Search results for: drug safety
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 5002

Search results for: drug safety

4882 Healthcare Professionals' Perspectives on Warfarin Therapy at Lao-Luxembourg Heart Centre, Mahosot Hospital, Lao PDR

Authors: Vanlounni Sibounheuang, Wanarat Anusornsangiam, Pattarin Kittiboonyakun, Chanthanom Manithip

Abstract:

In worldwide, one of the most common use of oral anticoagulant is warfarin. Its margin between therapeutic inhibition of clot formation and bleeding complications is narrow. Mahosot Hospital, warfarin clinic had not been established yet. The descriptive study was conducted by investigating drug-related problems of outpatients using warfarin, the value of the international normalized ratio (INR) higher than normal ranges (25.40 % of the total 272 outpatients) were mostly identified at Lao-Luxembourg Heart Centre, Mahosot Hospital, Lao PDR. This result led to the present study conducting qualitative interviews in order to help establish a warfarin clinic at Mahosot Hospital for the better outcomes of patients using warfarin. The purpose of this study was to explore perspectives of healthcare professional providing services for outpatients using warfarin. The face to face, in-depth interviews were undertaken among nine healthcare professionals (doctor=3, nurse=3, pharmacist=3) working at out-patient clinic, Lao-Luxembourg Heart Centre, Mahosot Hospital, Lao PDR. The interview guides were developed, and they were validated by the experts in the fields of qualitative research. Each interview lasted approximately 20 minutes. Three major themes emerged; healthcare professional’s experiences of current practice problems with warfarin therapy, healthcare professionals’ views of medical problems related to patients using warfarin, and healthcare professionals’ perspectives on ways of service improvement. All healthcare professionals had the same views that it’s difficult to achieve INR goal for individual patients because of some important patient barriers especially lack of knowledge about to use warfarin properly and safety, patients not regularly follow-up due to problems with transportations and financial support. Doctors and nurses agreed to have a pharmacist running a routine warfarin clinic and provided counselling to individual patients on the following points: how to take drug properly and safety, drug-drug and food-drug interactions, common side effects and how to manage them, lifestyle modifications. From the interviews, some important components of the establishment of a warfarin clinic included financial support, increased human resources, improved the system of keeping patients’ medical records, short course training for pharmacists. This study indicated the acceptance of healthcare professionals on the important roles of pharmacists and the feasibility of setting up warfarin clinic by working together with the multidisciplinary health care team in order to help improve health outcomes of patients using warfarin at Mahosot Hospital, Lao PDR.

Keywords: perspectives, healthcare professional, warfarin therapy, Mahosot Hospital

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4881 Psycho-Social Issues: Drug Use and Abuse as a Social Problem among Secondary School Youths in Urban Centres of Benue State, Nigeria

Authors: Ode Kenneth Ogbu

Abstract:

This study was designed as a survey to investigate the incidence of use and abuse of drug as a social problem among the Nigeria youths in the secondary schools in urban centres of Benue state. 500 SS 3 and fresh secondary school graduates in remedial science class of Benue State University Makurdi with mean age of 16.8 were randomly sampled for the study. An instrument called drug use and abuse perception questionnaire (DAPQ) with a reliability coefficient of 74 were administered to the students. Only 337 copies of the questionnaire were properly completed and returned which reduced the sample size of 337. The data were subjected to factor analysis. X2 statistic and frequency distribution using split half method. The result of the analysis showed that: the DAPQ yield seven baseline factors responsible for drug use and abuse; there was appreciable evidence that the study subjects used drugs (42.1%); alcohol topped the list of the drugs consumed; most students use their pocket money to buy drugs; drugs were purchased from unconventional, hidden places and 13 out of the 20 items of DAPQ were perceived as significant factors in drug use and abuse. The paper recommends proper intervention of government, parents and NGO’S among students to reduce cases of drug abuse.

Keywords: drug abuse, psychology, psychiatry, students

Procedia PDF Downloads 266
4880 The Importance of Fire Safety in Egypt

Authors: Omar Shakra

Abstract:

This paper contains a huge number of benefits that we can use it in several places and times in fire safety protection in the Middle East especially in Egypt . People here in Egypt did not consider the safety and fire protection as important as it is. But on the other hand, its very important for them to contain the fire systems and safety in every facility, the companies , hospitals , police stations , and even the super markets must use the fire system. It makes the facility safe to the visitors while they are using it.From my point of view as the owner Fire Safety Company called Deluge Egypt , i can say that not all of the companies use the fire system protection according to the high cost they prefer to build their company without the protection, and this is make the building totally unsafe to be used from the visitors or client.So, i am looking for new methods and technology to invest in Egypt, and this is through attending this Conference and let the audiences know more about the services i provide and [to let them know about the importance of the Fire Safety in Egypt. The Objectives of my research 1- The system that i used in my Company. 2- The benefits of the Fire System Protection. 3-The importance of the Fire System and safety. 4-The use of the new Technologies. 5-The hardships that i found while having new deals with new clients.

