Why training pharmaceutical regulatory professionals is key to improving health in Africa

By assuring the quality of medicines such as antimalarials, the region's health outcomes can be improved.

ACCRA, Ghana — In a quiet corner of greater Accra, in North Dzorwulu, lies a nondescript and isolated building. Red brick on the outside, clinically white on the inside, it’s here, on the fourth floor that potentially significant improvements in Africa’s health are being made, particularly when it comes to tackling malaria.

These improvements don’t stem from medical interventions or innovations, but from training. This is Ghana’s USP home — a global health organization focused on medicine quality — where pharmaceutical regulatory professionals from across Africa meet in classrooms and laboratories to receive comprehensive, hands-on training, allowing them to better detect the continent’s substandard and falsified medicines and, with it, improve the region’s health outcomes.

Patrick Owusu Danso is one such trainee. Having worked in Ghana’s Food and Drug Administration laboratories for more than eight years, he told Devex that the training refreshed and enhanced his skills in several ways.

“In our lab, we had an instrument that we had not received training on. It was a good opportunity for us to learn this technique and apply it to our work,” he explained across the test tubes and machines inside the center’s lab. “It was a practical, hands-on training … We looked at how to apply the pharmacopeia, good implementation practices, and good quality control lab practices.”

“If you come to do humanitarian [work], especially if you're providing health care services to target populations, then access to good quality medicines is key.”

— Kwasi Poku Boateng, country manager, USP-Ghana

By providing specialized and practical training — in areas such as quality management systems, good manufacturing practices, and quality control procedures, for professionals to be able to identify and recall substandard products — Danso explained that Ghana’s FDA was able to test more medicines and, by recalling substandard products, enhance access to crucial medicines, including antimalarials, that actually work.

“As part of the quality surveillance activities of the FDA Ghana, we sample and test pharmaceutical products, especially antimalarials. I would say that with this training we were able to improve our capacity to test more,” explained Danso, highlighting how the training improved the FDA’s ability to deliver credible test results, as well as help the agency meet accreditation requirements.

Speaking from inside Ghana’s FDA offices, FDA Chief Executive Officer Delese Mimi Darko noted that their recent postmarketing surveillance showed that the prevalence of poor-quality antimalarials had dropped from over 30 percent in 2008 to 1.4 percent last year. She attributed some of the success in quality-assured antimalarials to the training of FDA staff. “We’ve noticed that we are much better in reviewing documentation because of this training. We’re able to pick up insufficiencies and therefore help to improve the quality of the products.”

Darko explained that effective antimalarials are critical, given Ghana’s status as the 10th in the world for high incidence of malaria.

“We have a lot of antimalarials on the market — some are locally manufactured, and some are imported — and when USP-Ghana started, we had a very high figure of [substandard] antimalarials,” she said, explaining the reduction in failure rate. Darko also noted that most people in Ghana are at risk of contracting malaria — even multiple times, “so if the drug quality is assured, that’s a very big improvement and we seem to be doing our work in protecting public health and safety.”

The problem of poor-quality medicines

According to 2017 research by WHO, 1 in every 10 medicines in developing countries is substandard or falsified, but most of these reports come from the African region. Poor-quality medicines, anything ranging from amoxicillin to antimalarials, can fail to treat the ailment intended and result in continued illness or even death; every year, up to 116,000 people in sub-Saharan Africa die from poor-quality antimalarials alone.

Poor quality can stem from inadequate manufacturing, improper storage, or poor distribution. Perhaps the pills or injections aren’t maintained at the appropriate temperature or are left to expire beyond their optimum efficacy. Medicines can also be entirely falsified by frauds capitalizing on the out-of-pocket expenses people often are forced to pay for such treatments.

Refreshing the regulators: The impact of training

Launched in 2013, the USP-Ghana center has been strengthening Africa’s medicines quality assurance systems, increasing the supply of quality-assured medicines, and developing capacity to detect and remove poor-quality products from the market. By sharing scientific expertise and providing technical support and leadership, they help local regulators improve and sustain local health systems and enable manufacturers to supply essential medicines that actually work.

