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Citation: Hetzel MW, Page-Sharp M, Bala N, Pulford J, Betuela I, Davis TME, et al. (2014) Quality of Antimalarial Drugs and Antibiotics in Papua New Guinea: A Survey of the Health Facility Supply Chain. PLoS ONE 9(5): e96810. https://doi.org/10.1371/journal.pone.0096810
Editor: Joshua Yukich, Tulane University School of Public Health and Tropical Medicine, United States of America
Received: January 10, 2014; Accepted: April 11, 2014; Published: May 14, 2014
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Copyright: © 2014 Hetzel et al. 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.
Funding: This study was financially supported by a Global Fund to Fight AIDS, Tuberculosis and Malaria round 8 grant through the Papua New Guinea National Malaria Control Program (http://www.theglobalfund.org/). The chemical assays for this study were conducted in a facility supported by National Health and Medical Research Council (NHMRC) of Australia Project Grant 634343. TMED is supported by a NHMRC Practitioner Fellowship, MWH in 2013 by the research fund (Forschungsfonds) of the University of Basel (http://www.unibas.ch/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.
Poor quality drugs have been increasingly recognized as a global public health threat because they have the potential to result in inadequate treatment, cause adverse effects from toxic ingredients, and promote drug resistance. The nomenclature of the categories of poor quality medications can be confusing. The World Health Organization recently chose to group all categories together as “SSFFC”: substandard, spurious, falsely-labeled, falsified, and counterfeit. Revision of these categories as: “substandard” - drugs that for unintentional reasons do not meet the legally required quality specifications of a country’s regulators, “unregistered” - drugs that do not have the legally required marketing authorization from the country’s regulators, and “falsified” - drugs that are unlawful, and violate the regulators quality specifications, with criminal intent was subsequently suggested (Attaran et al.2012). Fernandez, et al. raise the issue that a genuine drug found to have an insufficient amount of an active ingredient could be substandard or degraded (Fernandez et al.2011), indicating poor quality drugs can result from issues in production or external factors such as environmental conditions, impacting quality after distribution. Downloads primesense nite win32 api version.
The true extent of the problem is difficult to ascertain. Reasons for this include the difficulty and expense in performing a methodologically sound study, reluctance of governments to disclose information and the fact that many of the effects on patients are difficult to detect and hidden in other public health statistics (Cockburn et al.2005). In his 2010 article, Newton states there is an urgent need for data of sufficient sample size, with random sampling design to reliably estimate the prevalence of poor quality medicines (Newton, et al.2010) Literature reviews of prevalence studies on falsified/substandard drugs report that the percentage of substandard drugs in various Asian and African countries range from 8-46% (Caudron et al.2008), and the median prevalence of substandard/falsified medicines was 28.5% (range 11–48%) (Almuzaini et al.2013). The World Health Organization (WHO) conducted a survey on the quality of selected anti-malarial medication in 6 subSaharan African countries, which found that 28.5% of the samples failed to meet testing requirements, with 11.6% having extreme deviations, and therefore likely to have negative health implications (Sabartova et al.2011a). Another WHO survey was conducted on the quality of anti-tuberculosis medications in Russia, and found 11.3% of the samples failed to meet study specifications, with 1.0% having extreme deviations (Sabartova et al.2011b). In 1999, WHO conducted a survey of drug quality in Myanmar and Vietnam, and found that 16% of the samples did not meet all specifications of testing (Wondemagegnehu1999).
Between 2004–2006 the pharmaceutical procurement system in Mongolia underwent decentralization, and is now 100% privatized. In the current system, the Division of Pharmaceutical and Medical Devices, Mongolian Ministry of Health (MoH) is responsible for the policy, planning and regulatory affairs in providing pharmaceutical care in Mongolia. The special licenses for manufacturing, importing, purchasing pharmaceuticals and medical devices are granted by the Special Permission Committee of the MoH. Drugs are distributed through drug wholesalers and retail drug outlets (community pharmacies and revolving drug funds (RDF)). Wholesalers can import and procure drugs with an approval and special permission from the Mongolian Minister of Health. In 2011, there were 158 registered drug wholesaling companies and 42 local drug manufacturing companies, some of which act as both wholesalers and retailers. Approximately 85% of all drugs are imported from other countries, primarily Russia and India, followed by Germany, Slovenia and China.
Poor quality drugs have been a concern in Mongolia, supported by the findings from a 2006 study on unregistered, falsified and substandard drugs (Mongolia Ministry of Health2006). Using convenience sampling methods, 225 samples were collected from 40 drug outlets around the country, 55 of which were felt to be “suspicious” and were sent for further testing. Sixteen of these were felt to be “inconsistent” and 8 were possibly counterfeit. A 2008 study by Tsetsegmaa found that 11 of the 16 medications reported in the surveillance were substandard (Tsetsegmaa2008). In a 2009 report, lack of knowledge about the effectiveness of drug quality monitoring in Mongolia was reported as a gap that should be a priority for further investigation (Abdelkrim2009).
This research study was undertaken to address these concerns, and provide data of good methodological quality to accurately determine the prevalence of substandard drugs in the rural and urban areas of Mongolia after the decentralization and privatization of the Mongolian pharmaceutical system. This information will be of value to Mongolian policy makers, public health officials and pharmaceutical practitioners to reliably determine the extent of the problem, and then can serve as a valid comparison for future studies to evaluate interventions to improve the drug supply quality. It will also help guide further research to better understand the health impact of poor quality medications in Mongolia.