Revised: 23 May 2013

Committees

Minutes of the 47th meeting of the Medicines Classification Committee - 1 May 2012

HELD IN THE MEDSAFE BOARDROOM, LEVEL 6, DELOITTE HOUSE, 10 BRANDON STREET, WELLINGTON. COMMENCING AT 9:30am

Present:
Dr Stewart Jessamine (Chair)
Dr Melissa Copland
Dr Timothy Healy
Mr Andrew Orange
Dr Mark Peterson
Dr Enver Yousuf
Ms Andrea Kerridge (Secretary)

Part Attendance (from Medsafe):
Mrs Alison Bailey (Advisor Science, Non-Prescription Medicines)
Dr Carole Firth (Team Leader, Prescription Medicines)
Ms Frances Greer (Advisor Science, Prescription Medicines)
Dr Susan Martindale (Principal Advisor Regulation)
Mrs Marie Prescott (Advisor Science, Non-Prescription Medicines)

Observers (for specific agenda items only)
Aspen Pharma Pty Limited
Neurim Pharmaceuticals Limited
Pharma Projects Limited
Pharmacybrands Limited
University of Otago

1 WELCOME

The Chair opened the 47th meeting at 9:30am and welcomed members and guests.

2 APOLOGIES

There were no apologies.

3 CONFIRMATION OF THE MINUTES OF THE 46TH MEETING HELD ON TUESDAY 15 NOVEMBER 2011

One member requested that two amendments be made to the minutes. Under item 5.9, the classification of medicines used by Podiatrists, the last paragraph and Recommendation statement should read 'except when supplied by a podiatrist' and not 'except when supplied to a podiatrist'. The Chair corrected the hard copy of the minutes as requested.

The minutes of the 46th meeting were then accepted as a true and accurate record. The minutes were signed and dated by the Chair.

4 DECLARATION OF CONFLICTS OF INTEREST

The Conflict of Interest forms were returned to the Secretary. All members declared they had no interests which would pose a conflict with any of the items on the agenda.

5 MATTERS ARISING

5.1 Objections to Recommendations made at the 46th meeting

No objections had been received.

5.2 Codeine

At the 42nd meeting on 3 November 2009, the Committee recommended that the decision to allow cough and cold preparations containing codeine to continue to be available at the pharmacy-only level would be reviewed in 12-18 months' time. This meeting represented the 18 month point.

Codeine is currently classified as:

  • prescription; except when specified elsewhere in the Schedule
  • restricted; in medicines for oral use containing not more than 15 mg of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 mg of codeine, when combined with 1 or more active ingredients in such a way that the substance cannot be recovered by readily applicable means or in a yield that would constitute a risk to health, for use as an analgesic and when sold in a pack of not more than 5 days' supply, approved by the Minister or the Director-General for distribution as a restricted medicine
  • pharmacy-only; in medicines for oral use, containing not more than 15 mg of codeine per solid dosage unit or per dose of liquid with a maximum daily dose not exceeding 100 mg of codeine, when combined with 1 or more active ingredients in such a way that the substance cannot be recovered by readily applicable means or in a yield that would constitute a risk to health, for the treatment of the symptoms of cough and cold and when sold in a pack of not more than 6 days' supply, approved by the Minister or the Director-General for distribution as a pharmacy-only medicine.

The Committee considered the following documentation to determine whether the reclassification had had the required impact, and more importantly whether the abuse of cough and cold medicines containing codeine had emerged as a problem following reclassification:

  1. A review from a New Zealand specialist who had emailed New Zealand Alcohol and Drug Clinic Medical Practitioners. Two questions had been asked. Firstly, whether they were aware of any changes of patterns of cases presenting to Services with dependency on over-the-counter analgesic codeine-containing products. Six reported a decrease, two an increase and three stated there had been no change. Secondly, whether they were aware of changing patterns to accessing codeine-containing cough and cold medicines. One response noted they were seeing more patients using cough mixture. Two responses did not see any changing patterns.
  2. Data supplied by Johnson & Johnson Pacific with permission from IMS - Over-the-counter codeine-containing products in New Zealand: Relationship between analgesics and cough and cold solid dose products (2009, 2010 and 2011). IMS collects data off invoices from wholesaler to pharmacy, plus direct distributers to pharmacy. The data showed that overall there has been a 49% fall in the volume of analgesic tablets containing codeine being distributed from wholesale to retail. Based on the total tablet sales data into pharmacy, there was no evidence that demand for analgesics with codeine had shifted to cough and cold products containing codeine as a consequence of the scheduling change in October 2010.
  3. Medsafe submission on the review of trends in new medicine applications for codeine-containing cough and cold preparations. In summary, there had been no apparent change in the volume of either codeine-containing analgesic or cough and cold products on the New Zealand market since the reclassification.
  4. McAvoy BR, Dobbin MDH, Tobin CL. 2011. Over-the-counter codeine analgesic misuse and harm: characteristics of cases in Australia and New Zealand. The New Zealand Medical Journal 124 (1346): 29-33. The aim of the study was to describe the characteristics of clients addicted to over-the-counter codeine analgesics presenting to an Auckland open-access clinic, and to compare them to clients admitted to a New Zealand detoxification unit, and in the Australian community. The study, which took place over a 12 week period at the beginning of 2010, identified that controls on over-the-counter codeine analgesics in both countries were not sufficient to limit non-medical use of these products. As a result, cases identified in the two countries escalated the number of self-administered tablets taken daily for misuse, resulting in codeine dependence and serious NSAID toxicity secondary to this dependence.

One submission was received after the closing date of the consultation period but was provided to the Committee. The submitter did not see any benefit in rescheduling codeine-containing cough and cold products into the restricted medicine classification, and made the following comments:

  1. Discussions with a number of Dispensary Managers confirmed they have not noticed a change in behaviour towards codeine cough-cold products.
  2. The products involved in codeine abuse were largely analgesic combination products as opposed to cough and cold combination products.
  3. Pharmacists were well-informed of the analgesic codeine rescheduling, and the possibility of a shift in behaviour. They have demonstrated their ability to manage the sales of misused products and showed they have the ability to highlight and manage this risk in the pharmacy setting, allowing the vast majority of New Zealanders who access codeine-combination cough and cold products in a responsible manner to continue to have access to them.

