Development and application of Adverse drug reactions reports QUality Algorithm (AQUA-12) score: a single-centre quality improvement initiative.

PURPOSE: To develop a reliable assessment tool to monitor the quality of adverse drug reaction (ADR) reports and evaluate its performance within a quaternary hospital setting. METHODS: Adverse drug reactions report QUality Algorithm (AQUA-12) was developed by a multidisciplinary team with the expertise in the management of ADRs. The design was based on data elements required to establish medication causality. Inter-rater reliability of AQUA-12 was evaluated over three rounds in two phases: development and prospective evaluation phases, by independent assessors both internal and external to the institutional ADR review processes. The characteristics and quality of ADR reports were subsequently assessed, and potential factors contributing to low-quality reports were identified. RESULTS: A total of 70 ADR reports were assessed, 20 in development and 50 in evaluation phases. The inter-rater reliability of AQUA-12 was found to be excellent in all three rounds (Cronbach's alpha of  ≥ 0.9, p < 0.001 for all). Approximately one in five reports concerned immediate hypersensitivity reactions while delayed hypersensitivity reactions constituted 60% of all reactions. AQUA-12 identified 18 (25.7%) reports as 'low-quality' with a score of  < 10. Identification of suspected medications (37.1%), description of index ADR (27.1%), and key events (ADR narrative, 35.7%) were the top data elements incomplete or missing from all reports. Univariable analyses identified the severity of the reaction as a factor associated with low quality of reports (p = 0.008). CONCLUSIONS: AQUA-12 is a practical and highly reliable assessment tool that can be utilised in hospital settings to regularly monitor the completeness of ADR reports to guide quality improvement initiatives.

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.

Hospitalisation with injection-related infections: Validation of diagnostic codes to monitor admission trends at a tertiary care hospital in Melbourne, Australia.

INTRODUCTION: Injection-related infections (IRI) cause morbidity and mortality in people who inject drugs. Hospital administrative datasets can be used to describe hospitalisation trends, but there are no validated algorithms to identify injecting drug use and IRIs. We aimed to validate International Classification of Diseases (ICD) codes to identify admissions with IRIs and use these codes to describe IRIs within our hospital. METHODS: We developed a candidate set of ICD codes to identify current injecting drug use and IRI and extracted admissions satisfying both criteria. We then used manual chart review data from 1 January 2017 to 30 April 2019 to evaluate the performance of these codes and refine our algorithm by selecting codes with a high-positive predictive value (PPV). We used the refined algorithm to describe trends and outcomes of people who inject drugs with an IRI at Alfred Hospital, Melbourne from 2008 to 2020. RESULTS: Current injecting drug use was best predicted by opioid-related disorders (F11), 80% (95% confidence interval [CI] 74-85%), and other stimulant-related disorders (F15), 82% (95% CI 70-90%). All PPVs were ≥67% to identify specific IRIs, and ≥84% for identifying any IRI. Using these codes over 12 years, IRIs increased from 138 to 249 per 100 000 admissions, and skin and soft tissues infections (SSTI) were the most common (797/1751, 46%). DISCUSSION AND CONCLUSION: Validated ICD-based algorithms can inform passive surveillance systems. Strategies to reduce hospitalisation with IRIs should be supported by early intervention and prevention, particularly for SSTIs which may represent delayed access to care.

Acute injection-related infections requiring hospitalisation among people who inject drugs: Clinical features, microbiology and management.

INTRODUCTION: People who inject drugs are at risk of hospitalisation with injection-related infections (IRI). We audited the clinical features, microbiology and management of IRI at a tertiary service in Melbourne to describe the burden and identify quality improvement opportunities. METHODS: We performed retrospective review of IRI admissions from January 2017 to April 2019. We extracted admissions where ICD-10 codes or triage text suggested injecting drug use, and the diagnosis suggested IRI. We reviewed these for eligibility and extracted data using a standardised form. We performed mixed-effects logistic regression to determine predictors of unplanned discharge. RESULTS: From 574 extracted candidate admissions, 226 were eligible, representing 178 patients. Median age was 41 years (interquartile range 36-47), 66% (117/178) male and 49% (111/226) had unstable housing. Over 50% (96/178) had a psychiatric diagnosis and 35% (62/178) were on opioid agonist therapy (OAT) on admission. Skin and soft tissue infection was the most common IRI (119/205, 58%), followed by bacteraemia (36/205, 18%) and endocarditis (26/205, 13%). Management included addictions review (143/226, 63%), blood-borne virus screening (115/226, 51%), surgery (77/226, 34%) and OAT commencement (68/226, 30%). Aggression events (54/226, 15%) and unplanned discharge (69/226, 30%) complicated some admissions. Opioid use without OAT was associated with almost 3-fold increased odds of unplanned discharge compared to no opioid use (odds ratio 2.90, 95% confidence interval 1.23, 6.85, p = 0.015). DISCUSSION AND CONCLUSION: Comorbidities associated with IRI may be amenable to opportunistic intervention during hospitalisation. Further research is needed to develop optimal models of care for this vulnerable patient group.

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.