INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

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.

Background: Data about performance measures (PM) in patients with ST segment Elevation Myocardial Infarction (STEMI) in low- and middle-income countries is really scarce. One of the reasons is the lack of appropriate measures for these scenarios where coronary intervention is not the standard treatment.

Objective: This study aimed to develop a set of PM and quality markers for patients with STEMI in these countries.

Methods: Two investigators systematically reviewed existing guidelines and scientific literature to identify potential PM by referring to documents searched through PubMed from 2010 through 2019, using terms "Myocardial Infarction", "STEMI", "quality indicator", and "performance measure". A modified Delphi technique, involving multidisciplinary panel interview, was used. A 15-member multidisciplinary expert panel individually rated each potential indicator on a scale of 1 (lowest) to 5 (highest) during three rounds. All indicators that received a median score ≥4.5, in final round without significant disagreement were included as PM.

Results: Through the consensus-building process, 84 potential indicators were found, of which 10 were proposed as performance measures and 2 as quality metrics, as follows: Pre-Hospital Electrocardiogram; Patients with reperfusion therapy; Pre-hospital Reperfusion; Ischemic time less than 120 minutes; System delay time less than 90 minutes; In-hospital Mortality; Complete in-hospital Treatment; Complete in-hospital Treatment in patients with Heart Failure; 30 day-Re-admissions; 30 day-mortality; Patients with in-hospital stress test performed; and, Patients included in rehabilitation programs.

Conclusion: This document provides the official set of PM of attention in ST segment Elevation Myocardial Infarction of the Cuban Society of Cardiology and Cuban National Group of Cardiology.

Background: Patients undergoing dialysis pose therapeutic challenges in terms of polypharmacy, administration of potentially inappropriate drugs, and drugs with the potential risk of toxicity.

Objective: This study evaluated the use of drugs, potentially inappropriate medicines (PIM), drugs with risk of Torsades de Pointes (TdP), and the complexity of the prescribed regimen using the medication regimen complexity index scale in patients undergoing hemodialysis.

Methods: A retrospective cohort study was carried out amongst patients receiving hemodialysis. Drugs were classified into one of four classes: (i) drugs used in managing renal complications, (ii) cardiovascular drugs, (iii) anti-diabetic drugs, (iv) drugs for symptomatic management, and (v) others. Drugs were considered as PIM according to the Can-SOLVE CKD working group from a network of Canadian nephrology health professionals. The study adhered to the CredibleMeds classification of drugs with known, possible, and conditional risk of TdP and the complexity of prescribed medicines was evaluated based on the pre-validated medication regimen complexity index scale based on form/route, frequency of dosing, and requirement of special instructions.

Results: Sixty-three participants were included in the study (49 males and 14 females) with the median (range) age of 45 (21-66) years. Cardiovascular drugs followed by drugs used for managing renal complications were the most common classes administered. Notably, 12 (19.1%) patients received one of the non-steroidal anti-inflammatory drugs, 21 (33.3%) received a proton pump inhibitor, three (4.8%) received pregabalin, two (3.2%) received opioid drugs, and one (1.6%) was administered celecoxib. Atorvastatin, furosemide, omeprazole, and allopurinol were the most common PIM drugs administered to the study participants followed by others. Drugs used for symptomatic management had significantly more PIM compared to other classes (p < 0.0001). Six (9.5%) patients received drugs with known TdP risk, one with possible TdP risk, and 61 with conditional risk. Median (range) medical regimen complexity index score was 26.5 (2-62.5).

Conclusion: A huge burden of drug therapy was observed in the hemodialysis patients in terms of higher proportions of PIM, complex medical regimen, and prescription of drugs with risk of TdP. Implementation of clinical decision support tools enhancing rational prescription and identification of drugs with TdP risk, introducing antimicrobial stewardship, and stepwise deprescription of the drugs with the least benefit-risk ratio are warranted.

Background: There is currently no widespread implementation of pharmacogenetic testing (PGx) methods in the practice of phthisiology service.

