Medicine Quality: the harder you look the worse it gets

2016 ◽  
Vol 2 (11) ◽  
Author(s):  
Roger Bate
Keyword(s):  
Drug Resistance ◽  
Font Size ◽  
Patient Death ◽  
Substandard Medicines ◽  
Falsified Medicines ◽  
Medicine Quality ◽  
Excellent Method

<p><span style="font-family: Calibri; font-size: medium;">The Minilab protocol is an excellent method of identifying falsified medicines, and two per cent (18 out of 899 samples) were falsified. However, as the data in this paper show, it considerably underestimates (by roughly 4.5%) the amount of substandard medicines in the market (roughly 12 per cent), especially among medicines made by Indian companies. In addition to considerable patient death, substandard antimicrobial medicines are likely to drive drug resistance. Policymakers should redouble efforts to identify and combat such medicines.</span></p>

scholarly journals Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative research in China, Indonesia, Turkey and Romania

2019 ◽  
Vol 4 ◽  
pp. 70 ◽  
Author(s):  
Elizabeth Pisani ◽  
Adina-Loredana Nistor ◽  
Amalia Hasnida ◽  
Koray Parmaksiz ◽  
Jingying Xu ◽  
...  
Keyword(s):  
Universal Health Coverage ◽  
World Health ◽  
Easy Access ◽  
Health Coverage ◽  
Political Commitment ◽  
Analytic Framework ◽  
Product Regulation ◽  
Falsified Medicines ◽  
Medicine Quality ◽  
Universal Health

Introduction: Substandard and falsified medicines undermine health systems. We sought to unravel the political and economic factors which drive the production of these products, and to explain how they reach patients. Methods: We conducted in-depth case studies in China, Indonesia, Turkey and Romania. We reviewed academic papers and press reports (n = 840), developing semi-structured questionnaires. We interviewed regulators, policy-makers, pharmaceutical manufacturers, physicians, pharmacists, patients and academics (n=88). We coded data using NVivo software, and developed an analytic framework to assess national risks for substandard and falsified medicines. We tested the framework against cases reported to the World Health Organization, from countries at all income levels. Results: We found that increasing political commitment to provision of universal health coverage has led to public procurement policies aimed at lowering prices of medical products. In response, legitimate, profit-driven pharmaceutical companies protect their margins by cutting costs, or withdrawing from less profitable markets, while distributors engage in arbitrage. Meanwhile, health providers sometimes protect profits by 'upselling' patients to medicines not covered by insurers. Cost-cutting can undermine quality assurance, leading to substandard or degraded medicines. Other responses contribute to shortages, irrational demand and high prices. All of these provide market opportunities for producers of falsified products; they also push consumers outside of the regular supply chain, providing falsifiers with easy access to customers. The analytic framework capturing these interactions explained cases in most high and middle-income settings; additional factors operate in the poorest countries. Conclusions: Most efforts to secure medicine quality currently focus on product regulation. However, our research suggests market mechanisms are key drivers for poor quality medicines, including where political commitments to universal health coverage are under-resourced. We have developed a framework to guide country-specific, system-wide analysis. This can flag risks and pinpoint specific actions to protect medicine quality, and thus health.

scholarly journals Medicine quality in high-income countries: The obstacles to comparative prevalence studies

2021 ◽  
Vol 5 ◽  
pp. 239920262110522
Author(s):  
Bernard David Naughton ◽  
Ebru Akgul
Keyword(s):  
Supply Chain ◽  
Supply Chains ◽  
Healthcare Systems ◽  
Regulatory Agencies ◽  
Pharmaceutical Supply Chain ◽  
Current Form ◽  
Prevalence Studies ◽  
Substandard Medicines ◽  
Medicine Quality ◽  
International Comparative

The entry of falsified and substandard medicines into the legitimate pharmaceutical supply chain has negative impacts on healthcare systems, patient safety, and patient access to medicine. The COVID-19 pandemic has highlighted the importance of access to safe medicine through legitimate pharmaceutical supply chains and the willingness of criminals to target medical products such as PPE (personal protective equipment) and COVID-19 treatments. In this article, we analyse data from the United Kingdom (UK) national medicine alert and recall database to identify and understand recent cases of substandard and falsified medicine in the UK’s healthcare systems. Using the UK as a case study, we describe that national drug alert and recall data are useful in their current form to record and understand cases of substandard and falsified medicines in the supply chain. However, if regulatory agencies published further data, these drug recall databases may be useful to support longitudinal and international comparative medicine quality studies. We suggest that regulatory agencies publish the number of affected medicine packs in each recalled batch, as part of the recall process. This will help policy makers, practitioners, and researchers to better understand, monitor and compare the quality of medicines within legitimate supply chains.

