Falsified Medicines Research Articles

Dentification of artemether-lumefantrine combination drugs using mid-infrared spectroscopy and chemometric tools

The high circulation of substandard and/or falsified medicines is a major public health problem worldwide, particularly in low-resource countries. This work was carried out with the aim of combating this scourge using mid-infrared spectroscopy. The study focused on combination therapies based on artemether-lumefantrine and involved the construction and validation of a model for rapid detection of falsifications of artemether-lumefantrine. Other antimalarial drugs were also used to assess the specificity of the models constructed. A total of 46 samples were analyzed, all collected in Benin, from pharmacies in Departmental Hospital Centres and private pharmacies. The spectra recorded in the range from 4000 to 650 cm-1 were preprocessed then a principal component analysis was applied to break down and visualize the data, and to highlight groupings or trends. This enabled to observe the differences and similarities between the spectra of artemether/lumefantrine, and to assess the differentiating factors from other antimalarial molecules. Also, a data-driven soft independent modelling of class analogy (DD-SIMCA) model was built to evaluate its ability to authenticate artemether-lumefantrine samples. The other antimalarial drugs were used to test model specificity. Built DD-SIMCA model allowed a clear identification of artemether-lumefantrine (sensitivity 100%) and a good discrimination of other antimalarials (specificity 98%). Keywords: Quality control, construction, validation, DD-SIMCA.

Experiences of Consumers on the Health Effects of Fake and Adulterated Medicines in Nigeria

Medicines are used to cure and treat ailments, relieve or eliminate disease symptoms, and slow down the disease process. Any attempt to disrupt this natural medicine process, using falsified medications, spells doom to a consumer of such medication. The challenge of fake medicines is a global one and affects developing and developed nations and currently assumes great significance as a result of globalization challenges, which have flattened the entire world, hence removing barriers to the movement of products and services. The cross-sectional survey was conducted, using six local government areas of Anambra State in South-East Nigeria, namely Awka, Nnewi, Onitsha, Aguata, Ogbaru, and Anaocha, among adults aged 18 years and above. A minimum sample size of 500 was calculated and stratified sampling was employed to select respondents in order to ensure that various population groups, the upper class, middle class, and lower class were represented. This research has shown that falsified medicine is an evil wind that blows nobody any good. It negatively affects every aspect of the citizen’s livelihood, ranging from their health, which manifests as treatment failures, deformities, loss of life to death, to loss of confidence in the healthcare providers, revenue losses to individuals, healthcare providers, manufacturers, and finally corruption of the genuine medicines supply chain with fake and adulterated medicines. The study has clearly shown the experiences of residents of Anambra State, South-East Nigeria with fake and adulterated medicines and also services as a wake-up call to medicines regulators like NAFDAC, PCN, the PSN, and Federal Ministry of Health to declare a state of emergency on the fight against fake and adulterated medicines and make enabling laws that are punitive enough towards the fight against this scourge, so that the healthcare and well-being of Nigerians would be assured at all times.

Quality of Essential Medicines from Different Sources in Enugu and Anambra, Nigeria.

This study investigated the quality of 13 essential medicines in the states of Enugu and Anambra, Nigeria. A total of 260 samples were purchased from licensed pharmaceutical manufacturers and wholesalers and from vendors in pharmaceutical markets with unclear licensing status. Samples were analyzed for identity, content, and dissolution according to the United States Pharmacopeia (USP) 42 monographs. Forty-five samples of this study could be examined for authenticity with the Mobile Authentication Service scheme of the Nigerian National Agency for Food and Drug Administration and Control. Out of all samples, 25.4% did not comply with the USP 42 specifications. Strikingly, 21 out of 22 dexamethasone tablet samples (95%) were out of specification (OOS). Nine out of 19 glibenclamide samples (47%) failed dissolution testing, and 7 out of 17 cotrimoxazole samples (41%) failed assay testing. Medicines against noncommunicable diseases showed a slightly higher percentage of OOS samples than anti-infectives (21.2% versus 17.6%). The rates of OOS samples were similar in medicines stated to be produced in Nigeria, India, and China but were very different between individual manufacturers from each of these countries of origin. Therefore, prequalification of products, manufacturers, and suppliers are very important for quality assurance in medicine procurement. Unexpectedly, the total proportions of OOS samples were similar from licensed vendors (25.2%) and from markets (25.5%). Four samples (1.5%), all collected in markets, were clearly falsified and did not contain the declared active pharmaceutical ingredients. The proportion of falsified medicines was found to be lower than frequently reported in the media for Nigeria.