Given the documentation presented, the Committee agreed that the reclassification seemed to have had the required impact. Overall there had been a 49% fall in the volume of analgesic tablets containing codeine sold. The Committee noted that the decrease coincided with the reclassification in October 2010 and the removal of pseudoephedrine products containing codeine from the market. There was also no evidence that abuse of cough and cold medicines containing codeine had emerged as a problem following reclassification. The Committee therefore concluded that a reclassification of cough and cold preparations containing codeine was not required at this time.

Recommendation

That a reclassification of cough and cold preparations containing codeine was not required at this time.

5.3 Methenamine hippurate

Methenamine hippurate is currently available as a general sale medicine marketed under the brand name Hiprex.

The Committee considered the following information, recommended at the 46th meeting, to decide whether a proposal to classify methenamine hippurate should be included on the agenda of the 48th meeting:

  1. A report from Medsafe on the action taken with the complaint regarding the promotion of Hiprex. The investigation was ongoing. Promotion of Hiprex had ceased. The New Zealand sponsor had contacted all pharmacies who had received the September 2011 promotional material and advised them to cease use of the material, and remove all point of sale marketing and promotional material relating to the campaign.
  2. Documentation containing sales data and adverse drug reports from iNova Pharmaceuticals (Australia) Pty Limited. There had been zero adverse drug reports related to Hiprex in New Zealand since 2006 and there were six adverse events reported in Australia over the past year. It was asserted that there was no justification for the upward classification considering the number of doses sold compared to the number and minor nature of the adverse drug reports.

The Committee considered the following question. If the product was being marketed appropriately, was there a requirement to look into the classification of methenamine hippurate at the next meeting?

Methenamine hippurate is considered to have an acceptable safety profile. To date there is no evidence of harm associated with its use. It has been available as a general sale item for a considerable amount of time. The only issue for the Committee was the inappropriate marketing that had occurred regarding the indication for the relief of urinary tract infections, which had apparently ceased.

Members did not agree that the claim from iNova Pharmaceuticals, that the majority of pharmacists tend to keep the product behind the counter with the restricted medicines rather than available for self-selection, could be supported. It was noted there is no legislative requirement for a general sale medicine to be behind the counter.

The Committee concluded there was insufficient evidence of a safety issue to warrant classifying methenamine hippurate at this time. However, Medsafe should continue to monitor the marketing of the product Hiprex.

Recommendation

That Medsafe should continue to monitor the marketing of the product Hiprex.

5.4 Oseltamivir

Oseltamivir is currently classified as a prescription medicine; except when sold in a pharmacy between the months of April to November inclusive by a registered pharmacist who is satisfied that the medicine is for the treatment of a consumer who is resident in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza.

As suggested at the 46th meeting, the Committee considered the reclassification of oseltamivir as a restricted medicine; for the treatment of a consumer who is in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza. The term resident is no longer included because, as discussed at the 46th meeting, the intent was that resident did not refer to a residency visa but rather to a consumer who was physically present in New Zealand.

Two pre-meeting comments had been received during the consultation period. One fully supported the reclassification to restricted medicine. Patients would have access to the medicine more efficiently, conveniently and it would increase its availability in the event of a pandemic.

The other supported the use of pharmacies to dispense treatment for influenza without a prescription all year round. However, the current consideration was not practical given the labelling requirements for a restricted medicine. The product Tamiflu as a prescription medicine is indicated for the treatment and prophylaxis of influenza and the reclassification would only allow for part of the indication to become a restricted medicine. Therefore two distinct packs would need to be created (prescription for the prophylaxis of influenza and restricted for the treatment of influenza). The submission suggested that the Committee consider the proposal to reclassify oseltamivir as a restricted medicine; for the treatment of a consumer who is in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza or is at risk of contracting influenza. A commitment to making a submission for this reclassification at the next meeting was stated with the following supporting comments:

  1. the pharmacy profession had done an excellent job managing oseltamivir during the influenza season
  2. many of the concerns raised about the reclassification of oseltamivir have not been realised, e.g. antiviral resistance, consumer stockpiling and inappropriate supply
  3. evidence suggests the influenza is the most common travel related infection preventable by a universal vaccine.

The Committee discussed the commitment to making a submission at the next meeting and all agreed that this submission should be allowed. Prevention advice was considered more appropriate than treatment advice and a pharmacist would be well placed to give such advice. The Committee were comfortable with the inclusion of prophylaxis in the classification statement, as long as the data in the submission supported this. The submission would need to include an assurance that there was a program in place to ensure the medicine Tamiflu was not seen as a replacement for vaccination.

Recommendation
  • That a submission to reclassify oseltamivir as a restricted medicine; for the treatment of a consumer who is in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza or is at risk of contracting influenza, was anticipated at the next meeting.
  • That this submission for reclassification should include information for consumers and appropriate pharmacist advice.

6 SUBMISSIONS FOR RECLASSIFICATION

6.1 Influenza vaccine
(Pharmacybrands Limited)

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

Purpose

This was a submission from Pharmacybrands Limited (the parent company for Life, Unichem, Amcal, Radius and Care Chemist Pharmacies in New Zealand) for the reclassification of influenza vaccine from prescription medicine to prescription medicine except when administered to an adult by a pharmacist who has successfully completed the New Zealand Qualifications Authority approved vaccinator's course and is complying with the immunisation standards of the Ministry of Health.

All influenza vaccinations currently marketed in New Zealand would be affected by the proposed change. The Committee noted there were five products currently marketed.

Background

All vaccines are currently classified as prescription, except when specified elsewhere in the Schedule.

