Therapeutic Advances in Drug Safety最新文献

{"title":"Patient-centered pharmacovigilance: priority actions from the inherited bleeding disorders community.","authors":"Fiona Robinson, Sonji Wilkes, Nathan Schaefer, Miriam Goldstein, Michelle Rice, Johanna Gray, Sharon Meyers, Leonard A Valentino","doi":"10.1177/20420986221146418","DOIUrl":"10.1177/20420986221146418","url":null,"abstract":"<p><p>Pharmacovigilance, the science and practice of monitoring the effects of medicinals and their safety, is the responsibility of all stakeholders involved in the development, manufacture, regulation, distribution, prescription, and use of drugs and devices. The patient is the stakeholder most impacted by and the greatest source of information on safety issues. It is rare, however, for the patient to take a central role and exert leadership in the design and execution of pharmacovigilance. Patient organizations in the inherited bleeding disorders community are among the most established and empowered, particularly in the rare disorders. In this review, two of the largest bleeding disorders patient organizations, Hemophilia Federation of America (HFA) and National Hemophilia Foundation (NHF), offer insights into the priority actions required of all stakeholders to improve pharmacovigilance. The recent and ongoing increase in incidents raising safety concerns and a therapeutic landscape on the cusp of unprecedented expansion heighten the urgency of a recommitment to the primacy of patient safety and well-being in drug development and distribution.</p><p><strong>Plain language summary: </strong><b>Patients at the center of product safety</b> Every medical device and therapeutic product has potential benefits and harms. The pharmaceutical and biomedical companies that develop them must demonstrate that they are effective, and the safety risks are limited or manageable, for regulators to approve them for use and sale. After the product has been approved and people are using it in their daily lives, it is important to continue to collect information about any negative side effects or adverse events; this is called pharmacovigilance. Regulators, like the United States (US) Food and Drug Administration, the companies that sell and distribute the products, and healthcare professionals who prescribe them are all required to participate in collecting, reporting, analyzing, and communicating this information. The people with the most firsthand knowledge of the benefits and harms of the drug or device are the patients who use them. They have an important responsibility to learn how to recognize adverse events, how to report them, and to stay informed of any news about the product from the other partners in the pharmacovigilance network. Those partners have a crucial responsibility to provide clear, easy-to-understand information to patients about any new safety concerns that come to light. The community of people with inherited bleeding disorders has recently encountered problems with poor communication of product safety issues, prompting two large US patient organizations, National Hemophilia Foundation and Hemophilia Federation of America, to hold a Safety Summit with all the pharmacovigilance network partners. Together they developed recommendations to improve the collection and communication of information about product safety so that patients can make","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986221146418"},"PeriodicalIF":3.4,"publicationDate":"2023-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/46/df/10.1177_20420986221146418.PMC9969430.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10824807","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":"Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study.","authors":"Chang Liu,&nbsp;Qianqian Zhang,&nbsp;Peiye Hui,&nbsp;Yan Wang,&nbsp;Guohui Li,&nbsp;Guangchao Cao,&nbsp;Zicheng Xue,&nbsp;Jing Zhang,&nbsp;Heng Zhang,&nbsp;Xin Huang,&nbsp;Jiyong Wu,&nbsp;Fusehng Sun,&nbsp;Meixing Yan","doi":"10.1177/20420986231181335","DOIUrl":"https://doi.org/10.1177/20420986231181335","url":null,"abstract":"<p><strong>Aims: </strong>To investigate the safety of oral iron therapy in pregnant women with iron-deficiency anemia (IDA) in the real world.</p><p><strong>Methods: </strong>A retrospective analysis was performed on 1792 pregnant patients with IDA who received oral iron supplements from 12 hospitals in Shandong Province from 1 April to 31 June 2021; follow-up and adverse reactions were recorded. They were divided into six groups according to the treatment drugs.</p><p><strong>Results: </strong>The overall adverse reaction rate was 15.4%, and the main adverse reaction site was the digestive system. The incidence of all kinds of oral iron adverse reactions from high to low in order: compound ferrous sulfate and folic acid tablets (21.88%); iron proteinsuccinylate oral solution (20.90%); ferrous succinate tablets (19.76%); ferrous succinate sustained-release tablets (18.00%); iron polysaccharide complex capsule (12.06%); and iron dextran oral solution (6.94%). It was found that there was a significant difference in the incidence of adverse reactions among the six drugs (<i>p</i> < 0.05). Pairwise comparison showed that the incidence of adverse reactions was higher in the iron proteinsuccinylate oral solution than that in the iron polysaccharide complex capsule (<i>p</i> < 0.05). There was no significant difference in the incidence of adverse reactions in different ages (<i>p</i> > 0.05), but there was a significant difference in the incidence of adverse reactions in different gestational ages (<i>p</i> < 0.05). In Adverse Drug Reaction (ADR) patients, the adverse reaction result of most patients is recovery or improvement, and there was no serious adverse reaction outcome such as sequela and death.