Diabetic Ketoacidosis with Lower-than-anticipated Glucose Levels, and Recalcitrant Metabolic Acidosis Requiring Rescue Hemodialysis in a Patient of COVID-19 Infection.

Coronavirus disease-2019 (COVID-19) has stood out as a disease of great medical interest, influencing disease evolution, and severity of diabetes mellitus. The intersection of COVID-19 infection and diabetes mellitus has unmasked inflammation and critical metabolic disturbances. We deliberate the case of a young woman, with type 2 diabetes mellitus, who was hospitalized for COVID-19 infection. Work-up revealed diabetic ketoacidosis (DKA) with lower-than-anticipated glucose levels, and acute metabolic acidosis. Refractoriness of metabolic acidosis to standard treatment required hemodialysis as a salvage therapy. How to cite this article: Vadi S, Bajpe S, Kulkarni N. Diabetic Ketoacidosis with Lower-than-anticipated Glucose Levels, and Recalcitrant Metabolic Acidosis Requiring Rescue Hemodialysis in a Patient of COVID-19 Infection. Indian J Crit Care Med 2022;26(6):752-754.

Authoring a periodic adverse drug experience report here's what you need to know!

Aggregate reporting involves preparation and submission of safety reports for a given medicinal product to worldwide regulatory agencies and constitutes an essential part of safety monitoring of a medicinal product. There are specific aggregate safety reports required for a molecule in development called development safety update reports while Periodic Adverse Drug Experience Reports (PADERs) and Periodic Safety Update Reports/Periodic Benefit-risk Evaluation Reports (PBRERs) are submitted for products with marketing authorization. Based on the periodic analysis of worldwide safety reports, product label is updated to optimize safe use of a medicinal product. PADERs are aggregate safety reports to be submitted to the Food and Drug Administration (FDA) for products approved for marketing in the United States (US). PADER submission starts once marketing authorization approval is received for a medicinal product by the sponsor. Quarterly and annual PADERs should be submitted within 30 and 60 days of data lock point, respectively. PADERs mainly involve presentation of case reports with serious unlisted events (15-day alert reports) in the form of narratives or in a tabular format. The present article focuses on the background, scope, structure of a PADER, and its submission timelines; lists differences between PADER and PBRER; and describes the knowledge, skills, and attitudes required for a PADER writer.

A day in the life of a pharmacovigilance case processor.

Pharmacovigilance (PV) has grown significantly in India in the last couple of decades. The etymological roots for the word "pharmacovigilance" are "Pharmakon" (Greek for drug) and "Vigilare" (Latin for to keep watch). It relies on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The PV data processing cycle starts with data collection in computerized systems followed by complete data entry which includes adverse event coding, drug coding, causality and expectedness assessment, narrative writing, quality control, and report submissions followed by data storage and maintenance. A case processor plays an important role in conducting these various tasks. The case processor should also manage drug safety information, possess updated knowledge about global drug safety regulations, summarize clinical safety data, participate in meetings, write narratives with medical input from a physician, report serious adverse events to the regulatory authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, and take on any other task as assigned by the manager or medical director within the capabilities of the drug safety associate. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

Audio-video recording of informed consent process: Boon or bane.

The Drugs Technical Advisory Board has recommended inclusion of audio-video (AV) recording of the informed consent process while conducting clinical trials in India. It is included as draft rule in the gazette of India notification dated 7(th) June 2013. This will soon become a law. There are many anticipated advantages of AV recording like reliability, transparency, and improvement in quality of conduct of informed consent process. However, at the same time the industry will need to address challenges in infrastructure, maintaining confidentiality, cost implication, and so on. AV recording will help reassure the government and community about standards maintained by the industry/institute while conducting informed consent process, thereby increasing society's faith in clinical research.