1

Welcome

2

Apologies

Apologies were received from Mrs Andi Shirtcliffe. Mrs Shirtcliffe had replaced Dr Enver Yousuf as an officer of the Ministry of Health on the Committee.

Although not present, Mrs Shirtcliffe provided comment on agenda items in advance of the meeting which were added to the discussion.

3

Confirmation of the minutes of the 51^st meeting held on Tuesday 8 April 2014

The Secretary requested that the following statement under agenda item 5.1.1 (sildenafil - proposed reclassification from prescription medicine to restricted medicine) be deleted from the minutes:

Training material and packaging would be reviewed by Medsafe as part of the product approval process.

The Committee agreed that the statement could be deleted because it was misleading. The final recommendation from the Committee was that sildenafil should be reclassified from prescription medicine to prescription medicine except when sold by a registered pharmacist under specific conditions. Any product containing sildenafil would still be a prescription medicine and so no application would be submitted to Medsafe. Also, reviewing training material is not part of Medsafe's product approval process.

The rest of the minutes of the 51^st meeting were accepted as a true and accurate record. The minutes were signed and dated by the Chair.

One member commented that from reading the minutes they were unsure whether this particular item (regarding the reclassification of sildenafil) would come back to the Committee for further discussion. The Chair confirmed that if an agenda item was to be added to the agenda of the next meeting, it would be stated in the minutes (under agenda item 9). The Secretary agreed to keep members informed of agenda items that progressed without coming back to a meeting.

The Chair also reminded the Committee that it is their role to make recommendations to the Minister of Health regarding the classification of medicines. It is the Minister of Health that makes any final decision. (Note that Ministerial powers in relation to classification have been delegated to the Chief Medical Officer who acts as the Minister's Delegate.)

4

Declaration of conflicts of interest

The Conflict of Interest forms were returned to the Secretary.

The following conflicts of interest were declared:

1. One member declared a potential conflict with agenda item 6.3, omeprazole - proposed reclassification from pharmacy-only medicine to general sale medicine. Payment had been received by the member from the New Zealand College of Pharmacists, who had received sponsorship from Bayer, for providing two education sessions when omeprazole was reclassified from prescription medicine to restricted medicine. This same conflict had been declared at the 44^th meeting on 2 November 2010 and the 46^th meeting on 15 November 2011. At the 46^th meeting the Committee agreed that by the next meeting (ie, the 47^thth meeting on 1 May 2012) enough time would have passed for this to cease being a conflict. Therefore the member could participate fully in the discussion regarding agenda item 6.3.
2. Another member declared they had published and presented on the use of proton-pump inhibitors in infants which posed a potential conflict with agenda item 6.3, omeprazole - proposed reclassification from pharmacy-only medicine to general sale medicine. The Committee agreed that, because the submission proposed a reclassification in sufferers of gastric reflux-like symptoms aged 18 years and older, the member could participate fully in the discussion regarding agenda item 6.3.

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

5

Matters arising

5.1

Objections to recommendations made at the 51^st meeting

No valid objections had been received.

5.2

Reclassification of rizatriptan from prescription medicine to restricted medicine following a recommendation at the 43^rd meeting

At the 43^rd meeting on 13 April 2010, the Committee recommended that rizatriptan 5 mg wafers should be reclassified from prescription medicine to restricted medicine for the acute treatment of migraine with or without aura.

The current classification of rizatriptan is:

• prescription medicine; except when specified elsewhere in this Schedule
• restricted medicine; for oral use in medicines for the acute relief of migraine attacks with or without aura in patients who have a stable, well-established pattern of symptoms, when in wafers containing 5 milligrams or less per wafer and when sold in a pack containing not more than 2 wafers approved by the Minister or the Director-General for distribution as a restricted medicine.

The Committee noted at the last meeting that, since this reclassification, the company had not produced an approved pack for sale as a restricted medicine.

The Committee were also presented with a summary of down-scheduled products following a reclassification submission since the 42^nd meeting on 3 November 2009. The summary consisted of 18 products, all of which had been approved at the new level of classification following the reclassification submission. So since November 2009 there had not been another situation where since a reclassification a company had not produced an approved pack for sale.

One comment was received during the consultation period. It supported keeping the classification of rizatriptan as a restricted medicine because the unavailability of a specific product was not viewed as affecting the classification status or the safety of supply from a pharmacist.

The Committee discussed potential options. No change to the prescription medicine and restricted medicine classifications of rizatriptan could be recommended. This would support the Committee's recommendation made at the 43^rd meeting. Alternatively, the Committee could recommend that rizatriptan be reclassified to a prescription medicine only which is what had happened in Australia. This recommendation would have no consequence on any products currently marketed. However, it would set a precedent for any future reclassifications when a reclassification is recommended but not followed with an application for a product at the new classification.

Following discussion the Committee agreed there was no safety information demonstrating that the initial recommendation to reclassify rizatriptan was inappropriate. The Committee therefore concluded that there should be no change to the prescription medicine and restricted medicine classification of rizatriptan.

Recommendation

That there should be no change to the current classification of rizatriptan.

5.3.3

Classification of cetirizine as a pharmacy-only medicine

The current classification of cetirizine is:

• prescription medicine; except for oral use
• pharmacy-only medicine; for oral use except in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 5 days' supply.

Cetirizine is available as a general sale medicine when in divided solid dosage forms for oral use containing 10 milligrams or less of cetirizine hydrochloride per dose form for the treatment of seasonal allergic rhinitis when sold in the manufacturer's original pack containing not more than 5 days' supply.

