Efficacy of a Longitudinal Project-Based Quality Improvement Curriculum in Pediatric Cardiology Fellowship.

Quality improvement knowledge is a requirement of fellowship training. Our goal was to evaluate the efficacy of a 3-year quality improvement and patient safety (QI/PS) curriculum that gives fellows both didactic knowledge and first-hand experience with improvement science, and meets Clinical Learning Environment Review (CLER) requirements. Knowledge assessment is obtained through pre- and post-surveys. A secondary measure of success is academic products resulting from fellows' QI/PS work, and future participation in QI/PS efforts. Since 2019, 51 pre-tests and 36 post-tests were completed, showing improvement across all competencies. Fellows have produced one published manuscript, two poster presentations, and two oral presentations describing their improvement work. Additionally, mentoring faculty members have gone on to lead other QI work throughout the division. This longitudinal QI/PS curriculum provides both knowledge and experience in QI/PS work. It also creates opportunities for academic publications and presentations, builds faculty expertise, and most importantly, works to improve multiple aspects of patient care. This curriculum can serve as a model for other cardiology fellowships working to meet CLER requirements.

Multidrug-resistant organisms: A significant cause of severe sepsis in pediatric intestinal and multi-visceral transplantation.

Severe sepsis in immunocompromised children is associated with increased mortality. This paper describes the epidemiology landscape, clinical acuity, and outcomes for severe sepsis in pediatric intestinal (ITx) and multi-visceral (MVTx) transplant recipients requiring admission to the pediatric intensive care unit (PICU). Severe sepsis episodes were retrospectively reviewed in 51 ITx and MVTx patients receiving organs between 2009 and 2015. Twenty-nine (56.8%) patients had at least one sepsis episode (total of 63 episodes) through December 2016. Bacterial etiologies accounted for 66.7% of all episodes (n = 42), occurring a median of 122.5 days following transplant (IQR 59-211.8 days). Multidrug-resistant organisms (MDROs) accounted for 73.8% of bacterial infections; extended spectrum beta-lactamase producers, vancomycin-resistant enterococcus, and highly-resistant Pseudomonas aeruginosa were the most commonly identified. Increased mechanical ventilation and vasoactive requirements were noted in MDRO episodes (OR 3.03, 95% CI 1.09-8.46 and OR 3.07, 95% CI 1.09-8.61, respectively; p < .05) compared to non-MDRO episodes. PICU length of stay was significantly increased for MDRO episodes (7 vs. 3 days, p = .02). Graft loss was 24.1% (n = 7) and mortality was 24.1% (n = 7) in patients who experienced severe sepsis. Further attention is needed for MDRO risk mitigation and modification of sepsis treatment guidelines to ensure MDRO coverage for this population.

Micturition syncope with asystole in a paediatric patient.

Syncope occurs frequently in children, and the differential includes situational syncope, specifically micturition syncope. We report the youngest child to our knowledge to have micturition syncope associated with a prolonged asystolic pause. He underwent a neurological and cardiovascular evaluation without additional findings. Behavioural modifications were instituted with no recurrent syncope.

Structural brain abnormalities in the common epilepsies assessed in a worldwide ENIGMA study.

