8 February 2005
Xenical reclassified: Prescription no longer necessary
Approval has been given for the weight-loss drug Xenical (Orlistat) to be sold by pharmacists without a prescription
from a doctor. New Zealand is the second country in the world after Australia to approve pharmacist sale of this
product.
The Medicines Classification Committee (MCC) has approved the application from the pharmaceutical company to have the
drug Orlistat (Xenical) reclassified from a prescription-only medicine to a restricted medicine.
Committee spokesman Dr Stewart Jessamine said: "In considering the application, the committee was satisfied that
consumers can self identify whether treatment with Xenical may be appropriate; the medicine is effective with long term
use, the side effect profile is acceptable, and obesity can be managed safely by the pharmacist using best-practice
guidelines. However, the MCC recommendation to approve was dependant on several conditions.
Firstly, due to concerns about internet sales of medicines, that the pharmacist would only sell Xenical following an
initial face-to-face consultation between a pharmacist and the consumer; and secondly, that the company co-operate with
pharmacy professionals to develop a patient management guideline.
These requirements were to ensure that the consumer who asks for Xenical will receive appropriate support and advice for
the management of obesity, and meets the criteria of having a BMI greater than 30.
"Since the November MCC meeting both of the committee's concerns have been resolved. Roche pharmaceuticals, the sponsors
of Xenical, completed the development of pharmacist training and patient management resources in collaboration with the
pharmacy profession, and the Pharmacy Council changed its Professional Code of Ethics to resolve the MCC concerns about
internet sales."
While the Ministry of Health has accepted the MCC recommendation to re-classify Orlistat, the decision can only come
into effect after the period for submission of appeals on the grounds of safety closes on February 25.
If there are no appeals at that time, the change of classification will be gazetted by early March. Pharmacists will
only then be able to start selling the product without a prescription.
NB: The Ministry of Health recommends a combination of good nutrition and regular physical activity for all people to
maintain a healthy weight. A balanced diet and regular physical activity are just as important for people trying to lose
weight, including those using a product such as Xenical.
ENDS