The Committee discussed the suggestion from one member that it may be more logical for the prescription medicine entry to read 'except when specified elsewhere in this Schedule'. This suggestion was also relevant to the classification of loratadine and fexofenadine. The prescription classification of both loratadine and fexofenadine is also 'except for oral use'.

The Chair explained that the intent of the Committee in recommending the reclassification of non-sedating antihistamines from prescription medicine to pharmacy-only medicine was to place them in a similar classification to the antihistamines already classified as pharmacy-only medicines. The pharmacy-only classification was for oral use in any pack size for any indication. The exemption allows a specific pack size and dose to be available as a general sale medicine for the treatment of seasonal allergic rhinitis.

The Committee noted that whilst it would be consistent with the rest of the Schedule to update the prescription medicines entries of cetirizine, fexofenadine and loratadine to 'except when specified elsewhere in this Schedule', there were no safety reasons necessitating such a change. The Committee agreed that there should be no change to the current classification of cetirizine.

However, this comment would be taken into account when the Schedule was next updated.

Recommendation

That there should be no change to the current classification of cetirizine.

5.4

Suggested guidance on training materials included in a submission for reclassification

Over the past few years, a number of reclassification submissions have resulted in a recommendation from the Committee to reclassify with the condition that some form of training course should be completed. These submissions have resulted in the following reclassifications:

• diphtheria, tetanus and pertussis (acellular, component) vaccine; prescription medicine except when administered in a single dose to a person 18 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
• influenza vaccine; prescription medicine except when administered to a person 18 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
• meningococcal vaccine; 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
• sildenafil; prescription medicine except in medicines for oral use containing 100 milligrams or less per dose unit when sold in the manufacturer's original pack containing not more than 12 solid dosage units for the treatment of erectile dysfunction in males aged 35-70 years by a registered pharmacist who has successfully completed a training programme endorsed by the Pharmaceutical Society of New Zealand
• trimethoprim; prescription medicine except in medicines for oral use containing 300 milligrams or less per dose unit when sold in a pack of 3 solid dosage units to a woman aged 16-65 years for the treatment of an uncomplicated urinary tract infection by a registered pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections
• varicella vaccine; prescription medicine except when administered for the prevention of herpes zoster (shingles) 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.

While it is not in the Committee's remit to discuss the training requirements of vaccinators or pharmacists, officials within Medsafe had suggested it would be pertinent for Medsafe, as the medicines regulator, to provide general guidance on what aspects of medicines information should be included in any training materials submitted with a submission for reclassification. This guidance could then be included in the document, Guidance on how to change the legal classification of a medicine in New Zealand, which is published on the Medsafe website (at http://www.medsafe.govt.nz/downloads/How_to_change_medicine_classification.pdf).).

The guidance on what to include in any training materials submitted with a submission for reclassification could include:

1. contacting a patient's general practitioner to ensure continuity of care
2. when to refer a patient to their general practitioner
3. approved indications
4. dosage and administration
5. contraindications
6. warnings and precautions
7. adverse effects
8. interactions
9. overdose
10. storage / handling
11. disposal
12. monitoring requirements if any
13. where a health care practitioner can obtain further information
14. requirements for updating knowledge (eg, would the vaccinator training course need to be completed annually?).

The Committee considered the suggested guidance as a starting point for discussion.

It was noted that, whilst the trend for requiring training for specific medicines was initially a useful step to instil trust and confidence around pharmacy's ability to deliver these medicines safely, there was uncertainty as to whether this approach should continue. Training provided was confidential to the submission for reclassification and there was no onus to update the training material in a recommendation for reclassification.

One member questioned whether a reclassification should be recommended by the Committee if so much was required in terms of training to mitigate any risk from reclassification, as this should be an argument for not reclassifying a medicine.

Specialist training is available to healthcare professionals to widen their scope of practice. In addition, pharmacists can undertake a postgraduate prescribing course. One member hoped that the training for specific medicines could eventually be incorporated into the undergraduate pharmacy degrees.

The Committee or Medsafe cannot enforce any pharmacist training. However, it was agreed that it would be useful to set up a meeting between Medsafe and the bodies responsible for pharmacy training to discuss the way forward. The Committee recommended starting this discussion by Medsafe meeting with the Medical Council of New Zealand and the Pharmacy Council of New Zealand. The New Zealand Medical Association, Pharmaceutical Society of New Zealand and any other organisation suggested by the two Councils should also be invited to subsequent meetings to ensure a sector wide approach.

The Committee agreed that the Chair should initially write to the Medical Council of New Zealand and the Pharmacy Council of New Zealand suggesting a meeting to discuss the training materials in a submission for reclassification. The Committee requested that they be allowed to comment on the content of the letter before it was sent.

Recommendation

That the Chair should write to the Medical Council of New Zealand and the Pharmacy Council of New Zealand suggesting a meeting to discuss the training materials in a submission for reclassification. The letter should be circulated to members for comment before being sent.

5.5

Matters arising for information

5.5.1

Letter from the Royal New Zealand College on General Practitioners

The Royal New Zealand College of General Practitioners were unable to provide comment on agenda items. An email from the Secretary regarding the published agenda had been blocked for unknown reasons so was not received.

However, The Royal New Zealand College of General Practitioners stated they were reassured to know that the two general practitioners on the Committee, while not attending as College representatives, would be able to provide a general practice perspective on the proposals under consideration.

