OBJECTIVE: To analyze the serious medication errors (MEs) on dabigatran, and their related factors, in order to avoid or reduce the occurrence of adverse events.
METHODS: Serious MEs related to dabigatran were extracted from the WHO global database of reported potential side effects of medicinal products (VigiBase) by using \"Medication errors and other product use errors and issues\" High Level Group Term (HLGT) of the international Medical Dictionary for Regulatory Activities (MedDRA). Well-documented reports, vigiGrade completeness score ≥ 0.80, or with an informative narrative were analyzed with a focus on the clinical features of the cases. The PCNE Classification for drug-related problems (DRP) was used to classify medication errors in our analysis of cases.
RESULTS: Until January 26, 2020, there were 453 cases with serious MEs related to dabigatran in VigiBase, and 113 were well-documented. Among these, 69 patients (61%) were hospitalized or had prolonged hospitalization, 16 (14%) had life-threatening events, and 12 (11%) died. The MEs occurred in the prescription phase in 77 cases, in administration in 35, and at the dispensing stage in one case. The MEs in prescription were related to a drug selection error in 44 cases (24 concerning contraindications and 20 drug interactions) and to dose error in 33 cases (17 with excessive dose; eight with insufficient frequency; four had an incorrect time; in three, the dose was too low; and in one, too frequent). The MEs in administration were medical-staff-related errors in five cases (three with wrong administration route, one administration omission, and one overdose), patient-related errors in 28 (14 insufficient dose or no administration, seven improper drug storage, four wrong administration method, and three over prescribed dose), and other errors in two (without efficacy monitoring). The dispensing error of a wrong drug strength occurred in a pharmacy. The main adverse events in the 113 patients were haemorrhage in 57 cases (50%) and ischemia in 29 cases (26%).
CONCLUSIONS: Based on the analysis of reports in VigiBase, serious MEs related to dabigatran mainly occurred during prescription and administration. Although the incidence of MEs with clinical consequences in the use of dabigatran cannot be determined, attention should be paid to selection of the appropriate dose to a right patient in the prescription, and to patient compliance and storage in drug administration. The patient harm mainly manifested itself as bleeding or ischemia including fatal outcome in rare patients.

Endogenous endophthalmitis caused by listeria monocytogenes is rare and serious, which is easily misdiagnosed initially. We present one case of endogenous endophthalmitis due to listeria monocytogenes in a cirrhotic patient, whose diagnosis was delayed 17 days after admission.

BACKGROUND: COVISHIELD, ChAdOx1 nCoV- 19 Corona Virus Vaccine was granted emergency use authorization (EUA) as the first vaccine in India in January 2021. Knowing what to anticipate after vaccination will reduce vaccine hesitancy in the public. This study aimed to identify and measure the adverse events following COVID-19 vaccination.
METHODS: A cross-sectional observational study was conducted at Goa Medical College, starting on February 21 till May 23, 2021. A total of 418 people were enrolled. We collected the data using the Microsoft Form and analyzed using Microsoft Excel and R-program.
RESULTS: Of the 418 vaccine recipients, the incidence rate of AEFI (Adverse Events Following Immunization) was 54.31%. Fever, fatigue, and headache were the most commonly reported systemic AEFIs. Among these, 54.7% of AEFI were mild, 42.38% were of the moderate category, and only 2.96% were of grade 3 severity. None of the AEFIs were severe enough for hospitalization. Most of them developed symptoms within 24 hours of the first dose. Complete recovery from AEFIs took a median time of 24 hours.
CONCLUSIONS: Most of our study findings were consistent with the phase 1, 2/3 trials findings of Oxford-AstraZeneca\'s ChAdOx1 vaccine. The AEFI symptoms were considered immune reactions to the vaccine. The AEFIs were more common among younger individuals and females. The chance of missing a serious adverse event like a thromboembolic phenomenon cannot be ruled out. We observed low AEFI rates with COVISHIELD in the Indian population compared to Oxford- AstraZeneca\'s ChAdOx1 vaccine in the UK-based population, which can be explained by preexisting immunity against adenovirus in the Indian population. However, based on the study findings, we may interpret that the COVISHIELD, Serum Institute of India, carries a good safety profile overall.

