Knowledge, attitude and practice among consumers about adverse drug reaction reporting

Background: Background: Adverse Drug Reaction (ADR) reporting by consumers is quite low in India. Assessing knowledge and attitude of consumers regarding ADR reporting and observing practice of ADR reporting among them can help explore probable causes for underreporting of ADRs by consumers.Methods: This was a cross-sectional study conducted in a tertiary care teaching hospital using investigator-administered questionnaire and interviewing indoor patients of Surgery, Medicine, Obstetrics & Gynaecology and Dermatology departments. The questionnaire was prepared to assess knowledge, attitude and practice of consumers about ADR reporting. Data was analysed using mean, standard deviation and percentages.Result: A total of 820 consumers of medicines were included. It was found that 32.2% consumers were not aware that a drug can produce adverse effects. After being explained about adverse drug reactions, 94.6% consumers felt that adverse drug reactions should be reported. However, 98.8% consumers were not aware of Pharmacovigilance Programme of India. After consulting about consumer reporting programme, majority of respondents (96.1%) felt that the direct consumer reporting programme helps reporting of ADRs. Moreover, 93.7% of consumers were willing to use it to report ADRs in future. Consumers preferred the Telephonic method with a Toll free number for ADR reporting followed by informing a health care professional.Conclusion: Poor knowledge and awareness about ADR reporting is the major factor for low to nearly absent ADR reporting by consumers in India

Prescribing pattern of analgesics used for postoperative pain and its correlate with patient and doctor satisfaction:

Background: Post operative pain is difficult to assessment and its management has been neglected at times. Moreover, the drug treatment involves administration of drug on as and when basis which leads to inadequate control. Methods: This observational, prospective study was conducted in 100 post-operative patients i.e., 50 each from surgery and orthopedics departments. Investigator enrolled post-operative patients within 24 hours of surgery and followed them for next 5 days or till hospital discharge, whichever was earlier. Analgesic prescribing pattern, self-assessment of pain, patient and doctor satisfaction using ASSIST questionnaire were recorded in Case Record Form and analysed. Results: Out of 100 patients, average number of analgesics prescribed post-operatively was 1.49±0.5 (baseline and all follow-up). 76.5% patients received NSAIDs which included diclofenac (44.29%) and paracetamol (30.87%). Opioids in the form of tramadol were prescribed in 23.49% patients. Mean least pain experienced by patients on day 1 was 2±0.75 which decreased to 1.32±0.63 on day 5. Mean worst pain decreased from 6.64±1.43 on day 1 to 3.38±1.17 on day 5. Average percentage of duration of severe pain was 35.2%±16.48 on day 1 which successively decreased to 16.32±8.26 on day 5. Average pain relief observed in 62.3% patients on day one increased to 80.88% on day 5. Patient satisfaction increased as pain score decreased (r=-0.73) and a strong positive correlation was observed between doctor satisfaction and patient satisfaction (r=0.91). Conclusions: Inadequate control of post-operative pain affects effective patient management and recovery. Incorporation of effective pain assessment scores in pain management is desirable

An evaluation of the technique of use of metered dose inhaler administration in bronchial asthma children

Background: Inadequate understanding and performance of drug administration using metered-dose inhaler (MDI) in paediatric population affects therapeutic outcome. Hence, this study aimed to evaluate the impact of two educational interventional methods for usage of MDI in paediatric patients of bronchial asthma.Methods: This prospective, interventional study was done in paediatric asthma patients who were prescribed drugs with (MDI) with/without spacer at outpatient department of pediatrics. Patients were divided in group A (video) or group B (leaflet) as per random table method and method to use MDI was assessed by using checklist as per WHO guide to good prescribing at baseline. Investigator taught the technique by a video (group A) and leaflet (group B) to the selected population. Patients were followed up after 15 days and assessed for use of MDI using the same checklist. Data were analysed by using paired and unpaired ‘t’-test.Results: A total of 100 pediatric asthma patients were included in study group A (50) and group B (50). The average no. of steps (WHO checklist) followed was significantly improved at post intervention in both group A (with spacer, p<0.0001) as well as B (without spacer, p<0.05). Although average no. of steps followed were more in group A, no significant difference was found between two groups after intervention.Conclusions: As video is an audio-visual method of demonstration, and hence help us memorise the step of inhalational technique in pediatric patients. Repeated demonstration/education to patients/caregivers may improve the method of MDI usage