5.5.2

Classification of avanafil, empagliflozin, ledipasvir and riociguat as prescription medicines

An out-of-session consultation took place in August 2014 regarding the classification of avanafil, empagliflozin, ledipasvir and riociguat.

The Committee recommended that avanafil, empagliflozin, ledipasvir and riociguat should be classified as prescription medicines. These classifications were gazetted on 4 September 2014.

5.6

Late agenda item - Classification of fluoride when present in drinking water

Two recent High Court cases (New Health New Zealand Incorporated v South Taranaki District Council and New Health New Zealand Incorporated v Attorney General) have determined that fluoride and fluoride producing substances are not medicines when used to fluoridate domestic water supplies in New Zealand. In n New Health New Zealand Incorporated v Attorney General, the High Court recommended a Regulation be made to the Medicines Regulations 1984 to exempt fluoride substances from the definition of medicines when used to fluoridate water.

It had been suggested that the recommendation may be achieved earlier by way of an update to the classification statements of fluoride in the Schedule (via section 106 of the Medicines Act 1981) whilst the update to the Medicines Regulations 1984 was being drafted. The Committee considered including the statement, 'except when present in public drinking water', to the current prescription medicine, restricted medicine and pharmacy-only medicine classifications of fluoride. These statements would specifically exempt fluoride from the Schedule when present in drinking water.

The Committee discussed whether a concentration should also be included in the Schedule. The concentration of fluoride in public drinking water should not exceed 1.5 mg/L so this could specifically be included. Alternatively, the Schedule already states that, unless specific reference is made otherwise, every reference to a medicine in the Schedule applies only if the concentration of the medicine is greater than 10 mg/L or kg. The Committee agreed that advice should be sought from Health Legal in the Ministry of Health regarding any specific reference to a concentration of fluoride when present in drinking water.

One member was concerned with updating the Schedule. The Schedule is a list of medicines. If fluoride was not considered a medicine when present in drinking water then it should not be referenced in a Schedule of medicines.

Recommendation

That if an update to the Schedule was required whilst the update to the Medicines Regulations 1984 was being drafted, the prescription medicine, restricted medicine and pharmacy-only medicine statements of fluoride should be updated to include the statement, 'except when present in public drinking water'.

That, if required, advice should be sought from Health Legal in the Ministry of Health regarding any specific reference to a concentration of fluoride when present in drinking water.

Secretary's note - Following the meeting, advice has been provided to Medsafe that this recommendation (ie, updating the Schedule) is no longer required. The Ministry has commenced urgent proceedings to update the Medicines Regulations 1984.

6

Submissions for reclassification

6.1

Beclomethasone - proposed reclassification from pharmacy-only medicine to general sale medicine
(Beconase Allergy & Hayfever 12 Hour, Pharmaceutical Solutions)

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

Purpose

This was a company submission for the reclassification of beclomethasone, in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less, from pharmacy-only medicine to general sale medicine for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age.

The Committee noted there were three products currently marketed that could be affected by the reclassification.

Background

At the 7^th meeting on 31 July and 1 August 1990, the Committee recommended that beclomethasone and its esters be classified as prescription medicines.

At the 9^th meeting on 28 May 1992, the Committee agreed not to recommend changing the prescription medicine classification of beclomethasone dipropionate.

At the 15^th meeting on 30 November 1995, the Committee recommended that the proposal to reclassify nasal beclomethasone for the treatment and prophylaxis of seasonal rhinitis be deferred to the next meeting pending further information.

At the 16^th meeting on 24 April 1996, the Committee recommended that beclomethasone 50 mcg aqueous nasal spray be reclassified as a restricted medicine when:

1. in a pack approved by the Director-General of Health for sale as a restricted medicine
2. indicated for the short-term treatment or prophylaxis of allergic rhinitis
3. for persons aged over 12 years
4. in a pack size of no more than 200 doses
5. a maximum daily dose of 400 mcg applies
6. accompanied by warnings and consumer information as required by the Ministry including information on when medical advice should be sought and warnings against long-term use, concurrent use with other steroids and use with nasal or sinus infection.

At the 21^st meeting on 25 March 1999, the Committee recommended that the classification of over-the-counter nasal corticosteroids beclomethasone, flunisolide and budesonide should be reviewed to establish a suitable minimum age limit for their use and to consider whether or not they should be reclassified as pharmacy-only medicines.

At the 24^th meeting on 2 November 2000, the Committee recommended that there be no change to the current classification of beclomethasone nasal sprays.

At the 27^th meeting on 23 May 2002, the Committee recommended that the indications for over-the-counter sale of beclomethasone and fluticasone be broadened to include both seasonal and perennial rhinitis and that Medsafe be asked to amend the relevant section of the New Zealand Regulatory Guidelines accordingly.

At the 30^th meeting on 26 November 2003, the Committee recommended that beclomethasone, fluticasone, mometasone and budesonide should each be reclassified from restricted medicine to pharmacy-only medicine when in aqueous nasal sprays for the short-term treatment or prophylaxis of allergic rhinitis when:

1. sold in the manufacturer's original pack which has received the consent of the Minister or the Director-General to its distribution as a pharmacy-only medicine
2. labelled to comply with the Australian guidelines for understandability
3. labelled with clear warnings about use with other steroids for asthma prevention.

At the 36^th meeting on 8 February 2007, the Committee recommended that the pharmacy-only Schedule entries for beclomethasone, budesonide, fluticasone, mometasone and triamcinolone be amended to include the indications for the prophylaxis or treatment of allergic rhinitis in adults and children over 12 years of age.

