Falsified Medicines Research Articles

Prevalence of Poor Quality Ciprofloxacin and Metronidazole Tablets in Three Cities in Cameroon.

Quality is one of the essential components of medicines and needs to be ensured to preserve the population's health. This can be achieved through post-marketing quality control of medicines and is one of the most important duties of national regulatory authorities. In collaboration with the Cameroonian National Drug Quality Control and Valuation Laboratory, the decision was made to initiate a prevalence study to assess the quality of antiinfective medicines in Cameroon. A total of 150 samples of ciprofloxacin tablets and 142 samples of metronidazole tablets were collected from 76 licensed pharmacies and 75 informal vendors in three cities in Cameroon using a random strategy wherever possible and a mystery shopper approach. Three tests were carried out on each of the samples. Visual inspection allowed to find two falsified samples (0.7%) due to lack of information about the manufacturing company, and five more samples (1.7%) were deemed to be substandard due to flaws in the product. An additional 13 samples (4.5%) failed disintegration testing, and six (2.1%) others failed high-performance liquid chromatography assay testing due to insufficient active pharmaceutical ingredient (API) content. All samples were found to contain some API. A prevalence of 7.9% substandard or falsified (SF) medicines was found. Moreover, the prevalence of outlets selling SF medicines was greater in the informal sector (26.7%) than in the formal sector (2.6%). Although the prevalence of SF medicines found was low, efforts need to be made by national regulatory authorities to monitor the pharmaceutical market more closely.

CRIMINAL OFFENCES RELATED TO ILLICIT TRAFFICKING IN FALSIFIED MEDICINES: INVESTIGATION PROBLEMS.

The aim: Formulate recommendations for improving the efficiency of detection and investigation of trafficking in falsified medicines, application of criminal¬istics knowledge. To analise the contemporary condition and the latest trends in combating this type of crimes and to justify the need for creation of a complex criminalistic methodic investigation. Materials and methods: Аnalysis of the applicable laws governing trade in medical products in Ukraine; judgments of courts of Ukraine for the period from 2013 to 2022; results of generalization of 128 criminal proceedings; active employee survey results (205 respondents) etc. Over the course of the present research, we have used general scientific and specialised research methods. Results and Conclusions: Increasing the effectiveness of combating the illegal circulation of falsified falsified medicines is a complex problem that encompasses a whole system of directions, requiring the combined efforts of international bodies and organizations, various scientists. One of the priority directions for the introduction of an effective mechanism for combating the distribution of falsified medicines is the development of a complex criminalistic methodic investigation.

“Enxugando Gelo?”: o trabalho dos profissionais na fiscalização sanitária de medicamentos na internet

Abstract Contemporary society is plagued with uncertainties and vulnerabilities, demanding from regulatory systems the surveillance of unregistered and/or falsified medicines sold online. This study investigates the work of federal health surveillance professionals in the inspection of medicines sold online and the elements that guide their technical decision. A qualitative, single case study based on the ergological approach was conducted between December 2020 and September 2021, with data collected by interviews and participant observation. Ergodialogical maps, developed using Atlas.ti, underlined the analysis of discursive practices classified according to the tri-polar knowledge-action-value schema, resulting in three categories. Professionals are always called upon to decide on and manage unpredictable situations, questioning the institutional capacity to understand and act on the problem. The work thus takes on the sense of “rolling a stone uphill” due to the volume of demands and the limited effects of surveillance on the e-commerce of medicines. Norms, technical knowledge, experience, and social responsibility, among other elements, inform the decision-making process of professionals, who are aware that, by acting, they protect public health. Different forms of knowledge, scientific or experiential, can better qualify decision-making in surveillance, making it more effective, assertive, and transparent.

