Clinician and Family Caregiver Perspectives on Deprescribing Chronic Disease Medications in Older Nursing Home Residents Near the End of Life.

INTRODUCTION: Nursing home (NH) residents with limited life expectancy (LLE) who are intensely treated for hyperlipidemia, hypertension, or diabetes may benefit from deprescribing. OBJECTIVE: This study sought to describe NH clinician and family caregiver perspectives on key influences on deprescribing decisions for chronic disease medications in NH residents near the end of life. METHODS: We recruited family caregivers of veterans who recently died in a Veterans Affairs (VA) NH, known as community living centers (CLCs), and CLC healthcare clinicians (physicians, nurse practitioners, physician assistants, pharmacists, registered nurses). Respondents completed semi-structured interviews about their experiences with deprescribing statin, antihypertensive, and antidiabetic medications for residents near end of life. We conducted thematic analysis of interview transcripts to identify key themes regarding influences on deprescribing decisions. RESULTS: Thirteen family caregivers and 13 clinicians completed interviews. Key themes included (1) clinicians and caregivers both prefer to minimize drug burden; (2) clinical factors strongly influence deprescribing of chronic disease medications, with differences in how clinicians and caregivers weigh specific factors; (3) caregivers trust and rely on clinicians to make deprescribing decisions; (4) clinicians perceive caregiver involvement and buy-in as essential to deprescribing decisions, which requires time and effort to obtain; and (5) clinicians perceive conflicting care from other clinicians as a barrier to deprescribing. CONCLUSIONS: Findings suggest a need for efforts to encourage communication with and education for family caregivers of residents with LLE about deprescribing, and to foster better collaboration among clinicians in CLC and non-CLC settings.

Optimal P2Y12 inhibitor durations in older men and older women following an acute myocardial infarction: A nationwide cohort study using Medicare data.

Study objective: Identify optimal P2Y12 inhibitor durations balancing ischemic-benefit and bleeding-risk outcomes after acute myocardial infarction (AMI) in older men and women. Design: Observational retrospective cohort with 2 years of follow-up, using clone-censor-weight marginal structural models to emulate randomization. Setting: 20 % sample of US Medicare administrative claims data. Participants: P2Y12 inhibitor new users ≥66 years old following 2008-2013 AMI hospitalization. Exposures: 12- to 24-month P2Y12 inhibitor durations in 1-month intervals. Main outcome measures: Effectiveness outcome (composite of all-cause mortality, recurrent AMI, ischemic stroke), safety outcome (hospitalized bleed), and negative control outcome (heart failure hospitalization). Results: Of 28,488 P2Y12 inhibitor new users, 51 % were female, 50 % were > 75 years old, 88 % were White/non-Hispanic, and 93 % initiated clopidogrel. Negative control outcome results for 16- through 24-month durations appeared most likely to meet assumptions of no unmeasured confounding. Compared to men taking 24-month therapy, men taking 16-month therapy had higher 2-year risks of the composite effectiveness outcome (relative risk [RR] = 1.08; 95 % confidence interval [95%CI]:1.00-1.15) with similar bleeding risks (RR = 0.98; 95%CI:0.85-1.13). Compared to women taking 24-month therapy, women taking 16-month therapy had similar 2-year risks of the composite effectiveness outcome (RR = 0.98; 95%CI:0.92-1.04) and lower bleeding risks (RR = 0.88; 95%CI:0.80-0.96). Conclusions: Older men taking 24-month P2Y12 inhibitor therapy had the lowest composite effectiveness outcome risk with no increased bleeding risk compared to shorter durations. Women taking 16-month versus 24-month P2Y12 inhibitor therapy had similar composite effectiveness outcome risks but a substantially lower hospitalized bleeding risk, suggesting durations beyond 15-17 months lacked benefit while increasing bleeding risk.

Effect of Deintensifying Diabetes Medications on Negative Events in Older Veteran Nursing Home Residents.