Keywords: fire, system, protection, fire hydrants, security, alarms

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4879 Public Bus Transport Passenger Safety Evaluations in Ghana: A Phenomenological Constructivist Exploration

Authors: Enoch F. Sam, Kris Brijs, Stijn Daniels, Tom Brijs, Geert Wets

Abstract:

Notwithstanding the growing body of literature that recognises the importance of personal safety to public transport (PT) users, it remains unclear what PT users consider regarding their safety. In this study, we explore the criteria PT users in Ghana use to assess bus safety. This knowledge will afford a better understanding of PT users’ risk perceptions and assessments which may contribute to theoretical models of PT risk perceptions. We utilised phenomenological research methodology, with data drawn from 61 purposively sampled participants. Data collection (through focus group discussions and in-depth interviews) and analyses were done concurrently to the point of saturation. Our inductive data coding and analyses through the constant comparison and content analytic techniques resulted in 4 code categories (conceptual dimensions), 27 codes (safety items/criteria), and 100 quotations (data segments). Of the number of safety criteria participants use to assess bus safety, vehicle condition, driver’s marital status, and transport operator’s safety records were the most considered. With each criterion, participants rightly demonstrated its respective relevance to bus safety. These findings imply that investment in and maintenance of safer vehicles, and responsible and safety-conscious drivers, and prioritization of passengers’ safety are key-targets for public bus/minibus operators in Ghana.

Keywords: safety evaluations, public bus/minibus, passengers, phenomenology, Ghana

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4878 A Qualitative Study: Determination of the Working Conditions and Knowledge Levels of Oncology Nurses in Terms of Employee Safety

Authors: Rujnan Tuna, Ulku Baykal

Abstract:

The antineoplastic drugs used in cancer treatment directly have adverse effects on health of both patients receiving the treatment and oncology nurses preparing and administering the treatment. The purpose of this study is to determine the working conditions of the oncology nurses in terms of employee safety as well as their knowledge levels regarding the safe use of antineoplastic drugs. This is a qualitative study conducted in the phenomenological design. Purposeful sampling method was used to carry out the interviews. The individual, in-depth, and semi-structured face-to-face interviews continued with 25 oncology nurses, who were working in an oncology centre in the city of Istanbul. Qualitative content analysis approach was used for the analysis of the obtained data in the study. The results of the study were gathered under 4 main themes; work-related factors, employee safety, working conditions, and training. The interviewed oncology nurses stated that the protective measures related to the safe use of the antineoplastic drugs were insufficient, and only 20% of the nurses have chemotherapy preparation certificate and they received this certificate after they started working in this unit. Also, after they had begun to work in that unit, they started to experience with so many health problems As happens all over the world, there have also been policies and standards regarding the safe use of antineoplastic drugs in Turkey; however, it is found that they remain insufficient to put into practice.

Keywords: antineoplastic drug, employee safety, nurse, oncology, qualitative study

Procedia PDF Downloads 200
4877 A Practical Model for Managing Beach Safety Focusing on Tourist Drownings in Koh Samui, Thailand

Authors: Siyathorn Khunon, Thanawit Buafai

Abstract:

This paper aims to investigate management of beach safety with a focus on tourist drownings in Samui. The data collected in this investigation will then lead to the proposal of a practical management model suitable for use in Samui. Qualitative research was conducted in the following manner: nine stakeholders from local government organizations and tourism businesses were interviewed in-depth. Additionally, a best practice case study from Phuket was applied to analyze beach safety. Twelve foreign tourists were also interviewed. Then, a focus group comprised of 32 people was used to determine practical solutions for enhancing tourists’ safety on the beach in Samui. A steering committee to coordinate between public and private organizations was proposed to manage and enhance tourists’ safety. A practical model is proposed to increase the safety level of tourists in Samui

Keywords: beach safety, drowning, tourist, Samui

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4876 The Framework of System Safety for Multi Human-in-The-Loop System

Authors: Hideyuki Shintani, Ichiro Koshijima

Abstract:

In Cyber Physical System (CPS), if there are a large number of persons in the process, a role of person in CPS might be different comparing with the one-man system. It is also necessary to consider how Human-in-The-Loop Cyber Physical Systems (HiTLCPS) ensure safety of each person in the loop process. In this paper, the authors discuss a system safety framework with an illustrative example with STAMP model to clarify what point for safety should be considered and what role of person in the should have.

Keywords: cyber-physical-system, human-in-the-loop, safety, STAMP model

Procedia PDF Downloads 280
4875 Polydopamine Nanoparticle as a Stable and Capacious Nano-Reservoir of Rifampicin

Authors: Tasnuva Tamanna, Aimin Yu

Abstract:

Application of nanoscience in biomedical field has come across as a new era. This study involves the synthesis of nano drug carrier with antibiotic loading. Based on the founding that polydopamine (PDA) nanoparticles could be formed via self-polymerization of dopamine at alkaline pH, one-step synthesis of rifampicin coupled polydopamine (PDA-R) nanoparticles was achieved by adding rifampicin into the dopamine solution. The successful yield of PDA nanoparticles with or without the presence of rifampicin during the polymerization process was characterized by scanning electron microscopy, Fourier transform infrared spectroscopy, and Raman spectroscopy. Drug loading was monitored by UV-vis spectroscopy and the loading efficiency of rifampicin was calculated to be 76%. Such highly capacious nano-reservoir was found very stable with little drug leakage at pH 3.

