currently explicitly within the scope of practice of pharmacists, it will be in the near future; and since it is not prohibited within the current scope, there is no impediment to pharmacists administering vaccines.

Recommendations

That the Chair write to the Pharmacy Council of New Zealand suggesting that they liaise with the Ministry of Health, as a part of their clinical governance role, to discuss the level of training required to become authorised vaccinators.

That the Committee confirm its earlier recommendation to reclassify diphtheria, tetanus and pertussis (acellular, component) vaccine (Tdap from prescription medicine to prescription medicine except when administered in a single dose to a person aged 18 years or over by a pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

That the Committee confirm its earlier recommendation to reclassify meningococcal vaccine from prescription medicine to prescription medicine except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

5.2

Review of the classification criteria

At the 47^th meeting on 1 May 2012, a Committee member suggested that revisiting the criteria used when considering a medicine for reclassification for non-prescription sale should be added to the agenda of the next meeting.

At the 48^th meeting on 30 October 2012, following discussion, the Committee recommended that:

1. the classification criteria would be considered at the next meeting
2. Medsafe should put together a paper with the outcome of the United Kingdom consultation and classification criteria options for discussion at the next meeting.

At the 49^th meeting on 17 June 2013, the Committee recommended that:

1. Medsafe should revise the paper as discussed
2. the Medsafe paper should be agreed out-of-session by the Committee and added to the agenda of the next meeting to allow for public consultation
3. the Medsafe paper should be considered at the next meeting alongside the consultation and review of the medicines and poisons scheduling arrangements in Australia.

The revised Medsafe paper was presented with the agenda of the 50^th meeting for consultation. During the consultation period, four pre-meeting comments were received, all making a number of suggestions to improve the guideline.

A suggested editorial change of the heading "Phases of the classification process" to the wording "Should the reclassification submission be successful…" was supported by the Committee to remove the implication that an application to the reclassification process always results in a classification change.

Proposals for changes to Phase 1: Part A

Based on a comment concerning health literacy in New Zealand and the importance of plain language health information, the Committee considered the practicality of requiring user testing for reading labels as a criteria for reclassification. The Committee noted that there is already such a requirement in the guidelines for Consumer Medicine Information sheets (CMIs). The Committee noted the issue of health literacy and encourages companies to consider this when putting together labelling for applications. The Committee commented that it would be very useful to see evidence of consumer testing but that it cannot be made a requirement, as this could create further barriers for applications, which is not the Committee's intention.

It was suggested that the reclassification criteria include quality use of medicines criteria. The Committee agreed with the sentiment that aligning reclassifications with best practises was a good thing, but were unsure as to whether it is essential. One member commented that the main concern was appropriate use of medications, which is covered adequately by information in the product datasheet.

Proposals for changes to Phase 1: Part B

One comment received was that when considering classification status from other countries, the Committee should take into consideration the differences in healthcare systems, and the fact that barriers to healthcare in New Zealand are much lower than in other countries. The Committee acknowledge the comment but concluded that under the current criteria, the Committee considers medicine availability in multiple countries, including those with high costs of healthcare such as the United States and those with lower costs such as the United Kingdom.

A suggestion to change Part B of the application form from "Reasons for requesting classification change" to "Benefits and risks of the reclassification" or similar was received and considered by the Committee. The Committee decided that the heading be changed to "Reasons for requesting classification change including benefit-risk analysis". An editorial change of Part B was also suggested, where the sentence "this section should be supported where relevant by the following" suggests that points 1-10 are voluntary and may not be needed in that order or to be included at all. The Committee agreed that the sentence should be reworded.

The Committee agreed with a suggestion to change Point 7 in Part B to "Contraindications and precautions".

Proposals for changes to Phase 2

Another editorial suggestion, which was accepted by the Committee, was changing the statement under Phase 2, "late comments on agenda items cannot usually be accepted" to "late comments on agenda items may not be accepted", which would leave the decision of whether or not to accept late comments to the discretion of the Committee.

Proposals for changes to Phase 3

Rewording was suggested for points a and b under Phase 3: Meeting and MCC recommendations. The Committee agreed that point a be changed to "show substantial safety in use in the prevention or management of the condition or symptom under consideration", and point b be changed to "be diagnosed and managed by a pharmacist".

Proposals for changes to Phase 5

The suggested editorial to change "Those who have made submissions to the MCC receive an email explaining the outcome before the minutes are published" to "Those who have made applications to the MCC receive an email explaining the outcome before the minutes are published" was agreed to by the Committee to remove the ambiguity between those who have submitted applications and those who have submitted comments.

It was suggested that the Committee give more than the current less than 24 hours notice to the applicant, before the minutes are published. The Committee agreed to recommend that Medsafe consider this change.

Proposals for changes to Phase 6

A suggestion was made to clarify when "Medsafe will advise the objector of the outcome and give the original applicant a chance to comment to the MCC about the objection", whether the original applicant can respond to the objection before or after the objection goes to the Committee. The Committee agreed that the objections should be made available to the applicant to respond before the objection goes to the MCC and that this should be made clear in the guideline.

Recommendations

That the heading "Phases of the classification process" be changed to "Should the reclassification submission be successful…"

That the heading of Part B be changed from "Reasons for requesting classification change" to "Reasons for requesting classification change including benefit-risk analysis".

That the description in Part B "this section should be supported where relevant by the following" be reworded to remove any confusion about what is required in the application.

That Point 7 in Part B should be changed to "Contraindications and precautions".

That the sentence "late comments on agenda items cannot usually be accepted" be changed to "late comments on agenda items may not be accepted".

That the principles when considering a medicine for non-prescription under Phase 3: Meeting and MCC recommendations be amended to:

1. show substantial safety in use in the prevention or management of the condition or symptom under consideration
2. be diagnosed and managed by a pharmacist
3. be easily self-diagnosed and self-managed by a patient

That the statement "Those who have made submissions to the MCC receive an email explaining the outcome before the minutes are published" be changed to "Those who have made applications to the MCC receive an email explaining the outcome before the minutes are published".

That Medsafe consider providing applicants with more than 24 hours notice regarding the submission outcome before publication of the minutes.

That clarity be provided around the statement "Medsafe will advise the objector of the outcome and give the original applicant a chance to comment to the MCC about the objection", explaining that the objections will made available to the applicant to respond before the objection goes to the MCC.

5.3

Amyl nitrite - amending the classification statement to include exempt laboratories

Amyl nitrite is 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.

This classification followed a recommendation from the Committee at the 42^nd meeting on 3 November 2009.

Medsafe recently received a number of queries from laboratories that possess sodium cyanide but are exempt from holding a controlled substance licence, wanting to know how to get a supply of amyl nitrite under current legislation.

After consideration, the Committee recommended the amendment of the classification statement to 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.

Recommendation

That the classification of amyl nitrite should be amended to 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.

5.4

Influenza vaccine - amending the classification statement from administration by a pharmacist to include all authorised vaccinators

At the 49^th meeting on 17 June 2013, the Committee foreshadowed that the classification of influenza vaccine (as prescription; except when administered to a person aged 18 years or over by a pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health), and potentially Tdap and meningococcal vaccine, should be amended from administration by a pharmacist to include all authorised vaccinators.

Four pre-meeting comments were received during the consultation period.

Three of the comments supported the change, so long as all vaccinators would be subject to the same requirements as pharmacists. One comment proposed that the reclassification include a registered nurse as opposed to an authorised vaccinator.

