Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 4039

Search results for: drug safety

4039 Pharmacovigilance: An Empowerment in Safe Utilization of Pharmaceuticals

Authors: Pankaj Prashar, Bimlesh Kumar, Ankita Sood, Anamika Gautam

Abstract:

Pharmacovigilance (PV) is a rapidly growing discipline in pharmaceutical industries as an integral part of clinical research and drug development over the past few decades. PV carries a breadth of scope from drug manufacturing to its regulation with safer utilization. The fundamental steps of PV not only includes data collection and verification, coding of drugs with adverse drug reactions, causality assessment and timely reporting to the authorities but also monitoring drug manufacturing, safety issues, product quality and conduction of due diligence. Standardization of adverse event information, collaboration of multiple departments in different companies, preparation of documents in accordance to both governmental as well as non-governmental organizations (FDA, EMA, GVP, ICH) are the advancements in discipline of PV. De-harmonization, lack of predictive drug safety models, improper funding by government, non-reporting, and non-acceptability of ADRs by developing countries and reports directly from patients to the monitoring centres respectively are the major road backs of PV. Mandatory pharmacovigilance reporting, frequent inspections, funding by government, educating and training medical students, pharmacists and nurses in this segment can bring about empowerment in PV. This area needs to be addressed with a sense of urgency for the safe utilization of pharmaceuticals.

Keywords: pharmacovigilance, regulatory, adverse event, drug safety

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4038 Comparative Study on the Evaluation of Patient Safety in Malaysian Retail Pharmacy Setup

Authors: Palanisamy Sivanandy, Tan Tyng Wei, Tan Wee Loon, Lim Chong Yee

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Background: Patient safety has become a major concern over recent years with elevated medication errors; particularly prescribing and dispensing errors. Meticulous prescription screening and diligent drug dispensing is therefore important to prevent drug-related adverse events from inflicting harm to patients. Hence, pharmacists play a significant role in this scenario. The evaluation of patient safety in a pharmacy setup is crucial to contemplate current practices, attitude and perception of pharmacists towards patient safety. Method: The questionnaire for Pharmacy Survey on Patient Safety Culture developed by the Agency for Healthcare and Research Quality (AHRQ) was used to assess patient safety. Main objectives of the study was to evaluate the attitude and perception of pharmacists towards patient safety in retail pharmacies setup in Malaysia. Results: 417 questionnaire were distributed via convenience sampling in three different states of Malaysia, where 390 participants were responded and the response rate was 93.52%. The overall positive response rate (PRR) was ranged from 31.20% to 87.43% and the average PRR was found to be 67%. The overall patient safety grade for our pharmacies was appreciable and it ranges from good to very good. The study found a significant difference in the perception of senior and junior pharmacists towards patient safety. The internal consistency of the questionnaire contents /dimensions was satisfactory (Cronbach’s alpha - 0.92). Conclusion: Our results reflect that there was positive attitude and perception of retail pharmacists towards patient safety. Despite this, various efforts can be implemented in the future to amplify patient safety in retail pharmacies setup.

Keywords: patient safety, attitude, perception, positive response rate, medication errors

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4037 Creation and Implementation of A New Palliative Care Drug Chart, via A Closed-Loop Audit

Authors: Asfa Hussain, Chee Tang, Mien Nguyen

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Introduction: The safe usage of medications is dependent on clear, well-documented prescribing. Medical drug charts should be regularly checked to ensure that they are fit for purpose. Aims: The purpose of this study was to evaluate whether the Isabel Hospice drug charts were effective or prone to medical errors. The aim was to create a comprehensive palliative care drug chart in line with medico-legal guidelines and to minimise drug administration and prescription errors. Methodology: 50 medical drug charts were audited from March to April 2020, to assess whether they complied with medico-legal guidelines, in a hospice within East of England. Meetings were held with the larger multi-disciplinary team (MDT), including the pharmacists, nursing staff and doctors, to raise awareness of the issue. A preliminary drug chart was created, using the input from the wider MDT. The chart was revised and trialled over 15 times, and each time feedback from the MDT was incorporated into the subsequent template. In the midst of the COVID-19 pandemic in September 2020, the finalised drug chart was trialled. 50 new palliative drug charts were re-audited, to evaluate the changes made. Results: Prescribing and administration errors were high prior to the implementation of the new chart. This improved significantly after introducing the new drug charts, therefore improving patient safety and care. The percentage of inadequately documented allergies went down from 66% to 20% and incorrect oxygen prescription from 40% to 16%. The prescription drug-drug interactions decreased by 30%. Conclusion: It is vital to have clear standardised drug charts, in line with medico-legal standards, to allow ease of prescription and administration of medications and ensure optimum patient-centred care. This closed loop audit demonstrated significant improvement in documentation and prevention of possible fatal drug errors and interactions.