Progressive functional decline in the epilepsies is largely unexplained. We formed the ENIGMA-Epilepsy consortium to understand factors that influence brain measures in epilepsy, pooling data from 24 research centres in 14 countries across Europe, North and South America, Asia, and Australia. Structural brain measures were extracted from MRI brain scans across 2149 individuals with epilepsy, divided into four epilepsy subgroups including idiopathic generalized epilepsies (n =367), mesial temporal lobe epilepsies with hippocampal sclerosis (MTLE; left, n = 415; right, n = 339), and all other epilepsies in aggregate (n = 1026), and compared to 1727 matched healthy controls. We ranked brain structures in order of greatest differences between patients and controls, by meta-analysing effect sizes across 16 subcortical and 68 cortical brain regions. We also tested effects of duration of disease, age at onset, and age-by-diagnosis interactions on structural measures. We observed widespread patterns of altered subcortical volume and reduced cortical grey matter thickness. Compared to controls, all epilepsy groups showed lower volume in the right thalamus (Cohen's d = -0.24 to -0.73; P < 1.49 × 10-4), and lower thickness in the precentral gyri bilaterally (d = -0.34 to -0.52; P < 4.31 × 10-6). Both MTLE subgroups showed profound volume reduction in the ipsilateral hippocampus (d = -1.73 to -1.91, P < 1.4 × 10-19), and lower thickness in extrahippocampal cortical regions, including the precentral and paracentral gyri, compared to controls (d = -0.36 to -0.52; P < 1.49 × 10-4). Thickness differences of the ipsilateral temporopolar, parahippocampal, entorhinal, and fusiform gyri, contralateral pars triangularis, and bilateral precuneus, superior frontal and caudal middle frontal gyri were observed in left, but not right, MTLE (d = -0.29 to -0.54; P < 1.49 × 10-4). Contrastingly, thickness differences of the ipsilateral pars opercularis, and contralateral transverse temporal gyrus, were observed in right, but not left, MTLE (d = -0.27 to -0.51; P < 1.49 × 10-4). Lower subcortical volume and cortical thickness associated with a longer duration of epilepsy in the all-epilepsies, all-other-epilepsies, and right MTLE groups (beta, b < -0.0018; P < 1.49 × 10-4). In the largest neuroimaging study of epilepsy to date, we provide information on the common epilepsies that could not be realistically acquired in any other way. Our study provides a robust ranking of brain measures that can be further targeted for study in genetic and neuropathological studies. This worldwide initiative identifies patterns of shared grey matter reduction across epilepsy syndromes, and distinctive abnormalities between epilepsy syndromes, which inform our understanding of epilepsy as a network disorder, and indicate that certain epilepsy syndromes involve more widespread structural compromise than previously assumed.

Obstetric Violence among Pregnant Jordanian Women: An Observational Study between the Private and Public Hospitals in Jordan.

BACKGROUND: Obstetric Violence (OV) is a public health matter that affects women and their children with an incidence rate between 18.3-75.1% globally. The delivery institution of public and private sectors represents a potential factor contributing to OV. This study aimed to assess OV existence among sample of pregnant Jordanian women and its risk factors domains between public and private hospitals. METHODOLOGY: This is a case-control study including 259 recently delivered mothers from Al-Karak Public and Educational Hospital and The Islamic Private Hospital. A designated questionnaire including demographic variables and OV domains was used for data collection. RESULTS: A significant difference was seen between patients delivering in the public sector compared to patients delivering the private sector in education level, occupation, monthly income, delivery supervision and overall satisfaction. Patients delivering in the private sector showed a significantly less physical abuse by the medical staff compared to patients delivering in the public sector, and patients delivering in a private room also showed a significantly less OV and risk of physical abuse compared to patients delivering in shared room. In public settings, medications information was lesser versus the private ones, additionally, there is significant association between performing episiotomy, physical abuse by staff and the delivery in shared rooms in private settings. CONCLUSION: This study showed that OV was less susceptible during childbirth in private settings compared to public settings. Educational status, low monthly income, occupation are risk factors for OV; also, features of disrespect and abuse like obtaining consent for episiotomy performance, delivery provision updates, care perception based on payment ability and medication information were reported.

Pharmacovigilance and assessment of drug safety reports during COVID 19.