Comments

Three pre-meeting comments were received during the consultation period. All three supported the reclassification proposal for the following reasons:

  1. improving access to immunisation supports the Government's call for pharmacy to work more closely with general practice to deliver better, sooner, more convenient services to the public
  2. enabling pharmacists to become certified vaccinators will increase the number of individuals vaccinated, and reduce the number of people who contract the influenza virus and the likelihood of spreading the virus to others
  3. certified pharmacists have been successfully vaccinating patients for a number of years in other countries, e.g. United States, Ireland, United Kingdom and Canada and there is evidence to support the safety and effectiveness of pharmacist vaccinators.
  4. it will allow for a greater pool of vaccinators to call upon at short notice during any potential pandemics
  5. the number of potential employee sick days may reduce due to more people being vaccinated and therefore protected from the influenza virus

The interested parties agreed with the submission that any pharmacist who intends to become an influenza vaccinator must complete the required vaccinator's course and comply with the immunisation standards of the Ministry of Health.

Discussion

The submission mirrored recent discussions within the Ministry of Health and supported increased rates of vaccination as a good public health measure. The indications for influenza vaccine are well known and the vaccine has an established safety profile, the main safety issue being the potential for an allergic reaction to occur following immunisation. However dealing with this type of event was covered within the training required to qualify as a vaccinator.

The level of resuscitation training required by pharmacists was queried. The observers confirmed that the requirements were the New Zealand Resuscitation Council's Level 3, which included administration of adrenaline in anaphylaxis.

One member commented that general practitioners see patients within two weeks of a vaccination with flu like symptoms and often it was difficult to explain that the vaccination was not the cause of the symptoms. The training material for pharmacists could include information on explaining this to patients.

One benefit of the reclassification proposal was considered to be an increase in vaccinations thus reducing the viral load in the community. It would also increase the pool of vaccinators in the community, the uptake of the vaccination by consumers and consumer convenience. Data from the United States supported these benefits and demonstrated increased rates of vaccination in both pharmacies and general practitioner offices in States where pharmacist vaccination is permitted.

Concerns were raised over the integration of care because having a vaccination in a pharmacy could move away from the coordination of care by a general practitioner. However, the potential for fragmentation of care was not seen as a big enough risk to prevent recommending reclassification.

A number of suggestions were made by the Committee. It would be useful for pharmacists to keep a log book of the vaccinations they had given to assist with completion of the New Zealand Qualifications Authority approved vaccinator's course and to comply with the immunisation standards of the Ministry of Health, and to more easily enable demonstration of ongoing competence. The consent form needs to ask about warfarin use. Also, the after immunisation form could include more information on redness.

The observers confirmed that the material would be an option for all pharmacies and not just those under Pharmacybrands. The observers also commented it was felt that patients and pharmacists would be agreeable to passing on information about a vaccination to a patient's general practitioner. The proposed inclusion of influenza vaccination in the National Immunisation Register will also help with the consolidation of care.

In conclusion the Committee felt that the submission was well thought out and well presented. Influenza vaccine should be reclassified from prescription medicine to prescription medicine except when administered to an adult by a pharmacist who has successfully completed the New Zealand Qualifications Authority approved vaccinator's course and is complying with the immunisation standards of the Ministry of Health. However, a letter should be sent from the Chair with the suggestions discussed to improve the training material and with a request that an assurance would be required to improve the quality of the material available for pharmacists.

Recommendation
  • That Influenza vaccine should be reclassified from prescription medicine to prescription medicine except when administered to an adult by a pharmacist who has successfully completed the New Zealand Qualifications Authority approved vaccinator's course and is complying with the immunisation standards of the Ministry of Health.
  • That a letter should be sent from the Chair with the suggestions discussed to improve the training material and with a request that an assurance would be required to improve the quality of the material available for pharmacists.

6.2 Melatonin 2 mg prolonged release tablet
(Circadin, Pharmacy Retailing (NZ) Limited trading as Healthcare Logistics)

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

Purpose

This was a company submission for the reclassification of melatonin 2 mg prolonged release tablets from prescription medicine to restricted medicine, in a pack of up to 30 tablets, when used as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 and over.

The submission proposed to send training material, reviewed by the Pharmaceutical Society of New Zealand and the Pharmacy Guild of New Zealand, to all community pharmacies after reclassification.

The Committee noted that Circadin was the only product currently marketed in New Zealand that would be affected by the proposed reclassification.

Background

Melatonin was classified urgently as a prescription medicine at the 16th meeting on 24 April 1996. Before classification a number of supplements had appeared on the New Zealand market bearing therapeutic claims. Melatonin was classified because it is a hormone and at the time there was insufficient data available regarding its effects and safety profile.

Comments

Two pre-meeting comments were received during the consultation period and both supported the reclassification. The interested parties commented that New Zealand's aging population, and that insomnia can become more common with age, makes the need for appropriate treatment especially pertinent. Some studies have shown that Circadin does not induce tolerance over time and that patients do not suffer withdrawal effects. Pharmacists are well placed to educate patients and provide advice on dealing with insomnia. It is extensively used as a dietary supplement in the United States. With appropriate advice and labelling melatonin was suitable for reclassification.

Discussion

Classification of melatonin was highly variable in other overseas jurisdictions. The data provided with the submission showed that melatonin had an acceptable safety profile and had sufficient evidence of efficacy to support its approval by several medicines regulators including Medsafe.

Concerns were raised over the proposed restrictions of use. It would be difficult for a pharmacist to tell if a patient was over 55 years of age. 55 years of age seems to have been chosen on efficacy rather than safety criteria. There was a possibility of off-label use in children and the safety data in children was unclear.

The Committee discussed the issue of diagnosing primary insomnia at length, particularly in the elderly. It is difficult to diagnose whether the presenting symptoms are tiredness or insomnia. In general practice a consultation regarding insomnia in the elderly is often one of the longer consults. Insomnia may be the result of another condition, e.g. depression. It is important to know what is expected and what is normal in sleep patterns in the elderly. The Committee was not concerned with the competence of pharmacists, but rather the time it would take to diagnose primary insomnia correctly as a lot of counselling and discussion would be required. The issue of providing advice on sleep hygiene was seen as critical to a consultation and this would also take time in a pharmacy. However, it was also discussed that the reclassification would allow consumers to seek advice and consultation from a healthcare professional rather than buying a product off-the-shelf which has limited, or no, evidence of efficacy. Many patients seek treatment for insomnia from over-the-counter products such as anti-histamines and herbal products without discussion with a healthcare professional.