The Committee noted the comments that suggested inclusion of any other healthcare provider in the entry for vaccines would require the professional bodies responsible for that healthcare practitioner to take on a similar role as the Pharmacy Council does with respect to pharmacist vaccinators. In view of this consideration, the Committee decided to defer making a decision and seek information regarding the opinion of the Nursing Council, asking if it:

1. considers that vaccination is covered by the nursing scope of practice
2. is prepared to explore and become responsible for managing the quality of the vaccine service provided by registered nurses
3. is prepared to assess compliance with the rules and accreditation for maintenance of vaccine cold chain
4. is prepared to create information resources for use by nurse vaccinators operating under the reclassification of vaccines, to support appropriate storage, supply, and choice of vaccines to be administered.

The Committee also recommended seeking input from the New Zealand Nurses Organisation, asking it if it was prepared to develop information resources to inform nurse decision making about the appropriateness of particular vaccines in a way similar to that created for pharmacy access.

Recommendation

That any decision to amend the schedule entries for vaccines to include all authorised vaccinators be deferred and reconsidered at a future meeting following the provision of further information from the Nursing Council and the New Zealand Nurses Organisation.

5.5

Naproxen - proposed reclassification from pharmacy-only medicine to general sale medicine
(Naprogesic, Bayer New Zealand Limited)

At the 49^th meeting on 17 June 2013, the Committee recommended that a revised submission to reclassify naproxen, in solid dose form for oral use containing 220 mg or less per dose form with a recommended daily dose of not more than 660 mg and in a pack containing not more than 15 tablets or capsules, from pharmacy-only medicine to general sale medicine would be considered at the current meeting.

Naproxen is currently classified as:

• prescription; except when specified elsewhere in the Schedule
• pharmacy-only; in solid dose form containing 250 milligrams or less per dose form in packs of not more than 30 tablets or capsules.

No revised submission was received before the meeting.

Five pre-meeting comments were received during the consultation period.

The Committee agreed that the comments would be considered again if and when a further submission is provided in the future.

Recommendation

No further recommendation was required.

5.6

Matters arising for information

5.6.1

Reclassification of glycopyrronium as a prescription medicine only

An out-of-session consultation took place in July 2013 regarding the classification of glycopyrronium.

Glycopyrronium was classified as:

• prescription; for injection
• restricted; except for injection.

The Committee recommended that glycopyrronium should be reclassified as a prescription medicine only. This classification was gazetted alongside the recommendations from the 49^th meeting.

Recommendation

No further recommendation was required.

5.6.2

Classification of peptide-based performance and image enhancing drugs

As foreshadowed at the 49^th meeting on 17 June 2013, the proposed classifications of the peptide-based performance and image enhancing drugs following further consultation were presented for finalisation.

No comments were received during the consultation period.

Foreshadowed recommendations:

Scheduling selective androgen receptor modulators to harmonise with Australia

At the 49^th meeting, the Committee foreshadowed that New Zealand should harmonise with Australia, and a class entry should be created for selective androgen receptor modulators as prescription medicines. Also, a new entry should be created for enobosarm (otherwise known as ostarine) as a prescription medicine.

The Committee agreed that as no objections had been received:

1. a class entry should be created to classify selective androgen receptor modulators as prescription medicines
2. enobosarm should be classified as a prescription medicine.

Harmonising with Australia by creating the following prescription medicine entry; 'insulin-like growth factors, except when specified elsewhere in the Schedule'

IGF-1 is currently classified as a prescription medicine under the name 'mecasermin' but its synthetic analogues do not appear to be. At the 49^th meeting, the Committee foreshadowed that a class entry should be created to classify insulin-like growth factors as prescription medicines, except when specified elsewhere in the Schedule. This harmonises with the Australian Standard for the Uniform Scheduling of Medicines and Poisons and captures the synthetic analogues and splice variants of IGF-1 as prescription medicines. These include:

1. IGF-1 LR3
2. IGF DES (1-3)
3. MGF.

The Committee agreed that as no objections had been received, a class entry should be created to classify insulin-like growth factors as prescription medicines; except when specified elsewhere in the Schedule.

Scheduling growth hormone releasing peptides under the term 'human growth hormone secretagogues'

At the 49^th meeting, the Committee foreshadowed that a class entry should be created for human growth hormone secretagogues as prescription medicines. While these substances may already be covered under the current class entry of hypothalamic releasing factors, there is a sufficient lack of clarity that it was deemed useful to create a new and clearer entry specifically for this class.

To further enhance clarity, the Committee also discussed adding individual substances to the Schedule. Sermorelin is already scheduled as a prescription medicine. It was foreshadowed that other synthetic growth hormone releasing peptides listed in the submission with recognised names should also be individually scheduled as prescription medicines. These substances are:

1. ipamorelin
2. hexarelin
3. tesamorelin.

Individually scheduling a naturally occurring stimulator of growth hormone secretion, ghrelin, was also discussed at the 49^th meeting.

The Committee agreed that as no objections had been received:

1. class entry should be created to classify human growth hormone secretagogues as prescription medicines
2. ipamorelin, hexarelin, and tesamorelin should be classified as prescription medicines
3. ghrelin should be classified as a prescription medicine.

Creating a class entry for 'melanocyte stimulating compounds' in the Schedule to capture unscheduled analogues such as bremelanotide

At the 49^th meeting, the Committee foreshadowed that a class entry should be created for melanocyte stimulating compounds, rather than scheduling the substances individually under their substance names. The term 'compound' was chosen so that both peptides and hormones would be included in the class entry while omitting naturally occurring melanotropic effects such as sunshine.

The Committee agreed that as no objections had been received, a class entry should be created to classify melanocyte stimulating compounds as prescription medicines.

Recommendations

That a class entry should be created to classify selective androgen receptor modulators as prescription medicines.

That enobosarm should be classified as a prescription medicine.

That a class entry should be created to classify insulin-like growth factors as prescription medicines; except when specified elsewhere in the Schedule.

That a class entry should be created to classify human growth hormone secretagogues as prescription medicines.

That ipamorelin, hexarelin, and tesamorelin should be classified as prescription medicines.

That ghrelin should be classified as a prescription medicine.

That a class entry should be created to classify melanocyte stimulating compounds as prescription medicines.

5.6.3

Classification of nitrous oxide as prescription only when supplied for inhalation

Nitrous oxide is currently classified as a prescription medicine. Medsafe suggested that the Committee foreshadow the clarification of nitrous oxide classification as a prescription medicine 'only when supplied for inhalation'. The reasoning behind this was that liquid nitrous oxide is commonly used in cryosurgery. Medsafe had proposed that it is appropriate to classify liquid nitrous oxide, when supplied in a cylinder that is attached to a spray gun for use in cryosurgery, as a medical device. This is because the liquid nitrous oxide is not producing its therapeutic effects through a physiological mechanism, but rather through a freezing effect produced by the physical properties of the liquid nitrous oxide becoming a gas.

The Committee agreed that classifying nitrous oxide as a prescription medicine 'only when supplied for inhalation' would still cover the potential for misuse.

Recommendation

That the Committee foreshadow clarification of the classification of nitrous oxide as a prescription medicine 'only when supplied for inhalation'.

6

Submissions for reclassification

6.1

Hyoscine butylbromide - proposed reclassification from prescription medicine to restricted medicine
(Gastro-Soothe, AFT Pharmaceuticals Limited)

Purpose

This was a company submission from AFT Pharmaceuticals Limited for the reclassification of hyoscine butylbromide 20 mg tablets (Gastro-Soothe), in a pack containing not more than 10 tablets or capsules, from prescription medicine to restricted medicine for the relief of muscle spasm of the gastrointestinal tract.

The reclassification proposal was based on the premise that hyoscine butylbromide 10 mg tablets are available as a restricted medicine in packs containing not more than 20 tablets or capsules and as such, the total amount of active ingredient per pack remains the same. The change of scheduling was proposed to make it easier for the consumer, and improve patient compliance as they would only need to take one tablet up to four times daily, rather than the current two hyoscine butylbromide 10 mg tablets up to four times daily.