Research on the Development of Methods for Detection of Substandard and Falsified Medicines by Clarifying Their Pharmaceutical Characteristics Using Modern Technology.

The existence of substandard and falsified medicines threatens people's health and causes economic losses as well as a loss of trust in medicines. As the distribution of pharmaceuticals becomes more globalized and the spread of substandard and falsified medicines continues worldwide, pharmaceutical security measures must be strengthened. To eradicate substandard and falsified medicines, our group is conducting fact-finding investigations of medicines distributed in lower middle-income countries (LMICs) and on the Internet. From the perspective of pharmaceutics, such as physical assessment of medicines, we are working to clarify the actual situation and develop methods to detect substandard and falsified medicines. We have collected substandard and falsified medicines distributed in LMICs and on the Internet and performed pharmacopoeial tests, mainly using HPLC, which is a basic analytic method. In addition to quality evaluation, we have evaluated the applicability of various analytic methods, including observation of pharmaceuticals using an electron microscope, Raman scattering analysis, near-IR spectroscopic analysis, chemical imaging, and X-ray computed tomography (CT) to detect substandard and falsified medicines, and we have clarified their limitations. We also developed a small-scale quality screening method using statistical techniques. We are engaged in the development of methods to monitor the distribution of illegal medicines and evolve research in forensic and policy science. These efforts will contribute to the eradication of substandard and falsified medicines. Herein, I describe our experience in the development of detection methods and elucidation of the pharmaceutical status of substandard and falsified medicines using novel technologies.

Search Engines and Generative Artificial Intelligence Integration: Public Health Risks and Recommendations to Safeguard Consumers Online.

The online pharmacy market is growing, with legitimate online pharmacies offering advantages such as convenience and accessibility. However, this increased demand has attracted malicious actors into this space, leading to the proliferation of illegal vendors that use deceptive techniques to rank higher in search results and pose serious public health risks by dispensing substandard or falsified medicines. Search engine providers have started integrating generative artificial intelligence (AI) into search engine interfaces, which could revolutionize search by delivering more personalized results through a user-friendly experience. However, improper integration of these new technologies carries potential risks and could further exacerbate the risks posed by illicit online pharmacies by inadvertently directing users to illegal vendors. The role of generative AI integration in reshaping search engine results, particularly related to online pharmacies, has not yet been studied. Our objective was to identify, determine the prevalence of, and characterize illegal online pharmacy recommendations within the AI-generated search results and recommendations. We conducted a comparative assessment of AI-generated recommendations from Google's Search Generative Experience (SGE) and Microsoft Bing's Chat, focusing on popular and well-known medicines representing multiple therapeutic categories including controlled substances. Websites were individually examined to determine legitimacy, and known illegal vendors were identified by cross-referencing with the National Association of Boards of Pharmacy and LegitScript databases. Of the 262 websites recommended in the AI-generated search results, 47.33% (124/262) belonged to active online pharmacies, with 31.29% (82/262) leading to legitimate ones. However, 19.04% (24/126) of Bing Chat's and 13.23% (18/136) of Google SGE's recommendations directed users to illegal vendors, including for controlled substances. The proportion of illegal pharmacies varied by drug and search engine. A significant difference was observed in the distribution of illegal websites between search engines. The prevalence of links leading to illegal online pharmacies selling prescription medications was significantly higher (P=.001) in Bing Chat (21/86, 24%) compared to Google SGE (6/92, 6%). Regarding the suggestions for controlled substances, suggestions generated by Google led to a significantly higher number of rogue sellers (12/44, 27%; P=.02) compared to Bing (3/40, 7%). While the integration of generative AI into search engines offers promising potential, it also poses significant risks. This is the first study to shed light on the vulnerabilities within these platforms while highlighting the potential public health implications associated with their inadvertent promotion of illegal pharmacies. We found a concerning proportion of AI-generated recommendations that led to illegal online pharmacies, which could not only potentially increase their traffic but also further exacerbate existing public health risks. Rigorous oversight and proper safeguards are urgently needed in generative search to mitigate consumer risks, making sure to actively guide users to verified pharmacies and prioritize legitimate sources while excluding illegal vendors from recommendations.

