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Background: The increasing prevalence of falsified and counterfeit medicines globally poses risks to international travellers. This narrative literature review examines the global challenge of falsified and counterfeit medicines, with a specific focus on risks for travellers. The aim is to provide a comprehensive understanding of this multidimensional issue, exploring potential solutions for effective intervention. Methods: A comprehensive search of databases, including PubMed, MEDLINE, and Scopus, as well as relevant reports from international organisations, was undertaken. There was a focus on extracting information pertaining to the prevalence, types, and geographical patterns of falsified and counterfeit medicines encountered by international travellers. Synthesising this information helped to identify overarching trends and patterns. This narrative review utilised a thematic analysis approach to synthesise the findings. Results: The findings revealed a diverse range of counterfeit drug categories, spanning from antibiotics to lifestyle medications, posing unique risks to travellers navigating the global pharmaceutical landscape. The review emphasises the geographical distribution of these drugs, with varying consequences for both high- and low-income nations. The inadequate formulations and inconsistent drug release arising from these practices pose severe threats to public health, especially for individuals travelling abroad. The review also highlights the significance of international collaboration in addressing this global challenge, as pharmaceutical supply chains seamlessly cross borders, necessitating a collaborative approach for effective regulation and enforcement. Conclusions: This review underscores the need for targeted research, collaborative interventions, and technological innovations to address the complexities associated with falsified and counterfeit medicines, ensuring the safety and well-being of international travellers.

BackgroundFalsified medicines and their international regulation impacts all healthcare sectors and their actors. These regulations aim to strengthen and protect the global pharmaceutical supply chain against falsified medicines. However, an evaluation of the impacts of these regulations on key stakeholders within the legitimate supply chain have not been explored.ObjectiveThis research aimed to evaluate both the positive and negative impacts of falsified medicines regulation on key stakeholders within the global pharmacy sector including including manufacturers, wholesalers, hospital pharmacies, community pharmacy and patients.DesignThis research consists of a systematic review and thematic analysis concerning falsified medicines regulation and the subsequent impacts of existing global regulations on healthcare. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and checklist were utilized for reporting in this systematic review.Data sources and methodsA search of three databases, Embase, ProQuest and PubMed, was undertaken to determine studies applicable to the research question. The Mixed Methods Appraisal Tool (MMAT) was used to assess methodological quality and risk of bias for all included studies.ResultsFrom the initial 657 studies, a final set of 13 relevant studies were identified. The most frequently reported falsified medicines regulation was the Falsified Medicines Directive (FMD) [n = 11]. The impact of falsified medicines regulation in the literature related to four areas: (1) Financial, (2) Social, (3) Organizational, and (4) Pharmacy Practice. These common themes across the included studies frequently relate to challenges and/or concerns associated with falsified medicines regulation implementation as well as both the logistics and practicality of incorporating falsified medicines regulations into daily operations.ConclusionImplementation and enforcement of falsified medicines regulation does not yet appear to categorically fulfill the primary aim of the regulations, to strengthen the drug supply chain. However, in recent years, such regulations have challenged the legitimate pharmaceutical supply change actors as they attempt to successfully implement these regulations. Studies mainly detail the negative impacts of regulation during the implementation phase but with the overall benefit pertaining to the prioritization and enhancement of patient care and safety within the healthcare sector.

Abstract Background Health systems are often susceptible to corruption risks. Corruption within health systems has been found to negatively affect the efficacy, safety, and, significantly, equitable distribution of health products. Enforcing effective anti-corruption mechanisms is important to reduce the risks of corruption but requires first an understanding of the ways in which corruption manifests. When there are public health crises, such as the COVID-19 pandemic, corruption risks can increase due to the need for accelerated rates of resource deployment that may result in the bypassing of standard operating procedures. Main body A rapid review was conducted to examine factors that increased corruption risks during the COVID-19 pandemic as well as potential anti-corruption, transparency and accountability (ACTA) mechanisms to reduce these risks. A search was conducted including terms related to corruption, COVID-19, and health systems from January 2020 until January 2022. In addition, relevant grey literature websites were hand searched for items. A single reviewer screened the search results removing those that did not meet the inclusion criteria. This reviewer then extracted data relevant to the research objectives from the included articles. 20 academic articles and 17 grey literature pieces were included in this review. Majority of the included articles described cases of substandard and falsified products. Several papers attributed shortages of these products as a major factor for the emergence of falsified versions. Majority of described corruption instances occurred in low- and middle-income countries. The main affected products identified were chloroquine tablets, personal protective equipment, COVID-19 vaccine, and diagnostic tests. Half of the articles were able to offer potential anti-corruption strategies. Conclusion Shortages of health products during the COVID-19 pandemic seemed to be associated with increased corruption risks. We found that low- and middle-income countries are particularly vulnerable to corruption during global emergencies. Lastly, there is a need for additional research on effective anti-corruption mechanisms.

Background: Health systems are often susceptible to corruption risks. Corruption within health systems has been found to negatively affect the efficacy, safety, and, significantly, equitable distribution of health products. Enforcing effective anti-corruption mechanisms is important to reduce the risks of corruption but requires first an understanding of the ways in which corruption manifests. When there are public health crises, such as the COVID-19 pandemic, corruption risks can increase due to the need for accelerated rates of resource deployment that may result in the bypassing of standard operating procedures. Main body: A rapid review was conducted to examine factors that increased corruption risks during the COVID-19 pandemic as well as potential anti-corruption, transparency and accountability (ACTA) mechanisms to reduce these risks. A search was conducted including terms related to corruption, COVID-19, and health systems from January 2020 until January 2022. In addition, relevant grey literature websites were hand searched for items. A single reviewer screened the search results removing those that did not meet the inclusion criteria. This reviewer then extracted data relevant to the research objectives from the included articles. 20 academic articles and 17 grey literature pieces were included in this review. Majority of the included articles described cases of substandard and falsified products. Several papers attributed shortages of these products as a major factor for the emergence of falsified versions. Majority of described corruption instances occurred in low- and middle-income countries. The main affected products identified were chloroquine tablets, personal protective equipment, COVID-19 vaccine, and diagnostic tests. Half of the articles were able to offer potential anti-corruption strategies. Conclusion: Shortages of health products during the COVID-19 pandemic seemed to be associated with increased corruption risks. We found that low- and middle-income countries are particularly vulnerable to corruption during global emergencies. Lastly, there is a need for additional research on effective anti-corruption mechanisms. [ABSTRACT FROM AUTHOR]