Background

At the 21^st meeting on 25 March 1999, in response to a submission for the reclassification of 10 mg hyoscine butylbromide tablets from restricted medicine to pharmacy-only medicine, the Committee agreed that there be no change to the classification.

At the 22^nd meeting on 10 November 1999, following an objection from the company to the recommendation made by the Committee at the 21^st meeting, the Committee agreed that there would still be no change to the current restricted medicine classification of 10 mg hyoscine butylbromide tablets.

At the 27th meeting on 23 May 2002 and the 29th meeting on 22 May 2003, the Committee maintained its stance that hyoscine butylbromide remain a restricted medicine in 10 mg tablets in packs containing not more than 200 mg.

At the 33^rd meeting on 9 June 2005, in response to the submission for the reclassification of hyoscine butylbromide to pharmacy-only medicine in medicines containing 20 mg or less and in packs containing not more than 200 mg of hyoscine butylbromide, the Committee recommended that there should be no change to the current classification.

Hyoscine butylbromide is currently classified as:

• prescription; except when specified elsewhere in the Schedule
• restricted; for oral use in medicines containing not more than 10 mg per dose form and in packs containing not more than 20 tablets or capsules.

Comments

Three pre-meeting comments were received during the consultation period.

Two of the comments supported the reclassification proposal for the following reasons:

1. the improved convenience for patients, as only one 20 mg tablet would be required at each dosing time instead of two 10 mg tablets
2. the pack size contains the same total amount of active ingredient as is currently available as a restricted medicine
3. pharmacists would have an important role in ensuring patients are aware of the availability of the two dose strengths, to minimise any confusion or the potential for an overdose.

A third comment pointed out that hyoscine butylbromide is a schedule 2 (pharmacy-only equivalent) medicine in Australia, when in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide. The comment suggested that the MCC consider whether complete harmonisation could be achieved at this time so that a pack containing 200 mg or less in total would be a pharmacy-only medicine.

Discussion

The Committee agreed that the proposal was logical and that there are no serious issues with the safety of the drug. The Committee noted that there is a difference in scheduling compared to Australia, but would like to see further data from the company before considering reclassification to pharmacy-only medicine. One Committee member also pointed out that pharmacists play an important role in discussing the causes of abdominal pain with the patient.

The Committee were concerned about the need to split tablets for dosing children less than 12 years of age. It was not apparent in the submission whether the tablets would be scored, and the Committee agreed that the company should discuss what is required for 10 mg doses for children with Medsafe. The Committee also felt that Medsafe should advise the company that there should be improvements in the labelling, such as a larger font size for the active ingredient and greater prominence to the strength of both the 20 mg tablet pack and the 10 mg tablet pack.

The Committee concluded that it would like to see another application to harmonise with Australia. The current application did not answer outstanding questions around reclassifying hyoscine butylbromide to pharmacy-only medicine.

Recommendation

That hyoscine butylbromide 20 mg tablets, in a pack containing not more than 10 tablets or capsules, should be reclassified from prescription medicine to restricted medicine for the relief of muscle spasm of the gastrointestinal tract.

That the company should consult with Medsafe regarding the appropriateness of halving the tablet to achieve doses for children less than 12 years of age.

That the company review its labels so that the 10 mg and 20 mg tablet packs are clearly distinguishable.

6.2

Ibuprofen - proposed reclassification from pharmacy-only medicine to general sale medicine
(Pharmaceutical Solutions in consultation with the New Zealand Retailers Association)

Purpose

This was a submission for the reclassification of ibuprofen when supplied in liquid form for oral use with a recommended maximum daily dose of not more than 1.2 g, when sold in the manufacturer's original pack containing not more than 4 g of ibuprofen and not more than 100 mL of product, and when labelled for use in children from three months, for the relief of pain and reduction of fever or inflammation from pharmacy-only medicine to general sale medicine.

Background

At the 7^th meeting on 31 July and 1 August 1990, the Committee decided that a recommendation to change the classification of liquid ibuprofen could not be made on the basis of the limited information available.

At the 13^th meeting on 26 May 1994, the Committee recommended that ibuprofen syrup be available as a restricted medicine when for children over 12 months of age. Also, in addition to the warnings suggested by the company, the labels should include warnings against use in children with dehydration, diarrhoea, or any known gastric problem.

Following the 13^th meeting, Committee members were consulted by telephone and agreed that a wider overview should be taken of liquid ibuprofen.

At the 14^th meeting on 2 November 1994, the Committee recommended that ibuprofen in liquid form be classified as a restricted medicine when:

1. sold in the manufacturer's original pack which has the consent of the Minister for sale as a restricted medicine
2. in pack sizes of not more than 200 mL
3. in strengths of 100 mg or less per 5 mL
4. contraindicated for use for children under 12 months of age
5. contraindicated for use in children with a temperature higher than 37.7 degrees centigrade
6. contraindicated for use in children suffering dehydration through diarrhoea and / or vomiting
7. juvenile rheumatoid arthritis is not included as an indication.

In a postal consultation conducted in May 1995, the Committee recommended that the temperature contraindication be removed for the sale of liquid ibuprofen as a restricted medicine.

At the 19^th meeting on 19 May 1998, the Committee recommended that ibuprofen should be a pharmacy-only medicine when in liquid form for oral use in medicines sold in the manufacturer's original pack containing 200 ml or less in volume and in strengths of 100 mg or less per 5 mL and when bearing the package information required in the New Zealand Regulatory Guidelines for the medicines to be sold over-the-counter.

At the 27^th meeting on 23 May 2002, the Committee recommended that:

1. the maximum daily dose for pharmacy-only solid dose and liquid ibuprofen should not exceed 1200 mg
2. the maximum pack size for pharmacy-only liquid preparations should not exceed 4 g of total ibuprofen content
3. packs for pharmacy-only sale should be in concentrations only of 100 mg in 5 ml or 200 mg in 5 ml of ibuprofen
4. the changes should be notified in the Gazette but Medsafe should be asked to include these changes and other requirements in the Regulatory Guidelines so that they would no longer be required to be listed in amendments to the Schedule
5. the Australian National Drugs and Poisons Schedule Committee be asked to adopt the Committee's recommendation limiting the concentrations of liquid ibuprofen permitted in Schedule 2 (pharmacy-only medicines).

At the 29^th meeting on 22 May 2003, the Committee noted that the Australian National Drugs and Poisons Schedule Committee had opted not to adopt their recommendation. There were no restrictions on the concentration for over-the-counter sale in Australia.

At the 46^th meeting on 15 November 2011, the Committee recommended that New Zealand should harmonise with Australia and increase the maximum allowable amount of ibuprofen in liquid preparations as a pharmacy-only medicine from 4 g to 8 g.

At the 48^th meeting on 30 October 2012, the Committee recommended that a submission to reclassify ibuprofen, when in liquid oral suspension in sachets each containing 200 mg or less of ibuprofen for use in adults or children 12 years of age and older, from pharmacy-only medicine to general sale medicine would be reconsidered at a future meeting if submitted.

