-
Turkish Journal of Pharmaceutical... Jul 2023Adverse drug reactions (ADRs) are a prominent cause of morbidity and mortality and higher healthcare expenditures. Healthcare professionals (HCPs) play a crucial role in...
Adverse drug reactions (ADRs) are a prominent cause of morbidity and mortality and higher healthcare expenditures. Healthcare professionals (HCPs) play a crucial role in ADR reporting through spontaneous reporting systems, but under-reporting is their major limitation. The goal of this study is to evaluate HCPs' knowledge, attitude, and practice regarding ADR reporting as well as the factors that influence reporting using research papers that are currently available. A literature search was conducted using sources such as PubMed, Scopus, and Google Scholar to find studies that evaluated HCPs' knowledge, attitudes, and practices regarding ADRs reporting in Ethiopia. A standard procedure of systematic review protocol was used to conduct this review. Demographic factors, sample size, response rate, survey delivery, HCP working setting, and encouraging and discouraging factors of ADR reporting were extracted from articles. A total of 17 articles were included in the systematic review out of 384. The number of HCPs in the included studies ranged from 62 to 708. Response rate ranges from 76.1% to 100%. Most of the research included in this evaluation looked at HCPs, who worked in hospitals. When pharmacists were compared to other HCPs, they were more likely to report ADRs; because they had higher knowledge, attitude, and practice. Lack of understanding, unavailability of reporting forms, uncertainty about the causal relationship between the drug and ADR, and failure to report because the ADR was well known were among the common hurdles to ADR reporting identified in research. To improve reporting, educational initiatives and continued training in pharmacovigilance and ADRs are frequently recommended considerations. In Ethiopia, there is a pressing need to close the gap in HCP knowledge, attitudes, and practice regarding PV and ADR reporting. To address this point, specific educational interventions based on existing gaps in ADR reporting should be developed and integrated into the health education curriculum or provided as in-service training after graduation.
PubMed: 37417202
DOI: 10.4274/tjps.galenos.2022.28034 -
European Cardiology 2024Low-dose aspirin lowers cardiovascular event risk; dual-pathway inhibition (DPI) using low-dose aspirin with low-dose rivaroxaban may reduce this risk further. A... (Review)
Review
Dual-pathway Inhibition with Low-dose Aspirin and Rivaroxaban versus Aspirin Monotherapy in Patients with Coronary Artery Disease and Peripheral Artery Disease: Systematic Literature Review and Meta-analysis.
BACKGROUND
Low-dose aspirin lowers cardiovascular event risk; dual-pathway inhibition (DPI) using low-dose aspirin with low-dose rivaroxaban may reduce this risk further. A systematic literature review and meta-analysis compared the efficacy, safety and net clinical benefit (NCB) of DPI with aspirin.
METHODS
PubMed and Embase were searched for randomised controlled trials reporting clinical efficacy, safety and NCB of DPI compared with aspirin alone in patients with coronary artery disease (CAD) and/or peripheral artery disease. Six articles representing four trials were included.
RESULTS
DPI versus aspirin alone significantly reduced major adverse cardiovascular events (HR 0.77; 95% CI [0.69-0.87]; p<0.01), increased International Society on Thrombosis and Haemostasis major bleeding events (HR 1.67; 95% CI [1.37-2.02]; p<0.01) and resulted in a significant NCB (HR 0.79; 95% CI [0.70-0.90]; p<0.01).
CONCLUSION
These results underscore the potential benefit of DPI in patients with CAD, including those in the immediate post-acute coronary syndrome stage and with established CAD, as well as patients with peripheral artery disease.
PubMed: 38708371
DOI: 10.15420/ecr.2023.40 -
Clinical Reviews in Allergy & Immunology Apr 2024An acute aseptic meningitis has been occasionally observed on intravenous polyclonal human immunoglobulin therapy. Since case reports cannot be employed to draw... (Meta-Analysis)
Meta-Analysis Review
An acute aseptic meningitis has been occasionally observed on intravenous polyclonal human immunoglobulin therapy. Since case reports cannot be employed to draw inferences about the relationships between immunoglobulin therapy and meningitis, we conducted a systematic review and meta-analysis of the literature. Eligible were cases, case series, and pharmacovigilance studies. We found 71 individually documented cases (36 individuals ≤ 18 years of age) of meningitis. Ninety percent of cases presented ≤ 3 days after initiating immunoglobulin therapy and recovered within ≤ 7 days (with a shorter disease duration in children: ≤ 3 days in 29 (94%) cases). In 22 (31%) instances, the authors noted a link between the onset of meningitis and a rapid intravenous infusion of immunoglobulins. Cerebrospinal fluid analysis revealed a predominantly neutrophilic (N = 46, 66%) pleocytosis. Recurrences after re-exposure were observed in eight (N = 11%) patients. Eight case series addressed the prevalence of meningitis in 4089 patients treated with immunoglobulins. A pooled prevalence of 0.6% was noted. Finally, pharmacovigilance data revealed that meningitis temporally associated with intravenous immunoglobulin therapy occurred with at least five different products. In conclusion, intravenous immunoglobulin may cause an acute aseptic meningitis. The clinical features remit rapidly after discontinuing the medication.