Legal regulation of the economic activities of pharmacies in Ukraine

The scientific article is devoted to the peculiarities of the legal regulation of the economic activity of pharmacies in Ukraine. The legislative and by-laws regulating the circulation of medicinal products have been studied. Scientific works devoted to the legal regulation of pharmaceutical activity have been studied. The peculiarities of the economic activity of pharmacies have been determined. A doctrinal definition of a pharmacy has been proposed as a business entity that carries out the wholesale purchase of medicinal products for retail sale to citizens as end consumers.
 It is claimed that the retail sale of medicinal products should occur based on a license if the pharmacy complies with the license terms of such activity. Licensing conditions are established for the pharmacy staff and the equipment on the premises for the storage of medicinal products. Requirements are set for the total area of the pharmacy and the size of the sales hall, staff room, and warehouse space. Attention is drawn to the fact that pharmacy employees must comply with the requirements of legislation on the protection of consumer rights. The subject of trade is specific products, that are medicinal products registered in Ukraine. Medicines must have the necessary manufacturer’s documentation. It is essential to prevent trade in falsified medicines. It has been concluded that several conditions characterize the contract for the supply of medicinal products. In particular, regarding the assortment and quantity of medicinal products, that are transferred to the property and the conditions of storage of medicine during transportation.
 It has been proposed to introduce a number of amendments to the Law of Ukraine “On Medicinal Products”. At the legislative level, it is necessary to regulate the legal status of pharmacies and the peculiarities of the retail trade of medicinal products. It has been claimed that a separate section should be established in the Law of Ukraine On Medicinal Products that would regulate the economic activity of pharmacies. In this section, it is necessary to provide norms that would regulate the conditions for the pharmacy establishment. It is necessary to establish requirements for the pharmacy staff, separate premises, and conditions for the storage of medicinal products. Features of the protection of the consumer’s rights of medicinal products should be established in the legislation by separate norms. Special terms of contracts for the supply of medicinal products should be enshrined in the branch legislation on the circulation of medicinal products.

Environmental DNA as an innovative technique to identify the origins of falsified antimalarial tablets—a pilot study of the pharmabiome

Falsified medicines are a major threat to global health. Antimalarial drugs have been particularly targeted by criminals. As DNA analysis has revolutionized forensic criminology, we hypothesized that these techniques could also be used to investigate the origins of falsified medicines. Medicines may contain diverse adventitious biological contamination, and the sealed nature of blister-packages may capture and preserve genetic signals from the manufacturing processes allowing identification of production source(s). We conducted a blinded pilot study to determine if such environmental DNA (eDNA) could be detected in eleven samples of falsified and genuine artesunate antimalarial tablets, collected in SE Asia, which could be indicative of origin. Massively Parallel Sequencing (MPS) was used to characterize microbial and eukaryote diversity. Two mitochondrial DNA analysis approaches were explored to detect the presence of human DNA. Trace eDNA from these low biomass samples demonstrated sample specific signals using two target markers. Significant differences in bacterial and eukaryote DNA community structures were observed between genuine and falsified tablets and between different packaging types of falsified artesunate. Human DNA, which was indicative of likely east Asian ancestry, was found in falsified tablets. This pilot study of the ‘pharmabiome’ shows the potential of environmental DNA as a powerful forensic tool to assist with the identification of the environments, and hence location and timing, of the source and manufacture of falsified medicines, establish links between seizures and complement existing tools to build a more complete picture of criminal trade routes. The finding of human DNA in tablets raises important ethical issues that need to be addressed.

The capacity of young national medicine regulatory authorities to ensure the quality of medicines: case of Rwanda

BackgroundAccess 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.ObjectiveThis 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.MethodsThis 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”.ResultsOf 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.ConclusionFindings 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.

