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.

Safety of Intravenous Iron Following Infusion Reactions.

BACKGROUND: Where an ongoing requirement for intravenous iron replacement exists after an index infusion reaction, current recommendations are limited to expert opinion and isolated case reports. OBJECTIVE: To evaluate the safety of recommencing an infusion or subsequent rechallenge following an infusion reaction to intravenous iron. METHODS: Infusion reactions to intravenous iron occurring between January 1, 2010, and December 31, 2019, at a metropolitan health network were identified. Patient characteristics, reaction type (mild, moderate, or severe hypersensitivity, delayed, or Fishbane: transient flushing and truncal myalgias), and outcomes of recommencing the index infusion or subsequent rechallenge were examined. RESULTS: Among 13,509 iron infusions, 195 infusion reactions occurred in 195 patients (1.4% of infusions). Recommencement of the index infusion (generally with a reduced infusion rate and premedication) was tolerated in 33 of 33 patients with Fishbane (20 of 20) or mild (9 of 9) and moderate (4 of 4) hypersensitivity reactions. Subsequent rechallenge (generally at standard infusion rates to an alternative formulation, ferric carboxymaltose) was successful in 68 of 69 patients with Fishbane (23 of 23), mild (26 of 26), moderate (16 of 17), and severe (3 of 3) hypersensitivity, or delayed (2 of 2) reactions. All 9 patients rechallenged to the original formulation (iron polymaltose) completed the infusion. CONCLUSIONS: Following an infusion reaction to intravenous iron infusion, recommencement of the index infusion is safe for Fishbane or mild and moderate hypersensitivity reactions. Subsequent rechallenge to an alternative formulation is tolerated, including in severe hypersensitivity reactions (albeit based on limited numbers). Where alternative formulations are not available, rechallenge to the same formulation could be considered, depending on the risk-benefit profile.

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.

Implementing a sustainable medication reconciliation process in Australian hospitals: The World Health Organization High 5s project.

BACKGROUND: Medication reconciliation (medrec) is a mandated patient safety strategy by national, including Australian, accreditation bodies. Yet there are no validated performance measures. OBJECTIVE: To determine the feasibility of implementing the World Health Organization (WHO) Medrec Standard Operating Protocol (SOP) in a range of Australian acute care facilities to achieve measurable and sustainable reductions in medication discrepancies occurring at admission. METHODS: A multicentre, prospective national study was conducted in ten academic, urban and regional hospitals to implement the SOP using WHO High 5s project and quality improvement methodology. Sites collected data on the rate of medrec performed within 24 h of admission in a random selection of 50 patients aged ≥65 years admitted via the emergency department, monthly for four years. Medrec quality was reviewed in a subset of 30 patients using three performance measures. Barriers, enablers and benefits of SOP implementation were collected using qualitative surveys. RESULTS: Ten health services reviewed 42,003 patient records. Of these, 20,162 (49.5%) had medicines reconciled within 24 h of admission. Four services increased, two decreased, and in four, medrec completion rates remained static. Mean number of unintentional and undocumented intentional medication discrepancies per patient decreased: 0.21 to 0.16 (p = 0.001) and 0.34 to 0.08 (p = 0.003), respectively. Unintentional discrepancies decreased from 15.2% to 11.1% (p = 0.001). Barriers to full implementation included: medrec not seen as a priority, limited resources and lack of electronic systems integration. Enablers included: use of medrec measures for feedback, educational resources, and 7-day week clinical pharmacy services. Benefits included improvements in medication safety culture and multidisciplinary teamwork. CONCLUSIONS: The WHO SOP was feasible, although challenging, to implement in a range of acute health services, and produced measureable and sustainable improvements in medicines information accuracy on admission. Sustaining the quantum of quality and timely medrec requires investment in pharmacist resources and electronic systems integration.

Upper airway involvement in Stevens-Johnson syndrome and toxic epidermal necrolysis.

BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare life-threatening hypersensitivity conditions associated with epidermal detachment and mucositis. The indication for flexible nasoendoscopy (FNE) and overall predictive factors for early intubation are unclear. OBJECTIVES: To describe the incidence of airway involvement and the key indicators for intubation in our SJS or TEN patient cohort. To determine the association between FNE findings and early intubation. METHODS: A retrospective review of 45 patients with biopsy proven SJS or TEN admitted to an Australian tertiary burns centre from 2010 to 2017. RESULTS: Thirty-five patients were diagnosed with TEN (77.8%), followed by overlap syndrome (SJS-TEN) (n = 6, 13.3%) and SJS (n = 4, 8.9%). Twenty (44.4%) patients were intubated; and all 20 had a diagnosis of TEN (100.0%) (p < 0.05). Intubated patients had a higher increase in total body surface area percentage(%) from day 1-3 [10.0% (IQR 0.0-23.8%)] and a longer length of stay [26.0 days (IQR 12.5-34.0)], compared to non-intubated patients [0.0% (IQR 0.0-4.0%)], [10.0 days (IQR 6.0-14.0)] (p < 0.05) respectively. The main indications for intubation were to facilitate operative and dressing management (47.4%) followed by airway involvement (26.3%). FNE was performed on 32 patients (71.1%), however FNE findings did not significantly influence intubation rates. CONCLUSION: More than half (n = 20, 57.1%) of the 35 patients diagnosed with TEN underwent intubation, mainly to facilitate operative and dressing management. FNE was performed on most patients, however there was no clear association between FNE findings and early intubation.