</p><p><strong>Conclusion: </strong>All the adverse reactions of oral iron were mainly gastrointestinal adverse reactions, and no heavy adverse reactions were found. Iron proteinsuccinylate oral solution has a higher incidence of adverse reactions than iron polysaccharide complex capsule. The results showed that oral iron was safer for anemia patients during pregnancy.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231181335"},"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/6f/1b/10.1177_20420986231181335.PMC10291403.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10664470","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":"Analysis of the nature and contributory factors of medication safety incidents following hospital discharge using National Reporting and Learning System (NRLS) data from England and Wales: a multi-method study.","authors":"Fatema A Alqenae,&nbsp;Douglas Steinke,&nbsp;Andrew Carson-Stevens,&nbsp;Richard N Keers","doi":"10.1177/20420986231154365","DOIUrl":"https://doi.org/10.1177/20420986231154365","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Improving medication safety during transition of care is an international healthcare priority. While existing research reveals that medication-related incidents and associated harms may be common following hospital discharge, there is limited information about their nature and contributory factors at a national level which is crucial to inform improvement strategy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Aim: &lt;/strong&gt;To characterise the nature and contributory factors of medication-related incidents during transition of care from secondary to primary care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Method: &lt;/strong&gt;A retrospective analysis of medication incidents reported to the National Reporting and Learning System (NRLS) in England and Wales between 2015 and 2019. Descriptive analysis identified the frequency and nature of incidents and content analysis of free text data, coded using the Patient Safety Research Group (PISA) classification, examined the contributory factors and outcome of incidents.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 1121 medication-related incident reports underwent analysis. Most incidents involved patients over 65 years old (55%, &lt;i&gt;n&lt;/i&gt; = 626/1121). More than one in 10 (12.6%, &lt;i&gt;n&lt;/i&gt; = 142/1121) incidents were associated with patient harm. The drug monitoring (17%) and administration stages (15%) were associated with a higher proportion of harmful incidents than any other drug use stages. Common medication classes associated with incidents were the cardiovascular (&lt;i&gt;n&lt;/i&gt; = 734) and central nervous (&lt;i&gt;n&lt;/i&gt; = 273) systems. Among 408 incidents reporting 467 contributory factors, the most common contributory factors were organisation factors (82%, &lt;i&gt;n&lt;/i&gt; = 383/467) (mostly related to continuity of care which is the delivery of a seamless service through integration, co-ordination, and the sharing of information between different providers), followed by staff factors (16%, &lt;i&gt;n&lt;/i&gt; = 75/467).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Medication incidents after hospital discharge are associated with patient harm. Several targets were identified for future research that could support the development of remedial interventions, including commonly observed medication classes, older adults, increase patient engagement, and improve shared care agreement for medication monitoring post hospital discharge.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;&lt;b&gt;Study using reports about unsafe or substandard care mainly written by healthcare professionals to better understand the type and causes of medication safety problems following hospital discharge&lt;/b&gt; &lt;b&gt;Why was the study done?&lt;/b&gt; The safe use of medicines after hospital discharge has been highlighted by the World Health Organization as an important target for improvement in patient care. Yet, the type of medication problems which occur, and their causes are poorly understood across England and Wales, which may hamper our efforts to create ways to improve care as they may not be based on what we k","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231154365"},"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/a0/b4/10.1177_20420986231154365.PMC10026140.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9174553","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":"Development and psychometric assessment of self-reported patient medication safety scale (SR-PMSS).","authors":"Ning Qin,&nbsp;Yinglong Duan,&nbsp;Shuangjiao Shi,&nbsp;Xiao Li,&nbsp;Haoqi Liu,&nbsp;Feng Zheng,&nbsp;Zhuqing Zhong,&nbsp;Guliang Xiang","doi":"10.1177/20420986231152934","DOIUrl":"https://doi.org/10.1177/20420986231152934","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;Patient medication safety can affect their clinical outcomes and plays an important role in patient safety management. However, few tools have been developed to assess patient medication safety. This study aimed to develop and validate the self-reported patient medication safety scale (SR-PMSS).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We developed SR-PMSS guided by the Donabedian Structure-Process-Outcome framework and used psychometric methods to test its validity and reliability.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 501 patients with an average age of 56.81 ± 14.47 were enrolled in this study. The SR-PMSS consisted of 21 items and 5 factors. The content validity was good with item-level content validity index (CVI) &gt; 0.78, average scale-level CVI (S-CVI) &gt; 0.9, and universal agreement S-CVI &gt; 0.8. Exploratory factor analysis extracted a five-factor solution with eigenvalues &gt; 0.1, explaining 67.766% of the variance. Confirmatory factor analysis showed good model fit, acceptable convergent validity, and discriminant validity. The Cronbach's α coefficient for SR-PMSS was 0.929, the split-half reliability coefficient was 0.855, and the test-retest reliability coefficient was 0.978.