scholarly journals Determinants of Adverse Drug Reactions Due to Tuberculosis Therapy in African Countries: a Systematic Scoping Review Protocol

2021 ◽  
Author(s):  
Tasmiya Raúfo Irá ◽  
Neusa Torres Tovela ◽  
Elisa López Varela ◽  
Pravina Devi Laljeeth ◽  
Richard Beharilal ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Scoping Review ◽  
Clinical Management ◽  
World Health ◽  
Health Concern ◽  
Cochrane Library ◽  
Drug Reactions ◽  
African Countries ◽  
Tuberculosis Therapy ◽  
Research Studies

Abstract Background: Adverse drug reactions (ADRs) remain a significant public health concern worldwide mainly in developing countries. Adverse drug reactions due to multi-drugs regimen for the treatment of tuberculosis (TB) have negative implications such as toxicity, leading to poor compliance and interruption of medication before completion. Understanding the profile of ADRs is critical to establishing specific strategies for early detection, prevention and clinical management. The present study aims to map the existing literature on the determinants of adverse drug reactions due tuberculosis therapy in African countries. Methods and analysis: The scoping review will be guided by Arksey and O’Malley framework as well as recommendations by Levac et al., and Colquhoun et al. The search strategy will include searching electronic databases such as Cochrane library, PubMed, EBSCOhost (including Medline), ProQuest, Google scholar; CINAHL with Full Text and other sources such as World Health Organization (WHO) and governmental websites. Peer-reviewed literature and grey literature of primary and secondary studies with different study designs which addresses the main question will be included. Studies published within the period of 2000 to 2020 are eligible. The selection process will involve screening titles, abstracts, full texts. A standardized data charting form will be created in google forms to extract relevant information from the included studies. The NVIVO software version 12 will be used for thematic analysis of the studies to summarize the review findings. The quality of the included studies will be assessed using Mixed Method Appraisal Tool (MMAT) version 2018 and Authority Accuracy Coverage Objectivity Date Significance (AACODS) checklist (for grey literatures).Discussion: The study anticipates finding and mapping relevant research studies in African context on determinants of adverse drug reactions due to tuberculosis therapy. The synthesis of this evidence base will help to identify research gaps and will serve as guidance for future research studies on strengthening of the pharmacovigilance system of ADRs and its clinical management in Africa. The study findings will be disseminated through the traditional academic platforms, such as peer-reviewed publications and presentations at relevant local and international conferences, symposiums, and seminars.Systematic review registration: Prospero Registration Number: CRD42020203617.

scholarly journals Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

2020 ◽  
Author(s):  
Daniele Sartori ◽  
Jeffrey Aronson ◽  
Igho Onakpoya
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Scoping Review ◽  
Suspected Adverse Drug Reaction ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Risk Minimization ◽  
Drug Reactions ◽  
Medicinal Products

Abstract Background: Signals of adverse drug reactions are the basis of some regulatory risk-minimization actions in pharmacovigilance, such as changes to the section of undesirable effects in Summaries of Products Characteristics (SmPCs). Reviews of the evidence of signals have highlighted that these are mostly supported by reports of adverse drug reactions or multiple types of evidence, but have so far been limited to specific medicinal products, time intervals, groups of adverse drug reactions and specific countries. The time that elapses between a report of a suspected adverse drug reaction and the communication of a signal has not been systematically investigated. Furthermore, difficulties in causally linking medicinal products to adverse events have been highlighted, but the elements of reports of suspected ADRs that authors used to support putative causal relationships have been rarely characterized.Methods: We plan a scoping review to chart the evidence underpinning signals in pharmacovigilance and the time that it takes to communicate a signal. We shall retrieve records from electronic databases, without language or publication restrictions; we shall apply backward and forward citation to adjust for variations in database indexing. We shall also hand-search the websites of 35 regulatory agencies/authorities, restricted publications from Uppsala Monitoring Centre, and drug bulletins in the list of International Society of Drug Bulletins. If websites do not report signals, signals will be requested from the competent stakeholder. We shall use the Oxford Centre for Evidence-Based Medicine Levels of Evidence to chart and summarize evidence. We shall use VigiBase, the World Health Organization’s Global Individual Case Safety Report database, to determine the date of reporting for reports of adverse drug reactions. Plots, or pictograms (if appropriate), will be used to represent the time from the first report of a suspected adverse drug reaction to a signal.Discussion: We expect that the findings from this exploratory investigation will be useful in better understanding global patterns of similarities or differences in regulatory decision-making in terms of evidence and timing of communications, and in identifying relevant research questions for future systematic reviews.Scoping review registration: osf.io/jtv38

scholarly journals Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital

2021 ◽  
Vol 12 ◽  
Author(s):  
Zakir Khan ◽  
Yusuf Karataş ◽  
Olcay Kıroğlu
Keyword(s):  
Retrospective Study ◽  
Adverse Drug Reactions ◽  
National Level ◽  
Small Sample ◽  
World Health ◽  
Health Concern ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Reactions ◽  
Paediatric Patients