Keywords: palliative care, drug chart, medication errors, drug-drug interactions, COVID-19, patient safety

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4036 Cannabis for the Treatment of Drug Resistant Epilepsy in Children

Authors: Sarah E. Casey

Abstract:

Epilepsy is the most common neurological disorder in children and approximately one-third of children with epilepsy have seizures that are uncontrolled on anticonvulsants alone. Cannabidiol is shown to be an effective treatment at reducing the amount of breakthrough seizures experienced by children with drug resistant epilepsy. Improvements in quality of life and overall condition were noted during cannabidiol treatment. Adverse side effects were experienced and were generally mild to moderate in nature. Additional double-blind, controlled studies with a more diverse sample population and standardized dosing are needed to ensure the efficacy and safety of cannabidiol use in children with drug resistant epilepsy.

Keywords: cannabis, drug resistant epilepsy, children, epilepsy

Procedia PDF Downloads 78
4035 Drugs, Silk Road, Bitcoins

Authors: Lali Khurtsia, Vano Tsertsvadze

Abstract:

Georgian drug policy is directed to reduce the supply of drugs. Retrospective analysis has shown that law enforcement activities have been followed by the expulsion of particular injecting drugs. The demand remains unchanged and drugs are substituted by the hand-made, even more dangerous homemade drugs entered the market. To find out expected new trends on the Georgian drug market, qualitative study was conducted with Georgian drug users to determine drug supply routes. It turned out that drug suppliers and consumers for safety reasons and to protect their anonymity, use Skype to make deals. IT in illegal drug trade is even more sophisticated in the worldwide. Trading with Bitcoins in the Darknet ensures high confidentiality of money transactions and the safe circulation of drugs. In 2014 largest Bitcoin mining enterprise in the world was built in Georgia. We argue that the use of Bitcoins and Darknet by Georgian drug consumers and suppliers will be an incentive to response adequately to the government's policy of restricting supply in order to satisfy market demand for drugs.

Keywords: bitcoin, darknet, drugs, policy

Procedia PDF Downloads 364
4034 The Safety Profile of Vilazodone: A Study on Post-Marketing Surveillance

Authors: Humraaz Kaja, Kofi Mensah, Frasia Oosthuizen

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Background and Aim: Vilazodone was approved in 2011 as an antidepressant to treat the major depressive disorder. As a relatively new drug, it is not clear if all adverse effects have been identified. The aim of this study was to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM) in order to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method: Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analyzed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post-marketing. Results: A total of 9708 adverse events had been recorded on VigiAccess, of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastro-intestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions: In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued post-marketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.

Keywords: adverse drug reactions, pharmacovigilance, post-marketing surveillance, vilazodone

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4033 Incorporation of Safety into Design by Safety Cube

Authors: Mohammad Rajabalinejad

Abstract:

Safety is often seen as a requirement or a performance indicator through the design process, and this does not always result in optimally safe products or systems. This paper suggests integrating the best safety practices with the design process to enrich the exploration experience for designers and add extra values for customers. For this purpose, the commonly practiced safety standards and design methods have been reviewed and their common blocks have been merged forming Safety Cube. Safety Cube combines common blocks for design, hazard identification, risk assessment and risk reduction through an integral approach. An example application presents the use of Safety Cube for design of machinery.

Keywords: safety, safety cube, product, system, machinery, design

Procedia PDF Downloads 119
4032 An Investigation on the Relationship between Taxi Company Safety Climate and Safety Performance of Taxi Drivers in Iloilo City

Authors: Jasper C. Dioco

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The study was done to investigate the relationship of taxi company safety climate and drivers’ safety motivation and knowledge on taxi drivers’ safety performance. Data were collected from three Taxi Companies with taxi drivers as participants (N = 84). The Hiligaynon translated version of Transportation Companies’ Climate Scale (TCCS), Safety Motivation and Knowledge Scale, Occupational Safety Motivation Questionnaire and Global Safety Climate Scale were used to study the relationships among four parameters: (a) Taxi company safety climate; (b) Safety motivation; (c) Safety knowledge; and (d) Safety performance. Correlational analyses found that there is no relation between safety climate and safety performance. A Hierarchical regression demonstrated that safety motivation predicts the most variance in safety performance. The results will greatly impact how taxi company can increase safe performance through the confirmation of the proximity of variables to organizational outcome. A strong positive safety climate, in which employees perceive safety to be a priority and that managers are committed to their safety, is likely to increase motivation to be safety. Hence, to improve outcomes, providing knowledge based training and health promotion programs within the organization must be implemented. Policy change might include overtime rules and fatigue driving awareness programs.

Keywords: safety climate, safety knowledge, safety motivation, safety performance, taxi drivers

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4031 Safety Profile of Three Commonly Prescribed Interleukin Inhibitors for Psoriasis Treatment: Analysis of Drug Safety Database - Vigibase

Authors: Akanksha Marwah, Kajal Kaushik, Amit Kamboj, Tarni Prakash Shrivastava

Abstract:

Monoclonal antibodies are known as biological agents targeting specific Interleukins, i.e., IL-17A, IL-17RA, IL-23, AND IL-12/23 associated with the pathogenesis of psoriasis and other chronic inflammatory disorders were comparatively analyzed using WHO VigiFlow ADR reporting database for safety evaluation globally. Spontaneous reports associated with three commonly prescribed interleukin inhibitors, namely; Secukinumab, Ustekinumab, and Brodalumab available in VigiLyze, were analyzed concerning patient demography, the profession of reporter, system organ class (SOC) affected, causality assessment, the seriousness of the adverse event and year-wise analysis of reported ADRs. According to WHO Adverse Reaction Terminology for causality assessment, only 'certain', 'probable,' or 'possible' ADRs were included. Association between drugs and any ADR was assessed by using the case/non-case methodology. The reported ICSRs are higher in numbers for Secukinumab (72926) as compared to Ustekinumab (41480) and Brodalumab (1419). A higher prevalence of ADRs was seen in females for Secukinumab (54.8%) and Ustekinumab (51.5%), while Brodalumab associated ADRs were more in males (55.5%). Out of all three drugs, Ustekinumab has caused more serious ADRs (45.0%) in patients. System organ class mostly reported for ADRs associated with all the three drugs included general disorders and administration site conditions (Avg. 35.53%), and the most reported preferred term was drug ineffective (12.0%) for all the three drugs. This study has identified the potential of the three most prescribed Interleukin inhibitors for causing specific ADRs in patients using these drugs. All these three drugs mostly cause the reaction associated with the involvement of administration sites and general disorders. surprisingly, the preferred term which was most reported for all these drugs was the drug ineffective, which indicates a failure of the drug to cause a therapeutic effect. More focused PV studies in clinical settings are needed to witness the safety profile of Secukinumab, Ustekinumab, and Brodalumab in the treatment of Psoriasis.

Keywords: adverse drug reactions, interleukins, case-non case study, poriasis

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4030 Adverse Drug Reactions Monitoring in the Northern Region of Zambia

Authors: Ponshano Kaselekela, Simooya O. Oscar, Lunshano Boyd

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The Copperbelt University Health Services (CBUHS) was designated by the Zambia Medicines Regulatory Authority (ZAMRA), formally the Pharmaceutical Regulatory Authority (PRA) as a regional pharmacovigilance centre to carryout activities of drug safety monitoring in four provinces in Zambia. CBUHS’s mandate included stimulating the reporting of adverse drug reactions (ADRs), as well as collecting and collating ADR reports from health institutions in the four provinces. This report covers the researchers’ experiences from May 2008 to September, 2016. The main objectives are 1) to monitor ADRs in the Zambian population, 2) to disseminate information to all health professionals in the region advising that the CBU health was a centre for reporting ADRs in the region, 3) to monitor polypharmacy as well as the benefit-risk profile of medicines, 4) to generate independent, evidence based recommendations on the safety of medicines, 5) to support ZAMRA in formulating safety related regulatory decisions for medicines, and 6) to communicate findings with all key stakeholders. The methodology involved monthly visits, beginning in early May 2008 to September, 2016, by the CBUHS to health institutions in the programme areas. Activities included holding discussions with health workers, distribution of ADR forms and collection of ADRs reports. These reports, once collected, were documented and assessed at the CBUHS. A report was then prepared for ZAMRA on quarterly basis. At ZAMRA, serious ADRs were noted and recommendations made to the Ministry of Health of the Republic of Zambia. The results show that 2,600 ADRs reports were received at the pharmacovigilance regional centre. Most of the ADRs reports that received were due to antiretroviral drugs, as well as a few from anti-malarial drugs like Artemether/Lumefantrine – Coartem®. Three hundred and twelve ADRs were entered in the Uppsala Monitoring Centre WHO Vigiflow for further analysis. It was concluded that in general, 2008-16 were exciting years for the pharmacovigilance group at CBUHS. From a very tentative beginning, a lot of strides were made and contacts established with healthcare facilities in the region. The researchers were encouraged by the support received from the Copperbelt University management, the motivation provided by ZAMRA and most importantly the enthusiasm of health workers in all the health care facilities visited. As a centre for drug safety in Zambia, the results show it achieves its objectives for monitoring ADRs, Pharmacovigilance (drug safety monitoring), and activities of monitoring ADRs as well as preventing them. However, the centre faces critical challenges caused by erratic funding that prevents the smooth running of the programme.

Keywords: adverse drug reactions, drug safety, monitoring, pharmacovigilance

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4029 Pattern of ICU Admission due to Drug Problems

Authors: Kamel Abd Elaziz Mohamed

Abstract:

Introduction: Drug related problems (DRPs) are of major concern, affecting patients of both sex. They impose considerable economic burden on the society and the health-care systems. Aim of the work: The aim of this work was to identify and categorize drug-related problems in adult intensive care unit. Patients and methods: The study was a prospective, observational study as eighty six patients were included. They were consecutively admitted to ICU through the emergency room or transferred from the general ward due to DRPs. Parameters included in the study as length of stay in ICU, need for cardiovascular support or mechanical ventilation, dialysis, as well as APACHE II score were recorded. Results: Drug related problems represent 3.6% of the total ICU admission. The median (range) of APACHE II score for 86 patients included in the study was 17 (10-23), and length of ICU stay was 2.4 (1.5-4.2) days. In 45 patients (52%), DRP was drug over dose (group 1), while other DRP was present in the other 41 patients (48%, group 11). Patients in group 1 were older (39 years versus 32 years in group 11), with significant impaired renal function. The need of inotropic drugs and mechanical ventilation as well as the length of stay (LOS) in ICU was significantly higher in group 1. There were no significant difference in GCS between both groups, however APACHE II score was significantly higher in group 1. Only four patients (4.6%) were admitted by suicidal attempt as well as three patients (3.4%) due to trauma drug-related admissions, all were in (group 1). Nineteen percent of the patients had drug related problem due to hypoglycaemic medication followed by tranquilizer (15%). Adverse drug effect followed by failure to receive medication were the most causes of drug problem in (group11).The total mortality rate was 4.6%, all of them were eventually non preventable. Conclusion: The critically ill patients admitted due to drug related problems represented a small proportion (3.6%) of admissions to the ICU. Hypoglycaemic medication was one of the most common causes of admission by drug related problems.

