Cutting Down Counterfeits in Cambodia: A Talk with USP's Lukulay

The fight against drug counterfeiting is one of endless challenges and, increasingly, proven victories. One recent triumph has been that, with help from the Promoting the Quality of Medicines (PQM) program, Cambodia has reduced the number of its illegal pharmacies by 65% and has taken great strides in managing its internal counterfeiting problem. We emailed USP's Dr. Patrick Lukulay, head of the program, to find out why the program is succeeding and if its lessons can be applied elsewhere:PhM: The PQM program helped Cambodia monitor illegal pharmacies and put together an action plan to close many of them, but what were the keys to actually being able to do so? How did the collaboration succeed so well? P.L.: PQM provides technical assistance, in collaboration with WHO and other partners, to the Ministry of Health Food and Drug Department, the Cambodian National Medicines Regulatory Authority to capacitate them in carrying out its key functions, one of which is strengthening the post-marketing surveillance. The key factors contributing to this success include: providing evidence-based data on medicines quality from the field to the MOH and Interministerial Committee to Combat Counterfeit and Substandard Medicines and Illegal Health Services (IMC) for action; improving the coordination and cooperation among parties within the IMC (health, customs, police, prosecutor, etc.) by convening regular meetings to discuss and plan for action; and the most importantly the new leadership, political will and commitments on the part of the Government, Ministry of Health, DDF and involved parties to take appropriate measure to close down the illegal outlets.

PhM: The PQM program relies upon "Minilabs" to assess the legitimacy of medicines in the market. What technologies serve as the basis for these labs, and do you continue to upgrade the technologies year to year?

P.L.: The PQM has been using the Minilab testing methods (basic tests) for screening of large number of samples for their basic quality attributes. The techniques used include:

1. physical/visual inspections for correct labeling, packaging and physical appearance of the products;

2. simple disintegration test, a prerequisite for dissolution property of a solid dosage form (tablets, capsule, etc.). If a product fails disintegration, it is unlikely that it would pass the dissolution test which is a test to determine a quality attribute of the product ability to absorb into the body system.

3. Thin-layer chromatography (TLC), a basic technique use to identify the presence of the active pharmaceutical in the product and semi-quantitatively determine its content.

After the basic tests, a subset of the samples are sent to the national quality control laboratories in accordance with the protocol for confirmatory analysis using compendial methods for assessing the samples' full physical and chemical quality attributes.

PhM: How will the program help Cambodia sustain this success and ensure that the illegal pharmacies do not proliferate again? Will the Cambodian government eventually assume full responsibility for suppressing illegal pharmacies, or will PQM maintain a presence?

P.L.: PQM is working alongside other organizations such as WHO, Interpol, and others to help provide assistance in addressing the issue of counterfeit and substandard medicines in Cambodia, which has always been challenging. The Cambodian Government is taking effective and decisive actions to stave off the proliferation of unregulated, counterfeit, or substandard medicines by closing illegal outlets, showing that they are recognizing the problem and doing something about it. It's a positive step forward for Cambodia that is seems that high ranking officials in the ministry are committed to solving this problem.

PhM: Resources for tracking and cracking down on such pharmacies are always limited, no matter what country. What lessons can be learned for other countries with similar issues, operating on limited resources?

P.L.: Closing illegal outlets is one aspect of dealing with the problem. However, there are many other facets to ensuring quality medicine in the pharmaceutical sector in Cambodia including procurement issues, importation, distribution, cold chain management, reliability/transportation, making sure that the medicines quality control labs are capacitated, regulatory authorities have adequate power and authority for greater impact, drug inspectors are effective, cooperation between ministries (interior-law enforcement, customs, health, etc) is effective.

--Paul Thomas