A Tool for Evaluating Medication Alerting Systems: Development and Initial Assessment.

BACKGROUND: It is well known that recommendations from electronic medication alerts are seldom accepted or acted on by users. Key factors affecting the effectiveness of medication alerts include system usability and alert design. Thus, human factors principles that apply knowledge of human capabilities and limitations are increasingly used in the design of health technology to improve the usability of systems. OBJECTIVE: This study aims to evaluate a newly developed evidence-based self-assessment tool that allows the valid and reliable evaluation of computerized medication alerting systems. This tool was developed to be used by hospital staff with detailed knowledge of their hospital's computerized provider order entry system and alerts to identify and address potential system deficiencies. In this initial assessment, we aim to determine whether the items in the tool can measure compliance of medication alerting systems with human factors principles of design, the tool can be consistently used by multiple users to assess the same system, and the items are easy to understand and perceived to be useful for assessing medication alerting systems. METHODS: The Tool for Evaluating Medication Alerting Systems (TEMAS) was developed based on human factors design principles and consisted of 66 items. In total, 18 staff members recruited across 6 hospitals used the TEMAS to assess their medication alerting systems. Data collected from participant assessments were used to evaluate the validity, reliability, and usability of the TEMAS. Validity was assessed by comparing the results of the TEMAS with those of prior in-house evaluations. Reliability was measured using Krippendorff α to determine agreement among assessors. A 7-item survey was used to determine usability. RESULTS: The participants reported mostly negative (n=8) and neutral (n=7) perceptions of alerts in their medication alerting system. However, the validity of the TEMAS could not be directly tested, as participants were unaware of any results from prior in-house evaluations. The reliability of the TEMAS, as measured by Krippendorff α, was low to moderate (range 0.26-0.46); however, participant feedback suggests that individuals' knowledge of the system varied according to their professional background. In terms of usability, 61% (11/18) of participants reported that the TEMAS items were generally easy to understand; however, participants suggested the revision of 22 items to improve clarity. CONCLUSIONS: This initial assessment of the TEMAS allowed the identification of its components that required modification to improve usability and usefulness. It also revealed that for the TEMAS to be effective in facilitating a comprehensive assessment of a medication alerting system, it should be completed by a multidisciplinary team of hospital staff from both clinical and technical backgrounds to maximize their knowledge of systems.

Predictors of Mortality in the Older Population: The Role of Polypharmacy and Other Medication and Chronic Disease-Related Factors.

BACKGROUND: Polypharmacy has been associated with increased mortality but the contribution of different medication-related factors to this is unknown. AIMS: The aim of this study was to identify demographic and medication-related predictors of mortality in the older population. Given the intrinsic link between polypharmacy and multimorbidity, the secondary aim was to examine if the medicines or underlying diseases predicted mortality. METHODS: Patients aged ≥ 65 years from an outpatient multimorbidity clinic were included. Medication-related factors included the medicines count, high-risk medicines, inappropriate medicines duplication, and potential drug-drug and drug-disease interactions. Logistic regression was used to identify mortality predictors within a year of clinic discharge from the outpatient clinic. Patients attend the clinic until medications and comorbidity management have been optimised, at which point they are discharged from the clinic, and their General Practitioner provides ongoing care. RESULTS: A total of 584 patients were included (median age 80.0 years) and 9.9% (n = 58) died within a year of discharge. Demographics, namely age (adjusted odds ratio [aOR] 1.05; 95% CI 1.01-1.09; p = 0.018) and being male (aOR 5.10; 95% CI 2.63-9.88; p < 0.001); chronic disease, namely heart failure (aOR 3.36; 95% CI 1.78-6.35; p < 0.001); and medication-related factors, namely the number of sedative and anticholinergic medicines (aOR 1.66; 95% CI 1.19-2.33; p = 0.003) predicted mortality in the study population. CONCLUSION: Whilst polypharmacy has been defined using the number of medicines in the literature, a combination of demographics, chronic disease and medications predicted mortality in our study. This provides guidance for the development of future tools and guidelines regarding the inclusion of key factors for identifying high-risk patients at risk of adverse health outcomes such as mortality.