The article researched the so-called "Pharmaceutical criminal offenses", which are contained in Chapter XIII of the Criminal Code of Ukraine (hereinafter, CCU), where a significant number of norms apply specifically to medicines. The purpose of the article is to study the history of the formation of pharmaceutical criminal offenses, problems of their qualification and the determination of prospects for their improvement. Currently, medicines are mentioned in Chapter XIII of the Special Part of the CCU (Art. 321-2); stupefy medicines that do not contain narcotic or psychotropic or their analogues (Art. 322, 324); medicines that contain narcotic or psychotropic substances or are their analogues (Art. 307, 308, 309, 318, 319 and 320); powerful or poisonous medicines (Art. 306, 321); falsified medicines (Art. 305, 321-1). During the research, several terminological inconsistencies were revealed; gaps related to the implementation of the Medicrime Convention, in particular, it was stated that medical products are not fully protected by the criminal law, because the CCU refers to medicines, and they are only part of medical products. It was established that certain aggravating circumstances provided for by Art. 13 of the Medicrime Convention, were not taken into account either as qualifying features or by Art. 67 of the CCU; measures have not been taken to ensure the possibility of bringing legal entities to justice for the crimes (Art. 11 of the Medicrime Convention). It was also emphasized that the approach according to which the qualification do as of illegal circulation of narcotic and psychotropic medicines under the articles of the so-called "drug crimes" needs to be reviewed. The problem of the lack of proper qualifications for radioactive (radiopharmaceutical) medicines and smuggling poisonous or powerful medicines has been singled out. [ABSTRACT FROM AUTHOR]

Have you ever looked at a powder diffractogram during a routine qualitative test and wondered how much of a particular powder compound is in the powder material? Several methods can work this out, but none of them could be used in our case because something was missing from each in performing a rapid quantity test for an active ingredient in a tablet. A semiquantitative method of an X-ray powder diffraction analysis of products containing sildenafil citrate is proposed. This method utilizes calibration curves for the most common compositions encountered in falsified and not-registered Viagra analogues. Sildenafil doses are established for singularly prepared powder probes of a medicinal product, and two runs of data collection are used: the first, the fast one, for the qualitative analysis of the product, and the second for selected 2θ regions for the API and identified excipients. An example of a product composed mainly of sildenafil citrate, gypsum and microcrystalline cellulose is discussed in detail. The data obtained from X-ray experiments were compared with the results obtained from validated liquid chromatography coupled to a diode array detector and mass spectrometry methods. [ABSTRACT FROM AUTHOR]

Counterfeit medicines pose a serious threat to health systems, industry and society. Globalization of commerce and the active online environment have significantly increased the health risks associated with counterfeiting medicines. Considering these alarming issues, the European Parliament and the Council have adopted a legislative framework aimed at combating the entry of falsified medicinal products into the legal supply chain, without affecting the functioning of the internal market for medicinal products for human use. This article aims to present the impact of the new legislative solutions known as the "Falsified Medicines Directive", by which, in 2011, the European Union took an imperative step in protecting public health, establishing the legal basis by which the falsification of medicines is a criminal law action, which deprives patients of safe and quality medical treatment. [ABSTRACT FROM AUTHOR]

Aim: The main objective of this study was to explore community pharmacists' knowledge of substandard and falsified medicines (SFs). Method: A descriptive cross-sectional study was conducted with community pharmacists in the Kingdom of Saudi Arabia using a pre-validated electronic survey. Key findings: Ninety-two community pharmacists participated in this study. Many of the respondents (68.5%) had no experience with identifying SFs. We identified a concerning trend of under-reporting SFs (P < 0.003). Respondents reported that SFs constitutes 1–5% of medicines, with weight loss medicines being the most targeted for falsification. Most of the respondents had a low level of awareness about the newly implemented anti-counterfeit system in Saudi Arabia called the 'Drug Track and Trace System' (28.3% not really, 23.1% not at all). Respondents showed low levels of knowledge about technologies available to detect SFs (P < 0.01). Conclusions: Community pharmacists' self-reported awareness and knowledge of SFs in Saudi Arabia was inadequate; this deficiency may affect their ability to protect their patients from potential harm by combating SFs. As a regulatory body responsible for issues related to SFs, the Saudi Food and Drug Authority should develop an action plan to equip community pharmacists with training in SFs to enhance their ability to respond to SFs. [ABSTRACT FROM AUTHOR]

Have you ever looked at a powder diffractogram during a routine qualitative test and wondered how much of a particular powder compound is in the powder material? Several methods can work this out, but none of them could be used in our case because something was missing from each in performing a rapid quantity test for an active ingredient in a tablet. A semiquantitative method of an X-ray powder diffraction analysis of products containing sildenafil citrate is proposed. This method utilizes calibration curves for the most common compositions encountered in falsified and not-registered Viagra analogues. Sildenafil doses are established for singularly prepared powder probes of a medicinal product, and two runs of data collection are used: the first, the fast one, for the qualitative analysis of the product, and the second for selected 2θ regions for the API and identified excipients. An example of a product composed mainly of sildenafil citrate, gypsum and microcrystalline cellulose is discussed in detail. The data obtained from X-ray experiments were compared with the results obtained from validated liquid chromatography coupled to a diode array detector and mass spectrometry methods.

