Dissertations / Theses on the topic 'Committees of safety'
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Ayers, Gerard. "Creative thinking and OHS committees in the NSW construction industry (1998/99) / Gerard F. Ayers." Thesis, The Author [Mt. Helen. Vic.] :, 1999. http://researchonline.federation.edu.au/vital/access/HandleResolver/1959.17/35271.
Full textBalderrama, Rafael J. "The social construction of compatibility : setting voluntary safety standards for agricultural tractors /." Diss., This resource online, 1996. http://scholar.lib.vt.edu/theses/available/etd-10192006-115616/.
Full textWyatt, Anne. "Training occupational health and safety committee members: a critical evaluation of the effectiveness of the 1987 workcover program." Thesis, The University of Sydney, 1996. https://hdl.handle.net/2123/29515.
Full textMillion-Rousseau, Emilie. "La représentation élue du personnel en matière de santé et de sécurité." Thesis, Paris 2, 2011. http://www.theses.fr/2011PA020032.
Full textSince the emergence of the CHSCT (health, safety and working conditions committee) in 1982, the elected representation of employees has profoundly changed. Employee representatives, works councils and the CHSCT have had to adapt to the considerable extension of the concepts of health and safety. The integration of the requirement to protect the mental health of workers in the Labour Code has radically altered the scope of competence of the CHSCT. The prevention of psychosocial risks quickly invited itself as the centre of its concerns, thereby extending the consultation obligation borne by the employer. Projects and measures that initially only required the consultation of the works council are now also subject to the prior opinion of the CHSCT. In this procedure of double consultation the employer is guided by the principle of specialty that turns the works council in a mere rubber stamp of the opinion of the specialized committee. The expansion of the CHSCT has caused reiterations and cumbersomeness. A reform must be considered. Transformation of the specialized body in a committee of the works council or redistribution of powers of each : the alternative offered requires discussion
Braman, Julia Marie Badger Murray Richard M. Murray Richard M. "Safety verification and failure analysis of goal-based hybrid control systems /cJulia M.B. Braman ; Richard Murray, committee chair and advisor." Diss., Pasadena, Calif. : California Institute of Technology, 2009. http://resolver.caltech.edu/CaltechETD:etd-05292009-111937.
Full textMiller, Kristi, Lisa Haddad, and Kenneth D. Phillips. "Educational Strategies for Reducing Medication Errors Committed by Student Nurses: A Literature Review." Digital Commons @ East Tennessee State University, 2016. https://dc.etsu.edu/ijhse/vol3/iss1/2.
Full textWikman, Jenny, and Johan Höglund. "Patientsäkerhet ur patientperspektiv : En kvantitativ granskning av Patientnämndens fall rörande patientsäkerhet 2015." Thesis, Uppsala universitet, Institutionen för folkhälso- och vårdvetenskap, 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-296102.
Full textBackground: The patients' advisory committee is an independent committee to which patients and relatives can file complaints and comments about their recieved care. The patients' advisory committee works with patient safety through reconnecting the patients' cases to their caregiver. Research regarding the patient useage of the Patients' advisory committee for reporting care injuries is currently quite uncharted. Study aim: The aim of the study was to investigate cases recieved at the Patients' advisory committee in a county in Sweden during 2015 to identify and describe the somatic care injuries reported by patients and relatives. Method: This study examines existing cases from the Patients' advisory committee and uses a quantitative, descriptive design. Main results: 86 out of 395 cases regarded somatic care injuries, of which 59 were severe care injuries. Women reported both severe and non severe care injuries more often than men. The most often occuring resason for a care injury was surgery-related complications. Conclusion: Only a small fraction of the total amount of cases regarded somatic care injuries. Severe care injuries appeared more often than non severe care injuries. More guidance and information to the patients and relatives is required from the caregivers to enlighten the occurance of care injuries. More research is needed regarding why women report care injuries more often than men.
Raymond, Meghan. "A phenomenological exploration of women's safe sex experiences in committed relationships." Diss., The University of Arizona, 2000. http://hdl.handle.net/10150/289186.
Full textSchamel, Craig R. "Idealism and Actualization. Saint-Just in Theory, Practice, and Exigency." Scholarship @ Claremont, 2012. http://scholarship.claremont.edu/cgu_etd/82.
Full textLancaster, Ramona C. "Quality Improvement Initiative to Reduce Fall Risk in the SNF." ScholarWorks, 2017. https://scholarworks.waldenu.edu/dissertations/7025.
Full textBoussat, Bastien. "Comités de Retour d'Expérience et culture de sécurité des soins." Thesis, Université Grenoble Alpes (ComUE), 2018. http://www.theses.fr/2018GREAS008/document.
