International Journal of Risk & Safety in Medicine - Volume 34, issue 1
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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: The COVID-19 pandemic highlighted the need for a new dynamic in the organization and practices of health services, as it required rapid restructuring to promote safe and harm-free assistance. OBJECTIVE: To assess the dimensions of the patient safety culture (PSC) from the perspective of the health team professionals in clinical-surgical ICU (G1) compared to a COVID-19 ICU (G2). METHODS: Cross-sectional, analytical, descriptive and inferential study, using the “Hospital Survey on Patient Safety Culture” questionnaire. RESULTS: The domain “Supervisor/Manager Expectations and Actions Promoting Patient Safety (PS)” was a potential weakness for G1 (p…= 0.003). G2 was most positive on improving PS, being informed about errors, considering PS as a top priority to management, and that the units work together to provide the best care (p > 0.05). G1 was most negative about the work culture with staff from other units, exchange of information across units, and shift changes (p > 0.05). The highest PS grade was related to greater communication, and a smaller frequency of events was reported only for G2 (p > 0.05). CONCLUSION: There must be a balance in terms of attention focused on PS between different ICUs in times of crisis, especially regarding the supervisors/managers actions.
Keywords: Patient safety, organizational culture, intensive care units, COVID-19
Abstract: BACKGROUND: Gender dysphoria is characterised by a sense of distress because of discordance between the self-perception of gender identity and the assigned sex. Hormonal treatment of transgender males uses testosterone to induce and preserve masculinisation. OBJECTIVE: The study investigated the safety of testosterone therapy in transgender males. METHODS: The present study used a retrospective file review of transgender male subjects who were treated with testosterone (initially transdermal testosterone gel and subsequently parenteral testosterone undecanoate) for at least 18 months and had subsequently achieved a serum testosterone level within the normal range of cisgender male counterparts. Changes…in somatometric data and blood biomarkers were investigated. RESULTS: The mean testosterone serum levels after approximately 18 months of treatment were about 545 ng/dL (SD ± 94 ng/dL). There was a statistically significant rise in body mass index (𝜒d = +1.23 kg/m2 ) with a reduction in blood glucose (𝜒d = −5.33 mg/dL) as well as statistically significant increases in aspartate transaminase (𝜒d = +4.3 U/L), haemoglobin (𝜒d = +1.72 g/dL), and haematocrit (𝜒d = +4.76%). In contrast, there were no significant changes in the lipidaemic profile of the subjects. CONCLUSIONS: Treatment with testosterone is routinely used for the promotion of virilising physical changes in transgender males. However, the likelihood of adverse effects of continuous treatment is still unclear. This study contributed to the notion that achieving testosterone levels within the target range is a prerequisite for the safety of the gender-affirming treatment.
Keywords: Transgender persons, testosterone, evidence-based medicine
Abstract: BACKGROUND: Since randomized controlled trials have indicated that adjuvant chemotherapy prolongs survival and reduces recurrence rates after surgical resection of pancreatic adenocarcinoma, a gemcitabine based chemotherapy has become part of the interdisciplinary treatment concept for pancreatic cancer in accordance to current guidelines. OBJECTIVES: The aim of this project was to analyse the validity of the CONKO-001 trial as a basis for the recommendation of adjuvant chemotherapy in many international guidelines. METHODS: We analysed the validity of the CONKO-001 trial regarding study design, recruitment period, participating institutions, patient selection, randomisation, stratification, standardization of surgical treatment and histological…examination, statistical methods and interpretation of results. We additionally analysed the study regarding the risk of bias using the RoB 2 Tool. Finally we reviewed the influence of the pharmaceutical industry and potential conflicts of interest. RESULTS: We identified several shortcomings of the study concerning the study protocol, the participating clinics, the patient recruitment, the randomization pattern, the standardization of surgical treatment and histological examination, the statistical methods, the evaluation of the results and the influence of the pharmaceutical industry. According to the Cochrane RoB 2 Tool the study was judged to raise some concerns in three of the five risk domains for the outcome “overall survival”. CONCLUSIONS: Based on our review, the results of the CONKO-001-study should be revisited and critically reviewed. The recommendation to include adjuvant chemotherapy with gemcitabine deserves a critical appraisal.
