Search Results (24)

Product-quality complaints are usually handled as pharmaceutical quality-system events, yet defects in sterility, potency, identity, packaging, labelling, storage, distribution or delivery-device function may affect medication use, treatment continuity and patient outcomes. This structured narrative review examines product-quality complaints (PQCs) as a patient-safety interface linking pharmaceutical quality systems, pharmacovigilance, medication-error prevention, recall action and pharmacoepidemiology. Existing pharmacovigilance, quality-management and recall systems address different components of this pathway, but no integrated framework was identified in the sources reviewed that specifies how product-quality complaints should be linked to exposure evidence and patient outcomes. Sources were identified through targeted PubMed searches and purposive retrieval of official regulatory, pharmacovigilance and public-health documents up to 5 June 2026; the review was not registered and included no quantitative synthesis. The sources identified concentrate on regulatory architecture, sentinel contamination events and shortage-associated harms; routine complaints are studied comparatively little, and no source identified reported the complaint-to-defect-to-exposure-to-outcome cascade with a complaint-level denominator. We propose the term patient-relevant complaint status (PRCS) for a complaint warranting patient-safety triage because the reported defect could plausibly affect exposure, sterility, potency, identity, delivery, medication use or treatment continuity, together with a TRACE workflow, a six-level clinical-consequence classification and separately graded certainty for defect confirmation, patient exposure and outcome attribution. These tools are proposed, unvalidated and hypothesis-generating; they do not convert complaints into adverse reactions, recalls into causality or spontaneous reports into incidence. Their intended role is to structure patient-safety triage, batch-aware linkage, exposure reconstruction, clinical follow-up and proportionate mitigation while causal attribution remains incomplete; this role requires prospective validation before routine implementation. Full article

Background: Antimicrobial resistance (AMR) poses a critical global public health challenge requiring comprehensive intervention strategies, including robust antibiotic stewardship programs. The European Commission’s 2017 One Health Action Plan against AMR established guidelines based on WHO’s AWaRe classification system, which categorizes antibiotics into Access, Watch, and Reserve groups to promote prudent use. However, the proliferation of substandard and falsified (SF) medical products increasingly undermines these stewardship efforts, with European regulatory agencies, including Belgium’s Federal Agency for Medicines and Health Products (FAMHP), reporting rising seizures of SF antibiotics. Objective: To assess the pharmaceutical quality of confiscated antibiotic samples and evaluate their potential contribution to AMR development. Methods: We conducted comprehensive pharmaceutical quality control testing on 40 SF antibiotic samples seized by the FAMHP between early 2024 and late 2025. Results: The analysis revealed significant deficiencies: 35% of samples contained antibiotics listed on international watch lists, while nearly 43% failed quality control testing. Dissolution defects represented the predominant failure mode, accounting for 29% of all samples tested. These defects can severely compromise drug bioavailability, clinical efficiency, and expose bacterial populations to sub-lethal concentrations of active pharmaceutical ingredients—a recognized driver of resistance development. Conclusions: Many seized samples appeared to be unregistered/unlicensed medicines that, while prohibited in the EU, may circulate legally elsewhere. This transnational dimension highlights how substandard products threaten global AMR control initiatives beyond individual patient safety. These findings underscore the urgent need to raise more awareness within the EU and for enhanced pharmaceutical quality assurance systems and much more international regulatory cooperation, particularly in low- and middle-income countries where such products circulate more readily. Full article

Prunella vulgaris L. (PV) is a versatile plant with medicinal and culinary applications globally. Its mature fruit-spikes (red-brown) are the primary source of traditional medicine and herbal tea. However, large-scale cultivation and harvesting inevitably leads to the unintended inclusion of immature green fruit-spikes, which are considered substandard medicinal parts. To explore the medicinal and nutraceutical potential of green fruit-spikes, our study systematically compared green and red-brown samples. The distinctions between the two fruit-spikes were characterized by determination of total water-soluble extract content, comprehensive chemical difference analysis, and quantitation of six phenolic acids, including Danshensu, caffeic acid, protocatechuic acid, protocatechualdehyde, salviaflaside, and rosmarinic acid. Additionally, variations in antioxidant activity were evaluated by DPPH and ABTS assays. As a result, 106 compounds were identified from the PV samples. Green spikes exhibited higher total water extract yield and contents of the six phenolic acids than the red-brown ones. Moreover, green samples showed greater accumulations of phenolic acids, flavonoids, and triterpenes. Concomitantly, stronger antioxidant activity was displayed in green spikes in both assay models. Caffeic acid, danshensu, rosmarinic acid, and protocatechualdehyde were identified as major contributors by Pearson correlation analysis. Our findings reveal that green fruit-spikes possess advantages in accumulating specific chemical profiles and exhibiting antioxidant activity, highlighting their untapped pharmaceutical and nutraceutical potential. Full article

