Adverse Events Following Immunization to CovId-19 vaccines in A Tertiary Care Hospital – A descriptive Study

Introduction: The pandemic due to Coronavirus disease 2019 (COVID-19) is a major health issue resulting in mortality across the globe. Multiple newer medications are being tried in treatment but with minimal success. The development of vaccines is occurring with unprecedented speed using different platforms with collaborations of academia and the pharmaceutical industries globally. These vaccines are approved for emergency use authorization by health authorities based on limited data from clinical trials. Hence, there is a need for active surveillance of vaccine recipients to monitor for safety. Methods: Adverse drug reaction monitoring centre (AMC) of our institute is actively involved in surveillance of recipients for adverse events following immunization (AEFI) who received vaccines for COVID-19 from the vaccination centre of the institute. As per the guidelines of National Coordinating Centre (NCC), Pharmacovigilance Programme of India (PvPI), designated staff of AMC follows up vaccine recipients over their registered mobile number post-vaccination for AEFI if any. This is a descriptive study of all the AEFI reported to NCC, PvPI between 16th January 2021 and 31st March 2021. Results: Of the 5793 doses of vaccination administered during the study period, 59.4% (3443) responded to follow up and 8.6% (299 of 3443) recipients reported 509 AEFI. The most common reported AEFI include fever, generalized body pains, and headache constituting 36.1%, 30.5%, and 18.5% respectively. 64.2% (327 of 509) of AEFI were reported from people younger than 45 years of age. Though females constituted 53.8% (161 of 299) of people who reported AEFI, total number of events reported from this group was 58% (295 of 509). More number of AEFI were observed after first dose of COVISHIELD compared to second dose. Conclusion: COVID-19 vaccination drive is rolled out in multiple phases for different age groups across the country. Many vaccinations are being approved for use in general public with limited data from clinical trials. Active surveillance of COVID-19 vaccines for AEFI helps us in further understanding safety issues beyond the clinical trial environment.

LoRa Network Based Integrated Sluice Gates Group Automation Control System

A kind of gate automation group control system is designed based on LoRa networking, which is composed of intelligent gate control subsystems installed on all levels of channels, LoRa network and a cluster control system running in the monitoring centre. The system uses the water level and flow rate method, Doppler ultrasonic flowmeter, and laser water level gauge to realize the automatic metering function of the gate; the ultra-low power gate cluster control system based on LoRa network realizes the intelligent control and wireless remote communication of the gate terminal; Provides three different types of gate automatic control modes to meet the water supply needs of different types of irrigation areas; through the design of dual-circuit redundant power supply system design for solar power supply and mains power supply, the power supply problem of the gate field work is solved; remote dynamic water transfer control application software package realize the remote control, automatic control and system linkage of the gate.

Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study

ObjectivesTo analyse and present the occurrence and severity of spontaneous adverse drug reaction (ADR) reports prospectively registered at an ADR monitoring centre (AMC) in Central India.Setting and dataThe survey was conducted between 2013 and 2019 at an ADR Monitoring Centre in Central India. ADRs were recorded using the standard ‘Suspected ADR Reporting form’.Outcome measuresThe causality of the ADRs were categorised using the WHO causality assessment scale to assess the relationship between a drug and the occurrence of an ADR.ResultsTotally 1980 spontaneous ADRs were reported involving 960 patients and 1316 drugs prescriptions. The occurrence of ADRs was common among male patients (64%) and patients of age between 19 and 65 years (81%). Antimicrobials caused 29% ADRs, followed by drugs of antiretroviral therapy (19%). Zidovudine caused most ADRs (88%) followed by ethambutol and ciprofloxacin. The ADRs of skin and subcutaneous tissue disorders (28%) were most common among all system organ classes followed by gastrointestinal systems (18%). Four per cent of all reported ADRs were severe. A peak of ADR reports was attained in 2016 with 224 reports, which decreased to 127 in 2019.ConclusionA high number of ADRs caused by antimicrobials is an alarming situation, which adds up to antimicrobial resistance. Judicious use of antimicrobials is yet again proven as need of the hour. Under-reporting of ADRs is evident in our study and is a major factor for the delay in the withdrawal of drugs responsible for causing ADRs. Interventions in terms of training and feedback are suggested to encourage and improve ADR reporting.