Framing access to essential medicines in the context of Universal Health Coverage: a critical analysis of health sector strategic plans from eight countries in the WHO African region

BackgroundFraming affects how issues are understood and portrayed. This profoundly shapes the construction of social problems and how policy options are considered. While access to essential medicines (ATM) in the World Health Organization (WHO) African Region is often framed as a societal problem, there is dominance of medical and technically oriented approaches to analyze and remedy the situation. Hence, the systematic application of social science approaches, such as framing theory, remains under-explored. Through a framing analysis of National Strategic Plans (NSPs) from eight countries, this study explores the applicability and potential usefulness of framing theory to analyze essential medicines policies.MethodsWe inductively coded the relevant NSP textual fragments using the qualitative content analysis software ATLAS.ti.22. Benford and Snow’s conceptualization of framing was used to organize the coded data into three frames: diagnostic (problems), prognostic (solutions) and motivational (values and ideological).ResultsThe following five diagnostic frames were dominant or in-frame: medicine unavailability, ineffective regulation, weak supply chain management, proliferation of counterfeit (substandard or falsified) medicines and use of poor quality medicines. Diagnostic frames related to financing, affordability, efficiency and corruption were given limited coverage or out of frame. Prognostic frames corresponded with how these problems were framed. Whilst Universal Health Coverage (UHC) and its guiding principles was the dominant motivational frame, we identified some frame discordance between the global discourse and national level policies.ConclusionsSocial science approaches such as framing analysis are applicable and useful to systematically analyze essential medicine aspects. By applying framing theory, we revealed that ATM aspects in the eight countries we analyzed are more often characterized in relation to availability at the expense of affordability which undermines UHC. We conclude that whilst UHC is a strong motivational frame to guide ATM aspects, it is insufficient to inform a comprehensive approach to address the problems related to ATM at country level. To effectively advance ATM, concerned actors need to realize such limitation and endeavor to gain a deeper understanding of how problems are framed and agendas are set at country level, the processes through which ideas and knowledge become policies, including the political demands, incentives and trade-offs facing decision-makers in selecting policy priorities.

Modeling the Health and Economic Impact of Substandard and Falsified Medicines: A Review of Existing Models and Approaches.

ABSTRACT.Substandard and falsified medicines are harmful to patients, causing prolonged illness, side effects, and preventable deaths. Moreover, they have an impact on the health system and society more broadly by leading to additional care, higher disease burden, productivity losses and loss of trust in health care. Models that estimate the health and economic impacts of substandard and falsified medicines can be useful for regulators to contextualize the problem and to make an economic case for solutions. Yet these models have not been systematically catalogued to date. We reviewed existing models that estimate the health and economic impact of substandard and falsified medicines to describe the varying modeling approaches and gaps in knowledge. We compared model characteristics, data sources, assumptions, and limitations. Seven models were identified. The models assessed the impact of antimalarial (n = 5) or antibiotic (n = 2) quality at a national (n = 4), regional (n = 2), or global (n = 1) level. Most models conducted uncertainty analysis and provided ranges around potential outcomes. We found that models are lacking for other medicines, few countries’ data have been analyzed, and capturing population heterogeneity remains a challenge. Providing the best estimates of the impact of substandard and falsified medicines on a level that is actionable for decision-makers is important. To enable this, research on the impact of substandard and falsified medicines should be expanded to more medicine types and classes and tailored to more countries that are affected, with greater specificity.

Encouraging rule on exemption from criminal liability for the circulation of falsified medicines: problems of legislative construction

