PharmaChk, a new portable anticounterfeiting device, has received a $2 million transition-to-scale grant from Saving Lives at Birth: A Grand Challenge for Development. PharmaChk is being developed in conjunction with researchers at Boston University (BU) to detect and quantify active ingredients in medicines. According to the United States Pharmacopeial Convention (USP), the device has the potential to revolutionize how pharmaceutical industry players in the supply chain around the world detect poor-quality drugs. The grant will further the development of the new device and bring it closer to commercial production.
Other methods to screen for substandard or counterfeit products in the field are limited in their ability to quickly and accurately quantify the actual amount of active ingredient in a sample as well as to determine how quickly that active ingredient dissolves so it can work in the body as intended.
In the spring of 2014, the first pilot study using PharmaChk on medicine samples was conducted at USP’s Center for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana. USP opened CePAT in May 2013 to help expand the number of trained experts and available tools to combat substandard and counterfeit drugs.
“The toll that poor-quality medicines take on global public health—particularly among the most vulnerable populations in the developing world—is staggering, with 99% of all maternal deaths occurring in developing countries,” said Ronald T. Piervincenzi, PhD, chief executive officer of USP, in a press release. “Helping to ensure patient access to good quality drugs—including those used for neonatal care, to fight infectious diseases or to maintain good maternal health—is a leading priority for USP.”
According to Patrick Lukulay, PhD, USP’s vice-president of global health impact programs and director of the Promoting the Quality of Medicines (PQM) program, “Having the appropriate amount of an active pharmaceutical ingredient is key for any medicine to be effective. A poor-quality medicine can be one without enough active ingredient, which can lead to both preventable disease progression and to the development of drug resistance in patients and the community. In other cases, a medicine may have the correct amount of active ingredient but be of poor quality—for example not dissolve properly or contain impurities—due to poor manufacturing or storage practices, which can also compromise the medicine’s ability to bring a clinical benefit to the patient.”
PharmaChk is being developed with support from the PQM program, which is funded by the US Agency for International Development (USAID), and seed funding from the Saving Lives at Birth partnership. USP works collaboratively with USAID to implement PQM. The Saving Lives at Birth partnership includes USAID, the Government of Norway, the Bill & Melinda Gates Foundation, Grand Challenges Canada (funded by the Government of Canada), and the United Kingdom’s Department for International Development. Saving Lives at Birth is a global call for groundbreaking, scalable solutions to prevent infant and maternal deaths around the time of birth and supports a wide variety of work across maternal and neonatal health, family planning, nutrition, and HIV.