OBJECTIVE: Guidelines advocate against tight glycemic control in older nursing home (NH) residents with advanced dementia (AD) or limited life expectancy (LLE). We evaluated the effect of deintensifying diabetes medications with regard to all-cause emergency department (ED) visits, hospitalizations, and death in NH residents with LLE/AD and tight glycemic control. RESEARCH DESIGN AND METHODS: We conducted a national retrospective cohort study of 2,082 newly admitted nonhospice veteran NH residents with LLE/AD potentially overtreated for diabetes (HbA1c ≤7.5% and one or more diabetes medications) in fiscal years 2009-2015. Diabetes treatment deintensification (dose decrease or discontinuation of a noninsulin agent or stopping insulin sustained ≥7 days) was identified within 30 days after HbA1c measurement. To adjust for confounding, we used entropy weights to balance covariates between NH residents who deintensified versus continued medications. We used the Aalen-Johansen estimator to calculate the 60-day cumulative incidence and risk ratios (RRs) for ED or hospital visits and deaths. RESULTS: Diabetes medications were deintensified for 27% of residents. In the subsequent 60 days, 28.5% of all residents were transferred to the ED or acute hospital setting for any cause and 3.9% died. After entropy weighting, deintensifying was not associated with 60-day all-cause ED visits or hospitalizations (RR 0.99 [95% CI 0.84, 1.18]) or 60-day mortality (1.52 [0.89, 2.81]). CONCLUSIONS: Among NH residents with LLE/AD who may be inappropriately overtreated with tight glycemic control, deintensification of diabetes medications was not associated with increased risk of 60-day all-cause ED visits, hospitalization, or death.

Disparities by sex in P2Y12 inhibitor therapy duration, or differences in the balance of ischaemic-benefit and bleeding-risk clinical outcomes in older women versus comparable men following acute myocardial infarction? A P2Y12 inhibitor new user retrospective cohort analysis of US Medicare claims data.

OBJECTIVES: To determine if comparable older women and men received different durations of P2Y12 inhibitor therapy following acute myocardial infarction (AMI) and if therapy duration differences were justified by differences in ischaemic benefits and/or bleeding risks. DESIGN: Retrospective cohort. SETTING: 20% sample of 2007-2015 US Medicare fee-for-service administrative claims data. PARTICIPANTS: ≥66-year-old P2Y12 inhibitor new users following 2008-2013 AMI hospitalisation (N=30 613). Older women compared to older men with similar predicted risks of study outcomes. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: P2Y12 inhibitor duration (modelled as risk of therapy discontinuation). SECONDARY OUTCOMES: clinical events while on P2Y12 inhibitor therapy, including (1) death/hospice admission, (2) composite of ischaemic events (AMI/stroke/revascularisation) and (3) hospitalised bleeds. Cause-specific risks and relative risks (RRs) estimated using Aalen-Johansen cumulative incidence curves and bootstrapped 95% CIs. RESULTS: 10 486 women matched to 10 486 men with comparable predicted risks of all 4 study outcomes. No difference in treatment discontinuation was observed at 12 months (women 31.2% risk; men 30.9% risk; RR 1.01; 95% CI 0.97 to 1.05), but women were more likely than men to discontinue therapy at 24 months (54.4% and 52.9% risk, respectively; RR 1.03; 95% CI 1.00 to 1.05). Among patients who did not discontinue P2Y12 inhibitor therapy, women had lower 24-month risks of ischaemic outcomes than men (13.1% and 14.7%, respectively; RR 0.90; 95% CI 0.84 to 0.96), potentially lower 24-month risks of death/hospice admission (5.0% and 5.5%, respectively; RR 0.91; 95% CI 0.82 to 1.02), but women and men both had 2.5% 24-month bleeding risks (RR 0.98; 95% CI 0.82 to 1.14). CONCLUSIONS: Risks for death/hospice and ischaemic events were lower among women still taking a P2Y12 inhibitor than comparable men, with no difference in bleeding risks. Shorter P2Y12 inhibitor durations in older women than comparable men observed between 12 and 24 months post-AMI may reflect a disparity that is not justified by differences in clinical need.

