Therapeutic Advances in Drug Safety最新文献

{"title":"Acceptability of a cross-sectoral hospital pharmacist intervention for patients in transition between hospital and general practice: a mixed methods study.","authors":"Charlotte Arp Sørensen, Linda Jeffery, Klaus Roelsgaard, Solveig Gram, Jannik Falhof, Philipp Harbig, Charlotte Olesen","doi":"10.1177/20420986231213714","DOIUrl":"https://doi.org/10.1177/20420986231213714","url":null,"abstract":"<p><strong>Background and objective: </strong>Drug-related problems (DRPs) are often seen when a patient is transitioning from one healthcare sector to another, for example, when a patient moves from the hospital to a General Practice (GP) setting. This transition creates an opportunity for information on medication changes and follow-up plans to be lost. A cross-sectoral hospital pharmacist intervention was developed and pilot-tested in a large GP clinic. The intervention included medication history, medication reconciliation, medication review, follow-up telephone calls, identification of possible DRPs and communication with the GP. It is unknown whether the intervention is transferable to other GP clinics. The aim of the study was to explore similarities and differences between GP clinics in descriptive data and intervention acceptability.</p><p><strong>Methods: </strong>A convergent mixed methods study design was used. The intervention was tested in four GP clinics with differing characteristics. Quantitative data on the GP clinics, patients and pharmacist activities were collected. Qualitative data on the acceptability were collected through focus group interviews with general practitioners, nurses and pharmacists. The Theoretical Framework of Acceptability was used.</p><p><strong>Results: </strong>Overall, the intervention was found acceptable and relevant by all. There were differences between the GP clinics in terms of size, daily physician work form and their use of pharmacists for <i>ad hoc</i> tasks. There were similarities in patient characteristics across GP clinics. Therefore, the intervention was found equally relevant for all of the clinics. Shared employment with unique access to health records in both sectors was important in the identification and resolution of DRPs. Economy was a barrier for further implementation.</p><p><strong>Conclusions: </strong>The intervention was found acceptable and relevant by all; therefore, it was considered transferable to other GP clinics. Hospital pharmacists were perceived to be relevant healthcare professionals to be utilized in GP, in hospitals and in the cross-sectoral transition of patients.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231213714"},"PeriodicalIF":4.4,"publicationDate":"2023-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10725152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138799858","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":"Understanding, readiness, and response of healthcare professionals in combating falsified medical products in Eritrea: a population-based survey.","authors":"Yodit Fitsum, Azania Werede, Abubeker Mahmud Saleh, Eyasu H Tesfamariam, Francis Magombo, Freminatos Misghina, Hermella Yemane, Iyassu Bahta, Liya Abraham, Merhawi Bahta, Merhawi Debesai, Meron Tesfagaber, Michael Ghirmai, Sirak Tesfamariam, Mulugeta Russom","doi":"10.1177/20420986231213713","DOIUrl":"10.1177/20420986231213713","url":null,"abstract":"<p><strong>Background: </strong>The circulation of falsified medical products is a global threat and is expected to be higher in low- and middle-income countries.</p><p><strong>Objective: </strong>This study was conducted to assess the understanding, readiness, and response of Eritrea's healthcare professionals (HCPs), and identify potential areas of intervention to combat circulation of falsified medical products.</p><p><strong>Design: </strong>This was a nationwide population-based cross-sectional survey, conducted in December 2021.</p><p><strong>Methods: </strong>This study enrolled representative samples of HCPs working in public and private health facilities. Two-stage stratified cluster sampling was used to select study participants and data were collected through face-to-face interviews. Descriptive statistics, Mann-Whitney <i>U</i> test, Kruskal-Wallis test along with their post hoc tests, Jonckheere-Terpstra, and logistic regression analyses were performed as appropriate.