Beclomethasone is currently classified as:

• prescription medicine; except when specified elsewhere in this Schedule
• pharmacy-only medicine; for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less.

Comments

A total of seven pre-meeting comments were received during the consultation period.

All seven did not support the reclassification proposal. Comments in opposition of the reclassification proposal could be summarised into the following themes:

1. pharmacist intervention is required to ensure the product is appropriate for the condition
2. counselling of patients regarding inappropriate use or overuse is essential
3. concern over inappropriate use in children under 12 years of age
4. risks associated with the use of intranasal steroid sprays
5. the argument that supermarkets are open for longer hours than pharmacies is not valid
6. allergic rhinitis is not a life-threatening condition therefore after-hours emergencies are unlikely
7. there is no unmet clinical need in the community
8. supermarkets do not contribute to providing safety statistics or monitor medicine misuse and side effects.

Discussion

The intention of the reclassification was to provide consumers with access to treatment for seasonal allergic rhinitis with the convenience and choice of purchasing the product for short-term treatment in an environment which is not limited in hours of availability and /or location as it is in pharmacy. The submission argued that supermarkets are generally open longer hours than pharmacies. Few pharmacies are open on Sundays and grocery stores are more prevalent in rural areas. The submission suggested the reclassification would enable access to consumers with after hour requirements.

The Committee were not convinced with the ease of access argument within the submission because the onset of action of beclomethasone is not immediate. There would be no need to buy the medicine late at night. Pharmaceutical Solutions explained their reasoning was meeting parents' perceived need to give treatment to their child.

The submission suggested that the reclassification would also provide an option for parents / caregivers who have pre-teen children who suffer from the effects of seasonal allergic rhinitis. The Committee noted there was limited data on the safety of beclomethasone in 12-18 year olds in the submission and so were uncomfortable with its use in under 18 year olds. In the United Kingdom beclomethasone is available as a general sale medicine in persons aged 18 years and over. Although in the United Kingdom it is a general sale medicine it is predominantly sold in pharmacies with access to pharmacist advice if required. The Committee were concerned that the age limit of the reclassification to general sale could not be enforced and if reclassified there was no barrier to a parent buying it for a younger child. Pharmaceutical Solutions commented that they understood the Committees concerns around the age. They suggested the sponsor could be approached to change the age in the reclassification proposal to 18 years and older.

One member queried how to ensure that beclomethasone was not one of a number of steroids being taken without the input of a healthcare professional. Hayfever sufferers often have asthma which involves taking other steroids. It was suggested that the general view of consumers was that supermarket medicines were safer than those purchased at a pharmacy and so they were more likely to exceed the recommended daily dose or use the medicine for unapproved indications.

The submission also stated that the efficacy and safety profile of beclomethasone dipropionate was well established. Its widespread use and the meta-analysis included with the submission confirmed this. The proposed reclassification was not expected to increase the potential risk of adverse events nor the potential for abuse or misuse. However, the Committee queried the safety of beclomethasone if it was available as a general sale medicine and how any risks could be mitigated at this level of sale. Clear instruction was required on how to use the nasal spray to receive the maximum benefit and the submission did not include a different label for general sale. Pharmaceutical Solutions commented that when sold at the pharmacy-only level guidance on how to use the nasal spray was not necessarily provided by a pharmacist. Also, most consumers purchasing the medicine in a supermarket would have used the product previously. Most likely following a prescription from a doctor.

Although not included in the submission, Pharmaceutical Solutions confirmed they did have support from the sponsor of Beconase Allergy & Hayfever 12 Hour for the reclassification submission. The Chair commented that support from the sponsor was a much more convincing argument for reclassification compared to the accessibility of a product.

Overall the Committee were unsure if the benefits outweighed the risk of beclomethasone being made available as a general sale medicine in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less, for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age. Especially in the under 18 age group. The Committee concluded that beclomethasone should not be reclassified and made available as a general sale medicine.

Recommendation

That beclomethasone, in aqueous nasal sprays delivering up to 50 micrograms per actuation when the maximum recommended daily dose is no greater than 400 micrograms (200 micrograms per nostril) in a pack containing 200 actuations or less, should not be reclassified from pharmacy-only medicine to general sale medicine for the treatment or prophylaxis of allergic rhinitis in adults and children over 12 years of age.

6.2

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

One representative of the submitting company observed the discussion but left the meeting room before a final recommendation was made.

Purpose

This was a company submission for the reclassification of omeprazole, in solid dose form containing 10 mg or less, 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.

The Committee noted there were two products currently marketed that could be affected by the reclassification.

Background

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

Omeprazole was considered for down-scheduling 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.

At the 50^th meeting on 12 November 2013, the Committee recommended 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, for the short-term symptomatic relief of gastric reflux-like symptoms in sufferers aged 18 years and older.

Omeprazole is currently classified as:

• prescription medicine; except when specified elsewhere in the Schedule
• pharmacy-only medicine; 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

A total of eight pre-meeting comments were received during the consultation period.

All eight did not support the reclassification proposal. Comments in opposition of the reclassification proposal can be summarised into the following themes:

1. potential for adverse effects
2. interactions with other medications
3. increased risk of inappropriate use
4. omeprazole may mask the symptoms of heart attack / angina / gastric cancer and delay diagnosis therefore pharmacist intervention is required
5. pharmacists can refer a patient to a general practitioner when necessary
6. omeprazole should only be used for short-term use
7. supermarkets already sell indigestion remedies
8. inappropriate use in small children and babies
9. uncertainty of how the age limit of 18 years and older will be enforced
10. the argument that supermarkets are open for longer hours than pharmacies is not valid
11. supermarkets do not contribute to providing safety statistics or monitor medicine misuse and side effects.

