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Poor quality medicines have a wide range of public health impacts, ranging from poor outcomes, including treatment failure and even death economic consequences for patients, for the society, and the legitimate pharmaceutical industry and engendering drug resistance. Recent cases of poor quality medicines include contaminated isosorbide mononitrate, which led to 125 deaths in Pakistan anti-visceral leishmaniasis medications found in Bangladesh that did not contain any of the expected active pharmaceutical ingredient (API) miltefosine and contaminated methylprednisolone injections that led to an epidemic of fungal infections in the US. Much of this work has focused on antimalarials, but there is evidence that poor quality antibiotics and anti-tuberculosis drugs are focally common. Over the last decade, there has been increasing interest and concern regarding the quality of medicines worldwide, stimulating research into their epidemiology and novel detection methods. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.Ĭompeting interests: The authors have declared that no competing interests exist. Paul Newton is supported by the Wellcome Trust of Great Britain ( ). The authors are also thankful for access to MS instrumentation acquired through the ACT Consortium and the NSF/NASA Center for Chemical Evolution. PD was partially supported by the ACT Consortium ( which is funded through a grant from the Bill & Melinda Gates Foundation to the London School of Hygiene & Tropical Medicine. All drug purchasing was handled in-country by an independent organization subcontracted by FHI 360. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.įunding: Sample collection, HPLC analysis, dissolution testing and TLC screening were funded through a contract between Prosalud Inter Americana ( ) to FHI 360. Received: NovemAccepted: MaPublished: April 18, 2014Ĭopyright: © 2014 Monge et al.
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PLoS ONE 9(4):Įditor: Wei Yan, University of Nevada School of Medicine, United States of America (2014) A Tiered Analytical Approach for Investigating Poor Quality Emergency Contraceptives. Further chemical characterization of the poor quality ECP samples included the identification of the excipients by 2D Diffusion-Ordered Nuclear Magnetic Resonance Spectroscopy (DOSY 1H NMR) indicating the presence of lactose and magnesium stearate.Ĭitation: Monge ME, Dwivedi P, Zhou M, Payne M, Harris C, House B, et al. Quantitation by UHPLC-triple quadrupole tandem MS (QqQ-MS/MS) indicated that the wrong ingredient was present in the ECP sample at levels which could have significant physiological effects. By combining ultrahigh performance liquid chromatography-ion mobility spectrometry-mass spectrometry (UHPLC-IMS-MS) and direct analysis in real time MS (DART-MS) the unknown compound was identified as the antibiotic sulfamethoxazole. One batch was found to contain a wrong active ingredient, with no detectable levonorgestrel. In a survey to assess ECP medicine quality in Peru, 7 out of 25 different batches showed inadequate release of levonorgestrel by dissolution testing or improper amounts of active ingredient. In response to the detection of poor quality ECPs commercially available in the Peruvian market we developed a tiered multi-platform analytical strategy. Emergency contraceptive pills (ECPs) are an important birth control method that women can use after unprotected coitus for reducing the risk of pregnancy. Reproductive health has been deleteriously affected by poor quality medicines.