Keywords: drug related problems, ICU, cost, safety

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4028 Effects of Using a Recurrent Adverse Drug Reaction Prevention Program on Safe Use of Medicine among Patients Receiving Services at the Accident and Emergency Department of Songkhla Hospital Thailand

Authors: Thippharat Wongsilarat, Parichat tuntilanon, Chonlakan Prataksitorn

Abstract:

Recurrent adverse drug reactions are harmful to patients with mild to fatal illnesses, and affect not only patients but also their relatives, and organizations. To compare safe use of medicine among patients before and after using the recurrent adverse drug reaction prevention program . Quasi-experimental research with the target population of 598 patients with drug allergy history. Data were collected through an observation form tested for its validity by three experts (IOC = 0.87), and analyzed with a descriptive statistic (percentage). The research was conducted jointly with a multidisciplinary team to analyze and determine the weak points and strong points in the recurrent adverse drug reaction prevention system during the past three years, and 546, 329, and 498 incidences, respectively, were found. Of these, 379, 279, and 302 incidences, or 69.4; 84.80; and 60.64 percent of the patients with drug allergy history, respectively, were found to have caused by incomplete warning system. In addition, differences in practice in caring for patients with drug allergy history were found that did not cover all the steps of the patient care process, especially a lack of repeated checking, and a lack of communication between the multidisciplinary team members. Therefore, the recurrent adverse drug reaction prevention program was developed with complete warning points in the information technology system, the repeated checking step, and communication among related multidisciplinary team members starting from the hospital identity card room, patient history recording officers, nurses, physicians who prescribe the drugs, and pharmacists. Including in the system were surveillance, nursing, recording, and linking the data to referring units. There were also training concerning adverse drug reactions by pharmacists, monthly meetings to explain the process to practice personnel, creating safety culture, random checking of practice, motivational encouragement, supervising, controlling, following up, and evaluating the practice. The rate of prescribing drugs to which patients were allergic per 1,000 prescriptions was 0.08, and the incidence rate of recurrent drug reaction per 1,000 prescriptions was 0. Surveillance of recurrent adverse drug reactions covering all service providing points can ensure safe use of medicine for patients.

Keywords: recurrent drug, adverse reaction, safety, use of medicine

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4027 Safety Factors for Improvement of Labor's Health and Safety in Construction Industry of Pakistan

Authors: Ahsan Ali Khan

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During past few years, researchers are emphasizing more on the need of safety in construction industry. This need of safety is an important issue in developing countries. As due to development they are facing huge construction growth. This research is done to evaluate labor safety condition in construction industry of Pakistan. The research carried out through questionnaire survey at different construction sites. Useful data are gathered from these sites which then factor analyzed resulting in five factors. These factors reflect that most of the workers are aware of the safety need, but they divert this responsibility towards management and claim that the work is more essential for management instead of safety. Moreover, those work force which is unaware of safety state that there is lack of any training and guidance from upper management which lead to many unfavorable events on construction sites. There is need of implementation safety activities by management like training, formulation of rules and policies. This research will be helpful to divert management attention towards safety need so they will make efforts for safety of their manpower—the workers.

Keywords: labor's safety, management role, Pakistan, safety factors

Procedia PDF Downloads 86
4026 In Silico Studies on Selected Drug Targets for Combating Drug Resistance in Plasmodium Falcifarum

Authors: Deepika Bhaskar, Neena Wadehra, Megha Gulati, Aruna Narula, R. Vishnu, Gunjan Katyal

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With drug resistance becoming widespread in Plasmodium falciparum infections, development of the alternative drugs is the desired strategy for prevention and cure of malaria. Three drug targets were selected to screen promising drug molecules from the GSK library of around 14000 molecules. Using an in silico structure-based drug designing approach, the differences in binding energies of the substrate and inhibitor were exploited between target sites of parasite and human to design a drug molecule against Plasmodium. The docking studies have shown several promising molecules from GSK library with more effective binding as compared to the already known inhibitors for the drug targets. Though stronger interaction has been shown by several molecules as compare to reference, few molecules have shown the potential as drug candidates though in vitro studies are required to validate the results.