The Committee agreed that the short term side effect profile of melatonin may be considered safer than the sedating anti-histamines which are often used to treat insomnia.

Circadin is licensed for use for up to 13 weeks. The observers confirmed that 13 weeks was chosen because this was the amount of time approved in Europe based on the clinical trial data, i.e. short term use as defined in international guidelines was considered to be three months which is the equivalent of 13 weeks. Concerns were raised around what would happen to a patient, if the medicine was reclassified to restricted, after the 13 weeks and how a pharmacist would manage this. The observers advised that referral to a doctor would be appropriate at this point.

The Committee considered the risk:benefit profile of melatonin and whether it was appropriate for classification as a restricted medicine. The main risk would be a patient being diagnosed with insomnia incorrectly. However, the risk would only be present for the 13 weeks maximum. If the symptoms did not go away after 13 weeks then consultation with a doctor and more appropriate treatment would be the next step.

The Committee uses the following definition adopted in 1990 by the Commission of the European Communities for suitability for non-prescription sale: 'Medical products which may be available without prescription shall show a substantial safety in use in the treatment of minor ailments or symptoms, usually capable of rapid and spontaneous relief, which are easily identifiable by users and do not justify a medical consultation'. The Committee felt that the use of melatonin in the elderly did not quite meet these criteria. Circadin was a relatively new product and it is the first time that side effect reports had been systematically collected for a melatonin product. The Periodic Safety Update Reports presented in the submission showed that significant adverse events can occur and, although no new safety signals have been reported to date, the company has had to investigate some events. The Committee agreed they would like to know more about the safety profile of melatonin now that safety data was being collected systematically.

To qualify for a shift from prescription to non-prescription status, a prescription medicine should have been marketed for three years or more in a market with a sophisticated adverse reactions reporting scheme, have had wide use during those three years, have a low adverse reaction profile with serious reactions occurring only rarely and be suitable for non-prescription sale. It was noted that Circadin has been marketed for over four years so it does meet this criterion. It has been widely used overseas but had only recently been granted consent in New Zealand.

To mitigate some of the risks, the Committee suggested that the labelling, algorithm and training material for pharmacists could include:

  1. guidance for pharmacists on how to advise patients in a timely fashion
  2. the differences between tiredness and insomnia
  3. conditions that may be presenting as insomnia (a screening tool may be useful to exclude any other conditions that maybe preventing sleep)
  4. expectations of sleep which needs a careful assessment and patient education
  5. seasonality in sleep disorders with more sleep issues occurring in winter
  6. sleep hygiene (e.g. what factors can hinder sleep)
  7. contraindications
  8. use with off-label indications
  9. safety data from patients who are aged 55 and over
  10. an emphasis that treatment was for up to 13 weeks only
  11. if symptoms persist for longer than 13 weeks advice that a doctor should be consulted
  12. a plan to prevent patients from getting another 13 week treatment
  13. keeping the clear indication on the pack.

The Committee noted that in providing this information the Consumer Medicine Information would need to also be reworked.

The observers indicated that they would be willing to include this information and suggested a number of ideas to the Committee. They confirmed they would be willing to consult with a sleep specialist to finalise further advice on insomnia and sleep hygiene. A pack insert could be created separately from the Consumer Medicine Information. A sheet with frequently asked questions could also be provided to pharmacists.

Overall the Committee felt that the labelling, algorithm and training material for pharmacists needed more work and that there was not enough data at present supporting the proposed indication to overcome the main concerns about the product i.e. misdiagnosis and the possible adverse effects of delaying consultation with a doctor for a maximum of 13 weeks.

The Committee felt the submission had merit and indicated it would be prepared to consider a revised submission to reclassify melatonin 2 mg prolonged release tablets from prescription medicine to restricted medicine, in a pack of up to 30 tablets, when used as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 and over, at a future meeting.

Recommendation

That a revised submission to reclassify melatonin 2 mg prolonged release tablets from prescription medicine to restricted medicine, in a pack of up to 30 tablets, when used as monotherapy for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 and over, would be considered at a future meeting.

6.3 Trimethoprim 300 mg tablet
(TMP, Pharmacybrands Limited)

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

Purpose

This was a submission from Pharmacybrands Limited (the parent company for Life, Unichem, Amcal, Radius and Care Chemist Pharmacies in New Zealand) for the reclassification of trimethoprim from prescription medicine to prescription medicine except when supplied in packs of three tablets to women aged 16 to 70 years for uncomplicated urinary tract infection by a pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections. The submission also suggested an alternative reclassification to restricted medicine when supplied in packs of three tablets to women aged 16 to 70 years for uncomplicated urinary tract infection by a pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections.

A proposal for a training programme on pharmacists providing trimethoprim for urinary tract infections from the New Zealand College of Pharmacists (April 2012) was tabled at the meeting. The College proposed to deliver a nation-wide audio conference on the treatment of urinary tract infection to be supplemented by appropriate readings based on recognised treatment guidelines, published medical articles and other relevant material. The audio conference would be recorded and made available to those unable to attend and / or as a reference for future use. The timing of the development of the course content and release would correspond with the gazettal of the reclassification.

The Committee noted there were two products currently marketed in New Zealand that would be affected by the proposed reclassification.

Background

Trimethoprim was classified as a prescription medicine at the 7th meeting on 31 July and 1 August 1990. At the 9th meeting on 28 May 1992 there was divided opinion over whether or not trimethoprim was appropriate for over-the-counter sale for short term use and comments from interested parties were sought. Comments were received at the 10th meeting on 11 November 1992 and the Committee concluded that, on the basis of the outside information received, there should be no change to the classification of trimethoprim. At the 32nd meeting on 25 November 2004, following the proposal by a Committee member, it was agreed that trimethoprim would not be a suitable candidate for reclassification to an over-the-counter medicine.

