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[NOTE: This is an UPDATE to a case study initially published in 2009. Read the original case study for appropriate context.]

Significant progress is being made in the effort to stem the flow of counterfeit and substandard drugs in greater Mekong Asia, and valuable lessons have been learned, but there are still substantial challenges, according to Patrick Lukulay, director of the Promoting the Quality of Medicines (PQM, formerly the Drug Quality and Information) Program for the United States Pharmacopeia (USP).

“We measure success in three ways,” Lukulay says. “The first indicator is a decrease in the number of counterfeit and substandard drugs we find in our monitoring program, and I am happy to report that we are seeing a downward trend in the proportion of counterfeit and substandard drugs.”

“The second indicator is the number of regulatory actions that have been taken as a result of the monitoring program, and there have been a number of closures of retail pharmacies, particularly in Cambodia, as the result of our monitoring activities,” he says.

In 2009, there were estimates that approximately 1,100 illegal outlets were operating in Cambodia. As of October 2011, the Ministry of Health Department of Drugs and Food reported that fewer than 10 illegal outlets are still in operation following crackdowns by the authorities. Since the majority of counterfeit medicines are circulating in illegal or black markets, the drastic reduction in illegal outlets should result in a reduction in counterfeits in circulation and in public exposure to these harmful products.

He adds, “The third indicator is the level of awareness of the population of the issue of counterfeit drugs. Unfortunately, the awareness is not as pronounced as we would like it. We would like more awareness. To achieve this, we created a multi-pronged approach by designing materials for community outreach and education such as poster campaigns, radio and television public service announcements, and engaging local partners on the ground. In addition, over the past few years we developed the Pharmacide Media Initiative to increase public awareness about counterfeits, bringing together various co-sponsors to create a variety of media products targeted to populations in Southeast Asia.”

He notes that since the problem of counterfeit medicines in the region is so pervasive, it is very difficult to adequately cover all sectors and all populations at risk. Almost every type of drug and dietary supplement is counterfeited, and while quantification is extremely difficult, field observation indicates that antibiotics and antimalarials are the most counterfeited drugs. It requires working with partner organizations and governments to ensure a broad yet targeted approach to combat counterfeit medicines. Lukulay’s organization is in the process of designing a number of targeted behavior change communications strategies, as well as engaging donors and other partners on regional and international levels to address the issue.

He observes that several important lessons have been learned in the effort against counterfeit and substandard drugs. “One of the lessons is that it’s really going to take a regional effort to fight the counterfeit issue. We need to form a network of countries to get them to communicate better, share best practices, and exchange information so that a grain in one country is not reversed by the occurrence in another country.”

Another key matter that must be addressed is the issue of human resource depletion, Lukulay emphasizes. “Having people drop out is a huge problem. We train them, and as they obtain expertise, they become more valuable and leave the public sector for the private sector where the pay is higher. We have to establish a pool of experts in the region so there is constant replacement of human resources in the field.”

He adds there is also a significant need for coordination of donor efforts in the region to avoid duplication. “We need to find out who is helping who so that we can direct efforts to the right places,” he says.

Looking to the future, Lukulay points out that medicine quality monitoring efforts have not yet become sustainable within each country. “Governments have not been setting aside money to fund their own monitoring efforts,” he says. “All the monitoring activities have been funded by USAID, although we have been able to leverage funds from the Global Fund in Cambodia, and that is helping with the monitoring. In addition, the PQM program has increased its footprint in a number of countries, and the scope of work has increased. Also, we’re helping a number of local pharmaceutical manufacturers to improve their Good Manufacturing Practices, and the scope of our work in assisting national labs to gain accreditation has increased.”

Accreditations are important because they provide the evidence that a laboratory can conduct quality control testing in accordance with international standards and that the results they generate are accurate and reliable and can be used to take enforcement actions that are defensible.

Lukulay concludes, “The work is always done in partnership with the national government and local institutions that are doing similar work. The partnerships are improving; they are more aware of our work, and the relationships are getting stronger.”

By Jock Elliott