An intensive monitoring of adverse drug reactions in pediatric hospitalized patients of a tertiary care hospital

Background: Children are at a higher risk of therapeutic failure due to major difference in pharmacokinetic, pharmacodynamics of drugs, off-label use and divergence of their illness from adult. The safety of drugs used in adult patients cannot be extrapolated to a pediatric age group. Hence, this study aimed to evaluate the incidence and overall pattern of adverse drug reactions in pediatric patients hospitalized in pediatric wards at a tertiary care hospital in India.Methods: Pediatric patients up to 12 years hospitalized in two randomly selected pediatric units were enrolled and followed up daily till discharge. Detailed information of patients and ADRs (adverse drug reactions) if any were recorded from case records. ADRs were assessed for incidence, onset, duration, management, outcome, causality, severity, preventability, seriousness and risk factors. Appropriateness of drug treatment in patients with ADRs was analyzed using Phadke’s criteria. Data was analyzed using student’s t test, ANOVA and Chi square test.Results: A total of 700 patients were enrolled (mean age 3.95±0.12 years). A total of 66 ADRs observed in 58 patients. Intravenous (70.4%) being most common route for ADRs. The incidence of ADRs was 8.28%. Majority of ADRs occurred within 1 day, commonly affected skin and appendages followed by (28.78%), GI (25.75%) ADRs were frequently associated with antimicrobials (69.38%) and vaccines and sera (12.24%). Majority of reactions were mild (56%%), non-serious (77.2%), not preventable (95.4%), recovered completely at discharge (83.33%) and had possible (77.2%) causal association with suspect drug. Age group 0-3 years and prescription of ≥5 drugs were risk factors for occurrence of ADRs. Semi rational drug therapy was observed in 65.5% patients.Conclusions: Clinicians should be vigilant regarding occurrence of ADRs in pediatrics especially during the first week of hospitalization. Risk factors like 0-3 years of age and multiple drugs should be taken into consideration during treatment of these patients to help minimize adverse drug reactions

An Optimized Cell-Based Assay To Assess Influenza Virus Replication by Measuring Neuraminidase Activity and Its Applications for Virological Surveillance

Year-round virological characterization of circulating epidemic influenza viruses is conducted worldwide to detect the emergence of viruses that may escape pre-existing immunity or acquire resistance to antivirals. High throughput phenotypic assays are needed to complement the sequence-based analysis of circulating viruses and improve pandemic preparedness. The recent entry of a polymerase inhibitor, baloxavir, into the global market further highlighted this need. Here, we optimized a cell-based assay that considerably streamlines antiviral and antigenic testing by replacing lengthy immunostaining and imaging procedures used in current assay with measuring the enzymatic activity of nascent neuraminidase (NA) molecules expressed on the surface of virus-infected cells. For convenience, this new assay was named IRINA (Influenza Replication Inhibition Neuraminidase-based Assay). IRINA was successfully validated to assess inhibitory activity of baloxavir on virus replication by testing a large set (\u3e150) of influenza A and B viruses, including drug resistant strains and viruses collected during 2017–2022. To test its versatility, IRINA was utilized to evaluate neutralization activity of a broadly reactive human anti-HA monoclonal antibody, FI6, and post-infection ferret antisera, as well as the inhibition of NA enzyme activity by NA inhibitors. Performance of IRINA was tested in parallel using respective conventional assays. IRINA offers an attractive alternative to current phenotypic assays, while maintaining reproducibility and high throughput capacity. Additionally, the improved turnaround time may prove to be advantageous when conducting time sensitive studies, such as investigating a new virus outbreak. This assay can meet the needs of surveillance laboratories by providing a streamlined and cost-effective approach for virus characterization

Relations between lipoprotein(a) concentrations, LPA genetic variants, and the risk of mortality in patients with established coronary heart disease: a molecular and genetic association study