Pharmacological and Toxicological Effects of Phytocannabinoids and Recreational Synthetic Cannabinoids: Increasing Risk of Public Health

Synthetic Cannabinoids (CBs) are a novel class of psychoactive substances that have rapidly evolved around the world with the addition of diverse structural modifications to existing molecules which produce new structural analogues that can be associated with serious adverse health effects. Synthetic CBs represent the largest class of drugs detected by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) with a total of 207 substances identified from 2008 to October 2020, and 9 compounds being reported for the first time. Synthetic CBs are sprayed on natural harmless herbs with an aim to mimic the euphoric effect of Cannabis. They are sold under different brand names including Black mamba, spice, K2, Bombay Blue, etc. As these synthetic CBs act as full agonists at the CB receptors, they are much more potent than natural Cannabis and have been increasingly associated with acute to chronic intoxications and death. Due to their potential toxicity and abuse, the US government has listed some synthetic CBs under schedule 1 classification. The present review aims to provide a focused overview of the literature concerning the development of synthetic CBs, their abuse, and potential toxicological effects including renal toxicity, respiratory depression, hyperemesis syndrome, cardiovascular effects, and a range of effects on brain function.

Remote Monitoring Programs for Cardiac Conditions

Remote monitoring is a type of telehealth whereby health care is delivered to patients outside traditional settings by allowing health data to be exchanged between patients and health care providers using telecommunication techniques (e.g., video conferencing) or stand-alone devices (e.g., portable heart rate monitors). The goals of remote monitoring centre around promoting home-based self-management to improve patient outcomes and/or reduce health system usage. CADTH’s Health Technology Assessment included the following analyses: A Realist Review: This sought to identify key perceived or actual mechanisms of remote monitoring programs. Substantial evidence was available regarding the use of remote monitoring programs for heart failure (n = 64) and cardiac rehabilitation (n = 23), limited evidence was available for atrial fibrillation (n = 4), and none was available for hypertension. A Perspectives and Experiences Review: This thematic synthesis of primary qualitative research sought to understand and describe peoples’ experiences with and perspectives on remote monitoring programs for cardiac conditions. CADTH also engaged patients and caregivers directly in a patient engagement section. An Ethics Review: This sought to identify and reflect upon key ethical issues that should be considered when contemplating the implementation of remote monitoring programs. Overall, the vast majority of sampled patients, caregivers, and health professionals consistently found or perceived remote monitoring programs across different cardiac conditions to be easy to use and beneficial to health. Remote monitoring programs may be an attractive adjunct as opposed to an alternative to existing health professionals and services. Although remote monitoring programs may ultimately reduce avoidable hospitalizations, they may increase net costs and workload during set-up and operational phases without careful pathway design and expectations management. More research is needed to identify the costs and cost-effectiveness of remote monitoring programs across chronic cardiac conditions.

GEM Centre: Completion report for Phase 2 funding, 2017–2020

In 2014, the Australian Council for Educational Research (ACER) and the Australian Government’s Department of Foreign Affairs and Trade (DFAT) established a partnership under the Global Education Monitoring Centre. Since then, there have been two funding periods: Phase 1 from 2014–2017 and Phase 2 from 2017–2020. Phase 3 will cover 2020–2023. This report documents the completion of Phase 2 funding and describes the shared priorities of DFAT and ACER through the GEM Centre, followed by the objectives and key outcomes of the work program during this period. The outcomes and lessons learned, together with findings from the GEM Centre mid-term review (MTR) in 2019,1 are reflected against the impact and sustainability of the ACER–DFAT partnership. The MTR validated the overall success of the GEM Centre and identified areas for further development, specifically to improve the effectiveness of the partnership. This report concludes with a brief outlook on how these developments will be addressed under Phase 3 of the GEM Centre.