Background: Access to quality medicines is a global initiative to ensure universal health coverage. However, the limited capacity of National Medicines Regulatory Authorities (NMRAs) to prevent and detect the supply of poor-quality medicines led to the predominance of sub-standard and falsified (SF) medicines in the supply chains of many countries. Therefore, this study was designed to assess the capacity of a young NMRA to ensure the quality of medicines with Rwanda as a case study. Objective: This study aimed to assess the capacity of the Rwanda FDA, a young NMRA, to identify gaps and existing opportunities for improving regulatory capacity and ensuring the quality of medicines. Methods: This study used a descriptive cross-sectional design with both quantitative and qualitative approaches. The quantitative approach used a self-administered questionnaire to collect data from employees of Rwanda FDA who are involved in medicine regulatory practices based on their positions while the qualitative research approach covered a desk review of key regulatory documents. The data collection tool was developed from the World Health Organization (WHO) Global Benchmarking Tool (GBT) for "Evaluation of National Regulatory System of Medical Products Revision VI". Results: Of the 251 WHO sub-indicators assessed, 179 sub-indicators (71%) were fully implemented, 17 sub-indicators (7%) were partially implemented, 9 sub-indicators (4%) were ongoing and 46 sub-indicators (18%) were not implemented by the time of the study. The results of the study showed that the estimated maturity level at which Rwanda FDA operates is maturity level 2. The study reported the challenges hindering the implementation of key regulatory functions that need to be addressed. Challenges reported include but are not limited to understaffing, lack of automation system, poor implementation of the quality management system, lack of screening technologies for SF medicines, low capacity of the quality control laboratory to test all sampled medicines and lack of regulatory inspection tools/equipment. Conclusion: Findings indicated that all key regulatory functions were operating and supported by the legal framework. However, the implementation of key regulatory functions faced challenges that need to be addressed for better organizational effectiveness and compliance with the requirements of a higher maturity level. [ABSTRACT FROM AUTHOR]

Background Access to quality medicines is a global initiative to ensure universal health coverage. However, the limited capacity of National Medicines Regulatory Authorities (NMRAs) to prevent and detect the supply of poor-quality medicines led to the predominance of sub-standard and falsified (SF) medicines in the supply chains of many countries. Therefore, this study was designed to assess the capacity of a young NMRA to ensure the quality of medicines with Rwanda as a case study. Objective This study aimed to assess the capacity of the Rwanda FDA, a young NMRA, to identify gaps and existing opportunities for improving regulatory capacity and ensuring the quality of medicines. Methods This study used a descriptive cross-sectional design with both quantitative and qualitative approaches. The quantitative approach used a self-administered questionnaire to collect data from employees of Rwanda FDA who are involved in medicine regulatory practices based on their positions while the qualitative research approach covered a desk review of key regulatory documents. The data collection tool was developed from the World Health Organization (WHO) Global Benchmarking Tool (GBT) for “Evaluation of National Regulatory System of Medical Products Revision VI”. Results Of the 251 WHO sub-indicators assessed, 179 sub-indicators (71%) were fully implemented, 17 sub-indicators (7%) were partially implemented, 9 sub-indicators (4%) were ongoing and 46 sub-indicators (18%) were not implemented by the time of the study. The results of the study showed that the estimated maturity level at which Rwanda FDA operates is maturity level 2. The study reported the challenges hindering the implementation of key regulatory functions that need to be addressed. Challenges reported include but are not limited to understaffing, lack of automation system, poor implementation of the quality management system, lack of screening technologies for SF medicines, low capacity of the quality control laboratory to test all sampled medicines and lack of regulatory inspection tools/equipment. Conclusion Findings indicated that all key regulatory functions were operating and supported by the legal framework. However, the implementation of key regulatory functions faced challenges that need to be addressed for better organizational effectiveness and compliance with the requirements of a higher maturity level.

The increasing prevalence of falsified and counterfeit medicines globally poses risks to international travellers. This narrative literature review examines the global challenge of falsified and counterfeit medicines, with a specific focus on risks for travellers. The aim is to provide a comprehensive understanding of this multidimensional issue, exploring potential solutions for effective intervention. A comprehensive search of databases, including PubMed, MEDLINE, and Scopus, as well as relevant reports from international organisations, was undertaken. There was a focus on extracting information pertaining to the prevalence, types, and geographical patterns of falsified and counterfeit medicines encountered by international travellers. Synthesising this information helped to identify overarching trends and patterns. This narrative review utilised a thematic analysis approach to synthesise the findings. The findings revealed a diverse range of counterfeit drug categories, spanning from antibiotics to lifestyle medications, posing unique risks to travellers navigating the global pharmaceutical landscape. The review emphasises the geographical distribution of these drugs, with varying consequences for both high- and low-income nations. The inadequate formulations and inconsistent drug release arising from these practices pose severe threats to public health, especially for individuals travelling abroad. The review also highlights the significance of international collaboration in addressing this global challenge, as pharmaceutical supply chains seamlessly cross borders, necessitating a collaborative approach for effective regulation and enforcement. This review underscores the need for targeted research, collaborative interventions, and technological innovations to address the complexities associated with falsified and counterfeit medicines, ensuring the safety and well-being of international travellers. [ABSTRACT FROM AUTHOR]

In the last few decades, the problem with falsified medicine became a global threat that accounts for millions of human lives and billions of financial loses for the national health authorities and pharmaceutical industry. Different measures were developed to fight their uncontrolled spread but had only limited success. The resolution that united the pharmaceutical supply chain actors worldwide is the introduction of track-and-trace systems, based on product serialization and verification. The European Union also adopted this solution, and its official operation began in 2019. Each Member State has specifics that have to be accounted for in the national transposition process and should influence the system design and functionalities. In Bulgaria, the responsible authorities seriously delayed to adopt an adequate legal and regulatory framework to support its smooth operation. This created many problems for some of the key supply chain participants – the wholesalers. Since the European system is not a full track-and-trace solution, their role in the verification process is limited and left to the national authorities to decide how to regulate it. At present, more than one year after the launch of the system, the national bylaws that should regulate their activities with reference to the European policy are still not enforced. The wholesalers are left to align their operations in a regulatory vacuum that may compromise the effectiveness of the policy and lead to sanctions for noncompliance.

