Updated 23 May 2013
Held in the Medsafe Boardroom, Level 6, Deloitte House, 10 Brandon Street, Wellington. Commencing at 9:45AM.
Dr Stewart Jessamine (Chair)
Dr David Galler (from 1:30pm)
Dr Jill Peckham
Dr Tim Healy
Ms Natalie Gauld
Mrs Andi Shirtcliffe
Mrs Carol Smith (Secretary)
Dr Enver Yousuf
The Chairman welcomed members to the 40th meeting and introduced Dr Enver Yousuf, the newly-appointed manager of Medsafe’s Regulatory Branch.
Dr Galler had sent notice that he would not be able to attend the morning session of the meeting.
The minutes of the 39th meeting were accepted as an accurate record of that meeting and were signed by the Chairman.
All but one of the members declared that they had no interests which would pose a conflict with any of the items on the current agenda.
One of the members declared interests which had already been declared at previous meetings. These were discussed in the absence of that member. The Committee agreed that these potential conflicts had occurred well in the past and had little relevance to any of the matters to be discussed at the meeting. It was agreed that there were no reasons to prevent the member from full participation in the meeting.
At the previous meeting the Committee had agreed to harmonise with the Australian Appendix A exemption from scheduling for blood and blood products in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The wording for the exemption discussed by the MCC was that which had been recommended by the NDPSC at its October 2007 meeting. This wording had been amended at a subsequent meeting to avoid inadvertent capture of recombinant versions of other naturally occurring human proteins. In order to harmonise with the Australian position, the recommendation made at the 39th MCC meeting also needed to be amended to avoid capture of these substances.
The current amended wording of the exemption from scheduling in Australia was as follows:
Human blood products including:
The Committee agreed that the intention was to harmonise with Australia on the classification of blood products and agreed that its earlier recommendation should be amended to align with the Australian exemption from scheduling for blood and blood products and to avoid capture of recombinant versions of other naturally occurring human proteins such as filgrastim, ancestim, interferon and erythropoietins.
Medsafe should establish which entries should be removed from the New Zealand medicines schedule in order to harmonise with Australia and to achieve Trans-Tasman harmonisation on the scheduling of blood and blood products.
Medsafe should also notify the New Zealand Blood Service of the change to the classification of blood and blood products.
That New Zealand should harmonise with Australia on the exemption from classification for blood and blood products.
There was ongoing discussion about whether or not chloramphenicol eye products should be reclassified from prescription medicines to restricted medicines. At the previous meeting members had delayed making a recommendation until further investigation had been undertaken in a number of areas.
The British Medicines and Healthcare Regulatory Authority (MHRA) had been approached with a request for access to the information on resistance issues which had supported the reclassification of chloramphenicol eye products in the UK. This information had been supplied in confidence by the MHRA and the MCC noted that, according to the information provided, resistance to chloramphenicol appeared to be low.
No response had been received from an enquiry to the Institute of Environmental Science and Research (ESR) with regard to resistance issues relating to chloramphenicol in New Zealand.
Nor had there been a response from any of the product sponsor companies submitting proposals for training pharmacists in correct diagnosis and appropriate sale of chloramphenicol eye products.
The Pharmaceutical Society had reiterated its support of the proposed reclassification and had outlined examples of possible courses of action which could be considered by the Society in conjunction with any of the sponsor companies. This included the development of a best practice assessment and treatment protocol. However, there were no details as to what should be included in the content of such a protocol.
Responses had been received from both the Royal Australian and New Zealand College of Ophthalmology and the New Zealand Association of Optometrists. Both bodies opposed reclassification of chloramphenicol eye products, principally on the grounds of the need for training and equipment to make a correct diagnosis of conditions suitable for treatment with chloramphenicol and of a possible increase in the development of resistant bacteria.
Discussion followed on:
As consensus could not be reached on some points the Committee agreed that a recommendation to reclassify chloramphenicol eye products should not be made at the current meeting. However, it was agreed that:
That chloramphenicol for ophthalmic use should remain a prescription medicine but should be exempt from prescription status when sold in practice by a registered optometrist.
At the previous meeting the MCC had recommended that all combination products containing more than 15 milligrams of codeine per dose unit should become prescription medicines. Until that time combination products containing codeine had been permitted under the Misuse of Drugs Act 1975, to be sold as pharmacy-only medicines in products containing up to 100 milligrams per dose unit and in unlimited pack sizes. In addition, the Committee had proposed that the following cut off points should apply to differentiate between pharmacy-only and restricted medicines containing codeine in combination with another active ingredient in order to place an element of control on the sale of larger packs and higher doses of codeine in combination products. The proposals had undergone consultation prior to the current meeting.
