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PubMed2002

[State of the art and problems in medical safety management].

The principle of medical safety management is to build a safe medical system that is equipped to prevent patient injuries due to medical errors occurring in it and not to attribute them only to individual responsibility. Methodologically, this means identifying and reducing the potential risk of medical errors by systematic reporting and tracking of errors and near misses. According to some major clinical studies on medical malpractice in the USA, the incidence of medical accidents is reported to be 3-5%, 30% of which were due to negligence, and 7-14% resulted in patients' deaths. It is also reported that 66% of the medical accidents occurred in surgical specialties and 45% were related to surgeries, which were shown to have the highest risk of medical accidents. On the other hand, according to a nationwide survey on reported errors and near misses in Japan, 50% were related to drugs, especially injections. Other major causes reported in the study were manipulation and management of medical instruments, downfalls of patients, and aspiration. These safety problems listed above were shown to compose 95% of all of medical errors and near misses. To establish a rational safety management system, it is necessary to develop research methods appropriate for the study of medical errors, which facilitate clinical research, and can be expected to yield sufficient scientific data. A generalized guideline for voluntary reporting of patients' deaths and injuries due to medical errors, in relation to Article 21 of the Doctors' Law should be established. However, for essential improvement of transparency and accountability in medicine, it is necessary to set up a new specialized institute to accept reports on medical errors, give hospitals advice for a safer medical system, and disclose information on medical errors. Moreover, such an institute should continue to study medical safety by analyzing nationwide reports of medical errors and near misses. For the latter purpose, legal protection of the disclosure of information must be assured.

General Surgery↗
PubMedDate not supplied

Medication safety in home infusion care.

Enhancing medication safety continues to be a critical focus area in healthcare. Barriers to improving safety include a culture of blaming individuals, underreporting of errors, and neglecting to analyze and improve systems. This article describes why medication safety should be linked with a non-punitive reporting system. Drug safety issues specific to home infusion care are identified, with practical recommendations for enhancing safety and reducing medication errors. Included in this discussion is the sentinel event alert for infusion equipment free flow and the JCAHO Patient Safety Goals for 2003.

Antineoplastic Agents↗
PubMed2006

Building safer systems by ecological design: using restoration science to develop a medication safety intervention.

BACKGROUND: Experts call for stronger safety cultures and transparent reporting practices to increase medication safety in today's strained healthcare environments. The field of ecological restoration is concerned with the effective, efficient, and sustainable repair and recovery of ecosystems that have been degraded, damaged, or destroyed. A study was undertaken to determine whether the lessons of restoration science can be adapted to the study of medication safety issues. METHODS: Working with 26 practitioners, the principles of good restoration were used to design and pilot an innovative multifaceted medication safety intervention. The intervention included focus groups with practitioners, the construction and administration of a research based medication safety inventory, repeat digital photography of environmental safety issues, and targeted environmental modifications. RESULTS: Participants were most concerned about staff education and the physical environment for medication administration. Ward staff used the research to build a healthy reporting culture, introduce regular discussions of near misses, develop education strategies, redesign delivery and storage processes, and renovate the environment. CONCLUSIONS: Members of a busy hospital ward successfully adapted methods of restoration science to study, redesign, and strengthen medication safety practices and ward safety culture within existing resources. Further research will be conducted to test the merits of restoration science for health care.

Alberta↗
PubMed2006

Demystifying medication safety: making sense of the terminology.

BACKGROUND: Although there is a growing interest in medication safety, there remains much confusion about the terminology used to describe the problem. Some have described the classification of medication safety terminology as haphazard. OBJECTIVE: The purpose of this commentary is to help provide some direction by clarifying the terminology. METHODS: A review of the medication safety literature was performed. A description of commonly used terms is provided and the implications of the misuse of terminology are discussed. RESULTS: There are inconsistencies in the definitions of commonly used terms that may affect the accuracy of event rates. This may have an adverse impact on the establishment of medication safety priorities and on the validity of cross-jurisdictional comparisons. CONCLUSIONS: As the medication safety literature continues to expand, it is imperative that standardized terminology be adopted and used consistently.

Adverse Drug Reaction Reporting Systems↗
PubMedDate not supplied

Intravenous medication safety and smart infusion systems: lessons learned and future opportunities.