Falsified medicines and healthcare supplements provide a major risk to public health and thus early identification is critical. Although a host of analytical approaches have been used to date, they are limited, as they require extensive sample preparation, are semi-quantitative and/or are inaccessible to low- and middle-income countries. Therefore, for the first time, we report a simple total analysis system which can rapidly and accurately detect falsified medicines and healthcare supplements. We fabricated a poly-lactic acid (PLA) pestle and mortar and using a commercial 3D printer, then made carbon black/PLA (CB/PLA) electrodes in the base of the mortar using a 3D printing pen to make an electrochemical cell. The pestle and mortar were able to crush and grind the tablets into a fine powder to the same consistency as a standard laboratory pestle and mortar. Using melatonin tablets to characterise the device, the 3D-printed pestle and mortar was able to detect the concentration of melatonin in the presence of insoluble excipients. The calibration plot showed a linear response from 37.5 to 300 µg/mL, where the limit of detection was 7 µg/mL. Electrochemical treatment was able to regenerate the CB/PLA working electrode allowing for repeated use of the device. In a blinded study, the device was able to accurately determine falsified melatonin tablets with recovery percentages between 101% and 105%. This was comparable to HPLC measurements. Overall, these findings highlight that our 3D-printed electrochemical pestle and mortar is an accessible and effective total analysis system that can have the ability to identify falsified medicines and healthcare supplements in remote locations. [ABSTRACT FROM AUTHOR]

Substandard and falsified medicines are a global health concern negatively affecting individuals, the public, the pharmaceutical industry and governments all over the world. This review aims to examine the global prevalence of substandard and falsified medicines, its impact on health and the health system, including socio-economic impacts and strategies for curbing this menace. A literature review of published articles between January 2000 and May 2020 was done with keywords "substandard", "counterfeit", and "falsified medicines". Articles were sourced from PubMed, World Health Organization (WHO) databases and Google Scholar. There are reports of substandard and falsified medicines from all WHO Regions with noticeable prevalence in the African Region. These medicines have been reported to cause death, antimicrobial resistance, increase prevalence of diseases, and loss of confidence in the health system. Increased patients spending, loss of productivity, strain of limited health systems resources, and loss of government revenue are major socio-economic implications of substandard and falsified medicines. An increase in criminal sanctions, global harmonization of drug regulatory authorities, and appropriate education of healthcare professionals and patients on how to prevent, detect, and respond to reported cases of substandard and falsified medicines are strategies that can be implemented to curb the menace of these medicines. Registered pharmacists and pharmacy students play critical roles in addressing this global health issue. [ABSTRACT FROM AUTHOR]

Background: The Falsified Medicines Directive (FMD) was implemented to minimise the circulation of falsified medicines in the legal pharmaceutical supply chain. Whilst pharmacists are involved in the final step of the FMD requirements with the decommissioning of medicines at the point of supply to patients, limited research has been conducted to investigate the impact of fulfilling these requirements on the relevant stakeholders. Objective: To examine community pharmacists' views on how the FMD has affected their practice. Methods: An online survey was disseminated via email in June 2020 to pharmacists in Ireland (n = 4727), who were invited to participate if practising full time or part time in community pharmacies. Quantitative data were captured through multiple option and Likert-scale questions, and analysed using descriptive and inferential statistics. Qualitative data were captured by use of a free-text box, with the open comments analysed thematically. Results: In total, 618 valid responses were received (13.1% response rate). Most perceived that FMD requirements increased waiting times for patients (82%) and reduced time interacting with patients (65%). Only 28% agreed/strongly agreed that the introduction of the FMD legislation improves patient safety. In the open comments, the need for medicine authentication was acknowledged, but it was believed that this should be the wholesalers' responsibility, not pharmacists' responsibility. The additional step of medicines decommissioning was viewed as a time-consuming distraction to clinical checks that increased the risk for error. Pharmacists complained that they were not remunerated for the lost staff productivity or the additional software and equipment costs. Many pharmacists felt that the increased workload was disproportionate to the small risk of patients receiving falsified medicines. Conclusions: Key stakeholder engagement is required to optimise the implementation and integration of the FMD procedures into community pharmacy practice with minimal impact on dispensing and without compromising patient care.

Background: Falsified medicines and their international regulation impacts all healthcare sectors and their actors. These regulations aim to strengthen and protect the global pharmaceutical supply chain against falsified medicines. However, an evaluation of the impacts of these regulations on key stakeholders within the legitimate supply chain have not been explored., Objective: This research aimed to evaluate both the positive and negative impacts of falsified medicines regulation on key stakeholders within the global pharmacy sector including including manufacturers, wholesalers, hospital pharmacies, community pharmacy and patients., Design: This research consists of a systematic review and thematic analysis concerning falsified medicines regulation and the subsequent impacts of existing global regulations on healthcare. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and checklist were utilized for reporting in this systematic review., Data Sources and Methods: A search of three databases, Embase, ProQuest and PubMed, was undertaken to determine studies applicable to the research question. The Mixed Methods Appraisal Tool (MMAT) was used to assess methodological quality and risk of bias for all included studies., Results: From the initial 657 studies, a final set of 13 relevant studies were identified. The most frequently reported falsified medicines regulation was the Falsified Medicines Directive (FMD) [ n  = 11]. The impact of falsified medicines regulation in the literature related to four areas: (1) Financial, (2) Social, (3) Organizational, and (4) Pharmacy Practice. These common themes across the included studies frequently relate to challenges and/or concerns associated with falsified medicines regulation implementation as well as both the logistics and practicality of incorporating falsified medicines regulations into daily operations., Conclusion: Implementation and enforcement of falsified medicines regulation does not yet appear to categorically fulfill the primary aim of the regulations, to strengthen the drug supply chain. However, in recent years, such regulations have challenged the legitimate pharmaceutical supply change actors as they attempt to successfully implement these regulations. Studies mainly detail the negative impacts of regulation during the implementation phase but with the overall benefit pertaining to the prioritization and enhancement of patient care and safety within the healthcare sector., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Melia, English and Naughton.)

