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Africa is making strides in fighting poor quality medicines, but more is action is needed, says Ronald Piervincenzi.
The global counterfeit drug trade, a multi-billion dollar industry, is thriving across Africa.
For mothers trying to buy life-saving medicines for their children, a trip to the pharmacy or drug shop can sometimes be like a dangerous game of Russian roulette.
There’s also a chance the mother leaves the pharmacy or other medicine outlets such as dispensaries with a medicine that’s not fake, but substandard in quality. When medicines are mishandled, mislabelled or improperly stored, they often end up ineffective, or worse, directly being harmful to the sick person who needs them.

The costs associated with the use of both counterfeit and substandard medicines — to individuals, families and health systems — are staggering. Every year, more than 122,000 African children under the age of five lose their lives as a result of counterfeit antimalarials alone. [1]
Poor quality medicines are also fuelling the spread of antibiotic resistance, a growing issue of global concern. [2]

“The costs associated with the use of both counterfeit and substandard medicines — to individuals, families and health systems — are staggering.”

Ronald Piervincenzi, USP

Many substandard medicines contain the correct active ingredient, but at a lower amount, which fails to properly kill bacteria, viruses or parasites. The most resistant of the “bugs” survive and multiply. Unfortunately, we’re watching this process unfold for some of the world’s biggest killers, such as tuberculosis and malaria, posing a serious public health threat within and beyond the African continent.
Counterfeit and poor quality medicines also place an enormous economic strain on families, who must dole out additional money to buy quality medicines or pay medical bills for hospitalisations caused by ineffective or harmful drugs. Countries, too, face economic losses.
Need for right tools
A major part of this problem is that substandard medicines, whether they contain the wrong levels of active ingredients or are contaminated, are difficult to detect without the right tools and know-how, especially in low-resource settings. The US Pharmacopeial Convention (USP), where I work, has been trying to address this issue around the world, including in Africa.
Three years ago, the USP opened the Center for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana, to improve pharmaceutical quality in Ghana and across Africa. The centre serves as a platform to train African professionals and build capacity for domestic and sustainable drug quality systems. Since 2013, CePAT has helped train 190 professionals from 32 African countries.
In addition to training, CePAT has also assisted with drug screening. In 2013, USP — through its Promoting the Quality of Medicines Program and in collaboration with Ghana Food and Drugs Authority (GFDA) — discovered serious issues with the quality of oxytocin, a drug used to treat excessive blood loss within 24 hours of birth. In fact, data showed that 90 per cent of the oxytocin tested in Ghana was substandard. [3]
Based on these findings, the Ghana FDA met with the ministry of health procurement unit to impress upon them the need to have all government-procured products vetted and registered by the FDA before they are imported into the country. The FDA also issued nation-wide press release informing the public about the poor quality batches and recalled them from the market.

Impacts of CePAT
This month (10 February), the USP and CePAT opened a brand new lab to train pharmaceutical and regulatory professionals in microbiology testing. Hopefully, thanks to this new lab, more pharmaceutical professionals across Africa will be able to learn to detect medicines that have been contaminated by microorganisms, and will be able to keep more people in their community safe from poor quality medicines arising from contaminated products.
What’s more, this lab was designed specifically for use in low-resource settings, meaning it could serve as a model for other countries and national laboratories to replicate.
Despite our efforts, millions of people across Africa can still be at risk every time they walk into a pharmacy or drug shop. Given the sheer number of fake and poor quality medicines on the market, we’re going to need quite a bit more help building the capacity to detect them.

“And, no matter how many fake and poor quality medicines we detect, our work is fruitless without the partnership of those who can enforce higher standards.”

Ronald Piervincenzi, USP

CePAT already offers scholarships to pharmaceutical professionals from across the continent. With additional resources, we could help bring more people from across Africa to Ghana to learn the skills they need to assess the quality of medicines in their home countries.
Importance of partnerships
And, no matter how many fake and poor quality medicines we detect, our work is fruitless without the partnership of those who can enforce higher standards. National governments must commit to ensuring safe medicines for their citizens. And then, they must make sure regulatory agencies are adequately staffed and equipped — and that their staff is properly trained. Communities, too, should get involved and hold their governments accountable for ensuring that only quality-assured medicines reach the shelves of local pharmacies, dispensaries or other medicine outlets.

Governments across the continent are already making great strides to improve health outcomes in their countries. Increased focus on stronger health systems and universal health coverage is pointing us in the right direction, toward a future where all Africans can access the health care and the medicine they need. Fake and poor quality medicines threaten this progress. As we work to increase access to medicines across the continent, we need to ensure that we’re increasing access to medicines that work. Millions of lives are depending on it.
Ronald Piervincenzi is the chief executive officer of the United States Pharmacopeial Convention (USP), which helps to set drug quality standards and improve drug quality assurance around the world. Follow Ronald on Twitter: @RonPiervincenzi
This piece was produced by SciDev.Net’s Sub-Saharan Africa English desk.


[1] John P. Renschler and others Estimated under-five deaths associated with poor-quality antimalarials in Sub-
Saharan Africa (The American Journal of Tropical Medicine and Hygiene, 3 April 2015)
[2] Nicholas White Antimalarial drug resistance and combination chemotherapy (Philosophical Transactions of the Royal Society of London B: Biological Sciences, 29 April 1999)
[3] Eric Karikari-Boateng Post-market quality surveillance project: maternal healthcare products (oxytocin and ergometrine) on the Ghanaian market report of first round (Ghana Food and Drugs Authority and USP, February 2013).