Discussion

This was the second submission proposing the reclassification of omeprazole, in solid dose form containing 10 mg or less, 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. Bayer explained they had addressed the Committee's comments regarding the first submission in making this second submission. The labelling and patient information had been improved as suggested.

Bayer confirmed that 65% of sufferers of gastric reflux-like symptoms currently purchase treatment from a supermarket, suggesting supermarkets were preferred over pharmacies. This consumer data was purchased by Bayer.

The Committee summarised their concerns with the submission.

Gastric reflux-liidity leading to further hyperacidity. This provided further evidence that counselling from a healthcare practitioner maybe required.

The pack insert advises the consumer to see a doctor or pharmacist in defined circumstances. But

1. key symptoms can be difficult to accurately diagnose, even by clinicians. Gastroesophageal reflux is not suitable for short-term treatment alone.
2. One member queried how short-term use was defined as multiple packs could be purchased from a supermarket at any one time.
3. With the status quo pharmacy-only classification, a pharmacist is available to answer any questions that may be required by a consumer.
4. Concerns were also raised over the placement of Losec on a supermarket shelf next to antacids, which may confuse consumers into thinking it is an antacid when it is not.
5. Omeprazole interacts with a number of other medicines. For example, in the September 2014 issue of Prescriber Update one key message was that there is the potential for a pharmacokinetic and / or pharmacodynamic interaction between omeprazole and citalopram / escitalopram (article available at http://www.medsafe.govt.nz/profs/PUArticles/PDF/Prescriber%20Update%20Sept%202014.pdf).
6. Rebound hyperacidity has been observed in healthy volunteers who take omeprazole. This makes it difficult to stop taking omeprazole, more omeprazole would be taken to treat the hyperacidity leading to further hyperacidity. This provided further evidence that counselling from a healthcare professional may be required.
7. The pack insert advises the consumer to see a doctor or pharmacists in defined circumstances but the pack insert cannot be read without buying the pack and opening it.
8. Concerns were raised about off-label use in children.

In response to the Committee's discussion, Bayer commented that Losec is a safe product that is widely used around the world.

In conclusion, the Committee agreed that Losec had value when used appropriately. However, the submission did not address the mitigation of the risk from its potency, metabolism and potential for interaction, off-label use, harm, rebound with continuous use which may conceal other medical issues and use in children.

The main concern was the interaction of omeprazole with other medicines which requires counselling from a healthcare practitioner. This risk cannot be mitigated. Bayer could not provide a counter argument for this concern.

The Committee went on to discuss whether the need for counselling from a healthcare practitioner would provide an argument for reclassifying omeprazole back to a restricted medicine. The Chair agreed to ask Medsafe's Pharmacovigilance Team for a report at the next meeting on whether there was any new evidence of interactions of omeprazole with other medicines (eg, on QT interval) to support a reclassification to restricted medicine.

Recommendation

That omeprazole, in solid dose form containing 10 mg or less, should not be reclassified 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.

That Medsafe's Pharmacovigilance Team should be asked to produce a report for the next meeting on whether there was any new evidence of interactions of omeprazole with other medicines to support a reclassification to restricted medicine.

6.3

Paracetamol in combination with phenylephrine
(Maxiclear Sinus and Pain Relief and Maxiclear Cold and Flu Relief, AFT Pharmaceuticals)

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

Purpose

This was a company submission for the reclassification of paracetamol in combination with phenylephrine in packs containing:

• any number of solid dose units containing paracetamol 500 mg in combination with more than 2.5 mg phenylephrine per dose unit from general sale or pharmacy-only medicine to restricted medicine
• more than 20 solid dose units containing paracetamol 500 mg in combination with 2.5 mg phenylephrine or less per dose unit to remain a pharmacy-only medicine
• 20 or less solid dose units containing paracetamol 500 mg in combination with 2.5 mg phenylephrine or less per dose unit to remain a general sale medicine
• any number of sachets of powder containing 1000 mg paracetamol in combination with more than 5 mg phenylephrine per sachet from general sale or pharmacy-only medicine to restricted medicine
• more than 10 sachets of powder containing 1000 mg paracetamol in combination with 5 mg phenylephrine or less per sachet to remain a pharmacy-only medicine
• 10 or fewer sachets of powder containing 1000 mg paracetamol in combination with 5 mg phenylephrine or less per sachet to remain a general sale medicine.

For the paracetamol and phenylephrine combinations stated to remain as general sale or pharmacy-only medicine, it was assumed that the combination also complies with the relevant requirements for phenylephrine (eg, a product containing phenylephrine cannot be general sale if it is indicated for the treatment of the symptoms of cough and cold in children aged 6-12 years).

The Committee noted that there were 61 products currently marketed that could be affected by the reclassification.

Background

Paracetamol is currently classified as:

• prescription medicine; except when specified elsewhere in this Schedule
• pharmacy-only medicine; 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.

