Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus.

PURPOSE: Adverse drug reactions (ADRs) contribute significantly to healthcare burden. However, they are largely preventable through appropriate management processes. This narrative review aims to identify the quality indicators that should be considered for routine monitoring of processes within hospital ADR management systems. It also examines the potential reasons behind variation in ADR management practices amongst HCPs, and explores possible solutions, focusing on targeted education programmes, to improve both the quality and quantity indicators of ADR management processes. METHODS: A comprehensive literature review was conducted to explore relevant themes and topics concerning ADR management, quality indicators and educational interventions. RESULTS: Substantial variability exists in ADR management amongst healthcare professionals (HCPs) with regard to reporting rates, characteristics of ADRs reported, quality of assessment, completeness of reports and, most importantly, risk communication practices. These variable practices not only threaten patient safety but also undermine pharmacovigilance processes. To date, quality indicators to monitor ADR management practices within hospital settings remain ill-defined. Furthermore, evidence behind effective interventions, especially in the form of targeted education strategies, to improve the quality of ADR management remains limited. CONCLUSIONS: The focus of ADR management in hospitals should be to promote patient safety through comprehensive assessment, risk communication and safe prescribing. There is a need to develop a system to define, measure and monitor the quality of ADR management. Educational strategies may help improve the quality of ADR management processes.

A Survey on Knowledge Gaps in Assessment and Management of Severe Drug Hypersensitivity Reactions: Multicenter Cross-Sectional Study of Australian Health Care Providers.

Severe drug hypersensitivity reactions (DHRs) are often encountered by health care professionals (HCPs). We evaluated knowledge of doctors and pharmacists in the assessment and management of severe DHRs using a structured questionnaire. A cross-sectional study was conducted in 4 metropolitan hospital networks in Melbourne, Australia. A 13-question, scenario-based multiple-choice questionnaire to assess specific knowledge domains in drug hypersensitivity syndrome recognition, causality attribution, cross-reactivity patterns, appropriate diagnostic tests, and therapy was administered to HCPs of various vocation and specialty groups. Data were analyzed according to profession, self-reported experience, and preparedness in managing severe DHRs. Two hundred thirty-eight participants (45.0% senior doctors, 24.4% junior doctors, and 30.7% pharmacists) across a range of subspecialties achieved an overall median score of 7 (IQR, 5-8)-overall 55.6% correct responses to all questions-with senior doctors outperforming junior doctors and pharmacists (P < .001). The best performance by all participants was in DHR syndrome recognition (60.9%), and the poorest was in diagnostics/therapy (52.0%). HCP group and experience level were significantly associated with better performance in the knowledge domains of cross-reactivity and diagnostics/therapy (P = .003 and < .001, respectively), but not in the domains of syndrome recognition and causality attribution (P > .05). Levels of self-reported preparedness in DHR management were not associated with performance rates in any of the knowledge domains. This study demonstrated significant knowledge gaps in the recognition and management of severe drug hypersensitivity reactions. Targeted multidisciplinary education of staff caring for these patients is needed to improve knowledge gaps.

Adverse Drug Reactions Reported by Healthcare Professionals: Reaction Characteristics and Time to Reporting.

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.

More than skin deep. Ten year follow-up of delayed cutaneous adverse drug reactions (CADR).

AIMS: To determine the gaps in practice regarding appropriate ADR documentation and risk communication for patients diagnosed with severe cutaneous adverse drug reactions (CADR). METHODS: This was a retrospective observational cohort study conducted using hospital coding and databases to identify inpatients diagnosed with CADR from January 2004 to August 2014. Hospital discharge summaries, ADR reports and pharmacy dispensing records were reviewed for ADR documentation. Patients still living in Australia and who did not opt out of being contacted were invited to be surveyed by telephone to determine their understanding of recommendations, re-exposure rates and long-term effects. RESULTS: Of 85 patients identified, median age was 59 (IQR 44-72) years and 47.1% were male. The most common diagnosis was TENS (49.4%). Ten patients (11.8%) died as inpatients. Of the 81 patients with a drug-related causality, 47 (58%) had appropriate documentation in all three required medical record platforms. Of the 56 eligible patients, 38 (67.9%) were surveyed; 13% had no information provided upon discharge and 26.3% patients had a mismatch in knowledge of implicated medications. No surveyed patient had a relapse of CADR, but 23.7% had a subsequent unrelated allergic reaction. Thirteen patients (34.2%) reported long-term effects. CONCLUSIONS: We found gaps in the accuracy of ADR documentation and communication of risk at discharge, which indicated risks to patient safety. Electronic systems are being developed to improve documentation. Written information about CADR is being provided at discharge to improve patient understanding and knowledge.

Long-term reduction in adverse drug events: an evidence-based improvement model.

OBJECTIVES: To develop and test an evidence-based model for reducing medication errors and harm in hospitalized children. METHODS: Prospective interrupted time series study evaluating the effectiveness of a multifaceted, staged intervention over 4 years in a major urban pediatric referral hospital. Guidelines for safe pediatric prescribing were implemented by using an evidence-based model. Key components included early clinician engagement and improved multidisciplinary communication, consensus development, interactive education, and timely data feedback by using iterative Plan-Do-Study-Act cycles. Impact on medication error and harm (adverse drug events, [ADEs]) was measured by using standard definitions and a multimethod approach. Prospective data from voluntary reports by nursing, medical, and pharmacy staff and intensive chart review were combined. All data were reviewed by a multidisciplinary panel, including causality assessments for ADEs. RESULTS: Reviewed over 3 time periods were 1011 patients with 6651 medication orders. Total ADEs decreased by > 50% in the first year and this was maintained at 4 years. Greatest improvements were in potential ADEs, which decreased from 12.26 per 100 patients at baseline to 4.60 per 100 patients at 4 years (P < .05). Total medication errors decreased from 4.51 per 100 orders at baseline to 2.78 per 100 orders at 4 years (P < .05). Prescribing errors decreased by 65%, from 4.07 per 100 orders at baseline to 2.05 orders at 4 years (P < .05). CONCLUSIONS: A multifaceted, evidence-based model for safe prescribing guideline implementation, engaging multidisciplinary clinicians, was effective in reducing medication error and harm in hospitalized children, resulting in sustained long-term improvement.