Background: Lipoprotein(a) concentrations in plasma are associated with cardiovascular risk in the general population. Whether lipoprotein(a) concentrations or LPA genetic variants predict long-term mortality in patients with established coronary heart disease remains less clear. Methods: We obtained data from 3313 patients with established coronary heart disease in the Ludwigshafen Risk and Cardiovascular Health (LURIC) study. We tested associations of tertiles of lipoprotein(a) concentration in plasma and two LPA single-nucleotide polymorphisms ([SNPs] rs10455872 and rs3798220) with all-cause mortality and cardiovascular mortality by Cox regression analysis and with severity of disease by generalised linear modelling, with and without adjustment for age, sex, diabetes diagnosis, systolic blood pressure, BMI, smoking status, estimated glomerular filtration rate, LDL-cholesterol concentration, and use of lipid-lowering therapy. Results for plasma lipoprotein(a) concentrations were validated in five independent studies involving 10 195 patients with established coronary heart disease. Results for genetic associations were replicated through large-scale collaborative analysis in the GENIUS-CHD consortium, comprising 106 353 patients with established coronary heart disease and 19 332 deaths in 22 studies or cohorts. Findings: The median follow-up was 9·9 years. Increased severity of coronary heart disease was associated with lipoprotein(a) concentrations in plasma in the highest tertile (adjusted hazard radio [HR] 1·44, 95% CI 1·14–1·83) and the presence of either LPA SNP (1·88, 1·40–2·53). No associations were found in LURIC with all-cause mortality (highest tertile of lipoprotein(a) concentration in plasma 0·95, 0·81–1·11 and either LPA SNP 1·10, 0·92–1·31) or cardiovascular mortality (0·99, 0·81–1·2 and 1·13, 0·90–1·40, respectively) or in the validation studies. Interpretation: In patients with prevalent coronary heart disease, lipoprotein(a) concentrations and genetic variants showed no associations with mortality. We conclude that these variables are not useful risk factors to measure to predict progression to death after coronary heart disease is established. Funding: Seventh Framework Programme for Research and Technical Development (AtheroRemo and RiskyCAD), INTERREG IV Oberrhein Programme, Deutsche Nierenstiftung, Else-Kroener Fresenius Foundation, Deutsche Stiftung für Herzforschung, Deutsche Forschungsgemeinschaft, Saarland University, German Federal Ministry of Education and Research, Willy Robert Pitzer Foundation, and Waldburg-Zeil Clinics Isny

Interaction of Temperature and Light in the Development of Freezing Tolerance in Plants

Abstract Freezing tolerance is the result of a wide range of physical and biochemical processes, such as the induction of antifreeze proteins, changes in membrane composition, the accumulation of osmoprotectants, and changes in the redox status, which allow plants to function at low temperatures. Even in frost-tolerant species, a certain period of growth at low but nonfreezing temperatures, known as frost or cold hardening, is required for the development of a high level of frost hardiness. It has long been known that frost hardening at low temperature under low light intensity is much less effective than under normal light conditions; it has also been shown that elevated light intensity at normal temperatures may partly replace the cold-hardening period. Earlier results indicated that cold acclimation reflects a response to a chloroplastic redox signal while the effects of excitation pressure extend beyond photosynthetic acclimation, influencing plant morphology and the expression of certain nuclear genes involved in cold acclimation. Recent results have shown that not only are parameters closely linked to the photosynthetic electron transport processes affected by light during hardening at low temperature, but light may also have an influence on the expression level of several other cold-related genes; several cold-acclimation processes can function efficiently only in the presence of light. The present review provides an overview of mechanisms that may explain how light improves the freezing tolerance of plants during the cold-hardening period

Genomic Hypomethylation in the Human Germline Associates with Selective Structural Mutability in the Human Genome

