WHO To Evaluate Cambodia’s AIDS Drugs

A World Health Organization-ap­pointed expert is in Phnom Penh to evaluate the quality of the first Cambodian-made generic an­ti­-retroviral drugs and to prepare a re­port assessing the requirements for the drug to meet WHO quality standards.

With 2.6 percent of the population from 15 to 49 years old in­­fected with HIV, the virus that causes AIDS, and more than 20,000 people with the disease itself, Cambodia is considered to have the highest HIV rate in Southeast Asia.

According to Ly Penh Sun, chief of the technical bureau at the Na­tion­al Center for HIV/AIDS, about 1,300 patients are currently being treated with imported anti-retroviral drugs, which are used to treat AIDS by reducing the disease to a chron­ic medical condition.

Three months ago, the Cambo­dian Pharmaceutical Enterprise, launched the first Cambodian-made anti-retrovirals on the market. The company, half-owned by the government, re­ceived the Min­is­try of Health’s Good Manu­fac­turing Practice certificate and pro­­duces seven types of ARVs.

“The anti-retroviral drugs we chose to produce correspond to the national protocol,” CPE Di­­rec­tor Huot Sarim said. But the current de­mand for the drug is low.

Indeed, the main entities using ARV drugs in Cambodia—international NGOs Medecins Sans Fron­tieres-France, MSF-Belgium, Med­­ecins du Monde and Siha­nouk Hospital-Center of Hope—do not wish to use drugs that have not received a certificate of quality by an internationally recognized or­ganization.

“We do not use drugs that have not received the World Health Or­gan­ization’s quality standards,” said Jennifer Hines, medical director for the Center of Hope.

It could take months before the drug receives the WHO certificate, but “if they get it, I don’t see why we wouldn’t use them,” said MSF Chief of Mission Catherine Quillet.

But the drugs used by medical in­stitutions also depends on what has been stipulated by funding sources and intermediate entities handling those funds, experts said.

“If an organization funding these NGOs via the Ministry of Health allows the use of drugs that on­ly have a national GMP certificate, it’s not impossible that the care institutions end up with some Cam­bodian ARVs,” said Pharm­aciens Sans Frontieres Coordin­ator Alexis de Suremain. “But that hasn’t happened yet.”

Domestically made ARVs can al­ready be found in five of the big­gest pharmacies in Phnom Penh, and in two pharmacies in Siem Reap and Banteay Mean­chey province, Huot Sarim said.

“We give the drugs to about five to 10 patients a month,” said Koy Par­ady, manager of La Gare pharmacy in Phnom Penh. “These pa­tients come with a prescription or show us an old box of the drug they need.”

Aside from the issue of drug quality, AIDS experts say the availability of ARVs in pharmacies is a major danger in Cambodia.

As AIDS experts explain, an in­appropriately prescribed drug, or the lack of compliance with a competent physician’s prescription and schedule, can lead to disastrous ef­fects, such as developing drug re­sis­tance and the further possibility of transmitting of drug-resistant strains of HIV.

Although pharmacists insist they control who receives ARVs, it is a known fact that the drugs are often provided to patients over the counter, Quillet said. “It’s a particular problem in Cam­­bodia,” she said, “In other countries, there are re­gulation systems, but in Cam­bodia you do not have an actual policy to try to stop it.”

It is also said that about 80 percent of prescriptions given by “recognized prescriptors” are not in line with national protocols, ac­cording to de Suremain.

“Few people are actually capable of prescribing ARVs,” said Quillet. “We train the Cambodian doctors with whom we work, but the other ones do not yet have the education or experience to prescribe the drugs.”

Pharmaciens Sans Frontieres and Center of Hope plan to open a cen­ter that will focus on the ac­cred­itation of doctors, in the public sector as well as in the private sector.

Accredited physicians will later be allowed to send their patients to the center’s pharmaceutical outlet to get cheaper ARV drugs than the ones found in pharmacies. The program, sponsored by the Global Fund, is scheduled to start in January.


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