Falsified medicines are a major threat to public health and safety. Since the falsifications become more sophisticated, the risk of falsified medicines to be proposed to patients in the EU increases every year. Such medicines represent a serious threat to global health and call for a comprehensive strategy both at European and international level. With the Falsified Medicines Directive and its supplementing Delegated Regulation the legislator has taken the necessary steps to preven falsified medicines from entering the legal supply chain. One of the measures that is being undertaken to achieve this goal is to mandate pharmaceutical companies and parallel distributors of mainly prescription medicines to apply safety features to their outer packaging. This guideline provides all manufacturers and parallel distributors with assistance in the upcoming implementation of the required measures for protection against falsification and describes in detail the on-boarding process to the European system against falsified medicines [ABSTRACT FROM AUTHOR]

Substandard and falsified (SF) medicines are a global health problem. Their high prevalence is a threat to public health in low- and middle-income countries (LMICs). However, there are few street-level investigations of how this market works. This case study examines the supply and demand for SF medicines in Southern Ethiopia. A cross sectional qualitative design, using semi-structured interviews supplemented by participant observation, was adopted. Study participants were selected using purposive, convenience, and snowball sampling techniques. They included pharmacists, physicians, wholesalers, pharmacy owners, regulatory staff, law enforcement agents and the local community. A total of 43 interviews were conducted. The study used Actor-Network Theory (ANT) as an analytic framework. The findings show that efforts to address the problem of SF medicines in Ethiopia struggle because of the lack of a clear framing of the issue and consensus on how it should be understood. The pharmaceutical market in Wolaita Zone, Southern Ethiopia is supplied with a wide variety of SF medicines from diverse sources. This complex supply chain emerges due to barriers to accessing essential medicines that are in demand. Control of SF medicines will require a range of interventions thoughtfully tailored to the local contexts and determinants of both supply and demand. The evidence of confusion, ambiguity, and uncertainty in defining the problem of SF medicines suggest that more research and policy work is required to refine understanding of the issue, and of the local market conditions that join demand and supply for different medicines in Southern Ethiopia. These are likely to apply more widely in comparable contexts throughout sub-Saharan Africa. The current global policy emphasis on stricter regulation and enforcement alone does not adequately address the social and economic factors that collectively create and shape user demand that is met by SF medicines. • The problem with SF medicines is that no clear framing and consensus exists. • The market supplies a wide variety of SF medicines from diverse sources. • The story of SF Medicines shows the barriers to accessing essential medicines. • Stricter regulation and enforcement do not adequately address factors creating user demand for SF medicines. • Control of SF medicines will require a matching range of interventions rather than a single method. [ABSTRACT FROM AUTHOR]

Abstract Background The influx of substandard and falsified medicines is a global public health challenge and its rapid detection is a key solution to the menace. This study used three screening methods and one confirmatory method for the quality assessment of 25 batches of artemether/lumefantrine dosage forms from the Ghanaian market to test that combined screening methods only can rapidly detect substandard and/or falsified medicines in areas where confirmatory methods may not be available. Methods The quality of artemether/lumefantrine tablet products obtained from pharmacies and licensed chemical seller shops within the Accra metropolis in Ghana were analysed using three screening methods (GPHF Minilab, Colorimetry and Counterfeit Drug Indicator) and one confirmatory method (high-performance liquid chromatography). Results The results showed that 18/25 batches of the artemether/lumefantrine samples passed using the combined screening and confirmatory methods and 5/25 batches of the artemether/lumefantrine samples failed using the combined screening and confirmatory methods. However, 1/25 batch of the artemether/lumefantrine samples failed using the combined screening methods but passed using the confirmatory method. Also, 1/25 batch of the artemether/lumefantrine samples passed using the combined screening methods but failed using the confirmatory method. This notwithstanding, the combined screening methods and the confirmatory method provided equivalent quality assessment profiles for 23/25 (92%) batches of the artemether/lumefantrine tablet products. Out of the 6 samples that failed the confirmatory test, 1/6, 2/6, and 3/6 failed on the high (> 110%), low (

The below article is a review regarding sociological and factual context of the implementation of Falsified Medicine Directive with a particular focus on Poland. In order to clarify the subject, a brief description of the phenomenon of falsified and counterfeit medicines, including an attempt at definition and disambiguation of those terms, is given. Further, the authors briefly describe the circumstances and effects of the implementation of the said directive in Poland. This includes outline of the solutions required and forced by the European and Polish law (serialization, anti-tempering devices, and personnel training) as well as practical information (and scientific background) on how provisions of the Directive are fulfilled in the setting of Polish community pharmacies and medicine wholesalers and which agents are responsible for the process of integration of the Directive into Polish law and reality. The presentation of the prevalence and extent of the phenomenon of falsified and counterfeit medicines in Poland and around the world includes mention of the most notable cases in the field along with research conducted and countermeasures undertook to tackle the issue. The part dedicated to review of the sociological context gives overview of the most notable of the very few research published in the field, both by Polish and foreign authors. Referenced articles describe awareness of the issue of counterfeit medicines among medical professionals and the general public. Investigated studies are immersed almost solely in the quantitative approach (authorial questionnaire used in cross-sectional studies) with a limited number of studies based on a qualitative approach, which constitutes an important gap in current knowledge. The authors conclude that counterfeit medicines pose an ever-growing threat to public health on both local and global level, that international cooperation and legislature dedicated to unification of laws aimed at counterfeit medicines, as exemplified by the said Directive, is an effective approach to the issue and that the current state of research does not allow for full understanding of patients’ perspective on the topic falsified medicines.