Drug safety in paediatric patients is a serious public health concern around the world. The paediatric patients are more prone to adverse drug reactions (ADRs) than adults. Moreover, there is a scarcity of information about ADRs in paediatric patients. This study was conducted to determine the frequency, causality, severity, preventability of paediatric patients’ ADRs reported in a tertiary care hospital in Adana, Turkey. A retrospective study was conducted on all spontaneously reported ADRs between January 01, 2020, to July 30, 2021, in paediatric patients. The ADRs reports were evaluated in terms of gender, age, ADR characteristics, suspected drugs and reporting source. All included ADRs reports were characterized according to the Naranjo Algorithm/World Health Organization (WHO) causality scales, Hartwig/Siegel and Common Terminology Criteria for Adverse Events (CTCAE) severity scales, the modified Schoumock and Thornton preventability scale and hospital pharmacovigilance center criteria for seriousness. Therapeutic groups were also coded using the WHO-Anatomical Therapeutic and Chemical (ATC) classification. During the study period, 8,912 paediatric patients who were admitted had 16 ADRs with 1.7 ADRs/1,000 admissions. The majority of ADRs were found in infants (31.2%) and children (56.2%) as compared to adolescents (12.5%). ADRs were observed more in females (81.2%) than males. Skin (62.5%) was the most affected organ due to the ADRs, and maculopapular rash and erythema multiforme were the most commonly reported symptoms. Most ADRs were probable/likely (93.7%), severe (50%), preventable or probably preventable (43.7%) and serious (37.5%). Antibiotics (93.7%) were found to be the most common cause of ADRs in paediatric patients. The majority of ADRs were associated with vancomycin (68.7%). Most of the ADRs were reported by a medical doctor in this study. This small sample size study highlights significant problems of ADRs in paediatric patients, mainly caused by antibiotics and with a majority of ADRs manifest as skin reactions. Furthermore, a high proportion of the identified ADRs were found to be preventable. More focused efforts are needed at the national level to avoid preventable ADRs in hospitals. Monitoring and management of ADRs and future studies would be beneficial for better patient care and safety.

scholarly journals Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

2020 ◽  
Author(s):  
Daniele Sartori ◽  
Jeffrey Aronson ◽  
Igho Onakpoya
Keyword(s):  
Adverse Drug Reactions ◽  
Systematic Reviews ◽  
Scoping Review ◽  
Data Retrieval ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Data Repository ◽  
Supporting Evidence ◽  
Causal Relationships ◽  
Drug Reactions

Abstract Background: Signals of adverse drug reactions (ADRs) form the basis of some regulatory risk-minimization actions in pharmacovigilance. Reviews of limited scope have highlighted that such signals are mostly supported by reports of ADRs or multiple types of evidence. . The time that elapses between a report of a suspected ADR and the communication of a signal has not been systematically characterized. Neither have the features of reports of suspected ADRs that authors used to support putative causal relationships, although difficulties with establishing causal relationships between medicinal products and adverse events have been highlighted. The objectives of this study will be to describe the evidence underpinning signals in pharmacovigilance, the features of reports of ADRs supporting signals, and the time that it takes to communicate a signal.Methods: . We shall retrieve records from PubMed, EMBASE, Web of Science, PsycINFO (from inception onwards), without language/design restrictions and apply backward citation screening . We shall hand-search the websites of 35 regulatory agencies/authorities, restricted publications from the Uppsala Monitoring Centre, and drug bulletins. Signals will be requested from the competent stakeholder, if absent from websites. We shall use VigiBase, the World Health Organization’s Global Individual Case Safety Report database, to determine the dates on which ADRs were reported . We shall manage records using EndNote (v. 8.2); one reviewer will screen titles/abstracts and full texts, a second will cross-validate the findings, and a third will arbitrate disagreements. Data will be charted via the Systematic Reviews Data Repository, following the same procedures as for data retrieval. Evidence will be categorized according to the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Features of reports of ADRs will be coded. Tables will display frequencies of types of evidence and features of reports of ADRs. We shall use plots or pictograms (if appropriate) to represent the time from the first report of a suspected ADR to a signal.Discussion: We expect the findings from this review will allow better understanding of global patterns of similarities or differences in terms of supporting evidence and timing of communications, and identify relevant research questions for future systematic reviews.Scoping review registration: osf.io/jtv38

scholarly journals Urban health nexus with coronavirus disease 2019 (COVID-19) preparedness and response in Africa: Rapid scoping review of the early evidence

