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: A set of enduring conditions have been reported in the literature involving persistent sexual dysfunction after discontinuation of serotonin reuptake inhibiting antidepressants, 5 alpha-reductase inhibitors and isotretinoin. OBJECTIVE: To develop diagnostic criteria for post-SSRI sexual dysfunction (PSSD), persistent genital arousal disorder (PGAD) following serotonin reuptake inhibitors, post-finasteride syndrome (PFS) and post-retinoid sexual dysfunction (PRSD). METHODS: The original draft was designed using data from two published case series (Hogan et al., 2014 and Healy et al., 2018), which represent the largest public collections of data on these enduring conditions. It was further developed with the involvement of a…multidisciplinary panel of experts. RESULTS: A set of criteria were agreed upon for each of the above conditions. Features of PSSD, PFS and PRSD commonly include decreased genital and orgasmic sensation, decreased sexual desire and erectile dysfunction. Ancillary non-sexual symptoms vary depending on the specific condition but can include emotional blunting and cognitive impairment. PGAD presents with an almost mirror image of unwanted sensations of genital arousal or irritability in the absence of sexual desire. A new term, post-SSRI asexuality, is introduced to describe a dampening of sexual interest and pleasure resulting from a pre-natal or pre-teen exposure to a serotonin reuptake inhibitor. CONCLUSIONS: These criteria will help in both clinical and research settings. As with all criteria, they will likely need modification in the light of developments.
Abstract: BACKGROUND: Hepatitis B virus (HBV) infection is a serious global public health problem, with significant morbidity and mortality from acute and chronic complications. Increasing awareness and improving knowledge of HBV helps reduce the risk of the disease. Although many studies have been conducted on HBV in Ghana, few have focused on examining knowledge, attitude and preventive practices among adolescents towards the disease. OBJECTIVE: The objective of this study was to assess HBV knowledge, attitude and practice (KAP) among adolescents in high schools in the Asante Mampong Municipality in the Ashanti Region of Ghana. METHODS: A descriptive…cross-sectional study was conducted among 398 adolescents from six senior high schools within the Asante Mampong Municipality. Data was collected using a 30-item structured questionnaire. Each item had two response options: “Yes” and “No”. A scoring system was generated and respondents were given a score on each item answered. A positive response to an item was scored 1 point and a negative response was scored 0. Scores were then summed up and averaged to give the mean knowledge, attitude and practice scores. RESULTS: The majority of the respondents were male (60%), between 15 and 17 years (45%), Christian (93%) and in their first year of study. The adolescents had basic knowledge, positive attitude, and poor practices towards HBV. There was no significant relationship between the demographic variables of the respondents and KAP mean scores. CONCLUSION: There is the need to introduce health education and awareness programs in schools within the Asante Mampong Municipality to improve students’ level of knowledge of HBV. Countrywide studies examining KAP towards HBV infection among adolescents are also warranted.
Keywords: Hepatitis B infection, adolescents, KAP scores, senior high school, Ghana
Abstract: BACKGROUND: Community pharmacists are among the most accessible health care providers. OBJECTIVE: This study evaluates the knowledge of community pharmacists about the risks associated with medication use during pregnancy. METHODS: A cross-sectional study was carried out in March 2021 among the 344 community pharmacies in the Kathmandu Valley, Nepal. Convenience sampling was used for data collection using a structured and validated questionnaire. RESULTS: The majority of participants were male: 264 (76.7%), 94.2% were between the age of 21 to 30 years, and 53.1% had work experience of less than one year. Over half had…completed diploma in pharmacy. Less than 10 medicines were dispensed to pregnant women daily in 61.6% of the pharmacies. Only 28.8% of the community pharmacists always inquired about pregnancy status from women in the reproductive age group. The mean knowledge score was significantly different among individuals with different work experience and qualifications (p < 0.001). There was also difference in mean scores according to average number of medicines dispensed daily (p = 0.006). The knowledge score also differed according to average number of medicines dispensed to pregnant woman and inquiry by the pharmacist about pregnancy status (p < 0.001). CONCLUSION: Our study revealed that the mean knowledge scores need improvement.
Keywords: Community pharmacy, knowledge, medication, pregnancy, Kathmandu valley
Abstract: BACKGROUND: Public access to data has been a major step in attempting to reduce bias in scientific literature. OBJECTIVE: Data to verify efficacy outcomes are now more accessible; however, little has been done to ensure public access to harms data from RCTs, which are equally important in ascertaining possible misreporting and protecting safety. METHODS: The treatment for adolescents with depression study (TADS) has influenced most international practice guidelines for treating children and adolescents with depression, supporting first-line prescription of fluoxetine in combination with cognitive behavioural therapy (CBT). However, after over 30 publications by the TADS team,…reporting on harms remains highly deficient. RESULTS: In undertaking a restoring invisible and abandoned trials (RIAT) reanalysis of TADS’ effectiveness and safety outcomes, we sought access to de-identified serious adverse events (SAE) data. This paper describes our unsuccessful efforts to obtain more detailed SAE data from TADS’ data custodians, highlighting several problematic blocks to comprehensive safety reporting. CONCLUSION: Comprehensive access to clinical trial data is necessary to ensure safe and fully informed guidelines for treating children and adolescents with depression.
Keywords: Patient safety, child psychiatry, antidepressants, open data access
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.