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The SR-PMSS was a valid and reliable instrument with good reliability and validity to evaluate the level of patient medication safety. The target users of the SR-PMSS are all people who are taking or have used prescription medications. The SR-PMSS can be used by healthcare providers in clinical practice and research to identify patients at risk for medication use and intervene with them to reduce adverse medication events and provide support for patient safety management.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;&lt;b&gt;SR-PMSS&lt;/b&gt; - &lt;b&gt;a self-reported tool to assess patient medication safety&lt;/b&gt;Medication therapy was the most common and frequent treatment method to prevent and cure diseases. Medication safety issues may occur in the process of medication use. Patient medication safety can affect their clinical outcomes and plays an important role in patient safety management. However, there are few tools to assess patient medication safety currently, and most of them focused on medication safety related to hospitals or healthcare workers. We developed the self-reported patient medication safety scale (SR-PMSS) guided by the Donabedian Structure-Process-Outcome framework. Then, we conducted a two-round expert consultation, clarity verification, and item simplification to determine the final version of the scale. The SR-PMSS consisted of 21 items and 5 factors and it had good validity and reliability. The target users of the SR-PMSS are all people who are taking or have used prescription medications. Healthcare providers can use the SR-PMSS in clinical practice and research to identify patients at risk for medication use and intervene with them to reduce adverse medication events and provide support for p","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231152934"},"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/54/25/10.1177_20420986231152934.PMC10052723.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9241366","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":"Assessing adverse drug reaction reports for antidiabetic medications approved by the food and drug administration between 2012 and 2017: a pharmacovigilance study.","authors":"Britney A Stottlemyer,&nbsp;Michael C McDermott,&nbsp;Mackenzie R Minogue,&nbsp;Matthew P Gray,&nbsp;Richard D Boyce,&nbsp;Sandra L Kane-Gill","doi":"10.1177/20420986231181334","DOIUrl":"https://doi.org/10.1177/20420986231181334","url":null,"abstract":"<p><strong>Objective: </strong>Between 2012 and 2017, the U.S. Food and Drug Administration (FDA) approved 10 antidiabetic indicated therapies. Due to the limited literature on voluntarily reported safety outcomes for recently approved antidiabetic drugs, this study investigated adverse drug reactions (ADRs) reported in the FDA Adverse Event Reporting System (FAERS).</p><p><strong>Research design and methods: </strong>A disproportionality analysis of spontaneously reported ADRs was conducted. FAERS reports from January 1, 2012 to March 31, 2022 were compiled, allowing a 5-year buffer following drug approval in 2017. Reporting odds ratios were calculated for the top 10 ADRs, comparing new diabetic agents to the other approved drugs in their therapeutic class.</p><p><strong>Results: </strong>127,525 reports were identified for newly approved antidiabetic medications listed as the primary suspect (PS). For sodium-glucose co-transporter-2 (SGLT-2) inhibitors, the odds of blood glucose increased, nausea, and dizziness being reported was greater for empagliflozin. Dapagliflozin was associated with greater reports of weight decreased. Canagliflozin was found to have a disproportionally higher number of reports for diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis. Assessing glucagon-like peptide-1 (GLP-1) receptor agonists, dulaglutide and semaglutide were associated with greater reports of gastrointestinal adverse drug reactions. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports.</p><p><strong>Conclusion: </strong>Pharmacovigilance studies utilizing a large publicly available dataset allow an essential opportunity to evaluate the safety profile of antidiabetic drugs utilized in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved antidiabetic medications to determine causality.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231181334"},"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/29/05/10.1177_20420986231181334.PMC10272667.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10018418","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":"Joint use of population pharmacokinetics and machine learning for optimizing antiepileptic treatment in pediatric population.","authors":"Ivana Damnjanović,&nbsp;Nastia Tsyplakova,&nbsp;Nikola Stefanović,&nbsp;Tatjana Tošić,&nbsp;Aleksandra Catić-Đorđević,&nbsp;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,&nbsp;Hanlie Steyn,&nbsp;Martine Vorster,&nbsp;Martie S Lubbe,&nbsp;Johanita R Burger","doi":"10.1177/20420986221143272","DOIUrl":"https://doi.org/10.1177/20420986221143272","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A document analysis was performed based on harmonised international guidelines (&lt;i&gt;n&lt;/i&gt; = 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 (&lt;i&gt;n&lt;/i&gt; = 7). The checklist was subjected to face and content validation by non-experts and PV experts.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The developed checklist can contribute towards assisting SADC NMRAs to formulate national PV guidelines that reflect current international practice, with local context incorporated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;&lt;b&gt;Developing a checklist for the evaluation of medicine safety guidelines in Southern Africa&lt;/b&gt; &lt;b&gt;Introduction:&lt;/b&gt; 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.&lt;b&gt;Methods:&lt;/b&gt; 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}