Keywords: drug loading, nanoparticles, polydopamine, rifampicin

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4874 Effect of Ethyl Cellulose and Hydroxy Propyl Methyl Cellulose Polymer on the Release Profile of Diltiazem Hydrochloride Sustained Release Pellets

Authors: Shahana Sharmin

Abstract:

In the present study, the effect of cellulose polymers Ethyl Cellulose and Hydroxy Propyl Methyl Cellulose was evaluated on the release profile of drug from sustained release pellet. Diltiazem Hydrochloride, an antihypertensive, cardio-protective agent and slow channel blocker were used as a model drug to evaluate its release characteristics from different pellets formulations. Diltiazem Hydrochloride sustained release pellets were prepared by drug loading (drug binder suspension) on neutral pellets followed by different percentages of spraying, i.e. 2%,4%, 6%, 8% and 10% coating suspension using ethyl cellulose and hydroxy-propyl methyl cellulose polymer in a fixed 85:15 ratios respectively. The in vitro dissolution studies of Diltiazem Hydrochloride from these sustained release pellets were carried out in pH 7.2 phosphate buffer for 1, 2, 3, 4, 5, 6, 7, and 8 hrs using USP-I method. Statistically, significant differences were found among the drug release profile from different formulations. Polymer content with the highest concentration of Ethyl cellulose on the pellets shows the highest release retarding rate of the drug. The retarding capacity decreases with the decreased concentration of ethyl cellulose. The release mechanism was explored and explained with zero order, first order, Higuchi and Korsmeyer’s equations. Finally, the study showed that the profile and kinetics of drug release were functions of polymer type, polymer concentration & the physico-chemical properties of the drug.

Keywords: diltiazem hydrochloride, ethyl cellulose, hydroxy propyl methyl cellulose, release kinetics, sustained release pellets

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4873 Approach to Functional Safety-Compliant Design of Electric Power Steering Systems for Commercial Vehicles

Authors: Hyun Chul Koag, Hyun-Sik Ahn

Abstract:

In this paper, we propose a design approach for the safety mechanism of an actuator used in a commercial vehicle’s EPS system. As the number of electric/electronic system in a vehicle increases, the importance of the functional safety has been receiving much attention. EPS(Electric Power Steering) systems for commercial vehicles require large power than passenger vehicles, and hence, dual motor can be applied to get more torque. We show how to formulate the development process for the design of hardware and software of an EPS system using dual motors. A lot of safety mechanisms for the processor, sensors, and memory have been suggested, however, those for actuators have not been fully researched. It is shown by metric analyses that the target ASIL(Automotive Safety Integrated Level) is satisfied in the point of view of hardware of EPS controller.

Keywords: safety mechanism, functional safety, commercial vehicles, electric power steering

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4872 Establishing a Drug Discovery Platform to Progress Compounds into the Clinic

Authors: Sheraz Gul

Abstract:

The requirements for progressing a compound to clinical trials is well established and relies on the results from in-vitro and in-vivo animal tests to indicate that it is likely to be safe and efficacious when testing in humans. The typical data package required will include demonstrating compound safety, toxicity, bioavailability, pharmacodynamics (potential effects of the compound on body systems) and pharmacokinetics (how the compound is potentially absorbed, distributed, metabolised and eliminated after dosing in humans). If the desired criteria are met and the compound meets the clinical Candidate criteria and is deemed worthy of further development, a submission to regulatory bodies such as the US Food & Drug Administration for an exploratory Investigational New Drug Study can be made. The purpose of this study is to collect data to establish that the compound will not expose humans to unreasonable risks when used in limited, early-stage clinical studies in patients or normal volunteer subjects (Phase I). These studies are also designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on their effectiveness. In order to reach the above goals, we have developed a pre-clinical high throughput Absorption, Distribution, Metabolism and Excretion–Toxicity (ADME–Toxicity) panel of assays to identify compounds that are likely to meet the Lead and Candidate compound acceptance criteria. This panel includes solubility studies in a range of biological fluids, cell viability studies in cancer and primary cell-lines, mitochondrial toxicity, off-target effects (across the kinase, protease, histone deacetylase, phosphodiesterase and GPCR protein families), CYP450 inhibition (5 different CYP450 enzymes), CYP450 induction, cardio-toxicity (hERG) and gene-toxicity. This panel of assays has been applied to multiple compound series developed in a number of projects delivering Lead and clinical Candidates and examples from these will be presented.

Keywords: absorption, distribution, metabolism and excretion–toxicity , drug discovery, food and drug administration , pharmacodynamics

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4871 Surface Modified Polyamidoamine Dendrimer with Gallic Acid Overcomes Drug Resistance in Colon Cancer Cells HCT-116

Authors: Khushbu Priyadarshi, Chandramani Pathak

Abstract:

Cancer cells can develop resistance to conventional therapies especially chemotherapeutic drugs. Resistance to chemotherapy is another challenge in cancer therapeutics. Therefore, it is important to address this issue. Gallic acid (GA) is a natural plant compound that exhibits various biological properties including anti-proliferative, anti-inflammatory, anti-oxidant and anti-bacterial. Despite of the wide spectrum biological properties GA has cytotoxic response and low bioavailability. To overcome this problem, GA was conjugated with the Polyamidoamine(PAMAM) dendrimer for improving the bioavailability and efficient delivery in drug-resistant HCT-116 Colon Cancer cells. Gallic acid was covalently linked to 4.0 G PAMAM dendrimer. PAMAM dendrimer is well established nanocarrier but has cytotoxicity due to presence of amphiphilic nature of amino group. In our study we have modified surface of PAMAM dendrimer with Gallic acid and examine their anti-proliferative effects in drug-resistant HCT-116 cells. Further, drug-resistant colon cancer cells were established and thereafter treated with different concentration of PAMAM-GA to examine their anti-proliferative potential. Our results show that PAMAM-GA conjugate induces apoptotic cell death in HCT-116 and drug-resistant cells observed by Annexin-PI staining. In addition, it also shows that multidrug-resistant drug transporter P-gp protein expression was downregulated with increasing the concentration of GA conjugate. After that we also observed the significant difference in Rh123 efflux and accumulation in drug sensitive and drug-resistant cancer cells. Thus, our study suggests that conjugation of anti-cancer agents with PAMAM could improve drug resistant property and cytotoxic response to treatment of cancer.

