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Comparison of Indian package inserts in public and private sector: an urgent need for self regulation  [cached]
Mohini S. Mahatme,Ganesh N. Dakhale,Sachin K. Hiware,Sumit S. Wankhede
International Journal of Basic & Clinical Pharmacology , 2013, DOI: 10.5455/2319-2003.ijbcp20130309
Abstract: Background: Package inserts are the authentic source of information for the new molecules in the market. Incomplete and incorrect product information may promote irrational prescribing and may have serious consequences. Hence, our aim was to analyse and compare the information supplied in the package insert according to the section 6.2 and section 6.3 of schedule D of Drugs and Cosmetic Act, 1940 in public (government) and private (non-government) sector. Methods: Package inserts of allopathic drugs which were supplied by government from drug store of tertiary care centre and hospital and from pharmacies on request were collected. A total of 270 package inserts in English were collected that is 38 from government hospital and 232 from the pharmacies nearby the hospital. The package inserts were analysed for the presentation of completeness of the information as per section 6.2 and 6.3. Results: The presentation of information on analysing 233 package inserts (28 government and 205 non government) was not uniform and it was difficult to locate and retrieve information easily due to lack of common layout and heading. Moreover, the package inserts were of variable shape and size with different font size which made it inconvenient for analysing as well as for reference. Posology and method of administration was incomplete in 3% package insert in non- government cases whereas in government supply it was 7%. Use of drug in pregnancy and lactation was deficient in 11% and 14% packages inserts of non-government sources and government sources respectively. Instructions for use were lacking in 25% and 29% package inserts of government and non-government sources respectively. Conclusions: The need of the hour is to further refine contents of the circulated package inserts to make them complete, reliable and up to date. This can be a step forward for ethical and effective dissemination of healthcare services in our growing society. [Int J Basic Clin Pharmacol 2013; 2(2.000): 165-169]
The Urgent Need for Robust Coral Disease Diagnostics  [PDF]
F. Joseph Pollock,Pamela J. Morris,Bette L. Willis,David G. Bourne
PLOS Pathogens , 2011, DOI: 10.1371/journal.ppat.1002183
Abstract: Coral disease has emerged over recent decades as a significant threat to coral reef ecosystems, with declines in coral cover and diversity of Caribbean reefs providing an example of the potential impacts of disease at regional scales. If similar trends are to be mitigated or avoided on reefs worldwide, a deeper understanding of the factors underlying the origin and spread of coral diseases and the steps that can be taken to prevent, control, or reduce their impacts is required. In recent years, an increased focus on coral microbiology and the application of classic culture techniques and emerging molecular technologies has revealed several coral pathogens that could serve as targets for novel coral disease diagnostic tools. The ability to detect and quantify microbial agents identified as indicators of coral disease will aid in the elucidation of disease causation and facilitate coral disease detection and diagnosis, pathogen monitoring in individuals and ecosystems, and identification of pathogen sources, vectors, and reservoirs. This information will advance the field of coral disease research and contribute knowledge necessary for effective coral reef management. This paper establishes the need for sensitive and specific molecular-based coral pathogen detection, outlines the emerging technologies that could serve as the basis of a new generation of coral disease diagnostic assays, and addresses the unique challenges inherent to the application of these techniques to environmentally derived coral samples.
Statistical Approach to Regulation of Nanotechnology: Need, Advantages and Disadvantages  [PDF]
Ricardo Santana Cabello, José Vega-Baudrit, Robin Zuluaga, Piedad Ga?án
Journal of Biomaterials and Nanobiotechnology (JBNB) , 2020, DOI: 10.4236/jbnb.2020.111002
Abstract: The need to have an express regulation covering nanotechnology has been the subject of debate in the scientific literature and identified as one of the main subsets of nanotechnology field research. However, most countries still do not have regulatory framework in order to guarantee consumer safety. This is the case of Costa Rica, one of the most promising countries in Latin America in terms of biotechnology and nanotechnology. This article presents a statistical study about the position of industry, academia and government institutions on the need to expressly regulate nanotechnology in Costa Rica. A qualitative study consisting of a survey of 79 forms was done to individuals representing the community involved with nanotechnology and institutions responsible for ensuring the safety of the citizen’s health, to conclude that the nanotechnology regulation should be created to protect the consumer in Costa Rica. The research also proposes aspects that should be taken into account in its drafting as well as the variables on which decisions should be made to authorize the commercialization of nanomaterials based on the findings of the literature.
Public and Private Food Safety Standards: Facilitating or Frustrating Fresh Produce Growers?  [PDF]
Jan Mei Soon,Richard N. Baines
Laws , 2013, DOI: 10.3390/laws2010001
Abstract: Global private food safety and quality standards have undergone some major overhauls during the past two decades, and these will continue to evolve with the recent emphasis on harmonization. The Global Food Safety Initiative (GFSI) attempts to ensure that harmonize retail standards are commendable and elegant in principle, but in practice, retailers continue to demand their own standard, whilst supporting GFSI’s benchmarking program. It is difficult to see such retailers giving up their own standards and the control they currently exert as chain captains. There is also the risk that too much harmonization will result in these standards losing their individuality and uniqueness. Amidst the struggle for private standard dominance, alternative approaches to risk management (e.g., self-assessment of risk, independent audits and risk ranking) may be the way forward, similar to how insurance risks are calculated for businesses. Furthermore, this risk-based approach could also lead to the effective implementation of co-regulation, where both public and private sector compliances are addressed together—a win-win situation. This paper considers the implications and future trends of fresh produce farming, and identifies five interventions ( i.e., assurance schemes), which include the do-nothing scenario to underpinning one’s brand or label with an existing scheme.