The Chairman told the Committee that the NDPSC working party on codeine had not yet completed its review of combination codeine products. He had reported to the working party that, at their previous meeting, the MCC had agreed that pack size limitations might be the only way to minimise the risks associated with abuse or misuse of codeine in combination products. As a member of the working party the Chairman had supported the view that, if it was believed that there was sufficient evidence to show that prolonged exposure to codeine products was associated with an increased risk of habituation leading to abuse, then limiting pack size would be sound risk management. Restricting the time of exposure to codeine would be a key factor in minimising the risk. He had indicated to the working party that he would favour a harm-minimising approach of limiting both dose and pack size but that this would be subject to advice from addiction specialists as to whether or not this would be the correct approach.
The Chairman said that it was important that New Zealand and Australia should be harmonised in their treatment of these products and that it would be prudent to postpone making a recommendation until the NDPSC had resolved its own position in regard to the classification of codeine in combination products. In the mean time, the current prescription medicine status of codeine in combination products containing more than 15 milligrams of codeine per dose unit should remain.*
The Committee agreed with the Chairman that a recommendation should be held over at that point in time. One member requested that, in the interim, information should be sought from drug abuse specialists about how ibuprofen and codeine products were being used in New Zealand.
No recommendation was required at the current time.
This was not implemented due to an objection. It will be discussed at the 41st meeting.
At the previous meeting the Committee had agreed not to reclassify oseltamivir from prescription medicine to restricted medicine. However, members had expressed interest in observing any additional information which might have emerged from the 2008 influenza season. In the previous year pharmacists had been permitted to sell oseltamivir during the influenza season under specific conditions. As 2007 had been a low influenza season with low sales of oseltamivir, the Committee had indicated that it would like to see data obtained from a second year of sale at the new level of availability before considering possible reclassification to restricted medicine. Concerns about possible increase in the emergence of resistance to oseltamivir and about opening the market for internet sales had been key factors in the Committee’s recommendation that the current arrangement should remain in place.
Current data remained largely unchanged. There appeared to be variable rates of resistance around the world. Resistance tended to be greatest in countries where there was little use of oseltamivir and continued to remain low in countries such as Japan where there was a high rate of use.
WHO had reported some instances of abnormalities in liver and renal function but there had been little reported on neurological side-effects.
The sponsor company who had made the earlier submission for reclassification had confirmed that there were no new data to present to the Committee.
Overall the Committee concluded that there were no new data which would justify any change to the current classification of oseltamivir.
No recommendation was required.
This was a Medsafe submission requesting a change to the classification of aloes when for internal use so that the pharmacy-only entry captured only the components responsible for stimulant laxative activity.
Aloin, the substance responsible for the laxative action, is present in the sap of aloe vera. It is not contained in the mucilaginous gel obtained from the leaves of aloe vera. The proposal was that products for internal use containing aloes should be classified as pharmacy-only medicines only when derived from the sap of the plant and containing aloin. Products containing no aloin and derived solely from the mucilaginous gel obtained from the leaves of aloe vera should be reclassified to general sale medicines.
Aloin should continue to be classified as a pharmacy-only medicine.
The Committee agreed that the intention to retain aloes as pharmacy-only medicines when for internal use was based on the decision to maintain stimulant laxatives at a more restrictive level of classification than bulk laxatives in order to encourage bulk laxatives as a first line treatment and to afford an element of control over abuse or misuse of stimulant laxatives. Accordingly members were happy for parts of the aloe plant which did not contain stimulant laxative substances to be reclassified to general sale when for internal use. They agreed that Medsafe should devise appropriate wording for the schedule to enable this to be put into effect.
That aloes for internal use should be classified as general sale medicines when obtained solely from the mucilaginous gel of the leaf and that products for internal use derived from all other parts of the aloe plant should remain pharmacy-only medicines.
This was a joint submission from Novartis and the New Zealand Association of Optometrists for the reclassification of 0.025% ketotifen fumarate eye drops from restricted medicine to pharmacy-only medicine and for an exemption from pharmacy-only status to allow sale by registered optometrists.
There was unanimous agreement that 0.025% ketotifen eye preparations fulfilled the criteria for sale as pharmacy-only medicines and should be reclassified. In addition, provision should be made to allow sale of these products by registered optometrists. No further discussion ensued.
That ketotifen should be reclassified from restricted medicine to pharmacy-only medicine when for ophthalmic use in medicines containing 0.025% or less except when sold in practice by a registered optometrist.
