International Journal of Risk & Safety in Medicine - Volume Pre-press, issue Pre-press
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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: Human error has been studied for large decades with special application to critical infrastructures and processes where the impact of such errors can induce severe or catastrophic consequences. In this sense it is of utmost importance to extend this type of analysis to other fields as medicine. OBJECTIVE: This study proposes a semi-quantitative human error risk assessment methodology, including the analysis of the so-called Performance Shaping Factors (PSFs), in order to contribute to health services improvement. METHODS: A questionnaire including the considered PSFs is answered in order to determine the impact of each PSF and…its influence on human error. It allows performing a Human Error Risk Assessment (HERA) for both the patient (HERAp) and the quality of the service (HERAq). RESULTS: The results show the PSFs with the highest impact factor. After applying corrective measures, it is possible to observe the impact on the reduction of the risk for patient and for the quality of the service. CONCLUSIONS: The application of the methodology with the inclusion of the impact of PSFs allows minimizing or mitigating failure modes with greater risk as well as increasing patient safety and promoting a better quality of medical procedures.
Keywords: Human Reliability Analysis, human error, health system, patient safety, mhFMEA
Abstract: BACKGROUND: Adverse events in hospitals may jeopardize the safety of patients. Failure in professional autonomy, organizational learning or in the contact between these two factors may explain the occurrence of injurious incidents in hospitals. OBJECTIVE: To study reasons for failure in contact between professional autonomy and organizational learning in resilient management of specialized health care through document analysis. METHODS: A total of 20 reports from the Norwegian Board of Health Supervision were evaluated by a retrospective in-depth document analysis. In the analysis of adverse events, we applied the Braut model to identify function or failure of…1. Professional autonomy, 2. Organizational learning and 3. Contact between professional autonomy and organizational learning. RESULTS: Multivariable regression analysis showed that ‘Failure in organizational learning’ was the only explanatory variable for ‘Failure in contact between doctors and nurses’ autonomy and organizational learning’. ‘Failure in organizational learning’ had the strongest effect on ‘Failure in contact between doctors and nurse’s autonomy and organizational learning’ (B = 1.69; 95% CI = 0.45 to 2.92). ‘Failure in professional autonomy’ showed no significant effect on this contact. CONCLUSIONS: ‘Failure in organizational learning’ is associated with ‘Failure in contact between professional autonomy and organizational learning’. ‘Failure in professional autonomy’ did not influence this contact.
Keywords: Professional autonomy, Organizational learning, Resilience management, Hospital, Specialized health care, Norwegian Board of Health Supervision
Abstract: BACKGROUND: Never Events (NE) are serious clinical incidents that are wholly preventable if appropriate institutional safeguards are in place and followed. They are often used as a surrogate of the quality of healthcare delivered by an institution. Most NEs are surgical and orthopaedic surgery is one of the most involved specialties. OBJECTIVE: The aim of this study was to identify common NE themes associated with orthopaedics within the National Health Service (NHS) of England. METHOD: We conducted an observational study analysing the annual NE data published by the NHS England from 2012 to 2020 to collate…all orthopaedic surgery-related NE and construct relevant recurring themes. RESULTS: We identified 460 orthopaedic NE out of a total of 3247 (14.16%) reported NE to NHS England. There were 206 Wrong implants/prostheses under 8 different themes. Wrong hip and knee prosthesis were the commonest “wrong implants” (n = 94; 45.63% and n = 91; 44.17% respectively). There were 197 “Wrong-site surgery” incidents in 22 different themes. The commonest of these was the laterality problems accounting for 64 (32.48%) incidents followed by 63 (31.97%) incidents of wrong spinal level interventions. There were 18 (9.13%) incidents of intervention on the wrong patients and 17 (8.62%) wrong incisions. Retained pieces of instruments were the commonest retained foreign body with 15 (26.13%) incidents. The next categories were retained drill parts and retained instruments with 13 (22.80%) incidents each. CONCLUSION: We identified 47 different themes of NE specific to orthopaedic surgery. Awareness of these themes would help in their prevention. Site marking can be challenging in the presence of cast and on operating on the digits and spine. Addition of a Real-time intra-operative implant scan to the National Joint Registry can avoid wrong implant selection while Fiducial markers, intraoperative imaging, O-arm navigation, and second time-out could help prevent wrong level spinal surgery.
