Revised: 12 March 2014

Committees

Commissioned Advice to the Deputy Director-General, Public Health

Ibuprofen Scheduling

Dr GR Boyd
Public Health Medicine Specialist

29 February 2004.

Summary

In this paper I agree with the recommendation by Medsafe that you accept the application for re-scheduling ibuprofen to general-sales classification when in certain pack sizes with certain labelling, contrary to the advice of the Medicines Classification Committee.

Background

On 26 January 2004 you received the minutes of the 30^th meeting of the Medicines Classification Committee accompanied by a Health Report from the Manager, Medsafe which recommended that you accept all but one of the recommendations made by the committee. That recommendation concerned the non-steroidal anti-inflammatory medicine ibuprofen. The Medsafe report argued against the committee's recommendation that oral forms of ibuprofen should remain classified as Pharmacy-only Medicines, in effect turning down an application from Boots Healthcare for a classification of ibuprofen as a general sales medicine when in packs containing no more than 25 tablets.

The meeting of the Medicines Classification Committee (MCC) took place on 26 November 2003 and since that date there have been several developments on this issue, particularly in Australia.

Medicines Classification

The MCC is a statutory committee established under the Medicines Act 1981 to provide advice to the Minister of Health on whether medicines should be restricted in their sale by being classified as Prescription Medicines, Restricted Medicines, or Pharmacy-only Medicines. Medicines not so classified are considered as "general sales medicines" and are not listed in the Schedules to the Medicines Act 1981. They are permitted to be sold from any retail outlet, but all other provisions of the Medicines Act regarding safety and quality (eg consent to market, labelling, packing, dispensing) still apply to these products.

The MCC's membership is prescribed by the legislation, with equal representation of nominees of the NZMA(2) and the Pharmaceutical Society of NZ(2) and two MoH officers. I understand that the term of appointment of three of the four external members has elapsed.

Ibuprofen

This was one of the first of a new class of non-steroidal anti-inflammatory medicines (NSAIMs) introduced in the third quarter of last century, following aspirin, which was introduced some 60 years before in 1899. Together aspirin, ibuprofen and the analgesic paracetamol form probably the three most commonly purchased over-the-counter medicines world-wide. Ibuprofen has similar levels of effectiveness as other NSAIMs for the pain and stiffness of arthritis and as an analgesic and antipyretic. While not without an adverse event profile, it is generally recognised as the gold-standard against which the safety of other NSAIMs and the newer cox-2 inhibitor medicines are judged.

Ibuprofen is prescribed in daily doses of up to 2.4g. per day (BNF 46) and is available in over-the-counter presentations in most countries, usually as 200mg. tablets. Australia has recently re-scheduled to their equivalent of "general-sales" and the USA (which does not have a pharmacy-only category) has permitted over-the-counter sale for many years. In the United Kingdom ibuprofen 200mg tablets in a limited size pack have been available on the general-sales list since 1996.

The Application

Boots Healthcare applied under the provisions of the Medicines Act 1981 for re-classification of ibuprofen 200mg. when in packs of no more than 25 tablets. I understand that you have the papers and so I do not intend to summarise the submissions considered by the MCC.

The MCC Recommendation and the Reasons Given in the Minutes

The reasons given for not supporting the application were:

• the availability of aspirin is insufficient justification for moving other NSAIMs to general-sale.
• rescheduling ibuprofen would set a precedent for other medicines in this class.
• the MCC did not perceive a need for an alternative to aspirin and paracetamol at supermarket level.
• without the availability of a pharmacist, there was a potential for interactions to occur with other medicines.
• the members considered that adverse reaction reporting data were not good indicators of actual events because the reactions were well-known and therefore not likely to stimulate doctors into writing a report.
• at the dose being recommended, the ibuprofen anti-inflammatory effect would be minimal
• the MCC was not convinced that the benefits associated with ibuprofen use outweighed the risks as an analgesic at a general-sale level
• the MCC was not satisfied that issues relating to interactions and increased risk in the elderly could be addressed by labelling alone.
• Access to professional advice was essential.

Further Developments

I have seen the agenda papers and the record of the discussions at the Australian National Drugs and Poisons Scheduling Committee at which a similar application for general sale of ibuprofen was considered. I understand that some of the material considered by the Australian committee was made available to the MCC. The meeting minutes concerning the discussion and deliberation in the Australian committee appear to be significantly more "risk- based " than those reported in the MCC draft minutes.

I was also in Australia during the campaign by the Pharmacy Guild there to raise public concern about the change of scheduling agreed to by the Australian committee and kept some of the newspaper clippings both for and against the change, which I have referred to in producing this report.

Analysis

I do not find the Medicines Classification Committee's reasons for declining to support the application to be compelling. Further, I do not consider some of the reasons given in the minutes of its meeting to be within its terms of reference or within the scope of the Medicines Act1981. Particularly, I do not consider that the committee should make determinations about safe use of medicines on the grounds of the members' views on the "need for wider availability " or of "setting a precedent for other medicines". The minutes contained no evidence that there had been a full assessment of the risk and no significant argument to support declining the application.

On the contrary, the Australian papers were examples of two diametrically opposing views put before the committee. Having read them both, I consider that there was certainly a more detailed argument during the Australian committee meeting than at the Medicines Classification Committee.

The Pharmacy Guild media campaign in Australia presented no new evidence except a survey of self-reporting by pharmacist Guild members on the number of times they had intervened in the possible purchase of an ibuprofen product by a customer in their shop. The survey was seriously flawed, by not being independent, by giving no indication of the packs sold without their intervention, and by the clear conflict of interest for pharmacists wanting to retain a monopoly of retailing ibuprofen. There was no evidence of reports of harmful effects from self-selecting ibuprofen in the Guild material.

Conclusions

The MCC came to a decision not to recommend general-sales status for ibuprofen with very little supporting evidence. The reasons given in the committee's minutes do not represent a clear safety risk assessment and are, in part, outside the scope of the Medicines Act 1981.

Where considerable effort had been put into opposing wider availability of ibuprofen (ie Australia) the totality of the evidence did not support the stance taken by the MCC.

Note: The Medicines Classification Committee is a statutory committee, but is neither an expert committee nor a decision-making committee. Its role is advisory, and I can recall several precedents where the Minister, or the Minister's delegate has not acted on the advice of the MCC, following the receipt of contrary advice from officials.

You also have the option of returning the matter to the MCC for re-consideration. Although I understand the majority of the external members will be new to the committee, they will still have been selected from amongst nominees from two professional organizations whose members have a vested interest in maintaining the status quo.

Recommendation

I support the recommendation from the Manager of Medsafe that you should authorise the general-sales classification for oral forms of ibuprofen 200mg when in packs of no more than 25 tablets and with a recommended daily dose of 1200mg. I support this on the basis of having evaluated the available evidence about risk to public health, and not on the grounds that New Zealand should harmonise its regulations with Australia.