Comprehensive geriatric assessment predicts azacitidine treatment duration and survival in older patients with myelodysplastic syndromes.

BACKGROUND: Treatment of older patients with myelodysplastic syndrome (MDS) is based on disease biology and performance status. Performance status, however, does not reflect increasing co-morbidities, functional dependence or psychosocial issues in older patients. PATIENTS AND METHODS: This prospective study evaluated the burden of geriatric related health issues, assessed feasibility of "tailored" Comprehensive Geriatric Assessment (CGA), and compared treatment duration and survival in older patients with MDS and oligoblastic acute myeloid leukemia with and without deficits in CGA domains (n = 98). RESULTS: Although only 27 (28%) patients had an Eastern Cooperative Oncology Group score ≥2, 78% (n = 77) patients had deficits in at least one CGA domain. Deficits were spread across all CGA domains, including dependence for instrumental activity of daily living (iADL; n = 33, 34%). Importantly, patients who were dependent for iADL (3.7 ±â€¯2.6 vs 12.1 ±â€¯7.9; p = .009), had cognitive impairment (3.5 ±â€¯2.1 vs. 10.9 ±â€¯7.9; p = .034) or impaired mobility (3.8 ±â€¯2.5 vs. 13.2 ±â€¯7.6; p = .001) completed significantly less azacitidine cycles as compared to those without these deficits. Cox-proportional regression showed that iADL dependency (hazard ratio 3.37; p = .008) and higher comorbidities (hazard ratio 4.7; p < .001) were associated with poor prognosis independent of disease related factors. Poor survival of iADL dependent patients was seen in both azacitidine (6 vs 19 months; p < .001) and supportive care cohorts (26 vs 48 months; p = .01). CONCLUSION: CGA detected geriatric related health issues, predicted poor survival and identified patients less likely to continue and benefit from azacitidine. Hence, CGA should be included in the treatment decision algorithm of older patients with MDS.

Development and Implementation of a Nurse-Led Model of Care Coordination to Provide Health-Sector Continuity of Care for People With Multimorbidity: Protocol for a Mixed Methods Study.

BACKGROUND: Innovative strategies are required to reduce care fragmentation for people with multimorbidity. Coordinated models of health care delivery need to be adopted to deliver consumer-centered continuity of care. Nurse-led services have emerged over the past 20 years as evidence-based structured models of care delivery, providing a range of positive and coordinated health care outcomes. Although nurse-led services are effective in a range of clinical settings, strategies to improve continuity of care across the secondary and primary health care sectors for people with multimorbidity have not been examined. OBJECTIVE: To implement a nurse-led model of care coordination from a multidisciplinary outpatient setting and provide continuity of care between the secondary and primary health care sectors for people with multimorbidity. METHODS: This action research mixed methods study will have two phases. Phase 1 includes a systematic review, stakeholder forums, and validation workshop to collaboratively develop a model of care for a nurse-led care coordination service. Phase 2, through a series of iterative action research cycles, will implement a nurse-led model of care coordination in a multidisciplinary outpatient setting. Three to five iterative action research cycles will allow the model to be refined and further developed with multiple data collection points throughout. RESULTS: Pilot implementation of the model of care coordination commenced in October 2018. Formal study recruitment commenced in May 2019 and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by March 2020. CONCLUSIONS: Nursing, clinician, and patient outcomes and experiences with the nurse-led model of care coordination will provide a template to improve continuity of care between the secondary and primary health care systems. The model template may provide a future pathway for implementation of nurse-led services both nationally and internationally. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15006.

Use of non-formulary high-cost medicines in an Australian public hospital.

