1

Welcome

2

Apologies

3

Confirmation of the minutes of the 52ND meeting held on Tuesday 21 October 2014

4

Declaration of conflicts of interest

5

Matters arising

5.1

Objections to recommendations made at the 52nd meeting

No valid objections have been received.

5.2

Azelastine for nasal use

Medsafe has received a New Medicine Application for a nasal spray that contains 0.15% w/v azelastine hydrochloride and is indicated for the treatment of hayfever symptoms caused by seasonal and non-seasonal allergies including pollen, house mites and pet hair.

Azelastine is currently classified as:

• prescription; except when specified elsewhere in this Schedule
• pharmacy-only; for nasal use; in topical eye preparations containing 0.05% or less.

The current nasal use classification does not include a strength limit. This is despite the fact that the only azelastine-containing nasal spray (Azep) currently approved in New Zealand is formulated at a lower strength (0.1% w/v) of azelastine hydrochloride.

This is a Medsafe submission (Adobe Acrobat document, 128 KB, 2 pages) requesting confirmation from the Committee that the pharmacy-only classification of azelastine hydrochloride remains appropriate when present in nasal preparations at 0.15% w/v.

5.3

Ketoprofen for topical use

Ketoprofen for topical use was reclassified from pharmacy-only medicine to general sale medicine at the 29th meeting on 22 May 2003.

In 2010, the European Medicines Agency (EMA) reviewed the safety of ketoprofen for topical use and concluded that there is a risk of:

• photosensitivity reactions, including photoallergy reactions (even in the case of hazy sun)
• co-sensitisation with octocrilene (an ingredient that may be present in some cosmetic and hygiene products).

As a consequence, the EMA recommended a number of risk minimisation measures. These included additional warnings regarding photoallergy and skin reactions after co-application of octocrilene-containing products, and a recommendation that ketoprofen topical products be subject to medical prescription. The EMA report, and annexes, are available under the ‘All documents’ tab at www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Ketoprofen_topical/human_referral_000238.jsp&mid=WC0b01ac%2005805c516f.

The classification of ketoprofen was not reconsidered in New Zealand at that time as no topical ketoprofen products were on the market. 

However, a New Medicine Application for a topical 2.5% ketoprofen gel has now been received. Following a request from Medsafe, the Committee will consider whether it is appropriate for ketoprofen for topical use to remain unscheduled (general sale) or whether, in view of the EMA recommendations, it should be up-scheduled.

5.4

Omeprazole – proposed reclassification from pharmacy-only medicine to restricted medicine

At the 52nd meeting on 21 October 2014, the Committee recommended 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.

The Committee will consider the report from Medsafe’s Pharmacovigilance Team (Adobe Acrobat document, 784 KB, 21 pages).

5.5

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

At the 52nd meeting on 21 October 2014, the Committee recommended that paracetamol in combination with phenylephrine should not be reclassified 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.

The Committee also 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.

Following publication of the minutes, AFT Pharmaceuticals informed Medsafe that the interaction between paracetamol and phenylephrine as a potential safety issue had now been suggested by three additional studies as well as the single study published by the date of the last meeting.

The Committee will revisit their recommendation made at the 52nd meeting in light of these three studies.

5.6

Public consultation process

After the closing date for submissions for each meeting, the agenda is published on the Medsafe website. There is a consultation period of approximately six weeks which provides an opportunity for interested parties to comment on the proposed agenda items.

A healthcare professional has raised concerns regarding the effectiveness of the Committee’s consultation process and whether the opportunity to comment on agenda items is published widely enough.

The Committee will discuss the consultation process, the expectations of the professional bodies in promoting public consultation and whether any improvements can be made.

The Committee would welcome any suggestions from the sector on improving the consultation process.

5.7

Matters arising for information

5.7.1

Classification of ceftolozane, efraloctocog alfa, eftrenonacog alfa, ibrutinib and selexipag

An out-of-session consultation took place in January 2015 regarding the classification of ceftolozane, efraloctocog alfa, eftrenonacog alfa, ibrutinib and selexipag.

