Revised: 23 May 2013

Committees

Minutes of the 26th meeting of the Medicines Classification Committee - 11 December 2001

Notes relevant to the 26th meeting of the Medicines Classification Committee held on 11 December 2001

All but one of the recommendations made at the 26th meeting were accepted by the Minister's Delegate on 25 February, 2002.

Proposed framework for herbal medicines and herbal medicines for which exemption from prescription medicine classification had been requested (Item No 8)

The Minister's Delegate did not accept the proposal made in item No 8 to apply a framework developed by the Committee to identify the appropriate classification for herbal medicines. In the first instance the framework was intended to be used in respect of herbal medicines which Australia had recommended should become prescription medicines in New Zealand. None of the classification changes recommended under item No 8 will be put into effect at this time.

Instead, the Minister's Delegate has accepted the following advice submitted by Medsafe:

Medsafe does not recommend that the proposal to adopt the MCC proposed framework for the classification of herbal medicines be adopted at this time for the following reasons:

  • MCC expertise is in the practice of medicine and the practice of pharmacy: members are not skilled in the field of herbal medicines
  • The consultation process was limited in its effectiveness and therefore there is no assurance that all relevant information was considered
  • Accepting the recommendations would result in unavailability of products for which there is no evidence of consumer harm in New Zealand.

Medsafe recommends that consideration of these classifications be deferred until the outcome of the government decision on the joint agency proposal is known later in the year. If the decision is positive, consideration of classification will be dealt with as part of the pre-implementation process. An expert committee of Australian and New Zealand members with knowledge of herbal medicines could be convened for this purpose.

Held on the 20th Floor, Grand Plimmer Tower, Gilmer Terrace, Wellington. Commencing at 10am.

PRESENT

Dr S Jessamine (Chair)
Dr T Bevin
Dr G Wardrope
Mr B McKone
Ms A Shirtcliffe
Mrs C Smith (Secretary)

IN ATTENDANCE

Dr S Alder, Chair, Australian National Drugs and Poisons Schedule Committee (NDPSC)
Dr N Rafter, Medsafe, (for part of the meeting)
Ms S Von Afehlt, Medsafe, (for part of the meeting)

1. WELCOME

The Chairman welcomed members to the meeting and extended a particular welcome to Dr Susan Alder, chair of the NDPSC. He informed the Committee that since the previous meeting, the recommendation to allow the emergency contraceptive pill to be sold by pharmacists and nurses who had gained accreditation in the field of sexual and reproductive health had come into effect and that there had appeared to be little public reaction. He said that the nurses were not yet ready to proceed with accreditation but hoped to have the process operational in the first part of the new year. One of the Pharmaceutical Society members said that the Society was in a similar position and hoped to have an accreditation process in place by the following April.

2. APOLOGIES

An apology was made for Ms Frances Hughes who was currently in the United States of America on a Harkness Fellowship. The Secretary said that she had informed Ms Hughes of matters to be discussed on the current agenda.

3. CONFIRMATION OF THE MINUTES OF THE 25TH MEETING

The minutes of the 25th meeting were confirmed as an accurate record of the meeting and were signed by the chairman.

4. DECLARATION OF CONFLICT OF INTERESTS

None of the members had interests which would be considered prejudicial to recommendations made about any of the matters to be discussed at the meeting.

5. MATTERS ARISING FROM THE 25TH MEETING

5.1 Objections to recommendations made at the 25TH meeting

There were no objections to any of the recommendations made by the Committee at the 25th meeting. However, there had been two objections to the decision of the Minister's Delegate not to accept the Committee's recommendation to increase paracetamol pack size limits for general sale in order to harmonise with those in Australia until further information had been considered (see 5.2 below). The validity of these two objections was questioned as the objection process provided only for objection to the grounds on which Committee recommendations were made. There was no provision for objection to a decision made by the Minister or Ministry official delegated to act on his or her behalf. While the terms of reference for the Committee were to provide advice to the Minister about the classification of medicines, the Minister could choose whether or not to accept such advice. The Chairman said he thought that if there were genuine concern about a decision not to accept a recommendation made by the Committee, the party concerned would need to submit further safety data to satisfy the concerns of the Minister or Delegate. However, in this case, he saw the decision of the Minister's Delegate as postponement until further information which had been available at the time of the previous meeting, had been considered, rather than a refusal to accept the Committee's recommendation.

