International Journal of Risk & Safety in Medicine - Volume 35, issue 3

Authors: Ziganshina, Liliya Eugenevna

Article Type: Editorial

DOI: 10.3233/JRS-246002

Citation: International Journal of Risk & Safety in Medicine, vol. 35, no. 3, pp. 203-206, 2024

Authors: Puliyel, Jacob | Hooker, Brian S.

Article Type: Research Article

Abstract: BACKGROUND: The self-controlled case series (SCCS) is often used to monitor vaccine safety. The evaluation of intussusception after the rotavirus vaccine is complicated because the baseline rate varies with age. Time-varying baseline risk adjustments with data from unexposed cohorts are utilised. Self-controlled risk interval (SCRI), with a shorter observation period, can also mitigate the problem by studying a control period close to the risk period. OBJECTIVE: An Indian rotavirus vaccine has previously been studied using SCCS. The risk of intussusception in the high-risk windows (21 days after vaccination) was comparable to the background risk. The aim was to …re-analyse data of an existing SCCS study using alternate statistical methods to examine vaccine safety. METHODS: We examined the mean age of intussusception in the vaccinated and the unvaccinated. We performed an SCRI analysis of the surveillance data from the SCCS study, limiting the observation period to 180 days. We analysed the time-to-intussusception from the last vaccination. Finally, we performed an SCCS analysis, excluding unvaccinated cases from the analysis. RESULTS: We found that the mean age of intussusception was significantly lower in the vaccinated (205 days) compared to the unvaccinated (223 days) (p -value 0.0026). The Incident Risk Ratio (IRR) on SCRI analysis was 1.62 (95% CI 1.07-2.44). There were significantly more intussusceptions in the first 30 days after vaccination compared to the next 30-day window. (92 vs 63 p -value = 0.009). We found that excluding unvaccinated infants from the SCCS analysis demonstrated significantly increased risk for the risk period 1–21 days after the 3rd dose (IRR 2.47, 95% CI 1.70-3.59). The risks of intussusception were missed in traditional SCCS analysis using unvaccinated infants as controls. CONCLUSION: Traditional risk adjustments using data from unexposed cohorts in SCCS may not be appropriate for investigating the risk of intussusception where vaccination lowers the mean age of intussusception. Show more

Keywords: Rotavac, vaccine adverse effects, self-controlled case series, intussusception, time-to-intussusception, vaccines, microbiology, pharmacoepidemiology, pharmacovigilance

DOI: 10.3233/JRS-230049

Citation: International Journal of Risk & Safety in Medicine, vol. 35, no. 3, pp. 207-215, 2024

Authors: Ishii, Keiko | Fujitani, Katsumi | Matsushita, Hironobu

Article Type: Research Article

Abstract: BACKGROUND: Organizational learning (OL) and interprofessional collaboration (IPC) are said to enhance medical safety in hospitals, but the relationship between these variables has not been quantitatively tested. OBJECTIVE: This study examines the mediating effects of IPC on the relationship between OL and safety climate (improvement, compliance, and patient/family involvement). METHODS: An anonymous self-reporting questionnaire was administered to 1,495 healthcare workers from November 2021 to January 2022. The questions regarded the hospital’s safety climate, OL, and IPC. A mediation analysis using structural equation modeling was conducted to examine the mediating role of IPC on the relationship between …OL and the three safety climates. The indirect effect was estimated using 2,000 bootstrap samples. RESULTS: Responses from 643 healthcare workers were analyzed. The direct effects of OL were 𝛽 = .74, 75 (p < .001) on improvement and involvement and 𝛽 = 0.1 (p > .05) on compliance. The indirect effects of IPC on improvement and involvement were 𝛽 = .14 (95%CI: .00 ∼ .06) and 𝛽 = .37 (95%CI: .04 ∼ .09), respectively. CONCLUSION: This study determined the mechanisms that enhance a hospital’s safety climate, demonstrating that IPC mediates the relationship between OL and improvement and patient/family involvement. However, OL and IPC are not related to compliance. Show more

Keywords: Interprofessional collaboration, safety climate, organizational learning, hospital management, mediation analysis, structural equation model

DOI: 10.3233/JRS-230026

Citation: International Journal of Risk & Safety in Medicine, vol. 35, no. 3, pp. 217-232, 2024