The speed and volume of clinical research to discover effective drug against novel corona virus has been remarkable. To address the unmet medical need, the regulations are made flexible and convenient without any relaxation in drug safety reporting. The pharmacovigilance activities, especially adverse event reporting regardless of clinical trials or clinical practice should continue as usual because patient safety is the priority. The exposure to experimental drugs with limited evidence of risk - benefit makes it more crucial to adapt robust safety monitoring, accuracy in adverse event reporting, and timely assessment. With the current restriction on physical contact, travel and free movements, isolation, quarantine, and huge clinical workload during pandemic, causality assessment will be more challenging. It may not be possible to capture details of all adverse events, thereby affecting completeness and quality of safety reports. A substantial number of COVID 19 patients will receive investigational drugs along with multiple other medications for clinical manifestations and drug therapy for lifestyle diseases. Causality assessment will be a challenge due to overlapping toxicities, multiple confounding, contributory factors, and insufficient data on safety and risk profile of combining drugs. Assessment will be unable to precisely determine the causality as certain or unlikely, although, it will be valuable in categorizing the causal association as "possible" adverse drug reactions and their scientific basis. Several of these detailed reports, when collated, can identify risk factors for possibilities of prevention or avoid harm. In the current situation of pandemic and uncertainty of experimental new and old repurposed drugs, causation needs to be viewed for the study drug with a public health perspective. After all, this is the best time tested approach to generate evidence and drug evaluation to prevent damage to prospective patients.

Early treatment outcome of bedaquiline plus optimised background regimen in drug resistant tuberculosis patients.

AIMS: Bedaquiline (BDQ) has been recently approved for drug resistant tuberculosis with active drug safety monitoring under programmatic condition. The present study was conducted to evaluate safety, tolerability and efficacy of bedaquiline plus optimised background regimen. METHODS: A prospective study was conducted on cohort of pre-extensively drug resistant (XDR) and XDR pulmonary TB patients. Eligible patients were closely monitored for cardiac safety, adverse events (AEs), clinical and microbiological improvement during BDQ (6 months) and post BDQ phase for twelve months. RESULTS: Of 127 patients enrolled, a significant increase in mean QTc interval was observed on 13th day and 3rd week as compared to baseline (p < 0.0001). Mean maximum increase of QTc was 37.92ms (95% CI, 14.1-61.74ms). Concomitant anti-TB medications, age, gender, low body mass index (BMI) had significant effect on QTc prolongation (p < 0.0001, p < 0.05). However, none of the patient required discontinuation of BDQ. Majority of AEs (86.3%) were non-serious and not preventable 108 (87.1%). The median time for sputum-culture conversion was 40.89 ± 3.5 days (95% CI, 34-48 days) and the treatment outcome was successful in 102 (80.3%) patients with negative sputum culture conversion. CONCLUSIONS: Bedaquiline containing regimen achieved favourable outcome. Although, bedaquiline along with concomitant anti-TB medications has the potential to prolong QTc interval, the benefit certainly outweighs the risk. This calls for a through pre-treatment cardiovascular and biochemical evaluation as a preventive measure and appropriate selection of patients for safe use of BDQ and successful outcome.

Incidence and Significance of GATA3 Positivity in Pancreatic Ductal Adenocarcinoma and Cholangiocarcinoma.

GATA3 is a transcription factor involved in the development and differentiation of lymphocytes, breast, and hair follicles. The protein is a useful immunohistochemical (IHC) marker for supporting diagnoses of breast or urothelial carcinoma. This can be especially helpful in metastatic neoplasms to help delineate site of origin. GATA3 is also reportedly positive in a percentage of pancreatic ductal adenocarcinomas (PDACs) and cholangiocarcinomas (CCs), but no study has closely evaluated this relationship with respect to clininopathologic features or patient outcome. Using tissue microarrays, we analyzed 240 PDACs and 60 CCs with GATA3 IHC and compared expression to various clinical and pathologic parameters. Overall, GATA3 positivity was seen in 16% of PDACs and 5% of CCs. GATA3 positivity in PDAC cases was more common in male patients (P=0.013). GATA3-positive PDACs trended toward worse survival on multivariate analysis (P=0.074). The only 3 GATA3-positive CCs were poorly differentiated (P=0.069); low case number precluded multivariate survival analysis for CCs. GATA3 positivity can occur in carcinomas of the pancreatobiliary system, which should be considered during IHC workup of neoplasms of unclear origin. This positivity seems to have minimal relevance to patient outcome.

An analysis of the use of antimicrobial agents in outdoor patients of ophthalmology.