Keywords: Orthopaedic surgery, never events, patient safety, medical errors, medical claims
Abstract: BACKGROUND: Anaesthesiology practitioners experience extraordinary pressure and stress in their daily work. OBJECTIVE: The purpose of this research is to assess the occupational factors and burnout syndrome among anaesthesiologists and anaesthesiology technicians in Kosovo. METHODS: This is a cross-sectional study carried out on a sample of 154 (out of 220) anaesthesiologists and anaesthesiology technicians in Kosovo. We collected the data using the Maslach Burnout Inventory and Occupational Role Stressors Scale. RESULTS: The mean ± SD age of the study sample was 42.5 ± 8.7 years, and 57% of them were working more than 40 h per…week. A high level of burnout in terms of depersonalization (DP) was found among 48 of anaesthesiologists and anaesthesiology technicians, 26 had high level of emotional exhaustion (EE). EE and DP showed significant positive correlation with work overload, managerial responsibility role, and overall occupational stress (p < 0.05). Female anaesthesiologists and anaesthesiology technicians showed higher score of personal achievement (PA) compared to males (p < 0.05). CONCLUSION: Approximately one-third of Kosovar anaesthesiologists and anaesthesiology technicians showed high level of burnout and it is rising as work overload and the role of managerial responsibility increases. Increasing the number of employed anaesthesiologists and anaesthesiology technicians in health institutions in Kosovo will lead to a better workload distribution and lower burnout syndrome.
Abstract: BACKGROUND: Pityriasis rubra pilaris (PRP) is a rare, acquired, chronic papulosquamous dermatosis which can occur in all ages. PRP can be associated with infection, autoimmunity, drugs and malignancies, and can be idiopathic. OBJECTIVE: PRP following vaccination has been rarely described in the literature. To the best of our knowledge, we report the first case of PRP two weeks following COVID-19 vaccination (Covishield). CASE REPORT: A 72-year-old male presented to the outpatient dermatology department at All India Institute of Medical Sciences – Bhopal with minimally pruritic superficial plaques since one week. The patient was vaccinated against COVID-19…with Covishield two weeks earlier. The lesions developed as erythematous scaly follicular papules and plaques over axilla that rapidly spread to the trunk in the following weeks and involved palms and soles as well as thickening and fissuring. The clinical features suggested PRP. The histopathology showed epidermal acanthosis with hypergranulosis alternating with parakeratosis and orthokeratosis with broad rete ridges with follicular plugging. The patient had started taking topical corticosteroids and emollients, which proved effective. There was no recurrence after receiving a second dose on follow-up. CONCLUSION: In patients presenting with new onset PRP in this COVID-19 era, the possibility of vaccine as a trigger should be taken into consideration, and further dosing should be carefully monitored in view of possible recurrence.