Ibuprofen is currently classified as:

• prescription; except when specified elsewhere in the Schedule
• restricted; for oral use in tablets or capsules containing up to 400 mg per dose form and in packs containing not more than 50 dose units and that have received the consent of the Minister or the Director-General to their distribution as restricted medicines and that are sold in the manufacturer's original pack labelled for use by adults and children over 12 years of age
• pharmacy-only; for oral use in liquid form with a recommended daily dose of not more than 1.2 grams for the relief of pain and reduction of fever or inflammation when sold in the manufacturer's original pack containing not more than 8 grams; for oral use in solid dose form containing not more than 200 mg per dose form and with a recommended daily dose of not more than 1.2 grams when sold in the manufacturer's original pack containing not more than 100 dose units; except in divided solid dosage forms for oral use containing 200 mg or less per dose form with a recommended daily dose of not more than 1.2 grams and when sold in the manufacturer's original pack containing not more than 25 dose units
• general sale; for external use; in divided solid dosage forms for oral use containing 200 mg or less per dose form with a recommended daily dose of not more than 1.2 grams and when sold in the manufacturer's original pack containing not more than 25 dose units per pack.

Comments

A total of seventeen pre-meeting comments were received during the consultation period. Three of the comments supported the reclassification for the following reasons:

1. increased availability of the medicine, both in location and hours of purchase
2. the wide toxicity safety margin of ibuprofen
3. there are very few safety concerns about the use of liquid ibuprofen
4. liquid ibuprofen is available as a general sale medicine in the United Kingdom, the United States, and Canada.

Fourteen of the comments opposed the reclassification for the following reasons:

1. fever in children is often over-treated by parents
2. the need for caution in children with asthma
3. the risk of impaired renal function, particularly in dehydrated children
4. ibuprofen can mask signs of infection in children
5. a lack of evidence for clinical benefits of changing the status of liquid ibuprofen in other jurisdictions
6. the risk of inadvertent dosing errors
7. the lack of health literacy and parental knowledge leading to inappropriate dosing
8. a high chance of confusion over labelling and dose strengths.

Discussion

Four representatives of the submission observed the discussion but left the meeting room before a final recommendation was made.

The Committee acknowledged the significant number of comments from the medical and pharmaceutical communities opposing the reclassification. One Committee member noted that the reason liquid non-steroidal anti-inflammatories and analgesics had been classified as pharmacy-only was for the provision of medical advice to parents and caregivers.

Committee members discussed the changing perception of the safety of ibuprofen and agreed that offering liquid ibuprofen for sale in supermarkets would send the wrong message about the risks and exaggerate the safety of the medicine for use in children.

All Committee members acknowledged the significant adverse effects of liquid ibuprofen, in particular, the potential for renal failure in children, and that users need to be made aware of the risks of inappropriate dosing. The Committee discussed labelling requirements to address these issues, and felt that the label should clearly state "do not use in children with diarrhoea and / or vomiting".

To avoid dosing confusion, the Committee believed that having more than one strength of liquid formulation available should be discouraged. The Committee also agreed that an accurate dosing device should be included in the package of all liquid paediatric medicines, regardless of classification.

One Committee member pointed out that there is a major label change coming up as New Zealand seeks to harmonise with Australia. As a result, there could be three different products with varying dosing instructions on the market until 2016, and therefore it would be irresponsible for the member to support a reclassification at a time when more explanation regarding dosing and administration may be needed to be given to the consumer.

The Committee discussed whether the potential for improved access was a significant benefit. It was concluded that there was provision for rural stores to sell pharmacy medicines and that the value of a small increase in access was outweighed by the value of the availability of professional advice in a pharmacy. The Committee agreed that the uncertain risk-benefit analysis, the number of opposing comments, and the imminent upcoming label changes meant that they could not support the reclassification based on the current submission at this point in time.

Recommendation

That ibuprofen when supplied in liquid form for oral use with a recommended maximum daily dose of not more than 1.2 g, when sold in the manufacturer's original pack containing not more than 4 g of ibuprofen and not more than 100 mL of product, and when labelled for use in children from three months, for the relief of pain and reduction of fever or inflammation should not be reclassified from pharmacy-only medicine to general sale medicine.

That all liquid ibuprofen medications should include an accurate dosing device.

6.3

Mepyramine - proposed reclassification from pharmacy-only medicine to general sale medicine
(Pharmaceutical Solutions in consultation with the New Zealand Retailers Association)

Purpose

This was a submission for the reclassification of topical mepyramine, in medicines containing 2% or less, from pharmacy-only medicine to general sale medicine.

The proposition of the application was to provide greater access to the medicine at a more convenient time and location. Due to the nature of the indication, it was proposed that most likely consumers may need the medication during weekends or off-peak hours and possibly in remote areas where they are more prone to insect bites, stings or nettle rash.

Background

At the 33^rd meeting on 9 June 2005, the Committee recommended that mepyramine should be classified as a prescription medicine with the exception of dermal use where mepyramine should be classified a pharmacy-only medicine.

Comments

Six pre-meeting comments were received during the consultation period.

Two comments supported the proposed reclassification for the following reasons:

1. mepyramine is currently available as a general sale medicine in the United States, the United Kingdom, and Canada
2. reclassification would improve access, both in location and hours of purchase
3. there have been no significant adverse events reported by the Centre for Adverse Reactions Monitoring after over 40 years on the market
4. the ease of self-diagnosis, coupled with clear label instructions and warnings, allows for safe use of mepyramine topical cream without the need for pharmacist advice.

Four comments opposed the reclassification for the following reasons:

1. the reclassification would take New Zealand out-of-sync with the Australian Schedule unless the same change is sought in Australia
2. the risk of inappropriate use or mismanagement which could delay more appropriate treatment
3. the risk of skin sensitisation.

Discussion

Four representatives of the submission observed the discussion but left the meeting room before a final recommendation was made.

The Committee commented that there is debate over the efficacy of topical mepyramine, but agreed that there was nothing in the side effect profile to suggest that there was a safety issues that would preclude to general sale.

One Committee member noted that topical mepyramine sold in supermarkets and general stores would offer an alternative to potentially more harmful skin treatments already available.

It was noted that there is only one relevant product currently marketed in New Zealand. This product comes in a 25 g pack, which seemed appropriate for a general sale medicine.

The Committee concluded that topical mepyramine should be reclassified to general sale medicine.

Recommendation

That topical mepyramine, in medicines containing 2% or less, in packs not exceeding 25 g, should be reclassified from pharmacy-only medicine to general sale medicine.

6.4

Omeprazole - proposed reclassification from pharmacy-only medicine to general sale medicine
(Losec, Bayer New Zealand Limited)

Purpose

This was a company submission for the reclassification of omeprazole, in solid dose form containing 10 mg or less and in packs containing not more than 14 dosage units, from pharmacy-only medicine to general sale medicine for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and older.

Background

Omeprazole was classified as a prescription medicine at the 6^th meeting on 10 March 1987.

Omeprazole was considered but no recommendations were made at the 7^th meeting on 31 July 1990, 26^th meeting on 11 December 2001, 28^th meeting on 19 November 2002, 33^rd meeting on 9 June 2005, 35^th meeting on 9 June 2006 and the 38^th meeting on 14 December 2007.

At the 40^th meeting on 25 November 2008, the Committee recommended that tablets or capsules containing 10 mg or less of omeprazole should be reclassified from prescription to restricted medicine when sold in packs which have received the consent of the Minister or the Director-General to their sale as restricted medicines and are sold in the manufacturer's original pack.

At the 42^nd meeting on 3 November 2009, the Committee recommended that:

1. tablets containing 20 mg of omeprazole or less should be classified as a restricted medicine when sold in packs approved by the Minister or the Director-General for distribution as a restricted medicine
2. the requirements for omeprazole to be classified as a restricted medicine should be inserted into the New Zealand Regulatory Guidelines for Medicines by Medsafe
3. Medsafe should be satisfied with the proposed warning labels of any product containing omeprazole seeking consent for distribution as a restricted medicine.

