Nonpharmacologic Treatments for Attention-Deficit/Hyperactivity Disorder: A Systematic Review.

CONTEXT: Nonpharmacologic treatments for attention-deficit/hyperactivity disorder (ADHD) encompass a range of care approaches from structured behavioral interventions to complementary medicines. OBJECTIVES: To assess the comparative effectiveness of nonpharmacologic treatments for ADHD among individuals 17 years of age and younger. DATA SOURCES: PubMed, Embase, PsycINFO, and Cochrane Database of Systematic Reviews for relevant English-language studies published from January 1, 2009 through November 7, 2016. STUDY SELECTION: We included studies that compared any ADHD nonpharmacologic treatment strategy with placebo, pharmacologic, or another nonpharmacologic treatment. DATA EXTRACTION: Study design, patient characteristics, intervention approaches, follow-up times, and outcomes were abstracted. For comparisons with at least 3 similar studies, random-effects meta-analysis was used to generate pooled estimates. RESULTS: We identified 54 studies of nonpharmacologic treatments, including neurofeedback, cognitive training, cognitive behavioral therapy, child or parent training, dietary omega fatty acid supplementation, and herbal and/or dietary approaches. No new guidance was identified regarding the comparative effectiveness of nonpharmacologic treatments. Pooled results for omega fatty acids found no significant effects for parent rating of ADHD total symptoms (n = 411; standardized mean difference -0.32; 95% confidence interval -0.80 to 0.15; I2 = 52.4%; P = .10) or teacher-rated total ADHD symptoms (n = 287; standardized mean difference -0.08; 95% confidence interval -0.47 to 0.32; I2 = 0.0%; P = .56). LIMITATIONS: Studies often did not reflect the primary care setting and had short follow-up periods, small sample sizes, variations in outcomes, and inconsistent reporting of comparative statistical analyses. CONCLUSIONS: Despite wide use, there are significant gaps in knowledge regarding the effectiveness of ADHD nonpharmacologic treatments.

Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting.

AIM: To describe the rationale and design of a pilot program to implement and evaluate pharmacogenetic (PGx) testing in a primary care setting. STUDY RATIONALE: Several factors have impeded the uptake of PGx testing, including lack of provider knowledge and challenges with operationalizing PGx testing in a clinical practice setting. STUDY DESIGN: We plan to compare two strategies for the implementation of PGx testing: a pharmacist-initiated testing arm compared with a physician-initiated PGx testing arm. Providers in both groups will be required to attend an introduction to PGx seminar. Anticipated results: We anticipate that providers in the pharmacist-initiated group will be more likely to order PGx testing than providers in the physician-initiated group. CONCLUSION: Overall, we aim to generate data that will inform an effective delivery model for PGx testing and to facilitate a seamless integration of PGx testing in primary care practices.

Use Of Rate And Rhythm Control Drugs In Patients Younger Than 65 Years With Atrial Fibrillation.

Little is known about the use of pharmacologic rhythm or rate control in younger atrial fibrillation (AF) patients in clinical practice. Using commercial health data from 2006 through 2010, patients aged <65 years with an initial AF encounter were categorized as receiving pharmacologic rhythm- or rate-control treatment. Factors associated with each treatment were determined. Cox models with inverse propensity-weighted estimators were used to compare times to AF, heart failure, cardiovascular, non-cardiovascular, and any-cause hospitalizations. Of 79,232 patients meeting the study criteria, 12,408 (16%) received a rhythm-control drug and 66,824 (84%) received only rate-controlling drugs. Only 2% and 0.1%, respectively, received electrical cardioversion and AF ablation during the initial AF encounter. Patients who were men (OR 1.10, 95% CI 1.06-1.15), had index encounters in later years (2010 versus 2006: OR 1.34, 95% CI 1.23-1.45), were in the southern United States, and had other cardiac comorbidities were more likely to receive a rhythm-control drug. There was a greater risk of AF (HR 1.40, 95% CI 1.31-1.50), cardiovascular (HR 1.26, 95% CI 1.20-1.33), and all-cause (HR 1.11, 95% CI 1.07-1.16) hospitalizations in the rhythm-control group, but there was no difference between groups in heart failure (HR 1.01, 95% CI 0.88-1.17) or non-cardiovascular (HR 1.04, 95% CI 0.99-1.09) hospitalizations. Among younger AF patients receiving initial pharmacologic treatment, antiarrhythmic drugs were used less frequently than only rate-controlling drugs, and were associated with a higher risk of subsequent hospitalization.