Abstract: BACKGROUND: Individuals with diabetes mellitus (DM) may be susceptible to non-steroidal anti-inflammatory drug (NSAID) – induced acute kidney injury (AKI) but data on NSAID-related adverse renal events is sparse. We aimed to evaluate the risk of acute kidney injury and/or hyperkalemia after systemic NSAID among individuals with DM and diabetic chronic kidney disease (CKD). METHODS: Retrospective cohort study of 3896 adults with DM with incident prescriptions between July 2015 and December 2017 from Singapore General Hospital and SingHealth Polyclinics. Laboratory, hospitalization and medication data were retrieved from electronic medical records. The primary outcome was the incidence of AKI…and/ or hyperkalemia within 30 days after prescription. RESULTS: AKI and/or hyperkalemia occurred in 13.5% of all DM and 15.8% of diabetic CKD. The association between systemic NSAID >14 days and 30-day risk of AKI and/or hyperkalemia failed to reach statistical significance in unselected DM (adjusted OR 1.62, 95% CI 0.99–2.65, p = 0.05) and diabetic CKD (adjusted OR 0.64, 95% CI 0.15–2.82, p = 0.64), but the odds of AKI and/or hyperkalemia were markedly and significantly increased when NSAID was prescribed with renin-angiotensin-aldosterone system (RAAS) blocker (adjusted OR 4.17, 95% CI 1.74–9.98, p = 0.001) or diuretic (adjusted OR 3.31, 95% CI 1.09–10.08, p = 0.04) and in the absence of diabetic CKD (adjusted OR 1.98, 95% CI 1.16–3.36, p = 0.01). CONCLUSION: NSAID prescription >14 days in individuals with DM with concurrent RAAS blockers or diuretics was associated with higher 30-day risk of AKI and/or hyperkalemia.
Keywords: NSAID, COX II inhibitor, renal failure, diabetes
Abstract: BACKGROUND: The majority of antidepressants inhibit serotonin reuptake and include the selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and the serotonin reuptake inhibiting tricyclic antidepressants. OBJECTIVE: The objective of this study was to investigate and describe the range and impact of reported adverse visual effects linked to serotonin reuptake inhibiting antidepressants. METHODS: Using data from a global database of patient spontaneous reports of drug adverse events, we systematically identified eligible reports of visual problems linked to the use of serotonin reuptake inhibiting antidepressants. We analyzed these data using simple descriptive statistics to present the…range and impact. RESULTS: We identified 124 reports of visual problems. Reports originate from 18 countries and involve 11 different drugs. The most commonly reported symptoms were vision blurred/visual acuity reduced (n = 79, 63.7%), night blindness (n = 22, 17.7%), vitreous floaters (n = 21, 16.9%), photophobia (n = 19, 15.3%), diplopia (n = 15, 12.1%), palinopsia (n = 13, 10.5%), visual field defect (n = 12, 9.7%), photopsia (n = 11, 8.9%) and visual snow syndrome (n = 11, 8.9%). 74 patients indicated that the side effect was bad enough to affect everyday activities, 62 had sought health care, and 50 indicated that their work had been affected. 49 patients reported an enduring vision problem after discontinuation of treatment. CONCLUSIONS: The data suggest that serotonin reuptake inhibiting antidepressants can produce a range of adverse effects on vision that in some cases can be long-lasting after discontinuation of the drug. Further efforts are needed to understand the mechanisms involved, the incidence among those prescribed these medications, and identify any risk or mitigation factors.
Abstract: BACKGROUND: Post-SSRI sexual dysfunction (PSSD) is an underrecognized and poorly understood medical condition characterized by sexual dysfunction that persists despite SSRI discontinuation. OBJECTIVE: We conducted a survey of individuals with PSSD to better characterize this condition and its impact on various quality of life concerns. METHODS: Surveys were distributed to an online support group for individuals with PSSD. Surveys assessed medications suspected of causing PSSD and symptoms experienced during and after treatment. Respondents reported the trajectory of their condition, the efficacy of different treatments, and the impact of PSSD on their quality of life.…RESULTS: 239 survey responses were included in this study. A majority of respondents had a history of SSRI use (92%) compared to only SNRI or atypical antidepressant use (8%). The overall severity of symptoms improved for 45% and worsened or remained the same for 37% of respondents after discontinuing treatment with serotonin reuptake inhibitors. Only 12% of respondents reported being counseled regarding potential sexual dysfunction while taking antidepressants. The majority rated the effect of PSSD on their quality of life as extremely negative (59%) or very negative (23%). CONCLUSION: PSSD can have an overwhelmingly negative impact on quality of life. Currently, it is unclear why certain individuals develop PSSD and there are no definitive treatments for this condition. Further research of PSSD and greater awareness of this condition is needed among prescribers of serotonin reuptake inhibitors to improve patient care.
