Replies to LegCo questions
LCQ8: Recall of analgesic drug
Following is a question by the Hon Chan Yuen-han and a written reply by the Secretary for Health, Welfare and Food, Dr York Chow, in the Legislative Council today (November 17):
Question:
It has been reported that an analgesic drug known as Vioxx was earlier confirmed as increasing the risk of heart attack and stroke in users, thus leading to an extensive recall initiated by the drug company concerned. However, the drug in question, which has been widely administered by medical practitioners in public hospitals and private clinics throughout Hong Kong, is still given to quite a number of patients after the drug company has announced the recall. In this connection, will the Government inform this Council whether the Hospital Authority and the Department of Health have:
(a) followed up the recall of the drug and instructed medical practitioners to stop giving it to their patients;
(b) instructed medical practitioners who have already given the drug to their patients to follow up the recall in order to prevent their patients from taking it further; and
(c) established procedures to ensure that frontline medical practitioners are provided with clear guidelines for handling similar incidents involving questionable drugs?
Reply:
The health of the people of Hong Kong is a matter close to Government's heart. In relation to pharmaceutical products which may be prescribed by medical practitioners in private clinics or hospitals or through the public hospital and clinic system, a registration and recall system is in place. The practice under such system is benchmarked against international practices and experience. Mandatory recall of pharmaceutical products is initiated once a pharmaceutical product is found by the Department of Health (DH) to be inflicting imminent health risk to the public. The requirements are set out in the Pharmaceutical Products Recall Guidelines drawn up by DH. Recalls of pharmaceutical products may also be initiated by the manufacturer for commercial or other reasons.
Vioxx, a prescription-only medicine in Hong Kong, is a case of voluntary recall by the manufacturer. The US manufacturer of the drug initiated a worldwide recall of the product based on the results of a recent study on the side effects arising from prolonged use (over 18 months) of the drug. The manufacturer issued a press release on September 30, 2004 announcing the voluntary recall of the drug and this was carried in local newspapers. It also notified all doctors, hospitals and dispensaries to which it had supplied Vioxx about the recall in writing on October 2 - 4, 2004 and advised them to follow-up with those patients who have been prescribed with the drug. The manufacturer started visiting hospitals, dispensaries and private doctors who have been supplied with Vioxx to facilitate latter's surrender of the drug. A hotline was also set up by the manufacturer to handle public enquiries on this recall exercise. The recall in Hong Kong was completed in the first week of November.
Vioxx is not supplied at DH clinics. In the Hospital Authority (HA) context, Vioxx belongs to category COX-II drugs and it is not a standard drug item in the HA Formulary. However, there are cases where a handful of patients, despite having been prescribed with conventional analgesic drug by attending doctors in public hospitals, still wish to purchase category COX-II drugs in local dispensaries by themselves. Doctors will, at their discretion and where appropriate make prescriptions to enable their patients to obtain such medicine at the community dispensaries.
(a) & (b) Since the manufacturer's public notification of a voluntary recall of Vioxx, the Department of Health (DH) has been closely monitoring the progress of the recall. Weekly report was submitted to DH by the manufacturer. A final report was submitted to DH on November 12. To supplement the issuance of the press release and the letter by the manufacturer to all doctors, hospitals and dispensaries to which it had supplied Vioxx, DH also issued a follow-up press release as well as a letter to all registered doctors in Hong Kong in late October reminding them of the early return of this pharmaceutical product to the supplier and prescribe other suitable forms of medication to their patients.
In the public hospital context, as soon as the HA received the report on the total recall of Vioxx, it notified its frontline staff by means of internal memo issued through Cluster Chief Executives, Hospital Chief Executives and Heads of Clinical Departments. HA also contacted patients' groups through the "Health InfoWorld" to bring the report to their attention and instructed hospitals as well as specialist out-patient departments to make appropriate arrangements for needy patients, e.g. arrange earlier follow-up consultations so that, where necessary, other suitable medication could be prescribed to patients. At the same time, the Chief Pharmacist's Office of HA maintained close contact with the manufacturer to understand the latest actions taken by the company so as to inform doctors and render necessary assistance to public hospital patients.
(c) As mentioned above, a set of Pharmaceutical Products Recall Guidelines is in place. The Guidelines which have been in force for a long time are widely distributed to manufacturers and importers of pharmaceutical products in Hong Kong. The Guidelines cover detailed information on the procedures to be adopted in drug recall exercises. These procedures include communication with parties to whom the drug has been supplied, and submission of progress and final reports to DH for monitoring purpose. In every recall exercise, DH closely monitors the actions taken and ensures that all the necessary steps are effectively and efficiently adhered to.
As a general practice, DH makes public announcements on recall exercises and explains the associated public health implications to the community. If the concerned pharmaceutical products are prescribed in DH clinics, clinic doctors will be asked to follow-up the case with patients who have been prescribed with the product.
HA has a set of comprehensive procedures to ensure that frontline doctors and staff are provided with clear guidelines to handle incidents involving questionable drugs. The procedures were formulated in line with the guidelines of health supervision authorities in various countries. Upon receipt of the recall notification from the drug company or where applicable, from DH, HA will promptly disseminate the information to frontline staff in hospitals through established channels. In this particular drug recall incident, doctors of the Rheumatism Department are the main targets of notification, and all of them are duly informed of the recall.
Ends/Wednesday, November 17, 2004
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