| Literature DB >> 29733431 |
Ar Kar Aung1,2,3, Mei Jie Tang1,4, Nikki Rae Adler3, Sara Lee de Menezes3, Michelle Sue Yen Goh5, Hui Wen Tee1, Jason Anthony Trubiano6,7, Robert Puy8, Celia Mary Zubrinich8, Linda Velta Graudins9,10.
Abstract
We describe adverse drug reaction (ADR) reporting characteristics and factors contributing to length of time to report by healthcare professionals. This is a retrospective study of voluntary reports to an Australian healthcare ADR Review Committee over a 2-year period (2015-2016). Descriptive and univariate models were used for outcomes, employing standardized ADR definitions. Hospital pharmacists reported 84.8% of the 555 ADRs: 70.3% were hospital onset reactions, and 71.7% were at least of moderate severity. Immunologically mediated reactions were most commonly reported (409, 73.7%). The median time to submit an ADR report was 3 (interquartile range 1-10) days. Longer median times to reporting were associated with multiple implicated agents and delayed hypersensitivity reactions, especially severe cutaneous adverse reactions. A total of 650 medications were implicated that involved multiple agents in 165/555 (29.7%) reports. Antimicrobials were the most commonly implicated agents. Immunologically mediated reactions were most commonly associated with antimicrobials and radiocontrast agents (P < .0001, odds ratio [OR] 3.6, 95%CI 2.4-5.5, and P = .04, OR 4.2, 95%CI 1.2-18.2, respectively). Opioids and psychoactive medications were more commonly implicated in nonimmunological reported ADRs (P = .0002, OR 3.9, 95%CI 1.9-7.9, and P < .0001, OR 11.4, 95%CI 4.6-27.8, respectively). Due to the predominant reporting of immunologically mediated reactions, a targeted education program is being planned to improve identification and accuracy of ADR reports, with the overall aim of improved management to ensure quality service provision and patient safety.Entities:
Keywords: Adverse drug reactions; hypersensitivity; medication safety; pharmacoepidemiology; pharmacovigilance
Mesh:
Year: 2018 PMID: 29733431 DOI: 10.1002/jcph.1148
Source DB: PubMed Journal: J Clin Pharmacol ISSN: 0091-2700 Impact factor: 3.126