2021 ◽  
Vol 9 ◽  
pp. 205031212199436
Author(s):  
Robert Kaba Alhassan ◽  
Jerry John Nutor ◽  
Aaron Asibi Abuosi ◽  
Agani Afaya ◽  
Solomon Salia Mohammed ◽  
...  
Keyword(s):  
Urban Health ◽  
Scoping Review ◽  
Empirical Studies ◽  
Grey Literature ◽  
Spillover Effects ◽  
Health Systems Strengthening ◽  
World Health ◽  
African Countries ◽  
Response Strategies ◽  
Early Evidence

Introduction: Severe acute respiratory syndrome coronavirus 2 also called coronavirus disease 2019 was first reported in the African continent on 14 February 2020 in Egypt. As at 18 December 2020, the continent reported 2,449,754 confirmed cases, 57,817 deaths and 2,073,214 recoveries. Urban cities in Africa have particularly suffered the brunt of coronavirus disease 2019 coupled with criticisms that the response strategies have largely been a ‘one-size-fits-all’ approach. This article reviewed early evidence on urban health nexus with coronavirus disease 2019 preparedness and response in Africa. Methods: A rapid scoping review of empirical and grey literature was done using data sources such as ScienceDirect, GoogleScholar, PubMed, HINARI and official websites of World Health Organization and Africa Centres for Disease Control and Prevention. A total of 26 full articles (empirical studies, reviews and commentaries) were synthesised and analysed qualitatively based on predefined inclusion criteria on publication relevance and quality. Results: Over 70% of the 26 articles reported on coronavirus disease 2019 response strategies across Africa; 27% of the articles reported on preparedness towards coronavirus disease 2019, while 38% reported on urbanisation nexus with coronavirus disease 2019; 40% of the publications were full-text empirical studies, while the remaining 60% were either commentaries, reviews or editorials. It was found that urban cities remain epicentres of coronavirus disease 2019 in Africa. Even though some successes have been recorded in Africa regarding coronavirus disease 2019 fight, the continent’s response strategies were largely found to be a ‘one-size-fits-all’ approach. Consequently, adoption of ‘Western elitist’ mitigating measures for coronavirus disease 2019 containment resulted in excesses and spillover effects on individuals, families and economies in Africa. Conclusion: Africa needs to increase commitment to health systems strengthening through context-specific interventions and prioritisation of pandemic preparedness over response. Likewise, improved economic resilience and proper urban planning will help African countries to respond better to future public health emergencies, as coronavirus disease 2019 cases continue to surge on the continent.

scholarly journals Research on simulation in radiography education: a scoping review protocol

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Mona Vestbøstad ◽  
Klas Karlgren ◽  
Nina Rydland Olsen
Keyword(s):  
Scoping Review ◽  
Search Strategy ◽  
Skills Training ◽  
World Health ◽  
Cochrane Library ◽  
Future Research ◽  
Design Elements ◽  
Ovid Medline ◽  
Scoping Reviews ◽  
Radiography Education

Abstract Background Today, there are fewer opportunities for health care students and staff for skills training through direct patient contact. The World Health Organization therefore recommends learning about patient safety through hands-on experience and simulation. Simulation has the potential to improve skills through training in a controlled environment, and simulation has a positive effect on knowledge and skills, and even patient-related outcomes. Reviews addressing the use of simulation across the different radiography specialties are lacking. Further knowledge on simulation in radiography education is needed to inform curriculum design and future research. The purpose of this scoping review is to explore, map, and summarize the extent, range, and nature of published research on simulation in radiography education. Methods We will follow the methodological framework for scoping reviews originally described by Arksey and O’Malley. We will search the MEDLINE, Embase, Epistemonikos, The Cochrane Library, ERIC, Scopus, and sources of grey literature. A comprehensive search strategy for Ovid MEDLINE was developed in collaboration with a research librarian. An example of a full electronic search from the Ovid MEDLINE (1641 articles records, January 9, 2020) is provided and will be used to adapt the search strategy to each database. Two independent review authors will screen all abstracts and titles, and full-text publications during a second stage. Next, they will extract data from each included study using a data extraction form informed by the aim of the study. A narrative account of all studies included will be presented. We will present a simple numerical analysis related to the extent, nature, and distribution of studies, and we will use content analysis to map the different simulation interventions and learning design elements reported. Any type of simulation intervention within all types of radiography specializations will be included. Our search strategy is not limited by language or date of publication. Discussion An overview of publications on simulation in radiography education across all radiography specialties will help to inform future research and will be useful for stakeholders within radiography education using simulation, both in the academic and clinical settings. Systematic review registration Open Science Framework (OSF). Submitted on October 18, 2020

scholarly journals A Scoping Review of Policies Related to the Prevention and Control of Overweight and Obesity in Africa