The Institute of Medicine report To Err Is Human: Building a Safe Health System greatly increased national awareness of the need to improve patient safety in general and medication safety in particular. Infusion-related errors are associated with the greatest risk of harm, and "smart" (computerized) infusion systems are currently available that can avert high-risk errors and provide previously unavailable data for continuous quality improvement (CQI) efforts. As healthcare organizations consider how to invest scarce dollars, infusion nurses have a key role to play in assessing need, evaluating technology, and selecting and implementing specific products. This article reviews the need to improve intravenous medication safety. It describes smart infusion systems and the results they have achieved. Finally, it details the lessons learned and the opportunities identified through the use of smart infusion technology at Brigham and Women's Hospital in Boston, Massachusetts.

Humans↗
PubMed2005

Multiplicity of medication safety terms, definitions and functional meanings: when is enough enough?

OBJECTIVES: To identify the terms and definitions used by organisations involved in medication safety and to examine differences in functional meaning using a novel scenario assignment method. METHODS: Medication safety related terms and definitions were sought from websites of organisations associated with medication safety. The functional meanings of terms and definitions were analysed and compared using a scenario assignment method where each definition found was assessed against four scenarios with a central theme. MAIN OUTCOME MEASURES: Medication safety related terms and definitions currently in use, similarities and differences in their functional meanings, and practical implications of the use of these terms and definitions. RESULTS: Thirty three of 160 websites searched were found to have one or more definitions for medication safety related terms. Twenty five different terms with 119 definitions were found. The most frequently defined groups of terms were "adverse event" (8 different definitions), "error" (n = 9), "near miss" (n = 12), "adverse reaction" (n = 8), and "incident" (n = 4). Substantial diversity of functional meanings of definitions was demonstrated using the scenario-assignment method. Of the five groups of frequently defined terms, definitions within the "adverse event", "near miss", and "incident" groups resulted in three functional meanings each, while two functional meanings resulted for "error" and "adverse reaction". CONCLUSION: The multiplicity of terms, definitions and, most importantly, functional meanings demonstrates the urgent need for agreement on standardisation of nomenclature describing medication related occurrences. This is an essential prerequisite to enable meaningful analysis of incidence data and development of medication safety improvement strategies.

Drug-Related Side Effects and Adverse Reactions↗
PubMed2006

Medication safety infrastructure in critical-access hospitals in Florida.

PURPOSE: The medication safety infrastructure of critical-access hospitals (CAHs) in Florida was evaluated. METHODS: Qualitative assessments, including a self-administered survey and site visits, were conducted in seven of nine CAHs between January and June 2003. The survey consisted of the Institute for Safe Medication Practices Medication Safety Self-assessment, the 2003 Joint Commission on Accreditation of Healthcare Organizations patient safety goals, health information technology (HIT) questions, and medication-use-process flow charts. On-site visits included interviews of CAH personnel who had safety responsibility and inspections of pharmacy facilities. The findings were compiled into a matrix reflecting structural and procedural components of the CAH medication safety infrastructure. RESULTS: The nine characteristics that emerged as targets for quality improvement (QI) were medication accessibility and storage, sterile product compounding, access to drug information, access to and utilization of patient information in medication order review, advanced safety technology, drug formularies and standardized medication protocols, safety culture, and medication reconciliation. CONCLUSION: Based on weighted importance and feasibility, QI efforts in CAHs should focus on enhancing medication order review systems, standardizing procedures for handling high-risk medications, promoting an appropriate safety culture, involvement in seamless care, and investment in HIT.

Drug Compounding↗
PubMed2026

The influence of organizational culture on medication safety practices and associated risk factors in the community setting: A systematic review.

BACKGROUND: Increasing attention has been given to the role of organizational culture in influencing medication safety practices across healthcare settings. The lack of widely accepted standardized instrumentation makes operational measurement of organizational culture and medication safety challenging. The purpose of this systematic review was to examine the impact of organizational culture on medication safety within community healthcare settings. METHODS: MEDLINE, CINAHL, Scopus, and Nursing & Allied Health were searched in August 2025 using keywords, subject terms, field codes, and Boolean operators to identify papers relevant to the review question; bibliographies of included studies were also reviewed. Screening and full-text review were completed independently by two reviewers with a third to adjudicate conflicts. The Critical Appraisal Skills Programme was used for quality assessment. The PRISMA statement guided the development and implementation of the review. RESULTS: Thirteen articles were included representing various community settings. Most studies reported on untoward medication events, but few measured systematically collected safety data before and after an intervention. Organizational culture was seldom defined or operationalized. Most studies were methodologically sound, but the overall level of evidence was weak to moderate. CONCLUSION: Organizational culture influences medication safety through aspects such as communication channels, teamwork, training, and an environment that allows error and near-miss reporting. Few studies explicitly evaluate the causal impact of culture interventions on measurable medication safety outcomes in community healthcare settings. Further research should incorporate standardized measurement tools and intervention-based, pre-post designs to better understand how organizational culture influences medication safety in community healthcare settings.