Medication-related anaphylaxis treated in hospital: Agents implicated, patient outcomes, and management lessons.

PURPOSE: On background of increasing medication-related anaphylaxis rates in Australia, our aim was to determine epidemiology, outcomes, adverse drug reaction (ADR) reporting rates, and accuracy of coding in patients treated for nonantimicrobial medication-related anaphylaxis in our hospital network. METHODS: From January 2010 to December 2015 patients treated in our hospital network for medication-related anaphylaxis were identified using International Classification of Diseases, 10th Edition diagnosis code T88.6. Cases were also extracted from the hospital ADR database. Medical records were reviewed to ensure consistent diagnosis and to extract clinical, documentation, and outcome data. RESULTS: Of 1110 patients coded as T88.6, 177 (15.9%) met the medication-related anaphylaxis definition. Eighty (40.8%) had anaphylaxis due to nonantimicrobial agents. Thirteen of these (16.3%) had a previous reaction to the same medication/group. In 51 (63.8%) patients, anaphylaxis occurred during inpatient stay, with 31 reactions occurring during surgery. Eighty-five medications were implicated, most commonly neuromuscular blocking agents (31, 36.5%) and nonsteroidal anti-inflammatory drugs. No trends were noted over the 6-year period, and there was no anaphylaxis-related mortality. Fifty-three (66.3%) patients were assessed in allergy clinics. One in 10 cases did not have the reaction documented in the discharge summary. Adverse drug reaction reports were received for 38 patients (47.5%). CONCLUSIONS: Although acute patient outcomes were excellent, gaps in practice were noted regarding ADR coding accuracy and reporting rates. One in 6 patients had a prior hypersensitivity reaction to a similar medication, so we recommend accurate documentation, ADR review with allergy follow-up, and patient held information to decrease re-exposure risk.

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.

Drug-induced liver injury is frequently associated with severe cutaneous adverse drug reactions: experience from two Australian tertiary hospitals.

BACKGROUND: Drug-induced liver injury (DILI) can be associated with certain cutaneous adverse drug reaction (cADR). AIMS: To demonstrate the prevalence of DILI in patients with cADRs. Severity and patterns of liver injury, risk factors, causal medications and outcomes are also examined. METHODS: A retrospective cohort study of patients with cADRs was conducted across two hospitals in Australia. Patients were identified through cross-linkage of multiple databases. RESULTS: One hundred and four patients with cADRs were identified. Of these, 33 (31.7%) had liver injury, representing 50% of patients with drug reaction with eosinophilia and systemic symptoms, and 30.2% of patients with Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). Most cases of liver injury (69.7%) were of a cholestatic/mixed pattern with severe disease in 18.2%. No significant risk factors for development of liver injury were noted, but peripheral lymphocytosis may represent a risk in patients with SJS (odds ratio, OR = 6.0, 95% confidence interval, CI: 1.8-19.7, P = 0.003). Antimicrobials were the most common class to be implicated in DILI. The median length of inpatient stay was longer in patients with liver injury compared to those without (19 vs 11 days, P = 0.002). The mortality rate in those with liver injury was 15.2% and 9.9% in those without. No patients required liver transplantation. CONCLUSIONS: DILI commonly occurs in patients with cADRs and is associated with longer inpatient stay. Patients with SJS/TEN and peripheral lymphocytosis appear to be at higher risk for developing associated liver injury.

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.

A Comparative Analysis Between Antibiotic- and Nonantibiotic-Associated Delayed Cutaneous Adverse Drug Reactions.