UNASSIGNED: Despite recommendations to integrate palliative care (PC) into care for critically ill trauma patients, little is known about current PC practices in trauma care to inform opportunities for improvement.
UNASSIGNED: Describe patterns of PC delivery among a large, critically ill trauma cohort.
UNASSIGNED: Retrospective cohort study of adult (≥18 years) trauma patients admitted to an intensive care unit (ICU) at an urban, level one trauma center in the United States from March 1, 2017 to March 1, 2019.
UNASSIGNED: We linked the electronic medical record with the institutional trauma registry. PC process measures included a PC consult order, advance care planning (ACP) note, and hospice use. Unadjusted results are reported for the total population, decedents, and subgroups at risk for poor outcomes (age ≥55 years, Black race ≥1 pre-existing comorbidity, and severe injury) after trauma.
UNASSIGNED: Among 1309 eligible admissions, 902 (68.9%) were male, 640 (48.9%) were Black, and 654 (50.0%) were ≥55 years old. Eighty-one (6.2%) patients received a PC consult order, 66 (5.0%) had an ACP note, and 13 (1.1%) were discharged to hospice. Among decedents (N = 91; 7%), 28 (30.8%) received a PC consult order and 36 (39.6%) had an ACP note. For high-risk subgroups, PC consult orders and ACP note rates ranged from 4.5-12.8% and 4.5-11.8%, respectively.
UNASSIGNED: PC delivery was rare among this cohort, including those at high risk for poor outcomes. Urgent efforts are needed to identify barriers to and develop targeted interventions for high quality PC delivery in trauma ICU care.

UNASSIGNED: During ongoing COVID-19 pandemic, researchers worked enormously to develop effective vaccines against COVID-19 infection. Two Indian-made vaccines [Covishield (ChAdOx1 nCoV-19) and Covaxin] were granted Emergency Use Authorization. India launched its COVID-19 vaccination drive starting with healthcare workers (HCW). Aim of the study was to evaluate adverse events following immunization (AEFI) amongst the HCW with two doses of Covishield vaccine. We also evaluated association of AEFI according to sex, profession and age groups.
UNASSIGNED: A prospective observational study was conducted in a tertiary care COVID dedicated hospital of Southern India from 16 Jan - 15 Apr 2021. Nine hundred and eighty one HCW who received 2 doses (4 weeks apart) were enrolled. Active and passive surveillance was conducted after 48 hours, and at days 8,15, 22 and 28 for both doses. The rate of AEFI for each dose was determined. Incidence and association of AEFI with various demographic variables was determined.
UNASSIGNED: 1020 non-serious and two serious AEFI (altered sensorium) were reported within 48 hours of first dose. Two hundred and twenty non-serious AEFI were reported within 48 hours of second dose. No AEFI was reported after 15 days for both the doses. We found no association of AEFI with sex and profession ( p >0.5). Significant association of AEFI was found with age ( p <0.01).
UNASSIGNED: Short-term AEFI were predominantly observed in first 48 hours. Incidence decreased in subsequent weeks with no occurrence after 15 days in both doses. Symptoms were mild in severity and short-lived. No serious AEFI attributable to vaccines were reported.

Chemical incidents can result in harm to public health and the environment. Although most are localised and have little impact, some affect wide areas, a range of sectors and may lead to many casualties. A public health response to assess the risks and provide advice to authorities and the public is usually required. In some cases, incidents may affect more than one country and require effective cross-border communication and coordination.
We describe tools and mechanisms to improve health security from cross-border chemical health threats and to support the implementation of the Decision of the European Parliament and the Council of the European Union (EU) on serious cross-border threats to health (Decision 1082/2013/EU).
Experts were recruited to a network and their suitability was assessed by using a skills framework. Input by relevant stakeholders such as the World Health Organisation and the European Centre for Disease Prevention and Control, followed by EU-wide exercises, ensured that tools developed were fit for purpose.
A network of public health risk assessors and a methodology for providing rapid independent expert public health advice during a chemical emergency have been developed.
We discuss the legacy of these mechanisms including their incorporation into the working arrangements for the EU Scientific Committee for Health, Environment and Emerging Risks and future developments in the field.

Serious alert and border rejection notifications on food contact materials (FCM) retrieved from the RASFF database were analyzed for the first time regarding the period 2012-2019. The findings indicate that China was the main transgressor country for both types of notifications. Official controls were responsible for most FCM serious alerts (91.78%), and border rejection (90.82%) notifications. Another novelty proposed herein, is the criterion for \"lag phases\" (time from sampling to notification dates). Overall percentage distributions of lag phases, for all RASFF Member States, for the intervals of 0-50 days and 51-≥101 days, were 25.09% and 67.87% for serious alert notifications and 65.21% and 29.34% for serious border rejection notifications. Differences in percent shares of lag phase intervals were observed between the top-four notifying countries, indicating a lack of harmonization in timely reporting of serious alert and border rejection notifications for FCM. Migration of primary aromatic amines and of metals were the most frequently notified hazards overall in the period of analysis. A decreasing trend is observed in the two more recent biannual averages of serious alert notifications for primary aromatic amines and metals, while decreasing for metals but increasing for primary aromatic amines in serious border rejection notifications.