Background Clinicians prescribe high-cost medicines for rare diseases and nonapproved indications when conventional therapies have failed. Objective To examine the use of non-formulary high-cost medicines at an Australian public hospital. Methods Retrospective audit of individual patient use applications for nonformulary medicines costing more than $5000 AUD per year at a large tertiary referral hospital in Adelaide, South Australia over a 12-month study period from January 2015 to December 2015. Main outcome measures Total cost of non-formulary high-cost medicines, medication class, indications for use, level of supporting evidence and proposed monitoring outcomes. Results Eighty-seven individual patient use applications were examined. All except one were approved, at a total cost of $1,339,203 AUD. The most common drug classes were anti-CD20 (n = 33, 38%), combined antiretrovirals (n = 10, 11%) and TNF-alpha antagonists (n = 10, 11%). There were 56 indications for these medicines with the majority being inflammatory conditions (n = 52, 60%), followed by infections (n = 14, 16%) and malignancies (n = 14, 16%). Of the first-time individual patient use applications (n = 63), there were 25 applications (40%) that provided a case series as supporting evidence. Approximately half of new individual patient use applications (n = 32) proposed an objective monitoring outcome, but few (n = 13, 21%) contained sufficient information to allow a third party to determine efficacy of the medication. Conclusions Non-formulary high-cost medicines are being used for a broad range of indications based largely on low levels of evidence. Prospective definition of an adequate response to treatment and reporting of these outcomes is required to improve the evidence-base and to aid decision-making for subsequent treatment courses.

Tools for Assessment of the Appropriateness of Prescribing and Association with Patient-Related Outcomes: A Systematic Review.

BACKGROUND: There are tools and criteria in the literature aimed at distinguishing between appropriate and inappropriate medicines use. However, many have not been externally validated with regard to patient-related outcomes, potentially limiting their use in clinical practice. OBJECTIVES: The aim of the study was to conduct a systematic review to summarise (1) available prescribing appropriateness assessment tools and criteria, and (2) their associations with patient-related outcomes (external validity). METHODS: A systematic review was conducted using MEDLINE, EMBASE and Informit (Health Collection) databases to screen for articles in English that examined (1) tools to assess the appropriateness of prescribing and (2) associations of tools with patient-related outcomes, published between 2000 and 2016, without any limits placed on the study design, participant age or setting. RESULTS: After screening 1710 articles, removing duplicates and shortlisting relevant articles, 42 prescribing assessment tools were identified. Out of the 42 tools, 78.6% (n = 33) provided guidance around stopping inappropriate medications, 28.6% (n = 12) around starting appropriate medications, 61.9% (n = 26) were explicit (criteria based) and 31.0% (n = 13) had been externally validated, with hospitalisation being the most commonly used patient-related outcome (n = 9, 21.4%). CONCLUSION: The results of this systematic review highlight the need for evidence-based and externally validated tools, which combine the different aspects of medication management to optimise patient-related outcomes. PROSPERO registration number: CRD42017067233.

Clinician agreement and influence of medication-related characteristics on assessment of polypharmacy.