Comparing Continuous and Binary Group-based Trajectory Modeling Using Statin Medication Adherence Data.

BACKGROUND: Of 58 medication adherence group-based trajectory modeling (GBTM) published studies, 74% used binary and 26% used continuous GBTM. Few studies provided a rationale for this choice. No medication adherence studies have compared continuous and binary GBTM. OBJECTIVE: The objective of this study was to assess whether continuous versus binary GBTM: (1) impacts adherence trajectory shapes; and (2) results in the differential classification of patients into adherence groups. METHODS: Patients were prevalent statin users with myocardial infarction hospitalization, 66+ years old, and continuously enrolled in fee-for-service Medicare. Statin medication adherence was measured 6 months prehospitalization using administrative claims. Final GBTM specifications beyond default settings were selected using a previously defined standardized procedure and applied separately to continuous and binary (proportion of days covered ≥0.80) medication adherence measures. Assignment to adherence groups was compared between continuous and binary models using percent agreement of patient classification and the κ coefficient. RESULTS: Among 113,296 prevalent statin users, 4 adherence groups were identified in both models. Three groups were consistent: persistently adherent, progressively nonadherent, and persistently nonadherent. The fourth continuous group was moderately adherent (progressively adherent in the binary model). When comparing patient assignment into adherence groups between continuous and binary trajectory models, only 78.4% of patients were categorized into comparable groups (κ=0.641; 95% confidence interval: 0.638-0.645). The agreement was highest in the persistently adherent group (∼94%). CONCLUSIONS: Continuous and binary trajectory models are conceptually different measures of medication adherence. The choice between these approaches should be guided by study objectives and the role of medication adherence within the study-exposure, outcome, or confounder.

Opening the black box of the group-based trajectory modeling process to analyze medication adherence patterns: An example using real-world statin adherence data.

PURPOSE: The rationale for choosing a final group-based trajectory modeling (GBTM) specification and evaluations of patient adherence patterns within groups are often omitted in the GBTM medication adherence literature. We aimed to (1) reveal the complexity of GBTM and (2) assess model discrimination of patient medication adherence patterns. METHODS: Medicare administrative claims were used to measure statin medication adherence as a continuous value in the 6 months before an acute myocardial infarction (AMI) hospitalization. Different GBTM specifications beyond default settings were constructed and compared with the Bayesian information criterion. Spaghetti plots were used to compare individual adherence patterns with group averages. RESULTS: Overall, 113,296 prevalent statin users met eligibility criteria. Four adherence groups were identified: persistently adherent, moderately adherent, progressively nonadherent, and persistently nonadherent. Spaghetti plots showed the persistently adherent and persistently nonadherent groups had relatively homogeneous adherence patterns that matched predicted trajectories well. Spaghetti plots also showed that, while adherence patterns in the progressively nonadherent group were not as homogeneous, most patients in this group appeared to be discontinuing statin therapy pre-AMI. CONCLUSIONS: Subjective decisions are necessary to identify a final trajectory model. Greater transparency and disclosure of these decisions in the medication adherence literature are needed. Individual patient adherence patterns from spaghetti plots provided additional diagnostic information about trajectory models beyond standard model-fit assessments to determine if group-average adherence estimates represent homogeneous patterns of medication adherence.

It's Not Too Late to Improve Statin Adherence: Association Between Changes in Statin Adherence from Before to After Acute Myocardial Infarction and All-Cause Mortality.