The article is devoted to the analysis of the legislative structure of the encouraging rule, which contains a special type of exemption from criminal liability for the circulation of falsified medicines. It is argued that the effectiveness of the incentive norm is primarily determined by qualitative approaches to formulating the content of the grounds and conditions of exemption from criminal liability. The specificity of this special type of exemption from criminal liability is determined by a set of objective and subjective features of the crime under Article 321-1 of the Criminal Code of Ukraine. The public danger of this crime is significant, which is confirmed by its classification by the legislator as serious and especially serious crimes. It is established that the provision in the structure of this article of a legislative compromise in the form of encouragement, first of all, pursues the goal of rapid detection and prevention of crime by encouraging a certain type of positive post-criminal behavior of the guilty.
 The position on recognizing as a condition for exemption from criminal liability the commission of actions that are alternatively provided for in part one of Article 321-1 of the Criminal Code of Ukraine, namely the manufacture, purchase, transportation, shipment, storage for sale of counterfeit medicines. It is noted that in the chain of actions aimed at introducing counterfeit drugs into circulation according to the degree of public danger, these forms of the objective side are equivalent.
 In contrast to the positions previously expressed in the science of criminal law, it is proposed to determine the objective (danger of the most falsified drugs in terms of the composition of substances contained in it) and sub effective criteria (awareness of the person who acts in accordance with Part 1 of Article 321-1, these dangerous signs).
 It is established that the existence of alternative grounds for dismissal creates problems in the application of this rule. The expediency of refusing to indicate the source of purchase of counterfeit medicines is justified, as active assistance in solving the crime includes this circumstance. Emphasis is placed on the inclusion in the legislative structure of the encouraging rule also to add the limits of the implementation of post-criminal behavior - to criminal prosecution. Based on the above, an updated version of the considered encouraging rule is proposed.

Characterizing Medicine Quality by Active Pharmaceutical Ingredient Levels: A Systematic Review and Meta-Analysis across Low- and Middle-Income Countries.

ABSTRACT.Substandard and falsified medicines are often reported jointly, making it difficult to recognize variations in medicine quality. This study characterized medicine quality based on active pharmaceutical ingredient (API) amounts reported among substandard and falsified essential medicines in low- and middle-income countries (LMICs). A systematic review and meta-analysis was conducted using PubMed, supplemented by results from a previous systematic review, and the Medicine Quality Scientific Literature Surveyor. Study quality was assessed using the Medicine Quality Assessment Reporting Guidelines (MEDQUARG). Random-effects models were used to estimate the prevalence of medicines with < 50% API. Among 95,520 medicine samples from 130 studies, 12.4% (95% confidence interval [CI]: 10.2–14.6%) of essential medicines tested in LMICs were considered substandard or falsified, having failed at least one type of quality analysis. We identified 99 studies that reported API content, where 1.8% (95% CI: 0.8–2.8%) of samples reported containing < 50% of stated API. Among all failed samples (N = 9,724), 25.9% (95% CI: 19.3–32.6%) reported having < 80% API. Nearly one in seven (13.8%, 95% CI: 9.0–18.6%) failed samples were likely to be falsified based on reported API amounts of < 50%, whereas the remaining six of seven samples were likely to be substandard. Furthermore, 12.5% (95% CI: 7.7–17.3%) of failed samples reported finding 0% API. Many studies did not present a breakdown of actual API amount of each tested sample. We offer suggested improved guidelines for reporting poor-quality medicines. Consistent data on substandard and falsified medicines and medicine-specific tailored interventions are needed to ensure medicine quality throughout the supply chain.

Pharmacists' views on the impact of the Falsified Medicines Directive on community pharmacies: A cross-sectional survey

BackgroundThe 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. ObjectiveTo examine community pharmacists' views on how the FMD has affected their practice. MethodsAn 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. ResultsIn 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. ConclusionsKey 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.

The plague of unexpected drug recalls and the pandemic of falsified medications in cardiovascular medicine as a threat to patient safety and global public health: A brief review.

Valsartan, losartan, and irbesartan, are widely used in the treatment strategies of cardiovascular medicine diseases, including hypertension and heart failure. Recently, many formulations for the aforementioned diseases contained active pharmaceutical ingredients and had been abruptly recalled from the market due to safety concerns mainly associated with unwanted impurities — nitrosamines, which are highly carcinogenic substances accidentally produced during manufacturing. Along with cardiovascular medications, formulations containing ranitidine were also recalled from the market. This poses a particular threat to public health due to the non-prescription status of these drugs. Regulatory authorities, including the Food and Drug Administration and European Medicines Agency among others, have taken action to minimize patient risk and improve the manufacturing quality as well as re-checking current guidelines and recommendations. While these steps are necessary to avoid further recalls, authorities should remember the growing concerns of patients regarding the safety and efficacy of pharmacotherapy. Apart from the genuine manufacturing mistakes mentioned above, falsified and counterfeit medications should be at the heart of global attention. The lack of a well-accepted definition of falsified/counterfeit medications has impeded political and scientific efforts to mitigate risk of this phenomenon. Falsified Medicines Directive should be considered the most pivotal legislation recently enacted to harmonize international cooperation. In summary, one should remember that only international and direct collaboration between patients, stakeholders, and authorities be considered a remedy for a pandemic of falsified medicines and plague of unexpected recalls due to safety concerns.