Assessment of pharmacovigilance guidelines in the Southern African Development Community: A document review.

Lack of harmonization in pharmacovigilance (PV) practice in resource-limited states in Africa has led to differentiation and marginalization, thus creating an environment where weak or absent PV systems may benefit from regional guidelines. To compare the PV guidelines of Southern African Development Community (SADC) member states to international guidelines and identify areas for improvement for aligning PV practice within the SADC region. We utilized a 73-item checklist to assess the PV guidelines of the SADC member states. Checklist parameters were rated using binary scoring. Only seven (Botswana, Mauritius, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe) of the 16 SADC member states had guidelines to assess. Of these, only four had supporting legislation. All seven national medicines regulatory authorities (NMRA)'s guidelines required reporting of local serious adverse drug reactions (ADRs). Four NMRAs implemented device vigilance; none specified submission timelines for ADRs associated with substandard or falsified medicines. Only three NMRAs required electronic transmission of individual case safety reports in the E2B format. Five NMRAs mandated safety monitoring during interventional clinical trials. Five NMRAs required aggregate reporting through periodic safety update reports. Only two NMRAs required submission of the development safety update report. Regarding risk management, four NMRAs required notification of actions taken by foreign NMRAs and four NMRAs expected to review Dear Healthcare Professional Letters before distribution by the marketing authorization holder. Areas for improvement of guidelines to establish common process standards and allow for synchronized submissions of comparable data to SADC NMRAs are provided.

The impact of global falsified medicines regulation on healthcare stakeholders in the legitimate pharmaceutical supply chain: a systematic review.

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. 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. 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. 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. 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. 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.

No progress on post-Brexit falsified medicines scheme in UK

No progress on post-Brexit falsified medicines scheme in UK

Substandard and falsified ivermectin tablets obtained for self-medication during the COVID-19 pandemic as a source of potential harm.

In 2019, a global viral pandemic, due to the SARS-CoV-2 virus, broke out. Soon after, the search for a vaccine and/or antiviral medicine began. One of the candidate antiviral medicines tested was ivermectin. Although several health authorities warned the public against the use of this medicine outside clinical trials, the drug was widely used at the end of 2020 and in 2021. Simultaneously, several reports started to emerge demonstrating serious adverse effects after self-medicating with ivermectin. It stands to reason that the self-administration of substandard or falsified (SF) medicines bearing harmful quality deficiencies have contributed to this phenomenon. In order to have a better view on the nature of these harmful quality deficiencies, SF ivermectin samples, intercepted in large quantities by the Belgian regulatory agencies during the period 2021-2022, were analyzed in our official medicines control laboratory. None of the samples (n = 19) were compliant to the quality criteria applicable to medicinal products. These SF products either suffered from a systematic underdosing of the active pharmaceutical ingredient or were severely contaminated with bacteria, two of which were contaminated with known pathogens that cause gastrointestinal illness upon oral intake. In addition to the direct risks of self-medicating with such a product, the improper usage and dosage of ivermectin medication might also facilitate ivermectin tolerance or resistance in parasites. This may have detrimental consequences on a global scale, certainly as the number of newly developed active pharmaceutical ingredients that can safely be used to combat parasites is rather scarce.