Comments

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

Four supported the reclassification proposal. Two of these supported the reclassification to prescription medicine, except when supplied in packs of three tablets to women aged 16 to 70 years for uncomplicated urinary tract infection by a pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections. One supported the reclassification to restricted medicine and the other supported both proposals. The following comments were also made:

  1. training for pharmacists is important to ensure they have the knowledge and skills to counsel patients appropriately
  2. other mechanisms could be put in place should concerns be raised about a pharmacist's competence
  3. the maximum age for treatment should be lowered to 65 years
  4. if the restricted classification was recommended there would need to be a suitably labelled pack with a copy of the Consumer Medicine Information in the carton
  5. reclassification would provide a more convenient method of obtaining treatment and increase patient access
  6. the provision of further education to pharmacists and the algorithm was supported
  7. reclassification could improve patient satisfaction and decrease costs without compromising care
  8. pharmacists should be required to undertake the training described.

Another submission, from a consultant clinical microbiologist, in support of the reclassification proposal was received after the closing date but was provided to the Committee.

Six did not support the proposal and made the following comments:

  1. the idea that there are mainly cases of "uncomplicated urinary tract infection" is grossly inaccurate
  2. no urinary tract infection is simple
  3. urinary tract infections provide a frequent opportunity for sexual health and smear history review, plus opportunity for many other diagnoses
  4. pharmacists are not trained in obstetrics and gynaecology, or to exclude pyelonephritis reliably
  5. increase of resistance to trimethoprim has increased significantly in recent years
  6. urinary tract infection are not easy to self-diagnose or be diagnosed by a pharmacist
  7. contraindications are either not known or not remembered
  8. the reclassification was not taken up in Britain
  9. opposed to further fragmentation of care for patients and have concerns that this proposal risks this
  10. removes the ability for the patient to have important and necessary conversations with their general practitioner
  11. urinary tract infections are not always a simple condition to treat
  12. general practitioners have not been involved in this reclassification process
  13. have considerable concern about who should be making the diagnosis
  14. many urinary tract infections are not uncomplicated and the correct diagnosis is critical
  15. resistance to trimethoprim is rapidly increasing in New Zealand
  16. there are better options available such as nitrofurantoin.
Discussion

Overall the Committee felt that the submission was well prepared. Both efficacy and consumer convenience was demonstrated by the data provided. It was acknowledged that pharmacists already treat and give advice regarding urinary tract infections.

The BPAC Guidelines presented with the submission, "Laboratory investigation of urinary tract infections and Antibiotics - Choices for common infections", provided evidence-based support for the reclassification. The Guidelines recommend that if there is no improvement by day two then further medical advice should be sought. It was noted that adoption of this reclassification and these Guidelines were consistent with best practice.

In terms of patient safety the Committee considered that making the correct diagnosis was imperative. It was queried as to whether, on the basis of questioning alone, a pharmacist could rule out sexually transmitted diseases. However, the Committee considered that this risk could be mitigated by the training provided to pharmacists.

It was considered that if a patient had previous urinary tract infections diagnosed by a doctor then a second diagnosis by a pharmacist or patient would be easier. The Committee noted this point but discussed whether the classification statement must include that the urinary tract infection was previously diagnosed by a doctor. It was noted that the Scottish Intercollegiate Guidelines Network's national guidance on the management of suspected bacterial urinary tract infections in adults did not differentiate between the first and subsequent presentations of urinary tract infections. It was also noted that several guidelines did not require the use of bench top tests or urinary culture before empiric use of trimethoprim in women presenting with symptoms of a urinary tract infection. Allowing pharmacy access to trimethoprim for use to treat the first episode of urinary tract infection would also be appropriate in terms of convenience.

The Committee considered that when a patient presents with their first urinary tract infection the training material for pharmacists should include advice to ask about renal pain and vaginal discharge. In addition, the Committee considered that the pharmacist should insist on general practitioner follow up if the patient presents with their first urinary tract infection.

The Committee considered that with the correct training there was no reason why pharmacists could not manage patients who present for the first time with a urinary tract infection.

Concerns were raised in submissions over inappropriate use of the medicine. The Committee considered that the potential impact of a delayed diagnosis, should a patient take trimethoprim for three days if they did not have a urinary tract infection, was minimal and far outweighed by the benefits of early treatment.

Resistance could be an issue if the medicine was used more widely. Although this risk was considered to be very low as most women who develop a urinary tract infection already present to their general practitioner for treatment. It was considered that pharmacist sale of trimethoprim may be more in line with best practice than the prescribing habits of general practitioners.

Concerns were also raised about the fragmentation of care a reclassification could result in. Consumers may also want to purchase the medicine ahead of any actual need. This risk already exists with other treatments of urinary tract infections from a pharmacy. It was suggested that a consumer could be given a card with the treatment received on it with instructions to pass that card onto their general practitioner if the symptoms do not resolve. It was also suggested that a warning statement could be added to the pack or dispensed label to advise "if symptoms do not resolve take this pack to your general practitioner". The Committee concluded that a patient should tell their general practitioner if they had taken trimethoprim to ensure continuity of care.

The upper age limit of 70 years of age proposed in the application was questioned by the Committee. Following discussion the Committee agreed that 65 years, the upper age limit set out in some other countries as described in the submission, was a more appropriate upper age limit. The 16 year old age group was also discussed. The Committee noted that while the treatment of a urinary tract infection in a young woman was not necessarily different the examination, investigation and advice required to manage a urinary tract infection in this age group would be. It was considered that the training material for pharmacists should include age related advice, the implications of increased sexual activity and other factors that lead to sexually transmitted diseases. One member suggested this would be a good opportunity for a pharmacy developed leaflet with advice on urinary tract infections.

The Committee accepted the evidence provided that a mid-stream specimen of urine or a dipstick test were not required and did not add to the management of uncomplicated urinary tract infection.

