Quality Tools and Strategy for Critical Alerts Process Improvements to Ensure Patient Safety
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ABSTRACT:
SUBMITTER: Jha P
PROVIDER: S-EPMC9763056 | biostudies-literature | 2022 Jun
REPOSITORIES: biostudies-literature
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Project description:BackgroundMany medicine quality problems are detected after they arrive at health facilities. Thus, critically defective medicines that may pose health risks to patients need to be withheld or recalled.AimsTo investigate the withheld and recalled medicines in relation to the types of defects, their total numbers, therapeutic categories, pharmaceutical dosage forms, and country of manufacturer during the study period.MethodsA retrospective review was performed on withheld and recalled medicines published on the publicly available National Medicines Regulatory Authority (NMRA) official website in Sri Lanka between June 2018 and August 2021. Details on substandard medicines (SM) were extracted and documented. Each record of SM was individually reviewed to determine the type of defect, subsequent action taken by NMRA, therapeutic category, pharmaceutical dosage form, and country of manufacturer.ResultsA total of 163 defects were identified in 143 defective medicines, among which the most common types of defects were contamination (n = 59, 36.2%), stability defects (n = 41, 25.2%), packaging and labelling defects (n = 27, 16.6%) and active pharmaceutical ingredient defects (n = 26, 15.9%). Out of 143 total defective medicines identified, anti-infectives accounted for 41.9%, while parenteral preparations (44.0%) were found to be frequently defective. Nearly 70% of the recalled and withheld medicines were of Indian origin, and some manufacturers were identified to be repeatedly involved.ConclusionsThis study revealed that contamination was the most frequent cause of defective medicines, while parenteral preparations and anti-infectives were the most susceptible pharmaceutical dosage form and therapeutic category found to be substandard, respectively. In addition, the findings show that some manufacturers were accountable for repetitive withholdings and recalls, which reflects the ignorance of quality control measures and weak regulatory inspections as a violation of Good Manufacturing Practice (GMP).
| S-EPMC10496228 | biostudies-literature
Project description:ObjectivesTo engage critical care end-users (survivors and caregivers) to describe their emotions and experiences across their recovery trajectory, and elicit their ideas and solutions for health service improvements to improve the ICU recovery experience.DesignEnd-user engagement as part of a qualitative design using the Framework Analysis method.SettingThe Society of Critical Care Medicine's THRIVE international collaborative sites (follow-up clinics and peer support groups).SubjectsPatients and caregivers following critical illness and identified through the collaboratives.InterventionsNone.Measurements and main resultsEighty-six interviews were conducted. The following themes were identified: 1) Emotions and experiences of patients-"Loss of former self; Experiences of disability and adaptation"; 2) Emotions and experiences of caregivers-"Emotional impacts, adopting new roles, and caregiver burden; Influence of gender roles; Adaptation, adjustment, recalibration"; and 3) Patient and caregiver-generated solutions to improve recovery across the arc of care-"Family-targeted education; Expectation management; Rehabilitation for patients and caregivers; Peer support groups; Reconnecting with ICU post-discharge; Access to community-based supports post-discharge; Psychological support; Education of issues of ICU survivorship for health professionals; Support across recovery trajectory." Themes were mapped to a previously published recovery framework (Timing It Right) that captures patient and caregiver experiences and their support needs across the phases of care from the event/diagnosis to adaptation post-discharge home.ConclusionsPatients and caregivers reported a range of emotions and experiences across the recovery trajectory from ICU to home. Through end-user engagement strategies many potential solutions were identified that could be implemented by health services and tested to support the delivery of higher-quality care for ICU survivors and their caregivers that extend from tertiary to primary care settings.
| S-EPMC9671858 | biostudies-literature
Project description:Cannabis legalization has occurred in several countries worldwide. Along with steadily growing research in Cannabis healthcare science, there is an increasing interest for scientific-based knowledge in plant microbiology and food science, with work connecting the plant microbiome and plant health to product quality across the value chain of cannabis. This review paper provides an overview of the state of knowledge and challenges in Cannabis science, and thereby identifies critical risk management and safety issues in order to capitalize on innovations while ensuring product quality control. It highlights scientific gap areas to steer future research, with an emphasis on plant-microbiome sciences committed to using cutting-edge technologies for more efficient Cannabis production and high-quality products intended for recreational, pharmaceutical, and medicinal use.
