QRM Process

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

Funded by USAID, USP’s Drug Quality and Information Program was established to work closely with law enforcement agencies and local drug enforcement agency staff to improve quality assurance and control for medicines around the world. DQI established a training and quality monitoring program in Madagascar that is showing substantive results, and inspiring new programs just like it elsewhere in Africa and around the world.  In a recent interview with Pharmaceutical Manufacturing, DQI Director Patrick Lukulay discusses challenges and how they’re being overcome.

DQI has recently taken part in a study of antimalaria drug quality in Africa, a summary of which will soon be available.

PhM: Where is DQI focusing its efforts? 

P.L.: Our work in Madagascar is ongoing, and, altogether, we have targets in nine African nations. We are now exporting a program like Madagascar’s to Mali. We’re also working with Ghana. In addition, we’re extending other efforts in Russia and may start a program in Pakistan. Senegal and the Mekong region of Southeast Asia have been regions of focus as well. All told, we’re operating in 24 countries, and we aim to have strong drug quality monitoring programs established that cover all crucial border areas where we operate.

PhM: Please tell us about your program in Madagascar.

P.L.:  In 2003, the head of Madagascar’s drug regulatory authority approached USAID because he wanted to improve the country’s drug quality control and assessment system. Any time USAID receives a request, we are then charged with assessing existing systems, identifying gaps and areas that need strengthening. 

First, we worked with the local drug regulatory authority to assess quality systems. The following year, we provided HPLC, dissolution test, Karl Fischer, IR spectroscopy and other equipment to help the local regulatory authorities perform quality testing.

We then had to train people on how to use the equipment, and how to use good laboratory practices. We also helped provide a software product called SIAMED to improve the country’s system for drug registration. Madagascar’s regulators now have a computerized system that recalls all incoming drugs, expiration date, softness of drugs, and other key properties. 

Within two years, by June of 2006, technicians had reached the level of competence required.

USP Madagascar

Shown here, trainers involved in Madagascar's
drug quality monitoring program.

PhM: What were the biggest challenges with this program?

P.L.: The first was a scarcity of skilled personnel at the drug regulatory authority. They didn’t have required training, and there wasn’t enough equipment.

Another issue was staff retention. Many experienced staff members would leave for jobs with private industry because they paid better. Yet another concern was sustainability. These programs cannot last forever, and we wanted the program to continue effectively after we left.

PhM: We don’t often hear about Madagascar in connection with counterfeits. How bad was the situation there and what progress have you made so far?

P.L.: Within five years, our drug quality monitoring program, involving sentinel sites that test random samples in the field, showed that the percentage of fake or substandard drugs had slipped to 4%. Madagascar’s drug regulatory authority withdrew nine lots of product from the market in 2006, four lots the following year, but 16 lots in 2008.

Madagascar has also developed a pharmacovigilance program to monitor the safety of medicines newly introduced into the country. Together with the World Health Organization (WHO), we’ve trained staff in drug safety monitoring. Madagascar has just become a member of the WHO international drug monitoring program, and is reporting any adverse drug events to the WHO monitoring center in Uppsala, Sweden. 

So one year after we established the pharmacovigilance program, Madagascar is now taking a lead in monitoring and reporting among francophone sub-Saharan African countries.

PhM: How much does it cost to run something likeMadagascar’s drug quality monitoring program?

P.L.: The program costs $250,000 a year, and the amount of staff time spent is about 25-30% full time equivalent from USP.

PhM: How large a staff did you have and how did you prevent turnover at the local regulatory agency?

P.L.: We had to encourage the drug regulatory authority to recruit more people. The solution to attrition was interesting. We developed the lab to a point where it could perform contract analytical testing for private industry. This new business allowed the lab to get additional funds so that it could afford better salaries for staff.

PhM: What training is required for Madagascar’s QA and QC staff?

P.L.: The basic background required was a B.S. degree in chemistry or pharmacy. We didn’t have to recruit anyone outside of the country.

PhM: How many people were involved in this project?

P.L.: We had two staff members for the DQI program. So far, we’ve trained 18 staffers to work for the program; four people from USP are involved in various training programs.

PhM: $250,0000 per year seems an incredibly low figure for a project of this scope. How did you keep costs down?

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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