Tramadol is a synthetic opioid that is widely used as an analgesic for alleviating pain of moderate to medium intensity. With potency estimated to be about one-tenth that of morphine, tramadol is considered as relatively safe with regard to poisonings or dependency. Yet there are increasing reports of widespread non-medical consumption of tramadol in North and West Africa. The Egyptian government has requested the UN Commission of Narcotic Drugs to put tramadol under international control. This will have profound implications for the treatment of acute and chronic pain across developing countries where tramadol is often the only available analgesic, because controlled substances are impossible to obtain for health care practitioners. The tramadol sold outside of medical establishments is often adulterated and substandard, part of the massive trade in falsified medicines that is possibly far more devastating than the hedonic use of psychoactive substances. Yet the international machinery in place to control medical products is feeble and the penalties for medicrime are modest next to drug trafficking offences. The article suggests that international controls need to re-assess their priorities to focus on human and patient well-being. A further shift is needed away from repressive measures against consumers, to tighter regulation in the production and distribution of medications and pharmaceutical substances. This must involve a wide range of stakeholders, including health care practitioners, the pharmaceutical industry, pharmacists, patients associations, and the public at large.

Using poor-quality antibiotics leads to increased risk of the development of microorganism-resistant strains, treatment failure, loss of confidence in health systems, and associated socio-economic impacts. The prevalence of poor-quality antibiotics has been found to be high in some of the Low and Middle-Income Countries (LMICs), but no data were available on the situation in Rwanda. This study was conducted to obtain data and inform health professionals on the quality of the 12 most-used selected antibiotics from private retail pharmacies in Rwanda. The investigation was conducted on 232 batches collected from randomly selected private retail pharmacies in all provinces of Rwanda, and concerned only with visual inspection and assay tests. Visual inspection was performed using a tool adopted by the International Pharmaceutical Federation (FIP) to identify manufacturing defects. An assay test quantified the Active Pharmaceutical Ingredient (API) in each collected batch using high-performance liquid chromatography (HPLC) coupled with an ultraviolet-visible (UV) detector, and the results were reported as the percentage content of the amount of APIs stated on the label. A total of 232 batches were analyzed, manufactured in 10 countries; the main country of manufacture was Kenya, with almost half of the batches (49.6%). The results of the visual inspection did not show the presence of counterfeit/ falsified antibiotics on the Rwandan market in this study but revealed weaknesses in labeling: more than 90% of the analyzed batches of the 12 antibiotics did not present the dosage statement on their label, and the complete list of excipients was missing in more than 20% of the analyzed batches. The assay test using HPLC confirmed the presence of APIs in 100% of the analyzed batches. However, moderate deviations from acceptable ranges of the API content defined by M. M. Nasr & C. M. Stanley in 2006 for erythromycin and the United States Pharmacopoeia 2018 for the other 11 molecules were found. The failure rate to meet the quality requirements in terms of the percentage content of active pharmaceutical ingredients declared on the labels was estimated at 8.2% in total, with 3.9% and 4.3% containing more and less than the amount of APIs stated on the labels respectively. The most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.

Context: Falsified-medicines pose a worldwide problem to patients, healthcare professionals, pharmaceutical companies, and governments. Community pharmacists are usually the last points of contact with patients and can protect them by quarantining falsified medicines. Hence, their opinions are valuable in exploring how the profession can combat this. Aims: To explore the opinion of pharmacists with respect to falsified medicines. Methods: A postal survey was developed and distributed to 359 pharmacies via the local pharmaceutical committee in Hampshire, UK. Descriptive statistics and hypothesis testing was conducted. Hypothesis testing (95% CI, α = 0.05) will be conducted to identify any gender differences, differences based on years of experience and differences based on number of working hours per week. Results: A 14% response rate was achieved. Pharmacists surveyed believe that falsified-medicines pose a significant problem to the profession on a five-point Likert scale (4.02 ± 1.078). A pharmacist’s intervention can prevent or disrupt the supply to patients (4.12 ± 0.824) and training courses can improve pharmacist’s knowledge (4.06 ± 0.843). Pharmacists are not confident and capable in identifying falsified-medicines (2.62 ± 1.105). This is surprising and unexpected because pharmacists are medicines-expert. A 10-item scale is validated (72.2% Cronbach alpha). Conclusions: Falsified-medicines pose a small but significant and growing challenge to the profession. There is underutilization of the high street community pharmacist in identifying falsified-medicines. Healthcare professionals should report suspect counterfeits to the MHRA.

The statistics, listed in the article, prove that the most frequent encroachment on the life and health of citizens in the field of production and circulation of medicines and medical products is the falsification of medicines that is in demand every day and advertised on television and radio; including painkillers, antibiotics, psychotropic substances. There are a number of factors contributing to the commission of offenses in the sphere of production (manufacturing), storage, sales (realizations), import of medicines. The sphere of public procurement of medicines remains the most corrupted area of public relations. Thus, the most widespread type of crime in the health sector is theft of budget funds by excessive prices on market prices, when organizing the purchase of medicines, products and medical equipment for health care institutions. The most widespread corruption schemes for public procurement of medicines in Ukraine are the so-called «cartel conspiracies», in other words, behind-the-scenes agreements between companies on the distribution of winning bidding and excess pricing of medicines in the State Register of wholesale and retail prices. All considered violations require the development of a clear regulatory mechanism at the legislative and regulatory levels of the processes of production, control and marketing of medicinal products; only such actions will contribute to counteracting fraud and illicit circulation of falsified medicines and will provide protection of life and health of citizens. [ABSTRACT FROM AUTHOR]