OBJECTIVES: The study was aimed to analyze commonly used antimicrobials in outdoor patients of ophthalmology department. MATERIALS AND METHODS: The study was an observational, cross-sectional study carried out in the Department of Pharmacology and Ophthalmology after approval from the head of departments and Institutional Ethics Committee. All the patients age 18 years and above who were prescribed antimicrobials and gave consent were included in study. Data were recorded in a case study form containing relevant patient information and results of general, ocular, and special examinations along with the details of antimicrobials prescribed. Data were analyzed according to the World Health Organization/International Network for Rational Use of Drugs indicators and appropriate statistical tests. RESULTS: A total of 900 patients who were prescribed antimicrobial agents (AMAs) were included in the study. The most common chief complaint was diminution of vision (25.78%). The most common indication of use of AMAs was for treating ocular infections (50.22%). The most commonly prescribed antimicrobial group was fluoroquinolone (FQ) (63.8%) and the most common drug was moxifloxacin (35.95%). The most common dosage form of AMAs was eye drops (68.55%). The average number of drugs per encounter was 4.41. The percentage of encounters with injectables prescribed was 0.67%. The percentage of use of antibiotics was 100%. The percentage of total drugs and AMAs prescribed by generic name was 41.5 and 11.92, respectively. The percentage of antimicrobial drugs prescribed from essential drugs list was 34.24%. The mean duration of antimicrobial therapy was 7.2 ± 4.54 days. CONCLUSION: More than half of the patients are prescribed multiple AMAs. Moxifloxacin, a newer generation FQ , was the most commonly prescribed AMA in our study. Educational interventions and strict adherence to hospital antimicrobial use policy are needed to restrict the use of AMAs and increase rational prescribing.

Prevalence and characteristics of e-cigarette users among Malaysian current and ex-smokers.

INTRODUCTION: Electronic cigarettes (ECs) are new devices that have been accepted widely by both smokers and non-smokers. However, the evidence on EC used in Malaysia is scarce. The objective of this study was to determine the prevalence of EC use and the socio-demographic and smoking characteristics associated with current EC use among Malaysian current and ex-smokers. METHODS: This was a sub-analysis of data from a cross-sectional, national-population- based EC study conducted from May to June in 2016 in Malaysia. A detailed description of the sampling methods can be found in the National E-cigarette Survey (NECS) 2016 report. Briefly, data were obtained from 1396 individuals who had ever been smokers, i.e., 957 (68.6%) current smokers and 439 (31.4%) ex-smokers. RESULTS: Current EC use was found predominantly among current smokers (8.0%) as compared with ex-smokers (4.3%). Among current smokers, the main reasons given for smoking ECs were wanting to try it (44.7%), followed by intention to quit tobacco smoking (15.8%) and to reduce tobacco smoking (10.5%). Using multiple logistic regression analysis, we found that among current smokers, current EC users were more likely to be younger, i.e., 18-44 years (aOR= 4.83, 95% CI= 1.97-11.86, p=0.001), urban residents (aOR= 1.89, 95% CI= 1.15-3.11, p=0.012), single/ divorced/ widowed (aOR= 2.11, 95% CI= 1.24-3.61, p=0.006) and students (aOR= 2.25, 95% CI= 1.01-5.01, p=0.048). Among exsmokers, only younger respondents (18-44 years old) was reported as being more likely to be current EC users (aOR= 3.81, 95% CI= 1.14-12.76, p=0.030). CONCLUSION: This study showed that currently using and ever having used ECs were more prevalent among current smokers. The reasons given for initiating EC use among current smokers were mainly wanting to try it, followed by intention to quit and to reduce tobacco smoking. Current EC use appears to be common among current smokers who are younger, urban residents, single/divorced/widowed and students. Therefore, EC cessation intervention strategies and policies should target these high-prevalence groups.

Normal cerebral cortical thickness in first-degree relatives of temporal lobe epilepsy patients.