Keywords: drug resistance, gallic acid, PAMAM dendrimer, P-glycoprotein

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4870 Development and Evaluation of Simvastatin Based Self Nanoemulsifying Drug Delivery System (SNEDDS) for Treatment of Alzheimer's Disease

Authors: Hardeep

Abstract:

The aim of this research work to improve the solubility and bioavailability of Simvastatin using a self nanoemulsifying drug delivery system (SNEDDS). Self emulsifying property of various oils including essential oils was evaluated with suitable surfactants and co-surfactants. Validation of a method for accuracy, repeatability, Interday and intraday precision, ruggedness, and robustness were within acceptable limits. The liquid SNEDDS was prepared and optimized using a ternary phase diagram, thermodynamic, centrifugation and cloud point studies. The globule size of optimized formulations was less than 200 nm which could be an acceptable nanoemulsion size range. The mean droplet size, drug loading, PDI and zeta potential were found to be 141.0 nm, 92.22%, 0.23 and -10.13 mV and 153.5nm, 93.89 % ,0.41 and -11.7 mV and 164.26 nm, 95.26% , 0.41 and -10.66mV respectively.

Keywords: simvastatin, self nanoemulsifying drug delivery system, solubility, bioavailability

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4869 Heavy Liquid Metal Coolant – the Key Safety Element in the Complex of New Nuclear Energy Technologies

Authors: A. Orlov, V. Rachkov

Abstract:

The future of Nuclear Energetics is seen in fast reactors with inherent safety working in the closed nuclear fuel cycle. The concept of inherent safety, which lies in deterministic elimination of the most severe accidents due to inherent properties of the reactor rather than through building up engineered barriers, is a cornerstone of success in ensuring safety and economic efficiency of future Nuclear Energetics. The focus of this paper is one of the key elements of inherent safety - the lead coolant of a nuclear reactor. Advantages of lead coolant for reactor application, influence on safety are reviewed. BREST-OD-300 fast reactor, currently being developed in Russia withing the “Proryv” Project utilizes lead coolant and a special set of measures and devices, called technology of lead coolant that ensures safe operation in a wide range of temperatures. Here these technological elements are reviewed, and current progress in their development is discussed.

Keywords: BREST-OD-300. , fast reactor, inherent safety, lead coolant

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4868 Formulation and in vitro Evaluation of Sustained Release Matrix Tablets of Levetiracetam for Better Epileptic Treatment

Authors: Nagasamy Venkatesh Dhandapani

Abstract:

The objective of the present study was to develop sustained release oral matrix tablets of anti epileptic drug levetiracetam. The sustained release matrix tablets of levetiracetam were prepared using hydrophilic matrix hydroxypropyl methylcellulose (HPMC) as a release retarding polymer by wet granulation method. Prior to compression, FTIR studies were performed to understand the compatibility between the drug and excipients. The study revealed that there was no chemical interaction between drug and excipients used in the study. The tablets were characterized by physical and chemical parameters and results were found in acceptable limits. In vitro release study was carried out for the tablets using 0.1 N HCl for 2 hours and in phosphate buffer pH 7.4 for remaining time up to 12 hours. The effect of polymer concentration was studied. Different dissolution models were applied to drug release data in order to evaluate release mechanisms and kinetics. The drug release data fit well to zero order kinetics. Drug release mechanism was found as a complex mixture of diffusion, swelling and erosion.

Keywords: levetiracetam, sustained-release, hydrophilic matrix tablet, HPMC grade K 100 MCR, wet granulation, zero order release kinetics

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4867 Development of the Drug Abuse Health Information System in Thai Community

Authors: Waraporn Boonchieng, Ekkarat Boonchieng, Sivaporn Aungwattana, Decha Tamdee, Wongamporn Pinyavong

Abstract:

Drug addiction represents one of the most important public health issues in both developed and developing countries. The purpose of this study was to develop a drug abuse health information in a community in Northern Thailand using developmental research design. The developmental researchers performed four phases to develop drug abuse health information, including 1) synthesizing knowledge related to drug abuse prevention and identifying the components of drug abuse health information; 2) developing the system in mobile application and website; 3) implementing drug abuse health information in the rural community; and 4) evaluating the feasibility of drug abuse health information. Data collection involved both qualitative and quantitative procedures. The qualitative data and quantitative data were analyzed using content analysis and descriptive statistics, respectively. The findings of this study showed that drug abuse health information consisted of five sections, including drug-related prevention knowledge for teens, drug-related knowledge for adults and professionals, the database for drug dependence treatment centers, self-administered questionnaires, and supportive counseling sections. First, in drug-related prevention knowledge for teens, the developmental researchers designed four infographics and animation to provide drug-related prevention knowledge, including types of illegal drugs, causes of drug abuse, consequences of drug abuse, drug abuse diagnosis and treatment, and drug abuse prevention. Second, in drug-related knowledge for adults and professionals, the developmental researchers developed many documents in a form of PDF file to provide drug-related knowledge, including types of illegal drugs, causes of drug abuse, drug abuse prevention, and relapse prevention guideline. Third, database for drug dependence treatment centers included the place, direction map, operation time, and the way for contacting all drug dependence treatment centers in Thailand. Fourth, self-administered questionnaires comprised preventive drugs behavior questionnaire, drug abuse knowledge questionnaire, the stages of change readiness and treatment eagerness to drug use scale, substance use behaviors questionnaire, tobacco use behaviors questionnaire, stress screening, and depression screening. Finally, for supportive counseling, the developmental researchers designed chatting box through which each user could write and send their concerns to counselors individually. Results from evaluation process showed that 651 participants used drug abuse health information via mobile application and website. Among all users, 48.8% were males and 51.2% were females. More than half (55.3%) were 15-20 years old and most of them (88.0%) were Buddhists. Most users reported ever getting knowledge related to drugs (86.1%), and drinking alcohol (94.2%) while some of them (6.9%) reported ever using tobacco. For satisfaction with using the drug abuse health information, more than half of users reflected that the contents of drug abuse health information were interesting (59%), up-to date (61%), and highly useful to their self-study (59%) at high level. In addition, half of them were satisfied with the design in terms of infographics (54%) and animation (51%). Thus, this drug abuse health information can be adopted to explore drug abuse situation and serves as a tool to prevent drug abuse and addiction among Thai community people.