Topics: Humans; Meningitis, Aseptic; Immunoglobulins, Intravenous; Acute Disease; Child; Adolescent; Pharmacovigilance; Child, Preschool; Immunization, Passive
PubMed: 38739354
DOI: 10.1007/s12016-024-08989-1 -
BMJ Medicine 2023To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms...
OBJECTIVE
To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of serious adverse events in drug trials published on PubMed versus clinical trial summaries on ClinicalTrials.gov.
DESIGN
Systematic review.
DATA SOURCES
PubMed and ClinicalTrials.gov registries were searched from 1 December 2019 to 17 February 2022.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Randomised clinical trials evaluating the efficacy and safety of drugs used to treat covid-19 disease in participants of all ages with suspected, probable, or confirmed SARS-CoV-2 infection were included. Clinical trials were screened on title, abstract, and text by two authors independently. Only articles published in French and English were selected. The Cochrane risk of bias tool for randomised trials (RoB 2) was used to assess risk of bias.
RESULTS
The search strategy identified 1962 randomised clinical trials assessing the efficacy and safety of drugs used to treat covid-19, published in the PubMed database; 1906 articles were excluded after screening and 56 clinical trials were included in the review. Among the 56 clinical trials, no study had a high score for quality of reporting of adverse events, 60.7% had a moderate score, 33.9% had a low score, and 5.4% had a very low score. All clinical trials with a very low score for quality of reporting of adverse events were randomised open label trials. For reporting of serious adverse events, journal articles published on PubMed under-reported 51% of serious adverse events compared with clinical trial summaries published on ClinicalTrials.gov.
CONCLUSIONS
In one in three published clinical trials on covid-19 drugs, the quality of reporting of adverse events was low or very low. Differences were found in the number of serious adverse events reported in journal articles versus clinical trial summaries. During the covid-19 pandemic, risk assessment of drugs in clinical trials of covid-19 drugs did not comply with good practice recommendations for publication of results.
SYSTEMATIC REVIEW REGISTRATION
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) EUPAS45959.
PubMed: 37779893
DOI: 10.1136/bmjmed-2022-000352 -
Vaccine: X Jun 2024The GAIA (Global Alignment on Immunisation Safety Assessment in Pregnancy) consortium was established in 2014 with the aim of creating a standardised, globally... (Review)
Review
INTRODUCTION
The GAIA (Global Alignment on Immunisation Safety Assessment in Pregnancy) consortium was established in 2014 with the aim of creating a standardised, globally coordinated approach to monitoring the safety of vaccines administered in pregnancy. The consortium developed twenty-six standardised definitions for classifying obstetric and infant adverse events. This systematic review sought to evaluate the current state of adverse event reporting in maternal vaccine trials following the publication of the case definitions by GAIA, and the extent to which these case definitions have been adopted in maternal vaccine safety research.
METHODS
A comprehensive search of published literature was undertaken to identify maternal vaccine research studies. PubMed, EMBASE, Web of Science, and Cochrane were searched using a combination of MeSH terms and keyword searches to identify observational or interventional studies that examined vaccine safety in pregnant women with a comparator group. A two-reviewer screening process was undertaken, and a narrative synthesis of the results presented.
RESULTS
14,737 titles were identified from database searches, 435 titles were selected as potentially relevant, 256 were excluded, the remaining 116 papers were included. Influenza vaccine was the most studied (25.0%), followed by TDaP (20.7%) and SARS-CoV-2 (12.9%).Ninety-one studies (78.4%) were conducted in high-income settings. Forty-eight (41.4%) utilised electronic health-records. The majority focused on reporting adverse events of special interest (AESI) in pregnancy (65.0%) alone or in addition to reactogenicity (27.6%). The most frequently reported AESI were preterm birth, small for gestational age and hypertensive disorders. Fewer than 10 studies reported use of GAIA definitions. Gestational age assessment was poorly described; of 39 studies reporting stillbirths 30.8% provided no description of the gestational age threshold.
CONCLUSIONS
Low-income settings remain under-represented in comparative maternal vaccine safety research. There has been poor uptake of GAIA case definitions. A lack of harmonisation and standardisation persists limiting comparability of the generated safety data.
