Ibuprofen to be available from supermarkets

Ibuprofen to be available from supermarkets

The over-the-counter pain reliever medicine ibuprofen will be able to be sold from both supermarkets and pharmacies from May, the Ministry of Health announced today.

The Ministry’s senior advisor in Medsafe Dr Stewart Jessamine says this change means that consumers in New Zealand will have the same access to ibuprofen as consumers in the United States, the United Kingdom and Australia. Consumers here will soon be able to buy small packets of ibuprofen from the same places where they buy similar products like aspirin and paracetamol.

The decision to increase consumer access to ibuprofen arises from an application made by Boots Healthcare to the Medicines Classification Committee (MCC).

Dr Jessamine says “In reaching this decision, the Ministry considered information from the MCC, Medsafe and an independent expert.”

“Although the MCC did not support ibuprofen becoming available from supermarkets,” Dr Jessamine said “Medsafe and the independent expert believed that in this instance the safety profile of low-dose ibuprofen means it is suitable for sale from shops and supermarkets.”

Dr Jessamine says “Most recommendations made by the MCC are accepted by the Minister without change or comment from Medsafe, but the decision to accept alternate advice on an application is not that unusual and has occurred on several occasions in the past ten years.”

Dr Jessamine says “While the decision to allow ibuprofen to become available from supermarkets was opposed by pharmacists in Australia, no new safety evidence has emerged as a result of its opposition."

Medsafe is satisfied that the controls it has placed on the dose, pack size and labeling of ibuprofen adequately manage the risks associated with use of this medication to the point that if used according to the instructions it has a similar level of safety as aspirin or paracetamol.

Q & As

What brands of ibuprofen are available in New Zealand Over-the-counter brands of ibuprofen currently available in New Zealand include: Nurofen (Boots), Act-3 (Whitehall), Panafen (GlaxoSmithKline).

Why has the sales restriction on ibuprofen been lifted? Boots Healthcare who market Nurofen in New Zealand applied to the Medicines Classification Committee of Medsafe asking that it consider allowing ibuprofen to be sold from shops and supermarkets. The application included data on the safety and effectiveness of ibuprofen. Details on the application, the Minutes of the meeting, the MCC’s recommendations, and the Medsafe and independent expert reports can be found on the Medsafe website within the Classification Issues link at http://www.medsafe.govt.nz/profs.htm

The application to the MCC includes a range of data including safety data from spontaneous adverse reaction programmes in Australia and New Zealand (where the product has been available for patient self-selection in pharmacies), and from the USA and UK where the product is available in supermarkets.

In addition to safety data, the application contained the results of a clinical trial mimicking use in the supermarket-type setting and information on consumer testing of the labels and warning statements required for the product to be available from shops etc.

Why was the restriction on in the first place? Ibuprofen has been on the market in New Zealand for 20 or more years and first entered the market as a prescription medicine. As its safety profile has become better defined, ibuprofen has been considered by the MCC on several occasions and reclassified from prescription only to pharmacy-only where a product containing ibuprofen can be selected and purchased by a consumer from a pharmacy.

There are four levels of medicines classification. • Products in the most severely restricted classification level are classified as prescription medicines and can only be made available to the public pursuant to prescriptions written by medical practitioners or other persons specified in the legislation such as midwives or optometrists. • Products in the next level down of classification are called restricted medicines and these are medicines, which can only be sold by a pharmacist within a pharmacy and that sale must be recorded in a register. • The next level of classification is the pharmacy-only medicine category and all products in this class must be sold through a registered pharmacy. Any staff member working within a pharmacy may sell pharmacy-only medicines. • The lowest level of medicines classification is the so-called unclassified group. These products are often referred to as general sale medicines and can be sold from any retail outlet

What did the Medicines Classification Committee recommend? Details on the classification process can be found at the Medsafe website within the Classification Issues link at http://www.medsafe.govt.nz/profs.htm

Having considered the data at its last meeting the MCC thought ibuprofen should remain as a pharmacy-only medicine.

Why has the advice of the committee not been taken up? The committee provides advice to the Minister of Health, however the classification process permits Medsafe to provide comment and advice to the Minister on the committee’s recommendations. In this case Medsafe did not support the MCC’s recommendations. Copies of the Medsafe report can be found on the Medsafe website.

What are the potentially harmful side-effects? As with all medicines, ibuprofen has a number of side effects. Medsafe is satisfied that the evidence indicates that restricting the dose of the medication to 1200mg per day, the duration of treatment to 3-4 days and careful labeling reduces the risk of developing side effects to similar levels to those seen for aspirin and paracetamol. Further details of the side effect profile of prescription medicine doses of ibuprofen can be found at the Medsafe website ( http://www.medsafe.govt.nz/DatasheetPage.htm) by searching under the ingrediant name ibuprofen.

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