BACKGROUND: The difference in clinical presentation, causality assessments, and outcomes of patients with delayed antibiotic-associated cutaneous adverse drug reactions (AA-cADR) and nonantibiotic-associated (NA)-cADR is ill defined. OBJECTIVE: We examined the etiology of AA-cADR, with regard to the type of antibiotic exposure, allergy labeling, and patient outcomes, in comparison with NA-cADR. METHODS: A retrospective observational inpatient cohort study of cADR was performed from January 2004 to August 2014. Patients were divided into AA-cADR and NA-cADR groups for analysis. cADR was defined as erythema multiforme, fixed drug eruption, acute generalized erythematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS), drug-associated linear IgA disease, Stevens-Johnson syndrome, and toxic epidermal necrolysis. RESULTS: Of the 84 patients with cADR, 48% were AA-cADR. Male sex (60% vs 32%, P = .004), median length of stay (14.5 vs 11 days, P = .05), median Charlson comorbidity index (3 vs 1, P = .03), and inpatient mortality (20% vs 5%, P = .04) were higher in AA-cADR compared with NA-cADR. The median drug latency was lower in AA-cADR (6 vs 20 days, P = .001). Sulfonamide antibiotics and glycopeptides were implicated in 20% of AA-cADR. DRESS was more frequently reported in AA-cADR. After cADR diagnosis, further antibiotic therapy was administered in 64% of patients, higher in AA-cADR (75%, 30 of 40) compared with NA-cADR (55%, 24 of 44) (P = .06). Fluoroquinolones (53% vs 21%, P = .02), glycopeptides (vancomycin and teicoplanin; 70% vs 38%, P = .05), and carbapenems (33% vs 13%, P = .11) were used more commonly in AA-cADR. CONCLUSIONS: Antibiotics were the cause of cADR requiring hospital admission in 48% of episodes, and were associated with longer length of stay, higher age-adjusted Charlson comorbidity index, shorter drug latency, and mortality. In AA-cADR, glycopeptide and sulfonamide antibiotic exposure predominated.

Old but not forgotten: Antibiotic allergies in General Medicine (the AGM Study).

OBJECTIVES: To determine the nature, prevalence and description accuracy of recorded antibiotic allergy labels (AALs) in a cohort of general medical inpatients, and to assess the feasibility of an oral antibiotic re-challenge study. DESIGN: Multicentre cross-sectional study. SETTING AND PARTICIPANTS: All patients admitted to the general medical units of Austin Health and Alfred Health, 18 May - 5 June 2015. MAIN OUTCOME MEASURES: Baseline demographics, medical and allergy history, infection diagnoses and antibiotic prescribing data for general medical inpatients were collected. A questionnaire was administered to clarify AAL history, followed by correlation of responses with electronic and admissions record descriptions. A hypothetical oral re-challenge in a supervised setting was offered to patients with low risk allergy phenotypes (non-immediate reaction, non-severe cutaneous adverse reaction, or unknown reaction more than 10 years ago). RESULTS: Of the 453 inpatients, 107 (24%) had an AAL (median age, 82 years; interquartile range, 74-87 years); 160 individual AALs were recorded, and there was a mismatch in AAL description between recording platforms in 25% of cases. Most patients with an AAL were women (64%; P < 0.001), and more presented with concurrent immunosuppression than those without an AAL (23% v 8%; P < 0.001). ß-Lactam penicillins were employed less frequently in patients with an AAL (16% v 35%; P = 0.02), while ceftriaxone (32% v 20%; P = 0.02) and fluoroquinolones (6% v 2%; P = 0.04) were used more often. Fifty-four per cent of patients with AALs were willing to undergo oral re-challenge, of whom 48% had a low risk allergy phenotype. CONCLUSIONS: AAL prevalence in general medical inpatients was 24%, and was associated with excessive use of broad spectrum antibiotics. Allergies in a large proportion of patients with AALs were incorrectly documented, and were non-immune-mediated and potentially amenable to oral re-challenge. A direct oral re-challenge study in carefully selected patients with low risk allergy phenotypes appears feasible.

Recommendations and Low-Technology Safety Solutions Following Neuromuscular Blocking Agent Incidents.

BACKGROUND: Neuromuscular blocking agents (NMBs) are high-risk medications used to facilitate endotracheal intubation and artificial ventilation. In an incident at a metropolitan tertiary referral and teaching public hospital in Australia, a neurosurgical patient became unresponsive at the start of surgery. It was determined that cisatracurium was administered in error in place of midazolam; the patient was ventilated and the emergency surgery continued. Two additional non-operating room (OR) drug-swap cases involving cisatracurium were reported within 12 months of this event, resulting in a comprehensive review of NMB safety. METHODS: A root cause analysis (RCA) resulted in multiple interventions to decrease the risk of selection and administration errors: (1) review of NMB packaging and introduction of in-house NMB labeling by pharmacy procurement staff before distribution; (2) implementation of a medication administration in anesthetics guideline with ongoing education; (3) audit of storage with removal of NMBs; (4) review of new products by medication safety pharmacists and a senior anesthetist before distribution; and (5) use of red-barrel syringes for administering NMBs was expanded to all areas using NMBs to minimize syringe-swap incidents. RESULTS: In the four years since full implementation of interventions, there have been no reports of cisatracurum selection errors. An incident of atracurium administration resulted in further recommendations for review of OR cart storage. Ongoing monitoring via medication safety walkrounds, by OR staff, by the perioperative pharmacist, and through the hospital's medication incident monitoring system has not detected any further NMB incidents. CONCLUSIONS: Technological solutions have been shown to decrease the risk of NMB errors, yet multifaceted low-technology solutions may be an effective, cheaper alternative.

