BackgroundPoor quality medicines have devastating consequences. A plethora of innovative portable devices to screen for poor quality medicines has become available, leading to hope that they could empower medicine inspectors and enhance surveillance. However, information comparing these new technologies is woefully scarce.MethodsWe undertook a systematic review of Embase, PubMed, Web of Science and SciFinder databases up to 30 April 2018. Scientific studies evaluating the performances/abilities of portable devices to assess any aspect of the quality of pharmaceutical products were included.ResultsForty-one devices, from small benchtop spectrometers to ‘lab-on-a-chip’ single-use devices, with prices ranging from US$20 000, were included. Only six devices had been field-tested (GPHF-Minilab, CD3/CD3+, TruScan RM, lateral flow dipstick immunoassay, CBEx and Speedy Breedy). The median (range) number of active pharmaceutical ingredients (APIs) assessed per device was only 2 (1–20). The majority of devices showed promise to distinguish genuine from falsified medicines. Devices with the potential to assay API (semi)-quantitatively required consumables and were destructive (GPHF-Minilab, PharmaChk, aPADs, lateral flow immunoassay dipsticks, paper-based microfluidic strip and capillary electrophoresis), except for spectroscopic devices. However, the 10 spectroscopic devices tested for their abilities to quantitate APIs required processing complex API-specific calibration models. Scientific evidence of the ability of the devices to accurately test liquid, capsule or topical formulations, or to distinguish between chiral molecules, was limited. There was no comment on cost-effectiveness and little information on where in the pharmaceutical supply chain these devices could be best deployed.ConclusionAlthough a diverse range of portable field detection devices for medicines quality screening is available, there is a vitally important lack of independent evaluation of the majority of devices, particularly in field settings. Intensive research is needed in order to inform national medicines regulatory authorities of the optimal choice of device(s) to combat poor quality medicines.

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ObjectivesAntimicrobial resistance (AMR) is a significant global health threat with substandard and falsified (SF) antibiotics being neglected contributing factors. With their relationships poorly understood, more research is needed in order to determine how interventions to reduce SF antibiotics should be ranked as priorities in national AMR action plans. We assessed the evidence available on the global prevalence of SF antibiotics, examined the quality of the evidence and discussed public health impact.Materials/MethodsWe searched PubMed, Embase, Google and Google Scholar for publications on antibiotic quality up to 31 December 2020. Publications reporting on the prevalence of SF antibiotics were evaluated for quantitative analysis and assessed using the Medicines Quality Assessment Reporting Guidelines.ResultsOf the 10 137 screened publications, 648 were relevant to antibiotic quality. One hundred and six (16.4%) surveys, published between 1992 and 2020 and conducted mainly in low-income and middle-income countries (LMICs) (89.9% (480/534) of the data points), qualified for quantitative analysis. The total number of samples tested for quality in prevalence surveys was 13 555, with a median (Q1–Q3) number of samples per survey of 47 (21–135). Of the 13 555 samples, 2357 (17.4%) failed at least one quality test and the median failure frequency (FF) per survey was 19.6% (7.6%–35.0%). Amoxicillin, sulfamethoxazole-trimethoprim and ciprofloxacin were the most surveyed antibiotics, with FF of 16.1% (355/2208), 26.2% (329/1255) and 10.4% (366/3511), respectively. We identified no SF survey data for antibiotics in the WHO ‘Reserve’ group. The mean Medicine Quality Assessment Reporting Guidelines score was 11 (95% CI 10.1 to 12.2) out of 26.ConclusionsSF antibiotics are widely spread with higher prevalence in LMICs. The quality of the evidence is poor, and these data are not generalisable that 17.4% of global antibiotic supply is SF. However, the evidence we have suggests that interventions to enhance regulatory, purchasing and financial mechanisms to improve the global antibiotic supply are needed.PROSPERO registration numberCRD42019124988.

BackgroundThe global prevalence of diabetes mellitus is increasing alarmingly. However, the quality of vital medicines and medical products used to treat and monitor diabetes remains uncertain but of potential great public health significance. Here, we review the available evidence on the quality of antidiabetic medicines and supplies for self-monitoring of blood glucose (SMBG) and discuss their potential impact for the patients and society.MethodsSearches were conducted in PubMed, Embase, Google Scholar, Google and relevant websites in English and French. The Medicine Quality Assessment Reporting Guideline (MEDQUARG) was used to assess the quality of medicine quality surveys.Results52 publications on the quality of antidiabetic medicines, including 5 medicine quality prevalence surveys and 20 equivalence studies, were analysed. The prevalence surveys and equivalence studies included 674 samples of which 73 (10.8%) were of poor quality. The median (Q1–Q3) concordance with MEDQUARG items was 30.8% (19.2%–42.3%). No prevalence surveys on SMBG supplies’ quality were found, but 29 publications, including falsified products and incorrect results due to strip degradation or contamination, were identified.ConclusionThere is little accessible evidence on the quality of antidiabetic medicines and SMBG supplies. Surveys were poorly designed and reported, making data aggregation and interpretation problematic. Despite these caveats, these results suggest that there are important issues with the quality of medical products for diabetes that need focused monitoring. There is an urgent need to achieve consensus protocols for designing, conducting and reporting medical product quality surveys.PROSPERO registration numberCRD42016039841.