The Committee recommended that ceftolozane, ibrutinib and selexipag should be classified as prescription medicines, and that efraloctocog alfa and eftrenonacog alfa should be available as general sale medicines.

These classification recommendations were gazetted on 19 February 2015.

6

Submissions for reclassification

6.1

Nitrofurantoin – proposed reclassification from prescription medicine to restricted medicine
(Green Cross Health Limited)

This is a submission (Adobe Acrobat document, 1,350 KB, 21 pages) for the reclassification of nitrofurantoin from prescription medicine to restricted medicine in tablets containing 50 mg or less, when dispensed in packs of 20 tablets, for the treatment of uncomplicated cystitis in women aged 16-65 years.

6.2

Oral contraceptives – proposed reclassification from prescription medicine to restricted medicine
(Green Cross Health Limited)

This is a submission (Adobe Acrobat document, 1,614 KB, 30 pages) for the reclassification of selected oral contraceptives (ethinylestradiol with norethisterone, ethinylestradiol with levonorgestrel, norethisterone, levonorgestrel and desogestrel) from prescription medicine to restricted medicine when supplied for oral contraception by a registered pharmacist who has successfully completed a training course for the supply of oral contraceptives.

7

New medicines for classification

7.1

Bilastine – proposed classification as a pharmacy-only medicine
(Labixten, Te Arai BioFarma Limited)

This is a company submission (Adobe Acrobat document, 747 KB, 20 pages) for the classification of bilastine as a pharmacy-only medicine in tablets containing 20 mg or less, when sold in a pack containing not more than 30 tablets, for the treatment of the symptoms of allergic rhinoconjunctivitis (seasonal and perennial) and urticaria.

7.2

Otilonium bromide – proposed classification as a restricted medicine
(Menoctyl, Te Arai BioFarma Limited)

This is a company submission (Adobe Acrobat document, 629 KB, 20 pages) for the classification of otilonium bromide as a restricted medicine in tablets containing 40 mg or less, when sold in a pack containing not more than 30 tablets, for the symptomatic treatment of irritable bowel syndrome and painful, spastic conditions of the distal enteric tract (colon and rectum), and for the relief of abdominal pain, distension and motility disorders in patients older than 18 years of age caused by smooth muscle spasm of distal parts of the intestinal tract.

7.3

Racetams – proposed classification as prescription medicines

The Ministry of Health has received numerous queries regarding the regulatory position of cognitive enhancing products containing a group of compounds known collectively as racetams or racetam-like substances, and whether there should be restrictions on their importation into New Zealand.

Given the nootropic (and other therapeutic) claims associated with the racetam class of substances, it is appropriate to regard them as medicines Scheduling them as prescription medicines would be consistent with the approach to piracetam and levetiracetam, two racetams that are currently scheduled as prescription medicines.

Such classification would also mean access to the substances could be controlled and would reduce the risk of harm occurring to consumers due to inappropriate use.

This is a Medsafe submission (Adobe Acrobat document, 279 KB, 7 pages) that requests classification of the following racetam and racetam-like substances as prescription medicines: aloracetam, aniracetam, brivaracetam (and its stereoisomers), cebaracetam (and its stereoisomers), coluracetam, dimiracetam (and its stereoisomers), doliracetam (and its stereoisomers), dupracetam, eitracetam, fasoracetam (and its stereoisomers), fonturacetam (and its stereoisomers), imuracetam, molracetam, nebracetam (and its stereoisomers), nefiracetam, nicoracetam, noopept (and its stereoisomers), oxiracetam (and its stereoisomers), piperacetam, pramiracetam, rolipram (and its stereoisomers), rolziracetam, seletracetam (and its stereoisomers).

8

Harmonisation of the New Zealand and Australian schedules

8.1

New chemical entities which are not yet classified in New Zealand

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 - October 2014

Decisions also included under agenda item 8.1.

9

Agenda items for the next meeting

10

General business

10.1

New Zealand’s domestic regulatory reform

An update will be provided following the announcement that the Australian and New Zealand Governments have agreed to cease efforts to establish a joint therapeutic products regulator (the Australia New Zealand Therapeutic Products Agency (ANZTPA)).

11

Date of next meeting