At the 44^th meeting on 2 November 2010, the Committee recommended that:

1. omeprazole, in tablets containing 20 mg or less of omeprazole, with a maximum daily dose of 20 mg of omeprazole in a pack size of up to 14 dosage units, should be reclassified from restricted medicine to pharmacy-only medicine for the short-term, symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over, when sold in a pack approved by the Minister or the Director-General for distribution as a pharmacy-only medicine
2. Medsafe should update the New Zealand Regulatory Guidelines for medicines to reflect this recommendation and to ensure that the warnings statements for omeprazole read 'consult a pharmacist or doctor'.

At the 46^th meeting on 15 November 2011, the Committee recommended that:

1. the current pharmacy-only classification of omeprazole should be amended to increase the maximum allowed pack size from 14 to 28 dosage units
2. Medsafe should look at the labelling of all omeprazole products and harmonise with Australia where possible.

Omeprazole is currently classified as:

• prescription; except when specified elsewhere in the Schedule
• pharmacy-only; in divided solid dosage forms for oral use containing 20 milligrams or less with a maximum daily dose of 20 milligrams for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and over when sold in the manufacturer's original pack containing not more than 28 dosage units.

Comments

Eight pre-meeting comments were received during the consultation period, all opposing the reclassification for the following reasons:

1. the risk of common adverse effects including headache, diarrhoea, constipation, abdominal pain, nausea, and vomiting
2. the risk of more serious adverse effects such as interstitial nephritis, respiratory tract infections, and enteric infections such as campylobacter and clostridium
3. omeprazole may negatively affect bone strength due to impaired absorption of calcium carbonate, resulting in increased risk of fractures
4. a potential risk of gastric cancer and hypomagnesaemia
5. the risk of developing tolerance and subsequent rebound acid hypersecretion in long term use
6. omeprazole is a selective inhibitor of CYP2C19 and can alter the metabolism of other drugs, eg, clopidogrel, warfarin
7. no evidence for the clinical benefits of changing the classification has been provided from other overseas jurisdictions where omeprazole is available as a general sale medicine
8. proton pump inhibitors are currently overprescribed and overused in our community, and are not an appropriate first line treatment
9. potential for inappropriate long term use
10. potential for intermittent use to relieve symptoms rather than as a course of treatment
11. no explanation in the proposal as to how an age limit would be enforced for the purchase of omeprazole
12. the potential for missed differential diagnoses such as angina, myocardial infarction, or gastric cancer
13. the potential risks associated with use in pregnancy.

It was also noted that the proposal would take New Zealand further out-of-sync with the Australian schedule unless the same change is sought in Australia (The lowest classification in Australia is currently S3 [restricted medicine equivalent]).

Discussion

Two representatives of the company observed the discussion but left the meeting room before a final recommendation was made.

The Committee agreed that omeprazole is a generally well tolerated medicine with a good safety profile except for some unpredictable idiosyncratic adverse reactions, notably interstitial nephritis. It was pointed out that due to the small pack size; the risk of adverse drug reactions and tolerance is low.

Omeprazole is currently a general sale medicine in the United States, and the decision for reclassification to general sale in the United Kingdom was under review at the time of the meeting.

The Committee noted the significant number of comments that were all broadly against the proposal. A recurring theme raised in a number of the comments was the potential misuse of omeprazole as an intermittent therapy to treat symptoms, as a result of inappropriate self-selection. Committee members discussed the appropriateness of a medicine with an application as a course of therapy over ten days in a market generally aimed at temporary relief of symptoms. It was presented in the literature included in the submission that there was a low incidence of excessive long-term use of omeprazole, however the majority of users only used the treatment for one or two days until they were temporarily relieved of symptoms. The company expressed their willingness to adjust the labelling to emphasise the drug treatment as a course of treatment rather than a 'quick fix'.

The Committee suggested that the proposed Consumer Medicine Information sheet (CMI) included in the submission would require significant improvement before omeprazole were to be reclassified, particularly in relation to adverse effects.

The Committee also raised several labelling issues that required attention. One Committee member felt that there should be a greater emphasis on the labelling instruction "if symptoms persist, you must see your doctor". Another Committee member felt that the effect of omeprazole on the metabolism of several other medications should also be emphasised further, perhaps with a statement on the front of the package saying "if you are taking any prescription medicines, do not consume without consulting your general practitioner".

The Committee concluded that the safety and effectiveness of omeprazole is well documented, and that short term use of omeprazole has no additional risk compared to H2 antagonists currently available as general sale medicines. The Committee stated that the issue was around the appropriateness of the medicine for self-selection. The Committee then recommended that the current submission content did not provide sufficient reassurance that inappropriate self-selection can be prevented without pharmacist intervention given the current proposed labelling and CMI.

Recommendation

That omeprazole should not be reclassified from pharmacy-only medicine to general sale medicine in solid dose form containing 10 mg or less and in packs containing not more than 14 dosage units, from pharmacy-only medicine to general sale medicine for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and older.

6.5

Oxymetazoline - proposed reclassification from pharmacy-only medicine to general sale medicine
(Pharmaceutical Solutions in consultation with the New Zealand Retailers Association)

Purpose

This was a submission for the reclassification of oxymetazoline for nasal use, when labelled for use in adults and children over six years of age, from pharmacy-only medicine to general sale medicine.

Background

At the 37^th meeting on 17 May 2007, the Committee recommended that the submission from the New Zealand Association of Optometrists to allow oxymetazoline to be sold through optometry practices should be declined.

At the 38^th meeting on 14 December 2007, the Committee recommended that oxymetazoline should be exempt from pharmacy-only status when used or sold in practice by a registered optometrist.

Oxymetazoline is currently classified as pharmacy only; except for nasal use when sold at an airport; except for ophthalmic use when sold in practice by an optometrist registered with the Optometrists and Dispensing Opticians Board.

Comments

Ten pre-meeting comments were received during the consultation period.

Four of the comments supported the proposed reclassification for the following reasons:

1. reclassification would offer wider access to the medicine, both in location and hours of purchase
2. oxymetazoline has a well-established safety profile in New Zealand after over 40 years on the market
3. there have been no significant adverse events reported by the Centre for Adverse Reactions Monitoring.

The other six comments opposed the reclassification for the following reasons:

1. the risk of rebound nasal congestion
2. the risk of cardiovascular and central nervous system effects
3. oxymetazoline is contraindicated in certain cardiovascular conditions and acute angle glaucoma
4. oxymetazoline is contraindicated with monoamine oxidase inhibitors, tricyclic antidepressants, tetracyclic antidepressants, and beta-blockers
5. caution is required in a number of conditions including cardiovascular disease, hypertension, hyperthyroidism, pregnancy, in children, and in the elderly
6. a high risk of inappropriate self-diagnosis and therefore inappropriate treatment
7. the submission inconsistently seeks reclassification from 6 years up, but the labelling states "seek medical advice and consult doctor or pharmacist before use in children aged 6 to 12 years"
8. a lack of advice available to consumers
9. a lack of benefits from reclassification
10. the risk of inappropriate use in children under 6.

Discussion

Four representatives of the submission observed the discussion but left the meeting room before a final recommendation was made.

The Committee acknowledged the number of comments received from the medical and pharmaceutical communities. The major concern from all these comments was inappropriate use in children, and use over extended periods of time resulting in rebound nasal congestion.

The Committee stated that they were comfortable with oxymetazoline as a general sale medicine, and that broadly speaking, supermarkets are open longer hours than pharmacies, providing greater access to the medicine. However, the Committee agreed that a number of changes to the labelling and a limit to the product packaging size would be desirable.

One of the recurring supporting comments was that oxymetazoline is already available as a general sale medicine in the United Kingdom, the United States and Canada. The Committee noted however, that it is not indicated for use in children under the age of 12 in these jurisdictions.

