The Hong Kong Drug Safety Consortium has expressed strong opposition to a proposal by the Hospital Authority (HA) to introduce an unlicensed drug to treat patients with an age-related eye disease.

The consortium, composed of the Hong Kong Doctors Union, the Practising Pharmacists Association, and two patient organizations, stated at a press conference Friday that drugs without an approved license, also known as "off-label drugs", may compromise patient safety, adding that the measure proposed by the HA was "inappropriate", "unethical", and "purely due to cost considerations".

The HA disclosed at a meeting on February 10 that a drug that has not received approval for registration by the Department of Health will be used on patients with the age-related eye disease, acute macular degeneration (AMD). Every year, 3,000 new patients are found suffering AMD in Hong Kong, 500 being from low-income families, said Tsang Kin-ping, chairman of the Alliance for Patients' Mutual Help Organizations.

The disease can be effectively treated with a licensed and registered drug "Lucentis". But the drug costs approximately HK$8,000 for one dose. A course of treatment usually needs three doses, about HK$24,000. Yet the proposed off-label drug "Avastin" is much cheaper, costing only about HK$10,000 for three shots.

However, there is no long-term research to prove the safety and efficacy of the drug "Avastin", said Iris Chang, the president of the Practising Pharmacists Association.

Chang cited the opinion of a professor of Ophthalmology at the University of Sydney, Paul Mitchell, who believes that "Avastin" stays in patients' blood vessels for as long as three weeks, which is much longer than the 12 hours of "Lucentis". The longer the drug stays, he said, the greater the chances that it will cause cardiovascular crises, such as stroke and heart attack.

In response to the criticism, Secretary for Food and Health York Chow said the unlicensed "Avastin" and the approved "Lucentis" are the same type of medicine, even though produced by different pharmaceutical companies.

Chang, however, stressed that off-label drugs differ in the key respect that they may lack the required level of scientific evidence to support the products' safety, efficacy, and quality, and thus may pose unknown short-term or long-term safety risks to patients. "Off-label drugs are generally used when no better alternative is available," she noted.

This is the first time that the HA has proposed the introduction of an off-label drug to the HA formulary, she said.

Chang expressed her concern that once the door for off-label drug is opened, there will be more in the future, making the situation hard to control.

In Chang's opinion, the HA wrongly played the role of the Department of Health in deciding the safety of a certain drug. Moreover, she believes the HA has a conflict of interests in selecting drugs when it is responsible for operating and overseeing financial management of the public hospitals.

Meanwhile, to improve drug safety in Hong Kong, the Drug Safety Consortium suggested another law reform proposal to require drug wholesalers in the city to employ pharmacists, in order to minimize the risk caused by drug labeling mistakes of local drug distributors.

China Daily

(HK Edition 03/06/2010 page1)