Substandard/Counterfeit Antimicrobial Drugs

Kelesidis, Theodoros; Falagas, Matthew E.

doi:10.1128/cmr.00072-14

Cited by 175 publications

(195 citation statements)

References 127 publications

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“…Substandard antimicrobial drugs can result in administration of sub-optimal doses, which can lead to the development of antimicrobial resistance, especially with the use of a combination of antimicrobials such as anti-tuberculosis and antimalarial drugs [2].…”

Section: Original Articlementioning

confidence: 99%

“…According to both the United States Food and Drug Administration (US-FDA) and the World Health Organization (WHO), up to 10% of drugs worldwide are low quality medicines [2]. In developing countries, counterfeit medicines account for 10 to 30% of all medicines used, with rates higher than NAAS Rating: 4.14 30% in some regions of Latin America, South-East Asia or Sub-Saharan Africa [3].…”

Section: Introductionmentioning

confidence: 99%

“…They might also affect the economy of countries [4]. One of the serious effects on patients is that they can increase the morbidity and mortality of patients due to lack or insufficient therapeutic active ingredients [2]. Spread of internet pharmacies is a recent factor that has increased counterfeit medicines since the internet pharmacies, in most countries, have no regulations or registration processes [5].…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Analysis of Drug Contents of Cefotaxime Formulations Available in the Local Market and the Effect of Storage Conditions

Thamer¹,

Tjprc²

2018

IJMPS

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Section: Original Articlementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Analysis of Drug Contents of Cefotaxime Formulations Available in the Local Market and the Effect of Storage Conditions

Thamer¹,

Tjprc²

2018

IJMPS

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“…Counterfeit drugs waste individual incomes and lead to increases in government economic burden. Furthermore, these may decrease the overall public confidence in the efficacy of authentic medicines [3,4].…”

Section: Introductionmentioning

confidence: 99%

Blockchain Technology for Detecting Falsified and Substandard Drugs in Distribution: Pharmaceutical Supply Chain Intervention (Preprint)

Sylim¹,

Liu²,

Marcelo³

et al. 2018

Preprint

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BACKGROUND Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network. OBJECTIVE This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network. METHODS We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal. RESULTS Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type–specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history. CONCLUSIONS Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability. REGISTERED REPORT IDENTIFIER RR1-10.2196/10163

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“…Many studies regarding the quality of antimicrobial medicines have reported the circulation of a wide range of counterfeit and substandard medicines in many parts of Asia and Africa. All categories of antibiotics including old, common and new therapies such as the penicillins, macrolides, tetracycline, sulphonamides, quinolones and aminoglycosides have been affected 3,4,5 . These medicines have failed for a variety reasons including: no active pharmaceutical ingredient (API), too much or too little API, wrong API, inappropriate labelling, expired medicine, low bioavailability, failed disintegration and excessive degradation.…”

mentioning

confidence: 99%

Untitled

2016

IJPSR

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ABSTRACT:The persistent prevalence of poor-quality medicines in resourcelimited settings has contributed significantly to the alarming global trends in antibiotic resistance. Antibiotics are among the most used, abused and counterfeited medicines and therefore require regular monitoring and surveillance to provide reliable data for proper healthcare delivery. This study evaluated the quality of a total of 45 samples of Azithromycin, Erythromycin and Clindamycin distributed in Accra and Lagos by HPLC for active pharmaceutical ingredient (API) content and in-vitro dissolution for bioavailability. The results revealed that although all the samples contained the requisite API, only 27% were compliant with US Pharmacopoeia requirements for content. For Azithromycin and Clindamycin samples, the presence of excess API was the cause for non-compliance. Regardless of the high failure rate with respect to content, all Azithromycin samples exhibited good dissolution profiles, while 67% of Clindamycin and 36% of Erythromycin were compliant with invitro dissolution. These findings suggest that the population in the study sites and possibly in other parts of the sub regionis exposed to substandard antibiotics. Comprehensive measures by Drug Regulatory Authorities to monitor and enforce regulations governing production, importation, registration and storage of essential medicines are needed to address the problem.

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Substandard/Counterfeit Antimicrobial Drugs

Cited by 175 publications

References 127 publications

Analysis of Drug Contents of Cefotaxime Formulations Available in the Local Market and the Effect of Storage Conditions

Analysis of Drug Contents of Cefotaxime Formulations Available in the Local Market and the Effect of Storage Conditions

Blockchain Technology for Detecting Falsified and Substandard Drugs in Distribution: Pharmaceutical Supply Chain Intervention (Preprint)

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