The handheld, battery-operated device, called CD-3, was developed at the FDA’s Forensic Chemistry Center in Cincinnati, Ohio, and uses wavelengths of light to compare unverified drugs with authentic ones.
The decision to test CD-3 in Ghana comes as a recent peer-reviewed study published in The Lancet estimates that over one-third of anti-malarial drugs tested in sub-Saharan Africa failed chemical or package analysis.
In addition, more than 90 percent of the world’s malaria deaths occur in Africa, and “counterfeit or substandard antimalarial drugs are being encountered with increasing frequency, especially as drug resistance drives the cost of malaria treatments higher,” Andrea Fischer, a spokeswoman with the FDA, told In-Pharmatechnologist.com.
A February report from USP (US Pharmacopeial Convention) found greater than 50% failure rates after testing analgesics commonly prescribed to control malarial fever in Ghana.
How the Program will Work
“The CD-3s will be deployed alongside the existing screening technology to test several brands of WHO [World Health Organization] prequalified anti-malarial combination therapies which are available on the Ghanaian market, including” the combinations of artemether/lumefantrine, and artesunate/amodiaquine, Fischer said.
The pilot program for CD-3 will supplement other collaborations in Ghana. The FDA also currently collaborates with the Ghanaian FDA through the use of “wet chemical and spectrophotometric approaches to screen drug products, and provide information to Ghanaian regulatory authorities for government enforcement action when counterfeit products are identified,” she added.
The CD-3 screenings will occur at five USP sentinel sites in Ghana where existing minilabs are currently deployed.
Patrick Lukulay, PhD, vice president of the Global Health Impact Programs at USP (US Pharmacopeial Convention) told In-Pharmatechnologist.com that the sites were established based on a few criteria:
- Geographical location, including vulnerable areas such as borders with other countries;
- Areas where the incidence of malaria is high; and
- Locations where the Ghanaian Food and Drug Authority has provincial offices and staff.
The monitoring sites were previously established as part of PQM (Promoting the Quality of Medicines Program) activities in Ghana, which is implemented by USP and funded by USAID (US Agency for International Development) and the President’s Malaria Initiative, Lukulay said.
“The PQM program in the country is effective and the Ghanaian Food and Drug Authority has demonstrated resolve in taking action to combat falsified and substandard medicines,” he added.
Samples brought to the sites will be “obtained from various levels in the distribution chain in Ghana, including hospitals, clinics, and pharmacies (public and private),” Fischer said. “Confirmatory testing of suspect products will be done at the national quality control laboratory and provided to Ghanaian regulatory authorities for government enforcement action.”
For the CD-3 project, USP plans to work with the FDA to test the CD-3 tool at the previously established PQM sites “as a complementary surveillance tool, along with other detection devices in use,” Lukulay noted.
In addition to field screening, “the national quality control laboratory conducts further testing of products as needed,” but the “CD-3 offers something that none of the other approaches can – it requires brief training to be used effectively by non-scientific personnel and the cost is relatively low, allowing it to be used in the field, in remote areas,” Fischer added.
Information obtained from the test in Ghana will guide a second pilot project to look at the effectiveness of the tool in detecting counterfeit or substandard anti-malarial products “at various levels of the pharmaceutical supply chain in a second location, yet to be determined,” she added.
The FDA also announced last week it has signed a letter of intent with Corning Inc. to refine and improve CD-3 for large scale manufacturing.
Meanwhile, on May 13, the USP center for pharmaceutical advancement and training will open in Ghana. The center aims to “provide training to regulatory authorities and medicines quality control professional in all Sub-Saharan Africa,” Claudia Costabile, a spokeswoman for USP, told us.