</p><p><strong>Results: </strong>The study enrolled 707 HCPs, and 96.6% were successfully surveyed. The majority of the participants (62.5%) encountered products with suspected quality defects and 63.8% claimed that they had reported the incident(s) at least once. About 85% reported that complaints should be submitted to the Eritrean Pharmacovigilance Centre and 74.0% indicated that it should be reported at the earliest time possible even if the reporter lacks details. The standard reporting form for suspected product quality issues was correctly recognized by 13.8%. Overall, the median knowledge and attitude scores were found to be 9 out of 17 (interquartile range, IQR: 4.0) and 30 out of 35 (IQR: 4.0), respectively. Not knowing how to report (55.6%) and what to report (34.9%), no/delayed feedback from the regulatory authority (30.0%), and unavailability of reporting forms (29.0%) were the frequently reported barriers to reporting. In addition, profession (<i>p</i> = 0.027), no/delayed feedback (adjusted odds ratio [AOR]: 4.70; 95% CI: 2.17-10.18; <i>p</i> < 0.001), and not knowing how to report (AOR: 0.12; 95% CI: 0.05-0.28; <i>p</i> < 0.001) were found to be determinants of reporting suspected product quality defects.</p><p><strong>Conclusion: </strong>The readiness and response of Eritrea's HCPs in detecting and reporting falsified medical products seems promising, although a significant knowledge gap was observed.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231213713"},"PeriodicalIF":3.4,"publicationDate":"2023-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10725142/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138800007","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":"Modified Dixon sequential method to determine the effective dose of alfentanil compounded with propofol for day-case hysteroscopy.","authors":"Chenyang Xu, Rui Peng, Xiali Qian, Shanwu Feng, Hongmei Yuan","doi":"10.1177/20420986231214992","DOIUrl":"https://doi.org/10.1177/20420986231214992","url":null,"abstract":"<p><strong>Background: </strong>Propofol combined with alfentanil is suitable for intravenous anesthesia for day-case hysteroscopy.</p><p><strong>Objective: </strong>To investigate the median effective dose (ED₅₀) and 95% effective dose (ED₉₅) of alfentanil compounded with propofol for day-case hysteroscopy.</p><p><strong>Design: </strong>In all, 29 patients who volunteered for painless hysteroscopy in 2022 were recruited. 1.5 mg/kg propofol was given as a sedative to all patients. The trial was conducted using the modified Dixon sequential method, with an initial dose of 10 μg/kg of alfentanil, and the subject's alfentanil dose depended on whether the prior hysteroscopy had failed, which was defined as inadequate cervical dilatation and hysteroscope placement with the patient exhibiting body movement, frowning, or a MOAA/S score >1. If the hysteroscopy failed (i.e. a positive response), the subsequent subject's alfentanil dosage was raised, and conversely (i.e. a negative response), the dose was decreased, with the adjacent dose ratio always being 1:1.2. The formal test begins with the first crossover wave and lasts until seven crossover waves materialize.</p><p><strong>Methods: </strong>The probit method was used to calculate the ED₅₀, ED₉₅, and corresponding 95% confidence intervals (CIs) of alfentanil compounded with propofol for hysteroscopy.</p><p><strong>Results: </strong>The ED₅₀ and ED₉₅ of alfentanil combined with propofol for day-case hysteroscopy were 5.701 (95% CI: 3.841-7.069) μg/kg and 8.817 (95% CI: 7.307-20.868) μg/kg, respectively.</p><p><strong>Conclusion: </strong>Alfentanil at 8.817 μg/kg in conjunction with propofol is a successful and safe approach for day-case painless hysteroscopy.</p><p><strong>Trial registration: </strong>The trial registry name: Modified sequential method to determine the half-effective dose of alfentanil compounded with propofol for ambulatory hysteroscopy. The URL of registration is https://www.chictr.org.cn/showproj.html?proj=171786, where the full trial protocol can be accessed. Registration number: ChiCTR2200061619.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231214992"},"PeriodicalIF":4.4,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10702409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138799831","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":"Inappropriate quetiapine use at a large academic medical center: frequency of misuse and associated costs of adverse effects.","authors":"Winter Roth, David Dadiomov, Michelle Chu","doi":"10.1177/20420986231213173","DOIUrl":"https://doi.org/10.1177/20420986231213173","url":null,"abstract":"<p><strong>Background: </strong>Quetiapine is an antipsychotic with dose-related receptor affinity, which is commonly prescribed by specialties outside of psychiatry. Quetiapine can have adverse effects including weight gain, hyperglycemia, and falls. Therefore, quetiapine is a good focus medication to assess the need for an antipsychotic stewardship protocol.</p><p><strong>Objective: </strong>To assess the need for an antipsychotic stewardship protocol at a large, urban academic medical center by evaluating quetiapine usage.</p><p><strong>Design: </strong>A retrospective review of quetiapine dispensing history for all strengths (immediate release: 25, 50, 100, 200, 300 mg; extended release: 50, 150, 200, 300 mg) over 1 year (1 December 2021 to 30 November 2022) in patients aged 18 and older was conducted at a large, urban academic medical center.