Query: counterfeit medicine substandard falsified

title: Blockchain Based Counterfeit Medicine Authentication System
abstract: For a few decades, it is a very big challenge to monitor and keep track of genuine medicine in health care. Lacking a trust system and strong monitoring authority, syndicates can make counterfeit medicine easily. With the shifting of life critical healthcare, it becomes an emergency to ensure substandard drugs. Because counterfeit medicine has a deadly effect on the human body and has disastrous results. To detect the falsified medicine, we proposed a drug tracing system using blockchain technology. Our system is able to detect substandard and anomaly drugs from manufacturer company to patient's hand. Also can verify the defective and expired drugs in the market using smartphones by scanning QR (Quick Response) code. Blockchain security could make the system more transparent and reliable. This paper aims to ensure drug quality, transaction security, and data safety using blockchain technology.

title: Poor Quality Medicines in Cameroon: A Critical Review.
abstract: Poor quality medicines are the cause of many public health and socioeconomic problems. We conducted a review to acquire an overview of the situation concerning such medicines in Cameroon. Different searches were performed on databases from several websites of the WHO, the Ministry of Public Health of Cameroon, the Anti Counterfeit Medicine Research Institute, the Global Pharma Health Fund, and the Infectious Disease Data Observatory. We identified 92 publications comprised of 19 peer reviewed studies and 73 alerts. Based on studies completed, 1,664 samples were analyzed, and the prevalence of substandard and falsified (SF) medicines could be estimated for 1,440 samples. A total of 67.5% of these samples were collected from the informal sector, 20.9% from the formal sector, and 11.6% from both sectors. We found a prevalence of SF medicines across the peer reviewed studies of 26.9% whereas most of the SF medicines belonged to the anti infective class. The problem of SF medicines is not studied sufficiently in Cameroon; therefore, efforts should be made to conduct adequate studies in terms of representativity and methodology.

title: Time to Invest in Medicines Resilience
abstract: The Falsified Medicines Directive (FMD 2011/62/EC) (European Commission 2011) is designed to eliminate counterfeit medication and limit potential risk of harm to the public. We know that the world has changed since this directive was conceived. While enshrined in law (Moore 2019) we risk not being able to deliver on this directive (Barrett Al Mousawi 2018; Barrett 2020) The UK leaves the Europe Union on the 31st of December 2020, with it access to the 'national verification system' whereby dispensed medicines get verified against a European central database for their authenticity is lost. This makes the UK a target for flow of falsified medicines into its domestic market and as a route into Europe. Nobody wants this, except the spurious agents involved in the business of providing substandard medication. The UK also provides globally admired universal care and is responsible for securing and supplying medicines to patients via the NHS. Medicine costs have been rising (Acosta et al. 2019; Batista et al. 2019; European Medicines Agency 2018; Hughes 2019; Miljkovic et al. 2019) and can be linked to currency fluctuations and policy (Ewbank 2018; Kanavos et al. 2011; Kanavos et al. 2020) The concern is that there will be potential trade wars and with them, further volatility (e.g. currency, geopolitics, supply routes, and natural resources) putting medicine access at risk. Globally, we face increasingly difficult choices with concern about patients' access to medicines. The path to regulatory approval also seems convoluted and expensive for most small scale manufacturers. Increasingly, there are fewer large manufacturing sites and these are controlled by a few market participants. Looking at strategic, regional, and political pressures is vital when thinking about securing medicine supply across the world. Resources and research need to be dedicated to this area, as its importance is likely to grow.