Keywords: plasmodium, malaria, drug targets, in silico studies

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4025 A Comparative Analysis of Safety Orientation and Safety Performance in Organizations: A Project Management Perspective

Authors: Dina Alfreahat, Zoltan Sebestyen

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Safety is considered as one of the project’s success factors. Poor safety management may result in accidents that impact human, economic, and legal issues. Therefore, it is necessary to consider safety and health as a project success factor along with other project success factors, such as time, cost, and quality. Organizations have a knowledge deficit of the implementation of long-term safety practices, and due to cost control, safety problems tend to receive the least priority. They usually assume that safety management involves expenditures unrelated to production goals, thereby considering it unnecessary for profitability and competitiveness. The purpose of this study is to introduce, analysis and identify the correlation between the orientation of the public safety procedures of an organization and the public safety standards applied in the project. Therefore, the authors develop the process and collect the possible mathematical-statistical tools supporting the previously mentioned goal. The result shows that the adoption of management to safety is a major factor in implementing the safety standard in the project and thereby improving safety performance. It may take time and effort to adopt the mindset of safety orientation service development, but at the same time, the higher organizational investment in safety and health programs will contribute to the loyalty of staff to safety compliance.

Keywords: project management perspective, safety orientation, safety performance, safety standards

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4024 Sphingosomes: Potential Anti-Cancer Vectors for the Delivery of Doxorubicin

Authors: Brajesh Tiwari, Yuvraj Dangi, Abhishek Jain, Ashok Jain

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The purpose of the investigation was to evaluate the potential of sphingosomes as nanoscale drug delivery units for site-specific delivery of anti-cancer agents. Doxorubicin Hydrochloride (DOX) was selected as a model anti-cancer agent. Sphingosomes were prepared and loaded with DOX and optimized for size and drug loading. The formulations were characterized by Malvern zeta-seizer and Transmission Electron Microscopy (TEM) studies. Sphingosomal formulations were further evaluated for in-vitro drug release study under various pH profiles. The in-vitro drug release study showed an initial rapid release of the drug followed by a slow controlled release. In vivo studies of optimized formulations and free drug were performed on albino rats for comparison of drug plasma concentration. The in- vivo study revealed that the prepared system enabled DOX to have had enhanced circulation time, longer half-life and lower elimination rate kinetics as compared to free drug. Further, it can be interpreted that the formulation would selectively enter highly porous mass of tumor cells and at the same time spare normal tissues. To summarize, the use of sphingosomes as carriers of anti-cancer drugs may prove to be a fascinating approach that would selectively localize in the tumor mass, increasing the therapeutic margin of safety while reducing the side effects associated with anti-cancer agents.

Keywords: sphingosomes, anti-cancer, doxorubicin, formulation

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4023 Potential Drug-Drug Interactions at a Referral Hematology-Oncology Ward in Iran: A Cross-Sectional Study

Authors: Sara Ataei, Molouk Hadjibabaie, Shirinsadat Badri, Amirhossein Moslehi, Iman Karimzadeh, Ardeshir Ghavamzadeh

Abstract:

Purpose: To assess the pattern and probable risk factors for moderate and major drug–drug interactions in a referral hematology-oncology ward in Iran. Methods: All patients admitted to hematology–oncology ward of Dr. Shariati Hospital during a 6-month period and received at least two anti-cancer or non-anti-cancer medications simultaneously were included. All being scheduled anti-cancer and non-anti-cancer medications both prescribed and administered during ward stay were considered for drug–drug interaction screening by Lexi-Interact On- Desktop software. Results: One hundred and eighty-five drug–drug interactions with moderate or major severity were detected from 83 patients. Most of drug–drug interactions (69.73 %) were classified as pharmacokinetics. Fluconazole (25.95 %) was the most commonly offending medication in drug–drug interactions. Interaction of sulfamethoxazole-trimethoprim with fluconazole was the most common drug–drug interaction (27.27 %). Vincristine with imatinib was the only identified interaction between two anti-cancer agents. The number of administered medications during ward stay was considered as an independent risk factor for developing a drug–drug interaction. Conclusions: Potential moderate or major drug–drug interactions occur frequently in patients with hematological malignancies or related diseases. Performing larger standard studies are required to assess the real clinical and economical effects of drug–drug interactions on patients with hematological and non-hematological malignancies.

Keywords: drug–drug interactions, hematology–oncology ward, hematological malignancies

Procedia PDF Downloads 362
4022 Safety-Security Co-Engineering of Control Systems

Authors: Elena A. Troubitsyna

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Designers of modern safety-critical control systems are increasingly relying on networking to provide the systems with advanced functionality and satisfy customer’s needs. However, networking nature of modern control systems also brings new technological challenges associated with ensuring system safety in the presence of openness and hence, potential security threats. In this paper, we propose a methodology that relies on systems-theoretic analysis to enable an integrated analysis of safety and security requirements of controlling software. We demonstrate how to create a safety case – a structured argument about system safety – with explicit representation of both safety and security goals. Our approach provides the designers with a systematic approach to analysing safety and security interdependencies while designing safety-critical control systems.

