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Substandard and counterfeit medicines: A systematic review of the literature. BMJ Open 2013;3:e002923 (0)

by T Almuzaini, I Choonara, H Sammons
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Public Health Measures to Fight Counterfeit Medicine Market

by Saurabh Ram, Biharilal Shrivastava, Prateek Saurabh Shrivastava, Jegadeesh Ramasamy
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... delivery system.[3,4]sFindings ofsa systematic review revealed that thesprevalence ofscounterfeit drugs is high throughoutsAfrica and Asia in lower income countries andslower middle‑income countries.=-=[5]-=- Although, nossingle country is immune to the problem, thesmanner in which countries have been affectedsis variable ranging from production and tradesofsillegal medicines in developing countriessand c...

Counterfeit Drug Penetration into Global Legitimate Medicine Supply Chains: A Global Assessment

by Tim K. Mackey, Bryan A. Liang, Peter York, Thomas Kubic
"... Abstract. Counterfeit medicines are a global public health risk. We assess counterfeit reports involving the legitimate supply chain using 2009–2011 data from the Pharmaceutical Security Institute Counterfeit Incident System (PSI CIS) database that uses both open and nonpublic data sources. Of the 1 ..."
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Abstract. Counterfeit medicines are a global public health risk. We assess counterfeit reports involving the legitimate supply chain using 2009–2011 data from the Pharmaceutical Security Institute Counterfeit Incident System (PSI CIS) database that uses both open and nonpublic data sources. Of the 1,510 identified CIS reports involving counterfeits, 27.6 % reported China as the source country of the incident/detection. Further, 51.3 % were reported as counterfeit but the specific counterfeit subcategory was not known or verifiable. The most prevalent therapeutic category was anti-infectives (21.1%) with most reports originating from health-related government agencies. Geographically, Asian and Latin American regions and, economically, middle-income markets were most represented. A total of 127 (64.8%) of a total of 196 countries had no legitimate supply chain CIS counterfeit reports. Improvements in surveillance, including detection of security breaches, data collection, analysis, and dissemination are urgently needed to address public health needs to combat the global counterfeit medicines trade.

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"... rug therapy How safe is paracetamol? Kristina Star,1 Imti Choonara2 Paracetamol is the most widely used medi-cine in children, in hospital and in the com-munity. In most countries it is available over the counter and as a prescribed medicine. It is used as an analgesic and an antipyretic. Pain has h ..."
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rug therapy How safe is paracetamol? Kristina Star,1 Imti Choonara2 Paracetamol is the most widely used medi-cine in children, in hospital and in the com-munity. In most countries it is available over the counter and as a prescribed medicine. It is used as an analgesic and an antipyretic. Pain has historically been undertreated in children, especially in preverbal children. In contrast, fever is overtreated, especially in high-income countries. Concerns have been raised regarding the safety of paraceta-mol in relation to the development of liver

doi:10.4269/ajtmh.14-0393 Copyright © 2015 by The American Society of Tropical Medicine and Hygiene Responding to the Pandemic of Falsified Medicines

by Gaurvika M. L. Nayyar, Amir Attaran, John P. Clark, M. Julia Culzoni, Facundo M. Fern, James E. Herrington, Megan Kendall, Paul N. Newton, Joel G. Breman
"... 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 com-bating falsified pharmaceuticals include 1) lack of conse ..."
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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 com-bating 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

Substandard Antimalarials Available in Afghanistan: A Case for Assessing the Quality of Drugs in Resource Poor Settings

by Mirza Lalani, Harparkash Kaur, Nader Mohammed, Naiela Mailk, Albert Van Wyk, Sakhi Jan, Rishtya Meena Kakar, Mohammed Khalid Mojadidi, Toby Leslie
"... Abstract. Good-quality antimalarials are crucial for the effective treatment and control of malaria. A total of 7,740 individual and packaged tablets, ampoules, and syrups were obtained from 60 randomly selected public (N = 35) and private outlets (N = 25) in Afghanistan. Of these, 134 samples were ..."
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Abstract. Good-quality antimalarials are crucial for the effective treatment and control of malaria. A total of 7,740 individual and packaged tablets, ampoules, and syrups were obtained from 60 randomly selected public (N = 35) and private outlets (N = 25) in Afghanistan. Of these, 134 samples were screened using the Global Pharma Health Fund (GPHF) MiniLabÒ in Kabul with 33/126 (26%) samples failing the MiniLabÒ disintegration test. The quality of a subsample (N = 37) of cholorquine, quinine, and sulfadoxine/pyrimethamine tablets was assessed by in vitro dissolution testing following U.S. Pharmacopeia (USP) monographs at a bioanalytical laboratory in London, United Kingdom. Overall, 12/32 (32%) samples of sulfadoxine/pyrimethamine and quinine were found not to comply with the USP tolerance limits. Substandard antimalarials were available in Afghanistan demonstrating that continuous monitoring of drug quality is warranted. However, in Afghanistan as in many low-income countries, capacity to determine and monitor drug quality using methods such as dissolution testing needs to be established to empower national authorities to take appropriate action in setting up legislation and regulation. BACKGROUND Poor-quality drugs † in malaria-endemic countries are a threat to effective disease control and there has been an increase in reports of their detection in developing countries.1,2