Keywords: Post-SSRI sexual dysfunction, selective serotonin reuptake inhibitors, sexual dysfunction, adverse effects, drug side effects
Abstract: BACKGROUND: Governmental regulations of drug registration and licensing are not always followed by healthcare providers. OBJECTIVE: To explore the global research growth and patterns on systemic use of off-label and unlicensed drugs to gain knowledge about the magnitude of the problem and the main research themes encountered in this field. METHODS: SciVerse Scopus was searched for papers on off-label and unlicensed drug use from 1990 until December 31, 2020, without any language limitations. A bibliometric methodology was adopted to present the following indicators: top-cited documents, the most productive countries, top active journals, international research collaboration, the…most frequent author keywords, and research themes. RESULTS: The search query returned 1320 papers with an h-index of 66, published in 721 different journals. The Hospital Pharmacy journal ranked first (n = 43, 3.3%). In total, 5777 authors (median = 3) from 85 different countries contributed to the retrieved papers. The USA (n = 381, 28.9%) ranked first, followed distantly by Germany and Italy. The percentage of documents with international authors for active countries was from 8.8% for China to 42.3% for the Netherlands. The most frequent author keyword next to off-label was children/pediatrics. The keyword unlicensed was less frequently encountered than that for off-label. Major research themes in the retrieved papers focused on off-label drug use in hospitalized children/pediatrics, biological drugs such as rituximab and rFVIIa, psychiatric disorders, regulations, and questionnaire-based knowledge/attitude studies among community pharmacists and physicians. CONCLUSIONS: Research activity on off-label drug use has witnessed a general increase in the past two decades. The major research theme was off-label drug use in hospitalized children/pediatrics/neonates. The USA and certain European countries made a major contribution to this field.
Abstract: BACKGROUND: Using benzodiazepines (BZDs) or Z-drugs in poly-therapy is a critical issue. OBJECTIVE: Identifying factors influencing the use of BZDs/Z-drugs in poly- vs mono-therapy in patients with or without substance use disorders (SUDs). METHODS: 986 inpatients were analysed. Socio-demographic and clinical variables were collected. BZD/Z-drug doses were compared via the Defined Daily Dose (DDD) and standardized as diazepam dose equivalents. Mann-Whitney, Chi-square, Fisher test, hierarchical multivariate regression analyses were run referring to the whole sample and to subjects with current SUDs, lifetime SUDs, current and lifetime SUDs, non-SUDs. RESULTS: In the whole sample the…variance of being mono- vs poly-therapy users was explained by BZD/Z-drug formulation, DDD, duration of treatment, age of first BZDs/Z-drugs use (ΔR 2 = 0.141, p < 0.001). Among those with current SUDs (ΔR 2 = 0.278, p = 0.332) or current and lifetime SUDs (ΔR 2 = 0.154, p = 0.419), no variables explained the variance of being mono-vs poly-therapy users. Among lifetime SUDs subjects, the variance of being mono- vs poly-therapy users was explained by BZD/Z-drug formulation and age of first BZD/Z-drug use (ΔR 2 = 0.275, p < 0.001). Among non-SUDs subjects, the variance of being mono- vs poly-therapy users was explained by DDD and duration of treatment (ΔR 2 = 0.162, p = 0.001). CONCLUSIONS: Tablets, high drug doses, long duration of treatment, and early age of first use were more likely associated to poly- than mono-therapy. This suggests that patients have different clinical features and a pharmacological prescription should be tailored to them also based on the variables here analysed.
Keywords: Mono-therapy, poly-therapy, poly-pharmacy, substance use disorder, benzodiazepine, Z-drug