PubMed: 38495929
DOI: 10.1016/j.jvacx.2024.100464 -
Health Economics Review Feb 2024Adverse drug events (ADEs) are not only a safety and quality of care issue for patients, but also an economic issue with significant costs. Because they often occur... (Review)
Review
BACKGROUND
Adverse drug events (ADEs) are not only a safety and quality of care issue for patients, but also an economic issue with significant costs. Because they often occur during hospital stays, it is necessary to accurately quantify the costs of ADEs. This review aimed to investigate the methods to calculate these costs, and to characterize their nature.
METHODS
A systematic literature review was conducted to identify methods used to assess the cost of ADEs on Medline, Web of Science and Google Scholar. Original articles published from 2017 to 2022 in English and French were included. Economic evaluations were included if they concerned inpatients.
RESULTS
From 127 studies screened, 20 studies were analyzed. There was a high heterogeneity in nature of costs, methods used, values obtained, and time horizon chosen. A small number of studies considered non-medical (10%), indirect (20%) and opportunity costs (5%). Ten different methods for assessing the cost of ADEs have been reported and nine studies did not explain how they obtained their values.
CONCLUSIONS
There is no consensus in the literature on how to assess the costs of ADEs, due to the heterogeneity of contexts and the choice of different economic perspectives. Our study adds a well-deserved overview of the existing literature that can be a solid lead for future studies and method implementation.
TRIAL REGISTRATION
PROSPERO registration CRD42023413071.
PubMed: 38329561
DOI: 10.1186/s13561-024-00481-y -
Health Science Reports Dec 2023The reliability of interferon-gamma-release-assays (IGRAs) for tuberculosis (TB) testing in coronavirus disease 2019 (COVID-19) patients is unknown. This study aimed to...
BACKGROUND AND AIMS
The reliability of interferon-gamma-release-assays (IGRAs) for tuberculosis (TB) testing in coronavirus disease 2019 (COVID-19) patients is unknown. This study aimed to systematically review the prevalence of indeterminate TB-IGRA following SARS-CoV-2 infection or vaccination and to review associated factors.
METHODS
This systematic literature review was guided according to the PRISMA guidelines by searching PubMed, Scopus, Web of Science, Clinicalkey, and Cochrane Library. Studies reporting results of TB-IGRA tests (QuantiFERON [QFT]-TB, T-SPOT.TB) in COVID-19 patients or vaccines were included. The random effects model was used to assess the prevalence of indeterminate IGRA results. Heterogeneity was evaluated using the and 95% predictive interval.
RESULTS
Of the 273 citations screened, 12 articles were included in the final analysis including a total of 2107 patients. The overall pooled effect size proportion of indeterminate QFT-TB results, estimated in eight studies using the QFT-TB Plus assay, was 0.26 (95% CI: 0.205-0.324, = 0.158). The mean true effect size was 0.26 (95% predictive interval: [0.110-0.500]). A subgroup analysis was not undertaken due to the small number of studies. Indeterminate QFT-TB rates were associated with COVID-19 severity, steroid treatment, inflammation-related parameters, neutrophilia, and lymphopenia.
CONCLUSION
Indeterminate QFT-TB results in COVID-19 patients occur in almost one-quarter of tests performed. Further studies are needed to assess associated factors.
PubMed: 38130328
DOI: 10.1002/hsr2.1695 -
Journal of Anesthesia, Analgesia and... Apr 2024Propofol is the most commonly used hypnotic agent used during sedation and general anesthesia (GA) practice, offering faster recovery compared to benzodiazepines.... (Review)
Review
BACKGROUND
Propofol is the most commonly used hypnotic agent used during sedation and general anesthesia (GA) practice, offering faster recovery compared to benzodiazepines. However, cardiovascular impact of propofol and pain at injection are commonly encountered side effects. Ciprofol is a novel disubstituted phenol derivative, and there is growing evidence regarding its clinical use.
METHODS
We conducted a systematic literature search (updated on 23 July 2023) to evaluate safety and efficacy of ciprofol in comparison to propofol in patients undergoing procedures under sedation or GA. We focused on randomized controlled trials (RCTs) only, extrapolating data on onset and offset, and on the side effects and the pain at injection.
RESULTS
The search revealed 14 RCTs, all conducted in China. Eight RCTs studied patients undergoing sedation, and six focused on GA. Bolus of ciprofol for sedation or induction of GA varied from 0.2 to 0.5 mg/kg. In four studies using ciprofol for maintenance of GA, it was 0.8-2.4 mg/kg/h. Ciprofol pharmacokinetics seemed characterized by slower onset and offset as compared to propofol. Pain during injection was less frequent in the ciprofol group in all the 13 studies reporting it. Eight studies reported "adverse events" as a pooled outcome, and in five cases, the incidence was higher in the propofol group, not different in the remaining ones. Occurrence of hypotension was the most commonly investigated side effects, and it seemed less frequent with ciprofol.