Phenylephrine is currently classified as:

• prescription medicine; except when specified elsewhere in this Schedule
• pharmacy-only medicine; for nasal use in medicines containing more than 1%; for ophthalmic use in medicines containing 5% or less and more than 1%; for oral use in medicines containing more than 50 milligrams per recommended daily dose or in packs containing more than 250 milligrams of phenylephrine per pack; in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years
• general sale medicine; for nasal or ophthalmic use in medicines containing 1% or less; for oral use in medicines containing 50 milligrams or less per recommended daily dose and in packs containing 250 milligrams or less of phenylephrine per pack; except in medicines for the treatment of the symptoms of cough and cold in children aged 6-12 years.

If a medicine has more than one active ingredient, the active with the most restrictive classification determines the classification of the medicine.

Comments

A total of nine pre-meeting comments were received during the consultation period.

Two supported the reclassification proposal. Comments in support of the reclassification proposal can be summarised into the following themes:

• a general sale classification would mean supply was unmonitored
• there appears to be limited epidemiological evidence for the safety of phenylephrine
• upscheduling takes a proactive approach to the safety concern highlighted in the submission.

Six did not support the reclassification proposal. Comments that did not support the reclassification proposal can be summarised into the following themes:

• paracetamol and phenylephrine have had extensive use as pharmacy-only and general sale medicines with millions of units sold annually with no significant adverse events relating to cardiovascular disease or hypertension
• the safety concern is theoretical
• the submission is based primarily on a single study
• upscheduling will not be in the best interest of public health
• proposed changes would have a significant impact on sponsors and their products
• increased burden on pharmacies.

One was interested in the issues raised by the submission suggesting it presented new doubts about the risk-benefit ratio of the paracetamol and phenylephrine combination as a general sale medicine.

Discussion

The submission was based on the findings of one study, published in the New England Journal of Medicine as a letter to the Editor, which found that administration of 10 mg phenylephrine hydrochloride in combination with 1000 mg paracetamol (two tablets) effectively doubled the bioavailability of phenylephrine and quadrupled the maximum plasma concentration. This effectively gave a dose equivalent to 20 mg phenylephrine hydrochloride alone, which could potentially increase the risk of cardiovascular side effects in susceptible individuals such as the elderly.

AFT Pharmaceuticals confirmed they found this potential safety issue by accident during development of a new fixed-dose combination of paracetamol, ibuprofen and phenylephrine. They had then repeated the study three more times in the same study population yielding consistent results, however these three studies were yet to be published.

The Committee had been placed in an unusual situation as the clinical data had not yet been reviewed by Medsafe. A number of questions were raised about the study. The study was performed in a small group of healthy volunteers only and would need to be repeated with a larger, more varied cohort of research participants in different regions to see if the results would be replicated. The research participants had been fasting for 12 hours whereas typically patients taking the medicine would not.

It was noted that there were few major adverse reactions, as a result of taking higher than the recommended dose of phenylephrine, reported in international literature and none reported to the Centre for Adverse Reactions Monitoring (CARM) in New Zealand. However, this may be due to the nature of medicines that are sold over-the-counter and under reporting of adverse reactions. The Committee discussed whether there was a risk of increased incidence of strokes and cardiovascular events if a reclassification was not recommended. It was agreed that the amount of data and information presented with the submission was hypothesis generating at this stage. The Committee considered that there was still a question over the clinical relevance of this pharmacokinetic interaction given the lack of reported adverse events and volume of use of phenylephrine over many years.

The Committee also noted a large number of products would be affected by a reclassification.

The Committee agreed that a potential safety issue had been raised by the submission. However, there was not enough data or evidence to recommend a reclassification. The Committee recommended that the submission should be referred to Medsafe's Pharmacovigilance Team so that any adverse reactions from taking paracetamol in combination with phenylephrine could be actively monitored.

Recommendation

That paracetamol in combination with phenylephrine should not be reclassified as proposed in the submission.

That the submission should be referred to Medsafe's Pharmacovigilance Team so that any adverse reactions from taking paracetamol in combination with phenylephrine could be actively monitored.

7

New medicines for classification

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

7.1

Dasabuvir, ombitasvir and veruprevir - Viekira Pak 137.50mg / 250mg film coated tablet and Viekira Pak-RBV 200 mg RBV, 1000 mg RBV and 1200 mg RBV film coated tablets

Veruprevir and ombitasvir are co-formulated as film-coated immediate release tablets. The tablet also contains copovidone, d-alpha-Tocopheryl acid succinate, propylene glycol monolaurate, sorbitan monolaurate, silicon dioxide, sodium stearylfumarate, polyvinyl alcohol, macrogol 3350, purified talc, titanium dioxide, and iron oxide red. The tablets do not contain gluten. The strength for the fixed dose combination tablet is 75 mg veruprevir/50 mg ritonavir/12.5 mg ombitasvir.

Dasabuvir is formulated as a 250 mg film-coated, immediate release tablet containing microcrystalline cellulose, lactose, copovidone, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene macrogol 3350, purified talc, and iron oxide yellow, iron oxide red and iron oxide black.

Viekira Pak / Viekira Pak-RBV is indicated for the treatment of genotype 1 chronic hepatitis C infection, including patients with cirrhosis. Duration of therapy and addition of ribavirin are dependent on patient population.

Dasabuvir, ombitasivir and veruprevir are not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3).

Recommendation

That dasabuvir, ombitasvir and veruprevir should all be classified as prescription medicines.

7.2

Nintedanib - OFEV 100 mg and 150 mg soft gelatin capsules

Nintedanib is a triple angiokinase inhibitor blocking vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and β) and fibroblast growth factor receptors (FGFR 1-3) kinase activity. Ninetanib binds competitively to the ATB binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation and survival of endothelial as well as perivascular cells (pericytes and vascular smooth muscle cells). In addition Flt-3, Lck and Src kinases are inhibited.