title: Mobile apps for detecting falsified and substandard drugs: A systematic review
abstract: The use of substandard and counterfeit medicines (SCM) leads to significant health and economic consequences, like treatment failure, rise of antimicrobial resistance, extra expenditures of individuals or households and serious adverse drug reactions including death. Our objective was to systematically search, identify and compare relevant available mobile applications (apps) for smartphones and tablets, which use could potentially affect clinical and public health outcomes. We carried out a systematic review of the literature in January 2020, including major medical databases, and app stores. We used the validated Mobile App Rating Scale (MARS) to assess the quality of apps, (1 worst score, 3 acceptable score, and 5 best score) We planned to evaluate the accuracy of the mobile apps to detect SCM. We retrieved 335 references through medical databases and 42 from Apple, Google stores and Google Scholar. We finally included two studies of the medical database, 25 apps (eight from the App Store, eight from Google Play, eight from both stores, and one from Google Scholar) and 16 websites. We only found one report on the accuracy of a mobile apps detecting SCMs. Most apps use the imprint, color or shape for pill identification, and only a few offer pill detection through photographs or bar code. The MARS mean score for the apps was 3.17 (acceptable) with a maximum of 4.9 and a minimum of 1.1. The 'functionality' dimension resulted in the highest mean score (3.4) while the 'engagement' and 'information' dimensions showed the lowest one (3.0) In conclusion, we found a remarkable evidence gap about the accuracy of mobile apps in detecting SCMs. However, mobile apps could potentially be useful to screen for SCM by assessing the physical characteristics of pills, although this should still be assessed in properly designed research studies.

title: The Epidemic of Substandard and Falsified Medications in Iraq: Evaluating the Effectiveness of National Pharmacovigilance Alerts to Community Pharmacies
abstract: Assessing Iraqi experience with the impact of substandard and falsified (S/F) medicines can help other countries deal comprehensively with the underlying causes of this multifactorial problem. The tools used in this study to assess strategies to prevent the use of S/F medications can be used in other developing countries. This study investigated the problem of S/F medications at three levels: the Ministry of Health (MOH) pharmaceutical company representatives, and community pharmacists.  Study objectives were to evaluate the effectiveness of alerts about S/F medications issued by the national Iraqi Pharmacovigilance Center (IqPhvc) to community pharmacies and to explore the reasons and potential solutions for this problem from the perspective of both pharmaceutical companies and pharmacists.  This was an exploratory mixed method study. The qualitative phase comprised seven 1 h semi structured interviews and one focus group conducted via Zoom. Thematic analysis was used to analyse the qualitative data. The findings of the qualitative phase were then used to develop the survey items. The quantitative phase included an electronic survey distributed among pharmacists via two professional Facebook groups between 23 April and 19 May 2020. The Kruskal Wallis test was used to measure differences in pharmacists' knowledge of and ability to detect S/F medications according to their years of experience in the private sector.  Over the last 5 years (2016 2020) the IqPhvc received 183 reports about S/F medications from representatives of 25 international companies. Only 29 (15.8% of the reports were about falsified medications; the majority were about substandard (parallel) medicines. We interviewed 12 pharmacists (11 male, 1 female) representing ten large international pharmaceutical companies. We also received surveys from 590 pharmacists, of whom 475 (80.9% were women. Although 72% of the participants had not received any training in the identification of S/F medications, 59.4% of them easily identified S/F medications. Likewise, approximately three quarters of the participating pharmacists recognized genuine registered medications through three means: medication price sticker, cost, and packaging features. Although 61% of the pharmacists followed up alerts about S/F medications, only 25.6% were willing to report S/F medications.  Most reports to the IqPhvc were about substandard medications. Participants of the two study phases agreed on several reasons for the problem of S/F medications, including their low prices, the unavailability of registered medications, the lengthy medicine registration process, and inadequate awareness of S/F medications among healthcare providers and the public. They also agreed that national alerts and price stickers are helpful in the identification of S/F medications. Community pharmacists can increase their efforts to report S/F medicines, but they need training, awareness, and tools. The study highlighted the need for a track and trace system to detect S/F medicines in the supply chain. In brief, the problem of S/F medication is multifaceted. Reducing it will require effective collaboration among different entities, including health officials, border agencies, healthcare providers, and registered pharmaceutical companies.