It is not known how clinicians assess polypharmacy or the medication-related characteristics that influence their assessment. The aim of this study was to examine the level of agreement between clinicians when assessing polypharmacy and to identify medication-related characteristics that influence their assessment. Twenty cases of patients with varying levels of comorbidity and polypharmacy were used to examine clinician assessment of polypharmacy. Medicine-related factors within the cases included Beers and STOPP Criteria medicines, falls-risk medicines, drug burden index (DBI) medicines, medicines causing postural hypotension, and pharmacokinetic drug-drug interactions. Clinicians were asked to rate cases on the degree of polypharmacy, likelihood of harm, and potential for the medication list to be simplified. Inter-rater reliability analysis, correlations, and multivariate logistic regression analyses were conducted to identify medicine factors associated with clinicians' assessment. Eighteen expert clinicians were recruited (69.2% response rate). Strong agreement was observed in clinicians' assessment of polypharmacy (intraclass correlation coefficients [ICC] = 0.94), likelihood to cause harm (ICC = 0.89), and ability to simplify medication list (ICC = 0.90). Multivariate analyses demonstrated number of medicines (P < 0.0001) and DBI scores (P = 0.047) were significantly associated with assessment of polypharmacy. Medicines associated with harm were significantly associated with the number of medicines (P = 0.01) and Beers criteria medicines (P = 0.003). Ability to simplify the medication regimen was significantly associated with number of medicines (P = 0.03) and medicines from the STOPP criteria (P = 0.018). Among clinicians, strong consensus exists with regard to assessment of polypharmacy, medication harm, and ability to simplify medications. Definitions of polypharmacy need to take into account not only the numbers of medicines but also potential for medicines to cause harm or be inappropriate, and validate them against clinical outcomes.

Does antidepressant medication use affect persistence with diabetes medicines?

PURPOSE: This study aimed to examine the effect of antidepressant use on persistence with newly initiated oral antidiabetic medicines in older people. METHODS: A retrospective study of administrative claims data from the Australian Government Department of Veterans' Affairs, from 1 July 2000 to 30 June 2008 of new users of oral antidiabetic medicines (metformin or sulfonylurea). Antidepressant medicine use was determined in the 6 months preceding the index date of the first dispensing of an oral antidiabetic medicine. The outcome was time to discontinuation of diabetes therapy in those with antidepressant use compared with those without. Competing risks regression analyses were conducted with adjustment for covariates. RESULTS: A total of 29,710 new users of metformin or sulfonylurea were identified, with 7171 (24.2%) dispensed an antidepressant. Median duration of oral antidiabetic medicines was 1.81 years (95% CI 1.72­1.94) for those who received an antidepressant at the time of diabetes medicine initiation, by comparison to 3.23 years (95% CI 3.10­3.40) for those who did not receive an antidepressant. Competing risk analyses showed a 42% increased likelihood of discontinuation of diabetes medications in persons who received an antidepressant (subdistribution hazard ratio 1.42, 95% CI 1.37­1.47, p < 0.001). CONCLUSIONS: The results of this large population-based study demonstrate that depression may be contributing to non-compliance with medicines for diabetes and highlight the need to provide additional services to support appropriate medicine use in those initiating diabetes medicines with co-morbid depression.

Co-morbidity and potential treatment conflicts in elderly heart failure patients: a retrospective, cross-sectional study of administrative claims data.

BACKGROUND: Co-morbidity of both cardiac and non-cardiac conditions is common in the elderly with heart failure (HF) and can be associated with adverse clinical outcomes. OBJECTIVES: The aims of this study were to examine the prevalence of co-morbidity and potential treatment conflicts that may result in adverse clinical outcomes in a large cohort of elderly HF patients. METHODS: We conducted a cross-sectional study using administrative claims data (1 April to 31 July 2007) from the Department of Veterans' Affairs, Australia, on all veterans aged ≥65 years with HF. Co-morbidities were defined using the pharmaceutical based co-morbidity index Rx-Risk-V. Potential treatment conflicts for patients with HF and co-morbid diseases were identified from Australian clinical guidelines or reference compendia and their prevalence in the data were determined. RESULTS: A total of 6730 patients were included in the study, with a median of 6 co-morbid conditions (interquartile range [IQR] 4-7) and 11 (IQR 8-15) unique medicines. Almost the entire HF cohort (97.8%) were identified as having at least one co-morbid condition that may cause a potential treatment conflict, with 55% having three or more. The conditions identified as being of greatest concern, based on their prevalence and potential for treatment conflict, were chronic airways disease, depression, chronic pain/inflammatory disease, glaucoma, diabetes mellitus and diseases treatable with corticosteroids. CONCLUSIONS: Potential treatment conflicts are common in the highly co-morbid population of elderly patients with HF, and may influence the therapeutic management of not only HF but all conditions present.