Background Many older patients have a change in statin adherence-either an increase or a decrease-from before to after an acute myocardial infarction ( AMI ), but its association with mortality is unknown. Methods and Results Using Medicare administrative claims, a cohort of patients ≥66 years old with an AMI hospitalization from 2008 to 2010 was assembled. Statin adherence was measured for 180 days pre- AMI and 180 days post- AMI and categorized as severely nonadherent, moderately nonadherent, or adherent. Categorical change in statin adherence from pre- to post- AMI was assessed. Patients were then followed for up to 18 months for all-cause mortality. A Cox proportional hazards model was applied to estimate the effects of statin adherence change on all-cause mortality, adjusted for patient baseline characteristics. Of 101 011 eligible patients, 20% had a categorical increase in adherence, 16% decreased, and 14% remained nonadherent both pre- and post- AMI . Compared with patients who were always severely nonadherent (both pre- and post- AMI ), patients whose adherence increased from severely nonadherent to adherent (hazard ratio=0.83; 95% CI : 0.75-0.92) and patients who were always adherent (hazard ratio=0.88; 95% CI : 0.82-0.94) were less likely to die; patients whose adherence decreased from moderately nonadherent to severely nonadherent were more likely to die (hazard ratio=1.11; 95% CI : 1.01-1.22). Conclusions After an AMI , patients with decreased statin adherence had the worst mortality outcomes. However, patients with increased statin adherence had a similar risk of mortality compared with continuously adherent patients, suggesting that, even after an AMI , it is not too late to improve statin adherence.

Implications of Removing Rosiglitazone's Black Box Warning and Restricted Access Program on the Uptake of Thiazolidinediones and Dipeptidyl Peptidase-4 Inhibitors Among Patients with Type 2 Diabetes.

BACKGROUND: Medications are increasingly being approved with limited, short-term evidence regarding safety. Regulatory safety concerns may emerge for these drugs but later may be reversed if additional evidence suggests no warning is indicated. OBJECTIVE: To describe trends over time in the initiation of rosiglitazone and pioglitazone-both in the thiazolidinedione (TZD) class-and medications from the dipeptidyl peptidase-4 (DPP-4) inhibitor class before and after the FDA removed a black box warning and restricted access program for rosiglitazone regarding an increased risk of myocardial infarction. METHODS: This retrospective study evaluated initiation of TZDs and DPP-4 inhibitors using 2001-2015 administrative claims data from a U.S. commercially insured population. Patients were aged 18-64 years and were new users of either a TZD or DPP-4 inhibitor. Among all patients who were new users of either a TZD or a DPP-4 inhibitor during each quarter-year (Q), the percentage of patients who initiated rosiglitazone, pioglitazone, and DPP-4 inhibitors were calculated. RESULTS: There were 630,977 patients eligible for the study. During 2007, rosiglitazone initiators decreased from 39.1% to 8.0% in 2007 Q4 when the black box warning was implemented. During 2010, rosiglitazone initiators decreased from 7.6% to 1.0%, as safety evidence accumulated and the restricted access program requirement was announced. Rosiglitazone initiation remained below 1.0%, even after regulatory restrictions were removed in November 2013. Pioglitazone initiation decreased from 46.4% in 2010 Q1 to 14.8% in 2011 Q4 and remained relatively constant between 14.5% and 17.8% after regulatory restrictions for rosiglitazone were removed. After DPP-4 inhibitors first became available in 2006 Q3, initiation of this medication class increased rapidly, stayed relatively constant between 42.8% and 45.5% in 2009, and then quickly rose and remained above 80% from 2012 through 2015. CONCLUSIONS: This case study provides some evidence that adding and later reversing drug safety warnings-particularly those with restricted access requirements-may affect the uptake of the targeted product into the population when multiple clinically relevant treatment alternatives are available (such as type 2 diabetes). Once a treatment falls out of favor, removal of safety warnings and/or restricted access programs may not lead to increased use. DISCLOSURES: This project was not directly supported by any funding. Hickson was supported by the National Heart, Lung, and Blood Institute through a National Research Service Award (NRSA) training grant (4T32HL007055-41) as a postdoctoral research fellow with the Cardiovascular Disease Epidemiology Program at The University of North Carolina at Chapel Hill (UNC-CH). Cole was supported by a NRSA Predoctoral Traineeship from the Agency for Healthcare Research and Quality sponsored by The Cecil G. Sheps Center for Health Services Research, UNC-CH (grant no. T32-HS000032) and a predoctoral fellowship from the American Foundation for Pharmaceutical Education. Unrelated to this project, Cole was a part-time employee of Truven Health Analytics/IBM Watson Health. Dusetzina has nothing to disclose.

