Analysis of Cutaneous Adverse Drug Reactions at a Tertiary Care Hospital – a Prospective Study

Purpose: To analyze the clinical, pharmacological and economical aspects of the cutaneous adverse drug reactions (ADRs) reported at Civil Hospital, Ahmedabad, India.Methods: A prospective observational study over a period of one and half years (November 2006 to April 2008) was undertaken. Semi-spontaneous reporting along with a review of case record forms were used. The reports were analyzed for clinical pattern, causal drug groups, causality (WHO-UMC criteria), severity (Hartwig and Siegel scale) and preventability (modified Schumock and Thornton criteria). The cost of ADRs was calculated on the basis of hospital expenditure per patient and the amount spent by patients themselves.Results: Out of 143 reports, chemotherapeutic agents (39 %) were the most commonly suspected drugs followed by unknown medicines (29 %). Most of the ADRs were designated as possible or probable (69 %) and moderately severe (96.5 %) in nature. However, 14 – 16 % were definitely preventable. Cost incurred by the hospital was Indian national rupees (INR) 374,255, i.e.,USD 8241. While average cost incurred by outpatients was INR 99 (USD 2.18) and that of hospitalized patients was INR 264 (USD 5.81).Conclusion: A large number of cutaneous ADRs are due to unknown medicines. This calls for strict drug control mechanisms, patient education regarding self-medication and maintenance of prescription records. The cost associated with ADRs is high. ADR monitoring is essential to reduce patient suffering as well as to achieve the substantial savings in health care cost.Keywords: Cutaneous adverse drug reactions, Cost of ADRs, Preventability, Patient educatio

A COMPARISON OF CAUSALITY ASSESSMENT TOOLS FOR SUSPECTED ADVERSE DRUG REACTIONS IN HOSPITALIZED PATIENTS AT A TERTIARY CARE HOSPITAL

Objective: The objective of the study was to compare six causality assessment (CA) tools for suspected adverse drug reactions (ADRs) reported in hospitalized patients at a tertiary care hospital in India. Methods: Intensive ADR monitoring was performed in indoor patients of two randomly selected medicine units. A detailed case report of each suspected ADR (n=120) was provided to six independent experts for CA using either visual analog scale (VAS) or WHO-UMC scale. Investigator assessed causality using Naranjo’s scale, Koh et al. scale, the French method, and Karch and Lasagna scale. Similar causality categories from these scales were coded for correlation. Agreement among experts and that between various CA tools were analyzed using Cohen’s kappa and Fleiss kappa. Reasons for disagreements among different scales were evaluated. Results: A variation was observed in the total number of drugs suspected to cause ADR by experts and investigator. “Likely” and “Plausible” causality were suggested frequently by experts using VAS whereas “Possible” causal association was frequent according to experts using the WHO-UMC scale and also by the investigator using algorithms except Koh et al. scale. None to the slight agreement was observed among experts who used VAS (k=0.117), whereas a substantial agreement was observed among experts using the WHO-UMC scale (k=0.707). A substantial agreement was observed between Karch and Lasagna scale and the French method (k=0.740). Both scales demonstrated moderate agreement with Naranjo’s scale. Disagreement among the WHO-UMC scale, the French method, and Karch and Lasagna scale were associated with polypharmacy, serious ADRs, non-availability of laboratory data, and skin and subcutaneous tissue ADRs. Conclusion: A higher inter-rater agreement with the WHO-UMC scale suggests its utility for CA of suspected ADRs in indoor patients. The French method and Karch and Lasagna scale can be used for CA in hospitalized patients as an adjunct to Naranjo’s scale. Factors associated with disagreement should be considered at the time of reporting ADRs and evaluating causality

Reappraising the Role of Eplerenone in the Management of Heart Failure

Background: In India, the prevalence of heart failure (HF) is increasing at 1.2/1,000 people according to a study in northern India, and the mortality rate at 1 year (INTERnational Congestive Heart Failure [INTER-CHF]) is 37%. Due to the diverse phenotypes of HF, nonadherence to guideline-directed medical therapy (GDMT), resistance to uptitration of medication and underuse of mineralocorticoid receptor antagonists (MRAs), such as eplerenone, a uniform management approach may not be feasible. This review is aimed at assessing the burden of HF, reasons for underutilization of MRAs in treatment, evaluating the evidence and reappraising the disease-modifying role of eplerenone in HF management. Methods: An electronic database search was performed to identify relevant literature. Results: The review details various studies that demonstrate the role of MRA eplerenone as a disease-modifying agent in patients with mild-to-moderate hypertension and those with acute myocardial infarction (MI) complicated by left ventricular dysfunction and HF. It also outlines different patient profiles for eplerenone use and ways to handle minor side-effects. Conclusions: Eplerenone shows a promising effect in selectively blocking aldosterone receptors to suppress fibrosis and reverse cardiac remodeling

