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Pharmaceuticals under the microscope

Nearly 3 percent of pharmaceuticals from licensed outlets are counterfeit, though a greater portion failed tests assessing their quality, according to a new study conducted by Ministry of Health officials and Japanese researchers.

The study – published in this month’s issue of Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists – drew from 710 pharmaceutical samples taken between 2006 and 2008 in all eight districts of Phnom Penh as well as in Kandal, Takeo and Kampong Speu provinces.

All samples were purchased from licensed outlets.

Researchers found that there were “counterfeit medicines among commonly used lifesaving medicines, such as antibiotics, analgesics and anti-parasitics”.

In quality testing, 4.6 percent of the samples failed a high-performance liquid chromatography test for active ingredients, while 8.4 percent failed in solubility tests.

Pieter van Maaren, country representative for the World Health Organisation, said that drugs that failed quality testing were just as dangerous as counterfeit ones.

“Do not underestimate the importance of substandard medications because they’re equally as damaging as counterfeit ones,” he said.

Heng Bun Keat, director of the Ministry of Health’s Department of Drugs and Food, said the study’s numbers marked an improvement over years past and credited the government with making progress.

“The reduction of fake medicine to 3 percent is the result of the government’s efforts, including the Inter-Ministerial Committee to Fight against Counterfeit and Substandard Medicines,” he said.

Even with the lowered percentage of counterfeit pharmaceuticals on the market, the study called on the government to “improve and standardise pharmacy practices in the country” because nearly half of the packaging sampled had been opened or tampered with prior to sale.

Van Maaren also said this was a concern.

“When the packaging has been opened, you are no longer secure that what is in the box is what is on the label,” he said.

“It could have been opened in the pharmacy, or it could have been opened beforehand. Pharmacies shouldn’t accept something that’s already been opened.”

The study also found that non-licensed pharmacies were disappearing, especially in Phnom Penh, owing to enhanced regulatory efforts.

Heng Bun Keat said the government was “trying to find and eliminate illegal pharmaceutical shops, and also take control on the border because it’s a major place for transporting fake medicine”.

According to government data, the number of illegal pharmacies operating nationwide fell from 1,081 in November 2009 to 379 in March 2010.

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