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The latest lethal drug outbreak, the second within three months, should raise the alarm with regulators responsible for the health and safety of the public. In the latest case, an antibiotic clindamycin phosphate glucose injection, produced by an Anhui company, is believed to have caused three deaths and left more than 81 ill. The tally may worsen as further reactions are reported across the country. The drug regulators have reacted quickly in recalling the injections in circulation. They must continue this work to ensure no more bottles of this dangerous batch of injection remain on the market. Although the medical authorities are yet to come to a final judgment as to what exactly happened, the event should get regulators at all levels, manufacturers and hospitals thinking more seriously about drug security. The infamous Qiqihar fake drug incident not long ago was found to have involved poor management and regulation at several links in the chain. The public will wonder whether things are similar this time around. Media outlets and regulators have released little information to explain the adverse reactions. Nevertheless, preliminary investigations have provided some clues to decoding the case. A spokesman for the producer, Anhui Huayuan Worldbest Biology Pharmacy Company, a subsidiary of the Shanghai Worldbest Co Ltd, told China Central Television that mishandled sterilization during the production process was a "possible" cause. It was revealed the company had bought a new sterilizer and shortened the time of sterilization, but it was not explained by what manufacturing standard Huayuan had reduced this time. We need an answer to this question to define the responsibility of the company. It should also be remembered that, as early as 2003, the Adverse Drug Reaction Monitoring Center of the State Food and Drug Administration reportedly issued a nationwide warning against possible serious adverse effects of this drug. The notice reminded doctors of the need to be cautious when prescribing the drug. It is unknown whether the notice was adequately heeded, or what the regulators did after that to fix the source of those adverse reactions. However, we do know that the same drug that was subject to a warning nearly three years ago has now killed at least three people. We hope thorough investigations will reveal the truth. They must clearly define the responsibilities of the relevant parties so that such a tragedy will not happen again. (China Daily August 7, 2006) |
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