The observers were asked whether diabetics had been taken into account. Diabetics do not necessarily have complicated urinary tract infections but they may be more prone to infection. It was considered that it would be useful to have information for type I and II diabetics in the training material for pharmacists, i.e. these patients should be referred to their general practitioner. In addition to these changes the Committee considered that the training material for pharmacists should also include the importance of fluid intake and information for patients taking steroids.

On questioning, the observers confirmed that the preferred classification for trimethoprim was from prescription medicine to prescription medicine except when supplied in packs of three tablets to women aged 16 to 70 years for uncomplicated urinary tract infection by a pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections.

The Committee concluded that the data presented supported a reclassification and that the risks discussed could be mitigated in the training material for pharmacists. Following discussion the Committee recommended, with a majority vote, that trimethoprim should be reclassified to prescription medicine except when supplied in packs of three tablets to women aged 16 to 65 years for uncomplicated urinary tract infection by a pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections. It was also agreed that Medsafe should review and be satisfied with the training material for pharmacists.

Recommendation
  • That trimethoprim should be reclassified from prescription medicine to prescription medicine except when supplied in packs of three tablets to women aged 16 to 65 years for uncomplicated urinary tract infection by a pharmacist who has successfully completed the New Zealand College of Pharmacists' training in the treatment of urinary tract infections.
  • That Medsafe should review and be satisfied with the training material for pharmacists.

6.4 Vitamin D (colecalciferol)
(Medsafe)

Purpose

This was a Medsafe submission considering the reclassification of vitamin D, in tablets containing 1.25 mg of colecalciferol, from prescription medicine to restricted medicine for the prevention and treatment of vitamin D deficiency states in adults. The term "vitamin D" encompasses ergocalciferol (vitamin D2) and colecalciferol (vitamin D3). Both ergocalciferol and colecalciferol were considered part of this submission. The Committee were asked to consider:

Whether a pharmacist would have the necessary tools / support for diagnosing vitamin D deficiency in adults and for ongoing monitoring of the patient.

Whether pharmacists would require training if down-scheduling was to occur.

Whether the down-scheduling to restricted medicine should include doses taken monthly (up to 1.25 mg) or be restricted to those taken daily (e.g. up to 45 µg).

Whether the down-scheduling should be linked to a limit on pack size (e.g. to a supply of three months).

What warnings and precautions would need to be displayed on the labels (with any other warnings to appear in the package insert).

The Committee were also given the Consensus Statement on Vitamin D and Sun Exposure in New Zealand, published online on 14 March 2012 ( http://www.health.govt.nz/publication/consensus-statement-vitamin-d-and-sun-exposure-new-zealand).

The Committee noted there was one product currently marketed in New Zealand that would be affected by the proposed reclassification.

Background

At the 7th meeting on 31 July and 1 August 1990 ergocalciferol was classified as a prescription medicine (except in medicines containing 25 µg or less of ergocalciferol per daily dose) and vitamin D, its metabolites and derivatives, as prescription medicines (if the recommended daily dose exceeded 25 µg of vitamin D).

At the 37th meeting on 17 May 2007 it was recommended that the prescription medicine schedule entry for vitamin D should be amended to read 'for internal use in medicines containing more than 25 µg per recommended daily dose except in parenteral nutrition replacement preparations'.

At the 44th meeting on 2 November 2010, following the suggestion by a Committee member, it was recommended that Medsafe should make a submission proposing the reclassification of vitamin D, in tablets containing 1.25 mg or colecalciferol, from prescription medicine to restricted medicine for the prevention and treatment of vitamin D deficiency states in adults.

Vitamin D, ergocalciferol (vitamin D2) and colecalciferol (vitamin D3) are currently classified as:

prescription; for internal use in medicines containing more than 25 µg per recommended daily dose except in parenteral nutrition replacement preparations

general sale; for external use; for internal use in medicines containing 25 µg or less per recommended daily dose; in parenteral nutrition replacement preparations.

Comments

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

Four supported the reclassification proposal and made the following comments:

  1. it is primarily the role of informed clinicians and pharmacists to establish the appropriate balance regarding access and protection against possible harms
  2. the reclassification could improve access for specific patient groups at risk of vitamin D deficiency.
  3. it may result in long term benefits not only to individuals but also to the New Zealand health system - implementation could result in more vitamin D treatment leading to reduced hospitalisations due to falls and fractures
  4. appropriate advice and a limited number of tablets will minimise occurrence of inaccurate usage
  5. benefits of vitamin D supplementation in the prevention and treatment of falls has been well documented
  6. would be willing to develop guidance and training for pharmacists.

Two suggested that, should reclassification occur, specific conditions would be required to ensure safe use of the product:

  1. the tracking of purchasers of vitamin D could prevent purchasers going from pharmacy to pharmacy to obtain vitamin D
  2. purchasing tablets should be restricted to one tablet per month
  3. a tracking procedure should be put in place to prevent individuals going from pharmacy to pharmacy so they can sustain much higher dose rates.

Several submissions questioned the evidence presented in the application and pointed out that:

  1. the benefits of vitamin D supplementation may be overstated in the data analysis presented
  2. harm from vitamin D supplementation may be understated
  3. the existing body of research is unclear about the efficacy and safety of vitamin D
  4. vitamin D deficiency in New Zealand may be less common than previously thought.
Discussion

The Committee agreed that there was not enough evidence to support a reclassification to restricted medicine at this time and that the submission raised more questions than it answered. The literature presented was insufficient to demonstrate clear benefits from supplementation in the New Zealand population of interest, namely the frail elderly. The data was confounded by a number of factors including coadministration of calcium with vitamin D in some studies and contradictory in terms of risk and benefit.

It was agreed that 1.25 mg of colecalciferol per month was relatively safe and that, taken appropriately, the risk of harm was minimal. The risk that a patient could take more than one tablet per month, as monthly treatment is unusual, was noted. However, the Committee were more concerned that there was not enough evidence regarding the risk of long term use to support considering a change in classification.