Full textThe Experience Feedback Committee (EFC) is a tool designed to involve medical teams in patient safety management, through root cause analysis of adverse events within the team. This program was created in 2005, and was implemented in the vast majority of French hospitals. Despite its wide implementation in thousands of French medical teams, the EFC still lacks scientific evaluation. To our knowledge, the EFC framework and the association between EFC and patient safety culture have never been assessed. In this context, our work aimed to determine whether patient safety culture, as measured by the Hospital Survey On Patient Safety Culture (HSOPS), differed regarding care provider involvement in EFC activities. Using the original data from a cross-sectional survey of 3,888 employees at a single university hospital in France, we analyzed the differences in HSOPS dimension scores according involvement in EFC activities. We also specified the metrological properties of the transcultural adaptation of the HSOPS into French (psychometrics properties, variability of scoring strategies and missing data imputation methods). Our findings suggest that EFC participation may improve patient safety culture, teamwork and non-blame oriented processes. Despite several limitations, our study contributes to a better understanding of EFC and its position amongst patient safety systems. This thesis advocates research developments centered on health care givers involvement in patient safety management
Poley, Yann. "Accompagnement ergonomique de l'activité des représentants du personnel des CHSCT. Interventions ergonomiques sur les CHSCT de la SNCF." Thesis, Bordeaux, 2015. http://www.theses.fr/2015BORD0338/document.
Full textThis dissertation falls within a field of research in ergonomics focused on health and safety staff. It defends the idea that the activity of staff representatives is to be considered as work and that it is possible to contribute to the development of their activity thanks to ergonomic interventions.This research was carried out by studying seven CHSCTs (Occupational Health and Safety Committee) of different professions at the SNCF (French National Rail Company), and was ordered by their Observatoire de la Qualité de Vie au Travail (Monitoring Agency for Quality of Life in the Workplace). The members of the Observatoire wanted a scientific study to help them understand the functional difficulties encountered by the CHSCTs, and the possibilities for improving work analysis, in turn improving their prevention work.Thanks to an Ergonomic Work Analysis, we were able to understand the specificities of this activity. Several ergonomic interventions were organized in order to test previous local diagnostics. We were thus able to contribute to the development of the activity of staff representatives.This dissertation shows that staff representatives are practicians who, through their activity, contribute to problem solving in the company. The current regulations framework does not permit them to take into account the dynamic nature of employees' work situations, nor the possibilities for action in their own work. This has lead them to defining modes of action that are in line with the dynamic environment in which they are called upon to intervene.It is therefore necessary for them to build a common frame of reference in order to act together, while still retaining individual points of view. Inevitably, conflictuality and cooperation are inherent to the functioning of CHSCTs. This common framework however must be based upon other elements besides regulations, and it is necessary to give employees a say in the formation of both problems and solutions.It also appears to be difficult for them to discuss the individual and collective difficulties that they encounter. This contributes to the development of collective defenses, leading to a closed, in-house treatment of the workers situational problems.As such, ergonomic interventions must facilitate collective activity by questioning both individual and collective pratices and difficulties. The challenge for the ergonomist is that he cannot base his intervention upon a work collective, which must none-the-less produce a collective work. Therefore the contribution must work towards a common denominator between the members, allowing for the integration of both the complexity of work and the employees. In that, conflictuality and cooperation must be articulated around employees' work situations, and not only the application of regulations
Jégat, Sylvaine. "L'expertise et le comité d'entreprise : mise en perspective." Thesis, Paris 10, 2017. http://www.theses.fr/2017PA100134.
Full textGiven the complexity of the business environment, resorting to expertise proves to be essential for the works council to fully exercise its powers and ultimately for the council to contribute to the application of the employee involvement principle. A more realistic approach to expertise enables us to establish that the works council has two types of experts at its disposal: institutional experts (chartered accountants, technical experts, expert consultants and economic experts) and non-institutional experts (some of the works council commissions and the Health, Safety and Working Conditions Committee (CHSCT)). The relations between the works council and experts oscillate between a traditional perspective and an updated perspective. In a very traditional fashion, these two types of experts unevenly act as pathfinders for the works council. They provide the council with information but also process this information when it is necessary. More strangely, however, experts also appear to be involved in the decision-making process as well as in the process of consultation. Beyond the tasks that experts can perform for the works council, two kinds of underlying dynamic can be evidenced by the relations between the experts and the council: a relational dynamic between the various players involved in the expertise that is characterised by a subtle balance between dependence on and independence from one other, and a collective dynamic that indicates the existence of a collective expertise. This collective expertise consists in a system of collective intelligence that is necessary to the effectiveness of the employee involvement principle
Serrand, Charlotte. "Le traitement juridique des risques psychosociaux." Thesis, Paris 2, 2017. http://www.theses.fr/2017PA020022.
Full textThe legal obligation for any employer to preserve both the physical and mental health of their employees is complicated by the inner subjectivity of psychosocial risks, making their juridical analysis difficult. The actors interacting with or within any company contribute to a better understanding of those risks : the employer, employees, trade unions, and occupational doctor. Combatting harassment and burn-outs at work helped better consider psychosocial risks. They have become a real topic for collective bargaining as they imply for both the employer and the employees to take responsibility with regards to the nature of specific work accidents or professional illnesses. It stands today as a key element for theim provement of work conditions through an increase in well-being and a higher quality of life at work
Drochon, Victoria. "Le recours aux experts par les instances de représentation du personnel." Thesis, Paris 2, 2016. http://www.theses.fr/2016PA020046.