| S-EPMC7074860 | biostudies-literature
Project description:Background Medical devices are used widely for virtually every disease and condition. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood. Methods The authors defined a device using European directives and used publicly available information on the Medicines and Health Regulatory Authority website to determine the number of devices recalled from January 2006 to December 2010. Two reviewers independently assessed Field Safety Notices and Medical Device Alerts. The authors wrote to manufacturers to obtain further information and clinical data, and summarised data by year, Conformité Européenne classification, indication, and Food and Drug Administration recall system of severity. Results In total, 2124 field safety notices were issued over the 5-year period, an increase of 1220% (62 in 2006 to 757 in 2010). 447 Medical Device Alerts were issued in the same period, and 44% were assessed as a reasonable probability of causing serious adverse health consequences or death. The authors wrote to 192 manufacturers of withdrawn devices and received 101 (53%) replies; only four (2.1%) provided the clinical data the authors requested. A lack of available transparent data prevented full analyses of the safety impact. Of the highest-risk recalled devices, more than half were related to the cardiovascular system (25%) or musculoskeletal system (33%), and 88% (95% CI 80% to 97%) were assessed as a reasonable probability of causing serious adverse health consequences or death. For low-risk devices, the figure was 34% (95% CI 26% to 42%). Conclusion The number of medical devices subject to recalls or warnings in the UK has risen dramatically. A substantial number of these devices may have caused serious adverse effects in patients and contributed to healthcare costs. Significant problems exist in the UK with a lack of access to transparent data and a registry of the highest-risk devices.
| S-EPMC3191575 | biostudies-literature
Project description:BackgroundSurgery is a cornerstone of treatment for malignancy. However, significant variation has been reported in patterns and quality of cancer care for important health outcomes, including perioperative mortality. Surgical process improvement tools (SPITs) have been developed that focus on enhancing the processes of care at the point of care, as a means of quality improvement. This study describes SPITs and develops a conceptual framework by synthesizing the available literature on these novel quality improvement tools.MethodsA scoping review was conducted based on instruments developed for quality improvement in surgery. The search was executed on electronically indexed sources (MEDLINE, EMBASE, and the Cochrane library) from January 1990 to March 2011. Data were extracted, tabulated and reported thematically using a narrative synthesis approach. These results were used to develop a conceptual framework that describes and classifies SPITs.Results232 articles were reviewed for data extraction and analysis. SPITs identified were classified into 3 groups: clinical mapping tools, structure communication tools and error reduction instruments. The dominant instrument reported were clinical mapping tools, including: clinical pathways (113, 48%), fast track (46, 20%) and enhanced recovery after surgery protocols (36, 15%). Outcomes reported included: length of stay (174, 75%), readmission rates (116, 50%), morbidity (116, 50%), mortality (104, 45%), and economic (60, 26%). Many gaps in the literature were recognized.ConclusionWe have developed a conceptual framework of SPITs and identified gaps in current knowledge. These results will guide the design and development of new quality instruments in surgery.
| S-EPMC4112620 | biostudies-literature
Project description:BACKGROUND: Patient safety in primary care is a developing field with an embryonic but evolving evidence base. This narrative review aims to identify tools that can be used by family practitioners as part of a patient safety toolkit to improve the safety of the care and services provided by their practices. METHODS: Searches were performed in 6 healthcare databases in 2011 using 3 search stems; location (primary care), patient safety synonyms and outcome measure synonyms. Two reviewers analysed the results using a numerical and thematic analyses. Extensive grey literature exploration was also conducted. RESULTS: Overall, 114 Tools were identified with 26 accrued from grey literature. Most published literature originated from the USA (41%) and the UK (23%) within the last 10 years. Most of the literature addresses the themes of medication error (55%) followed by safety climate (8%) and adverse event reporting (8%). Minor themes included; informatics (4.5%) patient role (3%) and general measures to correct error (5%). The primary/secondary care interface is well described (5%) but few specific tools for primary care exist. Diagnostic error and results handling appear infrequently (<1% of total literature) despite their relative importance. The remainder of literature (11%) related to referrals, Out-Of-Hours (OOH) care, telephone care, organisational issues, mortality and clerical error. CONCLUSIONS: This review identified tools and indicators that are available for use in family practice to measure patient safety, which is crucial to improve safety and design a patient safety toolkit. However, many of the tools have yet to be used in quality improvement strategies and cycles such as plan-do-study-act (PDSA) so there is a dearth of evidence of their utility in improving as opposed to measuring and highlighting safety issues. The lack of focus on diagnostics, systems safety and results handling provide direction and priorities for future research.
| S-EPMC4288623 | biostudies-literature
Project description:ObjectiveTo examine the influence of dimensions of service quality on patient experience of primary care.Data sources/study settingData from the national GP Patient Survey in England 2014/15, with responses from 858,351 patients registered at 7,918 practices.Study designExpert panel and principal component analysis helped identify relevant dimensions of service quality. Regression was then used to examine the relationships between these dimensions and reported patient experience.Data collection/extraction methodsAggregated scores for each practice were used, comprising the proportion of positive responses to each element of the study.Principal findingsOf eight service quality dimensions identified, six have statistically significant impacts on patient experience but only two have large effects. Patient experience is highly influenced by practice responsiveness and the interactions with the physician. Other dimensions have small or even slightly negative influence. Service quality provided by nurses has negligible effect on patient experience.ConclusionsTo improve patient experience in primary health care, efforts should focus on practice responsiveness and interactions with the physician. Other areas have little influence over patient experience. This suggests a gap in patients' perspectives on health care, which has policy implications for patient education.
