Prescription on way out for Xenical

By REBECCA WALSH

The weight-loss drug Xenical is likely to be available without prescription before the end of the year.

But pharmacists will have to go through an education programme before they can sell it and must conduct an initial face-to-face consultation with anyone wanting to buy the drug.

The decision has disappointed GPs and groups working with people with eating disorders. They say pharmacists are not as well qualified as doctors to assess an individual's health needs, and worry that people with bulimia will abuse the drug.

At present, a doctor's prescription is needed for Xenical. Roche, the company that manufactures it, applied to have it re-classified as a pharmacy-only product.

It claimed that giving direct access to Xenical would lower healthcare costs by reducing the number of doctor visits and the long-term complications of obesity, such as heart disease and diabetes.

The Ministry of Health's Medicines Classification Committee has decided Xenical, which has been used by about 60,000 New Zealanders since April 1998, fits the "safety profile" for over-the-counter sales.

But it has deferred its recommendation until a training programme for pharmacists is set up with the guarantee of face-to-face consultations. The committee meets again in November.

Committee members said they had no significant concerns that the drug would be abused by people with eating disorders, but if it was they did not believe it would cause significant harm.

Anorexics would generally be identifiable and while the drug might be abused by obese bulimics, there were relatively few people who had eating disorders and were very overweight.

The consultation would be required because of some concerns that Xenical would be available over the internet without a prescription.

The committee said many people would not be able to afford the drug - it costs about $160 for a month's supply - and it doubted reclassification would affect New Zealand's epidemic levels of obesity and diabetes.

But Dr Peter Foley, chairman of the Medical Association's GP Council, said doctors were already trained in prescribing the drug and had a better understanding of a patient's overall health than a pharmacist.

Jane Tyrer, co-ordinator of the Auckland-based Eating Difficulties Education Network, said she was disappointed by the decision.

"I think it will be very difficult to prescribe it accurately without a doctor's consultation. People for whom it's not recommended will be able to access it."

But Pharmacy Guild president Richard Heslop said the decision was appropriate given the caveats.

The situation was similar to that already in place for the emergency contraceptive pill and he was not aware of any complaints about how that was handled.

Rob Mitchell, managing director of Roche Products (NZ), said the company would work with pharmacists and Medsafe to address "these two remaining process issues".

Pharmacists would be able to supply Xenical only to adults who were very overweight, with a body mass index (BMI) of 30 or more. Sales had to be recorded.

Customers could use a support programme which encouraged exercise and lifestyle changes.