5.2 Paracetamol pack sizes for general sale

At the previous meeting the Committee had recommended that maximum pack size limits for general sale paracetamol should be increased from 10 grams to 12.5 grams in order to harmonise with unscheduled pack size limits in Australia. However, the Minister's Delegate requested that the matter be re-examined in the light of the recent Ministry report, Restricting Access to Means of Suicide in New Zealand.

Relevant extracts from the report had subsequently been provided. These were discussed in detail by the members.

The Committee acknowledged the figures in the report which indicated that paracetamol was used in between 4% and 10% of suicide attempts However, it reiterated its earlier advice that limiting pack sizes would not decrease the toxicity of paracetamol overdoses as people were able to purchase multiple packs. In addition, paracetamol was often prescribed and dispensed in large volumes. Anecdotal evidence suggested that seriously suicidal patients often hoarded and stored medicines or 'venue' shopped to buy one or more packs from multiple outlets before overdosing. Pack size limits would not affect the outcome of an overdose in this scenario.

The Committee agreed with the report that lack of knowledge about the effects of paracetamol poisoning was often responsible for its choice as a means of suicide. Many people imagined that they would simply fall asleep and did not realise that they would die over a protracted period of painful liver failure. The nature of package warnings was revisited and it was agreed that there was a fine line between warning consumers of the danger of paracetamol poisoning and providing information which would point to paracetamol as an option for a means of suicide. It was recognised that there was a danger of promoting mixed messages about paracetamol. While it was widely promoted as a safer alternative to aspirin, the dangers of misuse were greater than for aspirin and should be emphasised. Members agreed that there should be some kind of warning on packages indicating that overdose would cause delayed liver failure.

Members felt that their earlier recommendation to ask grocery outlets to limit the sale of multiple packs would be the best control. The Committee observed that fewer '2 for the price of 1' specials were now being promoted for supermarket medicines and that an element of responsibility was already becoming evident. The Secretary said that the Non-Prescription Medicines Association had offered to assist in the process of developing a guideline for the sale of medicines by the grocery industry and to act as a conduit for its implementation. The Association also suggested that it might be possible to include such guidelines in its Code of Practice. Medsafe had responded by accepting the offer.

It was noted that the report, Restricting Access to Means of Suicide in New Zealand, did not recommend that there should be a reduction in paracetamol pack size. The report favoured the inclusion of methionine in the formulation as an ideal, though probably unfeasible, solution. It was noted that methionine tasted extremely unpleasant and would probably add considerably to the cost of products. In addition, it was not known what effect its inclusion would have on the stability of products.

The Committee concluded that there was no new safety data to suggest that an increase to maximum general sale pack sizes in order to harmonise with those in Australia would increase the risk of intentional paracetamol poisonings.

Recommendation
  • That New Zealand should increase the maximum pack size for sale of paracetamol as a general sale medicine from 10 grams to 12.5 grams in order to harmonise with the less restrictive Australian classification.
  • That the increase should take place only after the MCC had approved revised labelling requirements which were acceptable to both New Zealand and Australia
  • That labels should include a warning with specific reference to liver failure
  • That Medsafe should persevere with its intention to encourage grocery organisations to consider developing codes for the sale of medicines such as aspirin and paracetamol.

5.3 Belladonna

A recommendation on the Weleda submission had been deferred at the previous meeting pending an imminent recommendation from the NDPSC. Recommendations on belladonna alkaloids had been made by the NDPSC but were subsequently rescinded. A recommendation by the MCC was postponed until a final recommendation had been received from the NDPSC.

5.4 Hyoscine, hyoscyamine, hyoscyamus

As for belladonna, a recommendation on the Weleda submissions had been deferred pending a final recommendation from the NDPSC on all the belladonna alkaloids. It was hoped that the classification of belladonna alkaloids could be resolved satisfactorily at the next meeting.

5.5 Sabadilla

This Weleda submission had also been deferred at the previous meeting as the Committee felt there had been insufficient information available at the time. It was subsequently felt that sabadilla might be fitted into the proposed framework which the Committee had devised for the classification of herbal medicines. Weleda had since made a recommendation based on the proposed framework. Members agreed that the sabadilla submission should be considered in conjunction with the proposed framework. Discussion was deferred until after the discussion of the herbal framework. (see agenda item # 8 below). The Committee agreed that to reach a decision it required further information about the proposed dose forms, packaging and labelling, the setting in which they were to be used, and any information about the advantages to consumers from the proposed change or the possibility for inappropriate use. In the light of the discussion about the herbal framework and the policy decisions reached during that discussion, members felt that the company should be asked to make a further submission containing more detailed information relevant to the requirements of Parts A and B of the guidelines for the preparation of submissions for reclassification.

