Therapeutic Advances in Drug Safety最新文献

{"title":"Joint use of population pharmacokinetics and machine learning for optimizing antiepileptic treatment in pediatric population.","authors":"Ivana Damnjanović, Nastia Tsyplakova, Nikola Stefanović, Tatjana Tošić, Aleksandra Catić-Đorđević, Vangelis Karalis","doi":"10.1177/20420986231181337","DOIUrl":"https://doi.org/10.1177/20420986231181337","url":null,"abstract":"Purpose: Unpredictable drug efficacy and safety of combined antiepileptic therapy is a major challenge during pharmacotherapy decisions in everyday clinical practice. The aim of this study was to describe the pharmacokinetics of valproic acid (VA), lamotrigine (LTG), and levetiracetam (LEV) in a pediatric population using nonlinear mixed-effect modeling, while machine learning (ML) algorithms were applied to identify any relationships among the plasma levels of the three medications and patients’ characteristics, as well as to develop a predictive model for epileptic seizures. Methods: The study included 71 pediatric patients of both genders, aged 2–18 years, on combined antiepileptic therapy. Population pharmacokinetic (PopPK) models were developed separately for VA, LTG, and LEV. Based on the estimated pharmacokinetic parameters and the patients’ characteristics, three ML approaches were applied (principal component analysis, factor analysis of mixed data, and random forest). PopPK models and ML models were developed, allowing for greater insight into the treatment of children on antiepileptic treatment. Results: Results from the PopPK model showed that the kinetics of LEV, LTG, and VA were best described by a one compartment model with first-order absorption and elimination kinetics. Reliance on random forest model is a compelling vision that shows high prediction ability for all cases. The main factor that can affect antiepileptic activity is antiepileptic drug levels, followed by body weight, while gender is irrelevant. According to our study, children’s age is positively associated with LTG levels, negatively with LEV and without the influence of VA. Conclusion: The application of PopPK and ML models may be useful to improve epilepsy management in vulnerable pediatric population during the period of growth and development.","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231181337"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f1/11/10.1177_20420986231181337.PMC10288421.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10072661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The 6th European Pharmacovigilance Congress: speaker abstracts","authors":"M. M. Lino, S. Mather, A. Ayoub, R. Maroko","doi":"10.1177/20420986221144584","DOIUrl":"https://doi.org/10.1177/20420986221144584","url":null,"abstract":"Uppsala Monitoring Centre (UMC) is an independent and self-funded Swedish foundation. There are many stakeholders in the field of medicines safety, and by drawing on our different competences, skills and roles in the PV world, UMC strives to always pursue our vision: working together to advance medicines safety. UMC's different business areas focus on various external stakeholders, one of which focuses on the WHO Programme of International Drug Monitoring (WHO PIDM). Since 1968, the programme has provided a forum for WHO Member States to collaborate in pharmacovigilance. This enables programme members to be alerted to patterns of harm emerging across the world, but which might not be evident from their local data alone. There are now over 170 member countries/territories. The programme's operational activities were moved to Uppsala in 1978 under the sponsorship of the Swedish government, which marked the starting point for our organization and its designation as one of WHO's 800 Collaborating centres - the WHO Collaborating Centre for International Drug Monitoring.1 UMC is custodian and manager of VigiBase, WHO's global database of reported potential side effects of medicinal products. This gold mine is used to generate insights for various PV stakeholders. The WHO PIDM members, which are usually the national regulatory authorities, collect reports of adverse events from patients, physicians, the pharmaceutical industry and other stakeholders within their national PV systems. VigiBase accumulates the data from programme members, and currently contains about 33 million case reports. For other external stakeholders, VigiBase data can be made available with limited level of detail via VigiBase Services, open to, for example, academia, the pharmaceutical industry and health care providers.2,3 Besides VigiBase maintenance, our Collaborating Centre also provides programme members with IT solutions for data collection and analysis in their national setting to support their mission for safe products in their markets. There are many IT solutions, but to highlight two: VigiFlow, for example, is a data collection and management system, used by over 100 members as their national safety database. And in VigiLyze, members have a powerful analysis tool free of charge, which can analyse national data as well as data in