Full textBetween 1946 and 2016, this is more than twenty new cases in which the employee representatives were granted the right to resort to the services of experts, and only eight in the last three years. The ever-expanded possibility to be assisted by external experts might suggest that the expertise statutory regime is efficient. The ease with which the law associates experts to each new measures taken in favor of the social dialogue cannot hide the persistent difficulties encountered by the legislator to preserve the original function of expertise : an informative function. The controversial nature of the right to resort to the services of experts and the increasing amount of litigation in this area are manifestations of its failures. A study of the scope and the conditions under which the experts might be appointed urges to the construction of a more coherent system, that would ensure the effectiveness of the right to resort to experts while maintaining the employee representatives’ competence and voices
Marthinus, Mercia. "Morele opvoeding aan leerders binne die konteks van plekke van veiligheid in Wes-Kaapland." Thesis, Link to the online version, 2005. http://hdl.handle.net/10019/1589.
Full textSenate, University of Arizona Faculty. "Faculty Senate Minutes October 2, 2017." University of Arizona Faculty Senate (Tucson, AZ), 2017. http://hdl.handle.net/10150/626015.
Full textHertz, Carolyn D. "The committees of correspondence, inspection and safety in old Hampshire County, Massachusetts, during the American Revolution/." 1993. https://scholarworks.umass.edu/theses/1605.
Full textFANG, MAN-HSUAN, and 方蔓瑄. "Study on the Maintenance Status of Fire Safety Equipment for Collective Residence in Non-Management Committees-A Case Study of 6 to 10-story Buildings in Shulin District." Thesis, 2019. http://ndltd.ncl.edu.tw/handle/d2c725.
Full text東南科技大學
營建與空間設計系營建科技與防災碩士班
107
Taiwan is a narrow and long island with a dense population. The type of building has changed from a single dwelling to a condominium. When a fire breaks out, the importance of the immediate action of the fire safety equipment should not be underestimated. Instant notification and fire fighting can reduce the chance of casualties and minimize the loss of property. When the firefighters rescued, they found that the fire safety equipment doesn't work immediately. After investigation, non-management committees is the majority in these case.The main reason which has led to no maintenance of the fire safety equipment is the cognition of residents who lived in the collective housing built 84 years ago is not synchronized by regulation, and lack of a well- management system. In recent years,the governments have been committed to help the community make regular declaration for examination and repair of fire safety equipment to let fire safety device remain best state.This study mainly takes 6 to 10-story buildings which is non-management committee in Shulin District as an example. Through the analysis of each case, the problems they encounter in the process of improving fire safety equipment improvement are finding person who can handle anything about community,convening a meeting all householder take part in, explaining the regulations to householder to let them understood, and the financial problems. After interviews by experts, we understand that the security inspection teams in current are mainly based on propaganda, supplemented by enforcement, and put forward the advantages and disadvantages. Finally, we analyze the effectiveness of each implementation method. It is more efficient by propaganda. Regardless of the size of the community,each community security inspector takes 6 working hours. After 9 months, the rate of the improvement of fire safety equipment has achieved to 93%. Compared with enforcement by ticket, every 14 households takes more than 10 working hours. A standard operating procedure about improvement of non-management committee’s fire safety equipment recommended for the security inspector to follow. It is recommended that the follow-up can be explored whether the half-year improvement period is appropriate or not, in order to achieve the most appropriate balance between the law and the practice.
Brijlall, Mathurapersadh. "Analysis of employee participation in occupational health and safety activities in a cement manufacturing organisation in South Africa." Thesis, 2015. http://hdl.handle.net/10500/21746.
Full textBusiness Management
DBL
Chiu, Ping-Hun, and 邱品翰. "A Study on Restructuring Railway Safety and Investigation Committee in Taiwan." Thesis, 2005. http://ndltd.ncl.edu.tw/handle/88946522644872194765.
Full text逢甲大學
交通工程與管理所
93
When a railway accident occurred in Taiwan area, there are many railway authorities will proceed the investigation and examination of the accident, such as the Railway Safety Committee (RSC) for Taiwan Railway Administration (TRA), The Traffic Bureau of Taipei City Government for Taipei Rapid Transit Corporation (TRTC), The Chiayi Forrest District Office of Taiwan Forestry Bureau for the Alishan Forest Railway. Meanwhile, the Taiwan High Speed Railway (THSR) and Kaoshiung MRT are under constructing now, so that these railway organizations don’t have the specific RSC yet. From literature reviews, many countries had founded the independent RSC to investigate the railway accident, such as the National Transportation Safety Board (NTSC) of the United States of America, the Canadian Transportation Accident Investigation and Safety Board (CTAISB), the Aircraft and Railway Accidents Investigation Commission (ARAIC) of Japan, the Rail Accident Investigation Branch (RAIB) of the United Kingdom, and the Australian Transport Safety Bureau (ATSB). The purposes of RSC of each country are to prevent the railway accident and improve the railway safety. However, when an accident occurred in Taiwan, the accident will be investigated by the internal RSC of the railway authorities. Therefore, there still have many responsible accidents, so that the present RSC is not suitable. The methodologies of this study are literature review; analysis of the background of revolution, relevant laws, organization structures, organizational functions, investigation procedures, and the publication of accident report, etc.; uses the expert questionnaires investigation, (there are 25 out of 32 effective questionnaires.) then selects the Fuzzy Analytic Hierarchy Process (FAHP) and Technique for Order Preference by Similarity to Ideal Solution (TOPSIS) to analyze the questionnaires. The Hierarchy structure contains one objective, four evaluation levels, eleven evaluation criteria, and three alternatives. The objective of this study is to discover the best alternative for reorganization of RSC in Taiwan area. The result shows that set up a new RSC in the Ministry of Communication and Transportation (MOTC) is the preferable alternative. If this alternative will be accepted by the MOTC, not only increase the investigation creditability of railway safety, but also improve the prevent function of railway safety.