Decision support for evidence-based pharmacotherapy detects adherence problems but does not impact medication use.

Although evidence-based pharmacotherapies are a principal component of patient care, 30-50% of patients do not take their medications as prescribed. We conducted a randomized trial of two clinical decision support (CDS) interventions in 2219 patients: patient adherence reports to providers (n=744), patient adherence reports to providers + email notices to care managers (n=736), and controls (739). At 18-month follow-up, there were no treatment-related differences in patient medication adherence (overall, by medication class, and by medical condition). There also were no treatment-related differences in patient clinical and economic outcomes. Thus, while this study's CDS information interventions were successfully delivered to providers and care managers, and were effective in identifying medication adherence deficits and in increasing care manager responses to medication adherences issues, these interventions were not able to alter patient medication behavior.

Improving care transitions: current practice and future opportunities for pharmacists.

During the past decade, patient safety issues during care transitions have gained greater attention at both the local and national level. Readmission rates to U.S. hospitals are high, often because of poor care transitions. Serious adverse drug events (ADEs) caused by an incomplete understanding of changes in complex drug regimens can be an important factor contributing to readmission rates. This paper describes the roles and responsibilities of pharmacists in ensuring optimal outcomes from drug therapy during care transitions. Barriers to effective care transitions, including inadequate communication, poor care coordination, and the lack of one clinician ultimately responsible for these transitions, are discussed. This paper also identifies specific patient populations at high risk of ADEs during care transitions. Several national initiatives and newer care transition models are discussed, including multi- and interdisciplinary programs with pharmacists as key members. Among their potential roles, pharmacists should participate on medical rounds where available, perform medication reconciliation and admission drug histories, apply their knowledge of drug therapy to anticipate and resolve problems during transitions, communicate changes in drug regimens between providers and care settings, assess the appropriateness and patient understanding of drug regimens, promote adherence, and assess health literacy. In addition, this paper identifies barriers and ongoing challenges limiting greater involvement of pharmacists from different practice settings during care transitions. Professional degree programs and residency training programs should increase their emphasis on pharmacists' roles, especially as part of interdisciplinary teams, in improving patient safety during care transitions in diverse practice settings. This paper also recommends that Accreditation Council for Pharmacy Education (ACPE) standards include specific language regarding the exposure of students to issues regarding care transitions and that students have several opportunities to practice the skills needed for effective care transitions. Moreover, reimbursement mechanisms that permit greater pharmacist involvement in providing medication assistance to patients going through care transitions should be explored. Although health information technology offers the potential for safer care transitions, pharmacists' use of information technology must be integrated into the national initiatives for pharmacists to be effectively involved in care transitions. This paper concludes with a discussion about the importance of recognizing and addressing health literacy issues to promote patient empowerment during and after care transitions.

Extent of and reasons for nonuse of implantable cardioverter defibrillator devices in clinical practice among eligible patients with left ventricular systolic dysfunction.

BACKGROUND: Several studies that used claims and registry data have reported that 40% to 80% of patients eligible for an implantable cardioverter defibrillator (ICD) fail to receive one in clinical practice, and the rates are especially high among women and blacks. The extent and documented reasons for nonuse of ICDs among patients with left ventricular systolic dysfunction are unknown. METHODS AND RESULTS: Using hospital claims and clinical data, we identified patients hospitalized with a heart failure diagnosis and left ventricular ejection fraction ≤30% between January 1, 2007, and August 30, 2007, at a tertiary-care center. Using claims data, we determined placement of an ICD or cardiac resynchronization therapy with defibrillation device at any time up to 1 year after hospitalization. Medical records for patients without an ICD were abstracted to determine reasons for nonuse. Patients with an ICD were compared with patients without an ICD and also with patients without an ICD who did not have any contraindication for an ICD as identified through chart abstraction. Of the 542 potentially eligible patients identified, 224 (41%) did not have an ICD. In the initial adjusted analysis, female sex (odds ratio=1.90; 95% CI, 1.28 to 2.81) and increasing age (odds ratio=1.07; 95% CI, 1.04 to 1.11) were associated with a higher likelihood of not having an ICD. After detailed chart review, of the 224 patients without an ICD, 117 (52%) were ineligible for the device and 38 (17%) patients refused the device, resulting in only 69 (13%) patients eligible for an ICD who failed to receive one. In this subsequent adjusted analysis, remaining factors associated with a higher likelihood of not having an ICD were absence of ventricular arrhythmias (odds ratio=4.93; 95% CI, 2.56 to 9.50), noncardiology hospital service (odds ratio=3.73; 95% CI, 1.98 to 7.04), and lack of health insurance (odds ratio=3.10; 95% CI, 1.48 to 6.46). CONCLUSIONS: On the basis of a detailed chart review, the true rate of ICD underuse may be substantially lower than previous estimates. In addition, after accounting for ICD eligibility criteria, patient sex and age disparities in ICD therapy were no longer present.