Objective: The aim of this study is to determine how informed and prepared phthisiologists, residents, and postgraduate students of the Russian Medical Academy of Continuing Professional Education (RMACPE, Moscow) use PGx techniques in their work to improve treatment safety, predict the occurrence of adverse reactions (ADRs), and personalize therapy.

Methods: A survey was conducted among phthisiologists (n = 314) living in different regions of the Russian Federation and studying at RMACPE, such as residents and post-graduate students (n = 185). The survey was developed on the Testograf.ru web platform and had 25 questions for physicians and 22 for residents and post-graduate students.

Results: More than 50% of respondents are ready to use PGx in clinical practice and thus are aware of the method's possibilities. At the same time only a small part of participants were aware of the pharmgkb.org resource. The absence of PGx in clinical guidelines and treatment standards, according to 50.95% of phthisiologists and 55.13% of students of RMACPE, the absence of large-scale randomized clinical trials, according to 37.26% of phthisiologists and 43.33% of students, and the lack of physician knowledge on PGx, according to 41.08% of phthisiologists and 57.83% of students, are all factors that prevent the implementation of PGx in Russia.

Conclusion: According to the survey, the overwhelming majority of participants recognize the importance of PGx and are willing to use the method in practice. However, there is a low level of awareness among all respondents about the possibilities of PGx and the pharmgkb.org resource. The implementation of this service could significantly increase patient compliance, lower ADRs, and enhance anti-tuberculosis (TB) therapy quality.

Background: Although antidepressant medication (ADM) has produced small advantages over pill placebo in randomized controlled trials, consuming ADM has predicted prospectively increasing depressive symptom severity in samples of community-dwelling adults.

Objective: We extended the community literature by testing ADM's relations to changes in personality and quality of life that may underpin depression.

Method: In this longitudinal, observational study, community-dwelling adults (N = 601) were assessed twice, 8 months apart on average. Assessments included depressive symptoms, personality, life satisfaction and quality, and prescription medication consumption.

Results: Consuming ADM at time 1 predicted relative increases in depressive symptoms (dysphoria), maladaptive traits (negative affect, negative temperament, disinhibition, low conscientiousness), personality dysfunction (non-coping, self-pathology), and decreases in life satisfaction and quality from time 1 to 2, before and after adjustment for age, gender, race, income, education, physical health problems, and use of other psychotropics. In no analysis did ADM use predict better outcomes.

Conclusion: Among community-dwelling adults, ADM use is a risk factor for psychosocial deterioration in domains including depressive symptoms, personality pathology, and quality of life. Until mechanisms connecting ADM to poor outcomes in community samples are understood, additional caution in use of ADM and consideration of empirically supported non-pharmacologic treatments is prudent.

Background: Medication reconciliation is advocated to ensure the continuity, safety, and effective use of medicines across transitions of care.

Case report: In this report, we describe the case of a 90-year-old female with previous diagnoses of atrial fibrillation and cutaneous metastatic breast cancer presenting with bilateral ulcerative lesions on the chest wall. The patient was diagnosed with Deep Vein Thrombosis at the Emergency Department and started on rivaroxaban, although the patient was already taking edoxaban. This therapeutic duplication was noticed only one week later, even though she was already experiencing significant bleeding managed through a prescribing cascade. Despite the technical error (action-based), it is possible to identify several weaknesses in the organisation's structure, which provided a trajectory of accident opportunity.

Conclusion: Anticoagulants are ranked first for the highest priority to receive a medication reconciliation. To achieve an optimal level of medication reconciliation, we ought to recognise and correct latent failures.

Background: Medical ethics guidelines require of clinical trial investigators and sponsors to inform prospective trial participants of all known and potential risks associated with investigational medical products, and to obtain their free informed consent. These guidelines also require that clinical research be so designed as to minimize harms and maximize benefits.