OBJECTIVE: To examine cerebral cortex thickness in asymptomatic first-degree relatives of patients with mesial temporal lobe epilepsy (MTLE). METHODS: We investigated 127 asymptomatic first-degree relatives of patients with MTLE due to hippocampal sclerosis (HS) (mean age ± SD = 39.4 ± 13 years) and 203 healthy control individuals (mean age ± SD = 36.0 ± 11 years). Participants underwent a comprehensive clinical evaluation and structural brain MRI at 3 study sites. Images were processed simultaneously at each site using a surface-based morphometry method to quantify global brain measures, hippocampal volumes, and cerebral cortical thickness. Differences in brain measures between relatives of patients and controls were examined using generalized models, while controlling for relevant covariates, including age and sex. RESULTS: None of the asymptomatic first-degree relatives of MTLE + HS patients showed evidence of HS on qualitative image assessments. Compared to the healthy controls, the asymptomatic relatives of patients displayed no significant differences in intracranial volume, average hemispheric surface area, or hippocampal volume. Similarly, no significant cerebral cortical thinning was identified in the relatives of patients. This was consistent across the 3 cohorts. CONCLUSION: Lack of cortical thickness changes in the asymptomatic relatives of patients indicates that the previously characterized MTLE + HS-related cortical thinning is not heritable, and is likely driven by disease-related factors. This finding therefore argues for early and aggressive intervention in patients with medically intractable epilepsy.

A safety analysis of different drug regimens used in human immunodeficiency virus-positive patients.

BACKGROUND: Long-term toxicity of antiretroviral agents is rarely addressed in initial clinical trials. Effective pharmacovigilance is essential for long-term safety of antiretroviral therapy (ART). MATERIALS AND METHODS: All adverse drug reactions (ADRs) reported due to ART between January 2014 and September 2016 were analyzed as per different drug regimens used. ADRs were also analyzed for system organ classification, seriousness, time relationship of ADRs with drug therapy, causality (as per the World Health Organization-Uppsala Monitoring Centre scale and Naranjo algorithm), and severity (Hartwig and Siegel scale). Comparison was done between (tenofovir + lamivudine + efavirenz [TLE]) and (zidovudine + lamivudine + nevirapine [ZLN]) regimens. RESULTS: During a study period, 2983 patients were on ART. The most common drug regimen prescribed was TLE (1805) followed by ZLN (326). A total of 325 (10.89%) ADRs were reported in which 150 ADRs were reported in TLE regimens (46%) and 130 in ZLN regimens (40%). The mean age of patients with ADRs was 40 ± 12.56 years and men (58.1%) were more affected than women (41.8%). The most common system organ involved in ZLN regimen was blood (50, 39%) and skin (35, 27%), while it was neurological (63, 42%) and renal disorder (27, 18%) in TLE regimen. Most of ADRs were observed after 1 month of therapy (79.5%) and showed possible causal relation with drug therapy (78.15%). Majority of ADRs were mild in nature (86.7%). The serious ADRs were reported more in ZLN (18%) regimen as compared to TLE (9%) (P < 0.05). CONCLUSION: Both ART regimens are associated with ADRs affecting all body system; however, the frequency and severity of ADR are high with ZLN regimen.

Efficient derivatization of methylphosphonic and aminoethylsulfonic acids related to nerve agents simultaneously in soils using trimethyloxonium tetrafluoroborate for their enhanced, qualitative detection and identification by EI-GC-MS and GC-FPD.