Keywords: drug addiction, health informatics, big data, development research

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4866 A Fuzzy TOPSIS Based Model for Safety Risk Assessment of Operational Flight Data

Authors: N. Borjalilu, P. Rabiei, A. Enjoo

Abstract:

Flight Data Monitoring (FDM) program assists an operator in aviation industries to identify, quantify, assess and address operational safety risks, in order to improve safety of flight operations. FDM is a powerful tool for an aircraft operator integrated into the operator’s Safety Management System (SMS), allowing to detect, confirm, and assess safety issues and to check the effectiveness of corrective actions, associated with human errors. This article proposes a model for safety risk assessment level of flight data in a different aspect of event focus based on fuzzy set values. It permits to evaluate the operational safety level from the point of view of flight activities. The main advantages of this method are proposed qualitative safety analysis of flight data. This research applies the opinions of the aviation experts through a number of questionnaires Related to flight data in four categories of occurrence that can take place during an accident or an incident such as: Runway Excursions (RE), Controlled Flight Into Terrain (CFIT), Mid-Air Collision (MAC), Loss of Control in Flight (LOC-I). By weighting each one (by F-TOPSIS) and applying it to the number of risks of the event, the safety risk of each related events can be obtained.

Keywords: F-topsis, fuzzy set, flight data monitoring (FDM), flight safety

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4865 Reducing Crash Risk at Intersections with Safety Improvements

Authors: Upal Barua

Abstract:

Crash risk at intersections is a critical safety issue. This paper examines the effectiveness of removing an existing off-set at an intersection by realignment, in reducing crashes. Empirical Bayes method was applied to conduct a before-and-after study to assess the effect of this safety improvement. The Transportation Safety Improvement Program in Austin Transportation Department completed several safety improvement projects at high crash intersections with a view to reducing crashes. One of the common safety improvement techniques applied was the realignment of intersection approaches removing an existing off-set. This paper illustrates how this safety improvement technique is applied at a high crash intersection from inception to completion. This paper also highlights the significant crash reductions achieved from this safety improvement technique applying Empirical Bayes method in a before-and-after study. The result showed that realignment of intersection approaches removing an existing off-set can reduce crashes by 53%. This paper also features the state of the art techniques applied in planning, engineering, designing and construction of this safety improvement, key factors driving the success, and lessons learned in the process.

Keywords: crash risk, intersection, off-set, safety improvement technique, before-and-after study, empirical Bayes method

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4864 Enhancement of 2, 4-Dichlorophenoxyacetic Acid Solubility via Solid Dispersion Technique

Authors: Tamer M. Shehata, Heba S. Elsewedy, Mashel Al Dosary, Alaa Elshehry, Mohamed A. Khedr, Maged E. Mohamed

Abstract:

Objective: 2,4-Dichlorophenoxy acetic acid (2,4-D) is a well-known herbicide widely used as a weed killer. Recently, 2,4-D was rediscovered as a new anti-inflammatory agent through in silico as well as in-vivo experiments. However, poor solubility of 2,4-D could represent a problems during pharmaceutical development in addition to lower bioavailability. Solid dispersion (SD) refers to a group of solid products consisting of at least two different components, usually a hydrophobic drug and hydrophilic matrix. It is well known technique for enhancing drug solubility. Therefore, selecting SD as a tool for enhancing 2,4-D could be of great interest to the formulator. Method: In our project, several polymers were investigated (such as PEG, HPMC, citric acid and others) in addition to drug polymer ratios and its effect on solubility. Evaluation of drug polymer interaction was investigated through both Fourier Transform Infrared (FTIR) and Differential Scanning Calorimetry (DSC). Finally, in-vivo evaluation was performed for the best selected preparation through inflammatory response of rat induce hind paw. Results: Results indicated that, citric acid 2,4-D and in ratio of 0.75 : 1 showed modified the dissolution profile of the drug. The FTIR resltes indicated no significant chemical interaction, however DSC showed shifting of the drug melting point. Finally, Carragenan induced rat hind paw edema showed significant reduction of the drug solid dispersion in comparison to the pure drug, indicating rapid and complete absorption of the drug in solid dispersion form. Conclusion: Solid dispersion technology can be utilized efficiently to enhance the solubility of 2,4-D.