Objective: To examine Merck's scientific rationale for using a reactogenic aluminum-containing "placebo" in Gardasil HPV vaccine pre-licensure clinical trials.

Methods: We examined the informed consent form and the recruitment brochure for the FUTURE II Gardasil vaccine trial conducted in Denmark; and we interviewed several FUTURE II trial participants and their treating physicians. We also reviewed regulatory documentation related to Gardasil vaccine approval process and the guidelines on evaluation of adjuvants used in human vaccines.

Results: It was found that the vaccine manufacturer Merck made several inaccurate statements to trial participants that compromised their right to informed consent. First, even though the study protocol listed safety testing as one of the study's primary objectives, the recruitment brochure emphasized that FUTURE II was not a safety study, and that the vaccine had already been proven safe. Second, the advertising material for the trial and the informed consent forms stated that the placebo was saline or an inactive substance, when, in fact, it contained Merck's proprietary highly reactogenic aluminum adjuvant which does not appear to have been properly evaluated for safety. Several trial participants experienced chronic disabling symptoms, including some randomized to the adjuvant "placebo" group.

Conclusion: In our view, the administration of a reactive placebo in Gardasil clinical trials was without any possible benefit, needlessly exposed study subjects to risks, and was therefore a violation of medical ethics. The routine use of aluminum adjuvants as "placebos" in vaccine clinical trials is inappropriate as it hinders the discovery of vaccine-related safety signals.

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.

Background: Recently, antivirals, including remdesivir, have been repurposed to treat COVID-19 infections. Initial concerns have been raised about the adverse renal and cardiac events associated with remdesivir.

Objective: This study aimed to analyse the adverse renal and cardiac events associated with remdesivir in patients with COVID-19 infections using the US FDA adverse event reporting system.

Method: A case/non-case method was used to determine adverse drug events associated with remdesivir as the primary suspect drug between January 1, 2020, and November 11, 2021, for patients with COVID-19 infections. Cases were reports for remdesivir with ≥1 ADEs as preferred terms included in the Medical Dictionary of Regulatory Activities (MedDRA) system organ classes 'Renal and urinary disorders' or 'cardiac' disorders. To measure disproportionality in reporting of ADEs, frequentist approaches, including the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used. 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, and EBGM > 1 for ADEs with ≥4 reports. Sensitivity analyses were undertaken by excluding reports for non-Covid indications and medications strongly associated with AKI and cardiac arrhythmias.

Results: In the main analysis for remdesivir use in patients with COVID-19 infections, we identified 315 adverse cardiac events comprising 31 different MeDRA PTs and 844 adverse renal events comprising 13 different MeDRA PTs. Regarding adverse renal events, disproportionality signals were noted for "renal failure" (ROR = 2.8 (2.03-3.86); EBGM = 1.92 (1.58-2.31), "acute kidney injury" (ROR = 16.11 (12.52-20.73); EBGM = 2.81 (2.57-3.07), "renal impairment" (ROR = 3.45 (2.68-4.45); EBGM = 2.02 (1.74-2.33). Regarding adverse cardiac events, strong disproportionality signals were noted for "electrocardiogram QT prolonged" (ROR = 6.45 (2.54-16.36); EBGM = 2.04 (1.65-2.51), "pulseless electrical activity" (ROR = 43.57 (13.64-139.20); EBGM = 2.44 (1.74-3.33), "sinus bradycardia" (ROR = 35.86 (11.16-115.26); EBGM = 2.82 (2.23-3.53), "ventricular tachycardia" (ROR = 8.73 (3.55-21.45); EBGM = 2.52 (1.89-3.31). The risk of AKI and cardiac arrythmias were confirmed by sensitivity analyses.

Conclusion: This hypothesis-generating study identified AKI and cardiac arrhythmias associated with remdesivir use in patients with COVID-19 infections. The relationship between AKI and cardiac arrhythmias should be further investigated using registries or large clinical data to assess the impact of age, genetics, comorbidity, and the severity of Covid infections as potential confounders.