Keywords: controlling software, integrated analysis, security, safety-security co-engineering

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4021 The Role of Long-Chain Ionic Surfactants on Extending Drug Delivery from Contact Lenses

Authors: Cesar Torres, Robert Briber, Nam Sun Wang

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Eye drops are the most commonly used treatment for short-term and long-term ophthalmic diseases. However, eye drops could deliver only about 5% of the functional ingredients contained in a burst dosage. To address the limitations of eye drops, the use of therapeutic contact lenses has been introduced. Drug-loaded contact lenses provide drugs a longer residence time in the tear film and hence, decrease the potential risk of side effects. Nevertheless, a major limitation of contact lenses as drug delivery devices is that most of the drug absorbed is released within the first few hours. This fact limits their use for extended release. The present study demonstrates the application of long-alkyl chain ionic surfactants on extending drug release kinetics from commercially available silicone hydrogel contact lenses. In vitro release experiments were carried by immersing drug-containing contact lenses in phosphate buffer saline at physiological pH. The drug concentration as a function of time was monitored using ultraviolet-visible spectroscopy. The results of the study demonstrate that release kinetics is dependent on the ionic surfactant weight percent in the contact lenses, and on the length of the hydrophobic alkyl chain of the ionic surfactants. The use of ionic surfactants in contact lenses can extend the delivery of drugs from a few hours to a few weeks, depending on the physicochemical properties of the drugs. Contact lenses embedded with ionic surfactants could be potential biomaterials to be used for extended drug delivery and in the treatment of ophthalmic diseases. However, ocular irritation and toxicity studies would be needed to evaluate the safety of the approach.

Keywords: contact lenses, drug delivery, controlled release, ionic surfactant

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4020 Unbreakable Obedience of Safety Regulation: The Study of Authoritarian Leadership and Safety Performance

Authors: Hong-Yi Kuo

Abstract:

Leadership is a key factor of improving workplace safety, and there have been abundant of studies which support the positive effects of appropriate leadership on employee safety performance in the western academic. However, little safety research focus on the Chinese leadership style like paternalistic leadership. To fill this gap, the resent study aims to examine the relationship between authoritarian leadership (one of the ternary mode in paternalistic leadership) and safety outcomes. This study makes hypothesis on different levels. First, on the group level, as an authoritarian leader regards safety value as the most important tasks, there would be positive effect on group safety outcomes through strengthening safety group norms by the emphasis on etiquette. Second, on the cross level, when a leader with authoritarian style has high priority on safety, employees may more obey the safety rules because of fear due to emphasis on absolute authority over the leader. Therefore, employees may show more safety performance and then increase individual safety outcomes. Survey data would be collected from 50 manufacturing groups (each group with more than 5 members and a leader) and a hierarchical linear modeling analysis would be conducted to analyze the hypothesis. Above the predictive result, the study expects to be a cornerstone of safety leadership research in the Chinese academic and practice.

Keywords: safety leadership, authoritarian leadership, group norms, safety behavior, supervisor safety priority

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4019 Drug Use Knowledge and Antimicrobial Drug Use Behavior

Authors: Pimporn Thongmuang

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The import value of antimicrobial drugs reached approximately fifteen million Baht in 2010, considered as the highest import value of all modern drugs, and this value is rising every year. Antimicrobials are considered the hazardous drugs by the Ministry of Public Health. This research was conducted in order to investigate the past knowledge of drug use and Antimicrobial drug use behavior. A total of 757 students were selected as the samples out of a population of 1,800 students. This selected students had the experience of Antimicrobial drugs use a year ago. A questionnaire was utilized in this research. The findings put on the view that knowledge gained by the students about proper use of antimicrobial drugs was not brought into practice. This suggests that the education procedure regarding drug use needs adjustment. And therefore the findings of this research are expected to be utilized as guidelines for educating people about the proper use of antimicrobial drugs. At a broader perspective, correct drug use behavior of the public may potentially reduce drug cost of the Ministry of Public Health of Thailand.

Keywords: drug use knowledge, antimicrobial drugs, drug use behavior, drug

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4018 Silymarin Loaded Mesoporous Silica Nanoparticles: Preparation, Optimization, Pharmacodynamic and Oral Multi-Dose Safety Assessment

Authors: Sarah Nasr, Maha M. A. Nasra, Ossama Y. Abdallah

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The present work aimed to prepare Silymarin loaded MCM-41 type mesoporous silica nanoparticles (MSNs) and to assess the system’s solubility enhancement ability on the pharmacodynamic performance of Silymarin as a hepatoprotective agent. MSNs prepared by soft-templating technique, were loaded with Silymarin, characterized for particle size, zeta potential, surface properties, DSC and XRPD. DSC and specific surface area data confirmed deposition of Silymarin in an amorphous state in MSNs’ pores. In-vitro drug dissolution testing displayed enhanced dissolution rate of Silymarin upon loading on MSNs. High dose Acetaminophen was then used to inflict hepatic injury upon albino male Wistar rats simultaneously receiving either free Silymarin, Silymarin loaded MSNs or blank MSNs. Plasma AST, ALT, albumin and total protein and liver homogenate content of TBARs or LDH as measures of antioxidant drug action were assessed for all animal groups. Results showed a significant superiority of Silymarin loaded MSNs to free drug in almost all parameters. Meanwhile prolonged administration of blank MSNs had no evident toxicity on rats.