regional collaborations with instant access to the global data in VigiBase and others' experiences as a reference. Safety signals found by UMC and other programme members are also available in VigiLyze. The Collaborating Centre generates and shares credible and evidence-based information on the safety of medicines and vaccines for further decision-making by regulators and scientific high-level committees. That work relies on the use of sophisticated methods for signal detection, but also on internal and external clinical expertise. Selected signals are also published in scientific journals to reach a broader audience such as the prescribers. In ad","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47006892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a checklist for the assessment of pharmacovigilance guidelines in Southern Africa: a document review.","authors":"Nokuthula L Makhene, Hanlie Steyn, Martine Vorster, Martie S Lubbe, Johanita R Burger","doi":"10.1177/20420986221143272","DOIUrl":"https://doi.org/10.1177/20420986221143272","url":null,"abstract":"<p><strong>Introduction: </strong>National regulatory systems in Southern Africa reflect various stages of maturity, and pharmacovigilance (PV) practices are not aligned. In the absence of guidance for formulating PV guidelines in Southern African Development Community (SADC) countries, this study aimed to create a checklist that may be used to assess the rigour of PV guidelines in this region and provide guidance for the National Medicines Regulatory Agency (NMRA) authors.</p><p><strong>Methods: </strong>A document analysis was performed based on harmonised international guidelines (<i>n</i> = 22) that prescribed methods of PV regulation to identify themes and items to incorporate into a checklist. The contextualisation of the checklist to the African pharmaceutical environment was accomplished by referencing peer-reviewed journal articles (<i>n</i> = 7). The checklist was subjected to face and content validation by non-experts and PV experts.</p><p><strong>Results: </strong>The document review yielded 5 themes, 18 sub-themes, and 73 items structured into the checklist. Themes encompassed PV systems, definitions, individual case safety reporting, aggregate reporting, and risk management. Under PV systems, aspects of the quality management system were outlined, that is, the legal basis for PV, a description of the marketing authorisation holder's (MAH's) PV system, archiving of data, contracting of PV tasks, and the duties of the person responsible for the MAH's PV obligations. Definitions of the key terms and major stakeholders were identified. Reporting of individual case safety reports (ICSRs) was explicated by considering the criteria for reporting, categories of reportable information, expedited reporting requirements, reporting timelines, and ICSR reporting format. Aggregate report submission during the development and post-marketing phases was addressed. Risk management encompassed signal detection, re-evaluation of the benefit-risk ratio, the safety decision-making process, risk management planning, risk minimisation and safety communication.</p><p><strong>Conclusion: </strong>The developed checklist can contribute towards assisting SADC NMRAs to formulate national PV guidelines that reflect current international practice, with local context incorporated.</p><p><strong>Plain language summary: </strong><b>Developing a checklist for the evaluation of medicine safety guidelines in Southern Africa</b> <b>Introduction:</b> In Southern African Development Community (SADC) countries, the guidelines for medicine safety [pharmacovigilance (PV)] that marketing authorisation holders (MAHs) and healthcare professionals need to adhere to, are not aligned. We saw the need to develop a checklist that can be used to evaluate these guidelines.<b>Methods:</b> We studied international documents issued by the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Cou","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986221143272"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/51/8d/10.1177_20420986221143272.PMC9880583.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10584965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical relevance of potential self-medication drug interactions in antineoplastic and immune-modulating therapy among online pharmacy customers.","authors":"Florian Schindler,&nbsp;Timo Schinkoethe,&nbsp;Sven Mahner,&nbsp;Thomas Kolben,&nbsp;Rachel Wuerstlein,&nbsp;Carsten Culmsee,&nbsp;Nadia Harbeck,&nbsp;Tanja K Eggersmann","doi":"10.1177/20420986231188845","DOIUrl":"https://doi.org/10.1177/20420986231188845","url":null,"abstract":"<p><strong>Background: </strong>Modern oral antineoplastic and immune-modulating drugs offer an array of therapeutic advantages, and yet pose challenges in daily use for patients, physicians and pharmacists. In contrast to intravenous administration, these drugs are not subject to direct medical control. Recently, we have seen a huge rise in sales of non-prescription over-the-counter (OTC) medicines <i>via</i> the internet without any advice from a healthcare professional.