title: Cost savings of paper analytical devices (PADs) to detect substandard and falsified antibiotics: Kenya case study.
abstract: Over 10% of antibiotics in low and middle income countries (LMICs) are substandard or falsified. Detection of poor quality antibiotics via the gold standard method, high performance liquid chromatography (HPLC) is slow and costly. Paper analytical devices (PADs) and antibiotic paper analytical devices (aPADs) have been developed as an inexpensive way to estimate antibiotic quality in LMICs.  To model the impact of using a rapid screening tools, PADs/aPADs, to improve the quality of amoxicillin used for treatment of childhood pneumonia in Kenya.  We developed an agent based model, ESTEEM (Examining Screening Technologies with Economic Evaluations for Medicines) to estimate the effectiveness and cost savings of incorporating PADs and aPADs in amoxicillin quality surveillance in Kenya. We compared the current testing scenario (batches of entire samples tested by HPLC) with an expedited HPLC scenario (testing smaller batches at a time) as well as a screening scenario using PADs/aPADs to identify poor quality amoxicillin followed by confirmatory analysis with HPLC. Results Scenarios using PADs/aPADs or expedited HPLC yielded greater incremental benefits than the current testing scenario by annually averting 586 (90% uncertainty range (UR) 364 874) and 221 (90% UR 126 332) child pneumonia deaths, respectively. The PADs/aPADs screening scenario identified and removed poor quality antibiotics faster than the expedited or regular HPLC scenarios, and reduced costs significantly. The PADs/aPADs scenario resulted in an incremental return of $14.9 million annually compared with the reference scenario of only using HPLC.  This analysis shows the significant value of PADs/aPADs as a medicine quality screening and testing tool in LMICs with limited resources.

title: Counterfeit/Fake and Substandard Medicines A Global Bioethical Issue Requiring A Global Approach
abstract: Counterfeit drugs are a global problem and a public health hazard. Nearly 10 percent of all medicines sold worldwide are fake, leading to an estimated 100,000 deaths each year, equating to an additional economic burden of close to $200 billion annually. Counterfeit medicines also thwart public health efforts to control infectious diseases like Covid 19 and Tuberculosis and lead to the worsening of other public health crises such as anti microbial resistance (AMR) According to the CDC, more than 2.8 million antibiotic resistant infections in the U.S each year, with more than 35,000 people dying, have been reported. Globalization and the internet's expansion have led to the rapid spreading of poor quality medicines due to the high demand for cheap goods and lack of access before adequate detection and intervention are possible. Moreover, selling counterfeit medicine is more profitable with lesser penalties, even in the U.S. As a clandestine market, there is no precise magnitude of how the counterfeit medicine market flows. The WHO is alarmed by the lack of available data to demonstrate the extent and impact of fake/substandard medicines. Controlling counterfeit drugs' availability will not be easy; however, it has become necessary to protect public and global health. Through the lens of a case in Bangladesh that demonstrates how easy it is to sell and get away with selling fake medicines in developing countries this paper discusses how counterfeit medicines negatively contribute significantly to human lives and sufferings in developing and developed countries. No single policy will be effective based on the different issues faced on multiple fronts due to fake/substandard medicines. However, a broad based concerted effort across the various stakeholders to combat this counterfeit drug problem and secure the global supply chain is urgently needed.

