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Improving risk management systematically.

The management of risk is an ever more prevalent issue amongst healthcare professionals due to key changes in recent years driving visibility and transparency. Medical gases constitute an important area of risk--the gases are used, administered and handled by many different people and the chief executive is ultimately responsible. Such risks can be managed down by a hospital according to the letter and spirit of HTM 2022, EN737 and NMSR. The biggest failing of the current system where hospitals take it upon themselves to ensure compliance, is that typically little training is actually performed, there is almost no monitoring, and often people on the front line are unaware of the risks that they are running. A systematic response to managing risk is the only way forward, and a key decision a hospital needs to make is whether to persist towards this goal itself, or to involve a technical and clinical supplier. BOC Medical is in a key position to be of value.

Gases↗

[Protocols of health security in the light of some examples of risk management].

Throughout medical training, medical risk management is a subject that has been insufficiently addressed and treated without a global vision. Yet the different dangers often make the front page of a media that addresses the question of health security when there is a failure of the system or new legal developments. Added to this disequilibrium of communication and training is the great complexity of risk management. Not only is the nature of the potentially dangerous agents extraordinarily varied but also the entity that detects the risk is sometimes a stranger to the causes of its appearance. The surrounding regulations are themselves complex and dense. Using the examples that have arisen over the last 2 or 3 years, this article describes the current French protocols in risk management, that rely upon the agencies delivering their expertise, certain of which are endowed with the power of policing these regulations. In practice, the doctor should understand the role of these agencies, know how to find the validated information that they can provide, and understand his role in this picture. A role that is perceived as far away as long as the risk has not emerged, but is in the forefront once the event arises.

Animals↗

The emerging role of risk management.

This article discusses the emerging role of risk management for the PACU nurse. The risk management process is described in detail and compared with the nursing process in terms of assessment, planning, implementation, and evaluation. Tools that aid in assessment include incident reports, generic screening, patient complaints, and other factors. Specific examples relating to the PACU are used throughout the article. The article further describes skills needed in the field of risk management. Finally, implications for nursing are discussed including involvement in risk management, documentation, continuing education, and the position of risk manager.

Humans↗

The role of scientific research in risk assessment and risk management decisions.

Risk-based decisions are an integral part of societal efforts to protect the public from the harmful health effects of environmental pollution. Scientific information about the magnitude and extent of risks experienced by people and about the causes of those risks is a critical factor in setting priorities and choosing cost-effective mitigation strategies. To be effective in strengthening risk assessment and risk management decisions, research must focus on developing four types of predictive tools: (1) methods to screen and characterize toxicity; (2) biologically based dose-response models; (3) physiologically based pharmacokinetic models; and (4) integrated human exposure models. This approach is the key to reducing the uncertainties currently associated with many environmental health problems.

Decision Support Techniques↗

Risk management and electronic fetal monitoring: decreasing risk of adverse outcomes and liability exposure.

Electronic fetal monitoring (EFM) has the potential to promote fetal health and improve neonatal status at birth; however, EFM as a stand-alone tool is ineffective in avoiding preventable adverse outcomes. It is effective only when used in accordance with published standards and guidelines by professionals skilled in correct interpretation and when appropriate timely intervention is based on that interpretation. Interpretation and intervention are best accomplished as a collaborative perinatal team rather than individual activity. Only in these circumstances can EFM optimally contribute to fetal well-being and subsequent neonatal health. Risk management strategies to decrease potential liability are presented that can be accomplished with careful planning and collaboration among perinatal team members.

Female↗

Equipment management risk rating system based on engineering endpoints.

The equipment management risk ratings system outlined here offers two significant departures from current practice: risk classifications are based on intrinsic device risks, and the risk rating system is based on engineering endpoints. Intrinsic device risks are categorized as physical, clinical and technical, and these flow from the incoming equipment assessment process. Engineering risk management is based on verification of engineering endpoints such as clinical measurements or energy delivery. This practice eliminates the ambiguity associated with ranking risk in terms of physiologic and higher-level outcome endpoints such as no significant hazards, low significance, injury, or mortality.

Biomedical Engineering↗

Therapeutic risk management interventions: feasibility and effectiveness.

OBJECTIVE: To review the effectiveness and feasibility of risk management strategies implemented for drugs with significant known risks. DATA SOURCES: Published medical literature and regulatory archives, including proceedings of Food and Drug Administration advisory committee meetings. Iterative searches of the medical literature, the Internet, and Web-based government information sources were conducted throughout 2002-2003. Search terms were related to risk management, drug safety, and the names of specific medications known to be subject to risk management programs. STUDY SELECTION: Key studies that illustrated examples of risk management and evaluated risk management programs were selected by the authors. DATA EXTRACTION: Performed manually by the authors. DATA SYNTHESIS: Much of the information regarding the effectiveness of risk management interventions in reducing risk is anecdotal; little information has been published. Given the demand for evidence-based clinical decision making, pharmaceutical manufacturers and the health care community must understand whether these programs are achieving their ultimate goals of reducing risks to patients, while making needed therapies available. This paucity of evidence points to new opportunities for researchers across disciplines to better understand the feasibility and effectiveness of these interventions and the impact of the interventions at the patient, practitioner, and public health levels. Such research needs to be published so that future programs and policy can be informed by these early examples. CONCLUSION: For interventions to be effective in reducing risk, they must effect change in physician prescribing, pharmacist dispensing, and patient adherence. Risk intervention programs that are overly burdensome to physicians, pharmacists, or patients are unlikely to succeed in achieving the desired outcome of reducing individual risk. In addition, risk management programs should be scaleable and implemented in a systematic fashion to accommodate multiple simultaneous programs that can effectively manage the risk, rather than through a piecemeal approach.