Ho, Yung-Hui, and 侯永輝. "The Enterprise Labor Relation on Employees' Occupational Safety and Health Committee and Welfare Committee within the Enterprise-Based on a Case Study of Taiwan Tobacco and Liquor Corporation." Thesis, 2011. http://ndltd.ncl.edu.tw/handle/40014080993176464651.
Full text國立中正大學
勞工研究所
99
The main purpose of this case study is to examine the functioning of the mechanism and outputs within the employee benefits committee and the occupational safety and health committee, in which is the public-owned and targeted enterprise in Taiwan. This study is especially emphasized on how should the welfare system and the safety and health norm be correspond with the trend of the times, in addition to compositions, operations, outputs, decisions and activities within these two committees. This study uses secondary data processing and analyzing to analyze main findings within these two committees. These main findings are as follows: First, using the method of “consensus” in the operations and outputs of the committees are the best voting to decide in the meeting, not only to avoid more serious of conflict, but also can form the consensus of the enterprise. Second, the organization of the committee in the enterprise is suitably formed by law norms, and the members meet regularly and discuss the related topics within the enterprise through formal organization specification. Third, outputs of the welfare committee should be directed to current events and demands of all staffs to adjust the welfare measures, which are corresponded with the actual needs of employees and then increase on employee morale. Fourth, in order to establish the system of labor safety and reduce the incidence of occupational hazards, the occupational safety and health committee should be aimed at requirements and planning for labor safety and occupational hazard. Fifth, regardless of issues related to welfare or safety and health, the outputs of operations within the committees should enhance efficiency of outputs if the committees focus on demands of all staffs and safeguard perspectives.
SHAN, YU-CHIN, and 沈郁欽. "Study on Application of Inspection and Maintenance of Fire Safety Equipment in Apartment Buildings without Management Committee Communities." Thesis, 2017. http://ndltd.ncl.edu.tw/handle/v93ne3.
Full text大葉大學
環境工程學系碩士班
105
There are always public safety problems concerning no declaration or unqualified fire safety equipments to those apartment buildings without management committee communities. Have to be settled urgently.In this study, the questionnaire survey and analysis of the maintenance and management of the apartments without management committee were carried out. The surveyed samples were collected through those residents of the apartment building without management committee and no inspection and maintenance application in the Taichung City and the Changhua County. Nevertheless, in the study we found that the concept of fire protection and fire safety for residents are lower, also the recognition on inspection and maintenance system is generally low, too. In further study, we found that the length of the residence period and the owned house condition have significant difference on the recognition of inspection and maintenance system. It will be lower for the recognition of inspection and maintenance system as the residence period is longer. Also, non-owned households can lower the recognition of inspection and maintenance system, too. The worse condition for recognition of inspection and maintenance system is the longer the residence time and non-owned households. It can be found that the main reasons for not inspecting the fire safety equipments on the regular basis by Fire Protection Technician are the difficulty in consultation as well as financial burden, also no effective public power from fire authority and no trust on the service of inspection and maintenance. It is worth for government authority as reference to strengthen and improve the management of fire safety policy to in all apartment buildings.
Wu, Tsun-Hsiu, and 吳村修. "Research into the function on the committee of homeowner association for community safety-A case study in Luchu, Taoyuan." Thesis, 2013. http://ndltd.ncl.edu.tw/handle/59428801972198312995.