The World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations—Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe—have attained ML3 status, marking a significant milestone in the continent’s regulatory landscape. Achieving ML3 confers critical benefits, including reducing substandard and falsified medicines, which enhances public health safety and fosters trust in healthcare systems. This progress encourages local manufacturing, diminishing reliance on imported medicines and promoting economic development. Furthermore, ML3 NRAs are better equipped to address public health emergencies, enabling swift approvals for vaccines and therapeutics while upholding safety standards. Nonetheless, challenges persist, including fragmented regulatory systems, the prevalence of counterfeit medicines, and limited resources. Overcoming these hurdles necessitates enhanced organizational capacity, investments in training, and the promotion of collaboration among NRAs. There is an urgent call for greater political commitment and resource allocation to strengthen regulatory systems across Africa. Achieving and maintaining ML3 status is essential for enhancing medicine regulation, supporting local manufacturing, and improving public health outcomes across the continent. While progress has been made, sustained efforts are crucial to tackling existing challenges and harnessing the full potential of advanced regulatory frameworks. Full article

In recent years, an increasing number of case reports have mentioned the presence of illicit nootropics, smart drugs or mind doping products on the market. To better understand the extent of the problem, a market surveillance study was organised by the General European Official Medicines Control Laboratory Network and associated member Australia to detect substandard, falsified or illegal medicines or dietary supplements containing unauthorised nootropic molecules of natural or synthetic origin. From January 2020 to September 2024, 159 different samples were documented, which yielded a comprehensive dataset of 166 molecular identification entries. Within this dataset, 34 distinct molecules were identified. Most samples were sold or presented as dietary supplements (49%) or medicines (32%). The vast majority (69%) were collected from the illegal market. Prescription drugs and non-authorised drugs only available on prescription in Russia were found in pharmacological quantities; some of the latter (noopept, phenylpiracetam and phenibut) were intercepted as large bulk quantities of raw material. Unauthorised novel foods, prescription or higher amounts of melatonin, and clinically uncharacterised research molecules were also reported. This study highlights the need for more active monitoring and screening of such products, as consumption of some of the reported samples could have detrimental health effects. Furthermore, as a large number of the samples were presented as dietary supplements, consumers may not be aware of the possible dangers and side-effects of these products. Full article

The presence of substandard and falsified (SF) medicines poses a significant challenge in resource-limited countries. Low-quality antibiotics are commonly reported in low-income countries. The present study aimed to develop and validate a liquid chromatography method with ultraviolet detection (LC-UV) for the identity screening and assay of 13 different injectable antibiotics, i.e., cefepime, amoxicillin, cefazolin, ampicillin, chloramphenicol, ceftazidime, ceftriaxone, cefotaxime, vancomycin, flucloxacillin, cloxacillin, benzylpenicillin, and meropenem in pharmaceutical formulations. Separation was performed using an XBridge C18 column and gradient elution. Mixtures of acetonitrile and 20 mM phosphate buffer (pH 8.0) were used as the mobile phases. The screening method was validated in terms of specificity and robustness, while linearity, precision, accuracy, and sensitivity were checked for the quantification method. The determination coefficients (R²) following linear regression were all greater than 0.999. The method showed good precision, with relative standard deviation values below 1%. The percentage recovery values were close to 100%. The method was applied to analyze 17 injectable antibiotics collected from the Ethiopian market. All commercial samples analyzed contained the correct API and met USP content specifications. Full article

The global prevalence of counterfeit and low-quality pharmaceuticals poses significant health risks and challenges in medical treatments, creating a need for rapid and reliable drug screening technologies. This study introduces a cost-effective electrochemical paper-based device (ePAD) modified with functionalized bamboo-derived biochar (BCF) for the detection of paracetamol in substandard medicines. The sensor was fabricated using a custom 3D-printed stencil in PLA, designed for efficient production, and a 60:40 (m/m) graphite (GR) and glass varnish (GV) conductive ink, resulting in a robust and sensitive platform. The electroactive area of the ePAD/BCF sensor was determined as 0.37 cm². Characterization via SEM and cyclic voltammetry (CV) verified its structural and electrochemical stability. The sensor demonstrated linear detection of paracetamol from 5.0 to 60.0 µmol L⁻¹ with a detection limit of 3.50 µmol L⁻¹. Interference studies showed high selectivity, with recoveries of over 90%, and the sensor successfully quantified paracetamol in commercial analgesic and anti-flu samples. This sustainable, bamboo-based ePAD offers a promising solution for rapid on-site pharmaceutical quality control, with significant potential to enhance drug screening accuracy. Full article