This work is particularly important given a recent report by the World Health Organization, which found that 1 in 10 medicines in developing countries is substandard or falsified, with even higher levels in the African region, especially for medicines used to treat malaria and bacterial infections.

Given that regulators play the role of gatekeeper in ensuring medicines are good quality, safe, and effective, Kwasi Poku Boateng, country manager of USP-Ghana explained it is important they are trained to the highest levels.

“We realized that in most African countries there was a skills gap and a capacity constraint as far as medicines regulation was concerned,” said Boateng, adding that USP’s aim is to train this vital workforce to help in improving Africa’s health systems.

In the five years since the center opened, over 300 regulators, manufacturers, and academics from almost 40 African countries have received training, often free of charge. USP has funded around 90 percent of trainees so far, with further support coming from Merck KGaA in the form of sponsorship.

Training as a tool to improve medicine quality. Via YouTube.

Since its inception, USP-Ghana has also broadened its repertoire of courses, expanding from an initial two programs — on good manufacturing practices with quality control techniques and medicines registration dossier assessment — to the current 12 topics, while also incorporating programs in French and English. While many of these skills are part of initial pharmaceutical training, the USP-Ghana center offers a more in-depth and practical approach to detecting poor-quality products and even works with a local university to ensure newly qualified regulators and pharmacists get practical experience in detecting falsified and substandard medicines. Each semester, they offer training to 25 students to complement their formal education and put their theoretical knowledge into practice.

Dr. Isaac Asiedu-Gyekye, the dean of the University of Ghana’s pharmacy school, emphasized that while the university teaches about equipment and methods, visiting USP-Ghana allows students to see the reality of the work ahead of them.

“As a result of this exposure to modern-day equipment and methods of analyzing and determination of products, our students come out with skills, hands-on experience, and broadened knowledge,” he said.

Scaling Africa’s access to quality medicines

Boateng explained that by also working with regulators from different countries — Uganda, Nigeria, and Malawi — the organization is facilitating medicines regulation harmonization across Africa. A unified approach to detecting substandard products will make it more difficult for poor-quality or falsified medicines to cross borders and reach patients.

“One challenge we face is that because regulation is not the same in different countries, you have people who have some skills already, [while] some are virtually starting from scratch, so you need to give them the opportunity to develop,” said Boateng.

However, looking to the future, USP-Ghana plans to extend its work to address quality assurance, not only by working with individual country regulators but by concentrating on the supply chain too.

“At the market authorization stages and when a product gets into the distribution chain, if people don’t maintain the quality, it becomes a problem,” Boateng said.

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The challenge, he noted, is that while each country has one medicines regulatory authority, those in the supply chain are a diverse group from far-flung countries, meaning training would need to be on a much larger scale.

“It's quite difficult trying to engage them and get them in for training, but we think that that is an area that we would like to explore further,” said Boateng.

In addition, Boateng advised, there are still questions those working in the health sector should be asking themselves.

“If I have to dispense an antimalarial, do I have the skills to be able to do even a basic visual inspection to determine whether I'm potentially dealing with poor-quality or counterfeit medicines? And those donor programs who procure medicines, do they have the skills to use basic screening tools, at least to look out for poor-quality medicines?”

“If you come to do humanitarian [work], especially if you're providing health care services to target populations, then access to good quality medicines is key,”  Boateng observed, adding that the next frontier is to be able to train a critical mass of health workers. “They don't necessarily have to be the top experts who sit in medicines regulatory authorities, but those who interface with a patient on a day-to-day basis.”

Asiedu-Gyekye backed this up, noting that only by tackling poor-quality medicines can health outcomes improve.

“It’s about time we tackle this issue, and we can only do it when everyone is trained to appreciate the need for quality assurance and [has] the skills to perform all these tests and help maintain purity.”

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