Recommendation

That there should be no change to the current prescription medicine classification of sabadilla pending a further submission from Weleda.

6. SUBMISSIONS FOR RECLASSIFICATION

6.1 Omeprazole (Losec, AstraZeneca)

This was a company submission for the reclassification of 10 milligram omeprazole tablets in packs of 14 tablets from prescription medicine to pharmacy-only medicine for the symptomatic relief and short-term prevention of the recurrence of heartburn and indigestion.

Safety was not considered to be a barrier to OTC sale for omeprazole when used for limited indications, in low doses and for short-term or intermittent use. The Committee agreed that the medicine had a sufficiently favourable safety profile for it to qualify for OTC sale. In addition, the company had provided good warning statements in the package information. While masking of more serious conditions could occur to some degree, the risk was considered no higher than that associated with the H2 receptor antagonists.

The Committee discussed the suitability of the indications for OTC sale. They felt that it was unclear from the submission and the dose instructions whether the product was to be taken as a 10-day course or as a single dose for immediate relief when required. Although single doses on an 'as required' basis were implied in the package instructions, the Committee agreed that consumers would have more immediate relief from an H2 antagonist. Pharmacists agreed that they would recommend an H2 antagonist before omeprazole because of the more immediate onset of relief. In addition members questioned the need to take a course of medication for a condition which would resolve spontaneously within several hours. They noted that in a previous submission for reclassification of one of the H2 antagonists there had been studies done involving the administration of a meal especially designed to induce indigestion. No such studies appeared to have been done for omeprazole. Members questioned whether a single 10 milligram dose would be effective if used as an "as required" medication. It was generally thought that an H2 antagonist would be likely to be more effective for this purpose.

While symptomatic relief of heartburn and indigestion was considered to be a suitable indication for OTC sale, there was considerable doubt about the suitability of the short-term prevention of the recurrence of this condition. Members felt that the latter indication could be regarded as a chronic condition rather than one which was suitable for self-medication, that is, usually capable of rapid and spontaneous relief. It was agreed that ongoing heartburn and indigestion could be symptoms of some other condition which might require medical diagnosis if only to rule out a more serious underlying condition. It was noted that a medical consultation would be required if an H-pylori test were to be conducted.

While efficacy was not normally a criterion necessary for consideration for reclassification purposes, the Committee observed that the company had not obtained consent to market for the short-term prevention of the recurrence of indigestion. Nor had any data demonstrating efficacy for the proposed doses been presented in the submission. Members noted the discrepancy between the instructions on the outside of the pack and those in the package insert. It was agreed that two clear sets of dose instructions would be needed to cover the two different indications.

Members decided that the submission had failed to convince them that the condition, 'the short-term prevention of the recurrence of heartburn and indigestion', was suitable for self-medication and that the package and dose instructions were suitable for the indications for which reclassification was sought. They agreed that they would be willing to consider a submission for reclassification to restricted medicine at a later date should the company wish to make such a submission. However, the company would need to clarify the issues surrounding indications and dose instructions.

Recommendation

That there be no change to the current prescription medicine classification of omeprazole.

6.2 Fluocortolone (Ultraproct suppositories and ointment, Schering)

This was a company submission for the reclassification of fluocortolone in combination with cinchocaine in packs of 12 suppositories or in tubes of 30 grams from prescription medicine to restricted medicine.

The Committee was not in favour of making fluocortolone suppositories available over the counter. It acknowledged that fluocortolone was a moderately potent corticosteroid, more potent than hydrocortisone, and that the Committee had recently agreed to use 1% hydrocortisone as a benchmark for OTC topical corticosteroids. Use in the anal area would result in greater absorption than for other topical applications and this was seen as a further reason to require adequate justification on safety grounds to exceed the hydrocortisone benchmark. The company had not produced evidence to justify the OTC use of a more potent corticosteroid. While claims were made for a good safety record for the product, members thought that this would be mainly due to appropriate use under medical supervision. They agreed that large quantities would be required over a long period and they also saw potential for inappropriate use.

As there was an adequate range of products available OTC for similar indications, the Committee did not feel that consumers would be disadvantaged if the products were not reclassified.

The submission was seen mainly as a marketing issue which did not constitute valid grounds for reclassification. While loss of government funding might mean that a product would no longer be prescribed, a classification change would not ensure the continuation of that product.

Recommendation

That there be no change to the prescription medicine classification of fluocortolone.