The GPHF-Minilab™ is a portable toolkit for performing qualitative methods such as thin-layer chromatography (TLC) on common pharmaceuticals. It is particularly useful in resource-limited locations where it is more challenging to monitor for substandard and falsified (SF) medicines. However, the GPHF-Minilab™ TLC methods are only semi-quantitative at best and thus have issues monitoring product quality effectively. We have improved on the GPHF-Minilab™ TLC method for metronidazole, a common antibiotic, by making it fully quantitative. Sample solutions were spotted on TLC plates alongside three metronidazole standards at different concentrations. After development, plates were imaged in a lightbox with two different smartphone cameras. Images were processed through the open-source program ImageJ and resulting pixel data from the standard spots were used to create a calibration curve, enabling quantitation of the sample. The USP Metronidazole Tablet high-performance liquid chromatography (HPLC) assay was used as the reference method. We validated this TLC method using 250 and 500 mg metronidazole tablets from different manufacturers and assessed linearity, range, accuracy, precision, intermediate precision, specificity, and robustness. These improvements should enhance the GPHF-Minilab™ TLC methods for metronidazole product screening. Additionally, the procedure is extensible to other analytes, although further validation would be required for each Minilab method. Full article

The genus Amomum includes over 111 species, 6 of which are widely utilized as medicinal plants and have already undergone taxonomic revision. Due to their morphological similarities, the presence of counterfeit and substandard products remains a challenge. Accurate plant identification is, therefore, essential to address these issues. This study utilized 11 newly sequenced samples and extensive NCBI data to perform molecular identification of the six medicinal “Doukou” species. The plastomes of these species exhibited a typical quadripartite structure with a conserved gene content. However, independent variation shifts of the SC/IR boundaries existed between and within species. The comprehensive set of genetic sequences, including ITS, ITS1, ITS2, complete plastomes, matK, rbcL, psbA-trnH, and ycf1, showed varying discrimination of the six “Doukou” species based on both distance and phylogenetic tree methods. Among these, the ITS, ITS1, and complete plastome sequences demonstrated the highest identification success rate (3/6), followed by ycf1 (2/6), and then ITS2, matK, and psbA-trnH (1/6). In contrast, rbcL failed to identify any species. This research established a basis for a reliable molecular identification method for medicinal “Doukou” plants to protect wild plant resources, promote the sustainable use of medicinal plants, and restrict the exploitation of these resources. Full article

A hand-held NIR spectrophotometric method was developed, validated, and applied for the determination of tadalafil in tablets. The aim of our work was to develop analytical methods based on vibrational techniques using low-cost portable equipment. Based on different chemometric modeling, we attempted to validate the method, which gave encouraging results from the principal component analysis (PCA), DD-SIMCA, and PLS modeling. Following this, we optimized the method using an appropriate experiment plan. For validation, we used the total error approach with acceptance limits set at ±10% with a risk level of 5%. The method showed that it was possible to perform both qualitative and quantitative analysis of pharmaceutical products using low-cost portable NIR systems with chemometric tools. The developed approach enabled the completion of the first step in implementing an NIR method for quality control of tadalafil-based drugs in the DRC. Validation difficulties of the PLS method resulted from the lack of information about inter-day serial variations of spectral responses. It would be interesting to extend the study to a larger calibration interval in order to correct uncertainties that may result from the variability observed under different conditions and to verify robustness. These are the limitations of this work, but the results are nevertheless very encouraging. Full article

In daily life, counterfeit and substandard products, particularly currency, medicine, food, and confidential documents, are capable of bringing about very serious consequences. The development of anti-counterfeiting and authentication technologies with multilevel securities is a powerful means to overcome this challenge. Among various anti-counterfeiting technologies, fluorescent anti-counterfeiting technology is well-known and commonly used to fight counterfeiters due to its wide material source, low cost, simple usage, good concealment, and simple response mechanism. Spiropyran is favored by scientists in the fields of anti-counterfeiting and information encryption due to its reversible photochromic property. Here, we summarize the current available spiropyran-based fluorescent materials from design to anti-counterfeiting applications. This review will be help scientists to design and develop fluorescent anti-counterfeiting materials with high security, high performance, quick response, and high anti-counterfeiting level. Full article