scholarly journals Substandard and Falsified Medicines in Myanmar

Pharmacy ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 45
Author(s):  
Mirai Sakuda ◽  
Naoko Yoshida ◽  
Takashi Takaoka ◽  
Tomoko Sanada ◽  
Mohammad Sofiqur Rahman ◽  
...  
Keyword(s):  
World Health ◽  
Dissolution Test ◽  
Regulatory Guidance ◽  
Substandard Medicines ◽  
The World ◽  
Quality Testing ◽  
Falsified Medicines ◽  
Health Organization ◽  
The Relationship ◽  
Made In

Background: substandard and falsified medicines (SFMs) are a threat to public health. The availability of SFMs in Myanmar was reported by the World Health Organization (WHO) in 1999, but there have been few systematic surveys on falsified medicines in Myanmar since then. The aim of this study is to examine the extent of SFMs for sale in Myanmar. Methods: target medicines were tablets of candesartan, metformin, and pioglitazone, and infusions of ciprofloxacin and levofloxacin. Samples were collected from hospitals, pharmacies, and wholesalers located in the Mandalay region in 2015. We carried out observation testing, authenticity investigation, and quality testing to search for SFMs, and analyzed the relationship between SFMs and the price and store type. Results: There were no falsified medicines found in the authenticity check, though there remained a problem due to low response rates from manufacturers and regulatory authorities. In the quality test, some tablets of metformin and pioglitazone made in India failed the dissolution test. Conclusions: although no serious problems were found, some substandard medicines were detected. Regular surveys to monitor SFMs are therefore recommended, together with further regulatory guidance to improve conditions in all medicine manufacturers, distributors, and pharmacies.

scholarly journals Current Problems in Determining Objective Features of the Offence Under Article 238.1 of the Penal Code of Russia Federation

2020 ◽  
Vol 11 (4) ◽  
Author(s):  
Maksim Vinokurov
Keyword(s):  
Russian Federation ◽  
Research Work ◽  
Legal Regulation ◽  
Criminal Code ◽  
Effective Control ◽  
Medical Products ◽  
Substandard Medicines ◽  
Falsified Medicines ◽  
The Russian Federation ◽  
Objective Side

In the ongoing process of commercialization of products, the state is unable to ensure effective control over the process of manufacturing medical products. High-quality and safe medical products are the most important component of effective medical care, and access to such products is one of the main objectives in the development of production and state, designated in the UN. The study analyzed the disposition of Article 238.1 of the Criminal Code of the Russian Federation. In this research work, objective features of the crime were defined and their forms were examined; the interconnection of forms of the objective side of the crime was systematically analyzed; the normative legal regulation and practice of application of such notions as "production", "sale", "import", "falsified medicines", "substandard medicines", "medical products", etc. were also analyzed. We studied different approaches of legal scholars to these definitions. We concluded that some of those definitions were ambiguously interpreted. The study identified the actual problems of the mechanism of law enforcement of the investigated article of the Criminal Code of the Russian Federation and put forward a set of measures to address them.

Medicine quality, physicians, and patients

2020 ◽  
pp. 124-126
Author(s):  
Paul N. Newton
Keyword(s):  
Drug Resistance ◽  
Pharmaceutical Industry ◽  
Diagnostic Tests ◽  
Formal Analysis ◽  
Healthcare Systems ◽  
Poor Quality ◽  
Economic Losses ◽  
Objective Evidence ◽  
Medicine Quality ◽  
Selection Of

Poor-quality medicines negate the enormous advantages of modern pharmaceuticals and lead to avoidable morbidity and mortality; loss of confidence in medicines and healthcare systems; economic losses for patients, their families, governments, and the pharmaceutical industry; and—for anti-infectives—engender pathogen drug resistance. There are many examples of both falsified (due to fraudulent production) and substandard (due to in-factory negligence) medicines, vaccines, diagnostic tests, and devices. New portable diagnostic devices offer hope that they could empower medicine inspectors and pharmacists to obtain objective evidence for selection of suspicious samples for formal analysis. Much greater international effort is needed for the reporting of poor-quality medicines so that detection can be acted upon and patients protected.