Nintedanib is a small molecule tyrosine kinase inhibitor including the receptors platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptors (FGFR) 1-3, and vascular endothelial growth actor receptor (VEGFR) 1-3. Ninetanib binds competitively to the ATB binding pocket of these receptors and blocks the intracellular signalling which is crucial for the proliferation, migration and transformation of fibroblasts representing essential mechanisms of the IPF pathology. In addition nintedanib inhibits Flt-3, Lck and Src kinases.

OFEV is indicated in combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer of adenocarcinoma tumour histology after first line chemotherapy.

OFEV is also indicated for the treatment of Idiopathic Pulmonary Fibrosis and to slow disease progression.

Nintedanib is not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3).

Recommendation

That nintedanib should be classified as a prescription medicine.

7.3

Pomalidomide - Pomalyst 1 mg, 2 mg, 3 mg and 4 mg capsules

Pomalidomide has direct anti-myeloma tumouricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma (MM) tumour cell growth. Specifically, pomalidomide inhibits proliferation and induces apoptosis of haematopoietic tumour cells. Additionally, pomalidomide inhibits the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergises with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumour cell apoptosis. Pomalidomide enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes. Pomalidomide demonstrated anti-angiogenic activity in a mouse tumour model and the in vitro umbilical cord model.

Pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Pomalidomide is not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3).

Recommendation

That pomalidomide should be classified as a prescription medicine.

7.4

Siltuximab - Sylvant 100 mg and 400 mg powder for infusion

Siltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6. Siltuximab prevents the binding of human IL-6 to both soluble and membrane-bound IL-6 receptors (IL-6R), thus inhibiting the formation of the hexameric signalling complex with gp130 on the cell surface. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T and B- cells, lymphocytes, monocytes and fibroblasts, as well as malignant cells. IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. Overproduction of IL-6, in chronic inflammatory diseases and malignancies has been linked to anaemia and cachexia and has been hypothesised to play a central role in driving plasma cell proliferation and systemic manifestations in patients with CD.

Sylvant is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Siltuximab is not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3).

Recommendation

That siltuximab should be classified as a prescription medicine.

7.5

Turoctocog alfa - NovoEight 250 IU powder for injection

NovoEight (turoctocog alfa; human coagulation factor VIII) is a purified protein for use in the clinical management of factor VIII deficiency (haemophilia A or classic haemophilia). Turoctocog alfa is produced by recombinant DNA technology in Chinese hamster ovary cells and is a third generation FVIII product prepared without the use of serum or other animal-derived components. The manufacturing method of NovoEight minimises the risk of transmission of viral diseases.

NovoEight is indicated for the treatment and prophylaxis of bleeding episodes in patients with haemophilia A, including control and prevention of bleeding in surgical settings.

Turoctocog alfa is not scheduled in Australia in the Standard for the Uniform Scheduling of Medicines and Poisons (No.4, Amendment No.3).

Blood clotting factors were already available as general sale medicines. Therefore, turoctocog alfa should be made available as a general sale medicine.

Recommendation

That turoctocog alfa should be made available as a general sale 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

Insulin glargine

Insulin glargine is an insulin analogue. Insulin glargine is indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia.

In July 2014, the Delegate made a final decision to include insulin glargine in Schedule 4 (prescription medicine) with an implementation date of 1 October 2014.

Insulin glargine was already classified in New Zealand and Australia as a prescription medicine under the group entry for insulins. Therefore, no classification recommendation was required.

The Scheduling Secretariat in Australia had been approached for an explanation as to why insulin glargine was listed separately as well as being classified under the group entry. However, an explanation had not been received.

Recommendation

That insulin glargine should not be added to the New Zealand Schedule as a prescription medicine because it is already classified as a prescription medicine under the group entry for insulins.

8.1.2

Nalmefene

Nalmefene is an opioid antagonist. Nalmefene had been proposed for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high risk drinking level, without physical withdrawal syndrome and who do not require immediate detoxification. The product should be prescribed in conjunction with psychosocial support focused on treatment adherence and reducing alcohol consumption.

In July 2014, the Delegate made a final decision to include nalmefene in Schedule 4 (prescription medicine) with an implementation date of 1 October 2014.

The Committee noted that nalmefene would not be captured in the Schedules of the Misuse of Drugs Act 1975.

Recommendation

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

8.1.3

Normal human immunoglobulin

Normal human immunoglobulin is a human immunoglobulin G. Normal human immunoglobulin is indicated in adults and children for replacement therapy in Primary Immunodeficiency Disease and symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

In April 2014, the Delegate made a final decision to include normal human immunoglobulin in Schedule 4 (prescription medicine) with an implementation date of 8 April 2014.

Normal human immunoglobulin was already classified in New Zealand and Australia as a prescription medicine under the group entry for immunoglobulins. Therefore, no classification recommendation was required.

The Scheduling Secretariat in Australia had been approached for an explanation as to why normal human immunoglobulin was listed separately as well as being classified under the group entry. However, an explanation had not been received.

Recommendation

That normal human immunoglobulin should not be added to the New Zealand Schedule as a prescription medicine because it is already classified as a prescription medicine under the group entry for immunoglobulins.