In-hospital management of patients with atrial flutter.

BACKGROUND: Little is known about the use of drugs or procedures for management of atrial flutter (AFl) in routine clinical practice. We describe the extent of use of conversion therapies during AFl hospitalizations. METHODS: We examined hospitalizations for primary diagnoses of AFl using hospital claims from January 2000 to December 2004. Patients who received antiarrhythmic drugs, ablation, and/or electrical cardioversion for AFl were categorized as receiving a conversion therapy. Characteristics associated with use of conversion therapy versus no conversion therapy were determined. RESULTS: The study cohort included 19,825 hospitalizations. Of these, 13,059 (65.9%) included in-hospital use of > or =1 conversion therapies. Care by a noncardiologist (adjusted odds ratio [OR] 0.37, 95% CI 0.33-0.41), female sex (adjusted OR 0.84, 95% CI 0.79-0.90), nonwhite race (adjusted OR 0.83, 95% CI 0.74-0.92), and increasing age >70 years (adjusted OR 0.88, 95% CI 0.85-0.91) were associated with lower odds of conversion versus no-conversion therapy. Cardiomyopathy (adjusted OR 1.33, 95% CI 1.17-1.51), heart failure (adjusted OR 1.17, 95% CI 1.06-1.28), coronary artery disease (adjusted OR 1.14, 95% CI 1.05-1.22), secondary diagnosis of atrial fibrillation (adjusted OR 1.28, 95% CI 1.18-1.38), and hospitalization in 2000 or 2001 versus later years (adjusted OR 1.22, 95% CI 1.12-1.33) were associated with greater odds of conversion therapy versus no conversion therapy. CONCLUSION: One or more methods of conversion to sinus rhythm were used in two thirds of the hospitalizations with a primary diagnosis of AFl. Greater use of conversion therapies in patients with other heart disease were expected; however, lower use among elderly persons, females, and racial minorities may indicate some disparities in use and warrant further study.

Improving Medication Adherence in a Regional Healthcare Information Exchange using a Scalable, Claims-Driven, and Service-Oriented Approach.

Evidence-based pharmacotherapy is a central aspect of optimal patient care for many chronic conditions. However, medication non-adherence frequently inhibits the attainment of optimal pharmacotherapy regimens. In this study, we designed, developed, and implemented a multifaceted clinical decision support (CDS) intervention that supports evidence-based pharmacotherapy and enhanced medication adherence through the use of a scalable, claims-driven, and service-oriented approach. The intervention includes a medication management report and a low adherence alert based on thirteen evidence-based pharmacotherapy rules for seven chronic conditions. Reports and alerts are delivered to primary care clinics and care managers that participate in a healthcare information exchange in North Carolina. The resulting system architecture may enable this CDS intervention to be widely disseminated to healthcare networks through an open-source model.