scholarly journals Regulatory framework in Pakistan: situation analysis of medicine quality and future recommendations

2019 ◽  
Vol 12 (1) ◽  
Author(s):  
Huma Rasheed ◽  
Ludwig Hoellein ◽  
Khalid Saeed Bukhari ◽  
Ulrike Holzgrabe
Keyword(s):  
Pharmaceutical Industry ◽  
Case Reports ◽  
Public Health Problem ◽  
Poor Quality ◽  
Scientific Data ◽  
Regulatory Framework ◽  
World Health ◽  
Falsified Medicines ◽  
Medicine Quality

Abstract Background Quality issues in pharmaceuticals are identified as a huge global and public health problem, especially with reference to low- and middle-income countries like Pakistan. The 2011 “Fake Drug Crisis” acted as a driving force to reform the regulatory structures of the country and for establishing the autonomous “Drug Regulatory Authority of Pakistan”. Despite the fact that Pakistan possesses a huge pharmaceutical industry, there is a severe dearth of published literature and scientific evidence for the country regarding medicine quality and the prevalence of counterfeit and low-quality products, respectively. Aims and objectives This narrative review covers relevant features of the regulatory framework for pharmaceuticals in Pakistan, its national pharmaceutical industry, as well as a compilation and analysis of published literature for documentation of the country’s situation regarding the overall quality of medicines. Methods Available data including scientific publications on the quality of pharmaceuticals in peer reviewed journals, research reports, notifications, and alerts issued by the World Health Organization and other agencies were accessed and compiled. Post graduate dissertations were used to represent unpublished research data and drug safety alerts issued from the local Pakistan authority were analysed to assess the type and number of quality failures reported for pharmaceuticals. Results It could be clearly shown that there is negligible scientific data available on the issue of medicine quality in Pakistan. The anticipated number of 40–50% of poor-quality drugs in Pakistan cannot be defended by data available from the literature. Accessible technologies and strategies used in recent years at global level, especially in developing countries, were also reviewed and recommendations are devised for Pakistan to combat the fight against poor-quality medicines. Conclusion The case reports, investigations, and general data listed for Pakistan suggest the need of strengthening regulatory systems for premises and GMP inspections, analytical laboratories, as well as an overall capacity building in the field of unravelling and controlling substandard and falsified medicines. It is proposed that well-planned and properly funded studies need to be carried out for collecting critical statistics regarding the prevalence of substandard and falsified medicines in Pakistan.

scholarly journals Challenges in maintaining medicine quality while aiming for universal health coverage: a qualitative analysis from Indonesia

2021 ◽  
Vol 6 (Suppl 3) ◽  
pp. e003663
Author(s):  
Amalia Hasnida ◽  
Maarten Olivier Kok ◽  
Elizabeth Pisani
Keyword(s):  
Universal Health Coverage ◽  
Comparative Method ◽  
Scale Up ◽  
Production Costs ◽  
Health Coverage ◽  
Policy Makers ◽  
Pharmaceutical Manufacturers ◽  
Falsified Medicines ◽  
Medicine Quality ◽  
Universal Health

IntroductionIndonesia, the world’s fourth most populous nation, is close to achieving universal health coverage (UHC). A widely-publicised falsified vaccine case in 2016, coupled with a significant financial deficit in the national insurance system, has contributed to concern that the rapid scale-up of UHC might undermine medicine quality. We investigated the political and economic factors that drive production and trade of poor-quality medicines in Indonesia.MethodsWe reviewed academic publications, government regulations, technical agency documents and news reports to develop a semi-structured questionnaire. We interviewed healthcare providers, policy-makers, medicine regulators, pharmaceutical manufacturers, patients and academics (n=31). We included those with in-depth knowledge about the falsified vaccine case or the pharmaceutical business, medicine regulation, prescribing practice and the implementation of UHC. We coded data using NVivo software and analysed by constant comparative method.ResultsThe scale-up of UHC has cut revenues for physicians and pharmaceutical manufacturers. In the vaccine case, free, quality-assured vaccines were available but some physicians, seeking extra revenue, promoted expensive alternatives. Taking advantage of poor governance in private hospitals, they purchased cut-price ‘vaccines’ from freelance salespeople.A single-winner public procurement system which does not explicitly consider quality has slashed the price paid for covered medicines. Trade, industrial and religious policies simultaneously increased production costs, pressuring profit margins for manufacturers and distributors. They reacted by cutting costs (potentially threatening quality) or by market withdrawal (leading to shortages which provide a market for falsifiers). Shortages and physician-promoted irrational demand push patients to buy medicines in unregulated channels, increasing exposure to falsified medicines.ConclusionMarket factors, including political pressure to reduce medicine prices and healthcare provider incentives, can drive markets for substandard and falsified medicines. To protect progress towards UHC, policy-makers must consider the potential impact on medicine quality when formulating rules governing health financing, procurement, taxation and industry.