| S-EPMC6232513 | biostudies-literature
Project description:ObjectivesTo document and assess the experiences of 104 Agency for Healthcare Research and Quality (AHRQ)-funded health information technology (health IT) grantees in planning and implementing health IT systems.Data sourceGrant proposals and interviews with the AHRQ health IT grantees.Data collection methodExtracted descriptive data from the health IT grant proposals; conducted telephone interviews with principal investigators.Principal findingsAHRQ funding of the health IT projects provided important support for health IT development work in various health care settings. Successful implementation required commitment from top management, dedicated staff and financial resources, an open process to encourage buy-in and enthusiasm by end users, and sheer persistence. Technologies required tailoring to the specific organization's needs. Grantees felt their projects could be replicated by others, if organizations had ample IT expertise and resources. Evaluating the value of health IT was hampered by the absence of validated instruments and measures, organizational demands that competed with data collection, and lack of evaluation expertise among health IT implementers.ConclusionsExperiences of the health IT grantees provide rich information for use by health care providers, AHRQ, and other policy makers to help strengthen future health IT development efforts, including the need to improve evaluation design and standards to assess impact.
| S-EPMC2677035 | biostudies-literature
Project description:Purpose of programTraditionally, peer review was a closed process conducted only by individuals working in the research field. To establish a more integrated and patient-centered approach, one of Canada's largest kidney research networks (Can-SOLVE CKD) has created a Research Operations Committee (ROC) that includes patients as key members. The ROC represents one way for achieving meaningful patient-oriented research (POR).Source of informationCan-SOLVE CKD, a network created as part of the Canadian Institutes of Health Research (CIHR) Strategy for Patient-Oriented Research (SPOR).MethodsThe ROC consists of patients, physicians, scientists, Indigenous partners, experts in research methodology, and a member of Can-SOLVE CKD's operational team. On an annual basis, Can-SOLVE CKD's research teams provide the ROC with a review package, which incorporates information from patient engagement check-in calls and surveys, the project's knowledge translation plan and products, and a progress report written by the project team. The ROC evaluates the review package and provides feedback and recommendations accordingly.Key findingsThe transparent nature of the process, regular feedback and review, along with an overt accountability and scoring system, has been embraced by both patients and researchers. As a result of the ROC process, the number of patient leads for each project has grown over a 3-year period and more researchers have received POR and cultural sensitivity training.LimitationsWhile anecdotal evidence suggests this approach is beneficial for achieving POR, formal mechanisms of evaluation are currently lacking.ImplicationsThis ROC framework ensures patients are active contributors throughout the research process and could be adopted by other organizations to achieve a more patient-centered approach to research.
| S-EPMC7705288 | biostudies-literature
Project description:BackgroundInvesting in clinical education is important for adult urgent and emergency surgery and traumatology as it promotes registered nurses' competencies by providing professional development training to respond to urgent or emergency surgeries.ObjectiveTo examine registered nurses' self-assessment of the effects of virtual video simulation with an immediate debriefing approach on nursing process competencies, nursing care quality, incomplete care, and patient safety in surgical units.MethodsThis study used a quasi-experimental two-group pre- and post-test design. The study was conducted at two provincial hospitals in Cambodia. Participants included registered nurses employed in surgical units. The experimental group (n = 46) completed a virtual video simulation and immediate debriefing. The control group (n = 35) completed virtual training on the nursing process. Data were collected two months after a successful second-week follow-up using Competency of Nursing Process, Cambodian Nursing Care Quality, Care Left Undone, and Patient Safety scales. Wilcoxon signed-rank test and Mann-Whitney U test were used to evaluate the differences before and after the sessions. Generalized linear model was used to compare the differences between the two groups.ResultsThe results showed statistically significant improvements in the experimental group on competency, nursing care quality, patient safety, and reducing care left undone after the intervention. However, the control group revealed statistically insignificant differences. In addition, the experimental group provided positive feedback, such as experiencing a real patient scenario, developing critical-thinking, improving communication skills, and having an opportunity to ask questions.ConclusionOur study showed that VVS and immediate debriefing have the potential to support in-service training of RNs from diverse backgrounds. Particularly, integrating virtual video simulation and immediate debriefing may to promote competency in the nursing process and improve care outcomes.
| S-EPMC10520815 | biostudies-literature