Authors: Amghar, Hind | El Hani, Manal | Cherrah, Yahia | Serragui, Samira

Article Type: Research Article

Abstract: BACKGROUND: The ubiquity of social media has ushered in an era where uncontrolled content sharing extends to all subjects, including sensitive topics such as medication consumption. OBJECTIVE: To quantify the prevalence of YouTube videos providing information on glucocorticoids and to underscore the risks associated with inaccurate information, which might inadvertently promote inappropriate use of these medications. METHODS: The YouTube videos were selected using predefined keywords from February 20 to March 4, 2023. The videos were categorized into two groups. Category 1 promotes the misuse of corticosteroids, while Category 2 raises awareness about the risks associated with …these drugs. RESULTS: In total, 843 YouTube videos were included. Approximately 76% of the creators were women. Of these, category 1 videos (69.63%) predominated over Category 2 videos (30.37%). Regarding Category 1, dexamethasone was mentioned in 41.53% of cases, followed by hydrocortisone (17.30%). According to these YouTubers, these products/medications are mainly obtained from community pharmacies (58.09%), online shops (20.01%), and through illicit markets and the black market (13.46%). Weight gain was the most common objective, according to 32.62% of the YouTubers. CONCLUSION: This study highlights the prevalence of YouTube videos regarding the misuse of corticosteroids. The common focus on weight gain as an objective underscores the importance of educating content creators and viewers about responsible corticosteroid use. Targeted interventions are needed to promote safe and informed medication practices within this online environment. Show more

Keywords: YouTube, corticoids, misuse, weight gain, influencer, beauty criteria

DOI: 10.3233/JRS-230061

Citation: International Journal of Risk & Safety in Medicine, vol. 35, no. 3, pp. 233-245, 2024

Authors: ELMeneza, Safaa | Kadom, Abeer | Gafar, Heba

Article Type: Research Article

Abstract: BACKGROUND: Neonatal resuscitation is one of the most critical and risky events that requires a high level of individual skill and team performance. OBJECTIVE: To evaluate the effect of training of resuscitation teams on the frequency and type of medical errors (ME) that result from neonatal resuscitation. METHODS: A prospective observational study was performed using a checklist to detect ME related to neonatal resuscitation. RESULTS: The rate of ME was 24.82%. There was a significant reduction in the percentage of errors from 17.28% in pre- pre-training phase to 7.54% in post post-training phase. Near …miss MEs (98.77%) were significantly higher than adverse events. The active errors were significantly higher than latent errors, P < 0.001, and decreased from 39.19% during pre-training to 19.64% in the post-training phase. The commission ME s were significantly higher than the omission, P < 0.001. The latent errors percentage was 41.17% of the total errors and were not significantly reduced after training. CONCLUSION: Training sessions reduced ME that occurred during resuscitation, however careful distinguishing and recognizing the type of MEs is important to plan for further reduction of errors. Special attention to latent errors is imperative as it needs a specific approach rather than just training. Show more

Keywords: Medication errors, neonatal resuscitation, patient safety, training, debriefing

DOI: 10.3233/JRS-230056

Citation: International Journal of Risk & Safety in Medicine, vol. 35, no. 3, pp. 247-258, 2024

Authors: Obeng, Frank Yaw | Amponsah, Seth Kwabena | Ofori, Emmanuel Kwaku | Afriyie, Daniel Kwame

Article Type: Research Article

Abstract: BACKGROUND: Medication errors are known to cause adverse drug reactions, hospital admissions and mortality. In most resource-poor settings, medication errors occur but are undocumented. OBJECTIVE: This study sought to investigate medication errors in a diabetic clinic at Komfo Anokye Teaching Hospital (KATH), Ghana. METHODS: The research combined both qualitative and quantitative data collection methods. The quantitative aspect involved retrospectively reviewing patient folders over two years (1st January 2019 to 31st December 2021). Patients’ folders were reviewed to identify possible medication errors. The qualitative arm explored underlying factors and experiences related to medication errors through interviews with …healthcare workers. Ten healthcare professionals at KATH were interviewed using an interview guide. RESULTS: A total of 264 patients’ folders were retrieved. The majority (23.11%) of the patients were between 18 and 25 y.o., and there were more females (52.27%) than males. About 60% of the patients had diabetes and hypertension comorbidity. The overall prevalence of medication errors was 18.18%. The most prevalent type of medication error identified was wrong drug formulation (n = 19, 39.58%). About 47.92% of the medication errors resulted in adverse events and this was predominantly caused by antidiabetic drugs (47.83%) and anti-hypertensive drugs (34.78%). Patients in the age category of 26–35 y.o. [aOR: 0.31, CI: 0.11–0.90] had reduced odds of medication errors whilst patients with comorbidity of diabetes and hypertension [aOR: 5.95, CI: 2.43–14.60] had an increased odds of medication errors. Large patient population, low staff numbers and inadequate knowledge of drugs by healthcare workers were factors that contributed to medication errors. CONCLUSION: Medication errors was moderately high in this diabetic clinic, and the errors led to a number of adverse events. Age, diabetes and hypertension comorbidity, large patient population, low staff numbers, and inadequate knowledge about drugs were identified as factors that influenced medication errors. Show more