scholarly journals Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites

2021 ◽  
Author(s):  
Shu Zhu ◽  
Naoko Yoshida ◽  
Hirohito Tsuboi ◽  
Ryo Matsushita ◽  
Kazuko Kimura
Keyword(s):  
Extended Release ◽  
The Internet ◽  
Content Uniformity ◽  
Substandard Medicines ◽  
Dissolution Tests ◽  
Two Samples ◽  
Sustained Release Tablets ◽  
Quality Testing ◽  
Falsified Medicines ◽  
States Pharmacopeia

Abstract Background Low-quality medicines and falsified medicines represent long-standing problems in developing countries. In Southeast Asia, the circulation of low-quality diabetes drugs (metformin) has been confirmed. It is possible that low-quality metformin has entered Japan via personal import through the Internet. This study evaluated the pharmaceutical quality and authenticity of metformin tablets obtained via the Internet in Japan. Methods In total, 33 samples of 500-mg metformin tablets and 7 samples of extended-release/sustained-release tablets (500, 750, and 1,000 mg) were purchased via personal import in January 2017. Confirmation of a prescription was never requested purchase. The obtained samples were subjected to visual observations and authenticity investigations. Additionally, quantitative analysis, content uniformity and dissolution tests were performed using HPLC–PDA. Results Our authenticity investigations revealed that seven samples were genuine products, whereas the authenticity of the remaining 33 samples was unclear. Referring to United States Pharmacopeia 2014 for validation, four samples failed quality testing, five samples failed content uniformity testing, and two samples failed dissolution testing. Conclusions Our findings illustrate that metformin tablets of poor-quantity and unregistered/unlicensed doses are available online and that it is important to increase consumer awareness about the presence of these medicines on the Internet to prevent the purchase of substandard medicines.

scholarly journals Identification of Substandard and Falsified Medicines: Influence of Different Tolerance Limits and Use of Authenticity Inquiries

2021 ◽  
Author(s):  
Cathrin Hauk ◽  
Nhomsai Hagen ◽  
Lutz Heide
Keyword(s):  
Chemical Analysis ◽  
Active Pharmaceutical Ingredients ◽  
Total Rate ◽  
Tolerance Limits ◽  
Dr Congo ◽  
Middle Income ◽  
Pharmaceutical Ingredients ◽  
Middle Income Countries ◽  
Falsified Medicines ◽  
Medicine Quality

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.

African populations are vulnerable to falsified drugs

2017 ◽  
Keyword(s):  
Sub Saharan Africa ◽  
Antimalarial Drug Resistance ◽  
Content Type ◽  
The United Kingdom ◽  
Substandard Medicines ◽  
African Populations ◽  
Falsified Medicines ◽  
Resistant Strains ◽  
Sub Saharan ◽  
Drug Resistant Strains

Subject Substandard and falsified drugs in Africa. Significance In January, the World Customs Organisation (WCO) reported record seizures in Africa of 113 million fake medicines, including antimalarials and antibiotics. News from the WCO comes amid reports of multi-drug resistant strains of malaria from Africa being imported into the United Kingdom. Both reports add to the mounting evidence of the burden of falsified medicines in Africa and their potential effects. Impacts Antimalarial drug resistance is widespread in South-east Asia and is a looming threat in sub-Saharan Africa (SSA). Rapid technologies to detect falsified and substandard medicines will be crucial to the next phase of malaria control and elimination. Where oversight and regulation is weak, technological innovation will increasingly allow patients to authenticate medications. States with higher levels of corruption and criminality may facilitate illicit medicine imports.

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