Recent Regulatory Efforts in Africa Aim to Fight Counterfeit Drugs
Improving drug quality and combating the threat of counterfeit and substandard medications were the goals of recent efforts by regulators and leaders across Africa, where fake drugs are a particularly serious problem.
Ghana
Regulators in Ghana last week found that substandard and counterfeit versions of 13 antimalarial drugs were in use in sites across the nation. The discovery of the fake medicines was made possible by the Medicines Quality Monitoring surveillance program, which is a collaboration between the Ghana Food and Drugs Board (FDB), the US Pharmacopeial Convention (USP), and the US Agency for International Development (USAID). The program was established in 2008 and is implemented by USP’s Promoting the Quality of Medicines (PQM) initiative, which aims to improve the drug quality in developing countries.
A recall of the antimalarial drugs was initiated, and the names of the outlets where the drugs were uncovered were publicized. According to a USP press statement, the release of those locations was “intended as a strong deterrent, making pharmacy and hospital procurement personnel more vigilant about their suppliers.”
Patrick Lukulay, director of the PQM program, said, “It’s important to keep in mind that all these fake and substandard medicines were found just in one round of postmarket surveillance, just of antimalarials. The existence of many more substandard and counterfeit medications for other types of medicines and in other locations and facilities must be assumed. Public education and official collaborations between public and private sectors are both essential to protecting public health here in Ghana and in many other developing nations.”
Liberia
Liberia established a new regulatory authority to oversee the country’s medicines by signing into law the Liberia Medicines and Health Products Regulatory Authority (LMHRA) Act earlier this month. The legislation addresses the growing problem of substandard and counterfeit drugs in the nation’s market, according to a USP press release. USP’s PQM found that postmarketing sampling and testing that the organization conducted in March 2010 revealed a failure rate of 44% when 104 of 234 samples tested failed either simple disintegration, thin-layer chromatography, or both.
“We celebrate this important milestone in the history of the pharmaceutical sector of our country,” Reverend Tijli Tarty Tyee, Sr., chief pharmacist of the Republic of Liberia, said in the press release. “We believe that the implementation [of this Act] will be the most important aspect of the law that can ensure the protection of the citizens within our borders.”
Zambia
A pharmacist in Zambia called on the government last week to empower regulators to help fight the spread of counterfeit drugs. According to an article in the Zambia Post, Christopher Sakala said in a presentation during the Stop Stockout Campaign anticounterfeiting seminar in Lusaka that the country’s Pharmaceutical Regulatory Authority needs more inspectors, saying that five for the entire country conducting inspections at two entry points is simply not enough.
“The Pharmaceutical Regulatory Agency needs to be equipped properly. It is a professional body that works very hard to check on the quality of medicines the Zambian patients consume. This is a body that is serious with issues of public health, but they work under difficult conditions,” Sakala said.
He also advised health institutions to employ licensed pharmacists to distinguish between legitimate and counterfeit drugs.
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