Abstract: BACKGROUND: As Twitter has gained significant popularity, tweets can serve as large pool of readily available data to estimate the adverse events (AEs) of medications. OBJECTIVE: This study evaluated whether tweets were an early indicator for potential safety warnings. Additionally, the trend of AEs posted on Twitter was compared with AEs from the Yellow Card system in the United Kingdom. METHODS: English Tweets for 35 drug-event pairs for the period 2017–2019, two years prior to the date of EMA Pharmacovigilance Risk Assessment Committee (PRAC) meeting, were collected. Both signal and non-signal AEs were manually identified and…encoded using the MedDRA dictionary. AEs from Yellow Card were also gathered for the same period. Descriptive and inferential statistical analysis was conducted using Fisher’s exact test to assess the distribution and proportion of AEs from the two data sources. RESULTS: Of the total 61,661 English tweets, 1,411 had negative or neutral sentiment and mention of at least one AE. Tweets for 15 out of the 35 drugs (42.9%) contained AEs associated with the signals. On pooling data from Twitter and Yellow Card, 24 out of 35 drug-event pairs (68.6%) were identified prior to the respective PRAC meetings. Both data sources showed similar distribution of AEs based on seriousness, however, the distribution based on labelling was divergent. CONCLUSION: Twitter cannot be used in isolation for signal detection in current pharmacovigilance (PV) systems. However, it can be used in combination with traditional PV systems for early signal detection, as it can provide a holistic drug safety profile.
Keywords: Safety signal, Twitter, social media, pharmacovigilance, adverse events
Abstract: BACKGROUND: Antimuscarinics are the backbone of the pharmacological management of overactive bladder. Still, concerns have been raised over the nervous system (NS) adverse drug events (AEs) due to their dissimilarities to muscarinic receptor-subtype affinities. OBJECTIVE: This study aimed to identify the nervous system and gastrointestinal adverse drug events (ADEs) associated with solifenacin use in older adults (≥65 years). METHODS: A case/non-case analysis was performed on the reports submitted to the FDA Adverse Event Reporting System (FAERS) between 01/01/2004 and 30/06/2020. Cases were reports for solifenacin with ≥1 ADEs as preferred terms included in the Medical Dictionary…of Regulatory Activities (MedDRA) system organ classes ‘nervous system’ or ‘gastrointestinal’ disorders. Non-cases were all other remaining reports for solifenacin. The case/non-cases was compared between solifenacin and other bladder antimuscarinics. Frequentist approaches, including the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used to measure disproportionality. The empirical Bayesian Geometric Mean (EBGM) score and information component (IC) value were calculated using a Bayesian approach. A signal was defined as the lower limit of 95% confidence intervals of ROR ≥ 2, PRR ≥ 2, IC > 0, EBGM > 1, for ADEs with ≥4 reports. RESULTS: 107 MedDRA preferred terms (PTs) comprising 970 ADE reports were retrieved for nervous system disorders associated with solifenacin. For gastrointestinal disorders, 129 MedDRA PTs comprising 1817 ADE reports were retrieved. Statistically significant results were found for ‘altered state of consciousness’: ROR = 9.71 (2.13–44.35), PRR = 9.69 (2.12–44.2) and IC = 1.29 (0.93–1.66). CONCLUSIONS: The disproportionality reporting of ‘altered state of consciousness ’, a previously unidentified ADE, was unexpected. Further monitoring of this ADE is needed to ensure patient safety, as this could be linked to poor balance and falls in older adults.
Keywords: Antimuscarinics, patient safety, pharmacovigilance, pharmacoepidemiology, elderly, reporting odds ratio
Abstract: BACKGROUND: According to the World Health Organization (WHO), any woman in childbearing age who have decided not to take permanently an oral contraceptive but who are sexually active has the right to access emergency contraception (EC). Despite this, in many European countries there are no specific laws governing the criteria for access to emergency oral contraceptives (EOCs) for girls under 18, especially about the need for third party consent. This normative vacuum is dangerous as it risks creating confusion and entrusting the management of the fundamental right of self-determination to the discretion of others. Moreover, in European Union (EU) countries,…there is an inequality in terms of access to contraceptive supplies, reimbursement criteria and the availability of information online. OBJECTIVE: Our article compares the criteria for access to EOCs (Ulipristal Acetate-UPA and Levonorgestrel-LNG) in the various EU countries to highlight possible disparities and consequent inequalities. METHODS: Government and ministerial websites, European agencies websites, and Contraceptive Use by Method 2019 (WHO) have been consulted. RESULTS: There are some differences between the various European countries that could configure inequality in EU countries. CONCLUSIONS: It would be appropriate a definitive levelling of the legislation of the European Union on emergency contraception associated with massive information and awareness campaigns.