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

Authors: Ralph Edwards, I. | Lindquist, Marie

Article Type: Editorial

DOI: 10.3233/JRS-228001

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 209-209, 2022

Authors: Sikimić, Vlasta | Stuart, Mike | Shaw, Jamie

Article Type: Editorial

DOI: 10.3233/JRS-227015

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 211-216, 2022

Authors: Stegenga, Jacob

Article Type: Research Article

Abstract: The COVID-19 pandemic has shown us that there are numerous research questions—empirical, political, and philosophical—that need addressing both prior to, during, and after a pandemic. The current organisation of medical research has hindered our ability to efficiently answer these questions. This in turn suggests that there ought to be changes to how the medical research agenda is set.

Keywords: COVID-19, pandemic, research agenda, well-ordered science

DOI: 10.3233/JRS-227016

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 217-221, 2022

Authors: Fernández Pinto, Manuela

Article Type: Research Article

Abstract: BACKGROUND: The COVID-19 pandemic has shocked society worldwide. Multiple efforts went immediately into developing treatments for managing and vaccines for preventing the disease. National and international initiatives emerged to deal with the deep economic and social inequalities in our world today. OBJECTIVE: To show that the global inequalities that have become salient during the COVID-19 pandemic and specially with the global vaccination campaign, are the result of a highly privatized system of research and development (R&D), which is first and foremost profit-driven, and where epistemic and social concerns are not prioritized. METHODS: Philosophical analysis. …RESULTS: After exploring the current organization of scientific research, as well as its impact in the development of research at a global scale, the paper shows the way in which this highly privatized organization of research has permeated scientific research on COVID-19, identifying who is currently benefiting from pandemic science, and who on the contrary is suffering the consequences of this organization. Using the COVAX mechanism as an example, the paper argues that international efforts to counteract the power of commercially-driven science has not rendered the expected results. CONCLUSIONS: The current organization of science ought to be shaken and restructured if we aim to be better prepared to address the global challenges of the future with the relevant scientific and technological development. Show more

Keywords: Social organization of science, pandemic science, COVAX, privatization of science, coronavirus

DOI: 10.3233/JRS-227017

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 223-228, 2022

Authors: Sismondo, Sergio

Article Type: Research Article

Abstract: BACKGROUND: The pharmaceutical industry is believed to receive considerable support through research and development (R&D) tax credits. OBJECTIVE: The objectives of this paper are (a) to show that many of the pharmaceutical industry’s apparent R&D activities are entangled with marketing efforts, and (b) to argue that supporting these activities through tax credits does not serve public interests in health. METHODS: The bulk of this paper summarizes the author’s extended qualitative mixed-methods approach to following connections between pharmaceutical research and marketing. RESULTS: The pharmaceutical industry’s R&D should be understood as broadly entangled with marketing, and …so generally should be understood as integrated research, development and marketing (RD&M). CONCLUSIONS: R&D tax credits to the pharmaceutical industry largely do not serve public interests. Show more

Keywords: Research and development (R&D), pharmaceutical industry, marketing, tax credits

DOI: 10.3233/JRS-227018

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 229-234, 2022

Authors: Injac, Rade

Article Type: Research Article

Abstract: BACKGROUND: The new type of virus (SARS-CoV-2 or COVID-19) from Coronaviridae family, discovered in 2019, caused a global pandemic with several massive lock-downs around the globe. Science and politicians became the center of world attention, receiving many questions without having clear answers. The hopes of many rested on vaccine development, which was done fast, facing novel challenges such as the massive production and distribution for several billions of people. OBJECTIVE: In this paper, the global reaction to the pandemic is reviewed along with some critical comments. METHOD: Different groups, including nations, took part in global …lockdowns, while vaccine development was running in parallel without having enough capacity for some of the biggest medical demands in history. This review will bring together views from all interested groups in this pandemic crisis. RESULTS: The Western world waited too long (4 months), after the first case was confirmed in China, to introduce lock-down and safety measures. On the other side, vaccine development was done too fast to give clear long-term safety profiles of the medications developed. Due to the focus on development, it was overlooked that production and distribution of sterile products such as vaccines might have limitations globally. Usually when such limitations occur, power comes to the surface. Therefore, buyers who had power will get the vaccines they need first. However, we should recognize the economic impact that directly influenced healthcare funding. All of this will lead to post-crisis challenges, including depression, violence, suicide, migration, and many other social problems. CONCLUSIONS: The COVID-19 pandemic is a test for all of us, which many governments, industries and non-state actors are failing. It is a perfect “general probe” to detect some of the weaknesses of the current structure of global health. If politics and science do not work together to make a global production plan for vaccines and learn from this pandemic, then all of the lives lost were for nothing. Show more