Organizational Culture↗
PubMed2006

Pediatric medication safety and the media: what does the public see?

BACKGROUND: In the safety community, it is widely thought that a culture of safety is required to achieve high levels of safety. However, the press tends to report accidents, which are negative by their nature. Pediatric cases are often especially tragic. Relatively few data have been available on the role that the media play in forming opinions about patient safety and the subsequent impact on the culture of safety. METHODS: To address these issues, we analyzed newspaper coverage of pediatric medication errors and adverse drug events. We searched Lexis Nexis for newspaper articles on pediatric medication safety from the United States, Canada, United Kingdom, Australia, and Ireland, during a 10-year period (1994-2004), by using specific keywords. Main outcome measures were the number of articles (adjusted for population), the type of events covered, and article slant. We also examined qualitatively the overall themes and the extent to which these articles portrayed a culture of safety to the public. RESULTS: Throughout the world, there was a steady increase in articles on pediatric medication safety, peaking in 2003, with the highest per-capita rate in Canada. Approximately 65% of articles were about patient incidents, 20% mentioned policy, and 25% discussed research. Of the reported events judged to be negative for patient safety, 75% were covered in a neutral manner and 19% were covered in an unduly negative manner. CONCLUSIONS: Media coverage of pediatric medication safety has increased in the past 10 years. Reporting of patient safety failures was generally fair, and reports were generally framed in light of a culture of safety.

Child↗
PubMedDate not supplied

Practical tools for medication safety in acute care.

Identifying goals in the areas of institutional culture, infrastructure, clinical practice, and technology in hospitals minimizes the risk of medication errors among inpatients. As part of the Pathways for Medication Safety project, a model strategic plan provides seven goals for hospitals to consider in their medication safety efforts. A view of risk assessment from individual health care practitioners can aid a team effort to decease medication errors. Preparing for point-of-care bar-coding for medications will help easy implementation of this new technology. Pathways for Medication Safety provides a toolbox with useful methods and techniques for acute care settings.

Critical Pathways↗
PubMed2026

Medication safety in older adults in India: an integrative PhD synthesis of direct evidence and contextual implementation evidence.

BACKGROUND: Unsafe medication practices among older adults are an important global health concern, particularly in low- and middle-income countries where multimorbidity, fragmented care, self-medication, and informal healthcare provision intersect. OBJECTIVE(S): To synthesize direct evidence on medication safety among older adults in India and contextual evidence on deprescribing and community-level provider interventions relevant to safer medication use. METHODS: This PhD synthesis integrates four studies: a record-based cross-sectional study on polypharmacy and cardiovascular autonomic function in Kolkata; a six-city community study of 600 Indian older adults; a systematic review and meta-analysis on deprescribing preventive medications in frail or end-of-life older adults; and a systematic review of informal healthcare provider interventions in low- and middle-income countries. Studies I-II provided direct Indian older-adult evidence, while Studies III-IV provided indirect contextual evidence for their optimization and implementation. RESULTS: Polypharmacy was associated with higher anticholinergic burden and numerically higher cardiac autonomic neuropathy although residual confounding limits causal interpretation. In the multicity study, one-third had polypharmacy, while potentially inappropriate medications, prescribing omissions, and self-medication were common. Risks were higher with multimorbidity, recent hospitalization, care transitions, or living alone. Deprescribing showed no statistically significant increase in mortality, hospitalization, or major cardiovascular events, but heterogeneity was high and certainty low to very low. Informal-provider interventions showed the potential to improve knowledge, referral, case management, and medication-related practices. CONCLUSIONS: Medication safety among older adults in India requires an integrated continuum approach, but direct evidence supports only some components and implementation strategies that need prospective evaluation.

Humans↗
PubMed2003

Improving medication safety: the measurement conundrum and where to start.