Verification of the active pharmaceutical ingredient in tablets using a low-cost near-infrared spectrometer

The present study investigated the possibilities and limitations of using a low-cost NIR spectrometer for the verification of the presence of the declared active pharmaceutical ingredients (APIs) in tablet formulations, especially for medicine screening studies in low-resource settings. Spectra from 950 to 1650 nm were recorded for 170 pharmaceutical products representing 41 different APIs, API combinations or placebos. Most of the products, including 20 falsified medicines, had been collected in medicine quality studies in African countries. After exploratory principal component analysis, models were built using data-driven soft independent modelling of class analogy (DD-SIMCA), a one-class classifier algorithm, for tablet products of penicillin V, sulfamethoxazole/trimethoprim, ciprofloxacin, furosemide, metronidazole, metformin, hydrochlorothiazide, and doxycycline. Spectra of amoxicillin and amoxicillin/clavulanic acid tablets were combined into a single model. Models were tested using Procrustes cross-validation and by projection of spectra of tablets containing the same or different APIs. Tablets containing no or different APIs could be identified with 100 % specificity in all models. A separation of the spectra of amoxicillin and amoxicillin/clavulanic acid tablets was achieved by partial least squares discriminant analysis. 15 out of 19 external validation products (79 %) representing different brands of the same APIs were correctly identified as members of the target class; three of the four rejected samples showed an API mass percentage of the total tablet weight that was out of the range covered in the respective calibration set. Therefore, in future investigations larger and more representative spectral libraries are required for model building. Falsified medicines containing no API, incorrect APIs, or grossly incorrect amounts of the declared APIs could be readily identified.Variation between different NIR-S-G1 spectroscopic devices led to a loss of accuracy if spectra recorded with different devices were pooled. Therefore, piecewise direct standardization was applied for calibration transfer.The investigated method is a promising tool for medicine screening studies in low-resource settings.

European Directive on Falsified Medicines: Lights and shadows for the Hospital Pharmacy

European Directive on Falsified Medicines: Lights and shadows for the Hospital Pharmacy

Machine Learning Approach for Spectral Signature Based Chemical Composition Analysis using Hyperspectral Data

Abstract: Number of techniques to identify falsified medications, including thin layer chromatography (TLC), analytical methods, eye examination, and the use of sophisticated labs with strong equipment and technical specialists. Such techniques take more time and call for sophisticated labs, specialized specialists in that field, and sample preparation. This research uses hyperspectral data to develop a spectral pattern for identifying falsified medications. Near infrared spectroscopic techniques are commonly used for this task because of their many advantages. For this research, we used the wide spectral range ASD Field Spec4 Spectroradiometer (350-2500 nm). We chose 43 solid pharmaceutical medicines from various brands for our task. The tablet powder has been altered by adding various amounts of calcium carbonate (CaCO3) to imitate falsified medicines. Then, we gather the spectral signature throughout all stages of contamination and use machine learning categorization methods to assess it. Partial least squares regression has a remarkable accuracy rate of 98.9% for hyperspectral data with NIR spectroscopy, while logistic regression, support vector machines, and random forests all provide accuracy of 75%. This hyperspectral data coupled with a database of pharmaceutical spectra creates a practical field-testing method to identify fake medications that is quick, simple to use, and requires no technological expertise.

