Experts’ Discussion on Current Affairs
How to ensure drug safety and effectiveness?
News extract
A4
Local
Daily News
March 24 2009
Drugs mishaps at five pharmaceutical companies
Food and Health Bureau Secretary vowed to improve
drug regulatory system
The media has recently exposed a good number of incidents involving
medicines. As a result, Hong Kong people have lost faith in their drug
provider and regulatory system. Food and Health Bureau Secretary York
Chow admitted that since these incidents had not occurred for many years thus
employees of different levels had became lax in their work and that staff
workers’ level has to be increased to rebuild a good drug regulatory system.
The Health Department and the Hospital Authority have reacted with instant
remedy measures including the shutting down of all pharmaceutical factories
in Hong Kong for inspection and checking the quality and effective date of
drugs in clinics and hospital. As for the five pharmaceutical companies where
mishaps happened, Food and Health Bureau expressed they had violated
different drugs regulations and will give the cases to the Department of Justice
for prosecution.
Recently discovered drugs accidents in Hong Kong
‧
Europharm Laboratoires Co. Ltd ‘Allopurinol’ was found to be infected with
‘rhizopus microspourus’ fungus (March 2009)
‧
Marching Pharmaceutical Ltd was found have changed the expiration date of
its drugs (March 2009）
‧
Christo Pharmaceuticals Ltd sold unregistered ‘500 pills pack’ diabetic drug
metformin (March 2009)
‧
Unipharm Trading Company（importer of western medicine）is suspected of
self-labeling depression drugs without labeling license (March 2009)
‧
Drugs from Japanese Otsuka Pharmaceutical Group’s factory in Indonesia
have Water for Injection B.P. exceeding 30% of standard to the Hospital
Authority (March 2009)
‧
Yau Ma Tei Jockey Club distributed expired cough syrup ( March 2009）
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©2009 Hong Kong Educational Publishing Co.
Current Affair Discussion
‘Action on Smoking or Health’ Chairman Dr. Lo Wing Lok(勞永樂) :
The local drug testing system is faulty and superficial, Food and Health Bureau
should re-inspect pharmaceutical factories and test the drugs to prevent more innocent
citizens from being harm.
The Practising Pharmacists Association of Hong Kong President Iris Jacqueline
Chang (鄭綺雯) :
These pharmaceutical companies went around the ‘back door’ and employed the fait
accompli tactic, selling the drugs to the Hospital Authority and disregarding patients’
interests. …The Hospital Authority did not do its job, did not enforce the regulatory
mechanism. It is all very disappointing and difficult to accept, it did not know if the
drugs were registered or not. How then can the patients receive their rightful
protection!
Drug Education Resources Centre Education Director-General Chui Chun-ming (崔俊
明):
There are only a small number of pharmacists who are responsible for inspecting
pharmaceutical factories. There isn’t even a choice to switch the pharmacists around,
so it is easy for them to become friendly with pharmaceutical companies, which is no
good for regulating practice. In reality, as of now, the list of Hong Kong’s pharmacists
is not transparent. The pharmaceutical industry and the Pharmacy and Poisons Board
have not established any website to provide the public with information about the
pharmacists. Also, the Hospital Authority only makes one inventory of its drugs once
per year, mainly to inspect the quantity and expiry date of the drugs. The drugs with
he closer expiry date get moved to the first few rolls of the shelf so that pharmacists
would use them first. After the inspection by pharmacists, senior pharmacists review
them. There are also four small-scale inventories each year, each time inspecting 40 to
50 types of drug. As present, the hospitals do not inspect purified water, I recommend
that they should inspect each batch of purified water.
Department of Health Deputy Director of Health Dr. Gloria Tam (譚麗芬) :
In the past, there were 28 in the pharmaceutical inspection team, now it is increased to
40. The main points of inspection would be the quality of microorganism and safety.
The department had sent letters to the pharmaceutical producers, importers and agents
to ensure that they understand their legal responsibility and duty.
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Hospital Authority (Cluster Services) Director Dr. W. L. Cheung (張偉麟):
The Hospital Authority will inspect hospitals and clinics, and the quality and expiry
date of purchased drugs. Because of the enormous amount of inventory, all pharmacy
staff, ward staff and others will need to work overtime during Saturday and Sunday
holiday to carryout the inspection speedily. The Hospital Authority will raise the
whole regulatory system and will ask staff at all levels to raise their alertness and
manage expired drugs well to ensure that the drugs we provide to the patients are safe.
Hong Kong Association of the Pharmaceutical Industry Vice President Dr. Anthony
Chan (陳崇光) :
When patented drugs are taken out of the factory, each batch goes through a series of
tests, including tests for the amount of fungus, drug properties such as solubility. They
also needed the certificate of analysis (COA) to prove that the products had passed
standard and quality benchmarks and were made exactly according to the original
recipe. To improve the regulatory system, we may follow in this direction and
legislate law so that every batch of non-patent drugs must have a COA, but the cost
will increase. People need to consider carefully on the matter.
Questions
1. ‘Hong Kong’s drug safety and public drug providing system have serious flaws.’
Try to find evidence from the source.
2. With reference to the source, to ensure drug safety and effectiveness, what
measures should the authority make? Explain your answer.
3. In light of the source, do you think the responsibility of ensuring drug safety and
effectiveness rest solely on the regulatory departments? Explain your answer with
reference to the source and based on your knowledge.
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©2009 Hong Kong Educational Publishing Co.