</p><p><strong>Objectives: </strong>The aim of this study was to investigate whether the risk of known potential drug-drug interactions between modern oral antineoplastic and immune-modulating drugs and OTC drugs differs between sales in traditional community pharmacies <i>versus</i> online pharmacies.</p><p><strong>Design: </strong>Real-life sales data from community and online pharmacies were used as basis for the analysis.</p><p><strong>Methods: </strong>We determined the most frequently purchased antineoplastic and immune-modulating drug-substances in 14 local community pharmacies within the Munich area, Germany and identified the OTC substance groups that could potentially cause interactions with oncological therapies. Using sales data from 11 local community pharmacies and three online pharmacies, we investigated whether OTC purchases differed between the two sales channels.</p><p><strong>Results: </strong>We identified 10 relevant OTC substance classes and detected significant variations in patients' preferred sales channels between the drug classes. Certain OTC drugs, which seem to be bought more often over the internet, pose risks during antineoplastic and immune-modulating therapy.</p><p><strong>Conclusion: </strong>Patients should therefore be proactively made aware of the corresponding risks in order not to jeopardize the activity of the antineoplastic and immune-modulating drugs and thus the success of their therapy.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231188845"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b0/f6/10.1177_20420986231188845.PMC10460262.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10106397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapy of women with multiple sclerosis: an analysis of the use of drugs that may have adverse effects on the unborn child in the event of (unplanned) pregnancy.","authors":"Marie-Celine Haker,&nbsp;Niklas Frahm,&nbsp;Michael Hecker,&nbsp;Silvan Elias Langhorst,&nbsp;Pegah Mashhadiakbar,&nbsp;Jane Louisa Debus,&nbsp;Barbara Streckenbach,&nbsp;Julia Baldt,&nbsp;Felicita Heidler,&nbsp;Uwe Klaus Zettl","doi":"10.1177/20420986221143830","DOIUrl":"https://doi.org/10.1177/20420986221143830","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Although effective contraception is strongly recommended during the therapy of women with multiple sclerosis (MS) with some immunomodulatory drugs, unplanned pregnancies still occur. Adequate medication management is essential to avoid foetal harm in the event of an unplanned pregnancy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim was to screen for medications used in women of childbearing age with MS that may pose a risk of side effects on foetal development.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Sociodemographic, clinical and medication data were collected from 212 women with MS by structured interviews, clinical examinations and medical records. Using the databases from Embryotox, Reprotox, the Therapeutic Goods Administration and on the German summaries of product characteristics, we assessed whether the taken drugs were potentially harmful regarding the foetal development.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The majority of patients (93.4%) were taking one or more drugs for which a possible harmful effect on the foetus is indicated in at least one of the four databases used. This proportion was even higher in patients who used hormonal contraceptives (birth control pills or vaginal rings) (PwCo, &lt;i&gt;n&lt;/i&gt; = 101), but it was also quite high in patients who did not use such contraceptives (Pw/oCo, &lt;i&gt;n&lt;/i&gt; = 111) (98.0% and 89.2%, respectively). PwCo were significantly more likely to take five or more medications with potential foetal risk according to at least one database than Pw/oCo (31.7% &lt;i&gt;versus&lt;/i&gt; 6.3%). PwCo were also more severely disabled (average Expanded Disability Status Scale score: 2.8 &lt;i&gt;versus&lt;/i&gt; 2.3) and more frequently had comorbidities (68.3% &lt;i&gt;versus&lt;/i&gt; 54.1%) than Pw/oCo.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Data on the most commonly used drugs in MS therapy were gathered to study the risk of possible drug effects on foetal development in female MS patients of childbearing age. We found that the majority of drugs used by patients with MS are rated as having a potential risk of interfering with normal foetal development. More effective contraception and special pregnancy information programmes regarding the therapy management during pregnancy should be implemented to reduce potential risks to mother and child.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;&lt;b&gt;Use of drugs not recommended during pregnancy by women with multiple sclerosis&lt;/b&gt; &lt;b&gt;Introduction:&lt;/b&gt; Patients with multiple sclerosis (MS) often have to take different drugs simultaneously. During the therapy with some immunomodulatory drugs, effective contraception is strongly recommended. Nevertheless, unplanned pregnancies occur regularly in women with MS.