The Committee felt that the labelling should clearly state that the medicine is not for use in children under the age of 12 years old unless advised to do so by a healthcare professional.

The Committee agreed that bolder labelling instructions were required to warn against use for longer than three days, to avoid the risk of rebound congestion. Due to potential contraindications, the Committee also felt that there must be a label statement instructing consumers to seek advice from a healthcare professional if they have any medical conditions or are taking any other medications.

The observers confirmed that the companies they were in contact with were open to making appropriate changes to labelling and packaging in their applications.

One Committee member pointed out that the advice from the general medical community at large is that parents should try other measures before turning to oxymetazoline. The question raised was whether labelling can successfully replace the health professional advice available in a pharmacy. Contrastingly, it was also argued that oxymetazoline may reduce the need to use other 'first-line' treatments currently available, which are potentially more harmful.

The Committee discussed the validity of the proposed benefits of reclassification. Members questioned whether a blocked nose is an emergency, and whether access to the medicine in the evenings or on weekends would provide a significant benefit. The Committee also noted that rural access to these medicines is already available where a town is more than 20 km from a pharmacy, and general stores are allowed to sell pharmacy-only medicine.

The Committee agreed that due to the risks of accidental poisoning from oxymetazoline, a smaller spray bottle size is desirable for a general sale medicine, and emphasised the importance of a sealed container that cannot be opened, as well as a child-resistant cap.

The Committee concluded that changes were needed in the submission to justify the reclassification to general sale medicine. Oxymetazoline would have to be available in a sealed spray bottle, with a child-resistant cap, and a total quantity of no greater than 20 mL. The labelling should state that the product is not for use in children under two years old, and not for use in children under 12 except under the advice or a doctor, nurse or pharmacist. There would also need to be a clear statement warning against prolonged use for more than three days, and consumers should seek advice from a doctor, nurse or pharmacist if they are taking any other medications.

Recommendation

That oxymetazoline for nasal use, when labelled for use in adults and children over six years of age, should not be reclassified from pharmacy-only medicine to general sale medicine.

That the Committee would be willing to reconsider a revised submission with the following packaging requirements:

1. pack size not exceeding 20 mL
2. sealed container where the lid cannot be removed
3. child resistant cap.

and the following label statement requirements:

1. do not use in children under 12 except under the advice of a doctor, nurse or pharmacist
2. do not use in children under two
3. do not use for longer than three days
4. seek advice from a doctor, nurse or pharmacist if you have any medical conditions or are taking and other medications.

6.6

Paracetamol - proposed reclassification from pharmacy-only medicine to general sale medicine
(Pharmaceutical Solutions in consultation with the New Zealand Retailers Association)

Purpose

This was a submission for the reclassification of paracetamol when supplied in liquid form for oral use and when labelled for use in children from one year and up, from pharmacy-only medicine to general sale medicine.

Background

Paracetamol is currently classified as:

• prescription; except when specified elsewhere in the Schedule
• pharmacy only; in liquid form; in suppositories; in tablets or capsules containing 500 milligrams or less and in packs containing more than 10 grams; in slow-release forms containing 665 milligrams or less and more than 500 milligrams; in powder form containing not more than 1 gram per sachet and more than 10 grams per pack
• general sale; in tablets or capsules containing 500 milligrams or less and in packs containing not more than 10 grams; in powder form in sachets containing 1 gram or less and not more than 10 grams.

Comments

A total of eighteen pre-meeting comments were received during the consultation period. Three of the comments supported the reclassification for the following reasons:

1. increased availability of the drug, both in location and hours of purchase
2. no significant safety concerns
3. liquid paracetamol is available as a general sale medicine in the United Kingdom, the United States, and Canada.

Fifteen of the comments opposed the reclassification for the following reasons:

1. fever in children is often over-treated by parents
2. the risk of gastrointestinal effects
3. the risk of hepatotoxicity and liver failure
4. a lack of evidence for the clinical benefits of changing the status of liquid paracetamol in other jurisdictions
5. the risk of inadvertent dosing errors
6. the lack of health literacy and parental knowledge, leading to inappropriate dosing
7. liquid paracetamol is one of the most common causes of poisoning in young children
8. the inappropriate indication for treatment of symptoms associated with vaccinations
9. the high chance of confusion over labelling and dose strengths.

Discussion

Four representatives of the submission observed the discussion but left the meeting room before a final recommendation was made.

The Committee acknowledged the significant number of comments from the medical and pharmaceutical communities opposing the reclassification. One Committee member noted that the reason liquid non-steroidal anti-inflammatories and analgesics had been classified as pharmacy-only was for the provision of medical advice to parents and caregivers.

One Committee member felt that the toxicity of the medicine had been downplayed in the submission, and noted that the proposed pack size for reclassification contained enough medicine to cause a toxic overdose in children up to 25 kg. The Committee agreed that when used appropriately, paracetamol is one of the safest medicines on the market. However, the greatest safety risk is in the form of unintentional overdoses. One Committee member noted that there were over 5000 calls to the poison centre regarding paediatric paracetamol between 2003 and 2011.

The Committee discussed the difficulty and confusion for parents and caregivers surrounding appropriate dosing for their child. The Committee stated that it would like to see accurate measuring devices provided with all liquid paediatric formulations, regardless of their classification. Committee members were also uncomfortable with the potential for confusion due to the availability of different dose strengths.

The Committee concluded that reclassifying liquid paracetamol to general sale before the upcoming label statement requirement changes are introduced (as New Zealand seeks to harmonise with Australia), would be irresponsible. Members also agreed that the reclassification to general sale would oppose the general trend within the medical community of regarding paracetamol with increasing caution.

Recommendation

That paracetamol when supplied in liquid form for oral use and when labelled for use in children from one year and up, should not be reclassified from pharmacy-only medicine to general sale medicine.

That all liquid paracetamol medicines should include an accurate dosing device.

6.7

Sildenafil - proposed reclassification from prescription medicine to restricted medicine
(Silvasta, Douglas Pharmaceuticals Limited)

Purpose

This was a company submission for the reclassification of sildenafil 25 mg, 50 mg and 100 mg film coated tablets (Silvasta) from prescription medicine to restricted medicine, when supplied by a pharmacist who has successfully completed the approved training programme and is accredited to supply sildenafil, for the treatment of erectile dysfunction in males aged 35-70 years.

Background

At the 41^st meeting on 14 May 2009, the Committee recommended that the analogues of sildenafil, tadalafil, and vardenafil should be classified as prescription medicines.

Sildenafil and its structural analogues are currently classified as prescription medicine.

Comments

A total of thirteen pre-meeting comments were received during the consultation period. Eight of the comments supported the reclassification for the following reasons:

1. improved access to sildenafil would benefit men as well as their partners
2. the screening assessment is appropriate and may also provide earlier detection for those at risk of cardiovascular diseases
3. easier access would reduce the illicit supply from overseas
4. sildenafil has a well-established medicine safety and efficacy profile.

Five of the comments opposed the reclassification for the following reasons:

1. reclassification to a restricted medicine would mean the Medsafe Investigation and Enforcement team would no longer be able to stop the importation of sildenafil at the border
2. a thorough assessment by a clinician should be conducted before sildenafil is prescribed
3. there are contraindications with other medications such as nitrates and alpha-blockers
4. reclassification to a restricted medicine would put New Zealand out-of-sync with the Australian Schedule unless the same change is also sought in Australia
5. the monetary incentives for pharmacy owners would lead to some promoting themselves as sildenafil suppliers rather than medical professionals
6. the proposed screening process for cardiovascular risk is not thorough enough.

Discussion

Three representatives of the company observed the discussion but left the meeting room before a final recommendation was made.