Use of beta-blockers in patients with an implantable cardioverter defibrillator.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) are indicated for both primary and secondary prevention of sudden cardiac arrest. beta-Blockers are also indicated in most patients who have an indication for an ICD; however, their use in this population is not well described. Some clinicians may be unaware of the recommendation for beta-blockers in this population. OBJECTIVE: To explore beta-blocker use among ICD recipients. METHODS: Adults who received their first ICD at Duke Hospital between July 1999 and July 2004 for primary or secondary prevention of sudden cardiac arrest were identified. Using hospital data, beta-blocker use was determined at time of discharge, and characteristics of users were compared with those of nonusers. Continued use of beta-blockers after ICD implant was explored in the subset of patients included in the Duke Databank for Cardiovascular Disease (DDCD). RESULTS: The study cohort comprised 804 patients, 652 (81%) with ICD for secondary prevention of sudden cardiac arrest and 152 (19%) for primary prevention. The median age was 65 years and 75% of the patients were men. A total of 544 (68%) received a beta-blocker at time of ICD implant. There were no substantial changes in the proportion of patients with beta-blocker use from 1999 through 2004, overall or within the primary or secondary prevention groups. However, beta-blocker use was higher in the secondary prevention group than in the primary prevention group (69% vs 60%; p = 0.02). A higher proportion of beta-blocker users versus nonusers had ischemic heart disease (82% vs 68%; p < 0.0001), heart failure (84% vs 71%; p < 0.0001), previous myocardial infraction (51% vs 44%; p = 0.05), and ventricular arrhythmias (82% vs 76%; p = 0.04). Of the 425 patients included in the DDCD, only 241 (57%) were receiving beta-blockers at time of implant and during clinical follow-up. CONCLUSIONS: Lower than optimal use of beta-blockers suggests the need for new methods of including evidence-based medications in clinical practice, especially for complex patients for whom numerous clinical practice guidelines may apply.

Predictors of early discontinuation of evidence-based medicine after acute coronary syndrome.

Use of evidence-based medicine (EBM) improves outcomes after acute coronary syndromes (ACS), yet patients often discontinue prescribed therapies after discharge. Although such discontinuation is well documented, patients' reasons for medication discontinuation have not been reported. MAINTAIN is a longitudinal follow-up registry of CRUSADE/ACTION, which enrolled patients during an ACS hospitalization from January 2006 to September 2007. All discharge medications were obtained from hospital charts. Patients were interviewed by telephone 3 months after discharge to determine if EBM classes prescribed at discharge were continued (aspirin, clopidogrel, beta blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and lipid-lowering medications). If discontinuation occurred, patients were asked if it was with provider knowledge/input or not (self-discontinuation). A multivariable logistic regression model was performed to identify factors associated with self-discontinuation of prescribed EBM. Of the 1,077 patients interviewed, 1,006 (93.4%) were discharged on aspirin, 816 (75.8%) on clopidogrel, 982 (91.2%) on beta blockers, 745 (69.2%) on angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and 968 (89.9%) on lipid-lowering medications. At 3-month follow-up, 304 patients (28.2%) had discontinued > or =1 of these prescribed EBM classes. Although many reported provider involvement, most discontinuation (61.5%) was self-determined. Factors independently associated with self-discontinuation were no pharmacy coinsurance, increasing number of medications, not using reminder tools (e.g., pillbox), lower education, and dialysis. In conclusion, 1/3 of patients with ACS discontinue > or =1 of their prescribed EBMs within 3 months of hospital discharge, and most of this discontinuation is without provider involvement. Patient education, better prescription drug coverage, and reminder strategies may improve use of EBMs at 3 months after discharge from ACS admission.

Transfusion practice and outcomes in non-ST-segment elevation acute coronary syndromes.

OBJECTIVES: To describe the association between transfusion and outcomes as a function of nadir hematocrit (HCT) in patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS). BACKGROUND: The adverse outcomes associated with transfusion in NSTE ACS is uncertain and may vary by nadir HCT of the transfused. METHODS: Using data from 44242 patients with NSTE ACS in 400 US hospitals in the CRUSADE initiative (January 2004-December 2005), we describe blood transfusion as a function of nadir HCT and associated outcomes across nadir HCT groups (30%). We further explore patient and process variation across hospital quartiles defined by transfusion use. RESULTS: Overall, 22.2% of patients with NSTE ACS are anemic and 10.4% receive a blood transfusion during their care. Likelihood of transfusion rose from 1% when nadir HCT was >30% to 70% when nadir HCT was 30% (adjusted OR 3.47 [2.30-5.23]) had higher mortality. CONCLUSION: Anemia and transfusion are common in the care of NSTE ACS. The observed association between transfusion and adverse outcomes is neutral in the nadir HCT range where transfusions are most often given and trends strongly to benefit when nadir HCT is

Enoxaparin dosing and associated risk of in-hospital bleeding and death in patients with non ST-segment elevation acute coronary syndromes.

