International Journal of Risk & Safety in Medicine - Volume 33, issue 3

Authors: Frazão, Daniela | Sobral, José

Article Type: Research Article

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. Show more

Keywords: Human Reliability Analysis, human error, health system, patient safety, mhFMEA

DOI: 10.3233/JRS-210019

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 287-298, 2022

Authors: Aboustate, Natalie | Jureidini, Jon

Article Type: Research Article

Abstract: BACKGROUND: Public access to data has been a major step in attempting to reduce bias in scientific literature. 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. OBJECTIVE: 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 and we aimed to redress this lack. METHODS: 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. RESULTS: 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. Show more

Keywords: Patient safety, child psychiatry, antidepressants, open data access

DOI: 10.3233/JRS-210022

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 299-308, 2022

Authors: Kafle, Sajala | Jha, Nisha | Sapkota, Yunima | Shankar, Pathiyil Ravi

Article Type: Research Article

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 median knowledge score was significantly different among individuals with different work experience and qualifications (p < 0.001). There was also difference in median 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 median knowledge scores need improvement. Show more

Keywords: Community pharmacy, knowledge, medication, pregnancy, Kathmandu valley

DOI: 10.3233/JRS-210026

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 309-318, 2022

Authors: Hafez, Ahmed T. | Omar, Islam | Purushothaman, Balaji | Michla, Yusuf | Mahawar, Kamal

Article Type: Research Article

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. Show more

Keywords: Orthopaedic surgery, never events, patient safety, medical errors, medical claims

DOI: 10.3233/JRS-210051

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 319-332, 2022

Authors: Mungmunpuntipantip, Rujittika | Wiwanitkit, Viroj

Article Type: Letter

DOI: 10.3233/JRS-220010

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 333-333, 2022