On the efficacy of safety-related software standards  [PDF]
Mario Fusani,Giuseppe Lami
Computer Science , 2014,
Abstract: Difficulty of safety-related software standards to help producing software for safe systems is discussed. Some research activity and other actions are proposed to focus on and possibly resolve long-lasting related problems.
The urgent need to change the current medical approach on tobacco cessation in Latin America
Ponciano-Rodríguez,Guadalupe;
Salud Pública de México , 2010, DOI: 10.1590/S0036-36342010000800035
Abstract: despite of the accumulation of scientific evidence confirming the health consequences of smoking and the new paradigm of smoking as a disease where nicotine is the drug that modifies the functional and morphological characteristics of the brain in dependent smokers, tobacco smoking continues as an important public health problem in many latin american countries. in contrast with big advances in the tobacco control area, as an example the framework convention on tobacco control signed by 168 countries, the role of health professional in the fight against tobacco is still less than ideal. in many latin american schools of medicine, deficiencies in medical education has led to insecure physicians when they have to motivate their patients to stop smoking or to prevent young people to begin tobacco consumption. if each general practitioner or specialist during their daily medical assistance could talk to their smoker patients about the big benefits of stop smoking and support them to get free of tobacco, we would be winning a battle against smoking. also if we could achieve generations of young non smoking doctors, who could be a real example for patients, this could also impact the prevalence of smokers. in this article we analyze the neurobiological bases of nicotine addiction, which we think are missing in the medical curriculum and could help doctors to understand tobacco smoking as a disease rather than a risk factor, and discuss the main reasons supporting an urgent change in the medical approach of tobacco cessation in latin america as well as the need to actualize the medical curriculum in order to give physicians the skills needed to intervene successfully with their smoker patients and to be themselves non smokers.
Food Safety Traceability Systems in the Maritime Catering Logistics  [PDF]
Basem Azmy Saad Boutros, Mahmoud Mahmoud Hewedi, Kevin R. Roberts, Farida M. Megahid
Food and Nutrition Sciences (FNS) , 2014, DOI: 10.4236/fns.2014.515158
Abstract:

This paper aims to explore food safety traceability in the onboard food and beverage operations on cruise ships through a case study approach. Semi-structured interviews were conducted with galley and foodservice staff. Additionally, a self-administered questionnaire was designed and distributed to logistics managers and employees of three Egyptian cruise companies. Results indicated that cruise ships in this study use paper-based and manually-entered (electronically stored) data traceability systems. Managing food safety by effective product recall, complying with legislation, and improving product quality are among the most important perceived benefits identified by foodservice staff. Maintaining a good reputation, ensuring food safety, reducing foodborne illnesses, suppliers' commitment to quality specifications, and maintaining guest confidence are considered the most important benefits from implementing a food traceability system. The results also depicted that the challenges managers face implementing or improving a food traceability system included high cost, absence of unified traceability standards between cruise companies and food suppliers, shortage of skilled staff, and lack of knowledge and satisfaction with current foodservice operation systems onboard cruise ships. Other findings elucidated that the critical success factors for implementing traceability included strict food traceability legislation, ensuring the adequacy and correctness of traceability information, adopting a food traceability system by the cruise company management, the standardization of food traceability information identification, and technology support for food traceability systems implementation from government. Other factors were reported of less importance. This research concluded the urgent need for more cooperation between cruise companies, food suppliers, and relevant governmental authorities to adopt food traceability systems and the need of authorizing and setting compulsory standards and regulations.

FOOD SAFETY AND STANDARDS LAWAND POLICY IN INDIA
ASHISH SHRIVASTAVA
Indian Streams Research Journal , 2012,
Abstract: Acountry develops in the real sense if it's people are healthy and prosperous i.e. if they can have healthy and notorious food which is as per standards of food safety . Only then a country can grow well . United nations Development Programme (UNDP) also prepare Human Development Index(HDI) on the basis of public health, education and income. It shows the importance of health of the people for the growth of nation and as symbol of human development .India despite having a huge population [121.02 cr.(2011)] and being very big economy as well, legging in the world not in GDPbut in the health of the people. The economy in financial terms is growing in quantum but is it sufficient ? This question leads us to confront with some harsh realities about health in India. As we are concerned here about food safety and public health , we should have quick review of data recently reviled by UNDP's(HDI), Global Hunger Index(GHI) and Food Safety and Standards Authority of India(FSSAI) about adulteration to get an idea about the situation of India .
Need for Safety in Different Social and Economic Groups  [PDF]
Olga Yu. Zotova
Psychology in Russia : State of Art , 2011,
Abstract: The article gives an account of the empirical study results aimed at analyzing the degree of need for safety's satisfaction. The findings demonstrate that the degree of need for safety as a basic personality want strongly depends on gender, age-related and professional distinctions.
Current status of the regulation for medical devices  [cached]
Shah Anuja,Goyal R
Indian Journal of Pharmaceutical Sciences , 2008,
Abstract: In the light of escalating use of medical devices, stringent regulatory standards are required to ensure that the devices are safe, well studied and have least adverse reactions. Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. India has emerged as one of the leaders in pharmaceutical industry. Like many other amendments in Drugs and Cosmetics Act that have boosted the global confidence in pharmaceutical industry in India, guidelines for devices will encourage the much needed research in medical devices. Pharmacy personnel can certainly play an important role in the regulation of medical devices. Safety, risks, effectiveness and performance of the medial devices need to be well established and regulated properly. It is hoped that the guidelines are implemented and regulated properly with effective outcome.
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