Keywords: COVID-19, global pandemic, vaccine, development, production

DOI: 10.3233/JRS-227019

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 235-248, 2022

Authors: Tricarico, Gerardo | Travagli, Valter

Article Type: Research Article

Abstract: BACKGROUND: The pandemic that began around February 2020, caused by the viral pathogen SARS-CoV-2 (COVID-19), has still not completed its course at present in June 2022. OBJECTIVE: The open research to date highlights just how varied and complex the outcome of the contagion can be. METHOD: The clinical pictures observed following the contagion present variabilities that cannot be explained completely by the patient’s age (which, with the new variants, is rapidly changing, increasingly affecting younger patients) nor by symptoms and concomitant pathologies (which are no longer proving to be decisive in recent cases) in relation to …medium-to-long term sequelae. In particular, the functions of the vascular endothelium and vascular lesions at the pre-capillary level represent the source of tissue hypoxia and other damage, resulting in the clinical evolution of COVID-19. RESULTS: Keeping the patient at home with targeted therapeutic support, aimed at not worsening vascular endothelium damage with early and appropriate stimulation of endothelial cells, ameliorates the glycocalyx function and improves the prognosis and, in some circumstances, could be the best practice suitable for certain patients. CONCLUSION: Clinical information thus far collected may be of immense value in developing a better understanding of the present pandemic and future occurrences regarding patient safety, pharmaceutical care and therapy liability. Show more

Keywords: COVID-19, pharmaceutical care, therapy liability, best practice, home treatment, vascular endothelial glycocalyx, epigenetics

DOI: 10.3233/JRS-210064

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 249-259, 2022

Authors: Neziri, Shpresa | Tahirbegolli, Bernard | Selmani, Erza | Gallopeni, Florim

Article Type: Research Article

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. Show more

Keywords: Cross-sectional study, burnout, MBI, anaesthesiology, stress

DOI: 10.3233/JRS-200038

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 261-268, 2022

Authors: Otchere, Godfred | Dwomoh, Emmanuel | Kumah, Emmanuel | Ankomah, Samuel Egyakwa | Fusheini, Adam | Agyei-Baffour, Peter | Afriyie, Emmanuel Kwasi | Agyei, Samuel Kofi

Article Type: Research Article

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. Show more

Keywords: Hepatitis B infection, adolescents, KAP scores, senior high school, Ghana, HBV

DOI: 10.3233/JRS-200077

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 269-279, 2022

Authors: Cioffi, Andrea | Cecannecchia, Camilla | Cioffi, Fernanda | Bolino, Giorgio | Rinaldi, Raffaella

Article Type: Research Article

Abstract: BACKGROUND: Induced abortion is a medical practice that has always been much discussed all over the world. Abortion is allowed in most European countries at the request of the woman with limitations that are imposed mainly by the gestational age. However, there are legislative differences between European countries which impose stringent limits on the use of induced abortion. OBJECTIVE: This article analyzes the European legislation on abortion, with a particular focus on countries in which there have been recent legislative changes in recent years, and the possible consequent risk of inequality among European women. METHODS: Government …and ministerial websites of the countries analyzed have been consulted to investigate abortion laws in Europe. In addition, the Global Abortion Policies Database of the World Health Organization was also consulted for a regulatory comparison. RESULTS: The differences between the various European countries are considerable. Although guaranteed by most legislation, abortion remains a fragile right in some European countries. CONCLUSION: Different legislation in the various countries of Europe causes difficulties for women who want to have an abortion but who reside in states where there are strict limits to abortion. In addressing the issue of induced abortion, we must not forget that the center of this practice is the woman. For this reason, it is essential to apply a reasoning based on respect for women’s rights: freedom, health, and self-determination. Show more

Keywords: Abortion, rights, inequality, women, Europe

DOI: 10.3233/JRS-200095

Citation: International Journal of Risk & Safety in Medicine, vol. 33, no. 3, pp. 281-286, 2022

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