3D-printed electrochemical pestle and mortar for identification of falsified pharmaceutical tablets.

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 300µg/mL, where the limit of detection was 7µg/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.

Benchtop NIR data standardization on handheld spectrometers to identify paracetamol tablets

AbstractNear‐infrared spectroscopy (NIRS) allows innovative applications in terms of quality control, for example, in raw materials verification, in process analytical technology (PAT), and in discrimination between genuine and falsified medicines. The development of small and cheap handheld devices is expanding in the field, while trying to keep similar performances as benchtop instruments have. Considering traceability and quality control of drug compounds, this work is intended to identify 13 different paracetamol tablets on the Belgian market by using NIRS. The performances of a Fourier‐transform near‐infrared spectroscopy (FT‐NIR) benchtop and two handheld NIR spectrometers were investigated comparatively. All spectra were collected through the blister in the reflectance diffuse mode. NIR spectral fingerprints were pretreated and analyzed using principal component analysis (PCA) and classified with soft independent modeling of class analogy (SIMCA). The performances of the spectrometers were evaluated after standardization of the reference benchtop database to the handheld spectrometers. The instrumental response of the benchtop spectrometer was standardized towards the handheld device using the piecewise direct standardization (PDS) algorithm. These investigations permitted the advantages and limitations of NIR data standardization on predictive models to be pointed out. The SIMCA models based on the spectral data of the benchtop (B), handheld 1 (H1), and handheld 2 (H2) instruments had an accuracy of 99.2%, 97.7%, and 96.2%, respectively. The same accuracy was obtained with the models of the transferred benchtop spectra for the H1 and H2 devices. However, adding handheld spectra to the transferred benchtop spectra resulted in models with improved accuracy: from 97.7% to 98.5% for the H1 instrument and from 96.2% to 97.7% for the H2 instrument. The proposed strategy highlights the potential of using a reference database collected by NIRS for pharmaceutical analyses by handheld NIR spectrometers in terms of traceability.

A Literature Review on the Global Burden and Impact of Substandard and Falsified Medicine

Abstract 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.

Government misses consultation deadline for post-Brexit scheme to detect fake medicines

Ministers have missed their own deadline to begin a consultation process on implementing a UK version of the Falsified Medicines Directive (FMD). The FMD, which introduced an EU-wide scheme to spot fake and falsified medicines in February 2019, ceased to apply in Great Britain when the Brexit transition period ended on 31 December 2020. However, […]

Сучасні пріоритети формування фармацевтичного ринку України в контексті забезпечення якості лікарських засобів

