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.