title: Identification of Substandard and Falsified Medicines: Influence of Different Tolerance Limits and Use of Authenticity Inquiries
abstract: Substandard and falsified medicines have severe public health and socioeconomic effects, especially in low and middle income countries. The WHO has emphasized the need for reliable estimates of the prevalence of such medicines to efficiently respond to this problem. In the present study, we used 601 medicine samples collected in Cameroon, the DR Congo, and Malawi to assess the rates of substandard and falsified medicines based on different criteria. Based on the specifications of the U.S. Pharmacopoeia for the amount of the active pharmaceutical ingredients, the rate of out of specification medicines was 9.3% By contrast, this rate ranged from 3.3% up to 35.0% if the tolerance limits of other pharmacopoeias or recently published medicine quality studies were used. This shows an urgent need for harmonization. Principal methods to assess the rate of falsified medicines are packaging analysis, chemical analysis, and authenticity inquiries. In the present study, we carried out an authenticity inquiry for the aforementioned medicine samples, contacting 126 manufacturers and 42 distributors. Response rates were higher for samples stated to be manufactured in Asia (52.4% or Europe (53.8% than for samples manufactured in Africa (27.4% P 0.001) One sample had been identified as falsified by packaging analysis by the local researchers and two additional ones by chemical analysis. Notably, seven additional falsified samples were identified by the authenticity inquiries. The total rate of falsified medicines resulted as 1.7% Considerations are discussed for assessing the rates of "substandard" and "falsified" medicines in future medicine quality studies.

title: Substandard and Falsified Medicines: Proposed Methods for Case Finding and Sentinel Surveillance
abstract: The World Health Organization and others warn that substandard and falsified medicines harm health and waste money, especially in low and middle income countries. However, no country has measured the market wide extent of the problem, and no standardized methods exist to estimate the prevalence of either substandard or falsified medicines. This is, in part, because the task seems overwhelming; medicine markets are huge and diverse, and testing medicines is expensive. Many countries do operate some form of postmarket surveillance of medicine, but their methods and goals differ. There is currently no clear guidance on which surveillance method is most appropriate to meet specific public health goals. In this viewpoint, we aimed to discuss the utility of both case finding and risk based sentinel surveillance for substandard and falsified medicines, linking each to specific public health goals. We posit that choosing the system most appropriate to the goal, as well as implementing it with a clear understanding of the factors driving the production and sale of substandard and falsified medicines, will allow for surveillance resources to be concentrated most efficiently. We adapted principles used for disease outbreak responses to suggest a case finding system that uses secondary data to flag poor quality medicines, proposing risk based indicators that differ for substandard and falsified medicines. This system potentially offers a cost effective way of identifying "cases" for market withdrawal, enhanced oversight, or another immediate response. We further proposed a risk based sentinel surveillance system that concentrates resources on measuring the prevalence of substandard and falsified medicines in the risk clusters where they are most likely to be found. The sentinel surveillance system provides base data for a transparent, spreadsheet based model for estimating the national prevalence of substandard and falsified medicines. The methods we proposed are based on ongoing work in Indonesia, a large and diverse middle income country currently aiming to achieve universal health coverage. Both the case finding and the sentinel surveillance system are designed to be adaptable to other resource constrained settings.

title: Small scale dissolution test screening tool to select potentially substandard and falsified (SF) medicines requiring full pharmacopoeial analysis
abstract: The purpose of this study was to design a convenient, small scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The probability of metronidazole samples complying with the US Pharmacopoeia (USP) dissolution test for immediate release tablet formulations was predicted from small scale dissolution test results using the following criteria: (1) 95% confidence interval lower limit (95% CIlow) of the average dissolution rate of any n 3 of n 24 units of each sample, and (2) average and minimum dissolution rates for any n 3 of n 24 units. Criteria values were optimized via bootstrap sampling with Thinkeye data mining software. Compliant metronidazole samples in the USP first stage and second stage dissolution test showed complying probabilities of 99.7% and 81.0% respectively, if the average dissolution rate of n 3 units is equal to or greater than the monograph specified amount of dissolved drug (Q; 85% of labeled content for metronidazole) The complying probabilities were 100.0% and 79.0% respectively, if the average dissolution rate of n 3 units is 91% or higher and the minimum dissolution rate is 87% or higher. Suitable compliance criteria for the small scale dissolution test are: average dissolution rate of n 3 units is Q 6% or more and minimum dissolution rate is Q 2% or more.