Image of a stack of boxes marked

Keeping Medicines Safe .

Counterfeit and substandard medicines put millions of lives at risk in developing countries. In Kenya, Chemonics is equipping local testing labs to root out these killers.

In countries like the United States, many patients take for granted that the medication they pick up at their local pharmacy, whether for heart disease or the common cold, meets high quality standards. That the right amount of the active ingredient is present. That it has not deteriorated. That it does not contain harmful agents.

Unfortunately, acquiring medication is a riskier proposition for millions in poverty. According to the U.S. Food and Drug Administration, up to 25 percent of medicines in the developing world are counterfeit or substandard. In Kenya, low-quality medicines have proliferated due to weak regulations and inadequate infrastructure in local quality testing laboratories. The flow of these drugs into pharmaceutical supply chains poses a serious public health threat, with potentially fatal consequences.

For the past five years, USAID and Chemonics have managed and strengthened Kenya’s largest antiretroviral (ARV) supply chain through the Kenya Pharma project, serving 420,000 people living with HIV who are on antiretroviral therapy (ART). As Chief of Party Ruth Njoroge explains, ensuring quality has always been a top priority:

“If quality is poor, we’re not doing much to help patients. For people living with HIV, this means more than quality ARVs. They also need quality medicine for opportunistic infections,” she said.

“I go to meetings with Kenyan suppliers and tell them we can have test results in a few days, and they don’t believe me. They want me to hire other companies. But I tell them, ‘Believe it.’ Then it happens, and they are astonished."

Ruth Njoroge, chief of party of Kenya Pharma

“If quality is poor, we’re not doing much to help patients. For people living with HIV, this means more than quality ARVs. They also need quality medicine for opportunistic infections."

Ruth Njoroge, chief of party of Kenya Pharma

“We believe that NQCL’s prudent use and servicing of the donated equipment will undoubtedly lead to curbing of counterfeit, spurious, and sub-standard medicines in the market, meeting the government’s goal of ensuring that the medicines availed to the public are safe and of high quality."

Dr. H.K. Chepkwony, director of NQCL.

To improve Kenya’s ability to meet its own pharmaceutical testing and post-market surveillance needs in the long term, the Chemonics team worked with two local testing laboratories: the National Quality Control Lab (NQCL) and Mission for Essential Drugs and Supplies (MEDS). The team supplied each lab with equipment that speeds up testing times and improves the accuracy of results by reducing contamination and the need for retesting. It also built a state-of-the-art electronic laboratory information management system (LIMS) that enables the labs to track and trace samples, speeding up analysis and reporting, and trained staff in how to use the system. Finally, by contracting the labs for quality assurance testing, Pharma provides ample opportunities to gain experience and generate revenue to be reinvested in the labs.

“We believe that NQCL’s prudent use and servicing of the donated equipment will undoubtedly lead to curbing of counterfeit, spurious, and sub-standard medicines in the market, meeting the government’s goal of ensuring that the medicines availed to the public are safe and of high quality,” said Dr. H.K. Chepkwony, director of NQCL.

2

local testing laboratories provided with equipment, training, and business opportunities

420,000

people living with HIV on antiretroviral therapy served through project

5

days' turnaround time for laboratory tests; down from 50 days previously

With access to this training, equipment, and business opportunities, the laboratories have already seen their turnaround times have go from 50 days to just five days. Ultimately, the labs have been able to test a greater number of samples per month and deliver more reliable results, giving local stakeholders more confidence in their capabilities and generating more revenue.

“I go to meetings with Kenyan suppliers and tell them we can have test results in a few days, and they don’t believe me. They want me to hire other companies. But I tell them, ‘Believe it.’ Then it happens, and they are astonished,” said Ms. Njoroge.