6.3 Paracetamol 665mg modified release tablets (GlaxoSmithKline)

This was a company submission for reclassification from prescription medicine to pharmacy-only medicine. This submission had been withdrawn from the agenda of the 25th meeting and an updated version had been resubmitted for the current meeting. In the interim a submission had been considered by the NDPSC in Australia for exemption from pharmacy-only status to allow the product to be available on general sale.

However, this had been unsuccessful and the product remained pharmacy-only in Australia where there was no 500 milligram upper limit on the amount of paracetamol permitted in OTC tablets or capsules. A copy of the relevant extract from the NDPSC minutes had been provided for members' information. The product was generally regarded as being potentially useful for the overnight management of pain or fever and a product which doctors would like to be able to prescribe.

However, there were serious concerns about issues related to dose frequency and to overdose so that members did not consider the product suitable for sale at pharmacy-only level.

Traditionally, consumers were accustomed to taking paracetamol 4 times per day. The Committee feared that confusion could easily arise between 665 milligram modified release tablets and the standard 500 milligram immediate release tablets, resulting in greater-than-normal doses as consumers failed to note the difference between the two types of products. It was felt that professional intervention was required to ensure that consumers were aware of the difference in the dose regimen and took note of the package information.

With regard to overdose, there was concern that modified release paracetamol would continue to be absorbed for a longer period than immediate release paracetamol. While the company had demonstrated that this had not been a problem in the United States where a modified release product had been available on general sale for a number of years, the Committee was not reassured by the American data.

It noted that while the American product was 50% immediate release and 50% slow release, the product proposed for registration in New Zealand was 31% immediate release and 69% slow release. The Committee also noted that the product would not currently qualify for consent to market as the New Zealand Regulatory Guidelines specified that paracetamol should be contained in doses of 500 milligrams or 250 milligrams. While there were a number of products containing doses other than these, they were likely to be grandfathered products which had predated the paracetamol guidelines. None contained doses greater than 500 milligrams.

A change to the paracetamol guidelines would be required in order for the product to be granted consent to market at any level of classification.

Members agreed that the product should not be available as a pharmacy-only medicine in view of:

  • the difference in dosage from standard paracetamol
  • the potential for public misunderstanding about dose frequency
  • the increased safety risk in cases of overdose

They felt that access should be limited and that counselling by a health professional was necessary for the safe use of the product. They agreed that local experience of use of the product should be gained before any consideration was given to a less restrictive classification.

Recommendation

That paracetamol in modified release tablets containing 665 milligrams should maintain its current classification as a prescription medicine.

7. NEW MEDICINES FOR CLASSIFICATION

7.1 Eflornithine Hydrochloride

At the previous meeting the Committee had asked that further information be sought as to why this should not be classified as an OTC medicine. Members reviewed the additional information supplied by the secretary of the Medicines Assessment Advisory Committee. In view of this information and the fact that this was a completely new indication for a medicine which had been used over the past 15 years in Africa and Europe, the Committee agreed that this should be a prescription medicine until more information was available on its safety for the new indication.

Recommendation

That eflornithine hydrochloride should be classified as a prescription medicine.

7.2 New chemical entities for classification

The Committee considered the new chemical entities which had been submitted by the Medicines Assessment Advisory Committee for classification. It was agreed that most of these should become prescription medicines because of their status as new chemical entities and the nature of the conditions for which they were indicated.

Members thought that levocetirizine was probably suitable for the same level of OTC classification as cetirizine and other similar OTC antihistamines. However, they had queries about QT prolongation and requested further information about cardiac conduction and drowsiness in comparison to cetirizine before recommending a pharmacy-only classification. It was agreed that this matter could be resolved out of session by either telephone or email in order to include the classification of levocetirizine with the classification of the other new chemical entities considered at the meeting.

Secretary's note
After out-of session consultation the Committee agreed that levocetirzine should be classified in the same way as cetirizine.

