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PubMed2002

Health and safety management systems: liability or asset?

Health and safety management systems have a background in theory and in various interests among employers and workplace health and safety professionals. These have resulted in a number of national systems emanating from national standard-writing centres and from employers' organizations. In some cases these systems have been recognized as national standards. The contenders for an international standard have been the International Organization of Standardization (ISO) and the International Labour Organization (ILO). The quality and environmental management systems of ISO indicate what an ISO health and safety management standard would look like. The ILO Guidelines on Safety and Health Management Systems, by contrast, are stringent, specific and potentially effective in improving health and safety performance in the workplace.

Canada↗
PubMed2004

Relationships between accident investigations, risk analysis, and safety management.

Several different approaches to achieve safety are in common use, and examples are accident investigations (AI), risk analysis (RA), and safety management systems (SMS). The meaning of these concepts and their practical applications vary quite a lot, which might cause confusion. A summary of definitions is presented. A general comparison is made of application areas and methodology. A proposal is made how to indicate parameters of variation. At one end of the scale there are organisations, which are highly organised in respect to safety. At the other end are small companies with informal safety routines. Although the three concepts differ in a number of respects, there are many links between them which is illustrated in a model. A number of relations have been described mainly concerned with more advanced organisations. Behind the practical safety work, there are varying sets of more or less explicit explanations and theories on safety and accident causation. Depending on the theory applied, the relations between approaches can be more or less clear and essential.

Humans↗
PubMed2004

Evaluation of improved safety management program for outpatient drug dispensing in terms of effect on potential adverse drug events.

Dispensing errors may cause serious health damage. To eradicate dispensing errors, we implemented new safety management strategies, including the development of a dispensing-support system with a computerized check function. We previously evaluated and reported the usefulness of these new strategies for safety management by comparing the incidence of potential adverse drug events (PADEs) before and after the implementation of these strategies. In the present study, we compared the incidence of PADEs from outpatient prescriptions in the late phase 5 years after the start of the new safety management program with that before the implementation. The incidence of PADEs from outpatient prescriptions after the start of these strategies (late phase) was significantly lower than that before their introduction (p<0.001), similar to the results in the early phase. When examining PADEs with respect to category, the incidence of PADEs related to the dispensing of a wrong drug, such as those related to errors in the drug name or standard/dosage form of the same drug, in the late phase was significantly lower than that before the new program began (p<0.05), as was also the case in the early phase. The incidence of PADEs related to errors in counting tablets/capsules was also significantly lower (p<0.01, p<0.05). With respect to the level of influence on patients (level 0 to 3a), the incidence of level-0 PADEs, which represents potential errors that were prevented, in the late phase was significantly lower than that before implementation (p<0.01), as was also demonstrated in the early phase. The incidence of level-1 PADEs in the late phase was significantly lower than that before implementation (p<0.05), but not in the early phase. No level-2 or higher PADE occurred in the early or late phases after the start of the new safety program. When the PADEs were examined with respect to possible contributing factors, the incidences of PADEs associated with the presence of multiple standards in the early and late phases were significantly lower than that before (p<0.05). These results suggest the long-term usefulness of this series of newly introduced strategies for safety management.

Adverse Drug Reaction Reporting Systems↗
PubMed2005

[A contribution of a pharmaceutical department to the safety management of an outpatient's cancer chemotherapy].

A concern about safety management is growing rapidly in the field of an outpatient's cancer chemotherapy. Therefore, the pharmaceutical department of Tokai University Hachioji Hospital has employed; (1) a system to check injection prescriptions accompanied by records of drug administration and (2) an injection drug preparation worksheet for a certain communication. The results that examined their usability were as follows: (1) a prescription check found a deviation of recipes from the protocol, then all of the deviations were revised, (2) use of the worksheet with an indicated cancellation line completely prevented preparation mistakes in the case of a prescription change. Consequently, the safety management of an outpatient's cancer chemotherapy has made progress due to an application of the system and worksheet by the pharmaceutical department.

Ambulatory Care↗
PubMed2006

Information systems in food safety management.