</p><p><strong>Methods: </strong>An antipsychotic protocol for safe and effective quetiapine use was developed utilizing its package insert, clinical guidelines, and primary peer-reviewed literature. Once identified by prescription fill, a retrospective chart review was completed for quetiapine indication, dose, and frequency. Each prescription was reviewed for appropriateness using the antipsychotic stewardship protocol.</p><p><strong>Results: </strong>Out of 521 quetiapine prescriptions for 181 unique patients, 67% of scripts were inappropriate. The costs associated with this inappropriate use were extrapolated to be over $350,000 per year when accounting for long-term harms associated with the development of type 2 diabetes mellitus and falls in older adults.</p><p><strong>Conclusion: </strong>Promoting the safe and effective use of antipsychotics through developing and implementing an antipsychotic stewardship protocol may reduce patient harm and associated costs from inappropriate use.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231213173"},"PeriodicalIF":4.4,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10702410/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138799825","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":"Opportunities and challenges of pharmacovigilance in special populations: a narrative review of the literature.","authors":"Yanping Li,&nbsp;Yuanlin Wu,&nbsp;Tingting Jiang,&nbsp;Haiyan Xing,&nbsp;Jing Xu,&nbsp;Chen Li,&nbsp;Rui Ni,&nbsp;Ni Zhang,&nbsp;Guiyuan Xiang,&nbsp;Li Li,&nbsp;Ziwei Li,&nbsp;Lanlan Gan,&nbsp;Yao Liu","doi":"10.1177/20420986231200746","DOIUrl":"https://doi.org/10.1177/20420986231200746","url":null,"abstract":"<p><p>The relatively new discipline of pharmacovigilance (PV) aims to monitor the safety of drugs throughout their evolution and is essential to discovering new drug risks. Due to their specific and complex physiology, children, pregnant women, and elderly adults are more prone to adverse drug reactions (ADRs). Additionally, the lack of clinical trial data exacerbates the challenges faced with pharmacotherapy in these populations. Elderly patients tend to have multiple comorbidities often requiring more extensive medication, which adds additional challenges for healthcare professionals (HCPs) in delivering safe and effective pharmacotherapy. Clinical trials often have inherent limitations, including insufficient sample size and limited duration of research; as some ADRs are attributed to long-term use of a drug, these may go undetected during the course of the trial. Therefore, the implementation of PV is key to insuring the safe and effective use of drugs in special populations. We conducted a thorough review of the scientific literature on PV systems across the European Union, the United States, and China. Our review focused on basic physiological characteristics, drug use, and PV for specific populations (children, pregnant women, and the elderly). This article aims to provide a reference for the development of follow-up policies and improvement of existing policies as well as provide insight into drug safety with respect to patients of special populations.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231200746"},"PeriodicalIF":4.4,"publicationDate":"2023-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6a/ba/10.1177_20420986231200746.PMC10540608.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41149189","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":"HIV/AIDS patients' knowledge, attitude, and practice toward anti-retroviral therapy medications' adverse effects and associated factors in Tikur Anbessa Specialized Hospital.","authors":"Zenebe Negash, Yohannes Yibeltal, Akeberegn Gorems Ayele","doi":"10.1177/20420986231194752","DOIUrl":"10.1177/20420986231194752","url":null,"abstract":"<p><strong>Background: </strong>Adverse effects (AEs) have been reported with all antiretroviral therapy (ART) medications, and it was among the most common cause for switching or terminating therapy and drug non-adherence. Even though AEs of ART medications are common and to be expected, little study has been conducted on the understanding of patients on the AEs. Therefore, this study aimed to assess patients' knowledge, attitude, and practice (KAP) toward ART medications' AEs and associated factors.</p><p><strong>Methods: </strong>A cross-sectional study design was applied using an interviewer-administered questionnaire from June to September 2021 on human immunodeficiency virus/acquired immunodeficiency syndrome patients on follow-up at Tikur Anbessa Specialized Hospital, Ethiopia. Data was gathered, cleaned, and analyzed using SPSS version 23. Logistic regression analysis was performed to assess the relationship between the independent variable and patients' knowledge and attitude about the AEs of ART medication. A <i>p</i>-value of 0.05 was used to determine the statistical significance.