Recommendation
  • That levocetririzine should be classified as a pharmacy-only medicine for oral use and a prescription medicine for other uses in the same way as cetirizine.
  • That the following medicines be classified as prescription medicines
    • Agalsidase-beta rch
    • Atosiban acetate
    • Bimatoprost
    • Dibotermin alfa
    • Dutasteride
    • Escitalopram oxalate
    • Etoricoxib
    • Factor VIII inhibitor bypassing fraction
    • Fondaparinux sodium
    • Imatinib mesylate
    • Methyl 5-aminolevulinate hydrochloride
    • Olopatadine
    • Parecoxib sodium
    • Pimecrolimus
    • Peginterferon alpha 2a
    • Rasburicase
    • Rosuvastin
    • Tadalafil
    • Teriparatide
    • Travoprost
    • Valdecoxib
    • Vaganciclovir HCl

8. PROPOSED FRAMEWORK FOR HERBAL MEDICINES AND HERBAL MEDICINES FOR WHICH EXEMPTION FROM PRESCRIPTION MEDICINE CLASSIFICATION HAD BEEN REQUESTED

At the previous meeting a framework had been developed and proposed as a tool to help identify the appropriate classification for herbal medicines. The framework was intended to be used principally in situations where there was no adequate safety data on the formulated product to assist members identify safe "cut-off" levels for doses below which the herbal medicine could safely be self-selected by consumers. Herbal medicines that would deliver doses above the cut of levels proposed were regarded as needing to be supplied by a trained health professional. The framework had been published on the website as part of the normal consultation process following a meeting of the MCC. In addition, a number of bodies with particular interest in this field had been consulted individually. However, there had been a relatively low response rate to this consultation.

No suggestions had emerged from the consultation process for a more effective approach to classifying these medicines. The committee noted that some respondents had assumed that the committee intended to review the classification of all herbal medicines in the Schedule. This was not the case; the intention was to use the framework when a proposal to reclassify was considered.

There was also confusion about whether the framework would be used instead of the published criteria for classification recommendations or in conjunction with these. The Committee agreed that it should be made absolutely clear that the framework would only be used when considering the toxicity criterion, allowing all other criteria required in a submission for classification of herbal medicines to be taken into account in the same way as for other medicines. This would ensure that issues such as interactions, side effects and contraindications were taken into account. With regard to chronic toxicity, the Committee noted that dietary supplements and herbal medicines tended to be used over a longer term. Therefore long-term use would need to be a consideration when looking at the classification of herbal medicines.

Members agreed that if there were significant safety concerns then medicines should be prescription medicines. In cases where there was lack of safety data or data on long-term use, then the medicines should be prescription medicines until such data became available

The Committee discussed the role of herbalists and the need for registration if herbalists were to be given access to classified medicines. It was recognised that, without a registration process, there was no way of distinguishing between highly-trained, competent herbalists and those with inadequate or minimal training. The Committee supported the establishment of a registration process for those qualified in the field of herbal and/or complementary medicines in order to enable access to classified products.

Problems associated with Chinese medicine were also discussed and it was noted that these problems were not confined to New Zealand.

The Committee agreed on the following points:

  • Submissions for classification of herbal medicines should be made in the same format as for other types of medicines and should contain data relating to both part A and part B of the requirements for classification submissions as specified in The New Zealand Regulatory Guidelines.
  • In the absence of adequate safety data about a herbal medicine, then from a public health perspective, the medicine should be classified as a prescription medicine until safety data became available to justify an OTC classification.
  • If data indicated that there were significant safety concerns about a herbal medicine, then from a public health perspective, the medicine should be classified as a prescription medicine until safety data became available to justify an OTC classification.
  • In the absence of significant safety concerns or where data indicated that acute toxicity was dose-related, the proposed framework should be applied to the toxicity criterion when submissions were made for classification at levels other than prescription medicine. Pack size and concentration should allow no more than 10% of the lowest fatal dose for OTC sale. Medsafe should modify the proposed framework to pick up some of the suggestions made during the consultation process where these were considered useful.
  • In addition to the toxicity criterion, all other relevant criteria should apply to submissions for classification of herbal medicines as for other medicines.

It was not considered necessary to make a formal recommendation about the above points but these should be incorporated into the Committee's policy statements.

Acorus calamus

The Committee agreed that there did not appear to be any doubt that carcinogenicity had been demonstrated though this was more evident in some varieties than others. While it was possible that there was a safe dose there was no way of guaranteeing this as there was no way to establish a threshold for carcinogenicity. Nor was there any way of knowing whether effects were cumulative. Absorption was possible even from external products. As acorus calamus was banned from all human use in Australia under Appendix C of the SUSDP it was felt that it should be classified as prescription medicine at all strengths in New Zealand in accordance with the agreed principles of harmonisation.

Amygdalin

Amygdalin, the main component of laetrile, was recognised as having a toxicity profile similar to that of hydrocyanic acid. The Committee agreed that the same cut-off points could apply as for hydrocyanic acid.