&lt;b&gt;Methods:&lt;/b&gt; Here, we investigated whether the 212 patients included in this study were taking drugs with known possibility of harm to the development of an unborn child. This was done using four different drug databases.&lt;b&gt;Results:&lt;/b&gt; A subset of 111 patients was not taking hormonal co","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986221143830"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/22/61/10.1177_20420986221143830.PMC10060274.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9241369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of lower limb amputation in diabetic patients using SGLT2 inhibitors <i>versus</i> DPP4 inhibitors or GLP-1 agonists: a meta-analysis of 2 million patients.","authors":"Yang Lu,&nbsp;Caiyun Guo","doi":"10.1177/20420986231178126","DOIUrl":"https://doi.org/10.1177/20420986231178126","url":null,"abstract":"<p><strong>Background: </strong>The objective of this review was to assess the risk of lower limb amputation (LLA) in type 2 diabetic patients based on the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) <i>versus</i> dipeptidyl peptidase 4 inhibitors (DPP4i) or glucagon-like peptide-1 receptor agonists (GLP1a).</p><p><strong>Methods: </strong>PubMed, CENTRAL, Scopus, Web of Science, and Embase were referenced for articles published up to 5 February 2023. All types of studies comparing the drugs for LLA risk and reporting hazard ratios (HR) were included.</p><p><strong>Results: </strong>Thirteen studies with 2,095,033 patients were included. Meta-analysis of eight studies comparing SGLT2i with Dipeptidyl peptidase inhibitors (DPPi) showed that there was no difference in the risk of LLA between the two drug groups (HR: 0.98 95% CI: 0.73, 1.31 <i>I</i>² = 89%). The outcomes were unchanged on sensitivity analysis. Another pooled analysis of six studies found no significant difference in the risk of LLA between SGLT2i and GLP1a users (HR: 1.26; 95% CI: 0.99, 1.60; <i>I</i>² = 69%). The exclusion of a single study showed an increased risk of LLA with SGLT2i (HR: 1.35; 95% CI: 1.14, 1.60; <i>I</i>² = 14%).</p><p><strong>Conclusion: </strong>The current updated meta-analysis found no significant difference in the risk of LLA between SGLT2i and DPP4i users. A tendency of increased risk of LLA was noted with SGLT2i as compared to GLP1a. Further studies shall increase the robustness of current findings.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231178126"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/22/9e/10.1177_20420986231178126.PMC10272677.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10035951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Flow rate accuracy of infusion devices within healthcare settings: a systematic review.","authors":"Opeyemi Atanda,&nbsp;Jonathan West,&nbsp;Tom Stables,&nbsp;Chris Johnson,&nbsp;Robert Merrifield,&nbsp;James Kinross","doi":"10.1177/20420986231188602","DOIUrl":"https://doi.org/10.1177/20420986231188602","url":null,"abstract":"<p><strong>Background: </strong>One in five patients admitted to the hospital treated with intravenous (IV) fluid therapy suffer complications due to inappropriate administration. Errors have been reported in 13-84% of the preparation and administration of IV medications. The safe delivery of IV fluids requires precise rate administration.</p><p><strong>Objectives: </strong>This systematic review aims to determine the accuracy of infusion sets and devices and examine the factors that affect the flow rate accuracy of devices.</p><p><strong>Data sources and methods: </strong>Six databases (CINAHL, MEDLINE PubMed, EMBASE, Web of Science and Cochrane Database of systematic reviews) were systematically searched. Search terms included infusion pumps, infusion devices, flow rate accuracy, fluid administration rate, gravity-led infusion set and fluid balance. Studies were included if they examined infusion devices' flow rate accuracy and drop rates for fluids or non-oncological drugs. Findings were tabulated and synthesised qualitatively. The quality of the studies was examined based on the design of the studies due to their heterogeneity.</p><p><strong>Results: </strong>Eight studies were included: Four studies were conducted on human subjects in the hospital environment; studies recruited 182 participants between the ages of 18 and 94 years. Two studies examined flow rate accuracy in recruited patients across 509 observations and 2387 drip hours. No trials prospectively assessed the accuracy of infusion pumps in the clinical domain, and no studies were reported on patient safety outcomes. Four studies examined the impact of mechanical and physiological factors on the flow rate accuracies of infusion devices. Height and back pressure simulated vibrating conditions, the viscosity of IV fluid and the positions of patients were reported to have a significant impact on infusion volume and flow rates of infusion devices. Additionally, giving sets that vary from the manufacturer's specifications are reported to increase error percent by 10-20%.