Abstract Background Falsely labelled, falsified (counterfeit) medicines (FFCm’s) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm’s is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool. Methods The tool consists of a questionnaire referring to a watch-list of FFCm’s identified in Europe, including symptoms of their use and individual risk factors, and a scoring form. To refine the questionnaire and reference method, a pilot-study was performed in 105 self-reported users of watch-list medicines. Subsequently, the tool was validated under “real-life conditions” in 371 patients in 5 ambulatory and in-patient care sites (“sub-studies”). The physicians participating in the study scored the patients and classified their risk of harm as “unlikely” or “probable” (cut-off level: presence of ≥2 of 5 risk factors). They assessed all medical records retrospectively (independent reference method) to validate the risk classification and documented their perception of the tool’s value. Results In 3 ambulatory care sites (180 patients), the tool correctly classified 5 patients as harmed by FFCm’s. The positive and negative likelihood ratios (LR+/LR-) and the discrimination power were calculated for two cut-off levels: a) 1 site (50 patients): presence of two risk factors (at 10% estimated health care system contamination with FFCm’s): LR + 4.9/LR-0, post-test probability: 35%; b) 2 sites (130 patients): presence of three risk factors (at 5% estimated prevalence of use of non-prescribed medicines (FFCm’s) by certain risk groups): LR + 9.7/LR-0, post-test probability: 33%. In 2 in-patient care sites (191 patients), no patient was confirmed as harmed by FFCm’s. The physicians perceived the tool as valuable for finding harm, and as an information source regarding risk factors. Conclusions This “decision aid” is a systematic tool which helps find in medical practice patients harmed by FFCm’s. This study supports its value in ambulatory care in regions with health care system contamination and in certain risk groups. The establishment of systematic communication between authorities and the medical community concerning FFCm’s, current patterns of use and case reports may sustain positive public health impacts.

Abstract Falsified, counterfeit and adulterated medicines are an endemic problem worldwide that results in both monetary and health-related losses. Developing fast and reliable methods that are able to present a timely result based on the drug's spectral profile is an effort that is sure to benefit those involved in the whole distribution chain. We propose herein a Laser Desorption/Ionization imaging-based method that provides simple and minimal sample preparation; this method is capable of providing specific markers that characterize adulterations, using as proof of concept one of the most adulterated drug products for oral use, sildenafil. Our approach is able to provide quality markers, which can be applied in the fast screening of any product within the same molecular class. This same strategy may be a useful alternative to provide accurate measurements with high specificity for unraveling contaminants and/or byproducts in virtually any given pharmaceutical product. Graphical abstract fx1 Highlights • An expeditious method for the direct analysis of drug products in real time. • Quality markers are established for comparing and differentiating reference, generic and falsified drug products. • Solid-state laser desorption/ionization is useful to assess species with little sample preparation and matrix interference. [ABSTRACT FROM AUTHOR]

Abstract Falsified medicines represent a serious threat to public health. Among the different measures to effectively combat this scourge, analytical methods play a key role in their detection and removal from the market before they reach patients. The present study evaluates for the first time the potential of a benchtop low-field (LF) Nuclear Magnetic Resonance (NMR) spectrometer for uncovering drug falsification by focusing on the analysis of fifteen erectile dysfunction and nine antimalarial medicines, the most commonly reported falsified medicines in developed and developing countries respectively. After a simple and rapid sample preparation and ≈ 5 min of spectrum recording, LF 1H NMR allows to conclude on the quality of the medicine: presence or absence of the expected active pharmaceutical ingredient (API), presence of unexpected API, absence of any API. Some 2D experiments are also described but although conclusive they are hampered by the duration of the experiments. The LF 1H NMR assay, based on the internal standard method, is validated by the determination of its accuracy, repeatability, limits of detection (LOD) and quantification (LOQ), and by comparison of the data obtained on some medicines after 45 min of spectrum recording to those measured with high-field 1H NMR. Because of its saving capabilities (cost, space, user experience), LF 1H NMR spectroscopy might become a routine screening tool in laboratories in charge of detecting falsified medicines. Graphical abstract fx1 Highlights • Benchtop low-field (60 MHz) NMR was evaluated to uncover falsified medicines. • Qualitative 1H NMR spectra were obtained in 5 min. • Low-field 1H NMR assay, based on the internal standard method, was validated. [ABSTRACT FROM AUTHOR]

Substandard and falsified medicines need to be acknowledged as everyone's problem, whether on street markets in rural Africa or in illegal online pharmacies in the UK. Poor-quality medicines have a detrimental impact on health, mainly when found among antimicrobials used to treat infectious disease in high burden populations. Often, discussions around substandard and falsified medicines include causal factors or consequences in isolation and may be presented with regional focuses and minimal global harmonisation. There are ongoing efforts to combat substandard and falsified medicines through legislation, manufacturing practices and supply chain management, as well as detection and reporting methods. Alongside these efforts, from a social perspective, we should optimise the resourceful positioning of pharmacists in all industries, as well as public health education and engagement. This article provides a rounded and comparative insight into substandard and falsified medicines for healthcare professionals and summarises the limitations to our knowledge and their effect on public health in high-income countries and low-to-middle-income countries. [ABSTRACT FROM AUTHOR]

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.