Drug Approval↗

[Investigation and multivariate statistical analysis of the factors influencing risk management].

A questionnaire survey for medical practitioners was conducted to clarify their basic awareness and concepts of risk management. One hundred and sixty-three medical practitioners participated in the fourth. Chugoku Yakugaku Kenkyukai. More than 50% of the participants (n = 83, aged 39.7 +/- 10.8 years) answered correctly questions about the awareness of risk management and the existence of a risk management committee in their medical institution. All of those survey participants had experienced common risk managements incidents (approximately 12 times/year) during working hours. When multivariate statistical analysis was performed on the survey results, the factors influencing the presence of a risk management committee in a medical institution were a system for the submission of incident reports, the number of beds, and the presence of a person assigned to manage risk. The analysis showed that in a number of cases medical institutions did not have a system for incident reports and did not appoint risk management staff. Moreover, the analysis showed that factors influencing the presence of a risk management committee were staff age, experience in submitting incident reports, and participation of the top executive in the operation of the risk management committee. Participants younger than 40 years of age were dissatisfied with the reporting system of risk management committees those older. The younger group usually reported incidents to those older than 40 years of age, who only accepted the reports and did not submit them to the risk management committee. In conclusion, our results suggest that in a risk management program it is important to establish a committee and a system for the submission of incident reports. Incident reports should not only include expressions of regret for medication errors but also propose a plan for improvement.

Adult↗

Risk management in a polio-free world.

Inherent in the decision to launch the Global Polio Eradication Initiative in 1988 was the expectation for many people that immunization against poliomyelitis would eventually simply stop, as had been the case with smallpox following its eradication in 1977. However, the strategies for managing the risks associated with a "polio-free" world must be continuously refined to reflect new developments, particularly in our understanding of the live polioviruses in the oral poliovirus vaccine (OPV) and in the international approach to managing potential biohazards. The most important of these developments has been the confirmation in 2000 that vaccine-derived polioviruses (VDPVs) can circulate and cause polio outbreaks, making the use of OPV after interruption of wild poliovirus transmission incompatible with a polio-free world. A comprehensive strategy has been developed to minimize the risks associated with eventual OPV cessation, centered on appropriate long-term biocontainment of poliovirus stocks (whether for vaccine production, diagnosis, or research), the controlled reintroduction of any live poliovirus vaccine (i.e., from an OPV stockpile), and appropriate use of the inactivated poliovirus vaccine (IPV). Although some aspects of this risk management strategy are still debated, there is wide agreement that no strategy would entirely eliminate the potential risks to a polio-free world. The current strategy for risk management in a polio-free world will continue to evolve with better characterization of these risks and the development of more effective approaches both to reduce those risks and to limit their consequences should they occur.

Disease Outbreaks↗

Risk management in pathology and laboratory medicine.

An effective risk-management program focuses attention on and minimizes events that ideally should not occur. In the laboratory, risk-management issues can be divided along two major lines: (1) patient-care-related issues and (2) employee-related issues (safety). The Joint Commission on Accreditation of Healthcare Organizations, Chicago, Ill, has established formal requirements for risk-management programs for hospitals and clinical departments. These requirements include patient-care-related activities and management functions related to the safety-management functions. The concept of a formal risk-management program may be new to pathologists and laboratory professionals; the components of the program are traditional elements of laboratory policies and procedures. Key items identified as building blocks for risk management are these: (1) risk prevention, (2) risk identification, (3) risk assessment, (4) corrective actions, and (5) loss control. Through the systematic implementation of a comprehensive risk-management program, laboratories have the opportunity to reduce liability exposure and improve the quality of care and services.

Humans↗

Teaching risk management to physicians.

In summary, the risk manager should take an active role in educating the medical staff. The seven areas discussed can serve as a checklist for the risk manager and, of course, can be expanded. The risk management strategies described should be encouraged to become a part of physicians' daily practice patterns. Physicians then will be better prepared to help their patients deal with adverse outcomes as well as feel more comfortable about the medical-legal environment in which they practice.

Communication↗

Personalized cardiovascular risk management linking SCORE and behaviour change to Web-based education.