</p><p><strong>Conclusion: </strong>Infusion devices are an important source of error in administering IV fluids. Yet, there needs to be more prospective trial data to support their clinical accuracy and the impact on patient outcomes. Future flow variability and accuracy studies should capture their impact on patient safety and clinical outcomes.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231188602"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10363896/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10353666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serious neurological adverse events following immunization against SARS-CoV-2: a narrative review of the literature.","authors":"Sara Eslait-Olaciregui,&nbsp;Kevin Llinás-Caballero,&nbsp;David Patiño-Manjarrés,&nbsp;Thomas Urbina-Ariza,&nbsp;Juan Fernando Cediel-Becerra,&nbsp;Camilo Alberto Domínguez-Domínguez","doi":"10.1177/20420986231165674","DOIUrl":"https://doi.org/10.1177/20420986231165674","url":null,"abstract":"<p><p>Amid the coronavirus disease 2019 (COVID-19) pandemic, massive immunization campaigns became the most promising public health measure. During clinical trials, certain neurological adverse effects following immunization (AEFIs) were observed; however, acceptable safety profiles lead to emergency authorization for the distribution and use of the vaccines. To contribute to pharmacovigilance and lessen the potential negative impact that vaccine hesitancy would have on immunization programs, we conducted a review of the scientific literature concerning the epidemiological data, clinical presentation, and potential mechanisms of these neurological AEFIs. There is some epidemiological evidence linking COVID-19 vaccines to cerebral venous sinus thrombosis, arterial ischemic stroke, convulsive disorder, Guillain-Barré syndrome, facial nerve palsy, and other neurological conditions. Cerebral venous sinus thrombosis has been associated with a thrombotic thrombocytopenia induced by the vaccine, similar to that induced by heparin, which suggests similar pathogenic mechanisms (likely involving antibodies against platelet factor 4, a chemokine released from activated platelets). Arterial ischemic stroke is another thrombotic condition observed among some COVID-19 vaccine recipients. Vaccine-induced convulsive disorder might be the result of structural abnormalities potentially caused by the vaccine or autoimmune mechanisms. Guillain-Barré syndrome and facial nerve palsy may also be linked to the immunization event, possibly due to immune mechanisms such as uncontrolled cytokine release, autoantibody production, or bystander effect. However, these events are mostly uncommon and the evidence for the association with the vaccine is not conclusive. Furthermore, the potential pathophysiological mechanisms remain largely unknown. Nevertheless, neurological AEFIs can be serious, life-threatening or even fatal. In sum, COVID-19 vaccines are generally safe and the risk of neurological AEFIs does not outweigh the benefits of immunization. However, early diagnosis and treatment of neurological AEFIs are of utmost importance, and both health professionals and the public should be aware of these conditions.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231165674"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4a/34/10.1177_20420986231165674.PMC10201278.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9888106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Funding and financial sustainability of pharmacovigilance: suggested models for funding pharmacovigilance in resource-limited African countries.","authors":"Ambrose O Isah,&nbsp;Abimbola O Opadeyi,&nbsp;Henry Tumwijukye,&nbsp;Frank Cobelens,&nbsp;Diede Smith,&nbsp;Margareth Ndomondo-Sigonda,&nbsp;Linda Harmark,&nbsp;Paul Tanui,&nbsp;Edine Tiemersma,&nbsp;Blandina T Mmbaga,&nbsp;Gugu Mahlangu,&nbsp;Stephen A Ayinbuomwan,&nbsp;Rachida Soulaymani,&nbsp;Jayesh M Pandit","doi":"10.1177/20420986231188836","DOIUrl":"https://doi.org/10.1177/20420986231188836","url":null,"abstract":"<p><strong>Background: </strong>An important factor hindering the growth of pharmacovigilance (PV) in resource-limited settings is the lack of adequate funds to establish a functional National Pharmacovigilance System. Consequently, the crucial function of monitoring and ensuring the availability of safe medicines in these settings cannot be guaranteed considering the peculiarities of diseases and medicines used.</p><p><strong>Objectives: </strong>The objective of this paper is to provide an overview as to the availability of potential sources of funds, which could be explored to ensure Medicine Safety and to proffer a potential framework likely to ensure sustainable funding of PV in Africa.</p><p><strong>Methods/processes: </strong>The process of developing this framework entailed a review of PV financing in some developed economies, a landscape study of funding of PV in some African countries, an in-depth understanding of the PV system and the organisational structure and nexus between the regulatory agencies and National Pharmacovigilance Centre. Critical points for consideration included the sources of funds, revenue pool, the disbursement of funds, budgeting and expenditure profile and the legal framework. Consultative meetings, webinars and interviews with experts were carried out.