Full text銘傳大學
公共事務學系碩士在職專班
101
An Englishman''s home is his castle.” This saying goes to show that the importance of “home” is self-evident worldwide. With the rising pace of economic growth and urbanization, high-rise buildings are now tightly arrayed everywhere in Taiwan. Industrialization and the fast-paced lifestyles have also made people more detached from one other and the relationships between neighbors are not what they used to be in the past. Therefore the indifference causes the crime rate to rise annually. It is the government’s priority to maintain the order in our society and provide people with protection of their lives and wealth. However it cannot achieve these goals by simply relying on the criminal justice system or police enforcement. Studies have shown that a comprehensive strategy is needed to achieve public security. Even under the narrow definition of crime prevention, courts, correction facilities, schools, rehabilitation centers, communities, urban planning, personal safety, the police, all play a role. It will be difficult to complete the crime prevention task if any one of the players is missing. The committee of homeowner associations takes charge in making decisions for the community. It is also the link between the police and the neighborhood. This paper, through peer journal review and in-depth interviews, illustrates the role, The committee of homeowner associations plays and the impact it has on in crime prevention in the community. The former methodology is based on collecting and analyzing research papers, periodicals, etc. on related theories (both domestic and abroad). By combining the peer review methodology, which builds an analytical structure based on the present literature and reinforces the research hypothesis, with the empirical data that will clarify and crystallize the issues and conclusions from the research, the hopeful result is a stronger self-protected and well-built community. Due to the effectiveness of long-term community safety promotion, this research also proposes the following as suggestions for crime prevention in the future. 1.Strengthen the management of security maintenance hardware. 2.Strengthen safety equipment and design of the community. 3.Promote the authentication mechanism between property management companies and security personnel. 4.Strengthen the relationship between the police and the public to implement crime prevention. 5.Assist to establish the community public security committee to enhance security defense energy. 6.Mobilize residents to participate in community crime prevention tasks and raise public awareness. 7.Continue promoting the “Dedicated Police Service District" system to improve performance. 8.Promote cooperation between civil and private departments to create a win-win situation.
Poho, Petronella Tryzina. "Identification of health needs and problems of Black employees in the Germiston City Health Department." Diss., 1994. http://hdl.handle.net/10500/15797.
Full textHealth Studies
M.A. (Nursing Science)
Wei, Chiang Tzu, and 江子瑋. "Study on the Effectiveness for the International Safe School Committee Certited-School in Taiwan." Thesis, 2011. http://ndltd.ncl.edu.tw/handle/32732578535001121042.
Full text大葉大學
設計暨藝術學院碩士在職專班
99
International Safe Schools are established by the cooperation of schools and communities to provide the faculty, students and community residents with safe places and systems. Recently, over 27 domestic schools have been certified for International Safe Schools while only 53 schools totally in the world are certified. This density in Taiwan wins first place. The goals of certification for International Safe Schools are promoting concepts and experience of International Safe Schools, and the related campus safety plans are developed through indicators to avoid and prevent injuries in campus from happening to ensure the campus safety plans are fulfilled. This study aimed at understanding the benefits of certifications of International Safety Schools for domestic schools. The bibliographies analysis, field observation, and depth interviews are employed to research on the capital data of domestic International Safety Schools, and then through the student survey, the current situation of International Safety Schools can be compared. The research objects are the faculty and students of domestic schools which has passed the safety school certification. The benefits of International Safety Schools are discussed from the campus accident data, and then the campus planning and environmental management are discussed conceptually to find out an appropriate planning architecture as a reference for schools which would like to execute the planning of International Safety Schools in the future. Based on the research results, the injuries from students of International Safety Schools do not decrease because of the certification of International Safety Schools. The data contains the statistics from schools and students with elvated awareness of injury accidents. 83% students are satisfied for the safety in campus. The places that the most accidents happen are playgrounds, corridors and classrooms in majority. The reasons of the happening of accidents for elementary school students are that the places are easily crowded with people, the places with very few people passed in and out, and the ground is easily slippery.
Jeng, Mau-Shiun, and 鄭懋勳. "A Study of Construction Safety Management Issues of Public Construction Committed Supervision –for Example of Elevated Railway System of MRT Development In Taichung." Thesis, 2013. http://ndltd.ncl.edu.tw/handle/64161401072073547816.
Full text逢甲大學
土木工程學系
101
The commissioned public construction supervising job currently focuses on analyzing the demerits of the secondary quality assurance, managing the construction progress, clarifying the interface responsibilities, etc. Research information on these and related areas are also available. However, the study on problems related to the supervising job on the construction safety of a commissioned public work is seldom found. In this study, researchers analyzed the possible problems and institutional blind spots that the supervising units were facing when carrying out the safety management through collecting information of projected constructions and sending out questionnaires, aiming to obtain solutions and to propose suggestions to serve as references for managing and supervising the safety of domestic constructions. And, a more agreeable and practicable processing mode is to be generated to result in lowering possibility of accident at work and reducing damage. The results showed that, according to the technical service contract signed with the construction owner, the supervising unit directly supervised the constructor to carry out every detail in the construction contract. The supervising unit was responsible not only for supervising the construction progress, construction quality, construction safety and sanitation, and environmental protection provided by the constructor, but had to watch its own personnel cost on the profit aspect. During the constructing period, the supervising unit truly performed the supervising job on the construction safety and sanitation, not just completing the paper work, was related to the contracted way of payment, mutual right and responsibility, attitude of the project owner, and conflict and compromise of the role responsibility. The number of the safety personnel increases to enhance the efficiency of the supervising and managing if the governmental authorities review and amend the relevant regulations and put the revised in the technical contracts and contract terms of the construction contract for all construction providers to completely authorize the supervising unit to execute the supervising jobs and to truly perform the safety and sanitation managing work.
