Responding to the Pandemic of Falsified Medicines

Abstract

Over the past decade, the number of countries reporting falsified (fake, spurious/falsely labeled/counterfeit) medicines and the types and quantities of fraudulent drugs being distributed have increased greatly. The obstacles in combating falsified pharmaceuticals include 1) lack of consensus on definitions, 2) paucity of reliable and scalable technology to detect fakes before they reach patients, 3) poor global and national leadership and accountability systems for combating this scourge, and 4) deficient manufacturing and regulatory challenges, especially in China and India where fake products often originate. The major needs to improve the quality of the world's medicines fall into three main areas: 1) research to develop and compare accurate and affordable tools to identify high-quality drugs at all levels of distribution; 2) an international convention and national legislation to facilitate production and utilization of high-quality drugs and protect all countries from the criminal and the negligent who make, distribute, and sell life-threatening products; and 3) a highly qualified, well-supported international science and public health organization that will establish standards, drug-quality surveillance, and training programs like the U.S. Food and Drug Administration. Such leadership would give authoritative guidance for countries in cooperation with national medical regulatory agencies, pharmaceutical companies, and international agencies, all of which have an urgent interest and investment in ensuring that patients throughout the world have access to good quality medicines. The organization would also advocate strongly for including targets for achieving good quality medicines in the United Nations Millennium Development Goals and Sustainable Development Goals.

Tackling the Problems Associated with Antimalarial Medicines of Poor Quality

“…These tools would also empower those inspecting the medicines throughout the supply chain [7]. Rather than having to wait for the samples to be sent to national or international laboratories, results would be available more or less immediately [7].…”

“…These tools would also empower those inspecting the medicines throughout the supply chain [7]. Rather than having to wait for the samples to be sent to national or international laboratories, results would be available more or less immediately [7]. Current methods for testing the quality of drugs in the ield include visual packaging inspection, lot number reporting via mobile phones, thin-layer chromatography, colorimetric tests, and simpliied spectroscopic methods [2,7].…”

“…Such tests can be conducted using quick, inexpensive methods in the ield with the aim of examining packaging and detecting drug contents [7]. These tools would also empower those inspecting the medicines throughout the supply chain [7].…”

“…Tests capable of accurately detecting and classifying poor-quality medicines at the point of entry into countries and at public and private pharmacies are essential for understanding the types, names, extent, and amount of poor-quality medicines being dispensed both nationally and globally [2,7].…”

“…The lost productivity and increased healthcare costs associated with the use of poor-quality antimalarials generally occur in resource-constrained countries that are already disproportionately bearing the global cost of malaria [36,40]. These countries generally lack the increased inancial resources needed to inspect, analyze and police the antimalarial supply chain [7].…”