CONCLUSION
Ciprofol for sedation or GA may be safer than propofol, though its pharmacokinetics may be less advantageous.
PubMed: 38589912
DOI: 10.1186/s44158-024-00159-1 -
Thrombosis and Haemostasis Apr 2024For the treatment of von Willebrand disease (VWD), von Willebrand factor (VWF) concentrates can be used in on-demand, long-term prophylaxis, and surgical prophylaxis...
BACKGROUND
For the treatment of von Willebrand disease (VWD), von Willebrand factor (VWF) concentrates can be used in on-demand, long-term prophylaxis, and surgical prophylaxis regimens.
METHODS
This systematic literature review was conducted to evaluate the efficacy, consumption, and safety of plasma-derived human coagulation FVIII/human VWF (pdVWF/FVIII; Voncento/Biostate) for the treatment of patients with any inherited VWD type. An electronic search was conducted in MEDLINE and Cochrane Library databases on VWD therapies. All retrieved publications were assessed against predefined inclusion/exclusion criteria following the Cochrane group recommendations. Associated pharmacovigilance data were collected across the same time period.
RESULTS
Eleven publications from eight study cohorts were identified for data retrieval. All were from multicenter studies and included both pediatric and adult patients. Eight publications included evaluations of the efficacy of pdVWF/FVIII for on-demand treatment, eight included long-term prophylactic treatment, and eight included surgical prophylaxis. Treatment protocols and VWF administration methods differed between studies, as did safety evaluations. The clinical response was rated as excellent/good for on-demand treatment in 66 to 100% of nonsurgical bleeds, 89 to 100% in the treatment of breakthrough bleeds during long-term prophylaxis treatment, and hemostatic efficacy in surgical procedures was 75 to 100%. Pharmacovigilance data confirmed a low incidence of adverse events in treated patients.
CONCLUSION
This review provides a comprehensive summary of studies that evaluated the use of pdVWF/FVIII in VWD demonstrating the long-term effectiveness and safety of this pdVWF/FVIII across all ages, types of VWD, and treatment settings.
PubMed: 38272065
DOI: 10.1055/a-2253-9701 -
Infectious Diseases and Therapy Apr 2024Estimating the burden of lower respiratory tract infections (LRTIs) increasingly relies on administrative databases using International Classification of Diseases (ICD)... (Review)
Review
INTRODUCTION
Estimating the burden of lower respiratory tract infections (LRTIs) increasingly relies on administrative databases using International Classification of Diseases (ICD) codes, but no standard methodology exists. We defined best practices for ICD-based algorithms that estimate LRTI incidence in adults.
METHODS
We conducted a systematic review of validation studies assessing the use of ICD code-based algorithms to identify hospitalized LRTIs in adults, published in Medline, EMBASE, and LILACS between January 1996 and January 2022, according to PRISMA guidelines. We assessed sensitivity, specificity, and other accuracy measures of different algorithms.
RESULTS
We included 26 publications that used a variety of ICD code-based algorithms and gold standard criteria, and 18 reported sensitivity and/or specificity. Sensitivity was below 80% in 72% (38/53) of algorithms and specificity exceeded 90% in 77% (37/48). Algorithms for all-cause LRTI (n = 18) that included only pneumonia codes in primary position (n = 3) had specificity greater than 90% but low sensitivity (55-72%). Sensitivity increased by 5-15%, with minimal loss in specificity, with the addition of primary codes for severe pneumonia (e.g. sepsis) while pneumonia codes were in secondary position, and by 13% with codes from LRTI-related infections (e.g. viral) or other respiratory diseases (e.g. empyema). Sensitivity increased by 8% when pneumonia codes were in any position, but specificity was not reported. In hospital-acquired pneumonia and pneumococcal-specific pneumonia, algorithms containing only nosocomial- or pathogen-specific ICD codes had poor sensitivity, which improved when broader pneumonia codes were added, in particular codes for unspecified organisms.
CONCLUSION
Our systematic review highlights that most ICD code-based algorithms are relatively specific, but miss a substantial number of hospitalized LRTI adult cases. Best practices to estimate LRTI incidence in this population include the use of all pneumonia ICD codes for any LRTI outcome and, to a lesser extent, those for other LRTI-related infections or respiratory diseases.
PubMed: 38498108
DOI: 10.1007/s40121-024-00949-8