Trimethyloxonium tetrafluoroborate (TMO·BF4) has been used in the simultaneous derivatization of phosphonic and 2-aminoethylsulfonic acids related to nerve agents in different soils for their enhanced detection and identification by electron ionization gas chromatography-mass spectrometry (EI-GC-MS). The panel of acids consisted of five Schedule 2 phosphonic acids (methyl methylphosphonic acid, ethyl methylphosphonic acid, isopropyl methylphosphonic acid, pinacolyl methylphosphonic acid and cyclohexyl methylphosphonic acid) along with two sulfonic acids, N,N-diethyl-2-aminoethylsulfonic acid and N,N-diisopropyl-2-aminoethylsulfonic acid. The acids were converted to their corresponding methyl esters at ambient temperature when present at a 10µgg-1 concentration in three separate soils: Virginia type A soil, Ottawa sand and Nebraska EPA soil. The concentration of the acids reflects values typically encountered during proficiency tests (PTs) administered annually by the Organisation for the Prohibition of Chemical Weapons (OPCW). Derivatization times to yield detectable signals for the methyl ester products for all the acids was found to vary among all three soil samples, however, it was found that generally the most optimal time across all the matrices involved was 3h after the addition of TMO·BF4. Concomitantly, the analysis of the samples was complemented using GC coupled to flame photometric detection (GC-FPD). The inclusion of GC-FPD in the analysis yielded stronger signals for all seven methylated analytes making their detection after merely 3h possible relative to the ones initially obtained with EI-GC-MS. Regarding the three soils employed in our study, a greater methylating efficiency was found in the Virginia type A soil and Ottawa sand yielding results that were significantly larger in magnitude to those found during the same time points for the Nebraska EPA soil sample. Prolonged reaction times (up to 72h) were explored to find the time for the highest yield of methyl ester production were found instead to be deleterious to the process showcasing the importance of the fast yielding nature of the process specifically in situations where time-sensitive analysis is crucial (e.g. OPCW-PT).

An Evaluation of Efficacy and Safety of Commonly Prescribed Drugs and Effect of These Drugs on Quality of Sleep in Patients Suffering From Zoster-Associated Pain.

This observational, prospective, single-center study was conducted to evaluate the efficacy and safety of commonly prescribed drugs for zoster-associated pain and their impact on quality of sleep at a tertiary care hospital in western India. Patients ≥18 years of age, newly diagnosed with zoster-associated pain were evaluated on days 0, 7, 14, 30, 60, 90, 120, 150, and 180 or until resolution of pain, whichever was earlier, using the Wong Baker FACES Pain Rating Scale, Neuropathic Pain Scale, and Insomnia Severity Index for intensity of pain, quality of pain, and quality of sleep, respectively. A total of 78 patients (46.0 [16.3] years) completed the study. They received nonsteroidal anti-inflammatory drugs (65), gabapentin (30), amitriptyline (27), and amitriptyline + gabapentin (21) for mean durations of 7.7 (3.0), 89.2 (7.2), 107.6 (46.3), and 104.5 (46) days, respectively. Improvement in the Wong Baker FACES Pain Rating Scale and Neuropathic Pain Scale score was similar among treatment groups except for a greater fall in Wong Baker FACES Pain Rating Scale score at days 7 and 120 and that in deep pain score at day 7 in combination treatment group vs the amitriptyline group. Clinically significant insomnia was detected in 35 patients at baseline and demonstrated progressive and similar improvement among groups. Treatment modification was required in 20 patients. Zoster-associated pain resolved in 69 patients. Nine adverse drug reactions, mostly mild, nonserious, and nonpreventable, were reported. To conclude, drugs commonly used for zoster-associated pain are effective and well tolerated. These have a similar effect on pain and quality of sleep, except for a possible greater effect of combination treatment in the early phase of intense and deep pain.

Chemical cross-linking of a variety of green fluorescent proteins as Förster resonance energy transfer donors for Yukon orange fluorescent protein: A project-based undergraduate laboratory experience.

Förster resonance energy transfer (FRET) is the basis for many techniques used in biomedical research. Due to its wide use in molecular sensing, FRET is commonly introduced in many biology, chemistry, and physics courses. While FRET is of great importance in the biophysical sciences, the complexity and difficulty of constructing FRET experiments has resulted in limited usage in undergraduate laboratory settings. Here, we present a practical undergraduate laboratory experiment for teaching FRET using a diverse set of green-emitting fluorescent proteins (FPs) as donors for a cross-linked Yukon orange FP. This laboratory experiment enables students to make the connection of basic lab procedures to real world applications and can be applied to molecular biology, biochemistry, physical chemistry, and biophysical laboratory courses. Published 2018. This article is a U.S. Government work and is in the public domain in the USA., 46(5):516-522, 2018.