Keywords: solid dispersion, 2, 4-D solubility, carragenan induced edema

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4863 Exploring the Meaning of Safety in Acute Mental Health Inpatient Units from the Consumer Perspective

Authors: Natalie Cutler, Lorna Moxham, Moira Stephens

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Safety is a priority in mental health services, and no more so than in the acute inpatient setting. Mental health service policies and accreditation frameworks commonly approach safety from a risk reduction or elimination perspective leading to service approaches that are arguably more focused on risk than on safety. An exploration what safety means for people who have experienced admission to an acute mental health inpatient unit is currently under way in Sydney, Australia. Using a phenomenographic research approach, this study is seeking to understand the meaning of safety from the perspective of people who use, rather than those who deliver mental health services. Preliminary findings suggest that the meanings of safety for users of mental health services vary from the meanings inherent in the policies and frameworks that inform how mental health services and mental health practice are delivered. This variance has implications for the physical and environmental design of acute mental health inpatient facilities, the policies and practices, and the education and training of mental health staff in particular nurses, who comprise the majority of the mental health workforce. These variances will be presented, along with their implications for the way quality and safety in mental health services are evaluated.

Keywords: acute inpatient, mental health, nursing, phenomenography, recovery, safety

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4862 Delivering Safer Clinical Trials; Using Electronic Healthcare Records (EHR) to Monitor, Detect and Report Adverse Events in Clinical Trials

Authors: Claire Williams

Abstract:

Randomised controlled Trials (RCTs) of efficacy are still perceived as the gold standard for the generation of evidence, and whilst advances in data collection methods are well developed, this progress has not been matched for the reporting of adverse events (AEs). Assessment and reporting of AEs in clinical trials are fraught with human error and inefficiency and are extremely time and resource intensive. Recent research conducted into the quality of reporting of AEs during clinical trials concluded it is substandard and reporting is inconsistent. Investigators commonly send reports to sponsors who are incorrectly categorised and lacking in critical information, which can complicate the detection of valid safety signals. In our presentation, we will describe an electronic data capture system, which has been designed to support clinical trial processes by reducing the resource burden on investigators, improving overall trial efficiencies, and making trials safer for patients. This proprietary technology was developed using expertise proven in the delivery of the world’s first prospective, phase 3b real-world trial, ‘The Salford Lung Study, ’ which enabled robust safety monitoring and reporting processes to be accomplished by the remote monitoring of patients’ EHRs. This technology enables safety alerts that are pre-defined by the protocol to be detected from the data extracted directly from the patients EHR. Based on study-specific criteria, which are created from the standard definition of a serious adverse event (SAE) and the safety profile of the medicinal product, the system alerts the investigator or study team to the safety alert. Each safety alert will require a clinical review by the investigator or delegate; examples of the types of alerts include hospital admission, death, hepatotoxicity, neutropenia, and acute renal failure. This is achieved in near real-time; safety alerts can be reviewed along with any additional information available to determine whether they meet the protocol-defined criteria for reporting or withdrawal. This active surveillance technology helps reduce the resource burden of the more traditional methods of AE detection for the investigators and study teams and can help eliminate reporting bias. Integration of multiple healthcare data sources enables much more complete and accurate safety data to be collected as part of a trial and can also provide an opportunity to evaluate a drug’s safety profile long-term, in post-trial follow-up. By utilising this robust and proven method for safety monitoring and reporting, a much higher risk of patient cohorts can be enrolled into trials, thus promoting inclusivity and diversity. Broadening eligibility criteria and adopting more inclusive recruitment practices in the later stages of drug development will increase the ability to understand the medicinal products risk-benefit profile across the patient population that is likely to use the product in clinical practice. Furthermore, this ground-breaking approach to AE detection not only provides sponsors with better-quality safety data for their products, but it reduces the resource burden on the investigator and study teams. With the data taken directly from the source, trial costs are reduced, with minimal data validation required and near real-time reporting enables safety concerns and signals to be detected more quickly than in a traditional RCT.

Keywords: more comprehensive and accurate safety data, near real-time safety alerts, reduced resource burden, safer trials

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4861 Development and Characterization Self-Nanoemulsifying Drug Delivery Systems of Poorly Soluble Drug Dutasteride

Authors: Rajinikanth Siddalingam, Poonguzhali Subramanian

Abstract:

The present study aims to prepare and evaluate the self-nano emulsifying drug delivery (SNEDDS) system to enhance the dissolution rate of a poorly soluble drug dutasteride. The formulation was prepared using capryol PGMC, Cremophor EL, and polyethylene glycol (PEG) 400 as oil, surfactant and co-surfactant, respectively. The pseudo-ternary phase diagrams with presence and absence of drug were plotted to find out the nano emulsification range and also to evaluate the effect of dutasteride on the emulsification behavior of the phases. Prepared SNEDDS formulations were evaluated for its particle size distribution, nano emulsifying properties, robustness to dilution, self-emulsification time, turbidity measurement, drug content and in-vitro dissolution. The optimized formulations are further evaluated for heating cooling cycle, centrifugation studies, freeze-thaw cycling, particle size distribution and zeta potential were carried out to confirm the stability of the formed SNEDDS formulations. The particle size, zeta potential and polydispersity index of the optimized formulation found to be 35.45 nm, -15.45 and 0.19, respectively. The in vitro results are revealed that the prepared formulation enhanced the dissolution rate of dutasteride significantly as compared with pure drug. The in vivo studies in was conducted using rats and the results are revealed that SNEDDS formulation has enhanced the bioavailability of dutasteride drug significantly as compared with raw drug. Based the results, it was concluded that the dutasteride-loaded SNEDDS shows potential to enhance the dissolution of dutasteride, thus improving the bioavailability and therapeutic effects.

