Proposals include having licensed pharmacist in every pharmacy

HONG KONG: A review committee, set up after a series of incidents that led to the deaths of patients at Hong Kong hospitals, has produced a set of 75 recommendations aimed at improving the safety of prescription drugs in the city.

The recommendations by the Review Committee on the Regulation of Pharmaceutical Products in Hong Kong, comes after nine months of study. The recommendations cover a broad range relating to the supply of drugs from manufacturing to retailing.

The panel was set up following a series of blunders that took place at local hospitals beginning last March. Five leukemia patients died at Queen Mary Hospital after they were medicated with Purinol - produced by Europharm. Pharmacological tests showed the drug had been contaminated with high levels of fungus.

Products from Marching Pharmaceutical of Hong Kong were recalled after authorities discovered falsified expiry dates on some products.

Christo Pharmaceuticals supplied unregistered diabetes drugs to public hospitals.

These and others fostered public outrage as well as anxiety about whether hospital patients were safe from medical blunders.

The work of the panel has been marked by heated debate throughout.

One set of proposals recommends that wholesalers and retailers handing non-poisons be required to be licensed. Then written records should be kept for transactions involving all pharmaceutical products. Ultimately the recommendations calls for a registered pharmacist to be present whenever a pharmacy is open for business.

"It will increase the cost to the pharmacy if a registered pharmacist is needed to be present during its operation hours," said Lee Oi-man, chairman of the Hong Kong General Chamber of Pharmacy Limited. "There are not enough registered pharmacists in Hong Kong. The recommendation should take at least four years to be adopted when the new generation of pharmacists has graduated from universities."

Hong Kong has more than 3,300 drug stores and only about 1,500 registered pharmacists.

Lee thought the recommendations might be effective in controlling the quality of pharmacies in Hong Kong.

"Drug retailers don't need to register a license at present and they can sell whatever they want," said Lee. "Forcing them to register can help control these drug retailers."

Yeung Chiu-fat, president of the Doctors Union, also thought plenty of time should be given for the industry to adapt to the new recommendations.

The recommendations propose that doctors be required to keep written records of orders to prevent errors during delivery of drugs. Yeung thought it would be a waste of time and not environmentally friendly. He added the written record actually may be kept by nurses who may not be as knowledgeable about a given drug as doctors.

"We have voiced a counter-suggestion but were ignored," said Yeung. "We suggested that doctors order the drugs they need, then sign when they receive the drugs from the manufacturers. Doctors would check before the drugs are administered to patients. Under the counter-proposal, whenever drugs are checked in or out, the process may be overseen by a professional."

Yeung emphasized at least three years time should be given for the whole industry to adapt to the new rule. He also thinks it would be effective for the set of recommendations to introduce microbiological monitoring for non-sterile drugs during the manufacturing process.

The panel recommends that all companies undertaking repackaging have a manufacturing license.

The review committee also recommends a "Centre for Drug Safety" office to help the government play a regulatory role in enhancing drug safety by planning and directing the implementation of related measures. It also urged the Department of Health to set up a team to draw up guidelines on risk communication and provide drug information to public.

Chaired by the Permanent Secretary for Food and Health (Health), Sandra Lee, the committee was set up in last March aimed to strengthen the regulatory regime of pharmaceutical products following a series of incidents concerning pharmaceutical products in Hong Kong in early 2009.

Since the first meeting of the review committee in last April, the committee has concluded a study and the report regarding the study will be discussed in the Legislative Council next Monday.

(HK Edition 01/06/2010 page1)