Comparison of Effect of Antidepressants on Psychomotor Functions.

OBJECTIVE: The comparison of the effect of antidepressants on psychomotor functions in patients with endogenous depression. MATERIALS AND METHODS: This prospective interventional study was carried out at a tertiary care teaching hospital on 95 literate patients with newly diagnosed endogenous depression matching inclusion and exclusion criteria. Patients were prescribed either desvenlafaxine (50 mg) or fluoxetine (40 mg) or sertraline (50 mg). Psychomotor functions were assessed by digit letter substitution, six letter cancellation, choice reaction time, hand steadiness and flicker fusion test at the baseline 1st month and 3rd month. Efficacy of drugs was also measured by Hamilton rating scale for depression. Data were analyzed by using ANOVA and P < 0.05 was considered as statistically significant. RESULTS: A total of 95 patients were enrolled. Fluoxetine, desvenlafaxine, and sertraline were prescribed in 32, 32, and 31 patients, respectively. At the end of 3 months, a significant improvement in psychomotor functions was observed in patients treated with sertraline (P < 0.05), while desvenlafaxine-treated patients did not show any significant change in any of the tests. Surprisingly, fluoxetine-treated patients showed deterioration in all psychomotor tests (P < 0.05). Hamilton rating score improved at the end of 3 months treatment as compared to baseline. Most commonly observed adverse reactions in all three drug groups were nausea (n = 20), dizziness (n = 3), headache (n = 20), and diarrhea (n = 3). CONCLUSION: Sertraline significantly improves psychomotor function as compared to desvenlafaxine while fluoxetine impairs.

Transfusion-related adverse reactions in pediatric and surgical patients at a tertiary care teaching hospital in India.

BACKGROUND: Use of blood and its components is lifesaving. However, their use is often associated with adverse events. OBJECTIVE: To analyze the pattern of adverse reactions associated with transfusion of blood and its components in pediatric and surgical patients at a tertiary care teaching hospital. MATERIALS AND METHODS: Patients receiving transfusion of blood or its components in a randomly selected unit each from Departments of Pediatrics, including thalassemia OPD and surgery, were monitored intensively for a period of 6 months. Clinical course, management, outcome, causality, severity, seriousness, and preventability of observed transfusion reactions (TRs) were analyzed. RESULTS: A total of 411 pediatric and 433 surgical patients received 594 and 745 transfusions respectively during the study period. Of these, TRs were observed in 69 (11.6%) children and 63 (8.4%) surgical patients. Majority of reactions in children (48, 69.5%) and surgical patients (51, 80.9%) were acute, developing within 24 h of transfusion. TRs were observed with packed cells (13.2%), cryoprecipitate (10%), platelet concentrate (14.3%) and fresh frozen plasma (1.3%) in pediatric patients and with packed cells (7.2%), whole blood (25%) and platelet concentrate (62.5%) in surgical patients. Most common TRs included febrile nonhemolytic TRs (FNHTRs) and allergic reactions. Reactions were more frequent in patients with a previous history of transfusion or those receiving more than one transfusion and in children, when transfusion was initiated after 30 min of issue of blood component. Majority of reactions were managed with symptomatic treatment, were nonserious, moderately severe, probably preventable and probably associated with the suspect blood component in both populations. CONCLUSION: Transfusion reactions in children and surgical patients are commonly observed with cellular blood components. Majority of reactions are acute and nonserious. FNHTRs and allergic reactions are the most common transfusion reactions. Risk of transfusion reactions is more in patients receiving multiple transfusions.

An evaluation of drug promotional literatures published in scientific medical journals.

