International Journal of Risk & Safety in Medicine - Volume Pre-press, issue Pre-press
Purchase individual online access for 1 year to this journal.
Price: EUR 155.00
The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: BACKGROUND: The prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) adverse reactions should start from the primary health center (PHC), as the first gatekeeper in community health services. However, there is no specific module available for health care professionals (HCPs) in Indonesia for the prevention of adverse drug reactions (ADR) at PHCs. NSAID is commonly used for the elderly treated at PHC in Indonesia, even though the ADR risk is well-known. OBJECTIVE: We aimed to develop a module to be used in PHC for preventing NSAID-associated upper gastrointestinal (GI) ADRs in elderly patients treated for musculoskeletal diseases. METHODS:…The module was developed based on inputs from focus group discussions (FGD) among government health officers, PHC representatives, clinical pharmacologists, internal medicine and community medicine clinicians, pharmacovigilance experts, and professional organizations. A pilot implementation was conducted to test its feasibility and its effect on the HCPs’ knowledge. RESULTS: Capacity building of HCPs, development of intra-HCP cooperation, as well as standard operating procedure (SOP) for the prescription of NSAID constituted important components of the module. A pilot study of the module in two PHCs showed that it was applicable with some recommendations for improvement in duration, number of participants, room space, presentation, and use of credit points as compliments. The HCPs’ knowledge was improved after following the module. CONCLUSIONS: Our study showed that the module is feasible in PHC in Indonesia and useful in improving knowledge of HPC.
Keywords: NSAIDs, primary health center, health care professional, elderly, adverse drug reactions, Indonesia
Abstract: BACKGROUND: The vaccine/autism controversy has caused vast scientific and public confusion, and it has set back research and education into genuine vaccine-induced neurological disorders. The great strawman of autism has been so emphasized by the vaccine industry that it, and it alone, often appears in authoritative discussions of adverse effects of the MMR and other vaccines. By dismissing the chimerical vaccine/autism controversy, vaccine defenders often dismiss all genuinely neurological aftereffects of the MMR (measles, mumps, and rubella) and other vaccines, including well-documented events, such as relatively rare cases of encephalopathy and encephalitis. OBJECTIVE: This report explains that…autism is not a physical or neurological disorder. It is not caused by injury or disease of the brain. It is a developmental disorder that has no physical origins and no physical symptoms. It is extremely unlikely that vaccines are causing autism; but it is extremely likely that they are causing more neurological damage than currently appreciated, some of it resulting in psychosocial disabilities that can be confused with autism and other psychosocial disorders. This confusion between a developmental, psychosocial disorder and a physical neurological disease has played into the hands of interest groups who want to deny that vaccines have any neurological and associated neuropsychiatric effects. METHODS: A review of the scientific literature, textbooks, and related media commentary is integrated with basic clinical knowledge. RESULTS: This report shows how scientific sources have used the vaccine/autism controversy to avoid dealing with genuine neurological risks associated with vaccines and summarizes evidence that vaccines, including the MMR, can cause serious neurological disorders. Manufacturers have been allowed by the US Food and Drug Administration (FDA) to gain vaccine approval without placebo-controlled clinical trials. CONCLUSIONS: The misleading vaccine autism controversy must be set aside in favor of examining actual neurological harms associated with vaccines, including building on existing research that has been ignored. Manufacturers of vaccines must be required to conduct placebo-controlled clinical studies for existing vaccines and for government approval of new vaccines. Many probable or confirmed neurological adverse events occur within a few days or weeks after immunization and could be detected if the trials were sufficiently large. Contrary to current opinion, large, long-term placebo-controlled trials of existing and new vaccines would be relatively easy and safe to conduct.
Abstract: National Health Systems are facing a very serious health emergency related to COVID-19. In this phase of emergency, it is essential to ensure the care of all affected patients but also to ensure the economic stability of the National Health System. This stability is undermined by the potential exponential increase in claims caused by healthcare-associated infections related to COVID-19. That is why it will be essential to use all means necessary to prevent this economic crisis, which could overlap with the health crisis.