Review of methodological challenges in comparing the effectiveness of neoadjuvant chemotherapy versus primary debulking surgery for advanced ovarian cancer in the United States.

Randomized trials outside the U.S. have found non-inferior survival for neoadjuvant chemotherapy (NACT) versus primary debulking surgery (PDS) for advanced ovarian cancer (AOC). However, these trials reported lower overall survival and lower rates of optimal debulking than U.S. studies, leading to questions about generalizability to U.S. practice, where aggressive debulking is more common. Consequently, comparative effectiveness in the U.S. remains controversial. We reviewed U.S. comparative effectiveness studies of NACT versus PDS for AOC. Here we describe methodological challenges, compare results to trials outside the U.S., and make suggestions for future research. We identified U.S. studies published in 2010 or later that evaluated the comparative effectiveness of NACT versus PDS on survival in AOC through a PubMed search. Two independent reviewers abstracted data from eligible articles. Nine of 230 articles were eligible for review. Methodological challenges included unmeasured confounders, heterogeneous treatment effects, treatment variations over time, and inconsistent measurement of treatment and survival. Whereas some limitations were unavoidable, several limitations noted across studies were avoidable, including conditioning on mediating factors and immortal time introduced by measuring survival beginning from diagnosis. Without trials in the U.S., non-randomized studies are an important source of evidence for the ideal treatment for AOC. However, several methodological challenges exist when assessing the comparative effectiveness of NACT versus PDS in a non-randomized setting. Future observational studies must ensure that treatment is consistent throughout the study period and that treatment groups are comparable. Rapidly-evolving oncology data networks may allow for identification of treatment intent and other important confounders.

Incidence of and Risk Factors for Severe Adverse Events in Elderly Patients Taking Angiotensin-Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers after an Acute Myocardial Infarction.

STUDY OBJECTIVE: To assess the incidence of and risk factors associated with severe adverse events in elderly patients who used angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) after an acute myocardial infarction (AMI). DESIGN: Retrospective cohort study. DATA SOURCES: Centers for Medicare & Medicaid Services Chronic Conditions Data Warehouse (Medicare service claims database), American Community Survey of the U.S. Census Bureau, and Multum Lexicon Drug database. PATIENTS: A total of 101,588 eligible Medicare fee-for-service beneficiaries 66 years or older, who were hospitalized for AMI between January 1, 2008, and December 31, 2009, and used ACEIs or ARBs within 30 days after discharge. MEASUREMENTS AND MAIN RESULTS: Primary outcomes were hospitalizations for acute renal failure (ARF) and hyperkalemia. The secondary outcome was discontinuation or suspension of ACEI/ARB therapy after a visit to a health care provider. The primary risk factors of interest were age, sex, race/ethnicity, and chronic kidney disease (CKD). Cumulative incidence curves and multivariable Fine-Gray proportional hazards models with 95% confidence intervals (CIs) were used with death as a competing risk in both intention-to-treat (ITT) and as-treated (AT) analyses. In the study cohort, 2.8% experienced ARF, 0.5% experienced hyperkalemia, and 63.7% discontinued ACEI/ARB therapy within 1 year after hospital discharge. Approximately half of the incidence of ARF and hyperkalemia occurred within 6 months after hospital discharge, but the cumulative incidence increased after 6 months. Patients older than 85 years had a higher rate of ARF (ITT hazard ratio [HR] 1.15, 95% CI 1.04-1.28) and hyperkalemia (ITT HR 1.33, 95% CI 1.05-1.68) compared with those aged 65-74 years. Patients with baseline CKD had higher rates of ARF (ITT HR 1.61, 95% CI 1.42-1.82), hyperkalemia (ITT HR 1.41, 95% CI 1.11-1.77), and ACEI/ARB therapy discontinuation or suspension (ITT HR 1.05, 95% CI 1.02-1.09). CONCLUSION: We found a low incidence of ARF and hyperkalemia in elderly patients treated with ACEIs or ARBs after AMI hospitalization. However, a high rate of treatment discontinuation might prevent a higher rate of occurrence of these events. Long-term careful monitoring of severe adverse events and timely discontinuation of ACEIs or ARBs among elderly patients with advancing age and CKD after an AMI is warranted in clinical practice.