RESEARCH ARTICLE Good Quality Locally Procured Drugs Can Be as Effective as Internationally Quality Assured Drugs in Treating Multi-Drug Resistant Tuberculosis

by Ejaz Qadeer, Razia Fatima, Katherine Fielding, Fahad Qazi, David Moore
"... Background Owing toGiven the high costs of drugs to treat multi-drug resistant tuberculosis (MDR-TB), the Green Light Committee (GLC) initiative enables TB programs to procure quality-assured drugs at reduced prices. Despite price reductions, internationally quality assured (IQA) drugs can be more e ..."
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Background Owing toGiven the high costs of drugs to treat multi-drug resistant tuberculosis (MDR-TB), the Green Light Committee (GLC) initiative enables TB programs to procure quality-assured drugs at reduced prices. Despite price reductions, internationally quality assured (IQA) drugs can be more expensive than locally procured drugs. There is little evidence to inform decision-makers about whether IQA drugs are more effective than local drugs. This is the first study to compare outcomes between MDR-TB patients treated using IQA, and locally procured drugs in the same hospitals during the same time period. Methods/Findings A retrospective cohort study was conducted in three hospitals across Pakistan. Data on baseline characteristics and treatment outcomes during the first six months of treatment were extracted from hospital records of adult culture-positive pulmonary MDR-TB patients starting treatment between January 2011 and June 2012. Two cohorts were defined: pa-tients receiving IQA drugs, and patients receiving locally procured non-IQA drugs. Data
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...ed in study hospitals was checked according to hospitals’ own guidelines. We recognize that ‘locally procured drugs’ encompasses a range of products which can include counterfeit and substandard drugs=-=[13]-=-, and that the drugs used in study hospitals may not be representative of all second-line antibiotics available on the local market in Pakistan or in other countries. Nevertheless, results from this s...

Substandard/Counterfeit Antimicrobial Drugs

by Theodoros Kelesidis, A Matthew E. Falagasb
"... ..."
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...d (57, 62), and the terms “substandard” and “counterfeit” were used interchangeably. Determining whether substandard drugs are also counterfeit is challenging, based on the limited available evidence =-=(59)-=-. In most cases, it is not known if the wrong concentration of the active component in a drug is the result of fraud, even after chemical analysis of a drug (59). In 2011, the WHO proposed the use of ...

doi:10.4269/ajtmh.14-0539 Copyright © 2015 by The American Society of Tropical Medicine and Hygiene Quality of the Antibiotics—Amoxicillin and Co-Trimoxazole

by Ifeyinwa Fadeyi, Mirza Lalani, Naiela Mailk, Albert Van Wyk, Harparkash Kaur
"... Abstract. Little is known about the quality of antibiotics despite being in high demand globally. Thirty five samples (27 brands) of the antibiotics amoxicillin (N = 20; 16 brands) and co-trimoxazole (N = 15; 11 brands), manufactured in six ..."
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Abstract. Little is known about the quality of antibiotics despite being in high demand globally. Thirty five samples (27 brands) of the antibiotics amoxicillin (N = 20; 16 brands) and co-trimoxazole (N = 15; 11 brands), manufactured in six

Correspondence to

by Tariq Almuzaini, Helen Sammons, Imti Choonara, Sammons H, Choonara I, Prepublication History
"... medicines in the UK: a retrospective review of drug ..."
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medicines in the UK: a retrospective review of drug
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...um Tc 99m (1), electrolyte infusion (1) and dextrose (1) Solution for injection Lack of sterility assurance at the time of manufacture Gen Teal Artificial Tears (1) Ophthalmic Solution Heparin sodium =-=(3)-=- Solution for injection Contamination with heparin-like contaminant Quetiapine (3) Tablets Cross-contamination of trace amounts of clindamycin in quetiapine active pharmaceutical ingredient during the...

Correspondence to

by Fadi El-jardali, Elie A Akl, Racha Fadlallah, Y Oliver, Fadlallah R, Et Al , 2014
"... Interventions to combat or prevent drug counterfeiting: a systematic review. BMJ ..."
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Interventions to combat or prevent drug counterfeiting: a systematic review. BMJ
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