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Pharmaceutics Jan 2022Pharmacovigilance is a science that involves the ongoing monitoring of adverse drug reactions to existing medicines. Traditional approaches in this field can be... (Review)
Review
Pharmacovigilance is a science that involves the ongoing monitoring of adverse drug reactions to existing medicines. Traditional approaches in this field can be expensive and time-consuming. The application of natural language processing (NLP) to analyze user-generated content is hypothesized as an effective supplemental source of evidence. In this systematic review, a broad and multi-disciplinary literature search was conducted involving four databases. A total of 5318 publications were initially found. Studies were considered relevant if they reported on the application of NLP to understand user-generated text for pharmacovigilance. A total of 16 relevant publications were included in this systematic review. All studies were evaluated to have medium reliability and validity. For all types of drugs, 14 publications reported positive findings with respect to the identification of adverse drug reactions, providing consistent evidence that natural language processing can be used effectively and accurately on user-generated textual content that was published to the Internet to identify adverse drug reactions for the purpose of pharmacovigilance. The evidence presented in this review suggest that the analysis of textual data has the potential to complement the traditional system of pharmacovigilance.
PubMed: 35213998
DOI: 10.3390/pharmaceutics14020266 -
Antidepressants and Vertebral and Hip Risk Fracture: An Updated Systematic Review and Meta-Analysis.Healthcare (Basel, Switzerland) Apr 2022Although antidepressant drugs appear to play an active role in increasing fracture risk, their weight is still unclear. We conducted a PRISMA compliant systematic review... (Review)
Review
Although antidepressant drugs appear to play an active role in increasing fracture risk, their weight is still unclear. We conducted a PRISMA compliant systematic review and meta-analysis through PubMed/Scopus/Cochrane libraries and registered with PROSPERO (registration number CRD42021254006) to investigate the relationship between antidepressant drugs categories, including SSRIs, SNRIs, and TCAs, and the risk of hip and vertebral fractures. After screening 3122 items, we finally found 26 papers for qualitative analysis and 11 for quantitative synthesis. A total of 15,209,542 adult and elderly patients were identified, with a mean follow-up of 51 months and a major prevalence of women. We identified results largely for SSRIs, with only a small amount of data for SNRIs, TCAs, and NaSSA. No data were found among the most recent categories of antidepressants, such as vortioxetine and esketamine. All included studies reported hip fractures, while three of them also included vertebral fractures. Overall, we observed a significant effect of SSRIs on fracture risk with a mean effect of 0.98 (95% CI = 0.75-1.20). This meta-analysis reveals that the use of SSRIs increases the risk of fractures. Clinicians' awareness in antidepressant prescription should optimize their potential while reducing this risk.
PubMed: 35627940
DOI: 10.3390/healthcare10050803 -
Phytotherapy Research : PTR Mar 2022This systematic review and meta-analysis were conducted to determine the effects of anthraquinone (AQ) laxatives on colorectal cancer (CRC). We searched PubMed, Embase,... (Meta-Analysis)
Meta-Analysis Review
This systematic review and meta-analysis were conducted to determine the effects of anthraquinone (AQ) laxatives on colorectal cancer (CRC). We searched PubMed, Embase, Google Scholar, and CENTRAL from inception until March 2021, for randomized controlled trials (RCTs) and observational studies. Through the systematic review, we identified 8 observational studies evaluating AQ laxatives use as a risk factor for CRC development, and 5 studies on CRC risk were included in the meta-analysis using a random-effects model. Through the meta-analysis, we found that a history of AQ laxatives use compared with "other" and "no laxatives" use was associated with CRC development (OR: 1.41; 95% CI: 0.94-2.11), although not at a statistically significant level. The possible association persists even after removal of the outlier studies (OR: 1.51; 95% CI: 0.97-2.34). Selection of cases and controls was judged at low or unclear risk of bias across almost all studies, and the quality of evidence was from moderate to low. In conclusion, it is not possible to associate the use of AQ laxatives with the development of CRC. However, the trend toward an increased risk of CRC provides a strong indication for investigating this issue by performing further high-quality studies.