Hawthorn is a type of natural food with significant medicinal and nutritional properties; it has been listed in the “Both Food and Drug” list by the Chinese Ministry of Health Item List since 1997. However, hawthorn varieties have complex origins, and there are significant differences in the content, type, and medicinal efficacy of the chemically active ingredients in different varieties of hawthorn. This leads to the phenomenon of mixed varieties and substandard products being passed off as high-quality. In this work, by using headspace gas chromatography–ion mobility spectrometry (HS-GC-IMS), we identified and analyzed volatile organic compounds (VOCs) in four varieties of hawthorn, establishing their characteristic fingerprints. As a result, a total of 153 peaks were detected, and 139 VOCs were also identified. As shown by the fingerprint profiles, the different hawthorn samples contained different VOCs. Meanwhile, by using principal component analysis (PCA), Euclidean distance, and partial least-squares discriminant analysis (PLS-DA), the relationship between the VOCs found in the different varieties of hawthorn was revealed. This study developed a simple, fast, accurate, and sensitive method for identifying, tracking, and evaluating hawthorn varieties. Full article

Antimicrobial resistance (AMR) jeopardizes the effectiveness of essential antimicrobial agents in treating infectious diseases. Accelerated by human activities, AMR is prevalent in Sub-Saharan Africa, including Kenya, due to indiscriminate antibiotic use and limited diagnostics. This study aimed to assess Kenya’s AMR efforts through a situational analysis of policy efficacy, interventions, and implementation, culminating in recommendations for strengthening mitigation. Employing two methodologies, this study evaluated Kenya’s AMR endeavors. A systematic scoping review summarized AMR dynamic, and an expert validated the findings, providing an on-the-ground perspective. Antibiotic resistance is driven by factors including widespread misuse in human medicine due to irrational practices, consumer demand, and substandard antibiotics. Heavy antibiotic use in the agricultural sector leads to contamination of the food chain. The National Action Plan (NAP) reflects a One Health approach, yet decentralized healthcare and funding gaps hinder its execution. Although AMR surveillance includes multiple facets, diagnostic deficiencies persist. Expert insights recognize proactive NAP but underscore implementation obstacles. Kenya grapples with escalating resistance, but commendable policy efforts exist. However, fragmented implementations and complexities persist. Addressing this global threat demands investment in healthcare infrastructure, diagnostics, international partnerships, and sustainable strategies. Full article

Background and Objectives: Respectful maternity care promotes practices that acknowledge women’s preferences and women and newborns’ needs. It is an individual-centered strategy founded on ethical and human rights principles. The objective of this systematic review is to identify the impact of income on maternal care and respectful maternity care in low- and middle-income countries. Materials and Methods: Data were searched from Google Scholar, PubMed, Web of Science, NCBI, CINAHL, National Library of Medicine, ResearchGate, MEDLINE, EMBASE database, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and Maternity and Infant Care database. This review followed PRISMA guidelines. The initial search for publications comparing low- and middle-income countries with respectful maternity care yielded 6000 papers, from which 700 were selected. The review articles were further analyzed to ensure they were pertinent to the comparative impact of income on maternal care. A total of 24 articles were included, with preference given to those published from 2010 to 2023 during the last fourteen years. Results: Considering this study’s findings, respectful maternity care is a crucial component of high-quality care and human rights. It can be estimated that there is a direct association between income and maternity care in LMICs, and maternity care is substandard compared to high-income countries. Moreover, it is determined that the evidence for medical tools that can enhance respectful maternity care is sparse. Conclusions: This review highlights the significance of improving maternal care experiences, emphasizing the importance of promoting respectful practices and addressing disparities in low- and middle-income countries. Full article

Cannabis is increasingly accepted by medical organizations for medicinal and research purposes. A traceability system is required for monitoring and controlling the use of cannabis. This work aimed to investigate the relationship between critical success factors (CSFs) for creating the innovation framework that affects the implementation of the cannabis traceability system. These factors are identified based on the digital supply chain by structural modeling. Additionally, the issue of patients’ safety is a crucial factor that needs to be considered. Total Interpretive Structural Modeling (TISM) and fuzzy MICMAC analysis techniques were applied to investigate the relationship between CSFs. Finally, the 14 CSFs affecting cannabis traceability systems were determined. The research results discovered that system reliability is the most significant key factor with the greatest influence and contribution to the achievement. The five CSFs based on TISM comprise harmonized strategic orientation, inter-organization collaboration, standardization, government regulations, and customer awareness. According to the conclusive dependence–driving power diagram, they have the most driving power in the implementation and operation traceability system. The innovation framework helps to establish the traceability system in a way that works well. This will build trust in the supply chain and prevent abuse and substandard products. Full article