Almas, Mariana Ferreira Baltazar de Matos. "Lessons learned on the design and the conduct of European Post Authorisation Safety Studies (PASS) : review of 3 years of PRAC oversight." Master's thesis, 2017. http://hdl.handle.net/10451/33982.
Full textIntroduction The new European Union (EU) Pharmacovigilance, implemented in 2012, aimed to establish a more proactive and efficient system for the early detection and prevention of issues related to the safety of medicinal products. This goal is reflected by the legal enforcement of Risk Management activities. As a consequence, it is necessary to submit a Risk Management Plan (RMP) with each application for a new marketing authorisation. This document includes a critical assessment of the known and unknown safety profile of the medicinal product and discusses the need to implement Pharmacovigilance and risk minimisation activities that go beyond the routine ones. A Post-Authorisation Safety Study (PASS) is an additional Pharmacovigilance activity conducted with the goal of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk minimisation measures (RMMs). They bridge Pharmacovigilance, which defines the mission, with Pharmacoepidemiology which provides the study methods. PASS can be imposed as condition or special obligation to the marketing authorisation and may also be requested upon conclusion of a safety related referral. The Pharmacovigilance Risk Assessment Committee (PRAC) is a committee of the European Medicines Agency (EMA) created by the new Pharmacovigilance legislation. It is responsible for the assessment of safety issues at EU level, as well as the monitoring of the Pharmacovigilance activities foreseen in the legislation. In addition, as a consequence of the efforts to increase transparency of the regulatory processes and decisions, the EMA publishes the PRAC monthly minutes on its website. These documents list all the assessed Pharmacovigilance procedures with a brief summary of the plenary decisions. The availability of these and other documents provided an opportunity to identify the PASS protocols submitted to the PRAC. The objective of the current dissertation was to describe the PASS landscape during the first three complete years of the new Pharmacovigilance legislation by characterising the purpose and methodology of the studies. It also aimed to give a critical perspective on the level of public available information on the PASS review process and PRAC feedback. Methods The minutes of the PRAC meeting minutes held from July 2012 to July 2015 were chronologically reviewed to identify and track all PASS protocols and respective rounds of review. The information from the minutes was complemented with a review of the European Public Assessment Reports (EPARs) for the medicinal products covered in the PASS, which provided information about the regulatory background. Moreover, the European Union electronic Register of Post-Authorisation Studies (EU PAS) Register available in the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) website was also searched to find information about PASS methodology and protocol documents. Upon protocol availability, it was possible to retrieve more granular information. Metrics regarding the PRAC assessment process were determined among protocols that were considered approved based on the following rules: there was information in the PRAC comments text, the PASS was found in the EU PAS Register, or more than one year had elapsed since the last assessment of that PASS protocol. Descriptive analyses were performed on actual data, with no imputations for missing data. Comparisons using chi-square test (with a significance level of 5%) were conducted. Results In total, 189 different PASS protocols were identified by reviewing the minutes of the PRAC meetings from July 2012 to July 2015, corresponding to 353 PASS protocol submissions to the PRAC. The outcome of PRAC assessment was only available in the minutes for approximately one third (30%) of the 353 assessments. Only half of the 189 PASS were available in the EU PAS Register at the data lock, July 2015. The majority of PASS (58%) concerned new marketing authorisations. About one third (31%) of the 189 PASS were imposed by the regulators. The vast majority of PASS (74%) had at least one objective related with investigation of safety concerns, while approximately one third (34%) included at least one objective of assessing drug utilisation and one fourth (25%) incorporated at least one objective related with assessment of effectiveness of RMMs. Almost one third of the PASS (31%) combined objectives of at least two of those categories. PASS were mainly designed as longitudinal studies (81%). However, the majority of PASS (56%) with at least one objective concerning the assessment of effectiveness of RMM had a cross-sectional design. Overall, slightly more PASS involved a primary data collection approach (58%). Among PASS with at least one objective related with assessment of drug utilisation, 58% leveraged data collection schemes already established for other purposes. More than two thirds of PASS (70%) focused on a single medicinal product as eligibility criteria (either patient exposure or prescribers of the medicinal product of interest), while broader exclusion criteria were less frequent. Among the 57 available protocol documents, only one third (33%) mentioned a comparator, such as another medicinal product, a non-exposed group or external data sources. All 57 PASS included at least one European country. The majority of the 18 available protocols in which at least one objective was to assess effectiveness of RMM did not specify how success of those measures would be ascertained. One third (33%) of these PASS aimed exclusively to assess effectiveness of RMM and were designed as cross-sectional studies using a questionnaire to assess knowledge and auto-reported behaviour. The most common areas of the protocol referred as responsible for the rejection of the protocols by the PRAC were related to inadequate study design (37%) and concerns with study feasibility (30%) requiring evidence that bias and limitations were adequately considered. The comments corroborate the general insight that the there was a limited level of detail in the PASS protocols. PRAC protocol assessment metrics were estimated among 37 imposed PASS considered approved. The results suggested a decrease in the median number of rounds of review from 3 to 2 and an average decrease of 6 months in overall review time between the first and the third year of the review. Discussion This was the first comprehensive characterisation of the PASS protocols submitted to the PRAC during the first three years under the new Pharmacovigilance legislation. Overall, the results showed that despite the unprecedented level of transparency achieved, which made this study possible, there is still room for improvement in the level of information provided by regulators and MAHs. An increased publication of the outcomes of PRAC assessment and more adherence to the EU PAS Register, would increase the pool of knowledge available to further improve PASS. It was also evident that there is and some lack of communication between different stakeholders, which may be worsened by the lack of uniform terminology. The limited level of detail in the protocols is not in line with good pharmacoepidemiology and good pharmacovigilance practices (GPP and GVP), both emphasising the need to include details on the reasoning behind the methodological decisions and feasibility considerations. The recognition of the singularity of PASS, as pharmacoepidemiological studies that have a specific mission within the medicinal products’ RMPs, calls for alignment of different parties and cross-pollination of different skills, including qualitative and quantitative approaches and combined study designs, to tailor the best approach for each safety question. Conclusion Cross-functional collaboration and communication across stakeholders, higher levels of transparency and the use of a harmonised terminology would be key to develop innovative methods, customised for the singular and multifaceted needs of PASS, an example of which being the assessment of effectiveness of RMM. The anticipated result would be the implementation of best practices that will certainly contribute to a safer use of medicinal products.