</p><p><strong>Results: </strong>About 230 people were enrolled in this study, with 51.3% of them female. Study participants had a mean age of 36 years (standard deviation = 14.19). Of 230 participants, 67.8% had received advice on the AEs of ART medications. Poor knowledge and attitude were observed among 47.8 and 51.3% of respondents, respectively. Prior AEs experience, lack of experiencing opportunistic infection, and lack of counseling about ART medications' AEs were associated with poor knowledge, whereas female gender and a lack of counseling regarding ART medications' AEs were associated with a negative attitude (<i>p</i> < 0.05). Even though most patients (81.7%) report AEs of the medication to professionals, a significant number of patients involved in malpractices such as taking other drugs to treat AEs (24.3%), not prepared to do anything (27.1%), change the suspected drug (24.3%), reduce the dose (18.7%), and use local herbal medicines to treat suspected AEs (20.2%).</p><p><strong>Conclusion: </strong>Overall, the study participants had poor knowledge, lack of positive attitudes, and non-adherence to the actual recommended practice toward AEs of ART medications. Lack of comorbidity, having prior AEs experience, and lack of counseling regarding ART medication AEs were associated with poor knowledge. Female gender and a lack of counseling on the AEs of ART medications were associated with a negative attitude.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231194752"},"PeriodicalIF":3.4,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e4/d0/10.1177_20420986231194752.PMC10475229.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10533339","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":"Hospital admissions attributed to adverse drug reactions in tertiary care in Uganda: burden and contributing factors.","authors":"Lillian Asio, Marble Nasasira, Ronald Kiguba","doi":"10.1177/20420986231188842","DOIUrl":"10.1177/20420986231188842","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug reactions (ADRs) contribute to the burden of disease globally and of particular concern are ADR-related hospital admissions.</p><p><strong>Objectives: </strong>This study sought to determine the burden, characteristics, contributing factors and patient outcomes of ADRs that were the primary diagnosis linked to hospital admission among inpatients in Uganda.</p><p><strong>Design: </strong>We conducted a cross-sectional secondary analysis of data from a prospective cohort study of adult inpatients aged 18 years and older at Uganda's Mulago National Referral Hospital from November 2013 to April 2014.</p><p><strong>Methods: </strong>We reviewed clinical charts to identify inpatients with an ADR as one of the admitting diagnoses and, if so, whether or not the hospital admission was primarily attributed to the ADR. Logistic regression was used to determine factors associated with hospital admissions primarily attributed to ADRs.</p><p><strong>Results: </strong>Among 762 inpatients, 14% had ADRs at hospital admission and 7% were primarily hospitalized due to ADRs. A total of 235 ADRs occurred among all inpatients and 57% of the ADRs were the primary diagnosis linked to hospital admission. The majority of ADRs occurred in people living with HIV and were attributed to antiretroviral drugs. HIV infection [aOR (adjusted odds ratio) = 2.97, 95% confidence interval (CI): 1.30-6.77], use of antiretroviral therapy (aOR = 5.46, 95% CI: 2.56-11.68), self-medication (aOR = 2.27, 95% CI: 1.14-4.55) and higher number of drugs used (aOR = 1.13, 95% CI: 1.01-1.26) were independently associated with hospital admissions attributed to ADRs.</p><p><strong>Conclusion: </strong>Antiretroviral drugs were often implicated in ADR-related hospital admissions. HIV infection (whether managed by antiretroviral therapy or not), self-medication and high pill burden were associated with hospital admissions attributable to ADRs. The high HIV burden in Sub-Saharan Africa increases the risk of ADR-related hospitalization implying the need for emphasis on early detection, monitoring and appropriate management of ADRs associated with hospital admission in people living with HIV.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"14 ","pages":"20420986231188842"},"PeriodicalIF":3.4,"publicationDate":"2023-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10387768/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10354754","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":"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":"&lt;p&gt;&lt;p&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;&lt;b&gt;Patients at the center of product safety&lt;/b&gt; 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}