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 4028
Author(s):  
Theodosia Adom ◽  
Anniza De Villiers ◽  
Thandi Puoane ◽  
André Pascal Kengne
Keyword(s):  
Scoping Review ◽  
Population Level ◽  
Overweight And Obesity ◽  
World Health ◽  
Environmental Drivers ◽  
African Countries ◽  
Food Industries ◽  
Nutrition And Diet ◽  
Health Organization ◽  
And Control

To address the issue of obesity, the World Health Organization (WHO) recommends a set of comprehensive programmes aimed at changing the obesogenic environments to provide opportunities for healthy food options and increased physical activity in the school, home, and at the population level. The objectives of this study were to examine the nature and range of policies related to overweight and obesity prevention in Africa, and to assess how they align with international guidelines. An existing methodological framework was adapted for this scoping review. A search of publicly available national documents on overweight/obesity, general health, and non-communicable diseases (NCDs) was undertaken from relevant websites, including WHO, ministries, and Google Scholar. Additional requests were sent to key contacts at relevant ministries about existing policy documents. The documents were reviewed, and the policies were categorised, using the Analysis Grid for Environments Linked to Obesity (ANGELO) framework. The framework categorises the environmental drivers of obesity into four domains (physical, economic, legislative, and socio-cultural) and two scales: macro (national, regional, sectors, food industries, media, etc.) and micro (household, institutional, and community). This review included documents from 41 African countries. The policy initiatives to prevent overweight/obesity target the school, family and community settings, and macro environments, and broadly align with global recommendations. The NCD documents were in the majority, with only two on obesity. The majority of the documents detailed strategies and key interventions on unhealthy diets and physical inactivity. The physical, legislative, and sociocultural domains were largely featured, with less emphasis on the economic domain. Additionally, nutrition- and diet-related policies were in the majority. Overlaps and interactions of policies were observed in the application of the ANGELO framework. This study has provided information on national policies and programmes in Africa and can be useful as a first point of call for policymakers. The overlapping and interaction in the initiatives demonstrate the importance of multi-sectoral partnerships in providing supportive environments for healthy behaviours.

scholarly journals Individual, community and societal correlates of insecticide treated net use among pregnant women in sub-Saharan Africa: a multi-level analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Edward Kwabena Ameyaw
Keyword(s):  
Pregnant Women ◽  
Sub Saharan Africa ◽  
World Health ◽  
Health Concern ◽  
Maternal And Newborn Health ◽  
African Countries ◽  
The World ◽  
Itn Use ◽  
Multi Level ◽  
Sub Saharan

Abstract Background Malaria in pregnancy is a crucial public health concern due to the enormous risk it poses to maternal and newborn health. The World Health Organisation therefore recommends insecticide-treated net (ITN) for pregnant women. The world over, sub-Saharan Africa bears the highest prevalence of malaria and its associated complications. This study investigated the individual, community and society level factors associated with ITN use among pregnant women in sub-Saharan Africa. Methods The study was conducted with Demographic and Health Survey data of 21 sub-Saharan African countries. A total of 17,731 pregnant women who possessed ITN participated in the study. Descriptive computation of ITN use by survey country and socio-demographic characteristics was conducted. Further, five multi-level binary logistic regression models were fitted with MLwiN 3.05 package in STATA. The Markov Chain Monte Carlo (MCMC) estimation procedure was used in estimating the parameters whilst the Bayesian Deviance Information Criterion was used for the model fitness test. Results On average, 74.2% pregnant women in SSA used ITN. The highest prevalence of ITN use occurred in Mali (83.7%) whilst the least usage occurred in Namibia (7%). Women aged 30–34 were more likely to use ITN compared with those aged 45–49 [aOR = 1.14; Crl = 1.07–1.50]. Poorest women were less probable to use ITN relative to richest women [aOR = 0.79; Crl = 0.70–0.89]. Compared to women who did not want their pregnancies at all, women who wanted their pregnancies [aOR = 1.06; Crl = 1.04–1.19] were more probable to use ITN. Women in male-headed households had higher likelihood of ITN use compared to those from female-headed households [aOR = 1.28; Crl = 1.19–1.39]. On the whole, 38.1% variation in ITN use was attributable to societal level factors whilst 20.9% variation was attributable to community level factors. Conclusion The study has revealed that in addition to individual level factors, community and society level factors affect ITN use in SSA. In as much as the study points towards the need to incorporate community and societal variations in ITN interventions, active involvement of men can yield better outcome for ITN utilisation interventions in SSA.