OBJECTIVE: To establish the healthcare factors that contribute to testicular torsion adverse events (orchidectomies) and \'near misses\'. The secondary objective was to identify areas suitable for impactful quality improvement initiatives to be undertaken by National Health Service (NHS) healthcare providers nationally.
METHODS: This was a retrospective record review and analysis, carried out in four phases. We applied the well-validated London Protocol patient safety incident analysis framework to all eligible serious incidents related to testicular torsion submitted by English NHS Trusts over a 12-year period to the Strategic Executive Information System database. Clinical reviewers established the incident population (Phase 1), were trained and piloted the feasibility of using the London Protocol (Phase 2), applied the protocol and themed the identified contributing factors linked to adverse events (orchidectomies) and near-misses (Phase 3), and reviewed the evidence for improvement interventions (Phase 4).
RESULTS: Our search returned 992 serious incidents, of which 732 were eligible for study inclusion and analysis. Of those, 137 resulted in orchidectomies, equivalent to one serious incident resulting in orchidectomy per month, and 595 were near misses. Factors contributing to all incidents were: individual staff/training (38%); team (18%); work environment (16%); task and technology (14%); and institutional context (13%). Subgroup analysis of incidents resulting in orchidectomies vs near misses demonstrated a different pattern of factors, with individual staff/training factors significantly more prominent: individual/training (88%); work environment (8%); and task and technology (1%). No evidenced improvement interventions were found in the literature.
CONCLUSIONS: This is the first study to our knowledge to systematically analyse and classify factors that are associated with loss of a testicle and related near-miss incidents in patients presenting with testicular torsion. In England, a significant number of orchidectomies occur annually as a consequence of healthcare serious incidents. In order to improve outcomes, we propose clinical support to aid the diagnosis of torsion, improved national clinical guidelines, development of specific standard operating procedures and (in the longer term) more exposure of trainees and medical students to urology to improve the testicular salvage rate.

UNASSIGNED: Obtaining intravenous (IV) access is one of the very frequent invasive procedures performed in hospital care settings. This has several complications some of which are serious in nature. However, the incidence and seriousness of these complications as well as the burden of this complication on patient management are often underestimated. Identification of susceptible patients and the risk factors are important to ensure better outcomes.
UNASSIGNED: The aim of this study was to document the various local complications of intravenous access and to identify the risk factors associated with it.
UNASSIGNED: Prospective observational study with three hundred and one surgical patients. Study duration of 1 year.
UNASSIGNED: Indication of IV access, site, size of IV cannula used, category of personnel involved as well as local complications at access site were documented. Dressing at cannula site were changed every 72 h or earlier. Cannula and site of access were changed in case of any complication.
UNASSIGNED: Results analysed using SPSS software (IBM Inc). Frequency calculated as average and percentage. Chi-square test used for statistical significance. Relative risk calculated.
UNASSIGNED: Females, overweight, diabetics and smokers were found at more risk. Requirement of major surgery, IV access by paramedical personnel, IV access over joints and when kept beyond 3 days were found to have more complications. 5.7% of patients had serious complications requiring surgical intervention.
UNASSIGNED: Our study shows that local complications at IV access site are very common with occurrence in more than fifty percent patients. Several risk factors are identified. Not all demographic and clinical risk factors are readily modifiable. However many of the complications can easily be minimized by following basic precautions.

BACKGROUND: Takotsubo cardiomyopathy is characterized by transient dysfunction of the medial to apical segment of the left ventricle. Recurrence within a few months or years has been reported and serious complications, including arrhythmia, acute cardiac shock and cardiac rupture, can arise; however, recurrence is rare and takotsubo cardiomyopathy is typically a reversible functional disorder.
METHODS: A 91-year-old Japanese woman with a past medical history of angina pectoris, hypertension and uterine carcinoma noted bilateral axillary pain and presented herself to an emergency room. Although the pain improved and she went home, there were several subsequent episodes of recurrent chest pain. At approximately 1 week after the onset, she was hospitalized as her symptom worsened. Electrocardiography showed low voltage in limb and chest leads, and ST-segment elevation in leads II, III, aVF and V3 to V6. Echocardiography revealed medial to apical dyskinesia and basal hypercontractility of the left ventricle, and cardiac tamponade. Pericardiocentesis improved the symptom, but not her cardiac dysfunction. At 3 days after her admission, cardiopulmonary resuscitation was performed due to ventricular fibrillation. She died on the 5th day of admission (2 weeks after the onset). At autopsy, the left ventricle was dilatated and the apical ventricular wall was thin. On microscopy, remarkable wavy change and thinning of myocardium were diffusely observed, especially at the apex and the anterior to lateral wall of the left ventricle, interventricular septum and right ventricle, intermingled with interstitial fibrosis, hemorrhage and neutrophil infiltration. Contraction band necrosis was mainly observed on the posterior to inferior wall of the left ventricle.
CONCLUSIONS: Our case showed severe morphological myocardial change after several chest pain episodes that were considered to be takotsubo cardiomyopathy. This notable case suggests that the frequent recurrence of serious takotsubo cardiomyopathy is life threatening and can lead to irreversible serious myocardial degeneration.