Keywords: Adverse events, diabetes, prescription, comorbidities, pharmaceuticals, medication error

DOI: 10.3233/JRS-230062

Citation: International Journal of Risk & Safety in Medicine, vol. 35, no. 3, pp. 259-270, 2024

Authors: Curtolo, Elisa | Micallef, Benjamin | Szijj, Janis Vella | Serracino-Inglott, Anthony | Borg, John-Joseph

Article Type: Research Article

Abstract: BACKGROUND: Understanding knowledge and attitudes of health care professionals (HCPs) towards adverse drug reaction (ADR) reporting can inform educational interventions promoting ADR reporting. OBJECTIVE: To explore knowledge, attitudes, practice, and barriers of local HCPs towards ADR reporting. METHODS: Focus groups involving HCPs from different settings were organized to help develop a questionnaire. The questionnaire was validated and disseminated to pharmacists, physicians, dentists and nurses practicing in Malta. A review of ADR reports reported in Malta from 2004 to 2021 was carried out to contextualise questionnaire findings. RESULTS: Overall, HCPs (n = 374) had …good knowledge on pharmacovigilance and a positive attitude towards ADR reporting however nurses were found to be less knowledgeable than physicians, dentists, and pharmacists. The main barrier for not reporting ADRs was difficulty to understand whether an adverse event occurred (n = 187). A total of 2581 ADR reports were reported in Malta. Among HCPs, physicians and dentists reported most ADRs (1060 reports), followed by pharmacists (307 reports) and nurses (257 reports). CONCLUSION: Further ADR educational and promotional efforts are needed to increase awareness on the importance of quality ADR reporting and increase the number of ADR reports reported by local HCPs. Show more

Keywords: Adverse drug reactions, adverse drug reaction reporting, drug safety, healthcare professionals, pharmacovigilance, spontaneous reporting

DOI: 10.3233/JRS-230055

Citation: International Journal of Risk & Safety in Medicine, vol. 35, no. 3, pp. 271-286, 2024

Authors: Atshemyan, Hakob | Khachatryan, Naira | Khachatryan, Anush | Mirzoyan, Narine

Article Type: Research Article

Abstract: BACKGROUND: The implementation of modified, all-oral shorter regimens for treatment of rifampicin-resistant tuberculosis has started in Armenia since August 2020 under the conditions of operational research. OBJECTIVE: This study aims to evaluate the safety and effectiveness of shorter regimens. METHODS: We evaluated cumulative incidence rates of serious adverse events, adverse events of grade 3 and greater and events resulting in treatment modifications or suspension for 52 study participants. RESULTS: A new, different pattern of adverse events emerged compared with the previous evaluations of drug safety of treatment for rifampicin-resistant tuberculosis. Arthralgia (23.1%) and peripheral …neuropathy (21.2%) took leading positions among the adverse events resulting in modifications of treatment. Some adverse events of interest (prolonged QT interval, elevated liver enzymes and anemia) remained relevant for the patients receiving new combinations of anti-TB drugs. The other adverse events (impaired hearing, acute kidney injury and hypokalemia) lost their significance for safety surveillance of rifampicin-resistant tuberculosis treatment. One unexpected serious adverse event (lymphoproliferative skin lesion) brought to a “failed treatment” outcome. The other serious adverse event was anemia. CONCLUSION: The shorter regimens proved to be safe and effective for treatment of rifampicin-resistant tuberculosis, but proper follow-up of adverse events is necessary. Show more

Keywords: Rifampicin-resistant tuberculosis, shorter regimens, adverse events

DOI: 10.3233/JRS-230039

Citation: International Journal of Risk & Safety in Medicine, vol. 35, no. 3, pp. 287-295, 2024