Abstract: BACKGROUND: Receiving safe health care services is among the first rights of patients. Ethical predictability is influential to identify the patient safety concerns in hospitals. OBJECTIVE: This study aimed to ascertain and compare ethical predictability of patient safety in selected hospitals in Mazandaran Province in Iran. METHODS: A cross-sectional design was applied in the current study. By applying the multistage method for sampling, the statistical population consisted of clinical units of selected public, social security, and private hospitals. Out of the 18 public hospitals, five teaching hospitals, nine private and five social security hospitals, one hospital…was randomly selected in Mazandaran Province from each cluster. In total, 938 patients participated in the study. Data entry and analysis was carried out by SPSS version 22 software. RESULTS: The results showed that ethical predictability in social security hospitals was higher than the results in private and public hospitals (p < 0.001). In addition, among the selected dimensions of ethical predictability of patient safety in the selected hospitals, blood management was the highest dimension. Safe drug management, error management, infection control, and safe clinical services were the middle priorities and management and leadership of patient safety had the lowest mean in the ethical predictability of patient safety in the selected hospitals in the province. CONCLUSION: Identifying the factors causing ethical predictability in order to improve patient safety and service quality, is of great help to managers and authorities in the field of health services. Such awareness helps managers to consider these factors in all decision making processes.
Keywords: Ethical predictability, quality of care, patient safety
Abstract: BACKGROUND: Physicians and nurses are responsible for reporting medical adverse events. Each views these events through a different lens subject to their role-based perceptions and barriers. Physicians typically engage with diagnosis and treatment while nurses primarily care for patients’ daily lives and mental well-being. This results in reporting and describing medical adverse events differently. OBJECTIVE: We aimed to compare adverse medical event reports generated by physicians and nurses to better understand the differences and similarities in perspective as well as the nature of adverse medical events using social network analysis (SNA) and latent Dirichlet allocation (LDA).…METHODS: The current study examined data from the Maccabi Healthcare Community. Approximately 17,868 records were collected from 2000 to 2017 regarding medical adverse events. Data analysis used SNA and LDA to perform descriptive text analytics and understand underlying phenomenon. RESULTS: A significant difference in harm levels reported by physicians and nurses was discovered. Shared topic keyword lists broken down by physicians and nurses were derived. Overall, communication, lack of attention, and information transfer issues were reported in medical adverse events data. Specialized keywords, more likely to be used by a physician were determined as: repeated prescriptions, diabetes complications, and x-ray examinations. For nurses, the most common special adverse event behavior keywords were vaccine problem, certificates of fitness, death and incapacity, and abnormal dosage. CONCLUSIONS: Communication and inattentiveness appeared most frequently in medical adverse events reports regardless of whether doctors or nurses did the reporting. Findings suggest feedback and information sharing processes could be implemented as a step toward alleviating many issues. Institutional management, healthcare managers and government officials should take actions to decrease medical adverse events, many of which may be preventable.
Keywords: Patient safety, social network analysis (SNA), latent Dirichlet allocation (LDA), medical adverse event, medical adverse event reporting system, physician, nurse
Abstract: BACKGROUND: Paresthesia is defined as a burning or prickling sensation or partial numbness caused by neural injury. OBJECTIVE: The purpose of this paper is to present a rare and unusual case report of odontogenic infection-induced inferior alveolar nerve (IAN) paresthesia along with cutaneous draining sinus on the face of a pediatric patient and to discuss the possible pathophysiologic mechanism of nerve injury. METHODS: A 14-year-old female patient with cutaneous sinus and paresthesia associated with inferior alveolar nerve was enrolled in the study and the clinical and radiological manifestations of sinus lesion were carefully evaluated.…RESULTS: The most appropriate treatment was carried out not only to resolve extraoral sinus but also to ensure progressive healing for the complete resolution of neurological disturbance. CONCLUSION: The simultaneous occurrence of infection and paresthesia strongly suggested a definitive relationship. Therefore, there seems to be a correlation between duration, origin, significance of the injury and the prognosis of paresthesia.
Abstract: BACKGROUND: Nosocomial infection is a significant burden on healthcare facilities. Its multifactorial nature renders it challenging to control. However, quality healthcare necessitates a safer service that poses no harm to the patient. OBJECTIVE: The aim of this project was to reduce the infection rates in the adult ICU to the benchmark levels. METHOD: An internal audit was conducted as a result of the high infection rates in the adult ICU. The audit started with root cause analysis using the fishbone quality tool. FOCUS-PDCA quality tool was used to design the framework. We opted to introduce a…change in the staff uniform laundry in addition to a campaign to improve hand hygiene compliance using a multimodality approach. Moreover, we conducted training on aseptic techniques in ventilation, urinary catheter, and central lines insertion. Finally, we changed the ventilator filter to a higher quality brand that meets the standard specifications. Infection rates were monitored before and after the proposed changes. RESULTS: There was a marked reduction in ventilator-associated pneumonia; however, it did not lower the benchmark rates. Catheter line-associated bloodstream infection declined from above to below the benchmark. Catheter-associated urinary tract infection rates were below the benchmark; however, they showed a noticeable reduction. Hand hygiene adherence showed an improvement from 80% to 84%. However, this was below the predetermined target level of 90%. CONCLUSIONS: A multimodal approach is necessary to improve hand hygiene adherence. In-hospital laundry is safer to control nosocomial infections. Quality improvement is a continuous process that guarantees a proper healthcare service as per the quality chasm.