The PULSE (Personalization Using Linkages of SCORE and behaviour change readiness to web-based Education) project objectives are to generate and evaluate a web-based personalized educational intervention for the management of cardiovascular risk. The program is based on a patient profile generated by combining: (a) an electronic patient data capture template (DCT); (b) the Systematic COronary Risk Evaluation (SCORE) algorithm; and (c) a Stage of Change determination model. The DCT inherently contains a set of evidence-based parameters for patient description and disease evaluation. The patient's stage of behaviour change determines messages consistent with the individual's change processes, decisional balance, and self-efficacy. The interventions are designed to address both medical and psychosocial aspects of risk management and, as such, we combine staged lifestyle modification materials and non-staged messages based on Canadian clinical guidelines to motivate personal risk management. The personalization decision logic is represented in Medical Logic Modules implemented in Java. An intelligent interactive system generates the personally relevant materials and delivers the education to the patient via the Web. An evaluation study will be conducted to determine whether web-based personalized educational strategies exert favourable influence on patient's interest, knowledge, and perceived compliance to the suggested lifestyle modifications.

Adult↗

Handling risk. Proactive risk management spans the spectrum of care delivery.

Risk management has changed in recent years. What once was a paper-pushing, claims issue has become a more involved process. Today, proactive risk management spans the spectrum of care. This article addresses the needs now facing risk managers and others involved in the care of patients and members, the data they need and how they can collect it. Financial and clinical data are discussed as they relate to the management of risk in today's managed care organization. This, certainly, is not an easy industry to get one's arms around.

Data Collection↗

Risk management : a European regulatory perspective.

Risk management for European regulators means the detection and assessment of risks, the development and selection of measures to reduce risk, and monitoring of the effectiveness of risk control; all aspects of pharmacovigilance intended to minimise risk to European Union citizens associated with use of medicinal substances. This incorporates earlier and better planning of pharmacovigilance through formal product risk-management plans, better use of information tools to protect public health and routine audit of effectiveness of regulatory action.

Drug-Related Side Effects and Adverse Reactions↗

Financial risk management of pharmacy benefits.

Financial risk management of pharmacy benefits in integrated health systems is explained. A managed care organization should assume financial risk for pharmacy benefits only if it can manage the risk. Horizontally integrated organizations often do not have much control over the management of drug utilization and costs. Vertically integrated organizations have the greatest ability to manage pharmacy financial risk; virtual integration may also be compatible. Contracts can be established in which the provider is incentivized or placed at partial or full risk. The main concerns that health plans have with respect to pharmacy capitation are formulary management and the question of who should receive rebates from manufacturers. The components needed to managed pharmacy financial risk depend on the type of contract negotiated. Health-system pharmacists are uniquely positioned to take advantage of opportunities opening up through pharmacy risk contracting. Functions most organizations must provide when assuming pharmacy financial risk can be divided into internal and external categories. Internally performed functions include formulary management, clinical pharmacy services and utilization management, and utilization reports for physicians. Functions that can be outsourced include claims processing and administration, provider- and customer support services, and rebates. Organizations that integrate the pharmacy benefit across the health care continuum will be more effective in controlling costs and improving outcomes than organizations that handle this benefit as separate from others. Patient care should not focus on payment mechanisms and unit costs but on developing superior processes and systems that improve health care.

California↗

Risk management concepts and strategies.

A variety of risk management strategies, concepts, and techniques not only enhance the quality of care, but also represent a significant contribution to the organization's efforts to reduce the frequency and severity of liability loss. The success of the risk management program depends on the participation of all members of the health care team, and the collaboration of the nursing staff and the risk management office creates a critical team in ensuring the effectiveness of the risk management program.

Communication↗

Medication use risk management: hospital meets home care.

Risk management is an objective strategy that seeks to eliminate or decrease the chances of financial loss and legal action. Risk management focuses on an actual mistake, an accident, or a potential similar occurrence. Risks occur in nursing in a variety of practice settings. Nursing has identified several key areas in which systematic change has improved and decreased the risk factor encountered in practice. This article targets medication usage and administration and the methods introduced in quality improvement processes to decrease risks and potentially reduce financial and legal risk.

Continuity of Patient Care↗

The art and science of risk management: a US research-based industry perspective.

The research-based pharmaceutical industry in the US strongly supports the concepts of risk management and sees formal risk management as playing a major role in the development of safe medicines for the public, as well as providing a mechanism to ensure that decisions concerning individual drug benefit and risk are made based on scientific evidence. Safe medicines refer to those drugs whose benefits have been found to outweigh their risks when they are used according to the approved labelling. Risk management is the comprehensive and proactive application of scientifically based methodologies to identify, assess, communicate and minimise risk throughout the life cycle of a drug so as to establish and maintain a favourable benefit-risk balance in patients. Although there are certainly a number of global risk management initiatives in place or being undertaken, harmonisation has yet to be achieved. Industry is faced with a variety of different risk management approaches and tools. There is a need to move the focus of risk management from the post-approval arena to earlier in the development process and tools need to be developed to support risk management throughout the lifecycle of a drug. The focus in the US on risk minimalisation strategies will also be an area for methodological development. A key factor in the success of overall risk management is the dialogue between industry and regulators throughout the development, review and marketing of the product. It is through such dialogue that appropriate, efficient and effective risk management strategies will be developed and implemented and the best decisions regarding the safe use of pharmaceutical products will be made.

Clinical Trials as Topic↗