Replies to LegCo questions

LCQ9: Adverse drug reaction

     Following is a question by the Hon Joseph Lee and a written reply by the Secretary for Food and Health, Dr York Chow, in the Legislative Council today (April 29):

Question:
     
     It is learnt that adverse reactions of the body to medicines may not be noticed immediately, and certain types of patients (such as elderly patients or patients who are taking various medicines at the same time) may have unexpected reactions to medicines.  Furthermore, adverse reactions to medicines may not be discovered during clinical trials and, therefore, certain risks exist in taking medicines newly introduced to the market.  In view of the aforesaid situation, quite a number of countries and places have already formulated a clear regulatory system on medicines.  In this connection, will the Government inform this Council

(a) whether it knows the number of patients who received treatment in public hospitals due to adverse reactions to medicines in each of the past five years; if such figures are not available, whether it will consider compiling the relevant statistics as soon as possible; and

(b) whether last year, it had considered formulating a clear and comprehensive regulatory system on medicines (including proactively monitoring the medicines on sale in the market and strengthening the notification mechanism on adverse reactions to medicines); if it had, of the details; if not, the reasons for that?


Reply:

President,

(a) According to the guidelines of the World Health Organisation (WHO), adverse drug reaction means uncommon signs and symptoms that occur at doses normally used for treatment.  It does not cover cases of overdose, not taking medications as instructed or using products adulterated with western drug ingredients.  The Department of Health (DH) has developed in 2005 a voluntary Adverse Drug Reactions Reporting Programme (ADRRP) to encourage healthcare professionals to report cases of adverse drug reaction to the DH.  Since then, the numbers of cases seeking treatment at public hospitals arising from adverse drug reactions reported to the DH are as follows:

     Year                No. of cases
     2005                     10
     2006                      9
     2007                  15
     2008                      4
     2009 (as at April 16)    1

(b) In addition to the ADRRP, the DH also monitors the safety, efficacy and quality of drugs on the market.  Details are:

(i) Drug Surveillance Programme:  The DH frequently conducts checks on drugs on the market.  These drugs are subject to both random and risk-based sampling for chemical and microbiological (for sterile products only) testing and checks for packaging, insert and labelling compliance.  The DH conducted a total of 2,335 tests last year, which has increased from 2,146 tests in 2007.

(ii) Toxicovigilance Programme:  It is a collaborative programme between the DH and the Hospital Authority (HA) implemented in 2007.  When the HA encounters patients suspected to have been affected by the consumption of harmful products, it refers to the DH for follow-up investigation.  Reports which have public health implications will be released to healthcare professionals, members of the general public and overseas health authorities when necessary.

     Besides, the DH will keep track of the scientific research findings, publication, notification and reports of the WHO and local stakeholders, such as the faculties of medicine of the two universities, the HA, private hospitals, private medical practitioners and private laboratories.  The DH will also conduct analysis and take follow-up actions where appropriate, including undertaking field epidemiological research and taking samples of evidence for examination.  If it is found that any drug may cause adverse reaction, the DH will take appropriate actions based on risk assessment, and will publish the information and notify the WHO if necessary.

     In the light of the recent drug incidents, the Government has set up a review committee to undertake a comprehensive review of the existing regulatory regime for pharmaceutical products.  The task force of the review committee led by the Director of Health will make recommendations on the enhancement of pharmacovigilance in Hong Kong.  The reporting, detection, assessment and prevention of adverse drug reaction will be part of the review.
 

Ends/Wednesday, April 29, 2009
Issued at HKT 12:42

NNNN