Topics: Anthraquinones; Colorectal Neoplasms; Constipation; Humans; Laxatives
PubMed: 35040201
DOI: 10.1002/ptr.7373 -
BioMed Research International 2021To describe and synthesize aspects of knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting and to explore associated...
AIM
To describe and synthesize aspects of knowledge, attitudes, and practice regarding pharmacovigilance and adverse drug reaction (ADR) reporting and to explore associated barriers from a nurse perspective.
METHODS
A systematic review was conducted. Electronic databases including MEDLINE, Embase, Scopus, and Web of Knowledge from January 2010 to October 2020 were searched. Original observational studies that were written in English and which focused on nurses' knowledge, attitudes, practice, and perceived barriers regarding pharmacovigilance and ADR reporting in various healthcare settings were included.
RESULTS
Twenty-three studies published in English from 2010 to 2020 were retrieved during the search process. Overall, in the knowledge domain, the median percentages of nurses who were aware of the definitions of ADRs were 74.1%, while only 26.3% were aware of the adverse drug reaction reporting form. In the attitude domain, 84.6% of nurses believed ADR reporting to be important for patient/medicine safety and 37.1% had a fear of legal liability following ADR reporting. Although 67.1% of nurses encountered ADRs during their professional life, only 21.2% had a history of ADR reporting. In addition, lack of knowledge/training (median: 47.1%) was identified as the most common barrier in ADR reporting from a nursing viewpoint.
CONCLUSION
Despite positive nurse attitudes, knowledge and practice in relation to pharmacovigilance activities and ADR reporting did not occur regularly or often. Improving nurses' knowledge through in-service training and degree-level education and addressing the main barriers of ADR reporting may help to achieve an improved level of reporting.
Topics: Adverse Drug Reaction Reporting Systems; Attitude of Health Personnel; Health Knowledge, Attitudes, Practice; Humans; Nurses; Pharmacovigilance
PubMed: 33937402
DOI: 10.1155/2021/6630404 -
Multimedia Tools and Applications May 2023The explosion of clinical textual data has drawn the attention of researchers. Owing to the abundance of clinical data, it is becoming difficult for healthcare...
The explosion of clinical textual data has drawn the attention of researchers. Owing to the abundance of clinical data, it is becoming difficult for healthcare professionals to take real-time measures. The tools and methods are lacking when compared to the amount of clinical data generated every day. This review aims to survey the text processing pipeline with deep learning methods such as CNN, RNN, LSTM, and GRU in the healthcare domain and discuss various applications such as clinical concept detection and extraction, medically aware dialogue systems, sentiment analysis of drug reviews shared online, clinical trial matching, and pharmacovigilance. In addition, we highlighted the major challenges in deploying text processing with deep learning to clinical textual data and identified the scope of research in this domain. Furthermore, we have discussed various resources that can be used in the future to optimize the healthcare domain by amalgamating text processing and deep learning.
PubMed: 37362695
DOI: 10.1007/s11042-023-15539-y -
PloS One 2013Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU). The evidence-base of randomised... (Comparative Study)
Comparative Study Review
BACKGROUND
Adequate sedation is crucial to the management of children requiring assisted ventilation on Paediatric Intensive Care Units (PICU). The evidence-base of randomised controlled trials (RCTs) in this area is small and a trial was planned to compare midazolam and clonidine, two sedatives widely used within PICUs neither of which being licensed for that use. The application to obtain a Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) required a dossier summarising the safety profiles of each drug and the pharmacovigilance plan for the trial needed to be determined by this information. A systematic review was undertaken to identify reports relating to the safety of each drug.