Diuretic Drug Utilization Study

1996 ◽  
Vol 12 (4) ◽  
pp. 169-176
Author(s):  
Jaime Torelló ◽  
José A Durán ◽  
María I Serrano
Keyword(s):  
Adverse Drug Reactions ◽  
Diuretic Therapy ◽  
University Hospital ◽  
World Health ◽  
Drug Reactions ◽  
Cardiac Symptoms ◽  
Medicine Service ◽  
Combined Use ◽  
Health Organization ◽  
The University

Objective: To evaluate the present use of diuretics in our institution, and determine the appropriateness of that use and the incidence of adverse reactions and interactions. Design: This retrospective study describes the indications for use of an identified drug or combination of drugs. By the time the data were collected, some patients had been discharged or had died. Setting: The study was carried out in a referral center, the University Hospital “Virgen Macarena,” Seville, Spain. Patients: All patients receiving diuretic therapy. Those undergoing hemodialysis or receiving home care were excluded from the study. Intervention: A therapeutic audit was performed using specific standards of reference. Two models were used — one for each of the most frequent indications, ascites and congestive heart failure (CHF). Main Outcome Measures: A structured protocol gathered data on (1) demographic characteristics, (2) causes of admission and pathologic antecedents, (3) diuretic treatment, (4) basic controls (24-h diuresis and daily basal weight), (5) clinical evolution, and (6) concurrent complementary studies. The protocol included a checklist of the most frequent adverse drug reactions and interactions whose degree of causality was determined by applying the modified algorithm of Karch-Lasagna, used in the World Health Organization voluntary reporting system of adverse drug reactions. Results: One hundred twenty-six patients (16% of total admissions) received diuretic therapy. Of these, 71% were analyzed; information in the medical records was incomplete for the rest (29%). Fifty-one percent of the patients were more than 60 years old. The most frequent admission diagnoses were cardiovascular (51.5%), followed by digestive (16.7%) diseases. A total of 134 cardiac symptoms was seen in 50 patients. The most notable were acute pulmonary edema (26%), ischemic cardiopathy (12%), and cardiogenic shock (8%). Most patients receiving diuretic therapy (47.3%) were admitted to the internal medicine service. The most-prescribed diuretic was furosemide (59%), followed by spironolactone (27%). The combined use of furosemide and spironolactone occurred in all but 1 of the patients with hepatic ascites (92%), whereas in those with CHF the figure for the combined use of furosemide and spironolactone fell to 38% (p = 0.001). In 63% of the patients with ascites, the spironolactone dosage was changed in the first 48 hours of treatment. There was a high percentage of deaths (21%) in the study patients. Conclusions: Therapeutic strategy often does not follow the guidelines laid down in the standards of reference on diuretic use in serious CHF and/or ascites in this institution.

scholarly journals Real-world data-based adverse drug reactions detection from the Korea Adverse Event Reporting System databases with electronic health records-based detection algorithm

2021 ◽  
Vol 27 (3) ◽  
pp. 146045822110330
Author(s):  
Hyunah Shin ◽  
Jaehun Cha ◽  
Youngho Lee ◽  
Jong-Yeup Kim ◽  
Suehyun Lee
Keyword(s):  
Adverse Event ◽  
Adverse Drug Reactions ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
World Health ◽  
Drug Reactions ◽  
Event Reporting ◽  
Medical Databases ◽  
Electronic Health

Pharmacovigilance involves monitoring of drugs and their adverse drug reactions (ADRs) and is essential for their safety post-marketing. Because of the different types and structures of medical databases, several previous surveillance studies have analyzed only one database. In the present study, we extracted potential drug–ADR pairs from electronic health record (EHR) data using the MetaNurse algorithm and analyzed them using the Korean Adverse Event Reporting System (KAERS) database for systematic validation. The Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Adverse Reactions Terminology (WHO-ART) were mapped for signal detection. We used the Side Effect Resource (SIDER) database to select 2663 drug-ADR pairs to investigate unknown drug-induced ADRs. The reporting odds ratio (ROR) value was calculated for the drug-exposed and non-exposed groups of drug–ADR pairs, and 19 potential pairs showed significant signals. Appropriate terminology systems and criteria are needed to handle diverse medical databases.

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