Keywords: self-emulsifying drug delivery system, dutasteride, enhancement of bioavailability, dissolution enhancement

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4860 Feedback of an Automated Hospital about the Performance of an Automated Drug Dispensing System’s Implementation

Authors: Bouami Hind, Millot Patrick

Abstract:

The implementation of automated devices in life-critical systems such as hospitals can bring a new set of challenges related to automation malfunctions. While automation has been identified as great leverage for the medication dispensing system’s security and efficiency, it also increases the complexity of the organization. In particular, the installation and operation stage of automated devices can be complex when malfunctions related to automated systems occur. This paper aims to document operators’ situation awareness about the malfunctions of automated drug delivery systems (ADCs) during their implementation through Saint Brieuc hospital’s feedback. Our evaluation approach has been deployed in Saint Brieuc hospital center’s pharmacy, which has been equipped with automated nominative drug dispensing systems since January of 2021. The analysis of Saint Brieuc hospital center pharmacy’s automation revealed numerous malfunctions related to the implementation of Automated Delivery Cabinets. It appears that the targeted performance is not reached in the first year of implementation in this case study. Also, errors have been collected in patients' automated treatments’ production such as lack of drugs in pill boxes or nominative carnets, excess of drugs, wrong location of the drug, drug blister damaged, non-compliant sachet, or ticket errors. Saint Brieuc hospital center’s pharmacy is doing a tremendous job of setting up and monitoring performance indicators from the beginning of automation and throughout ADC’s operation to control ADC’s malfunctions and meet the performance targeted by the hospital. Health professionals, including pharmacists, biomedical engineers and directors of work, technical services and safety, are heavily involved in an automation project. This study highlights the importance of the evaluation of ADCs’ performance throughout the implementation process and the hospital’s team involvement in automation supervision and management.

Keywords: life-critical systems, situation awareness, automated delivery cabinets, implementation, risks and malfunctions

Procedia PDF Downloads 63
4859 Evaluation of a Potential Metabolism-Mediated Drug-Drug Interaction between Carvedilol and Fluvoxamine in Rats

Authors: Ana-Maria Gheldiu, Bianca M. Abrudan, Maria A. Neag, Laurian Vlase, Dana M. Muntean

Abstract:

Background information: The objective of this study was to investigate the effect of multiple-dose fluvoxamine on the pharmacokinetic profile of single-dose carvedilol in rats, in order to evaluate this possible drug-drug pharmacokinetic interaction. Methods: A preclinical study, in 28 white male Wistar rats, was conducted. Each rat was cannulated on the femoral vein, prior to being connected to BASi Culex ABC®. Carvedilol was orally administrated in rats (3.57 mg/kg body mass (b.m.)) in the absence of fluvoxamine or after a pre-treatment with multiple oral doses of fluvoxamine (14.28 mg/kg b.m.). The plasma concentrations of carvedilol were estimated by high performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters of carvedilol were analyzed by non-compartmental method. Results: After carvediol co-administration with fluvoxamine, an approximately 2-fold increase in the exposure of carvedilol was observed, considering the significantly elevated value of the total area under the concentration versus time curve (AUC₀₋∞). Moreover, an increase by approximately 145% of the peak plasma concentration was found, as well as an augmentation by approximately 230% of the half life time of carvedilol was observed. Conclusion: Fluvoxamine co-administration led to a significant alteration of carvedilol’s pharmacokinetic profile in rats, these effects could be explained by the existence of a drug-drug interaction mediated by CYP2D6 inhibition. Acknowledgement: This work was supported by CNCS Romania – project PNII-RU-TE-2014-4-0242.

Keywords: carvedilol, fluvoxamine, drug-drug pharmacokinetic interaction, rats

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4858 Formulation and Evaluation of Ethosomes of Plumeria indica Linn. Flowers

Authors: Sumeet Dwivedi, Shweta Shriwas, Raghvendra Dubey

Abstract:

The number of products based on new drug delivery systems has significantly increased in the past few years, and this growth is expected to continue in the near future. These biopharmaceuticals present challenges to drug delivery scientists because of their unique nature and difficulty in delivery through conventional routes. Therefore, future research will focus on the delivery of these complex molecules through different routes, including oral, nasal, pulmonary, vaginal, rectal, etc. The aim of present study was to formulate and evaluate ethosomes of Plumeria indica flowers which may deliver the drug to targeted site more efficiently than marketed preparation and also overcome the problems related with oral administration of drug. The formulations were prepared with ethanol, lecithin, propylene glycol and were evaluated.

Keywords: ethosomes, herbal extract, plumeria alba, lecithin

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4857 Drug-Drug Plasma Protein Binding Interactions of Ivacaftor

Authors: Elena K. Schneider, Johnny X. Huang, Vincenzo Carbone, Mark Baker, Mohammad A. K. Azad, Matthew A. Cooper, Jian Li, Tony Velkov

Abstract:

Ivacaftor is a novel CF trans-membrane conductance regulator (CFTR) potentiator that improves the pulmonary function for cystic fibrosis patients bearing a G551D CFTR-protein mutation. Because ivacaftor is highly bound (>97%) to plasma proteins, there is the strong possibility that co-administered CF drugs that compete for the same plasma protein binding sites and impact the free drug concentration. This in turn could lead to drastic changes in the in vivo efficacy of ivacaftor and therapeutic outcomes. This study compares the binding affinity of ivacaftor and co-administered CF drugs for human serum albumin (HSA) and α1-acid glycoprotein (AGP) using surface plasmon resonance and fluorimetric binding assays that measure the displacement of site selective probes. Due to their high plasma protein binding affinities, drug-drug interactions between ivacaftor are to be expected with ducosate, montelukast, ibuprofen, dicloxacillin, omeprazole and loratadine. The significance of these drug-drug interactions is interpreted in terms of the pharmacodynamic/pharmacokinetic parameters and molecular docking simulations. The translational outcomes of the data are presented as recommendations for a staggered treatment regimen for future clinical trials which aims to maximize the effective free drug concentration and clinical efficacy of ivacaftor.