Screening of various botanical extracts for antioxidant activity using DPPH free radical method

Aiming at the exploration of herbal use by society, crude extracts of the seeds of some commonly used medicinal plants (Vitis vinifera, Tamarindus indica and Glycin max) were screened for their free radical scavenging  properties using ascorbic acid as standard antioxidant. Free radical scavenging activity was evaluated using 1,1-diphenyl-2-picrylhydrazyl (DPPH) free radical. The overall antioxidant activity of grape seeds (Vitis vinifera) was the strongest, followed in descending order by soybean (Glycin max) and tamarind (Tamarindus indica). The seeds extract of Vitis vinifera, Glycin max and Tamarindus indica showed 85.61%, 83.45% and 79.26%, DPPH  scavenging activity respectively.Key words: Antioxidant activity, DPPH, free-radical, Vitis vinifera, Glycin max, Tamarindus indica

A new technique for transumbilical insertion of central venous silicone catheters in newborn infants

Aim: A new technique allowing placement of umbilical silicone venous catheters (USVC) is described and compared with percutaneous silicone venous catheters (PSVC)

Pulmonary Mycobacterium avium-intracellulare is the main driver of the rise in non-tuberculous mycobacteria incidence in England, Wales and Northern Ireland, 2007-2012

BACKGROUND: The incidence of non-tuberculous mycobacteria (NTM) isolation from humans is increasing worldwide. In England, Wales and Northern Ireland (EW&NI) the reported rate of NTM more than doubled between 1996 and 2006. Although NTM infection has traditionally been associated with immunosuppressed individuals or those with severe underlying lung damage, pulmonary NTM infection and disease may occur in people with no overt immune deficiency. Here we report the incidence of NTM isolation in EW&NI between 2007 and 2012 from both pulmonary and extra-pulmonary samples obtained at a population level. METHODS: All individuals with culture positive NTM isolates between 2007 and 2012 reported to Public Health England by the five mycobacterial reference laboratories serving EW&NI were included. RESULTS: Between 2007 and 2012, 21,118 individuals had NTM culture positive isolates. Over the study period the incidence rose from 5.6/100,000 in 2007 to 7.6/100,000 in 2012 (p < 0.001). Of those with a known specimen type, 90 % were pulmonary, in whom incidence increased from 4.0/100,000 to 6.1/100,000 (p < 0.001). In extra-pulmonary specimens this fell from 0.6/100,000 to 0.4/100,000 (p < 0.001). The most frequently cultured organisms from individuals with pulmonary isolates were within the M. avium-intracellulare complex family (MAC). The incidence of pulmonary MAC increased from 1.3/100,000 to 2.2/100,000 (p < 0.001). The majority of these individuals were over 60 years old. CONCLUSION: Using a population-based approach, we find that the incidence of NTM has continued to rise since the last national analysis. Overall, this represents an almost ten-fold increase since 1995. Pulmonary MAC in older individuals is responsible for the majority of this change. We are limited to reporting NTM isolates and not clinical disease caused by these organisms. To determine whether the burden of NTM disease is genuinely increasing, a standardised approach to the collection of linked national microbiological and clinical data is required

In situ characterisation of surface roughness and its amplification during multilayer single-track laser powder bed fusion additive manufacturing

Surface roughness controls the mechanical performance and durability (e.g., wear and corrosion resistance) of laser powder bed fusion (LPBF) components. The evolution mechanisms of surface roughness during LPBF are not well understood due to a lack of in situ characterisation methods. Here, we quantified key processes and defect dynamics using synchrotron X-ray imaging and ex situ optical imaging and explained the evolution mechanisms of side-skin and top-skin roughness during multi-layer LPBF of Ti-6Al-4V (where down-skin roughness was out of the project scope). We found that the average surface roughness alone is not an accurate representation of surface topology of an LPBF component and that the surface topology is multimodal (e.g., containing both roughness and waviness) and multiscale (e.g., from 25 µm sintered powder features to 250 µm molten pool wavelength). Both roughness and topology are significantly affected by the formation of pre-layer humping, spatter, and rippling defects. We developed a surface topology matrix that accurately describes surface features by combining 8 different metrics: average roughness, root mean square roughness, maximum profile peak height, maximum profile valley height, mean height, mean width, skewness, and melt pool size ratio. This matrix provides a guide to determine the appropriate linear energy density to achieve the optimum surface finish of Ti-6Al-4V thin-wall builds. This work lays a foundation for surface texture control which is critical for build design, metrology, and performance in LPBF