Introdução A nova legislação europeia de Farmacovigilância, implementada em 2012, visou o estabelecimento de um sistema mais proativo e eficiente para a deteção atempada e prevenção de problemas de segurança dos medicamentos. A obrigação de submeter Planos de Gestão do Risco com todos os pedidos de Autorização de Introdução no Mercado (AIM) de novos medicamentos reflete esta direção. Nestes documentos o titular de AIM deve apreciar o perfil de segurança conhecido e desconhecido do medicamento e ponderar a necessidade de implementar atividades de Farmacovigilância ativa e medidas de minimização do risco para proteção da saúde pública. Os estudos de segurança pós-autorização (Post Authorisation Safety Studies, PASS) são uma atividade de Farmacovigilância ativa cujo objetivo é identificar, caracterizar ou quantificar o perfil de segurança de um medicamento ou medir a eficácia das medidas de gestão dos riscos. Resultam da convergência entre a Farmacovigilância que define a missão e a Farmacoepidemiologia que fornece os métodos para o estudo. De acordo com a nova legislação, as autoridades competentes podem impor a realização de PASS como condições da AIM ou em sede de AIM concedida em circunstâncias especiais. Outra novidade da nova legislação de Farmacovigilância foi a criação de um novo comité da Agência Europeia do Medicamento, o Pharmacovigilance Risk Assessment Committee (PRAC), que tem como objetivo avaliar todos os problemas de segurança de medicamentos ao nível da União Europeia e supervisionar todos os processos de Farmacovigilância que a legislação prevê. Como consequência dos esforços para aumentar a transparência das decisões e processos regulamentares, as minutas das reuniões mensais do PRAC são publicadas no website da Agência e listam todos os processos avaliados pelo PRAC, juntamente com um pequeno sumário das decisões tomadas em plenário. A disponibilidade destes documentos tornou possível a identificação dos protocolos dos PASS submetidos para avaliação do PRAC desde a implementação da nova legislação em Julho de 2012. A presente dissertação teve como objectivo a caracterização exaustiva dos protocolos dos estudos PASS submetidos ao PRAC durante os primeiros três anos da nova legislação de Farmacovigilância, descrevendo o âmbito e a metodologia dos estudos em várias vertentes. Pretendeu-se também reflectir sobre o nível de informação que se encontra publicamente disponível. Métodos Foram revistas todas as minutas das reuniões mensais do PRAC entre os períodos de Julho 2012 e Julho 2015 de modo a identificar cronologicamente todos os protocolos de PASS submetidos para avaliação do PRAC durante os três primeiros anos da nova legislação de Farmacovigilância. Para complementar a informação disponível nas minutas, foram consultados os Relatórios Públicos Europeus de Avaliação dos medicamentos em estudo, disponíveis no website da Agência, de forma a identificar o contexto regulamentar na origem do PASS. Por outro lado, foi também efetuada uma pesquisa no registo eletrónico de estudos de pós-autorização mantido pelo European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) para obter informações mais detalhadas sobre a metodologia do estudo incluindo os próprios documentos dos protocolos que, estando disponíveis, providenciaram uma fonte de informação mais detalhada e exata. O número de rondas de revisão a que os protocolos foram submetidos, assim como a duração do processo desde a primeira submissão do protocolo até à aprovação do mesmo, foram calculados para os protocolos considerados autorizados no fim do período em análise. Na ausência de informação sobre o resultado da última avaliação de um determinado protocolo, foi assumido que o protocolo fora aprovado quando se encontrava inserido no registo eletrónico do ENCePP ou quando o protocolo não fora novamente mencionado nas minutas do PRAC durante mais de um ano até Julho de 2015. Foram utilizadas estatísticas descritivas e análises bivariadas recorrendo ao teste de qui quadrado com nível de significância de 5%. Resultados Da revisão das minutas das reuniões mensais do PRAC entre Julho de 2012 e Julho de 2015 foram identificados 189 protocolos de PASS, de um total de 353 submissões para avaliação pelo comité. O resultado da avaliação pelo PRAC estava disponível em apenas cerca de um terço (30%) das 353 avaliações. Somente metade dos 189 PASS (49%) tinha sido inserida no registo eletrónico do ENCePP até Julho de 2015. A maioria dos 189 PASS (58%) dizia respeito a novas AIMs. Cerca de um terço (31%) dos 189 PASS foram impostos pelas Autoridades Regulamentares. A maior parte dos PASS incluía pelo menos um objetivo relacionados com a