Delay in disclosing batch numbers of mouldy Indonesian-made drug Enzyplex ‘intolerable’, Hong Kong pharmacists say
Professional bodies call for tighter checks on imported medication, but health minister says existing system adequate
Two professional bodies for Hong Kong pharmacists made public on Saturday the batch numbers of a round of Indonesian-made digestive drugs found to be contaminated with mould, calling the government’s delay in releasing the information “intolerable”.
The Practising Pharmacists Association and the Hong Kong Academy of Pharmacy urged officials to introduce testing at customs checkpoints to catch substandard drugs.
But Hong Kong’s health minister on Saturday insisted the existing system was adequate to protect public health.
The Hospital Authority, the statutory body which manages government hospitals, on Thursday announced that a type of Monascus mould had been found on Enzyplex tablets imported from the Southeast Asian country.
A patient in her 30s who had been suffering from lymphoma died after taking the drug. But the authority said the mould on the tablets was an “incidental” finding when the microbiology department at Queen Mary Hospital in Pok Fu Lam reviewed the deceased woman’s case.
The government’s Department of Health is now investigating the drug.
Mould scare prompts removal of indigestion drug Enzyplex from Hong Kong’s public hospitals and shops
Iris Chang, the pharmacists association’s president, said the batch numbers in question were 17234801 and 17235101.
She said she had attempted to contact the Department of Health, which oversees drug registrations and import controls, to obtain the numbers but was redirected to the Hospital Authority, which then took two days – over which time more than 10 emails went back and forth – before disclosing the information.
Chang called that process “intolerable”.
“We are astonished as to why they did not announce the batch numbers,” she said. “People are taking the medication and they have a right to know.”
She urged the department to disclose any other affected batches as soon as possible.
Earlier on Saturday Secretary for Food and Health Professor Sophia Chan Siu-chee insisted there were no problems with the current system for regulating drugs.
Hong Kong health authorities probe digestion drug after cancer patient’s medication found to be contaminated with mould
“We have a very robust mechanism for drug registration and usage,” she said.
Chan added that authorities had not received any complaints from patients taking the medication. However, consumers had “better not take the drug” and officials had demanded the manufacturer submit a report on the incident, she said.
Unam Corporation, the manufacturer, asked retailers, hospitals and clinics to immediately stop distributing and selling the drug until more tests had been done.
Consumers could return the product if it had not yet expired, the firm said.
Chang meanwhile questioned how the government’s system for registering and regulating drugs could possibly be robust when contaminated medication had reached patients.
“It is not easy to have a foolproof system ... but we can definitely imitate the practices of other countries, especially the mainland, in how they protect their citizens by doing a lot of random sampling and testing at ports,” she said.
Hong Kong did not carry out any testing until a drug had made it to market, Chang said.
She also warned that some manufacturers might view the situation as a loophole or an opportunity to export drugs to Hong Kong that might not be of the highest quality.
She urged patients not to take Enzyplex even if their medication was not from the two batches, and said they should wait until more information was available on any other affected drugs.
When asked why the relevant departments did not announce the two batch numbers, a Hospital Authority spokeswoman said it had passed the information to the Department of Health for dissemination.
A Department of Health spokesman only said the results of its investigation would be released when available, and further action taken if necessary.