Assessing the knowledge and practice of the Irish Community Pharmacists in reporting Adverse Drug Reactions and Falsified Medicines

Background: Pharmacovigilance is a critical aspect of healthcare, enabling the monitoring of adverse drug reactions (ADRs), eradication of falsified medicines (FMs), identification of medication errors, monitoring off-license drug use, addressing abuse and misuse, assessing lack of efficacy, tracking poisoning incidents, managing drug-drug/food interactions, ensuring the destruction of expired stock, and evaluating drug-related mortality. It is essential for healthcare professionals to be aware of their role in Pharmacovigilance.
 Objective: This study aims to assess the current knowledge and reporting practices of ADRs and FMs among community pharmacists in Ireland, focusing on two important components of Pharmacovigilance.
 Method: The research employed a cross-sectional, observational design, utilizing an online questionnaire survey to gain insights into the pharmacists' knowledge and practices related to Pharmacovigilance programs, ADR reporting, FMs, and their opinions on their role in these areas.
 Results: The study found that Irish colleges and universities played a significant role in providing Pharmacovigilance education to pharmacy students. The majority of pharmacists demonstrated a good understanding of Pharmacovigilance, but only a third of them were aware of Irish legislation in this regard. Additionally, only 20.23% of pharmacists believed that Irish patients were aware of ADR reporting, although 92.49% were familiar with the Health Products Regulatory Authority's (HPRA) ADR reporting system. The findings suggest the need for pharmacists to educate their patients about ADR reporting, while recognizing the convenience of the HPRA reporting system.
 Conclusion: Overall, the study revealed that most community pharmacists possess a solid understanding of the fundamental aspects of Pharmacovigilance, including ADRs and FMs. However, there are areas for improvement, such as raising awareness among patients about ADR reporting. The findings highlight the importance of continuous education and communication to enhance Pharmacovigilance practices among community pharmacists in Ireland.

Exploring the Knowledge and Practices of Adverse Drug Reaction and Falsified Medicine Reporting Amongst the Community Pharmacists of India

Background: Adverse drug reactions (ADRs) and falsified medicines (FMs) pose significant threat to patient safety and public health. Understanding the knowledge, experiences, and perspectives of community pharmacists in India regarding ADRs and FMs is crucial for effective intervention and prevention strategies.
 Objective: This study aimed to assess the knowledge, experiences, and perspectives of community pharmacists in India regarding ADRs and FMs. It sought to gather information on pharmacists' familiarity with the threats posed by ADRs and FMs, their understanding of relevant legislation, their personal encounters with ADRs and FMs, and their views on the distribution of FMs and the adequacy of existing legislation.
 Method: A survey was conducted among community pharmacists in India, and data were collected using a questionnaire. The survey included questions related to knowledge, experiences, and perspectives on ADRs and FMs. The responses were analysed to identify trends and key findings.
 Results: The analysis revealed that a significant majority of pharmacists demonstrated a fundamental understanding of ADRs and FMs. However, a relatively low percentage reported encountering ADRs as well as FMs in their practice, with an equally low proportion reporting these incidents to the appropriate authorities Majority of pharmacists believed that they plan an important role in reporting of ADRs but only half of the pharmacists’ surveyed things that they plan an important role in tackling the issue of FMs.
 Conclusion: The research highlights that community pharmacists in India have a good understanding of Pharmacovigilance and ADR reporting, although knowledge of Indian legislation needs improvement. Pharmacists demonstrate a positive attitude towards ADR reporting and promptly report encountered ADRs and FMs. Patient education, convenience of the reporting system, and strengthening FM legislation are areas that require attention. Major sources of FM distribution are online pharmacies and street hawkers. These findings contribute to enhancing pharmacovigilance practices and addressing FM distribution in India.

Usefulness of medicine screening tools in the frame of pharmaceutical post-marketing surveillance.