</p><p><strong>Results: </strong>The findings showed that most of the PV systems were mainly integrated into the regulatory agencies regarding operational and fiscal governance with few facilities being independent of the regulatory agencies. The main source of funding was from the government with significant donor funding which is ad hoc and non-sustainable. Several potential sources were identified but yet to be exploited. There were no legal provisions for PV financing. A framework likely to ensure sustainable PV financing is suggested to capture all available sources of funding, mine the potential sources providing a sizeable pool of revenue to address its activities and enabling legal framework which will engender autonomy. Furthermore, it will address the nexus between the regulatory agencies and the PV outfits, thus enabling appropriate share of resources and blockage of diversions.</p><p><strong>Conclusion: </strong>In all, addressing the various elements identified in this study and providing the legal provisions which guarantees some degree of autonomy will provide a sustainable mechanism for PV funding in the resource-limited setting of Africa.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231188836"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/32/c0/10.1177_20420986231188836.PMC10387667.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10354753","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between proton pump inhibitors and rhabdomyolysis risk: a post-marketing surveillance using FDA adverse event reporting system (FAERS) database.","authors":"Ali F Altebainawi,&nbsp;Lulwa A Alfaraj,&nbsp;Amjad A Alharbi,&nbsp;Fadwa F Alkhuraisi,&nbsp;Thamir M Alshammari","doi":"10.1177/20420986231154075","DOIUrl":"https://doi.org/10.1177/20420986231154075","url":null,"abstract":"<p><strong>Background: </strong>This research aims to explore and compare the signals of rhabdomyolysis from the use of Proton pump inhibitors (PPIs) using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>Rhabdomyolysis and related terms submitted between 2013 and 2021 were retrieved from the FAERS database. The data were analyzed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Empirical Bayes Geometric Mean (EBGM) and the information component (IC). The signals of rhabdomyolysis associated with PPIs use were detected in both 3-Hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) utilizers and non-utilizers.</p><p><strong>Results: </strong>A total of 7,963,090 reports were retrieved and analyzed. Fifty-seven reports linked PPIs to rhabdomyolysis out of 3670 reports from other drugs (non-statin included). The association of rhabdomyolysis and PPIs was significant in both statins included, and non-statin-included reports, although with varying degrees of association. The ROR was 2.5 (95% confidence interval [CI] 1.9-3.2) for PPIs in non-statin-included reports and 2 (95% CI: 1.5-2.6) for PPIs in statin-included reports.</p><p><strong>Conclusion: </strong>Significant signals of rhabdomyolysis were associated with PPIs. However, its signals were higher in non-statin-included reports compared to statin-included reports.</p><p><strong>Plain language summary: </strong><b>Plain language summaryProton Pump Inhibitors and rhabdomyolysis risk</b> <b>Background:</b> The FDA created the FDA Adverse Event Reporting System (FAERS) database to support post-marketing surveillance programs. The FAERS is a computerized database with more than nine million adverse event reports, including all reports from 1969 to the present. This research aims to explore and compare the signals of rhabdomyolysis from the use of proton pump inhibitors (PPIs) using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.<b>Research design and methods:</b> We retrieved rhabdomyolysis and related terms submitted between 2013 and 2021 from the FAERS database. Then, we analyzed the data that we found. We detected the signals of rhabdomyolysis associated with PPIs use in both statins utilizers and non-utilizers.<b>Results:</b> We retrieved and analyzed a total of 7,963,090 reports. We found 57 reports linked PPIs to rhabdomyolysis out of 3670 reports from other drugs (non-statin included). The association of rhabdomyolysis and PPIs was significant in both statins included, and non-statin-included reports, although with varying degrees of association.<b>Conclusion:</b> Significant signals of rhabdomyolysis were associated with PPIs. However, its signals were higher in non-statin-included reports than in statin-included reports.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231154075"},"PeriodicalIF":4.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/2b/1b/10.1177_20420986231154075.PMC9974623.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10846025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}