Response to Alert on Possible Infections with Mycobacterium chimaera From Contaminated Heater-Cooler Devices in Hospitals Participating in the Canadian Nosocomial Infection Surveillance Program (CNISP)

2018 ◽  
Vol 39 (4) ◽  
pp. 482-484 ◽  
Author(s):  
Dominik Mertz ◽  
Jennifer Macri ◽  
Susy Hota ◽  
Kanchana Amaratunga ◽  
Ian Davis ◽  
...  
Keyword(s):  
Informed Consent ◽  
Nosocomial Infection ◽  
Disease Control ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Infect Control Hosp ◽  
Surveillance Program ◽  
Infection Surveillance ◽  
The Us ◽  
Control And Prevention

Canadian hospitals were made aware of the risk of Mycobacterium chimaera infection associated with heater-cooler units (HCUs) through alerts issued by the US food and Drug Administration (FDA) and the US Centers for Disease Control and Prevention (CDC). In response, most hospitals conducted retrospective reviews for infections, informed exposed patients, and initiated a requirement for informed consent with HCU use.Infect Control Hosp Epidemiol 2018;39:482–484

scholarly journals Pulmonary embolism, transient ischaemic attack and thrombocytopenia after the Johnson & Johnson COVID-19 vaccine

2021 ◽  
Vol 14 (7) ◽  
pp. e243975
Author(s):  
Bilal Malik ◽  
Atefeh Kalantary ◽  
Kamal Rikabi ◽  
Arvind Kunadi
Keyword(s):  
Pulmonary Embolism ◽  
Informed Consent ◽  
Drug Administration ◽  
Reflux Disease ◽  
Transient Ischaemic Attack ◽  
Food And Drug Administration ◽  
Pulmonary Emboli ◽  
The Us ◽  
History Of ◽  
Ischaemic Attack

As with past illnesses, an approach has been taken to vaccinate the population and halt the spread of COVID-19. On 13 April 2021, the US Food and Drug Administration called for a halt in the administration of the Johnson & Johnson (J&J) COVID-19 vaccine due to reports of thrombosis and thrombocytopenia being associated with vaccination. We present the case of a 43-year-old woman with a history of dyslipidaemia, depression, gastro-oesophageal reflux disease and obesity presenting with dyspnoea, headache and light headedness of 3 days’ duration. Ten days prior, she had received the J&J COVID-19 vaccine. She was found to have thrombocytopenia, elevated D-dimers, pulmonary emboli and presented 1 day after discharge with an arterial clot despite being on apixaban. Six other US-based cases of venous thrombotic events are being reviewed at present. Patients should be informed of the possibility of such events to provide informed consent.

scholarly journals The problem of consent in emergency medicine research

CJEM ◽  
2001 ◽  
Vol 3 (03) ◽  
pp. 213-218 ◽  
Author(s):  
Jonathan D. Gray
Keyword(s):  
Emergency Department ◽  
Emergency Medicine ◽  
Informed Consent ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Policy Statement ◽  
Medicine Research ◽  
Emergency Department Setting ◽  
The Us

ABSTRACTThis paper outlines some of the ethical and practical dilemmas of securing true informed consent in resuscitation research in the prehospital or emergency department setting. Possible substitutes to such consent are discussed and evaluated. TheCanadian Tri-Council Policy Statementguidelines for emergency medicine research are compared to the US Food and Drug Administration rules, and the former are assessed and critiqued. Modifications to the current Tri-Council guidelines are suggested.

Laboratory-Confirmed Pandemic H1N1 Influenza in Hospitalized Adults: Findings from the Canadian Nosocomial Infections Surveillance Program, 2009-2010

2012 ◽  
Vol 33 (10) ◽  
pp. 1043-1046 ◽  
Author(s):  
Krista Wilkinson ◽  
Robyn Mitchell ◽  
Geoffrey Taylor ◽  
Barbara Amihod ◽  
Charles Frenette ◽  
...  
Keyword(s):  
Nosocomial Infection ◽  
Pregnant Women ◽  
Nosocomial Infections ◽  
H1n1 Influenza ◽  
Infect Control Hosp ◽  
Surveillance Program ◽  
Pandemic H1n1 ◽  
Pandemic H1n1 Influenza ◽  
Infection Surveillance ◽  
Second Wave

Surveillance for pandemic H1N1 influenza was conducted between June 1, 2009, and May 31, 2010, among adults at 40 participating hospitals in the Canadian Nosocomial Infection Surveillance Program. The first wave was characterized by a higher proportion of Aboriginals and pregnant women as well as severe outcomes, compared to the second wave.Infect Control Hosp Epidemiol 2012;33(10):1043-1046

scholarly journals 2020 FDA TIDES (Peptides and Oligonucleotides) Harvest

2021 ◽  
Vol 14 (2) ◽  
pp. 145
Author(s):  
Othman Al Musaimi ◽  
Danah Al Shaer ◽  
Fernando Albericio ◽  
Beatriz de la Torre
Keyword(s):  
Adverse Effects ◽  
Global Health ◽  
Drug Administration ◽  
Mode Of Action ◽  
Chemical Structure ◽  
Food And Drug Administration ◽  
Health Crisis ◽  
New Drug ◽  
Target Mode ◽  
The Us

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.

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