MCC agrees Xenical safe for pharmacy

News Release

MCC agrees Xenical safe for pharmacy

Recommendation deferred for assurances from pharmacists

Auckland, 24 June 2004 – The safety profile of weight loss medication Xenical® (orlistat) has been deemed suitable for sale over the counter in New Zealand pharmacies by the Medicines Classification Committee (a Ministerial Advisory Committee.

The MCC has however deferred a recommendation until their next meeting based on: the committee wishing to ensure that measures to train pharmacists about the sale of Xenical are in place and, that the initial sale of Xenical would require a face-to-face consultation.

“While we are very pleased with the committee’s positive findings that the safety profile of Xenical is suitable for OTC sale as a restricted medicine, we are naturally disappointed in a deferral decision,” said Rob Mitchell, Managing Director of Roche Products (New Zealand) Ltd. “We look forward to working with the pharmacy profession and Medsafe to address these two remaining process issues.”

Reclassification to a Pharmacist Only Medicine will allow Xenical to be supplied under the advice of a pharmacist to adults who are very overweight with a body mass index (BMI) of 30 or more. All sales of Pharmacist Only Medicines must be recorded in a register or computer. The pharmacy profession welcome the increased professional responsibility.

“Pharmacists are often the first port of call for people with health issues or questions and are therefore in a key position to help combat New Zealand’s alarming rise in obesity,” said Bernie McKone, President of the Pharmaceutical Society of New Zealand. "We are developing a comprehensive weight management education programme for pharmacists to ensure effective weight management counselling and better outcomes for people struggling to lose weight.”

Professor Jim Mann, Professor in Human Nutrition and Medicine at the University of Otago, supports the reclassification of Xenical while noting that diet and exercise measures remain the cornerstone of treatment for obesity. “For New Zealanders who are appreciably overweight or obese, especially those who have developed conditions associated with obesity, it may be necessary to offer an approach which can complement lifestyle changes. The availability of Xenical will provide such individuals with a clinically proven addition to the lifestyle changes that are essential to long term weight control.”

Xenical customers are able to access the Xenical Support Programme which provides ongoing support and follow-up by New Zealand registered dietitians. The Xenical Support Programme helps people learn to recognise the hidden fats in their diet and encourages them to increase their physical activity. Adding Xenical is approximately 68% more effective in helping people lose weight than diet alone.

ENDS

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