investigação de riscos ou ausência dos mesmos (74%), enquanto cerca de um terço (34%) continha pelo menos um objetivo relacionado com a avaliação de padrões de utilização do medicamento, e um quarto (25%) inseria pelo menos um objetivo relativo a avaliar a efetividade de atividades de minimização de risco. Cerca de um terço dos PASS (31%) combinava objetivos de pelo menos duas destas categorias. A grande maioria dos estudos PASS apresentava um desenho longitudinal (81%). No entanto, a maioria dos estudos com pelo menos um objetivo relacionado com avaliação da efetividade das medidas de minimização de risco (56%) tinha um desenho transversal. Constatou-se que um número ligeiramente superior de PASS (58%) tinha por base a recolha de dados primários (i.e. informação recolhida de novo para o estudo). Observou-se um padrão inverso entre os estudos com pelo menos um objetivo relativo à avaliação de padrões de utilização do medicamento dado que a recolha de dados em 58% destes estudos era baseada em fontes secundárias. No total, mais de dois terços (70%) dos estudos visavam a inclusão de uma população exposta exclusivamente ou prescritora do medicamento em avaliação. Verificou-se que os estudos com critérios de inclusão mais abrangentes, tais como outros medicamentos ou todos os doentes com determinada patologia, eram mais raros. A análise mais detalhada dos 57 protocolos disponíveis revelou que apenas um terço (33%) dos estudos referia um comparador (quer outro medicamento ou ausência do medicamento em estudo quer fontes externas) e que todos os PASS planeavam a inclusão de pelo menos um país europeu. Entre os 18 protocolos disponíveis de PASS com pelo menos um objetivo relativo à avaliação da efetividade das medidas de minimização do risco, a maioria não referia concretamente a forma como osucesso das mesmas seria avaliado. Um terço desses protocolos (33%) visava exclusivamenteinvestigar a efetividade dessas medidas através da aplicação de um questionário para avaliar oconhecimento e o comportamento auto-reportados. As áreas dos estudos referidas mais frequentemente como responsáveis pela rejeição dos protocolos pelo PRAC estavam relacionadas com aspetos do desenho do estudo (37%) e de exequibilidade (30%), sendo necessárias considerações adicionais para demonstrar que eventuais viés e limitações tinham sido adequadamente ponderados. Estes comentários corroboram a observação geral de que onível de detalhe incluído na maioria dos protocolos era escasso. A análise das métricas relativas ao número de revisões de cada protocolo e duração total do processo de revisão dos 37 protocolos com evidência de terem sido aprovados, sugeriu uma evolução positiva entre os PASS submetidos pela primeira vez no primeiro ano em análise e aqueles submetidos pela primeira vez no terceiro ano (redução de uma mediana de 3 para 2 revisões por protocolo e uma redução média de 6 meses na duração total de revisão). Discussão Este trabalho permitiu descrever pela primeira vez os protocolos de PASS submetidos ao PRAC durante os três primeiros anos da nova legislação de Farmacovigilância. Embora o facto deste trabalho ter sido possível reflita um nível de transparência sem precedentes, o nível de informação disponível é ainda limitado. Uma maior partilha das recomendações do PRAC resultantes da avaliação dos protocolos, uma maior adesão ao registo de PASS no portal eletrónico do ENCePP e o desenvolvimento de uma terminologia mais consistente, será importante para a partilha de boas práticas de modo a fomentar o desenvolvimento de PASS mais robustos. Por outro lado, o limitado nível de detalhe presente nos protocolos sugere alguma inconformidade com as boas práticas de Farmacoepidemiologia e Farmacovigilância, as quais enfatizam a fundamentação e descrição crítica dos métodos selecionados. Adicionalmente a articulação entre os objetivos dos PASS enquanto medidas adicionais de Farmacovigilância e os métodos empregues poderá beneficiar de uma maior colaboração entre os peritos de diferentes áreas. Conclusão Uma maior colaboração e partilha de informação e conhecimento entre diferentes áreas levará ao desenvolvimento de novos métodos customizados para as necessidades singulares dos PASS, tais como metodologias multidisciplinares direccionadas para avaliar a efetividade das medidas de minimização do risco. O resultado, contribuirá certamente para o estabelecimento de processos mais robustos e levará ao uso mais seguro dos medicamentos.
Chikutuma, Tendai. "The quality of early childhood development programmes in Harare primary schools in Zimbabwe." Thesis, 2013. http://hdl.handle.net/10500/13511.
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