BACKGROUND: The efficacy of enoxaparin sodium in non-ST-segment elevation acute coronary syndromes is well established; however, concerns remain regarding bleeding risk. The extent to which bleeding risk is attributable to excess dosing of enoxaparin is unclear. METHODS: Using data from the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) National Quality Improvement Initiative, we determined the frequency of administration of excess (>10 mg above the recommended dose), lower-than-recommended (>10 mg below the recommended dose), and recommended doses of enoxaparin. We also determined unadjusted and adjusted risks of in-hospital major bleeding and death associated with excess and lower-than-recommended doses of enoxaparin. RESULTS: Of 10 687 patients, 2002 (18.7%) received an excess dose and 3116 (29.2%) received a lower-than-recommended dose of enoxaparin. Patients receiving excess doses were older (median age, 78 vs 66 years), smaller (median body mass index [calculated as weight in kilograms divided by height in meters squared], 26.2 vs 27.8), and more likely to be female (59.5% vs 38.2%) than patients receiving recommended doses (P < .001 for all). After adjustment for baseline characteristics, an excess dose was significantly associated with major bleeding (odds ratio, 1.43; 95% confidence interval [CI], 1.18-1.75) and death (odds ratio, 1.35; 95% CI, 1.03-1.77) compared with a recommended dose. A lower-than-recommended dose was not associated with major bleeding (odds ratio, 1.01; 95% CI, 0.84-1.21), but there was a trend toward higher mortality (odds ratio, 1.25; 95% CI, 0.93-1.68). CONCLUSIONS: Almost half the patients treated with enoxaparin did not receive a recommended dose and had worse outcomes, especially those receiving an excess dose. Improved adherence to the recommended dose could substantially improve the safety profile of enoxaparin.

Multifaceted intervention to promote beta-blocker use in heart failure.

BACKGROUND: Despite a survival benefit and guideline recommendation for beta-blockers in left ventricular systolic dysfunction, beta-blockers are underused in clinical practice. METHODS: Medical practices with > or = 15 patients with heart failure (HF) in the Duke Databank for Cardiovascular Disease (DDCD) were identified for a prospective, randomized study using a multifaceted intervention to improve beta-blocker use. Intervention practices received provider education, patient education materials, feedback on beta-blocker use of their patients with HF, and access to telephone consultation with an HF expert. The primary outcome was a comparison between intervention and control practices of the proportion of patients with HF self-reporting beta-blocker use on their first routine DDCD follow-up in the postintervention year. A random effects model was used for the analysis. RESULTS: Post intervention, 2631 patients (1701 in 23 intervention practices and 930 in 22 control practices) completed DDCD follow-up. No significant difference in the proportion of patients with HF reporting beta-blocker use was found in the intervention versus control groups (OR 1.16, 95% CI 0.94-1.43, P = .2), although more patients in the intervention group started a beta-blocker than stopped a beta-blocker during the study period (P = .02). CONCLUSIONS: This multifaceted intervention did not significantly increase the mean proportion of patients taking beta-blockers within practices exposed to the intervention, although favorable trends were observed. Further studies are needed to identify and evaluate strategies for translating evidence into clinical practice to reduce the global health burden associated with HF.

Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease.