Juniperus sabina

Juniperus sabina, a highly toxic plant, was not recommended for internal use. External use could lead to severe skin irritation and resorbent poisoning. The essential oil, savin oil, was already noted as being classified as a prescription medicine. The Committee agreed that juniperus sabina should also be classified as a prescription medicine at all strengths to harmonise with the Australian Appendix C scheduling.

Pteridium

Weleda had requested a postponement to the classification of this substance as it had not been able to obtain the required information in time to prepare a submission. No other bodies had expressed interest in the classification of pteridium.

Pyrrolizidine alkaloids

Borago officinalis
Eupatorium cannabium
Petasites
Senecio
Symphytum
Tussilago farfara

Medicines containing pyrrolizidine alkaloids were dealt with as a group. The Committee agreed that, although there was wide variation in alkaloid content from species to species, in varieties within the same species and in seasonal differences with individual plants, there was no doubt about the hepatoxicity of pyrrolidizidine alkaloids.

Members discussed the Weleda proposal to accept the German cut-off points for pyrrolizidine alkaloids for general sale. It was recognised, that while these cut-off points were conservative, there were also requirements for label warnings which could not be enforced in New Zealand. While they agreed that there might be a cut-off point for safe internal use in general sale products, they felt that supervision was necessary because of the potential toxicity. For this reason they were unwilling to grant general sale status and thought that these should remain prescription medicines until such time as a mechanism became available to grant access to classified medicines for herbal practitioners through a registration system. However, rather than harmonise with the Australian listing in Appendix C of the SUSDP by requiring these medicines to be banned at all strengths, the Committee agreed that the general exemption of 10 milligrams per litre or per kilogram should apply in order to permit their use in homoeopathic medicines.

With regard to external use, the Committee agreed that the absorption rate appeared low.

Recommendations
  • That the following should be classified as prescription medicine at all strengths:
    • Acorus calamus
    • Juniperus sabina
  • That the following be classified as prescription medicines for internal use and the general exemption of 10 milligrams per litre or per kilogram should apply:
    • Borago officinalis
    • Eupatorium cannabium
    • Petasites
    • Senecio
    • Symphytum
    • Tussilago farfara
  • That Amygdalin should be classified as follows:
    • Prescription medicine; except when specified elsewhere in the schedule;
    • Pharmacy-only medicine; for oral use in packs containing 5 milligrams or less and more than 0.5 milligrams of cyogenic glycosides expressed as hydrocyanic acid
    • General sale medicine; for oral use in packs containing 0.5 milligrams or less of cyogenic glycosides expressed as hydrocyanic acid

9. FOR THE NEXT MEETING

9.1 Insulins

The Secretary informed the Committee that New Zealand and Australia had not yet harmonised on the classification of these. While there did not yet appear to have been a formal recommendation from the NDPSC, Medsafe was in favour of reclassifying insulins from restricted medicine to prescription medicine in order to harmonise. It was agreed that consultation should take place in order for a recommendation to be made at the next meeting.

9.2 Dicyclomine and propantheline

These two medicines had been omitted from earlier NDPSC recommendations for anticholinergics to become prescription medicines. As there were products registered in New Zealand which contained these medicines, consultation was necessary before a recommendation could be made.

9.3 Phenylpropanolamine

The NDPSC had recommended that New Zealand amend the prescription medicine entry to allow preparations containing 25 milligrams or less per recommended dose to be available as a restricted medicine when indicated for the relief of coughs or colds. The recommendation had been inadvertently overlooked. The Committee felt strongly that, although there were no products registered in New Zealand containing phenylpropanolamine, this should be a prescription medicine. The adverse effects and interaction were similar to those for ephedrine which was a prescription medicine in both countries.

Recommendation

That the NDPSC should be recommended to classify phenylpropanolamine as a prescription medicine (S4) at all strengths.

9.4 Prochlorperazine

One of the members pointed out that the only OTC pack of buccal prochlorperazine had been discontinued. This meant that pharmacists could no longer sell prochlorperazine for the relief of nausea associated with migraine because of the requirement in the schedule for the product to be sold only in the manufacturer's original pack appropriately labelled for that indication. The member thought the Committee should discuss whether this requirement should be removed from the schedule so that pharmacists could still sell prochlorperazine for this indication. He also thought it would be a good opportunity to amend the prochlorperazine entry so that the medicine could be used by appropriately accredited pharmacists and nurses in conjunction with the emergency contraceptive pill. The Committee agreed that this should be added to the agenda of the next meeting.

10. GENERAL BUSINESS

There were no items of general business.

The meeting ended at 4pm

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