The negative consequences of Substandard and falsified (SF) medicines are widely documented nowadays and there is still an urgent need to find them in more efficient ways. Several screening tools have been developed for this purpose recently. In this study, three screening tools were used on 292 samples of ciprofloxacin and metronidazole collected in Cameroon. Each sample was then analyzed by HPLC and disintegration tests. Seven additional samples from the nitro-imidazole (secnidazole, ornidazole, tinidazole) and the fluoroquinolone (levofloxacin, ofloxacin, norfloxacin, moxifloxacin) families were analyzed to mimic falsified medicines. Placebo samples that contained only inert excipients were also tested to mimic falsified samples without active pharmaceutical ingredient (API). The three screening tools implemented were: a simplified visual inspection checklist, a low-cost handheld near infrared (NIR) spectrophotometer and paper analytical devices (PADs). Overall, 61.1% of the samples that failed disintegration and assay tests also failed the visual inspection checklist test. For the handheld NIR, one-class classifier models were built to detect the presence of ciprofloxacin and metronidazole, respectively. The APIs were correctly identified in all the samples with sensitivities and specificities of 100%. However, the importance of a representative and up-to-date spectral database was underlined by comparing models built with different calibration set spanning different variability spaces. The PADs were used only on ciprofloxacin samples and detected the API in all samples in which the presence of ciprofloxacin was confirmed by HPLC. However, these PADs were not specific to ciprofloxacin since they reacted like ciprofloxacin to other fluoroquinolone compounds. The advantages and drawbacks of each screening tool were highlighted. They are promising means in the frame of early detection of SF medicines and they can increase the speed of decision about SF medicines in the context of pharmaceutical post-marketing surveillance.

Health, Economic, and Social Impacts of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review of Methodological Approaches.

Little is known about the adverse health, economic, and social impacts of substandard and falsified medicines (SFMs). This systematic review aimed to identify the methods used in studies to measure the impact of SFMs in low- and middle-income countries (LMICs), summarize their findings, and identify gaps in the reviewed literature. A search of eight databases for published papers, and a manual search of references in the relevant literature were conducted using synonyms of SFMs and LMICs. Studies in the English language that estimated the health, social, or economic impacts of SFMs in LMICs published before June 17, 2022 were considered eligible. Search results generated 1,078 articles, and 11 studies were included after screening and quality assessment. All included studies focused on countries in sub-Saharan Africa. Six studies used the Substandard and Falsified Antimalarials Research Impact model to estimate the impact of SFMs. This model is an important contribution. However, it is technically challenging and data demanding, which poses challenges to its adoption by national academics and policymakers alike. The included studies estimate that substandard and falsified antimalarial medicines can account from 10% to ∼40% of total annual malaria costs, and SFMs affect rural and poor populations disproportionately. Evidence on the impact of SFMs is limited in general and nonexistent regarding social outcomes. Further research needs to focus on practical methods that can serve local authorities without major investments in terms of technical capacity and data collection.

Problems of Falsification of Medicinal products in the conditions of the COVID-19 Pandemic: Adaptation of Ukrainian legislation to the norms of the European Union

The problem of distribution of low-quality medicinal products in Ukraine has become especially relevant against the background of the spread of the COVID-19 pandemic. The challenge to the national medical system became more tangible, as the fight against the virus and quarantine restrictions became heavy psychological blows for patients who sought appropriate treatment in an unofficial way. The purpose of the article is to analyze the problem of falsification of medicines in the conditions of a pandemic and to develop development models against the background of the study of European legislative norms. General scientific methods (synthesis, analysis, induction and deduction) became the main methods for writing the article. The methods of content analysis, systematic review of scientific literature, SMART and FINER principles were also used. The results highlighted one of the most important problems of the distribution of falsified and unlicensed drugs during the spread of COVID-19 - the semi-legal activity of pharmacies that work exclusively in the field of online sales. The requirements for their activities are quite loyal, and the distribution of low-quality or uncertified medicinal products is punished only administratively. The possibility of using European (primarily German) experience to counter the distribution of falsified medicines was discussed. Attention was also drawn to the geopolitical factor in the fight against COVID-19 – the use of the Russian vaccine “SPUTNIK V”, which in the conditions of Russian aggression can be assessed as a hybrid threat. The problematic nature of using this vaccine has been demonstrated, given the secrecy of the mechanism of conducting experiments. Resolutions of the European regulatory bodies allowed Ukrainian doctors not to use this vaccine either. This episode can be considered a positive moment of using European experience to establish medical rules for work in Ukraine. The conclusions note the need to reform Ukrainian legislation, take into account the European experience and harmonize with European regulations on the circulation of medical drugs. Such a step will make it possible to face modern challenges and significantly complicate the entry of counterfeit medicines into Ukraine.