Advances in biotechnology and the chemical synthesis of peptides have made biopharmaceuticals and synthetic peptide drugs viable pharmaceutical compounds today and an important source for tomorrow's drugs and therapies. Unfortunately, also falsifications and counterfeit versions of these powerful and promising drugs are offered illegally via the internet. Since these falsified preparations are produced outside the legally required quality systems, end-users have no guarantee regarding the efficacy and safety of these products. Although falsified samples of biotherapeutics were already analysed, looking at a specific aspect of their quality or identity, no systematic studies have been performed regarding the presence of different impurities or possible contaminations. Therefore, in order to obtain a better understanding of the potential health risks related to the usage of falsified polypeptide drugs we performed a systematic screening of the ten most frequently encountered falsified peptide drugs on the Belgian market acquired from three different suspected illegal internet pharmacies. The screening incorporated the analysis of the active pharmaceutical ingredient (API), API-related impurities, small molecule contaminants (defined as organic small molecules not belonging to the other categories), elemental impurities and residual solvents. This comprehensive study showed that these type of falsified drugs not only have a high variation in amount of drugs per unit and a low purity (ranging between 5% and 75% for cysteine containing peptides), but also contained the known toxic class one elemental impurities arsenic (As) and lead (Pb). One sample was contaminated with Pb while multiple samples were found with concentrations up to ten times the ICH toxicity limit for parenteral drugs. Subsequent speciation of As confirmed the elevated concentrations for As and demonstrated that all As was present in the more toxic inorganic form. Together with the (sometimes) high amount of peptide impurities and the inherent dangers associated with the use of unauthorized peptide drugs (such as doping peptides or preclinical drugs) this study confirms the reported potential health risks patients/users take when resorting to falsified peptide drugs. Moreover, the presence of the carcinogen As and the known accumulation in human tissues of Pb raises questions about potential sub-acute to chronic toxicity due to the long term administration of these falsified peptide drugs. [ABSTRACT FROM AUTHOR]

Abstract Based on WHO statistics, counterfeit medicines represent 10% of the global drug trade. According to Directive 2011/62/EU as regards the prevention of falsified medicines from entering into the legal supply chain, a unique identification should be put on each box of drugs to be able to track and trace them. The objective of this study is to develop a technology to mark an individual traceability code directly on the surface of the tablet. By using this technique, anyone with a camera-enabled phone and a suitable application installed should be able to authenticate these drugs. By marking the medicine's surface, patients could be protected from fake drugs. The aim of the present work was to study how different types of lasers affect the film coating of the tablet during the laser marking intervention. To sum up, the present findings may contribute to efficient and reliable laser marking solutions in the unique identification procedure. Based on our measurement results, it can be stated that the excimer UV laser is clearly the most suitable marking instrument for anti-counterfeiting coding on solid coated tablet form as this caused the least amount of chemical degradation of the polymer film. Graphical abstract Unlabelled Image [ABSTRACT FROM AUTHOR]

European Union (eu) action in the pharmaceutical sector has always had the dual objective of safeguarding public health by providing Europe with safe and effective medicines, while stimulating research, boosting innovation, and supporting the competitiveness of industry. To face major health, economic and scientific challenges, a series of measures have been adopted. Specific legal frameworks have been set up to improve patient safety by reducing the infiltration of counterfeit medicines into the supply chain, to increase the safety of medicines by modernising the pharmacovigilance system, as well as improving patient access by requiring high-quality health and medicine information. This article provides an overview of the new eu strategy aimed at increasing the safety and involvement of European patients, as well as the competitiveness of pharmaceutical industry in accordance with the principle of transparency. The analysis is carried out from a patients’ perspective addressing some paediatric specifications. [ABSTRACT FROM AUTHOR]

Medicine falsification is a global issue. Viagra, an erectile dysfunction therapeutic (EDT) medicine consisting primarily of sildenafil citrate, is the most commonly falsified medicine worldwide. Recently falsified EDTs have been reported multiple times in developing countries. The globalization of falsified EDTs has become a concern. In the present study, we selected sildenafil citrate tablets as an indicator and examined samples from a developing country, Cambodia, to investigate the availability of falsified sildenafil tablets in Cambodia and verify the current globalization status of falsified medicines from the standpoint of a developing country. Six samples of the originator Viagra, and 68 samples of generic sildenafil products were purchased from private drug outlets and wholesalers in Phnom Penh, Svay Rieng, and Battambang. The samples’ manufacturers were contacted to authenticate the samples. The quantities and dissolution rates of active ingredients were measured by a high-performance liquid chromatography system with photodiode array. Five generic samples were strongly suspected to be falsified medicines because of their extremely low quality; however, there was little distribution and no falsified medicine alleged to be produced by the originator of Viagra, which charges high prices. That finding indicates that falsification reflects local economic circumstances.

Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Falsely labelled, falsified (counterfeit) medicines (FFCm's) are produced or distributed illegally and can harm patients. Although the occurrence of FFCm's is increasing in Europe, harm is rarely reported. The European Directorate for the Quality of Medicines & Health-Care (EDQM) has therefore coordinated the development and validation of a screening tool.Methods: The tool consists of a questionnaire referring to a watch-list of FFCm's identified in Europe, including symptoms of their use and individual risk factors, and a scoring form. To refine the questionnaire and reference method, a pilot-study was performed in 105 self-reported users of watch-list medicines. Subsequently, the tool was validated under "real-life conditions" in 371 patients in 5 ambulatory and in-patient care sites ("sub-studies"). The physicians participating in the study scored the patients and classified their risk of harm as "unlikely" or "probable" (cut-off level: presence of ≥2 of 5 risk factors). They assessed all medical records retrospectively (independent reference method) to validate the risk classification and documented their perception of the tool's value.Results: In 3 ambulatory care sites (180 patients), the tool correctly classified 5 patients as harmed by FFCm's. The positive and negative likelihood ratios (LR+/LR-) and the discrimination power were calculated for two cut-off levels: a) 1 site (50 patients): presence of two risk factors (at 10% estimated health care system contamination with FFCm's): LR + 4.9/LR-0, post-test probability: 35%; b) 2 sites (130 patients): presence of three risk factors (at 5% estimated prevalence of use of non-prescribed medicines (FFCm's) by certain risk groups): LR + 9.7/LR-0, post-test probability: 33%. In 2 in-patient care sites (191 patients), no patient was confirmed as harmed by FFCm's. The physicians perceived the tool as valuable for finding harm, and as an information source regarding risk factors.Conclusions: This "decision aid" is a systematic tool which helps find in medical practice patients harmed by FFCm's. This study supports its value in ambulatory care in regions with health care system contamination and in certain risk groups. The establishment of systematic communication between authorities and the medical community concerning FFCm's, current patterns of use and case reports may sustain positive public health impacts. [ABSTRACT FROM AUTHOR]