Over recent years, the research community has been increasingly using preprint servers to share manuscripts that are not yet peer-reviewed. Even if it enables quick dissemination of research findings, this practice raises several challenges in publication ethics and integrity. In particular, preprints have become an important source of information for stakeholders interested in COVID19 research developments, including traditional media, social media, and policy makers. Despite caveats about their nature, many users can still confuse pre-prints with peer-reviewed manuscripts. If unconfirmed but already widely shared first-draft results later prove wrong or misinterpreted, it can be very difficult to “unlearn” what we thought was true. Complexity further increases if unconfirmed findings have been used to inform guidelines. To help achieve a balance between early access to research findings and its negative consequences, we formulated five recommendations: (a) consensus should be sought on a term clearer than ‘pre-print’, such as ‘Unrefereed manuscript’, “Manuscript awaiting peer review” or ‘’Non-reviewed manuscript”; (b) Caveats about unrefereed manuscripts should be prominent on their first page, and each page should include a red watermark stating ‘Caution—Not Peer Reviewed’; (c) pre-print authors should certify that their manuscript will be submitted to a peer-review journal, and should regularly update the manuscript status; (d) high level consultations should be convened, to formulate clear principles and policies for the publication and dissemination of non-peer reviewed research results; (e) in the longer term, an international initiative to certify servers that comply with good practices could be envisaged.

ObjectiveGood quality cardiovascular medicines and devices are crucial in the prevention and management of the ever-growing threats of cardiovascular diseases (CVDs) globally. Yet our current understanding of the extent and impact of substandard and falsified (SF) cardiovascular medical products is poor. Our objective was to review the available literature on SF cardiovascular medicines/devices, with a focus on prevalence studies to discuss their impacts on public health.MethodsSearches were conducted in Embase, PubMed, Web of Science, Google Scholar, Google and websites with interest in medicines/devices quality up to 31 August 2020. Articles in English and French identified in these searches were screened for eligibility. The Medicine Quality Assessment Reporting Guidelines was used to assess the quality of prevalence surveys, and we report according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.ResultsA total of 279 articles were included, which were subcategorised into prevalence surveys (n=28), equivalence studies (n=118), stability studies (n=5), routine quality control analyses (n=15), bioavailability studies (n=2), recalls/seizures/case reports (n=77), general discussions (n=24) and reviews (n=10). A failure frequency (defined as the proportion of samples that failed at least one quality test described in the report) of 525 (15.4%) was observed for the 3414 samples tested for quality in the 27 prevalence surveys with sufficient information for inclusion in our quantitative analysis. Nineteen surveys (70.4%) used convenience outlet sampling. The majority (88.8%, 3032/3414) of samples included in prevalence surveys were collected from low-income and middle-income countries. The most common defects were out-of-specification active ingredient(s) content, impurity/contaminant content and impaired dissolution. We found 26 incidents describing SF cardiovascular devices with 181 related deaths but no prevalence surveys.ConclusionThe data suggest that SF cardiovascular products are likely to be a serious public health problem that has received limited attention. We do not suggest that 15.4% of cardiovascular medicines are SF, and our findings highlight the need for more research with robust methodology to provide more accurate prevalence estimates in order to inform policy and implement measures to ensure the quality of cardiovascular medicines and devices within the supply chain. Ensuring that CVD medical products are of good quality would help ensure effectiveness and that the benefits of therapy are realised in the prevention and treatment of CVDs.

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RationaleAn epidemic of low‐quality medicines continues to endanger patients worldwide. Detection of such ‘medicines’ requires low cost, ambient ionization sources coupled to fieldable mass spectrometers for optimum sensitivity and specificity. With the use of triboelectric nanogenerators (TENGs), the charge required to produce gas‐phase ions for mass analysis can be obtained without the need for high‐voltage electrical circuitry, simplifying and lowering the cost of next‐generation mass spectrometry instruments.MethodsA sliding freestanding (SF) TENG was coupled to a toothpick electrospray setup for the purposes of testing if falsified medicines could be fingerprinted by this approach. Extracts from both genuine and falsified medicines were deposited on the toothpick and the SF TENG actuated to generate electrical charges, resulting in gas‐phase ions for both active pharmaceutical ingredients and excipients.ResultsOur previous work had shown that direct analysis in real time (DART) ambient mass spectrometry can identify the components of multiple classes of falsified antimalarial medicines. Experiments performed in this study show that a simple extraction into methanol along with the use of a SF TENG‐powered toothpick electrospray can provide similar detection capabilities, but with much simpler and rugged instrumentation, and without the need for compressed gases or high‐voltage ion source power supplies.ConclusionsTENG toothpick MS allows for rapid analyte ion detection in a safe and low‐cost manner, providing robust sampling and ionization capabilities.