Managing Adverse Effects and Drug Intolerance
Giuseppe Mancia, Guido Grassi, Konstantinos P. Tsioufis, Anna F. Dominiczak, Enrico Agabiti Rosei in Manual of Hypertension of the European Society of Hypertension, 2019
According to the World Health Organization (WHO) (14) and the European Medicines Agency (15,16) adverse effects can be classified (Figure 44.1) as: (i) adverse event, (ii) adverse drug reaction or (iii) unexpected adverse drug reaction. Adverse events are defined as a ‘medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related’, like an abnormal laboratory finding, a symptom or a disease (17–19). An adverse drug reaction is a harmful, unintended reaction to medicines which occurs at doses normally used for treatment (14,15,20). The unexpected adverse drug reaction – common or less common – is one which is not consistent, as described in the available summary of product characteristics of the drug (15). Overlapping and fused borders is a quite common case between all the aforementioned terms.
Regulation of Nutraceuticals and Functional Foods
Robert E.C. Wildman, Richard S. Bruno in Handbook of Nutraceuticals and Functional Foods, 2019
An adverse event is any health-related event associated with the use of a dietary supplement that is adverse. A serious adverse event is an adverse event which (A) results in (i) death, (ii) a life-threatening experience, (iii) inpatient hospitalization, (iv) a persistent or significant disability or incapacity, or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A). Once it is determined that a serious adverse event has occurred, the manufacturer, packer, or distributor (responsible person) of a dietary supplement whose name appears on the label of the supplement shall submit to the Secretary of Health and Human Services any report received of the serious adverse event accompanied by a copy of the label on or within the retail packaging of the dietary supplement. The responsible person has 15 business days to submit the report to the FDA after being notified of the serious adverse event. Following the initial report, the responsible person must submit follow-up reports of new medical information that they receive for 1 year.
Seronegative arthropathies
Rajan Madhok, Hilary Capell in The Year in Rheumatic Disorders Volume 4, 2004
INTERPRETATION. Sixteen patients with PsA that exhibited ongoing disease activity (>5 swollen and tender joints, erythrocyte sedimentation rate >25 mm/h, visual analogue score >25 mm) despite at least 6 months' MTX therapy were given infliximab in a multicentre, open-label pilot study. Three patients also exhibited axial disease. Psoriasis was confirmed by a dermatology investigator. Infliximab was administered at 0, 2, 6,14, 22 and 30 weeks in combination with MTX. At week 14 ACR20, ACR50 and ACR70 responses were observed in nine of 16, seven of 16 and seven of 16 patients respectively. By week 30 ACR20, ACR50 and ACR70 responses were observed in nine of 16, eight of 16 and eight of 16 patients, respectively. No withdrawals resulted from efficacy failure. Adverse events were observed in four of 16 patients. Severe infusion reactions led to withdrawal of two patients. No severe infections occurred.
Barriers to Self-Reporting Patient Safety Incidents by Paramedics: A Mixed Methods Study
Published in Prehospital Emergency Care, 2018
Julie E. Sinclair, Michael A. Austin, Christopher Bourque, Jennifer Kortko, Justin Maloney, Richard Dionne, Andrew Reed, Penny Price, Lisa A. Calder
PSIs in this study included patient care variances, near misses and adverse events. A patient care variance (PCV) is a deviation from the Advanced Life Support Patient Care Standards (ALS PCS). The ALS PCS reflects the current practices for paramedics in Ontario, Canada, and provides benchmarks for paramedic performance (18). A near miss is an incident that did not reach the patient and therefore no harm resulted (6). An adverse event is an event that results in unintended harm to the patient and is related to the care provided to the patient, rather than the patient's underlying medical condition (19). The objective of this study was to identify the barriers to self-reporting of PSIs by paramedics. This study also explored recommendations to improve PSI reporting as perceived by front-line paramedics. We sought to answer the following questions: What are the barriers identified by paramedics to self-reporting PSIs?What proportion of paramedics currently self-report PSIs?Does the level of training (advanced care paramedic vs. primary care paramedic) affect the intention to self-report a PSI?What could be done to improve paramedic self-reporting of PSIs?
Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study
Published in Current Medical Research and Opinion, 2022
Brenda M. Y. Leung, Priya Srikanth, Barbara Gracious, Irene E. Hatsu, Gabriella Tost, Valerie Conrad, Jeanette M. Johnstone, L. Eugene Arnold
An additional measure was the Pediatric Adverse Event Rating Scale (PAERS), which was required by the United States (US) Food and Drug Administration (FDA) to provide systematic monitoring of possible adverse reactions to the intervention. An adverse event is any unintended negative event after a medication has been administered correctly, in contrast to a side effect, which is a foreseeable unwanted effect7. The PAERS was developed to systematically measure adverse events in pediatric clinical trials. It has been used to evaluate child-reported tolerability8, assess perceived tolerability from different perspectives (patient, parent, physician)9, and characterize psychotropic medication-related AEs in very young children10. Few studies have reported results of the PAERS as a key measure of interest.
Concurrent versus terminal feedback: The effect of feedback delivery on lumbar puncture skills in simulation training
Published in Medical Teacher, 2023
Anna Liu, Melissa Duffy, Sandy Tse, Marc Zucker, Hugh McMillan, Patrick Weldon, Julie Quet, Michelle Long
Adverse events in healthcare are commonly related to surgical and medical procedures (Baker et al. 2004; Matlow et al. 2012). Of these, a major determinant of procedural outcomes is individual skill (Leape et al. 1991). Simulation-based medical education (SBME) is widely used to teach a variety of procedural skills and has the potential to reduce adverse events by allowing students to first practice skills on simulators and correct performance errors (Issenberg et al. 2005; Ma et al. 2011). A crucial component to the efficacy of SBME is feedback: non-judgmental, specific, and useful information provided to learners to improve future performance on a procedural task (Issenberg et al. 2005; McGaghie et al. 2010; Castro et al. 2021). However, there are knowledge gaps in how to optimize feedback delivery to maximize procedural skill acquisition, particularly in relation to timing of feedback (Hatala et al. 2014; Sattelmayer et al. 2016). The effect of timing of delivery of feedback during procedural skill training has been previously studied, comparing concurrent feedback, which the learner receives during the performance of the task, with terminal feedback, which is received only after the procedure is completed (Hatala et al. 2014; Sattelmayer et al. 2016).
Related Knowledge Centers
- Adverse Drug Reaction
- Adverse Effect
- Clinical Trial
- Complication
- Serious Adverse Event
- Good Clinical Practice
- Data Monitoring Committee
- Vaccine Adverse Event
- Adverse Outcome Pathway
- Antibody-Dependent Enhancement