Changes in Statin Adherence Following an Acute Myocardial Infarction Among Older Adults: Patient Predictors and the Association With Follow-Up With Primary Care Providers and/or Cardiologists.

BACKGROUND: Hospitalizations for acute myocardial infarctions (AMIs) are associated with changes in statin adherence. It is unclear to what extent adherence changes, which patients are likely to change, and how post-discharge follow-up is associated with statin adherence change. METHODS AND RESULTS: This retrospective study used Medicare data for all fee-for-service beneficiaries 66 years and older with an AMI hospitalization in 2008-2010 and statin use before their index AMI. Multivariable multinomial logistic regression models (odds ratio [OR] and 99% confidence interval [CI]) were applied to assess associations between both patient characteristics and follow-up with a primary care provider and/or cardiologist with the outcome of statin adherence change (increase or decrease) from the 6-month pre- to 6-month post-AMI periods. Of 113 296 patients, 64.0% had no change in adherence, while 19.7% had increased and 16.3% had decreased adherence after AMI hospitalization. Black and Hispanic patients were more likely to have either increased or decreased adherence than white patients. Patients who required coronary artery bypass graft surgery (OR, 1.34; 99% CI, 1.21-1.49) or percutaneous transluminal coronary angioplasty/stent procedure (OR, 1.25; 99% CI, 1.17-1.32) during their index hospitalization were more likely to have increased adherence. Follow-up with a primary care provider was only mildly associated with increased adherence (OR, 1.08; 99% CI, 1.00-1.16), while follow-up with a cardiologist (OR, 1.15; 99% CI, 1.05-1.25) or both provider types (OR, 1.21; 99% CI, 1.12-1.30) had stronger associations with increased adherence. CONCLUSIONS: Post-AMI changes in statin adherence varied by patient characteristics, and improved adherence was associated with post-discharge follow-up care, particularly with a cardiologist or both a primary care provider and a cardiologist.

Adherence Tradeoff to Multiple Preventive Therapies and All-Cause Mortality After Acute Myocardial Infarction.

BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors/angiotensin II receptor blockers (ARB), beta-blockers and statins are recommended after acute myocardial infarction (AMI). Patients may adhere to some, but not all, therapies. OBJECTIVES: The authors investigated the effect of tradeoffs in adherence to ACE inhibitors/ARBs, beta-blockers, and statins on survival among older people after AMI. METHODS: The authors identified 90,869 Medicare beneficiaries ≥65 years of age who had prescriptions for ACE inhibitors/ARBs, beta-blockers, and statins, and survived ≥180 days after AMI hospitalization in 2008 to 2010. Adherence was measured by proportion of days covered (PDC) during 180 days following hospital discharge. Mortality follow-up extended up to 18 months after this period. The authors used Cox proportional hazards models to estimate hazard ratios of mortality for groups adherent to 2, 1, or none of the therapies versus group adherent to all 3 therapies. RESULTS: Only 49% of the patients adhered (PDC ≥80%) to all 3 therapies. Compared with being adherent to all 3 therapies, multivariable-adjusted hazard ratios (95% confidence intervals [CIs]) for mortality were 1.12 (95% CI: 1.04 to 1.21) for being adherent to ACE inhibitors/ARBs and beta-blockers only, 0.98 (95% CI: 0.91 to 1.07) for ACEI/ARBs and statins only, 1.17 (95% CI: 1.10 to 1.25) beta-blockers and statins only, 1.19 (95% CI: 1.07 to 1.32) for ACE inhibitors/ARBs only, 1.32 (95% CI: 1.21 to 1.44) for beta-blockers only, 1.26 (95% CI: 1.15 to 1.38) statins only, and 1.65 (95% CI: 1.54 to 1.76) for being nonadherent (PDC <80%) to all 3 therapies. CONCLUSIONS: Patients adherent to ACE inhibitors/ARBs and statins only had similar mortality rates as those adherent to all 3 therapies, suggesting limited additional benefit for beta-blockers in patients who were adherent to statins and ACE inhibitors/ARBs. Nonadherence to ACE inhibitors/ARBs and/or statins was associated with higher mortality.