Keywords: human α-1-acid glycoprotein, binding affinity, human serum albumin, ivacaftor, cystic fibrosis

Procedia PDF Downloads 267
4856 Development of Risk Assessment and Occupational Safety Management Model for Building Construction Projects

Authors: Preeda Sansakorn, Min An

Abstract:

In order to be capable of dealing with uncertainties, subjectivities, including vagueness arising in building construction projects, the application of fuzzy reasoning technique based on fuzzy set theory is proposed. This study contributes significantly to the development of a fuzzy reasoning safety risk assessment model for building construction projects that could be employed to assess the risk magnitude of each hazardous event identified during construction, and a third parameter of probability of consequence is incorporated in the model. By using the proposed safety risk analysis methodology, more reliable and less ambiguities, which provide the safety risk management project team for decision-making purposes.

Keywords: safety risk assessment, building construction safety, fuzzy reasoning, construction risk assessment model, building construction projects

Procedia PDF Downloads 445
4855 Clinical and Microbiologic Efficacy and Safety of Imipenem Cilastatin Relebactam in Complicated Infections: A Meta-analysis

Authors: Syeda Sahra, Abdullah Jahangir, Rachelle Hamadi, Ahmad Jahangir, Allison Glaser

Abstract:

Background: Antimicrobial resistance is on the rise. The use of redundant and inappropriate antibiotics is contributing to recurrent infections and resistance. Newer antibiotics with more robust coverage for gram-negative bacteria are in great demand for complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), hospital-acquired bacterial pneumonia (H.A.B.P.), and ventilator-associated bacterial pneumonia (V.A.B.P.). Objective: We performed this meta-analysis to evaluate the efficacy and safety profile of a new antibiotic, Imipenem/cilastatin/relebactam, compared to other broad-spectrum antibiotics for complicated infections. Search Strategy: We conducted a systemic review search on PubMed, Embase, and Central Cochrane Registry. Selection Criteria: We included randomized clinical trials (R.C.T.s) with the standard of care as comparator arm with Imipenem/cilastatin/relebactam as intervention arm. Analysis: For continuous variables, the mean difference was used. For discrete variables, we used the odds ratio. For effect sizes, we used a confidence interval of 95%. A p-value of less than 0.05 was used for statistical significance. Analysis was done using a random-effects model irrespective of heterogeneity. Heterogeneity was evaluated using the I2 statistic. Results: The authors observed similar efficacy at clinical and microbiologic response levels on early follow-up and late follow-up compared to the established standard of care. The incidence of drug-related adverse events, serious adverse events, and drug discontinuation due to adverse events were comparable across both groups. Conclusion: Imipenem/cilastatin/relebactam has a non-inferior safety and efficacy profile compared to peer antibiotics to treat severe bacterial infections (cUTIs, cIAIs, H.A.B.P., V.A.B.P.).

Keywords: bacterial pneumonia, complicated intra-abdominal infections, complicated urinary tract infection, Imipenem, cilastatin, relebactam

Procedia PDF Downloads 157
4854 Food Safety Management in Riyadh’s Ministry of Health Hospitals

Authors: A. Alrasheed, I. Connerton

Abstract:

Providing patients with safe meals on a daily basis is one of the challenges in the healthcare sector. In Saudi Arabia matters related to food safety and hygiene have been the heart of the Ministry of Health (MOH) and Saudi Food and Drugs Authority (SFDA). The aim of this study is to examine the causes of inadequate implementation of food safety management systems such as HACCP in Riyadh’s MOH hospitals. By the law, food safety must be managed using a documented, HACCP based approach, and food handlers must be appropriately trained in food safety. Food handlers in Saudi Arabia are not required to provide a certificate or attend a food handling training course even in healthcare sectors. Since food safety and hygiene issues are of increasing importance for Saudi Arabian health decision makers, the SFDA has been established to apply food hygiene requirements in all food operations. It should be pointed out that the implications of food outbreaks on the whole society may potentially go beyond individual health impacts but also impact on the Nation’s health and bring about economic repercussions.

Keywords: food safety, patient, hospital, HACCP

Procedia PDF Downloads 832
4853 Erythema Multiforme Exudativum Major Caused by Isoniazid Hypersensitivity in a Child

Authors: Azwin Lubis, Rika Hapsari, Zahrah Hikmah, Anang Endaryanto, Ariyanto Harsono

Abstract:

Erythema Multiforme Exudativum Major (EMEM) is one of the drug allergy diseases. Drug allergies caused by isoniazid rarely causes EMEM. Cutaneous reactions caused by isoniazid were obtained in 0.98% of patients, but the precise occurrence of Steven Johnson’s Syndrome (SJS) and Toxic Epidermolisis Necrolisis (TEN) due to isoniazid is not known for certain. We present this case to show hypersensitivity of isoniazid in a child. Based on the history of drug intake, physical diagnostic tests, drug elimination and provocation; we established the diagnosis of isoniazid hypersensitivity. The child showed improvement on skin manifestation after stopped isoniazid therapy.

Keywords: erythema multiforme exudativum major, hypersensitivity, elimination test, provocation test

Procedia PDF Downloads 215