IOM report offers recommendations to combat distribution of fake, substandard medicines

The Institute of Medicine of the National Academies "is urging stronger regulation of pharmaceuticals around the world to combat the growing problem of fake and poor-quality medicines," NPR's "Shots" blog reports (Knox, 2/13). "The risks of fake and flawed medicines have leapt from developing nations to Western supply chains, thanks to gaps in oversight of drug wholesalers, lax law enforcement, and ineffective tactics for tracking drugs as they change hands, according to a report released Wednesday by the Institute of Medicine," the Wall Street Journal's "Corporate Intelligence" blog states, adding, "The authors of the ... study note that data and peer-reviewed research is thin and the scope of the problem is elusive" (Weaver, 2/13). However, "[o]ne 2011 investigation revealed that falsified or substandard drugs have been sold in at least 124 countries," HealthDay/U.S. News notes (Gardner, 2/13). "Counterfeit and substandard medications with little or no active ingredients can hasten drug resistance, do not treat disease, and boost health care costs," Agence France-Presse/GlobalPost writes, adding "products that contain dangerous ingredients have sickened and killed people around the world, the report explains" (2/13).

Among other recommendations, the 300-page report "says Congress needs to authorize the FDA to trace the authenticity of medications from raw ingredients to manufacture and through the distribution chain all the way to retail pharmacies"; "calls on the FDA to work with state licensing boards to regulate and report pharmacies [that violate standards] and launch a national database to report violators"; "calls on the World Health Organization to develop a global code of practice for pharmaceuticals"; and recommends "that the World Bank and other agencies provide low-interest loans to medium and small pharmaceutical companies in developing countries to beef up their equipment, supply chain and quality-control systems," according to NPR (2/13). "FDA Commissioner Margaret Hamburg didn't comment on the tracking system proposal but the agency already had begun some steps to better address the issue, including improving surveillance," the Associated Press/ABC News writes (Neergaard, 2/13).