This was a company submission for the reclassification of 15 milligram modified release capsules from prescription medicine to restricted medicine for the short-term, symptomatic relief of reflux-like symptoms in sufferers aged 18 years and over.
The Committee was largely satisfied with this submission. However, members noted that there were no “alarm signal” warning statements on the proposed pack. They agreed that appropriate warnings should be included on the pack.
Nor were members convinced that there was sufficient data to support the efficacy of a 15 milligram dose. According to the current data sheet the indications for Solox were:
To date Solox had not been approved for short-term symptomatic relief of reflux.
Dose instructions for the above indications were for 30 milligram capsules. Fifteen milligram capsules had been approved only for long-term maintenance for the prevention of relapsed duodenal ulcer and for long-term management of reflux oesophagitis after a minimum 4 weeks’ initial treatment of 30 milligrams per day.*
Before recommending a classification change, members agreed that they would like more clarification around the efficacy of the proposed dose regimen. They agreed not to recommend a change at the current meeting. However, they agreed to review further information forwarded by the company for the following meeting including draft labelling containing all the required warning statements.
That there be no change to the current prescription medicine classification of lansoprazole capsules.
A new medicine application seeking consent to market 15 milligram capsules for the indication requested in the submission would be required before Solox Relief could be marketed as an OTC medicine.
This was a company submission for reclassification of 10 milligram modified release capsules from prescription medicine to restricted medicine for relief of reflux-like symptoms (eg heartburn) in patients aged 18 and over. This submission was considered in conjunction with the submission below for 10 milligram Omezol capsules.
Subject to meeting the requirements in agenda item 6.5 below for sale as a restricted medicine, the committee agreed that 10 milligram omeprazole capsules should be reclassified to restricted medicine.
That tablets or capsules containing 10 milligrams or less of omeprazole should be reclassified from prescription medicine 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.
This was a company submission for reclassification from prescription medicine to restricted medicine for 10 milligram modified release capsules for the short-term, symptomatic relief of reflux-like symptoms in sufferers aged 18 years and over.
This submission was discussed in conjunction with the submission in agenda item 6.4 above.
The Committee agreed that both submissions were largely acceptable for OTC sale. Any outstanding issues relating to such matters as dosage and pack warning statements could be dealt with by requiring products to be sold OTC only when in packs approved for sale at that level. Medsafe should then include the requirements for OTC sale of omeprazole in the appropriate section of the New Zealand Regulatory Guidelines for Medicines .
The following requirements should be included in the Guidelines for the sale of omeprazole as a restricted medicine:
Comments specific to this submission
That tablets or capsules containing 10 milligrams or less of omeprazole should be reclassified from prescription medicine 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
The following new chemical entities had been submitted by the Medicines Assessment Advisory Committee for classification.
Golimumab is a fully human IgG1k anti-TNF alpha monoclonal antibody produced from a murine cell line which binds with high affinity to human TNF alpha and inhibits its bioactivity.
Golimumab is indicated for:
That golimumab should be classified as a prescription medicine.
In vitro electrophysiological studies had shown that lacosamide, in contrast to other analgesics and anticonvulsants, selectively enhanced slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing while exerting no effects on physiological neuronal excitability.
The proposed indications for lacosamide tablets were:
The proposed indication for lacosamide oral solution was as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
The proposed indication for lacosamide injection is as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older when oral administration is temporarily not feasible.
That lacosamide should be classified as a prescription medicine.
Liraglutide is a human glucagon-like peptide (GLP-1) analogue that binds to and activates the GLP-1 inhibitor. The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose dependent insulin secretion from the pancreatic beta cells.
Unlike GLP-1, liraglutide has a pharmacokinetic and pharmacodynamic profile in humans, suitable for once daily administration.
The proposed indication is for use as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus.
That liraglutide should be classified as a prescription medicine.
Prasugrel, a thienopyridine adenosine diphosphate (ADP) receptor antagonist, is an orally administered pro-drug requiring in vivo metabolism to form the active metabolite R-138727 that irreversibly inhibits platelet activation and aggregation mediated by the P2Y12 receptor. Prasugrel has a distinct chemical structure that permits efficient conversion to its active metabolite through rapid hydrolysis by carboxylesterases and then by multiple cytochrome P450 (CYP) enzymes.
The proposed indications are:
That prasugrel should be classified as a prescription medicine.
Anidulafungin is an antifungal indicated for the treatment of invasive candidiasis, including candidaemia.
That anidulafungin should be added to the New Zealand schedule as a prescription medicine.
