Global QC: On the Front Lines With DQI’s Patrick Lukulay

USP’s Drug Quality and Information Program is establishing training programs around the world. Its Madagascar program offers a model.

By Agnes Shanley, Editor in Chief

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P.L.: We had to be creative. For example, at the drug quality monitoring centers, we recruited university medical students during school holidays. After about a week of training they were ready to work with mini field labs, and we paid them per diem.

PhM: How do you think local authorities should react to cases of unintentionally substandard vs. counterfeit product?

P.L.: Substandard and counterfeit drugs are converging, so we believe that both cases should be treated as equally bad. It used to be that counterfeiters would use no or too little active ingredient. They now use the right active ingredient, but in adulterated or diluted form. We are raising awareness about poor quality products and the shops that sell them among formulators and the public.

PhM: What work is DQI doing in Russia?

P.L.: Russia has seen a huge emergence of multi-drug-resistant tuberculosis, so the efficacy of various treatment methods has been going down drastically. USAID wants us to conduct a study of the prevalence of substandard TB drugs [in Russia] to see whether drugs are being administered at the right concentrations, since microbes can develop resistance when patients receive too little of the active ingredient. We’re also assessing the impact of a book on prescribing practices in Russia, which we began publishing about 2-3 years ago.

PhM: Is your work in Madagascar completed?

P.L.: It’s still ongoing. We’re now expanding the technicians’ analytical scope, introducing them to bacterial endotoxin measurements.

PhM: Were there challenges you faced in working with local law enforcement?

P.L.: Madagascar has been a successful program because we received so much cooperation from law enforcement. Every time a product was identified as substandard or counterfeit, government action followed immediately. As a result, we have seen consistent improvement in product quality. Traders and manufacturers know that lots have been withdrawn, and shops closed, after poor quality material was detected.

It helped that, at the outset of the program, we established a memorandum of understanding (MOU) with government and law enforcement that spelled out our aims and expectations, clearly, setting a path for the program.

PhM: How would you characterize other nations’ enforcement commitment? 

P.L.: Some countries are very vigilant in taking enforcement actions, like Madagascar. In other cases, challenges remain. In Senegal, for instance, religious groups have strong influence over the government and some people affiliated with these groups are in the pharmacy business. In such cases, it can be difficult for the government to take strong action. In some nations, corruption is rampant, and government officials are often paid to be quiet. In Cambodia, when the Ministry of Health’s staff learns of counterfeited products, they do not have the authority to take action but must call the police. In some cases, manufacturers have bribed police.

What we try to do is to try to make alliances with international agencies like Interpol, as well as UNODC, the United Nations Office on Drugs and Crime, because they tend to have a bigger voice with governments. 

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