Evaluation of a pharmaceutical assessment screening tool to measure patient acuity and prioritise pharmaceutical care in a UK hospital.

OBJECTIVE: A service evaluation project was conducted to design a pharmaceutical assessment screening tool (PAST) to assign all inpatients a patient acuity level (PAL) to then help teams of clinical pharmacists prioritise the frequency of, and the seniority of, pharmacists performing patient reviews; assess clinical pharmacists' adherence to the tool; and identify when pharmacists do not adhere to the tool. METHODS: The PAST was developed by consensus methodology to prioritise departmental workflow for clinical pharmacists. The most pharmaceutically complex patients at the greatest risk of adverse drug events were expected to receive a PAL score of 3, while the least complex receive a PAL of 1. A quasi-experimental service evaluation study was conducted 6 months after implementation of the tool to quantify agreement between pharmacist-documented and expected per-guidance PALs. Patients were selected via random clusters from wards. For each patient, a PAL was calculated by the researcher and compared with the pharmacist-documented PAL. RESULTS: 20 patients (57%) had documented PALs that matched the expected PAL based on pharmacy departmental guidance. Seven of nine patients with overvalued pharmacist-documented PALs had no high-risk medications and no organ dysfunction. Four of six patients with undervalued pharmacist-documented PALs had cystic fibrosis, who should all automatically score the maximum level. CONCLUSIONS: Until electronic health records allow the calculation of PALs automatically, the utilisation of the current tool may be improved by eliminating unclear and unused portions of the tool and reiterating the true purpose of the tool to all pharmacists.

The electronic medication complete communication (EMC2) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

BACKGROUND: Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs. OBJECTIVE: To evaluate the effectiveness of the Electronic Medication Complete Communication (EMC2) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care. METHODS: The automated EMC2 Strategy consists of: 1) provider alerts to counsel patients on medication risks, 2) the delivery of patient-friendly medication information via the electronic health record, and 3) an automated telephone assessment to identify potential medication concerns or ADEs. The study will take place in two community health centers in Chicago, IL. Adult, English or Spanish-speaking patients (N=1200) who have been prescribed a high-risk medication will be enrolled and randomized to the intervention arm or usual care based upon practice location. The primary outcomes of the study are medication knowledge, proper medication use, and reporting of ADEs; these will be measured at baseline, 4weeks, and three months. Intervention fidelity as well as barriers and costs of implementation will be evaluated. CONCLUSIONS: The EMC2 Strategy automates a patient-friendly risk communication and surveillance process to promote safe medication use while minimizing clinic burden. This trial seeks to evaluate the effectiveness and feasibility of this strategy in comparison to usual care.

Evaluation of an alternative extended-infusion piperacillin-tazobactam dosing strategy for the treatment of gram-negative infections.