Given the data presented and all the comments received during the consultation period, the Committee concluded that vitamin D, in tablets containing 1.25 mg of colecalciferol, should not be reclassified from prescription medicine to restricted medicine for the prevention and treatment of vitamin D deficiency states in adults.

Recommendation

That vitamin D, in tablets containing 1.25 mg of colecalciferol, should not be reclassified from prescription medicine to restricted medicine for the prevention and treatment of vitamin D deficiency states in adults.

7 NEW MEDICINES FOR CLASSIFICATION

No new chemical entities were submitted to the Committee for classification. Harmonisation and a decrease in the number of new medicine applications could explain this.

8 HARMONISATION OF NEW ZEALAND AND AUSTRALIAN SCHEDULES

8.1 New chemical entities which are not yet classified in New Zealand

8.1.1 Aflibercept

Aflibercept is a fusion protein indicated for wet macular degeneration. It is presented as a sterile injectable.

In Australia in February 2012, the Delegate decided to include aflibercept in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.1.2 Belatacept

Belatacept is a selective immunosuppressant indicated for prophylaxis of organ rejection and preservation of a functioning allograft in adult patients receiving renal transplants. It has been used in combination with an interleukin-2 (IL-2) receptor antagonist, a mycophenolic acid (MPA) and corticosteroids.

In Australia in February 2012, the Delegate decided to include belatacept in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.1.3 Cabazitaxel

Cabazitaxel is a tubulin-binding taxane semi-synthetic drug with antitumour activity in docetaxel-resistant cancers. It shares the same basic structure as paclitaxel and docetaxel. It affects the mitotic spindle and microtubules of cells by binding to free tubulin of cells. Cabazitaxel has been investigated for use in combination with prednisone or prednisolone, in the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel containing regimen.

In Australia in September 2011, the Delegate decided to list cabazitaxel in Schedule 4 (prescription medicine) with an implementation date of 1 January 2012.

Recommendation

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

8.1.4 Catumaxomab

Catumaxomab is a rat-mouse hybrid monoclonal antibody that is specifically directed against the epithelial cell adhesion molecule EpCAM, which is overexpressed in most carcinomas, the CD3 antigen; and a third binding site that enables interaction with accessory immune cells. It differs from previous monoclonal antibodies by its trifunctional properties against tumour cells. Catumaxomab has been investigated for use in the treatment of malignant ascites in patients with EpCAM-positive carcinomas.

In Australia in September 2011, the Delegate decided to list catumaxomab in Schedule 4 (prescription medicine) with an implementation date of 1 January 2012.

Recommendation

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

8.1.5 Ceftaroline fosamil

Ceftaroline fosamil is a cephalosporin antibacterial, active against Gram-positive and Gram-negative bacteria. It binds to essential penicillin-binding proteins (PBPs). Affinity for PBP2a provides bactericidal action against Staphylococcus aureus and affinity for PBP2x provides bactericidal action against Streptococcus pneumonia. Ceftaroline fosamil is indicated for the empirical and directed treatment of patients with complicated skin and soft tissue infections and community-acquired bacterial pneumonia.

In Australia in February 2012, the Delegate decided to include ceftaroline fosamil in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.1.6 Eribulin mesylate

Eribulin mesylate is a synthetic macrocyclic ketone analogue of halichondrin B indicated as an anti-cancer drug.

In Australia in February 2012, the Delegate decided to include eribulin mesylate in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.1.7 Follistatin

Follistatin is an autocrine glycoprotein occurring naturally in humans and animals. It is an activin-binding protein which may inhibit the anterior pituitary's secretion of follicle stimulating hormone (FSH). Specifically, follistatin is a natural antagonist of myostatin (a potent negative regulator of skeletal muscle mass). Follistatin has also been referred to as FSH-suppressing protein. Follistatin was being investigated for its role in the regulation of muscle growth in mice, as an antagonist to myostatin, specifically in the treatment of spinal muscular atrophy.

The Delegate sought advice on the inclusion of follistatin in Schedule 4 (prescription medicine) or 8 (controlled drug).

In Australia in February 2012, the Delegate decided to include follistatin in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

The Committee considered referring follistatin for classification under the Misuse of Drugs Act 1975. However, it was concluded that the risk around the use of follistatin could be adequately dealt with as a prescription medicine.

Recommendation

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

8.1.8 Ingenol mebutate

Ingenol mebutate is a protein kinase C activator isolated from the plant Euphorbia peplus. The sap of the plant Euphorbia peplus (commonly known in Australia as Radium weed or milkweed) is a traditional remedy for skin conditions, including actinic keratosis. Ingenol mebutate is indicated for the topical treatment of solar (actinic) keratosis in adults.

In Australia in February 2012, the Delegate decided to include ingenol mebutate in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.1.9 Lixisenatide

Lixisenatide is an antidiabetic drug. It is an analogue of the incretin hormone, glucagon-like peptide 1 (GLP-1) and by acting as an agonist at the GLP-1 receptor, it has actions similar to those of exenatide (currently included in Schedule 4 (prescription medicine)). It is indicated:

for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control - in combination with metformin, a sulphonylurea or a basal insulin

in patients with insufficient glycaemic control - in combination with metformin and a basal insulin, metformin and a sulphonylurea or a sulphonylurea and a basal insulin

in patients with insufficient glycaemic control despite dual therapy.

In Australia in February 2012, the Delegate decided to include lixisenatide in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.1.10 Pitavastatin

Pitavastatin is a HMG-CoA reductase inhibitor or 'statin' which is indicated as an adjunct to diet for the treatment of adult patients with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, when response to diet and other non-pharmacological measures are inadequate.

In Australia in February 2012, the Delegate decided to include pitavastatin in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.1.11 Rifaximin

Rifaximin is an antibiotic substance and a derivate of rifamycin. It is indicated for the prevention of recurrence of hepatic encephalopathy in adults.