METHODOLOGY/PRINCIPAL FINDINGS
The Summary of Product Characteristics (SmPC) were obtained for each sedative. The MHRA were requested to provide reports relating to the use of each drug as a sedative in children under the age of 16. Medline was searched to identify RCTs, controlled clinical trials, observational studies, case reports and series. 288 abstracts were identified for midazolam and 16 for clonidine with full texts obtained for 80 and 6 articles respectively. Thirty-three studies provided data for midazolam and two for clonidine. The majority of data has come from observational studies and case reports. The MHRA provided details of 10 and 3 reports of suspected adverse drug reactions.
CONCLUSIONS/SIGNIFICANCE
No adverse reactions were identified in addition to those specified within the SmPC for the licensed use of the drugs. Based on this information and the wide spread use of both sedatives in routine practice the pharmacovigilance plan was restricted to adverse reactions. The Clinical Trials Authorisation was granted based on the data presented in the SmPC and the pharmacovigilance plan within the clinical trial protocol restricting collection and reporting to adverse reactions.
Topics: Adolescent; Child; Child, Preschool; Clonidine; Female; Humans; Hypnotics and Sedatives; Infant; Male; Midazolam; Pharmacovigilance; Randomized Controlled Trials as Topic; Sympatholytics
PubMed: 23554852
DOI: 10.1371/journal.pone.0051787 -
Stroke Feb 2018Pharmacokinetic and prior studies on thienopyridine and proton pump inhibitors (PPI) coadministration provide conflicting data for cardiovascular outcomes, whereas there... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND PURPOSE
Pharmacokinetic and prior studies on thienopyridine and proton pump inhibitors (PPI) coadministration provide conflicting data for cardiovascular outcomes, whereas there is no established evidence on the association of concomitant use of PPI and thienopyridines with adverse cerebrovascular outcomes.
METHODS
We conducted a systematic review and meta-analysis of randomized controlled trials and cohort studies from inception to July 2017, reporting following outcomes among patients treated with thienopyridine and PPI versus thienopyridine alone (1) ischemic stroke, (2) combined ischemic or hemorrhagic stroke, (3) composite outcome of stroke, myocardial infarction (MI), and cardiovascular death, (4) MI, (5) all-cause mortality, and (6) major or minor bleeding events. After the unadjusted analyses of risk ratios, we performed additional analyses of studies reporting hazard ratios adjusted for potential confounders.
RESULTS
We identified 22 studies (12 randomized controlled trials and 10 cohort studies) comprising 131 714 patients. Concomitant use of PPI with thienopyridines was associated with increased risk of ischemic stroke (risk ratio, 1.74; 95% confidence interval [CI], 1.41-2.16; <0.001), composite stroke/MI/cardiovascular death (risk ratio, 1.14; 95% CI, 1.01-1.29; =0.04), and MI (risk ratio, 1.19; 95% CI, 1.00-1.40; =0.05). Likewise, in adjusted analyses concomitant use of PPI with thienopyridines was again associated with increased risk of stroke (hazard ratios adjusted, 1.30; 95% CI, 1.04-1.61; =0.02), composite stroke/MI/cardiovascular death (hazard ratios adjusted, 1.23; 95% CI, 1.03-1.47; =0.02), but not with MI (hazard ratios adjusted, 1.19; 95% CI, 0.93-1.52; =0.16).
CONCLUSIONS
Co-prescription of PPI and thienopyridines increases the risk of incident ischemic strokes and composite stroke/MI/cardiovascular death. Our findings corroborate the current guidelines for PPI deprescription and pharmacovigilance, especially in patients treated with thienopyridines.
Topics: Brain Ischemia; Drug Therapy, Combination; Humans; Platelet Aggregation Inhibitors; Proton Pump Inhibitors; Stroke; Thienopyridines
PubMed: 29339434
DOI: 10.1161/STROKEAHA.117.019166 -
The Pediatric Infectious Disease Journal Feb 2017Noroviruses are increasingly recognized as a major cause of sporadic and epidemic acute gastroenteritis (AGE). Although there have been multiple studies published on... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Noroviruses are increasingly recognized as a major cause of sporadic and epidemic acute gastroenteritis (AGE). Although there have been multiple studies published on norovirus epidemiology in Latin America, no comprehensive assessment of the role of norovirus has been conducted in the region. We aim to estimate the role of norovirus in the Latin American region through a systematic review and meta-analysis of the existing literature.
