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） Experts’ Discussion on Current Affairs 03 page 1 ©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. Experts’ Discussion on Current Affairs 03 page 2 ©2009 Hong Kong Educational Publishing Co. 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. Experts’ Discussion on Current Affairs 03 page 3 ©2009 Hong Kong Educational Publishing Co.