Medication Safety: Experiential Learning for Pharmacy Students and Staff in a Hospital Setting.

Medication Safety has been an established pharmacy specialty in Australian hospitals since the early 2000s and is now one of the ten Australian hospital accreditation standards. Although advances have occurred, medication-related patient harm has not been eradicated. Victorian undergraduate pharmacy programs include some aspects of medication safety, however clinical pharmacy experience, along with interpersonal and project management skills, are required to prepare pharmacists to be confident medication safety practitioners. This article outlines the range of medication safety-related training offered at an Australian tertiary teaching hospital, including; on-site tutorial for undergraduate students, experiential placement for pharmacy interns, orientation for pharmacy staff and resources for credentialing pharmacists for extended roles. Improvements continue to be made, such as electronic medication management systems, which increase the safe use of medications and facilitate patient care. Implementation and evaluation of these systems require medication safety expertise. Patients' engaging in their own care is an acknowledged safety improvement strategy and is enhanced by pharmacist facilitation. Building educator skills and integrating experiential teaching with university curricula should ensure pharmacists have both the knowledge and experience early in their careers, in order to have a leading role in future medication management.

Probable fenofibrate-induced acute generalized exanthematous pustulosis.

PURPOSE: The case of a patient who experienced a severe adverse reaction requiring emergency treatment after a single dose of fenofibrate is described. SUMMARY: A 58-year-old woman with type 1 diabetes was hospitalized for treatment of an extensive blistering rash on the buttocks and trunk accompanied by fever, hypotension, tachycardia, neutrophilia, impaired renal function, and liver enzyme abnormalities. She reported that two days previously she had developed fever and vomiting four hours after taking her first dose of fenofibrate (145 mg). The patient required vasopressor support and was initially treated with broad-spectrum antibiotics for 3 days and a course of immune globulin. On hospital day 4, histopathology returned results consistent with acute generalized exanthematous pustulosis (AGEP), and the patient was subsequently treated with topical steroids. Gradual resolution of AGEP was noted at the time of her discharge from the hospital on day 7 and at one-week follow-up. Analysis of the case using the adverse drug reaction probability scale of Naranjo et al. yielded a score of 5, indicating a probable association between fenofibrate use and AGEP development. AGEP is a predominantly drug-induced condition but is not typically associated with fenofibrate use. Cutaneous eruptions in AGEP are often accompanied by systemic symptoms (e.g., fever, leukocytosis), and the disorder can also be associated with impaired creatinine clearance and elevated aminotransaminase levels. CONCLUSION: A woman with type 1 diabetes developed AGEP after taking a single dose of fenofibrate. Her cutaneous symptoms began to resolve within days of discontinuation of fenofibrate use.

Multicentre study to develop a medication safety package for decreasing inpatient harm from omission of time-critical medications.

QUALITY ISSUE: Omitting time-critical medications leads to delays in treatment and may result in patient harm. INITIAL ASSESSMENT: Published studies show that omission of prescribed medication doses is common. Although most are inconsequential, up to 86% of omitted medications place patients at some risk of harm. SOLUTION: Funding was obtained to develop a medication safety package to facilitate decreasing omitted dose incidents by audit, education and feedback. IMPLEMENTATION: A panel of nursing and pharmacy hospital staff in Victoria, Australia, reviewed existing audit tools and published studies to develop a critical medication list and audit tool. The tool, definitions and instructions were tested in 11 rural, urban and teaching hospitals. Qualitative feedback was sought to refine the tool using a Plan-Do-Study-Act model. An educational presentation was developed using reported incidents. EVALUATION: Staff in 11 hospitals tested the audit tool in 321 patients receiving 17 361 doses of medication. Feedback indicated audit data were useful for informing improvements in practice and for accreditation. The educational material consists of the User Guide, plus a presentation for nursing staff illustrated by six cases with questions, with instructions on how to decrease harm from omitted doses by ensuring correct documentation and prioritising time-critical medications. LESSONS LEARNED: A medication safety package using standard definitions and a critical medication list was successfully tested. It is now used by nursing and pharmacy staff across the state. Several interstate hospitals are using the tools as part of their hospital medication safety programmes.

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.