Medical experts call for more rigid regulations on labelling of antiseptics in HK after hundreds of patients were infected, suspected of unsuitable products to clean wounds

27-Sep-2019 Intellasia | South China Morning Post | 6:02 AM Print This Post

Medical experts have called for a more precise labelling system for antiseptic products to be created by tightening existing laws, after hundreds of patients in Hong Kong were believed to have used the wrong products for cleaning wounds.

The calls came as two more chlorhexidine antiseptic products, which were not suitable for cleaning lesions, were found to be contaminated with bacteria on Wednesday, bringing the total number of contaminated products to eight over the past week.

Five of them were identified with Burkholderia cepacia, one with Achromobacter, one with the two types of bacteria, and the remaining one with Ralstonia, according to the government’s announcements. All these bacteria are commonly found in the environment and can cause infections in those with weakened immune system.

So far, 184 patients, most of them renal patients requiring peritoneal dialysis, were reported to have had Burkholderia cepacia infections in the past two years. It was suspected that the infections were related to antiseptics, which were commonly used by peritoneal dialysis patients for skin disinfection and catheter exit site care at home.

A scientific committee on infection control, under the Centre for Health Protection, is expected to meet on Friday to discuss the matter.

The Pharmacy and Poisons Board of Hong Kong, which regulates the city’s pharmaceutical products, also decided last Friday that it would review whether current regulations of antiseptic products were sufficient.

Professor Yuen Kwok-yung, an expert on infectious diseases from the University of Hong Kong, said there should be clear indications on packing as to whether products can be used for wound care.

“At the moment, there is only the term ‘antiseptic solution’ on products… but it doesn’t state clearly what it should be used for,” Yuen said.

The packaging of the products in question carry wording like “for external use only”, but do not say whether the products can be used for wound cleansing.

Under current regulations, antiseptic products with low concentrations of chlorhexidine, which also lack medicinal claims and indications about use on broken skin, are not considered as pharmaceutical products. This means they do not need to be registered with the Department of Health.

But consumers could be confusing them with products that are suitable for wound care, as they have a similar appearance and a comparable concentration of antiseptics.

William Chui Chun-ming, president of the Society for Hospital Pharmacists of Hong Kong, said the uses and manufacturing of registered products are regulated by the government.

“The department would check if manufacturers have carried out microbiological tests,” he said.

He added that products intended for wound care are processed with extra steps for sterilisation during manufacturing. Products that have not undergone such processes should be used only as hand washes or for cleaning non-lesioned skin.

Chui criticised the city’s regulations for antiseptic products as “outdated”.

He said the labelling “for external use only” does not clearly indicate what the use should be.

“Wound care can also be considered external. From a pharmaceutical perspective, items that are not taken orally or injected into blood vessels are seen as being for external use,” Chui said.

He said that, in the long run, there should be changes in regulations to require antiseptic products to state clearly whether they can be used on broken skin.

Both Yuen and Chui agreed that strong regulations should also be in place for companies that involved the repackaging of those products. Kam Sing Medicine Co, one of the distributors named by the authorities as selling the antiseptic products in question, had earlier said it diluted the antiseptic concentrate bought from a supplier and repackaged it for sale.

“When registration is not needed and monitoring is lacking, there can be problems with the manufacturing process,” Yuen said.

But he added: “Antiseptic solutions are expected to be bacteria-free. If there’s a chance they might contain bacteria, the products should not carry the word ‘antiseptic’.”

Mary Catherine Cheng, a member of the Pharmacy and Poisons Board, said the board would make reference to overseas regulatory practice and consider whether there should be changes in regulations of antiseptic products.

In Britain, antiseptic products are regulated differently according to their uses. For example, those that claim to prevent a specific virus or infection are considered as medicines, and antiseptics used for cleaning medical apparatus are regulated as a medical device, which is regulated by a different set of standards and requirements.

Cheng said the board is expected to look into areas such as presentation and labelling of the products to decide whether to enhance the regulations of products.


Category: Hong Kong

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