Information systems are concerned with data capture, storage, analysis and retrieval. In the context of food safety management they are vital to assist decision making in a short time frame, potentially allowing decisions to be made and practices to be actioned in real time. Databases with information on microorganisms pertinent to the identification of foodborne pathogens, response of microbial populations to the environment and characteristics of foods and processing conditions are the cornerstone of food safety management systems. Such databases find application in: Identifying pathogens in food at the genus or species level using applied systematics in automated ways. Identifying pathogens below the species level by molecular subtyping, an approach successfully applied in epidemiological investigations of foodborne disease and the basis for national surveillance programs. Predictive modelling software, such as the Pathogen Modeling Program and Growth Predictor (that took over the main functions of Food Micromodel) the raw data of which were combined as the genesis of an international web based searchable database (ComBase). Expert systems combining databases on microbial characteristics, food composition and processing information with the resulting "pattern match" indicating problems that may arise from changes in product formulation or processing conditions. Computer software packages to aid the practical application of HACCP and risk assessment and decision trees to bring logical sequences to establishing and modifying food safety management practices. In addition there are many other uses of information systems that benefit food safety more globally, including: Rapid dissemination of information on foodborne disease outbreaks via websites or list servers carrying commentary from many sources, including the press and interest groups, on the reasons for and consequences of foodborne disease incidents. Active surveillance networks allowing rapid dissemination of molecular subtyping information between public health agencies to detect foodborne outbreaks and limit the spread of human disease. Traceability of individual animals or crops from (or before) conception or germination to the consumer as an integral part of food supply chain management. Provision of high quality, online educational packages to food industry personnel otherwise precluded from access to such courses.

Consumer Product Safety↗
PubMed1999

Towards integrated hygiene and food safety management systems: the Hygieneomic approach.

Integrated hygiene and food safety management systems in food production can give rise to exceptional improvements in food safety performance, but require high level commitment and full functional involvement. A new approach, named hygieneomics, has been developed to assist management in their introduction of hygiene and food safety systems. For an effective introduction, the management systems must be designed to fit with the current generational state of an organisation. There are, broadly speaking, four generational states of an organisation in their approach to food safety. They comprise: (i) rules setting; (ii) ensuring compliance; (iii) individual commitment; (iv) interdependent action. In order to set up an effective integrated hygiene and food safety management system a number of key managerial requirements are necessary. The most important ones are: (a) management systems must integrate the activities of key functions from research and development through to supply chain and all functions need to be involved; (b) there is a critical role for the senior executive, in communicating policy and standards; (c) responsibilities must be clearly defined, and it should be clear that food safety is a line management responsibility not to be delegated to technical or quality personnel; (d) a thorough and effective multi-level audit approach is necessary; (e) key activities in the system are HACCP and risk management, but it is stressed that these are ongoing management activities, not once-off paper generating exercises; and (f) executive management board level review is necessary of audit results, measurements, status and business benefits.

Food Handling↗
PubMed2005

An integrated approach for improving occupational health and safety management: the voluntary protection program in Taiwan.

A voluntary compliance program for occupational health and safety management, Voluntary Protection Programs (VPP), was implemented with a strategy of cooperation and encouragement in Taiwan. Due to limitations on increasing the human forces of inspection, a regulatory-based guideline addressing the essence of Occupational Health and Safety Management Systems (OHSMS) was promulgated, which combined the resources of third parties and insurance providers to accredit a self-improving worksite with the benefits of waived general inspection and a merit contributing to insurance premium payment reduction. A designated institute accepts enterprise's applications, performs document review and organizes the onsite inspection. A final review committee of Council of Labor Affairs (CLA) confers a two-year certificate on an approved site. After ten years, the efforts have shown a dramatic reduction of occupational injuries and illness in the total number of 724 worksites granted certification. VPP worksites, in comparison with all industries, had 49% lower frequency rate in the past three years. The severity rate reduction was 80% in the same period. The characteristics of Taiwan VPP program and international occupational safety and health management programs are provided. A Plan-Do-Check-Act management cycle was employed for pursuing continual improvements to the culture fostered. The use of a quantitative measurement for assessing the performance of enterprises' occupational safety and health management showed the efficiency of the rating. The results demonstrate that an employer voluntary protection program is a promising strategy for a developing country.

Cooperative Behavior↗
PubMedDate not supplied

How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated in this article, the reporting of ADRs via e-mail would cause real problems for the drug safety units. Finally, they consider that telephone call centres should be restricted to a specific communication problem such as crisis management or Dear Dr letters.

Adverse Drug Reaction Reporting Systems↗
PubMed2003

Process safety management in the pipeline industry: parallels and differences between the pipeline integrity management (IMP) rule of the Office of Pipeline Safety and the PSM/RMP approach for process facilities.

In 2001, the Federal Office of Pipeline Safety promulgated its pipeline integrity management rule for hazardous liquid pipelines. A notice of proposed rule making for a similar rule for gas pipelines was issued in January 2003. A final rule must be in place by the end of 2003. These rules derive from formal risk management initiatives of both the pipeline industry and the regulators beginning in the early to mid-1990s. The initiatives and resulting rules built on many of the process safety and risk management concepts and frameworks of the process industries, as modified for pipelines. Looking closely at the parallels and the differences is an interesting study of how the technical, public and industry-specific requirements affect the types of regulations, supporting management system frameworks and the technical activities for improving hazardous materials process safety. This paper is based on the experience of the author in project work with federal and state regulators and with industry groups and companies, in both the process and pipeline industries over the last 17 years. It provides insights into various alternative pathways for communicating process safety concepts and improving process safety as the concepts are translated into specific company and even individual employee actions. It specifically highlights how the commonalities and differences in the types and configurations of physical assets and operating practices of the pipeline companies and process facilities affect respective cultures, language and actions for process safety management.