Keywords: mesoporous silica nanoparticles, safety, solubility enhancement, silymarin

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4017 A Study on the Functional Safety Analysis of Stage Control System Based on International Electronical Committee 61508-2

Authors: Youn-Sung Kim, Hye-Mi Kim, Sang-Hoon Seo, Jaden Cha

Abstract:

This International standard IEC 61508 sets out a generic approach for all safety lifecycle activities for systems comprised of electrical/electronic/programmable electronic (E/E/PE) elements that are used to perform safety functions. The control unit in stage control system is safety related facilities to control state and speed for stage system running, and it performs safety-critical function by stage control system. The controller unit is part of safety loops corresponding to the IEC 61508 and classified as logic part in the safety loop. In this paper, we analyze using FMEDA (Failure Mode Effect and Diagnostic Analysis) to verification for fault tolerance methods and functional safety of control unit. Moreover, we determined SIL (Safety Integrity Level) for control unit according to the safety requirements defined in IEC 61508-2 based on an analyzed functional safety.

Keywords: safety function, failure mode effect, IEC 61508-2, diagnostic analysis, stage control system

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4016 The Interactive Effects of Leadership on Safety

Authors: Jane E. Mullen, Kevin Kelloway, Ann Rhéaume-Brüning

Abstract:

The purpose of this study is to examine the effects of perceived leader word-action alignment on subordinate extra-role safety behavior. Using survey data gathered from a sample of nurses employed in health care facilities located in Eastern Canada (n = 192), the effects of perceived word-action alignment (measured as the cross product of leaders speaking positively about safety and acting safely) on nurse safety participation was examined. Moderated regression analysis resulted in the significant (p < .01) prediction of nurse safety participation by the interaction term. Analysis of the simple slopes comprising the interaction term suggests that positively speaking about safety only predicted safety participation when leaders were also perceived by subordinates as acting safely. The results provide empirical support for the importance of the perceived alignment between leaders’ words, or espoused safety values and priorities, and their actions. Practical implications for safety leadership training are discussed.

Keywords: leadership, safety participation, safety performance, safety training

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4015 Role of Social Support in Drug Cessation among Male Addicts in the West of Iran

Authors: Farzad Jalilian, Mehdi Mirzaei Alavijeh, Fazel Zinat Motlagh

Abstract:

Social support is an important benchmark of health for people in avoidance conditions. The main goal of this study was to determine the three kinds of social support (family, friend and other significant) to drug cessation among male addicts, in Kermanshah, the west of Iran. This cross-sectional study was conducted among 132 addicts, randomly selected to participate voluntarily in the study. Data were collected from conduct interviews based on standard questionnaire and analyzed by using SPSS-18 at 95% significance level. The majority of addicts were young (Mean: 30.4 years), and with little education. Opium (36.4%), Crack (21.2%), and Methamphetamine (12.9%) were the predominant drugs. Inabilities to reject the offer and having addict friends are the most often reasons for drug usage. Almost, 18.9% reported history of drug injection. 43.2% of the participants already did drug cessation at least once. Logistic regression showed the family support (OR = 1.110), age (OR = 1.106) and drug use initiation age (OR = 0.918) was predicting drug cessation. Our result showed; family support is a more important effect among types of social support in drug cessation. It seems that providing educational program to addict’s families for more support of patients at drug cessation can be beneficial.

Keywords: drug cessation, family support, drug use, initiation age

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4014 Comparison Analysis on the Safety Culture between the Executives and the Operators: Case Study in the Aircraft Manufacturer in Taiwan

Authors: Wen-Chen Hwang, Yu-Hsi Yuan

Abstract:

According to the estimation made by researchers of safety and hygiene, 80% to 90% of workplace accidents in enterprises could be attributed to human factors. Nevertheless, human factors are not the only cause for accidents; instead, happening of accidents is also closely associated with the safety culture of the organization. Therefore, the most effective way of reducing accident rate would be to improve the social and the organizational factors that influence organization’s safety performance. Overview the present study is to understand the current level of safety culture in manufacturing enterprises. A tool for evaluating safety culture matching the needs and characteristics of manufacturing enterprises was developed by reviewing literature of safety culture, and taking the special backgrounds of the case enterprises into consideration. Expert validity was also implied for developing the questionnaire. Moreover, safety culture assessment was conducted through the practical investigation of the case enterprises. Total 505 samples were involved, 53 were executives and 452 were operators. The result of this study in comparison of the safety culture level between the executives and the operators was reached the significant level in 8 dimensions: Safety Commitment, Safety System, Safety Training, Safety Involvement, Reward and Motivation, Communication and Reporting, Leadership and Supervision, Learning and Changing. In general, the overall safety culture were executive level higher than operators level (M: 74.98 > 69.08; t=2.87; p < 0.01).

Keywords: questionnaire survey, safety culture, t-test, media studies

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4013 Pharmaceutical Science and Development in Drug Research

Authors: Adegoke Yinka Adebayo

Abstract:

An understanding of the critical product attributes that impact on in vivo performance is key to the production of safe and effective medicines. Thus, a key driver for our research is the development of new basic science and technology underpinning the development of new pharmaceutical products. Research includes the structure and properties of drugs and excipients, biopharmaceutical characterisation, pharmaceutical processing and technology and formulation and analysis.