METHODS
We carried out a literature search in MEDLINE, SciELO and LILACS. We included papers that provided information on the prevalence or incidence of norovirus (including seroprevalence studies and outbreaks), with a recruitment and/or follow-up period of at least 12 months and where the diagnosis of norovirus was confirmed by reverse transcription polymerase chain reaction. The data were pooled for meta-analysis to estimate the prevalence of norovirus AGE and norovirus asymptomatic infection with 95% confidence intervals (CIs).
RESULTS
Thirty-eight studies were included in the review. Overall, the prevalence of norovirus among AGE cases was 15% (95% CI: 13-18). By location, it was 15% in the community (95% CI: 11%-21%), 14% in outpatient settings (95% CI: 10%-19%) and 16% in hospital locations (95% CI: 12%-21%). The prevalence of norovirus among asymptomatic subjects was 8% (95% CI: 4-13). Norovirus GII.4 strains were associated with 37%-100% of norovirus AGE cases, but only 7% of norovirus asymptomatic detections.
CONCLUSIONS
Noroviruses are associated with almost 1 out of every 6 hospitalizations because of acute diarrhea in children younger than 5 years of age in Latin America.
Topics: Caliciviridae Infections; Child; Child, Preschool; Diarrhea; Disease Outbreaks; Gastroenteritis; Humans; Infant; Infant, Newborn; Latin America; Norovirus; Seroepidemiologic Studies
PubMed: 27755462
DOI: 10.1097/INF.0000000000001369 -
Therapeutic Innovation & Regulatory... Sep 2022In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing... (Review)
Review
BACKGROUND
In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries' PV systems' performance.
METHODS
EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries' PV performance.
RESULTS
Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range: 0-26). Higher average scores were obtained in the 'Core' (9.27/27) compared to 'Complementary' (5.59/36) indicators. Overall performance for 'Process' and 'Outcome' indicators was lower than that of 'Structural'.
CONCLUSION
This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance.
Topics: Data Collection; Developing Countries; Pharmacovigilance; World Health Organization
PubMed: 35657484
DOI: 10.1007/s43441-022-00415-y -
British Journal of Clinical Pharmacology Feb 2017Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current... (Review)
Review
AIMS
Current trends in pharmacovigilance systems are veering towards patient involvement in spontaneous reporting of adverse drug reactions (ADRs). The aim of the current systematic review was to identify what is known and what remains unknown with respect to patient reporting to pharmacovigilance systems.
METHODS
A systematic literature search was conducted in PubMed, CINAHL, Journals@Ovid and the Cochrane Library. Studies were included if they contained: (i) reviews about patient reporting; (ii) evaluation of patient reports to national or supranational pharmacovigilance authorities; (iii) a comparison between patient and healthcare professional (HCP) reports submitted to pharmacovigilance authorities; and (iv) surveys of patient experiences, opinions and awareness about reporting ADRs. The methodological quality of the studies was assessed according to principles of Grading of Recommendations, Assessment, Development and Evaluations (GRADE).
RESULTS
A total of thirty four studies were included. Five of the studies were reviews (two of which systematic reviews), fourteen retrospective observational studies, nine surveys and six applied mixed research methods. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with HCP reporting. In addition, patients describe the severity and impact of ADRs on daily life, complementing information derived from HCPs. Patient reporting is relatively rare in most countries.
CONCLUSIONS
Patient reporting adds new information, and perspective about ADRs in a way otherwise unavailable. This can contribute to better decision-making processes in regulatory activities. The present review identified gaps in knowledge that should be addressed to improve our understanding of the full potential and drawbacks of patient reporting.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Health Personnel; Humans; Patient Participation; Pharmacovigilance; Self Report
PubMed: 27558545
DOI: 10.1111/bcp.13098