In Australia in February 2012, the Delegate decided to include rifaximin in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.1.12 Taliglucerase alfa

Taliglucerase alfa is a recombinant active form of the human lysosomal enzyme beta-glucocerebrosidase, expressed in genetically modified carrot plant root cells and has been developed as a long-term enzyme replacement therapy for patients with a confirmed diagnosis of Gaucher disease.

In Australia in February 2012, the Delegate decided to include taliglucerase alfa in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.1.13 Velaglucerase alfa

Velaglucerase alfa is a highly purified recombinant active form of the human lysosomal enzyme beta-glucocerebrosidase, developed as a long-term enzyme replacement therapy for patients with a confirmed diagnosis of Type 1 Gaucher disease.

In Australia in February 2012, the Delegate decided to include velaglucerase alfa in Schedule 4 (prescription medicine) with an implementation date of 1 May 2012.

Recommendation

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

8.2 Decisions by the Secretary to the Department of Health and Aging in Australia, or the Secretary's Delegate 8.2.1 Decisions by the Delegate - September 2011

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

  1. ipilimumab - new entry in Schedule 4 (already classified as a prescription medicine in New Zealand)
  2. loperamide - to exempt loperamide from scheduling in divided preparations for oral use containing not more than 2 mg of loperamide in packs of 8 dosage units or less (which harmonised with New Zealand)
  3. nicotine - to extend the exemption from scheduling for nicotine in preparations for human therapeutic use to include all oromucosal use (which harmonised with New Zealand).

8.2.2 Decision by the Delegate - February 2012

a. Azelastine

Azelastine, when in topical eye preparations containing 0.05% or less, should be rescheduled from Schedule 3 (restricted medicine) to Schedule 2 (pharmacy-only medicine). The Committee considered harmonising with the above classification.

The Committee noted there were no products currently marketed in New Zealand that would be affected by harmonising with the proposed reclassification.

In New Zealand, azelastine was classified as a prescription medicine at the 16th meeting on 24 April 1996. At the 22nd meeting on 10 November 1999 it was recommended that azelastine should be classified as a prescription medicine for ophthalmic use until significant post-marketing data was available to demonstrate its safety. It was also confirmed that azelastine was scheduled as a pharmacy-only medicine for nasal use. At the 36th meeting on 8 February 2007 it was recommended that azelastine should be reclassified as a restricted medicine when in ophthalmic medicines containing 0.05% or less. Azelastine is currently classified as:

  • prescription; except when specified elsewhere in the Schedule
  • restricted; in medicines for ophthalmic use containing 0.05% or less
  • pharmacy-only; for nasal use.

Azelastine was considered to be safe. There was evidence of efficacy and no evidence of misuse. The Committee were comfortable with the discussions and decision made by the Delegate.

Recommendation

That New Zealand should harmonise with Australia and reclassify azelastine, when in topical eye preparations containing 0.05% or less, from restricted to pharmacy-only medicine.

b. Diclofenac

Dermal preparations containing more than 1% and up to 4% or less of diclofenac, except when for the treatment of solar keratosis, should be rescheduled to Schedule 2 (pharmacy-only medicine). The Delegate also confirmed that Schedule 4 (prescription medicine) remains appropriate for preparations containing more than 4% of diclofenac and for use in the treatment of solar keratosis, and preparations containing 1% or less remain unscheduled.

The Committee considered harmonising with the above classification.

The Committee initially considered a reclassification of topical preparations at the 3rd meeting on 17 September 1985. On receiving further information on the reclassification proposal, at the 4th meeting on 11 March 1986, the Committee recommended diclofenac in preparations for dermatological use be reclassified as pharmacy-only medicines. At the 18th meeting on 15 October 1997, the Committee recommended that diclofenac for topical use should become a general sale medicine. At the 46th meeting on 15 November 2011, it was recommended that diclofenac for the treatment of solar keratosis should be reclassified as a prescription medicine.

Diclofenac is currently classified in New Zealand as:

  • prescription; in preparations for the treatment of solar keratosis; except when specified elsewhere in the Schedule; except in preparations for external use other than for the treatment of solar keratosis
  • restricted; in solid dose form in medicines containing 25 mg or less and more than 12.5 mg per dose form in packs containing not more than 30 tablets or capsules
  • pharmacy-only; in solid dose form in medicines containing 12.5 mg or less per dose form in packs containing not more than 30 tablets or capsules and with a recommended daily dose of not more than 75 mg
  • general sale; in preparations for external use other than for the treatment of solar keratosis.

The Committee discussed whether there was sufficient data to support a claim that products containing diclofenac at concentrations up to 4% posed a sufficient risk to public health to warrant reclassification. The Committee noted that absorption of diclofenac did not vary significantly across concentrations from 2-4% and the side effect profile is essentially the same.

The Committee agreed they were satisfied with the approach taken at the last meeting, i.e. classifying diclofenac by indication. Diclofenac in New Zealand does not have a percentage concentration cut off point for external use. Therefore no Recommendation was required.

Recommendation

No Recommendation was required.

9 FOR THE NEXT MEETING

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

  1. a submission to reclassify oseltamivir as a restricted medicine; for the treatment of a consumer who is in New Zealand, is 12 years of age or more, and currently has the symptoms of influenza or is at risk of contracting influenza if one is received
  2. a review of the factors considered by the Committee when considering a medicine for reclassification for non-prescription sale.

10 GENERAL BUSINESS

10.1 Presentations

The following presentations were given to the Committee:

The article presented at the last meeting, "Improving the decision-making process for non-prescription drugs: A framework for benefit-risk assessment (Brass, Lofstedt and Renn, from Clinical Pharmacology & Therapeutics (advanced online publication 2 November 2011)), was again presented to the Committee. The article discusses the benefit and risk domains associated with non-prescription drugs and proposes a value-tree tool for identifying relevant benefit-risk attributes for such drugs. The Committee agreed they would be willing to receive submissions that use the value-tree tool.

11 DATE OF NEXT MEETING

To take place on a Tuesday in October 2012. The Secretary would email members for their availability.

There being no further business, the Chair thanked members and guests for their attendance and closed the meeting at 4:15pm.

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