Keywords: drug discovery, drug development, drug delivery

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4012 Tobephobia: Fear of Failure in Education Caused by School Violence and Drug Abuse

Authors: Prakash Singh

Abstract:

Schools throughout the world are facing increasing challenges in dealing with school violence and drug abuse by pupils. Therefore, the question of the fear of failure to meet the aims and objectives of education inevitably surfaces as it places increasing and challenging demands on educators and all other stakeholders to address this malaise. Multiple studies on the construct tobephobia (TBP) simply define TBP as the fear of failure in education. This study is a continuation of the exploratory studies on the manifestation of fear in education. The primary purpose of this study was to establish how TBP, caused by school violence and drug abuse affects teaching and learning in our schools. The qualitative research method was used for this study. Teachers admitted that they fear for their safety at school. Working in a fearful situation places a high rate of stress and anxiety on them. Tobephobic educators spend most of their time worrying about their fear of violence and drug abuse by pupils and are too frightened to carry out their normal duties. They prefer to stay in familiar surroundings for fear of being attacked by inebriated learners. This study, therefore, contributes to our understanding of the effects of TBP in our schools caused by school violence and drug abuse. Also, this study supplements the evidence accumulated over the past fifteen years that TBP is not a figment of someone’s imagination; it is a gruesome reality affecting the very foundation of our educational system globally to provide quality and equal education to all our learners in a harmonious, collegial school environment.

Keywords: tobephobia, tobephobic educators, fear of failure in education, school violence, drug abuse

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4011 Safety Profile of Anti-Retroviral Medicine in South Africa Based on Reported Adverse Drug Reactions

Authors: Sarah Gounden, Mukesh Dheda, Boikhutso Tlou, Elizabeth Ojewole, Frasia Oosthuizen

Abstract:

Background: Antiretroviral therapy (ART) has been effective in the reduction of mortality and resulted in an improvement in the prognosis of HIV-infected patients. However, treatment with antiretrovirals (ARVs) has led to the development of many adverse drug reactions (ADRs). It is, therefore, necessary to determine the safety profile of these medicines in a South African population in order to ensure safe and optimal medicine use. Objectives: The aim of this study was to quantify ADRs experienced with the different ARVs currently used in South Africa, to determine the safety profile of ARV medicine in South Africa based on reported ADRs, and to determine the ARVs with the lowest risk profile based on specific patient populations. Methodology: This was a quantitative study. Individual case safety reports for the period January 2010 – December 2013 were obtained from the National Pharmacovigilance Center; these reports contained information on ADRs, ARV medicine, and patient demographics. Data was analysed to find associations that may exist between ADRs experienced, ARV medicines used and patient demographics. Results: A total of 1916 patient reports were received of which 1534 met the inclusion criteria for the study. The ARV with the lowest risk of ADRs were found to be lamivudine (0.51%, n=12), followed by lopinavir/ritonavir combination (0.8%, n=19) and abacavir (0.64%, n=15). A higher incidence of ADRs was observed in females compared to males. The age group 31–50 years and the weight group 61–80 kg had the highest incidence of ADRs reported. Conclusion: This study found that the safest ARVs to be used in a South African population are lamivudine, abacavir, and the lopinavir/ritonavir combination. Gender differences play a significant role in the occurrence of ADRs and both anatomical and physiological differences account for this. An increased BMI (body mass index) in both men and women showed an increase in the incidence of ADRs associated with ARV therapy.

Keywords: adverse drug reaction, antiretrovirals, HIV/AIDS, pharmacovigilance, South Africa

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4010 Effects of Cannabis and Cocaine on Driving Related Tasks of Perception, Cognition, and Action

Authors: Michelle V. Tomczak, Reyhaneh Bakhtiari, Aaron Granley, Anthony Singhal

Abstract:

Objective: Cannabis and cocaine are associated with a range of mental and physical effects that can impair aspects of human behavior. Driving is a complex cognitive behavior that is an essential part of everyday life and can be broken down into many subcomponents, each of which can uniquely impact road safety. With the growing movement of jurisdictions to legalize cannabis, there is an increased focus on impairment and driving. The purpose of this study was to identify driving-related cognitive-performance deficits that are impacted by recreational drug use. Design and Methods: With the assistance of law enforcement agencies, we recruited over 300 participants under the influence of various drugs including cannabis and cocaine. These individuals performed a battery of computer-based tasks scientifically proven to be re-lated to on-road driving performance and designed to test response-speed, memory processes, perceptual-motor skills, and decision making. Data from a control group with healthy non-drug using adults was collected as well. Results: Compared to controls, the drug group showed def-icits in all tasks. The data also showed clear differences between the cannabis and cocaine groups where cannabis users were faster, and performed better on some aspects of the decision-making and perceptual-motor tasks. Memory performance was better in the cocaine group for simple tasks but not more complex tasks. Finally, the participants who consumed both drugs performed most similarly to the cannabis group. Conclusions: Our results show distinct and combined effects of cannabis and cocaine on human performance relating to driving. These dif-ferential effects are likely related to the unique effects of each drug on the human brain and how they distinctly contribute to mental states. Our results have important implications for road safety associated with driver impairment.

Keywords: driving, cognitive impairment, recreational drug use, cannabis and cocaine

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