Abstract: Background: Despite the improvement of anesthetic-related modalities, the incidence of unintended intraoperative awareness remains at around 0.005–0.038%. Objective: We aimed to describe the intraoperative awareness incidents that occurred across Thailand between January–December, 2015. Methods: Observational data was collected from 22 hospitals throughout Thailand. The awareness category was selected from incident reports according to the Perioperative Anesthetic Adverse Events in Thailand (PAAd Thai) study database and descriptive statistics were analyzed. The awareness characteristics and the related factors were recorded. Results: A total of nine intraoperative awareness episodes from 2000 incidents were observed. The intraoperative awareness…results were as follows: experience of pain (38.1%), perception of sound (33.3%), perception of intubation (9.5%) and feeling of paralysis (14.3%). The observed factors that affect intraoperative awareness were anesthesia-related (100%), patient-related (55.5%), surgery-related (22.2%) and systematic process-related (22.2%). The contributing factors were situational inexperience (77.8%) and inappropriate patient evaluation (44.4%). An awareness of anesthetic performer (100%) and experience (88.9%) were defined as incident-mitigating factors. The suggested corrective strategies were quality assurance activity (88.9%), improved supervision (44.4%) and equipment utilization (33.3%), respectively. Conclusion: Nine intraoperative awareness incidents were observed, however the causes were preventable. The anesthetic component seems to be the most influential to prevent these events.
Keywords: Complication, risk, unintentional awareness, national audit project
Abstract: BACKGROUND: Real-world safety of bevacizumab in cancer patients is limited. OBJECTIVE: To review the adverse drug reactions (ADRs) due to bevacizumab in cancer patients, in published case reports. METHODS: PubMed was searched; case reports of patients having any cancer, administered with bevacizumab (monotherapy/ combination) and reporting ADRs were included. Causality of ADRs was presented as reported in individual papers. ADRs were classified using the information in the USFDA-approved prescribing information (PI) of bevacizumab as ‘Serious’, ‘Common’, and ‘Post-marketing surveillance’ ADRs; ADRs not mentioned in the bevacizumab PI were termed as ‘non-label ADRs’. RESULTS: A…total of 130 published papers comprising 154 cases from 22 different countries were included. Most papers (102/130; 78.46%) had moderate methodological quality. Age range of patients was 9-77 years. Off-label use of bevacizumab was found in 34/154 cases (22.08%). Ninety-six unique ADRs were found among 154 ADRs; most reported ADRs affected circulatory, digestive, and respiratory systems (33, 32, and 26 cases respectively). Most commonly reported ADRs were posterior leukoencephalopathy, fistulae, and gastrointestinal perforation (17, 17, and 16cases respectively). Twenty-eight unique non-label ADRs (29.17%) were found. CONCLUSION: Bevacizumab is associated with more ADRs in the real world among cancer patients than those reported during clinical trials.
Keywords: Bevacizumab, safety; real world, cancer patients, off-label use
Abstract: BACKGROUND: Near-miss analysis is an effective method for preventing serious adverse events, including never events such as wrong-site surgery. OBJECTIVE: To analyze all near-miss incidents reported in a large general hospital in southern Brazil between January 2013 and August 2017. METHOD: We performed a descriptive retrospective study of near-miss incidents recorded in the hospital’s electronic reporting system in a large non-profit hospital (497 beds). The results are expressed as absolute (n ) and relative frequencies (%). Pearson’s chi-square test, Fisher’s exact test (Monte Carlo simulation) and linear regression were used. RESULTS: A total of…12,939 near-miss incidents were recorded during the study period, with linear growth in the number of reports. Near-miss incidents were most frequent for medication, followed by processes unspecified in the International Classification for Patient Safety framework, followed by information control (patient chart and fluid balance data), followed by venous/vascular puncture. The highest prevalence of reports was observed in inpatient wards, in adult, pediatric, and neonatal intensive care units, and in the surgical center/post-anesthesia care unit. Pharmacists and nursing personnel recorded most of the reports during the day shift. CONCLUSION: The most frequent categories of near-miss incidents were medication processes, other institutional protocols, information control issues, and venous/vascular puncture. The significant number of reported near-miss incidents reflects good adherence to the reporting system.
Keywords: Near miss, patient safety, medical errors, hospital incident reporting, patient harm, quality of care