Communication↗
PubMed1995

[Uvulopalatopharyngoplasty: safety managements and causes of failure].

Uvulopalatopharyngoplasty operations on 250 patients were reported. The safety managements and failing causes of UPPP were discussed. Safety managements included 5 aspects: 1. using-local anesthesia rather than general anesthesia; 2. intraoperative monitor ECG, blood pressure and oxygen saturation; 3. tracheotomy should be performed in the severe cases before UPPP; 4. preoperative physician consultation if patients complicated with cardiopulmonary problems; 5. separated nasal and UPPP operations into two stages. Failing causes included 4 aspects: 1. improper indication; 2. polyplace obstruction, specially hypopharyngeal obstruction; 3. postoperative local hemorrhage and infection; 4. the experience and the skill of the surgeon.

Adult↗
PubMed2000

[Internal control of working conditions as a form of occupational health and safety management--experience of Western European countries and the situation in Poland].

Good occupational health and safety management not only protects workers from hazards and health impairment, but also contributes to the success of the enterprise as a whole. The internal control of working conditions in an enterprise, carried out by an employer, is one of the forms of occupational health and safety management implemented widely in many western countries, for example in Scandinavian countries and Ireland. This method may serve employers as an useful tool for stimulating and developing programmes aimed at improving working conditions and supporting workers' health protection against various hazards occurring in the work environment. The experience of the western countries in developing and implementing the internal control system, and the adaptation of the principles of this system to suit Polish conditions helped the authors to produce a set of general rules and guidelines addressed to employers who decide to use the method of internal control in their enterprises.

Employment↗
PubMed2001

Good practice in health, environment and safety management in enterprise.

Good practice in health, environment and safety management in enterprise (GP HESME) is a process that aims at continuous improvement in health, environment and safety performance, involving all stakeholders within and outside the enterprise. This WHO program is supported by other international organizations, and the declaration of Ministers of Health and Ministers of Environment adopted in 1999. The basic issues of the GP HESME concept are presented as well as its prerequisites, benefits and participants. The key partners in GP HESME are employers and their organizations, representatives of employees, governmental agencies, local authorities, financial and insurance institutions, occupational health services, environmental and social services, associations of professionals, research and training institutions. The HESME system is intended to function at different levels: international, national, local community, and enterprise settings. The lists of expected benefits for each group of stakeholders are discussed. Evaluation of GP HESME is based on the criteria and indicators, the most important of them are briefly presented.

Europe↗
PubMed1996

Safety Management in Coal Mines-Risk Assessment.

The present state of accident hazard at work in the Polish mining industry is presented. A comparison is made of the accident indices in relation to other countries. A reference is made to the work safety management system implemented in the mines. Safety management is discussed in terms of risk management. On the basis of the natural death index and that of accidents at work, numerical scales are presented defining the limits of the inadmissable, tolerable, and acceptable risk. The course of variation of risk indices for fatal, serious, and minor accidents is evaluated. The results of the assessment for all kinds of accidents at work in the mining industry are presented.

coal mining↗
PubMed2000

Assessment of requirements on safety management systems in EU regulations for the control of major hazard pipelines.

The European Commission has carried out a thorough review and assessment on whether pipelines conveying dangerous substances need a level of control similar to chemical installations, based on consideration of the hazards and risks and on accidents world-wide. The study examines whether sufficient controls already exist within the European Union (EU) Member States, considering the control philosophy of the 'Seveso II' Directive and the need to support development of pipeline networks across the EU taking into account the principles of sustainability. Community legislation would be supported by a set of criteria for the classification of Major-Accident Hazard Pipelines. Such criteria are examined for the onshore transmission pipelines in the EU. The Commission study has shown that there is a large variation in the degree to which Member States have comprehensive 'major-accident hazard' legislation on pipelines, and that existing legislation rarely addresses elements of the Safety Management System. The assessment, based on a proposed Pipeline Safety Instrument, indicates that there will be added value in a European Instrument drawing on the principles of Seveso II Directive concerning Safety Management System requirements.

Accidents, Occupational↗
PubMed2006

Construction of a safety management system for drug use by using an RFID tag.

We constructed a safety management system for narcotic drug use by using an RFID tag with barcode. In this system, RFID tags are mainly used for postscript of information, while barcodes, especially standardized unit drug codes for distribution, are used for drug identification. The outline of the system is described in the present paper.

Electronic Data Processing↗