Introduction To enhance the probability of pharmacodynamic target attainment, piperacillin-tazobactam can be administered as either a continuous or extended-infusion dosage regimen for the treatment of gram-negative infections. Four hour extended-infusions of piperacillin-tazobactam 3.375 g administered intravenously (IV) every 8 h have been widely studied as an alternative to conventional, intermittent dosage regimens with largely favorable outcomes. Objective To assess the clinical and economic impact of a novel 3-h extended-infusion piperacillin-tazobactam dosing strategy for the treatment of gram-negative infections. Setting 433-bed community hospital in Lexington, KY. Methods Retrospective cohort study before and after the implementation of an alternative dosing protocol using a 3-h infusion of piperacillin-tazobactam 3.375 g IV every 6 h. Main outcome measures The primary outcome was in-hospital mortality. Secondary outcomes include length of stay, ICU length of stay, 30-day all-cause hospital readmissions, total cost per admission, complications, and a composite of in-hospital mortality and readmission within 30 days of discharge. Results Readmission within 30 days of hospital discharge was significantly reduced in the extended-infusion arm (1.2 vs. 13.7 %, P = 0.002). A composite endpoint of death or readmission was lower among patients who received the extended-infusion dosing regimen [ORadj 0.20; 95 % CI (0.07-0.57)]. However this was likely driven by reductions in readmission. Conclusion An alternative regimen of extended-infusion piperacillin-tazobactam resulted in a significant reduction in 30-day all-cause hospital readmission. These results indicate that 3-h infusions of piperacillin-tazobactam 3.375 g IV every 6 h may represent a clinically effective alternative to other commonly used regimens and results in fewer readmissions within 30 days.

Development of a new diabetes medication self-efficacy scale and its association with both reported problems in using diabetes medications and self-reported adherence.

BACKGROUND: Although there are several different general diabetes self-efficacy scales, there is a need to develop a self-efficacy scale that providers can use to assess patient's self-efficacy regarding medication use. The purpose of this study was to: 1) develop a new diabetes medication self-efficacy scale and 2) examine how diabetes medication self-efficacy is associated with patient-reported problems in using diabetes medications and self-reported adherence. PATIENTS AND METHODS: Adult English-speaking patients with type 2 diabetes were recruited from a family medicine clinic and a pharmacy in Eastern North Carolina, USA. The patients were eligible if they reported being nonadherent to their diabetes medicines on a visual analog scale. Multivariable regression was used to examine the relationship between self-efficacy and the number of reported diabetes medication problems and adherence. RESULTS: The diabetes medication self-efficacy scale had strong reliability (Cronbach's alpha =0.86). Among a sample (N=51) of mostly African-American female patients, diabetes medication problems were common (6.1±3.1) and a greater number of diabetes medications were associated with lower medication adherence (odds ratio: 0.35; 95% confidence interval: 0.13, 0.89). Higher medication self-efficacy was significantly related to medication adherence (odds ratio: 1.17; 95% confidence interval: 1.05, 1.30) and inversely related to the number of self-reported medication problems (ß=-0.13; P=0.006). CONCLUSION: Higher diabetes medication self-efficacy was associated with fewer patient-reported medication problems and better medication adherence. Assessing medication-specific self-efficacy may help to identify medication-related problems that providers can help the patients address, potentially improving adherence and patient outcomes.

Clinical and economic impact of meropenem resistance in Pseudomonas aeruginosa-infected patients.

BACKGROUND: The emergence of carbapenem resistance has had a significant impact on both clinical and economic outcomes. METHODS: A retrospective, observational cohort study was performed in a 433-bed tertiary care medical center. The cohort was established from all inpatients with Pseudomonas aeruginosa-positive cultures over a 3-year period. Two multivariate models were developed: a logistic regression model to evaluate the primary outcome of in-hospital mortality and a linear regression model to evaluate the secondary outcome of total hospital cost. RESULTS: The adjusted odds ratio for in-hospital mortality among patients with meropenem-resistant isolates was 2.89 (95% confidence interval [CI], 1.15-7.28). There were significantly more deaths in the meropenem-resistant group (28.1% vs 8.9%, P = .003). Patients with meropenem-resistant P aeruginosa experienced a 4-day increase in median length of stay versus those in the meropenem-susceptible group (14 vs 9 days, P = .004). Likewise, the percentage of patients who required intensive care unit (ICU) admission increased from 42% to 81.3% (P <.001). Meropenem resistance was also associated with a significant increase in total hospital cost by a factor of 1.42 among patients who were not admitted to the ICU (95% CI, 1.03-1.95). CONCLUSIONS: Our results demonstrate that meropenem resistance was a significant predictor of in-hospital mortality. Carbapenem resistance also resulted in a significant increase in hospital cost, but only among patients who were not admitted to the ICU.