8.1.4

Perampanel

Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid glutamate receptor on post-synaptic neurons. It had been proposed for adjunctive treatment of partial-onset seizures.

In July 2014, the Delegate made a final decision to include perampanel in Schedule 4 (prescription medicine) with an implementation date of 1 October 2014.

The Committee noted that perampanel would not be captured in the Schedules of the Misuse of Drugs Act 1975.

Recommendation

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

8.1.5

Serelaxin

Serelaxin is a recombinant human relaxin-2, a vasoactive peptide hormone. Serelaxin is proposed for use in patients with acute heart failure.

In April 2014, the Delegate made a final decision to include serelaxin in Schedule 4 (prescription medicine) with an implementation date of 8 April 2014.

Recommendation

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

8.2

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

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

1. febuxostat - should be included in Schedule 4 (prescription medicine) (which harmonised with New Zealand)
2. prucalopride - should be included in Schedule 4 (prescription medicine) (which harmonised with New Zealand)
3. simeprevir - should be included in Schedule 4 (prescription medicine) (which harmonised with New Zealand)
4. sofosbuvir - should be included in Schedule 4 (prescription medicine) (which harmonised with New Zealand)
5. umeclidinium bromide - umeclidinium should be included in Schedule 4 (prescription medicine) (which partially harmonised with New Zealand)
6. vilanterol - should be included in Schedule 4 (prescription medicine) (which harmonised with New Zealand).

8.2.1

Decisions by the Delegate - April 2014

Decisions also included under agenda item 8.1.
a) Esomeprazole

A new Schedule 3 (restricted medicine) entry should be created for 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.

The Committee considered harmonising with the above classification.

Esomeprazole is currently classified as a prescription medicine in New Zealand. The Committee noted there were no products currently available that could be affected by the proposed reclassification. Although hypothetically safer than omeprazole, there was less experience in using esomeprazole in New Zealand. The Committee agreed it would be preferable to wait until a submission for reclassification was received in New Zealand. Although there was no apparent safety reason not to harmonise, there was not enough information in the Reasons for the Delegate's Decision to make a recommendation.

Recommendation

That a restricted medicine entry should not be created for 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.

b) Macrogols

A new Schedule 2 (pharmacy-only medicine) entry should be created for macrogols in preparations for oral use as a liquid concentrate for laxative use.

The Committee considered harmonising with the above classification.

Macrogols, in oral preparations for bowel cleansing prior to diagnostic, medical or surgical procedures, are currently classified as restricted medicines in New Zealand. This classification followed a recommendation by the Committee at its 24^th meeting on 2 November 2000. At the 30^th meeting on 26 November 2003, the Committee recommended that macrogols should remain unscheduled for laxative use. Macrogols are available as general sale medicines for laxative use. The Committee noted there were currently nine products currently marketed that could be affected by a recommendation to reclassify.

From the information in the Reasons for the Delegate's Decision, it was unclear to the Committee why a pharmacy-only medicine entry should be created for macrogols in preparations for oral use as a liquid concentrate for laxative use. It was stated that there were concerns regarding the potential for misuse of the liquid concentrate so supply needed to be in an environment where advice from a healthcare professional would be available. However, no adverse events had been reported in New Zealand regarding laxative use.

The Committee agreed that the Scheduling Secretariat in Australia should be asked for further information on why this decision was made before a recommendation could be made.

Recommendation

That a new pharmacy-only medicine entry should not be created for macrogols in preparations for oral use as a liquid concentrate for laxative use.

That the Scheduling Secretariat in Australia should be asked for further information on why the Delegate decided to include a new Schedule 2 (pharmacy-only medicine) entry should be created for macrogols in preparations for oral use as a liquid concentrate for laxative use.

8.2.2

Decisions by the Delegate - May 2014

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

8.2.3

Decisions by the Delegate - July 2014

Decisions also included under agenda item 8.1.
a) Naproxen

A new Schedule 3 (restricted medicine) entry should be created for naproxen when in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age.

The Committee considered harmonising with the above classification.

Naproxen is currently classified as a:

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

The Committee noted there were no products currently marketed that would be affected by a recommendation to reclassify. The Committee agreed it would be preferable to wait until a submission for reclassification was received in New Zealand. Although there was no apparent safety reason not to harmonise, there was not enough information in the Reasons for the Delegate's Decision to make a recommendation.

Recommendation

That a new restricted medicine entry should not be created for naproxen when in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age.

8.2.4

Decisions by the Delegate - August 2014

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

9

Agenda items for the next meeting

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

1. the Committee will consider the report from Medsafe's Pharmacovigilance Team on whether there was any new evidence of interactions of omeprazole with other medicines to support a reclassification to restricted medicine.

10

General business

10.1

Articles for information

The Committee were presented with the following articles for information:

1. Pharmacy Today. 2014. Survey identifies opportunities. URL: www.pharmacytoday.co.nz (accessed 11/09/2014).
2. Pharmacy Today. 2014. Pharmacists should give scripts for minor ailments. URL: www.pharmacytoday.co.nz (accessed 11/09/2014).
3. Pharmacy Today. 2014. Pharmacy gets big tick in annual survey. URL: www.pharmacytoday.co.nz (accessed 11/09/2014).
4. Gauld N, Kelly FS, Kurosawa N, et al. 2014. Widening consumer access to medicines through switching medicines to non-prescription: A six country comparison. PLOS One. URL: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0107726 (accessed 25/09/2014).

11

Date of next meeting

To take place on a Tuesday in April 2015. The Secretary would email members for their availability.