The hotspots of structural polymorphisms and structural mutability in the human genome remain to be explained mechanistically. We examine associations of structural mutability with germline DNA methylation and with non-allelic homologous recombination (NAHR) mediated by low-copy repeats (LCRs). Combined evidence from four human sperm methylome maps, human genome evolution, structural polymorphisms in the human population, and previous genomic and disease studies consistently points to a strong association of germline hypomethylation and genomic instability. Specifically, methylation deserts, the ∼1% fraction of the human genome with the lowest methylation in the germline, show a tenfold enrichment for structural rearrangements that occurred in the human genome since the branching of chimpanzee and are highly enriched for fast-evolving loci that regulate tissue-specific gene expression. Analysis of copy number variants (CNVs) from 400 human samples identified using a custom-designed array comparative genomic hybridization (aCGH) chip, combined with publicly available structural variation data, indicates that association of structural mutability with germline hypomethylation is comparable in magnitude to the association of structural mutability with LCR–mediated NAHR. Moreover, rare CNVs occurring in the genomes of individuals diagnosed with schizophrenia, bipolar disorder, and developmental delay and de novo CNVs occurring in those diagnosed with autism are significantly more concentrated within hypomethylated regions. These findings suggest a new connection between the epigenome, selective mutability, evolution, and human disease

Effectiveness of Mechanisms and Models of Coordination between Organizations, Agencies and Bodies Providing or Financing Health Services in Humanitarian Crises: A Systematic Review.

BACKGROUND: Effective coordination between organizations, agencies and bodies providing or financing health services in humanitarian crises is required to ensure efficiency of services, avoid duplication, and improve equity. The objective of this review was to assess how, during and after humanitarian crises, different mechanisms and models of coordination between organizations, agencies and bodies providing or financing health services compare in terms of access to health services and health outcomes. METHODS: We registered a protocol for this review in PROSPERO International prospective register of systematic reviews under number PROSPERO2014:CRD42014009267. Eligible studies included randomized and nonrandomized designs, process evaluations and qualitative methods. We electronically searched Medline, PubMed, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL, PsycINFO, and the WHO Global Health Library and websites of relevant organizations. We followed standard systematic review methodology for the selection, data abstraction, and risk of bias assessment. We assessed the quality of evidence using the GRADE approach. RESULTS: Of 14,309 identified citations from databases and organizations' websites, we identified four eligible studies. Two studies used mixed-methods, one used quantitative methods, and one used qualitative methods. The available evidence suggests that information coordination between bodies providing health services in humanitarian crises settings may be effective in improving health systems inputs. There is additional evidence suggesting that management/directive coordination such as the cluster model may improve health system inputs in addition to access to health services. None of the included studies assessed coordination through common representation and framework coordination. The evidence was judged to be of very low quality. CONCLUSION: This systematic review provides evidence of possible effectiveness of information coordination and management/directive coordination between organizations, agencies and bodies providing or financing health services in humanitarian crises. Our findings can inform the research agenda and highlight the need for improving conduct and reporting of research in this field

Fluid challenges in intensive care: the FENICE study A global inception cohort study

Fluid challenges (FCs) are one of the most commonly used therapies in critically ill patients and represent the cornerstone of hemodynamic management in intensive care units. There are clear benefits and harms from fluid therapy. Limited data on the indication, type, amount and rate of an FC in critically ill patients exist in the literature. The primary aim was to evaluate how physicians conduct FCs in terms of type, volume, and rate of given fluid; the secondary aim was to evaluate variables used to trigger an FC and to compare the proportion of patients receiving further fluid administration based on the response to the FC.This was an observational study conducted in ICUs around the world. Each participating unit entered a maximum of 20 patients with one FC.2213 patients were enrolled and analyzed in the study. The median [interquartile range] amount of fluid given during an FC was 500 ml (500-1000). The median time was 24 min (40-60 min), and the median rate of FC was 1000 [500-1333] ml/h. The main indication for FC was hypotension in 1211 (59 %, CI 57-61 %). In 43 % (CI 41-45 %) of the cases no hemodynamic variable was used. Static markers of preload were used in 785 of 2213 cases (36 %, CI 34-37 %). Dynamic indices of preload responsiveness were used in 483 of 2213 cases (22 %, CI 20-24 %). No safety variable for the FC was used in 72 % (CI 70-74 %) of the cases. There was no statistically significant difference in the proportion of patients who received further fluids after the FC between those with a positive, with an uncertain or with a negatively judged response.The current practice and evaluation of FC in critically ill patients are highly variable. Prediction of fluid responsiveness is not used routinely, safety limits are rarely used, and information from previous failed FCs is not always taken into account