The article studies the current state of the pharmaceutical market of Ukraine in the context of ensuring the quality of medicinal products and preventing the spread of falsified medicinal products. It is found that according to the State Register of Medicinal Products of Ukraine, 13.664 drugs were registered in October 2020. It is further found that today in the structure of the assortment of medicines in the pharmaceutical market of Ukraine, foreign drugs make up more than 70%, and in certain classification groups they reach 90%. It is determined that the main importers of medicines to Ukraine are Germany, India, France, Italy, Slovenia and Hungary. It is specified that Ukraine practically does not have its own production of active pharmaceutical ingredients (APIs), about 80% of APIs is imported from China and India, therefore distributors are mainly responsible for the quality of APIs. It is found that in the period from 2000 to 2020, the State Drug Inspectorate annually detected and removed from circulation circa 4–117 series and 3–63 names of falsified medicinal products. It is determined that the counterfeiting and underground production of falsified medicinal products in 2017–2020 on the territory of Ukraine were detected both by the State Medical Service and law enforcement agencies. It is further determined that in 2017 the State Medical Service issued 18 orders prohibiting the circulation of falsified medicinal products, in 2018 – 11 respective prohibiting orders, in 2019 – 21, and in 2020 – 4 respective prohibiting orders. It is specified that over the past 10 years there has been a steady trend towards an increase in the number of falsified medicinal products in the pharmaceutical market of Ukraine. The main factors stimulating the circulation of falsified medicinal products have been established: the unstable economic situation in Ukraine; a developed system of online sales of medicines; the shortage of medicines creates the possibility of distribution of falsified medicines; high drug prices when compared with the average paying capacity of the population, as well as a large difference in market prices, which stimulates the sale of a cheaper counterfeit drug.

Survey of workflow and cost implications of decommissioning regarding the Falsified Medicines Directive in Hungarian hospital pharmacies

Objectives, setting and participantsIn July 2011, the EU adopted the Falsified Medicines Directive (FMD) primarily aiming to prevent the infiltration of falsified medicines into the legitimate supply chain. Our aim...

Combatting Substandard and Falsified Medicines: Public Awareness and Identification of Counterfeit Medications.

Objectives: The objective of this study was to determine the identification rate of substandard and falsified medications and its association with knowledge among public.Methods: This descriptive cross-sectional study was conducted in different geographic areas among a convenient sample of people aged 18 or older. A validated web-based electronic questionnaire was used for data collection tool. The questionnaire contained three sections assessing the following: (1) Sociodemographic data; (2) Knowledge regarding counterfeit medicines; and (3) Ability to identify counterfeit medicines, according to 12 questions rated on a five-point Likert scale. Univariate and multivariate logistic regression analyses were used to assess the association between sociodemographic factors and counterfeit medication identification rate.Results: A total of 320 people participated in the study. Only 98 participants (30.6%, 95% CI 25.6–35.7%) identified the counterfeit medications. Ability to correctly identify counterfeit medications was significantly higher in participants who were older (p = 0.016), single (p = 0.001), Asian (p = 0.001), or American (p = 0.019), as well as those who indicated that they would check the certification of the medications (p = 0.015) and report counterfeit medications to the authorities (p < 0.0001).Conclusions: These results underscore the need for greater public awareness of the hazards associated with counterfeit medicines.

Falsified and Substandard Medicines in Developing Countries: Seeking for The Sampling Procedure to Find them

Falsified and substandard medicines is a very important issue, especially in developing countries including Indonesia. World Health Organization (WHO) stated that 1 in 10 medicines in developing countries are substandard or falsified. It is result in risks for patients and health systems relating to ineffective drugs, prolong treatment times, possible side effects, increased healthcare spending, even the risk of serious illness and death. There are many factors responsible for this situation, namely the effectiveness of government control, public drug procurement policies, market and economic competition, the depletion of entry barriers driven by free and online trade, availability of raw materials, and mastery of technology on pharmaceuticals. The problem is how to find falsified and substandard medicines amidst so many kinds of medicines in market. If the sampling is done randomly on all types of medicines in all market, it will be less likely to find them. In addition, this kind of sampling technique will be expensive because it requires a lot of resources. Therefore, a risk-based systematic mechanism is needed to guide sampling procedure. This research was aimed to design a model that could be used as a reference. Using the system thinking method, we mapped out relationships between various factors and phenomena surrounding the issue. Then, the system dynamics modelling was developed with a focus on sentinel groups that were most at risk of drug counterfeiting cases. All relevant variables were discussed, and some recommendations were provided in this paper. We hope, using this recommendation, the sampling procedure becomes faster, more efficient, and more likely to find cases. It is because the more effective the way to control falsified and substandard medicines, the higher the protection that consumers or patients may get.