OBJECTIVES: Evaluation and comparison of ethical standards of published drug promotional literatures (DPLs) between different Indian and non-Indian scientific medical journals regarding compliance to the World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMAs) guidelines. MATERIALS AND METHODS: A cross-sectional, observational study was carried out at pharmacology department. DPLs published in Indian and non-Indian scientific medical journals available at central library of medical college during the period of 6 months were collected according to selection criteria. DPLs were evaluated and compared for compliance to ethical standards of drug promotion laid by the WHO and IFPMA. Data were analyzed using Fisher's exact test. RESULTS: Out of total 178 DPLs, 103 DPLs were from Indian journals and 75 DPLs were from non-Indian journals. When compared regarding compliance to all the 11 ethical criteria of WHO, no significant difference was found between DPLs published in Indian and non-Indian journals. However, DPLs from indian journals contained significantly less information regarding dosage regimen (P = 0.0096), adverse drug reactions (P = 0.0028), warnings (P = 0.0104) and major drug interactions (P < 0.0001) as compared to non-Indian journals. Compliance to all the five IFPMA criteria was significantly higher in DPLs of non-Indian journals (88%) than Indian journals (39%) (P < 0.0001). CONCLUSION: Noncompliance to ethical standards of WHO and IFPMA guidelines is more common in DPLs of Indian journals as compared to non-Indian journals. Thus strict implementation of regulatory measures regarding DPLs published in Indian medical journals is recommended.

Evaluation of impact of teaching clinical pharmacology and rational therapeutics to medical undergraduates and interns.

OBJECTIVES: To find out the impact of teaching clinical pharmacology and rational therapeutics (CPT) to medical undergraduates (UGs) and interns. MATERIALS AND METHODS: This cross-sectional, prospective study was conducted on three UGs batches and interns using two pretested validated structured questionnaires, modified from the work of Tobaiqy et al. The study was approved by the Institutional Ethics Committee. ANOVA and Chi-square test were used for statistical analysis. The value of P < 0.05 was considered statistically significant. RESULTS: A total of 379 UGs and 96 interns participated in this study. Mean knowledge score of interns was significantly reduced as compared to UGs (P < 0.0001). A significant increase in confidence for unsupervised prescribing of nonsteroidal anti-inflammatory drugs (99%), oral rehydration salt, iron salts was perceived among interns as compared to UGs (P < 0.05). However, 63.5% confessed problems in selection of drugs, drug-drug interactions, prescribing in special patient population. Although they were confident prescribing fixed dose combination for adult patients (89.5%), majority were hesitant to prescribe opioids (77%), steroids (76%), vaccines (75%), and antihypertensives (62%). CONCLUSION: The theoretical CPT teaching transfers knowledge to UGs; however, it is not retained in internship and does not adequately prepare interns to prescribe safe and rational drugs.

A Survey of Knowledge, Attitude, and Practice of Consumers at a Tertiary Care Hospital Regarding the Disposal of Unused Medicines.

OBJECTIVES: To evaluate the knowledge, attitude and practice of consumers in India about disposal of unused medicines. MATERIALS AND METHODS: A questionnaire comprising 11 questions evaluating the Knowledge (2), Attitude (3) and Practice (6) of unused medicines was prepared and pre validated before administering to 200 consumers of medicines attending the outpatient department of Civil Hospital Ahmedabad, a tertiary care teaching hospital in Western India. Requisite permissions from Institutional Ethics Committee and informed consent were obtained prior to recruiting them for the study. Responses were recorded, in Microsoft Excel® spreadsheet and evaluated for percentage response. RESULTS: Majority of the respondents (136, 68%) stored unused medicines at home. Analgesics (26.5%) were the most common unused medicine stored. Safe disposal of medicine was considered necessary by majority respondents (160, 80%) for different reasons like prevention of illegal/unintended use (84, 42%), prevention of environmental pollution (32, 16%) or possible ADR caused by old drugs (54, 27%). Only 78 (39%) respondents were aware of appropriate methods of disposal. Disposal in household trash (61, 30.5%) was the most common method used. Majority of respondents felt the need for a facility or programme to collect unused medicines (152, 76%) and an increased awareness among consumers regarding hazards and methods of disposal of unused medicines (154, 77%). CONCLUSION: Majority of consumers are aware about the need for safe disposal of unused medicines. But the right attitude for and practice of safe disposal of medicines is lacking. A need for increased awareness regarding safe disposal of medicines is acknowledged by majority of consumers.