The Committee agreed that sildenafil is an efficacious medicine with a well-established acceptable safety profile aside from a few very rare idiosyncratic events including the potential for cardiovascular adverse events such as hypotension when taken in combination with nitrates.

The Committee discussed the potential benefits of the proposed reclassification including:

1. an additional method of detecting cardiovascular disease
2. providing access to patients who may be too embarrassed to speak to their general practitioner
3. mitigation of internet purchases, providing a community benefit.

One Committee member noted that the cardiovascular screening does not include a cholesterol check or a blood glucose test. Other members of the Committee agreed that they were uncomfortable with patients not receiving a comprehensive cardiovascular check, especially if this were to reduce the number of patients visiting their general practitioner.

One Committee member was also uncomfortable with pharmacists performing just cardiovascular screening, as they felt consultation about erectile dysfunction should cover psychological assessment. It was pointed out that particularly in younger men (aged 35 to 45), erectile dysfunction is often a result of a confidence or anxiety issue that can be resolved with just one or two treatments using sildenafil. The Committee agreed that these patients may become unnecessarily over-treated.

The Committee discussed equipment used by pharmacists for checking blood pressure. Committee members questioned whether the equipment would need to be audited and recalibrated annually, to prevent the loss of accuracy over time. This then raised the question of what mechanism would be used to monitor the checks.

The Committee discussed the application, which included a proposal to share information from the patients' forms with the University of Otago, which would be used for service evaluation, monitoring, and research purposes. One Committee member pointed out previous studies had shown that patients were often supportive of their information being used for research, so long as the outcomes of the research were presented back to them. The Committee debated the ethics of the proposed research and whether an opt-out option should be included; as having patient information shared may produce a barrier to access. However, it was pointed out by the observers that this would limit the tracking of misuse. The Committee noted that the current proposed option meant those who chose not to have their information shared would be denied access to the medicine and referred to their general practitioner. The Committee agreed that this approach was not fair and contradicted the proposed benefit of the submission, which is to increase access to sildenafil. The need for a post-market study was also discussed as it was not clear what the benefit may be, particularly in light of the well-established safety profile of the medicine.

The Committee discussed potential border control issues if sildenafil were to be reclassified. One of the aims of the submission was to reduce the importation of unregulated sildenafil. The Committee was aware that wording of the reclassification would be very important. Simply reclassifying sildenafil as a restricted medicine would prevent the Medsafe Investigation and Enforcement team from being able to stop sildenafil at the border.

The Committee concluded that the risk profile of sildenafil reclassification is satisfactory. However, Committee members disputed the claimed benefit that there would be greater access to the medicine, stating that most men who are too embarrassed to talk to their general practitioner would also be too embarrassed to talk to their pharmacist and that there was little evidence in the submission to suggest otherwise. The Committee agreed that the proposed screening tool was inadequate as it did not provide a comprehensive cardiovascular risk check or the necessary psychological assessment required for the treatment of erectile dysfunction. The Committee felt that this sort of mechanism would work best in an integrated family health centre-type model.

Recommendation

That sildenafil 25 mg, 50 mg and 100 mg film coated tablets (Silvasta) should not be reclassified from prescription medicine to restricted medicine, when supplied by a pharmacist who has successfully completed the approved training programme and is accredited to supply sildenafil, for the treatment of erectile dysfunction in males aged 35-70 years.

6.8

Zoster (shingles) vaccine - proposed reclassification from prescription medicine to prescription medicine except when…
(Pharmacybrands Limited)

Purpose

This was a submission for the reclassification of Zoster (shingles) vaccine from prescription medicine to prescription medicine except when administered to a person 50 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

Background

Zoster (shingles) vaccine is currently not separately listed, but as a vaccine is classified as a prescription medicine.

Comments

Three pre-meeting comments were received during the consultation period, two of which supported the reclassification for the following reasons:

1. to increase the accessibility of the vaccine
2. to reduce the incidence of shingles, which can be difficult to treat
3. the convenience of receiving vaccinations at a community pharmacy.

The third pre-meeting comment stated that it would be important that any potential profits from administration fees and mark-ups are kept reasonable and that the marketing does not use fear to sell the product.

Discussion

Three representatives of the submission observed the discussion but left the meeting room before a final recommendation was made.

The Committee agreed that shingles is still a significant problem, despite a decrease in prevalence over the last two decades. The Committee agreed that there was a significant benefit to be gained from the vaccine.

The Committee believed that there were a few minor improvements that could be made to the proposed checklist and Consumer Medicine Information sheet.

One Committee member pointed out that the checklist did not ask patients if they had suffered from chicken pox in the past, which could lead to patients not susceptible to shingles receiving the vaccine unnecessarily. The observers commented that there is no potential for harm in exposing those who have not had chicken pox in the past.

The Committee requested clarity to define a 'high dose' of corticosteroids on the information sheet for health professionals included in the submission, which the observers agreed to provide.

The Committee discussed with the observers about immune deficiencies. It was concluded that the checklist question "Do you have immune deficiencies? Is the person taking medicines that affect the immune system?" was not sufficient and that an additional question "Do you have any medical conditions that may affect your immunity?" should be added in its own box, and examples included.

The Committee concluded that there were no major issues with the submission and would recommend the reclassification, subject to the amendments to the checklist and information sheet.

Recommendation

That Zoster (shingles) vaccine should be classified as prescription medicine except when administered to a person 50 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

That the reclassification is subject to the amendments being made to the checklist and information sheets, as raised by the Committee.

7

New medicines for classification

7.1

Umeclidinium bromide - Anoro Ellipta 62.5 mcg and 125 mcg powder for inhalation (TT50-9272, a)

Anoro Ellipta is available as a moulded plastic device containing two foil strips of either seven or 30 regularly distributed blisters, each containing a white powder formulation of either:

• 74.2 mcg of umeclidinium bromide (equivalent to 62.5 mcg of umeclidinium) and 25 mcg of vilanterol (as trifenatate)
• 148.3 mcg of umeclidinium bromide (equivalent to 125 mcg of umeclidinium) and 25 mcg of vilanterol (as trifenatate).

It was noted that vilanterol is already classified as prescription medicine in New Zealand.

Anoro Ellipta is indicated as a long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease.

Umeclidinium bromide is not included in the Standard for the Uniform Scheduling of Medicines and Poisons (1 September 2013) in Australia.

Recommendation

That umeclidinium bromide should be classified as prescription medicine.

7.2

Dabrafenib mesilate - Tafinlar 50 mg and 75 mg capsule for oral ingestion (TT50-9398, a)

Tafinlar is available as hard capsules containing 50 mg or 75 mg of dabrafenib mesilate, cellulose - microsrystalline, magenesium stearate, silica -colloidal anhydrous, iron oxide red, titanium dioxide, hyormellose, iron oxide black, shellac, butan-1-ol, isopropyl alcohol, propylene glycol, and ammonium hydroxide.

Tafinlar is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma.

Dabrafenib mesilate is classified as Schedule 4: Prescription Only Medicine in Australia (8 November 2013).

Recommendation

That dabrafenib mesilate should be classified as prescription medicine.

7.3

Obinutuzumab - Gazyva 1000 mg in 40 mL solution for infusion (TT50-9402)

Gazyva is supplied in a single-dose vial containing 40 mL of preservative-free concentrate solution for infusion. Each vial contains 1000 mg of obinutuzumab (25 mg/mL) with the following excipients: histidine, histidine hydrochloride monohydrate, trehalose dehydrate, and poloxamer 188.

Gazyva in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia.

It was noted that chlorambucil is already classified as a prescription medicine in New Zealand.

Obinutuzumab is not included in the Standard for the Uniform Scheduling of Medicines and Poisons (1 September 2013) in Australia.