A cross-sectional study on substandard and falsified medicines (fake or counterfeit drugs) in UK pharmacies during the COVID-19 pandemic

ABSTRACT Background Failure of the Falsified Medicines Directive (FMD) in the UK could mean that substandard and falsified medicines (SFs) enter the supply chain. Does this risk patients’ health? Readiness to implement FMD, and prevalence of SFs vs. regulator detection were assessed. Research design and methods A total of 12,040 primary care pharmacies across England were invited (April 2021–March 2022). Respondent postcodes were used to extract deprivation scores. Information request was placed with the medicine’s agency. Survey findings were used to calculate probability and power of a simulated trial. Results A total of 208 participants responded: Of the seven who identified SFs, all but one reported it; 61% were ready to implement FMD, 74.1% had adequate resources, 54.8% expected improved patient safety, and 17.8% had ever reported SFs. SFs were prevalent in deprived areas. Bayesian simulation shows 438 (p = 0.030) incidences with a 3% probability of SFs prevalence. The agency identified 15,238 SFs units in the supply chain (2019 and 2020). Results are credible, reliable, and generalisable, with corroborated longitudinal persistence. Conclusions FMD or equivalent processes need to be urgently reinstated. Deprived children may be more affected. Pharmacists are worried about liability. All health consultations should assess safety, and effectiveness of medicines. Findings should inform policy, systems planning, surveillance, and evaluations.

Design and Implementation of a Track n trace 2D Multi Scanner Bulk Code Reader for Pharmaceutical Packaging

With various compliance initiatives surrounding the traceability of medical drugs coming into prominence and with federal regulations becoming more stringent, there is a need to efficiently manage the supply chain process involving drug packaging. To enable traceability of the drugs being packaged, many manufacturers are implementing barcoding of product labels which contains a minimum of the attributes namely GTIN, lot number, serial numbers, expiry date, manufacturing dates, etc., to enable traceability of the packaged item. Currently, manufacturers are looking for ways to keep their supply chain moving at an efficient and optimal process. One of the challenges was to build automated equipment providing a well-defined and properly structured framework for functioning, designing, and implementing of Track N Trace Counterfeit Risk Management (CRM) application to increase the speed of the aggregation with the child-to-parent aggregation and generation of online case labels after the required child's Quantity in Multi carton aggregation station. Track N Trace Counterfeit Risk Management (CRM) allows the manufacturers to establish the parent-child relationship during packaging their drugs. Also, various guidelines US Drug Supply Chain Security Act (DSCSA), EU regulation (Falsified Medicines Directive-FMD), Brazilian Health Regulatory Agency (ANVISA), Indonesia's National Agency of Drug and Food Control (NADFC), India’s Directorate General of Foreign Trade - DGFT, and Australia TGA will need to be integrated into one single source of equipment that can meet with their barcoding regulation for tracking of drugs packed. Machine Vision systems are finding themselves in use in the pharma machinery and the "multi-carton" equipment that has been built for implementation for pharmaceutical packaging uses the vision systems architecture. We aimed to build a counterfeit risk management software solution that ensures compliance with various regulatory agencies by building a common framework that can be extensible for any further changes to the guidelines and/or additional regulatory guidelines from other countries. Lots of design architecture work has been refined through continuous process improvement practices and we developed a software tool that improves efficiency and requires minimal changes to the current manufacturing/packaging supply chain lines.

Why falsified medicines reach patients: an analysis of political and economic factors in Romania

IntroductionTo protect patients against falsified medicines, countries around the world implement stringent regulations. Despite efforts to protect supply chains in the European Union (EU), authorities continue to find falsified medicine....