Desvenlafaxine, the major active metabolite of venlafaxine, is a potent selective serotonin and norepinephrine reuptake inhibitor used to treat major depressive disorders.
That desvenlafaxine should be added to the New Zealand schedule as a prescription medicine.
Romiplostim was described as a unique peptide antibody that directly stimulates bone marrow to produce platelets by mimicking the action of thrombopoietin, the natural regulator of platelet production. It is indicated for the treatment of immune thrombocytopenic purpura, a chronic haematologic disorder in which the immune system destroys platelets and where the bone marrow is often unable to compensate for this loss.
That romiplostim should be added to the New Zealand schedule as a prescription medicine.
Rotigotine was described as a non-ergolinic aminotetralin dopamine-3/dopamine-2/dopamine-1 receptor agonist which is effective in the treatment of Parkinson’s disease. It is indicated as monotherapy or in combination with levodopa for the treatment of idiopathic Parkinson’s disease from early stage to advanced disease.
That rotigotine should be added to the New Zealand schedule as a prescription medicine.
Temsirolimus was described as an antineoplastic agent indicated for the treatment of advanced renal cell carcinoma.
That temsirolimus should be added to the New Zealand schedule as a prescription medicine.
The MCC had withheld making a recommendation on the classification of fluorides in New Zealand until the NDPSC had finalised its review of the scheduling of fluorides. This had now been completed. The finalised classification for fluorides in Australia was as follows:
In preparations for human use except when included in or expressly excluded from Schedule 2 or 3.
For human topical use:
Members agreed that there should be harmonisation with Australia on the classification of fluorides. They agreed that the wording which had been adopted in Australia was more straightforward than that currently used in the New Zealand schedule and would have only a limited impact on products currently on the market. It was noted that labelling guidelines would need to be put in place in the New Zealand Regulatory Guidelines for Medicines in order to be able to enforce the required warning and advisory statements and the requirement for child-resistant closures. Medsafe should be asked to put these requirements into effect and to devise suitable wording for the Schedule. Consultation would be required with the Chief Dental Officer in the Ministry of Health in order to ensure that access to fluoride products was available to the appropriate dental professionals.
That New Zealand should harmonise with Australia on the classification of fluoride products.
The NDPSC had recommended that a prescription medicine entry for nitric oxide should be added to the New Zealand schedule. A new medicine application had been received in Australia for a medicine containing nitric oxide.
Nitric oxide was described as a member of the respiratory stimulant class. The new medicine was indicated for use in conjunction with ventilatory support and other appropriate agents for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation.
It was noted that there was already a product registered in New Zealand containing nitric oxide in combination with other medical gasses. Although nitric oxide was not classified in New Zealand, the product was classified as a prescription medicine due to other classified ingredients. Classifying nitric oxide would have no regulatory impact on any medicine currently registered in New Zealand.
The Committee agreed that, according to the principle of harmonisation which stated that each country should accept into its schedule medicines which were prescription medicines in the other country, nitric oxide should be classified as a prescription medicine.
That nitric oxide should be classified as a prescription medicine.
The NDPSC had recommended that the New Zealand prescription medicine entry for alglucosidase alfa should be amended to alglucosidase.
That the schedule entry for alglucosidase alfa should be amended to alglucosidase.
Glyceryl trinitrate for rectal use should be classified as a restricted medicine.
The current schedule entry for glyceryl trinitrate for external use classified rectal use as a pharmacy-only medicine. There was one current glyceryl trinitrate rectal product registered in New Zealand.
The Australian recommendation had been based around concerns relating to use with sildenafil.
The Committee agreed that, although the risk associated with use of glyceryl trinitrate with sildenafil was low, the consequences were severe. For this reason members agreed that it would be desirable for pharmacists to provide advice about this at the point of sale. As use of this product was low in New Zealand and there were other safer alternative products available at pharmacy-only level, reclassification to restricted medicine was considered to be a prudent safeguard which would not impose a significant barrier to access.
It was agreed that glyceryl trinitrate for rectal use should be reclassified to restricted medicine and that pharmacists should be notified of risks associated with its use with sildenafil. In addition, Medsafe should be asked to include a warning about this in Prescriber Update.
That glyceryl trinitrate for rectal use should be reclassified from pharmacy-only medicine to restricted medicine.
A number of items were suggested as possible candidates for consideration at the following meeting. Whether or not these would be considered would depend largely on whether submissions for reclassification were received from sponsor companies or other interested bodies.
There were no items of general business.
The meeting ended at 4.15pm