Recommendation

That obinutuzumab should be classified as prescription medicine.

7.4

Sofosbuvir - Sovaldi 400 mg tablets (TT50-9356)

Sovaldi is available as film-coated tablets containing the 400 mg of sofosbuvir and the following excipients: mannitol, microcrystalline cellulose, croscarmellose sodium, silicon dioxide and magnesium stearate.

Sovaldi is indicated in combination with other agents for the treatment of chronic hepatitis C in adults.

Sofosbuvir is not included in the Standard for the Uniform Scheduling of Medicines and Poisons (1 September 2013) in Australia.

Recommendation

That sofosbuvir should be classified as prescription medicine.

7.5

Bendamustine hydrochloride - Ribomustin 25 mg in 10 mL and 100 mg in 40 mL powder (TT50-9353, a)

Ribomustin is available in vials containing 25 mg of bendamustine hydrochloride and 30 mg of mannitol, or 100 mg of bendamustine hydrochloride and 120 mg of mannitol.

Ribomustin is indicated:

• as a first line treatment of Chronic Lymphocytic Leukaemia (Binet stage B or C)
• for previously untreated indolent Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma (Ribomustin should be used in combination with rituximab in CD20 positive patients)
• for relapsed / refractory indolent Non-Hodgkin's Lymphoma.

Rituximab is already classified as a prescription medicine in New Zealand.

Bendamustine hydrochloride is not included in the Standard for the Uniform Scheduling of Medicines and Poisons (1 September 2013) in Australia.

Recommendation

That bendamustine hydrochloride should be classified as prescription medicine.

7.6

Ocriplasmin - Jetrea 2.5 mg/mL concentrate for injection (TT50-9280)

Jetrea is a 2.5 mg/mL concentrate for intravitreal injection.

Jetrea is indicated for the treatment of adults with vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

Ocriplasmin is classified as Schedule 4: Prescription Only Medicine in Australia (8 November 2013) in Australia.

Recommendation

That ocriplasmin should be classified as 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

Aclidinium bromide

Aclidinium bromide is a selective M3 muscarinic antagonist proposed for long-term maintenance of bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease.

In Australia in June 2013, the delegate decided to include aclidinium bromide in Schedule 4 (prescription medicine) with an implementation date of 1 September 2013.

Recommendation

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

8.1.2

Besifloxacin hydrochloride

Besifloxacin hydrochloride is a fourth-generation fluoroquinolone antibiotic. Besifloxacin hydrochloride 0.6 % ophthalmic drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:

• CDC coryneform group G
• Corynebacterium pseudodiphtheriticum
• Corynebacterium striatum
• Haemophilus influenzae
• Moraxella lacunata
• Staphylococcus aureus
• Staphylococcus epidermidis
• Staphylococcus hominis
• Staphylococcus lugdunensis
• Streptococcus mitis group
• Streptococcus oralis
• Streptococcus pneumoniae
• Streptococcus salivarius

Besifloxacin hydrochloride was not specifically scheduled in Australia, but captured under the Schedule 4 entry: 'antibiotic substances'. In March 2013, the delegate decided to include besifloxacin hydrochloride in Schedule 4 (prescription medicine) with an implementation date of 1 May 2013.

Recommendation

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

8.1.3

Crizotinib

Crizotinib is an inhibitor of receptor tyrosine kinases including ALK, Hepatocyte Growth Factor Receptor and Recepteur d'Origine Nantais. Translocations can affect the ALK gene, resulting in the expression of oncogenic fusion proteins. The formation of ALK fusion proteins results in activation and dysregulation of the gene's expression and signalling, which can contribute to increased cell proliferation and survival in tumours expressing these proteins.

Crizotinib is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer.

In Australia in June 2013, the delegate decided to include crizotinib in Schedule 4 (prescription medicine) with an implementation date of 1 September 2013.

Recommendation

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

8.1.4

Loteprednol etabonate

Loteprednol etabonate is a corticosteroid used in optometry and ophthalmology with proposed indications for:

• the treatment of post-operative inflammation following ocular surgery
• the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in oedema and inflammation.

In Australia in June 2013, the delegate decided to include loteprednol etabonate in Schedule 4 (prescription medicine) with an implementation date of 1 September 2013.

Recommendation

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

8.1.5

Pralatrexate

Pralatrexate is an antimetabolite and antineoplastic agent. It is a folate analogue that inhibits folate metabolism by binding to and inhibiting the enzyme dihydrofolate reducatase with effect on the synthesis of DNA.

Pralatrexate is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma.

In Australia in June 2013, the delegate decided to include pralatrexate in Schedule 4 (prescription medicine) with an implementation date of 1 September 2013.

Recommendation

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

8.1.6

Regorafenib

Regorafenib is an oral kinase inhibitor, acting on various membrane-bound and intracellular kinases involved in cellular functions and processes including oncogenesis, tumour angiogenesis, and maintenance of the tumour microenvironment.

Regorafenib is proposed for the treatment of patients with metastatic colorectal cancer irrespective of KRAS mutational status who have been previously treated with, or are not considered candidates for, fluoropyrimidine-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

In Australia in June 2013, the delegate decided to include regorafenib in Schedule 4 (prescription medicine) with an implementation date of 1 September 2013.

Recommendation

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

8.1.7

Ruxolitnib

Ruxolitinib is an antineoplastic agent and tyrosine kinase inhibitor proposed for the treatment of patients with primary myelofibrosis, postpolycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

In Australia in June 2013, the delegate decided to include ruxolitnib in Schedule 4 (prescription medicine) with an implementation date of 1 September 2013.

Recommendation

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

8.1.8

Vandetanib

Vandetanib is an antineoplastic agent that inhibits the activity of tyrosine kinases including members of the epidermal growth factor receptor family, vascular endothelial cell growth factor receptors.

Vandetanib is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

In Australia in June 2013, the delegate decided to include vandetanib in Schedule 4 (prescription medicine) with an implementation date of 1 September 2013.

Recommendation

That vandetanib 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)

8.2.1

Decisions by the Delegate - March 2013

Prucalopride

Prucalopride, a first class dihydroenzofurancarboxamide, is a selective high affinity serotonin receptor (5-HT4) agonist with enterokinetic activities.

Prucalopride is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.

The delegate made a final decision to include prucalopride in Schedule 4 of the Standard for the Uniform Scheduling of Medicines and Poisons, with an implementation date of 1 May 2013.

Prucalopride is classified as a prescription medicine in New Zealand.

Recommendation

No recommendation was required.

Diclofenac

In February 2013, the delegate made a decision to amend the Schedule 2 entry for diclofenac to include transdermal preparations for topical use containing 140 mg or less of diclofenac, with an implementation date of 1 May 2013.

At the 49^th meeting on 17 June 2013, the Committee recommended that the pharmacy-only medicine entry for diclofenac should not be amended to include transdermal preparations for topical use containing 140 mg or less of diclofenac.

The delegate noted that there had been a transcribing error during the drafting of the amended Schedule 2 entry in that the wording "containing 4 per cent of diclofenac" should have read "containing 4 per cent or less of diclofenac".

Recommendation

No recommendation was required.

8.2.2

Decisions by the Delegate - June 2013

No harmonisation decisions relevant to the Committee were made by the Delegate.

9

Agenda items for the next meeting

No items were added to the agenda for the next meeting at this point in time.

10

General business

The Chair confirmed that the New Zealand Medical Association had put forward two nominations for the vacant position on the Committee and that those two nominations would be sent to the Minister of Health to make an appointment if he felt one of them was a suitable candidate.

11

Date of next meeting

To take place on a Tuesday in early April 2013. The Secretary would email members for their availability.