The Impact of Smog Pollution on Audit Quality: Evidence from China

Audit quality usually refers to the quality that the auditing services accounting firm auditors provide to an enterprise in the form of an audit report. This study empirically analyzes the impact mechanism of smog pollution on audit quality, based on the data of A-share listed companies in the Shanghai and Shenzhen Stock Exchanges during the period 2013 to 2017 and the air quality monitoring data released by the China National Environmental Monitoring Centre covering the period 2013 to 2018. First, the empirical results show that smog pollution can lead to a decline in audit quality. Second, audit time plays a partial mediating role in the relationship between smog pollution and audit quality. Further analysis indicates that the negative impact of smog pollution on audit quality and the intermediary role played by audit time are only significant in the sample of “top 10” accounting firms. Third, the enterprise′s internal control level positively moderates the mediating effect of audit time on smog pollution and audit quality.

A 10-Year Single-Center Experience of Adverse Drug Reaction Monitoring

Background/Aims: Despite proper use of pharmaceuticals, adverse drug reactions (ADRs) can lead to problems related to patient safety. We analyzed the characteristics of ADRs, particularly serious adverse events (SAEs), in a single tertiary medical institution. Methods: Spontaneous ADR report data collected from 2010 to 2019 in Seoul National University Hospital were assessed. Causality was evaluated according to the World Health Organization-Uppsala Monitoring Centre criteria. Age, sex, onset, severity, seriousness, and system organ class (SOC) of ADRs and SAEs were analyzed. Results: During the study period, a total of 49,955 individual case safety reports were assessed as possible, probable, or certain. Although the number of gastrointestinal ADR reports was high (25.9%), severe cases were uncommon (2.6%). By contrast, the number of hematologic disorders was low (6.6%) but 39.2% of them were severe. Among ADRs, 10.2% were assessed as SAEs, the proportion of which was high at extreme ages and in males. Body as a whole-general disorders were the most frequently reported SOC for SAEs, followed by skin and appendage disorders. Antineoplastic agents and antibiotics were the most common causative agents of SAEs and ADRs. Anaphylactic reaction was the most frequent SAE (6.5%). Conclusions: The proportion of SAE differs according to SOC and drug. Attention should be paid to SAEs in children and older adults because the rate of SAEs is significantly higher at extreme ages.

The state of harm reduction in prisons in 30 European countries with a focus on people who inject drugs and infectious diseases

Background People who inject drugs are often imprisoned, which is associated with increased levels of health risks including overdose and infectious diseases transmission, affecting not only people in prison but also the communities to which they return. This paper aims to give an up-to-date overview on availability, coverage and policy framework of prison-based harm reduction interventions in Europe. Methods Available data on selected harm reduction responses in prisons were compiled from international standardised data sources and combined with a questionnaire survey among 30 National Focal Points of the European Monitoring Centre for Drugs and Drug Addiction to determine the level of availability, estimated coverage and policy framework of the interventions. Results Information about responses to health harms in prisons is limited and heterogeneous. Cross-country comparability is hampered by diverging national data collection methods. Opioid substitution treatment (OST) is available in 29 countries, but coverage remains low (below 30% of people in need) in half of the responding countries. Needle and syringe programmes, lubricant distribution, counselling on safer injecting and tattooing/piercing are scarcely available. Testing for infectious diseases is offered but mostly upon prison entry, and uptake remains low in about half of the countries. While treatment of infections is mostly available and coverage is high for human immunodeficiency virus (HIV) and tuberculosis, hepatitis B and C treatment are less often provided. Health education as well as condom distribution is usually available, but provision remains low in nearly half of the countries. Post-release linkage to addiction care as well as to treatment of infections is available in a majority of countries, but implementation is often partial. Interventions recommended to be provided upon release, such as OST initiation, take-home naloxone and testing of infections, are rarely provided. While 21 countries address harm reduction in prison in national strategic documents, upon-release interventions appear only in 12. Conclusions Availability and coverage of harm reduction interventions in European prisons are limited, compared to the community. There is a gap between international recommendations and ‘on-paper’ availability of interventions and their actual implementation. Scaling up harm reduction in prison and throughcare can achieve important individual and public-health benefits.