Tiered Technology Strategies for Testing Poor Quality Medicines.

MARÍA EUGENIA MONGE; MANSHUI ZHOU; PRABHA DWIVEDI; JOEL KEELOR; MICHAEL PAYNE; CHRIS HARRIS; DAVID JENKINS; PAUL N. NEWTON; PATRICIA TABERNERO; FACUNDO M. FERNANDEZ

Philadelphia

Congreso; Pittcon; 2013

As with disease pandemics, the globalization of the pharmaceutical trade has the potential to rapidly spread poor-quality medicines worldwide before adequate detection and intervention are possible. There are three main categories of poor quality medicines; degraded, substandard and falsified (counterfeit). Substandard products arise as a result of lack of expertise, poor manufacturing practices, or insufficient infrastructure whilst those falsified are the ‘products’ of criminals. Degraded medicines arise from poor storage conditions. Falsified drugs may not contain the active ingredient, may contain the wrong ingredients or may even contain toxic compounds. Substandard drugs, for example, may contain active pharmaceutical ingredient (API) amounts that are in excess of ±15% of the stated amount. Distinguishing between these three classes requires simultaneously identifying and quantifying the expected (or wrong) APIs. In this presentation, we will describe tiered analytical strategies that we have employed in the investigation of counterfeit anti-infectives and contraceptives in developing countries as part of the Counterfeit Drug Forensic Investigation Network (CODFIN) of the ACT Consortium. CODFIN facilitates the forensic chemical and biological analysis of suspected poor quality drugs and the dissemination of this information. The chemical and biological results are returned to the organization submitting the samples as soon as possible, and it is also forwarded to the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). In this talk we will also describe new instrumentation based on ion mobility spectrometry for detecting falsified drugs in field settings, and its application to several case studies. Finally, we will briefly introduce a new tool for antimalarial quality mapping developed by the drug quality scientific group of the WorldWide Antimalarial Resistance Network (WWARN).