The use of medication remains the most common intervention in health care. The complexity of both medication use and the medication management process, especially in the in-patient setting, create a significant risk for hospitalized patients. Despite the widespread recognition of the hazards that medication use poses to patients, there are no widely accepted or standardized methods to measure the safety of medication use. Where to focus measurement in medication safety is the subject of ongoing debate. Various groups have suggested measuring error-prone aspects of the medication use process such as errors in administration of medications or errors in dispensing of medications. Other groups have suggested measuring adverse drug events as a measure of the safety of medication use. Many studies in this area have outlined the great difficulty associated with getting clinicians to report either medication errors or adverse drug events voluntarily. In response to these challenges, yet more groups have developed non-voluntary reporting methods based on the use of "triggers", in either a chart review or electronic format. Medication safety is a complex process and measurement of it needs to be a core component throughout the whole process. With the introduction of computerized analysis of patient information, measurement becomes much easier and potentially more powerful and achievable than either incident reporting or chart reviews for purposes of accountability, prevention, and ongoing improvement of both process and clinical practice. This paper reviews approaches to measuring medication safety from the perspective of both harm and error, and outlines a strategy that combines both approaches in the electronic era.

Adverse Drug Reaction Reporting Systems↗
PubMed2002

Medication safety. A framework for change.

Innovative health care organizations are leading the way in taking medication safety from concept to reality. This month's fold-out section looks at those programs and provides tools for you to implement a medication safety program at your hospital.

Humans↗
PubMed2005

Medication safety program reduces adverse drug events in a community hospital.

BACKGROUND: There is widespread interest in improving medication safety, particularly in the hospital setting. Numerous suggestions have been made as to how this should be done, but there is a paucity of data demonstrating the effectiveness of any of the interventions that have been proposed. OBJECTIVES: To assess the impact of a wide ranging, community hospital based patient safety program on patient harm as measured by the rate of adverse drug events. DESIGN: An audit of discharged hospital patients was conducted from January 2001 to December 2003. Baseline data were collected for the first 6 months and multiple drug protocols and other interventions were instituted on the nursing units and in the pharmacy department over the subsequent 9 months (transition period). These interventions were largely based on information about medication risks acquired from internal medication event reporting. Each month of the study adverse drug events (ADE) were sought from a random sample of inpatient charts. A trigger tool was used to detect clues to ADEs, the presence of which was confirmed or excluded by detailed manual chart review. The severity of these events was categorized using the classification system of the National Coordinating Council for Medication Error and Reporting and Prevention. MAIN OUTCOME MEASURES AND RESULTS: Median ADEs per 1000 doses of medication dispensed declined significantly from 2.04 to 0.65 (p<0.001). Median ADEs per 100 patient days declined significantly from 5.07 to 1.30 (p<0.001). The proportion of inpatients with one or more ADE in the baseline period was 31% and declined threefold (p<0.001). The severity of reported medication events also declined. The number of ADEs associated conclusively with patient harm was 1.67 per total doses delivered in the baseline period and declined eightfold (p<0.001). CONCLUSION: The implementation of a carefully planned series of low cost interventions focused on high risk medications, driven by information largely from internal event reporting, and designed to improve a hospital's medication safety leads to a significant decrease in patient harm.

Adverse Drug Reaction Reporting Systems↗
PubMed2003

Findings from the ISMP Medication Safety Self-Assessment for hospitals.

BACKGROUND: Hospital medication practices should be assessed, awareness of the characteristics of a safe medication system heightened, and baseline data to identify national priorities established. DESIGN: A cross-sectional survey of U.S. hospitals (N = 6,180) was conducted in May 2000. The survey instrument contained 194 self-assessment items organized into 20 core characteristics and 10 larger domains. Hospitals were asked to voluntarily submit their confidential assessment data to the Institute for Safe Medication Practices (ISMP) for aggregate analysis. METHOD: A weighting structure was applied to the individual items and used to calculate core characteristic scores, domain scores, and overall self-assessment scores. These scores were then compared to identify areas most in need of improvement. RESULTS: The 1,435 participating hospitals scored highest in domains related to drug storage and distribution; environmental factors; infusion pumps; and medication labeling, packaging, and nomenclature issues. These hospitals scored lowest in domains related to accessible patient information, communication of medication orders, patient education, and quality processes such as double-check systems and organizational culture. CONCLUSIONS: Enormous opportunities exist to improve medication safety, especially in domains related to culture, information management, and communication.

American Hospital Association↗