Monitoring in high level care.

BACKGROUND: Prescribing for elderly patients in nursing homes in an area where appropriate patient monitoring is poorly managed. OBJECTIVE: This article discusses the use of some commonly prescribed medications in elderly nursing home residents and how these medications should be monitored. DISCUSSION: Many of the medications prescribed to nursing home residents may be appropriately prescribed initially, but their continuing prescription may be inappropriate in the setting of lack of effect and adverse reactions. It is important to appreciate that the response rate to many of the commonly prescribed medications such as tricyclic antidepressants, selective serotonin reuptake inhibitors, anticholinergics and antipsychotics, is limited in this population of patients and that they also have quite a significant potential for toxicity. Therefore, monitoring for the effects of therapy, as well as any potential adverse effects, is important to ensure the ongoing appropriateness of such prescriptions.

Writing the prescription and informing the patient.

BACKGROUND: Having decided on the generic drug to prescribe the prescription needs to be written and the patient informed regarding the treatment. OBJECTIVE: This article discusses some regulatory requirements for writing a legal prescription, but predominantly discusses important aspects of informing patients regarding drug therapy. DISCUSSION: The actual writing of a prescription is a small part of the prescribing process and needs to comply with local regulations. Including patients in the decision to embark on a treatment and informing them of drug treatment is a very important part of the prescribing process. There is no simple formula, but patients need to be informed on what they want to know, when they want to know it, and in the way that is most acceptable to them. It is important to use both verbal and written forms of communication and to allow patients to reflect over the information, ask questions, and be further informed over subsequent consultations. Consumer medicine information leaflets can be a useful aid, but require that the clinician understand and be prepared to answer questions raised by them.

Check suitability, minimise sue-ability!

BACKGROUND: Having chosen which drug to prescribe, the suitability of the medication needs to be checked before the prescription is written. OBJECTIVE: This article discusses what checking for suitability means and how it differs from specific considerations that a patient may have. DISCUSSION: A drug is unsuitable for a patient if it is very likely to cause a predictable adverse reaction, and its prescription, in the absence of extenuating circumstances, would be difficult to defend. A simple example is anaphylaxis to penicillins. It is important to distinguish between patients for whom certain drug therapy is unsuitable, and others who have specific considerations, where the drugs can still be prescribed, but where additional steps need to be undertaken either in prescribing or monitoring. Examples of each of these will be discussed.

Choosing a drug from within a class.

BACKGROUND: Having decided on a drug class, an individual drug needs to be chosen. OBJECTIVE: This article discusses the same four factors used in deciding the generic drug within a class as well as between different drug classes: efficacy, safety, suitability, and cost. DISCUSSION: The example of hypertension will be used to illustrate the choice of individual drugs within beta blockers and calcium channel blockers. Although a large number of options exist within each class, by considering the above factors, the choice is narrowed to only 1-2 preferred options. These drugs should then be added to the P- or Personal-drug list. By only prescribing agents on the P-drug list, the prescriber will become more familiar with their closing, adverse effects, and interactions, resulting in improved patient outcomes. Also when a new drug becomes available, it clearly needs to be better for the patient in terms of these factors, before it is added to the P-drug list.

Monitoring: to infinity and beyond!

BACKGROUND: For many patients, the initial prescription is only the beginning of the prescribing process, with the prescription needing to be repeated, sometimes for the life of the patient. OBJECTIVE: This article discusses the factors to consider when reviewing a patient for a repeat prescription and some approaches to long term pharmacotherapy. DISCUSSION: When writing repeat prescriptions it is important to take time to consider the physiological changes of aging, emergence of new contraindications in the patient, emergence of new evidence regarding drug therapy, and whether it is appropriate to consider drug withdrawal. The role of the pharmacist in the prescribing process, particularly in performing home medicine reviews, is also briefly discussed.