BACKGROUND: Studies have examined the use of evidence-based therapies for coronary artery disease (CAD) in the short term and at hospital discharge, but few have evaluated long-term use. METHODS AND RESULTS: Using the Duke Databank for Cardiovascular Disease for the years 1995 to 2002, we determined the annual prevalence and consistency of self-reported use of aspirin, beta-blockers, lipid-lowering agents, and their combinations in all CAD patients and of angiotensin-converting enzyme inhibitors (ACEIs) in those with and without heart failure. Logistic-regression models identified characteristics associated with consistent use (reported on > or =2 consecutive follow-up surveys and then through death, withdrawal, or study end), and Cox proportional-hazards models explored the association of consistent use with mortality. Use of all agents and combinations thereof increased yearly. In 2002, 83% reported aspirin use; 61%, beta-blocker use; 63%, lipid-lowering therapy use; 54%, aspirin and beta-blocker use; and 39%, use of all 3. Consistent use was as follows: For aspirin, 71%; beta-blockers, 46%; lipid-lowering therapy, 44%; aspirin and beta-blockers, 36%; and all 3, 21%. Among patients without heart failure, 39% reported ACEI use in 2002; consistent use was 20%. Among heart failure patients, ACEI use was 51% in 2002 and consistent use, 39%. Except for ACEIs among patients without heart failure, consistent use was associated with lower adjusted mortality: Aspirin hazard ratio (HR), 0.58 and 95% confidence interval (CI), 0.54 to 0.62; beta-blockers, HR, 0.63 and 95% CI, 0.59 to 0.67; lipid-lowering therapy, HR, 0.52 and 95% CI, 0.42 to 0.65; all 3, HR, 0.67 and 95% CI, 0.59 to 0.77; aspirin and beta-blockers, HR, 0.61 and 95% CI, 0.57 to 0.65; and ACEIs among heart failure patients, HR, 0.75 and 95% CI, 0.67 to 0.84. CONCLUSIONS: Use of evidence-based therapies for CAD has improved but remains suboptimal. Although improved discharge prescription of these agents is needed, considerable attention must also be focused on understanding and improving long-term adherence.

New antiarrhythmic agents for atrial fibrillation and atrial flutter: United States drug market response as an indicator of acceptance.

OBJECTIVE: To determine how well dofetilide and Betapace AF (sotalol, approved solely for atrial fibrillation and atrial flutter), with their detailed dosing and monitoring guidelines for safety, were accepted into clinical practice during the 2 calendar years after their introduction. METHODS AND RESULTS: We reviewed the number of new, refill, and total prescriptions of all antiarrhythmic agents in the United States from April 2000-December 2001 to assess use of dofetilide and Betapace AF in the drug market. Both were prescribed very infrequently throughout the study period. In addition, the infrequent reported use of these drugs for patients with atrial fibrillation and flutter indicated poor acceptance of these agents by prescribing physicians. We speculated that the restricted distribution and required educational program for dofetilide, as well as the availability of generic sotalol products, may have discouraged physicians from prescribing both dofetilide and Betapace AE CONCLUSION: A common goal for both the dofetilide risk-management program and the creation of a sotalol product indicated solely for atrial fibrillation and atrial flutter was to provide safer treatment for patients with these arrhythmias. Unfortunately, limited penetration of dofetilide and Betapace AF into the U.S. market suggests that drugs without a risk-management program or detailed dosing guidelines were more likely than dofetilide or Betapace AF to be selected for treatment of atrial fibrillation and atrial flutter.

Knowledge deficits related to the QT interval could affect patient safety.

BACKGROUND: Recently, some QT-prolonging, noncardiac medications were withdrawn from the U.S. drug market because of continued inappropriate use by health care practitioners despite warnings and label changes from both the drug manufacturers and the U.S. Food and Drug Administration. This led us to assess the health care practitioners' knowledge of the QT interval and medications that may prolong it. METHODS: We surveyed health care practitioners, primarily specialists in cardiology, to identify knowledge deficits related to the QT interval. RESULTS: From a total of 334 survey respondents, 157 (47%) were physicians; 271 (81%) stated that cardiology was their area of specialization. Most of the respondents (86%) said that they would check an ECG before and after starting QT-prolonging medications, but less than half (42%) of all respondents and only 60% of physician respondents were able to accurately measure a sample QT interval on the survey. Less than two-thirds (63%) of respondents were able to accurately identify possible QT-prolonging medications, while only about half (51%) could accurately identify medication combinations that might prolong the QT interval. CONCLUSIONS: We identified significant knowledge deficits regarding the QT interval and QT-prolonging medications. Additional research is needed to determine the extent to which these knowledge deficits may negatively affect patient safety. We must also develop effective strategies to eliminate these deficits.

Medication errors in hospitalized cardiovascular patients.

BACKGROUND: The Institute of Medicine's report To Err Is Human: Building a Safer Health System recommends pharmacist participation in patient rounds as an immediate approach to reducing medical errors. In the same report and in prior publications, cardiovascular drugs have been commonly associated with severe adverse drug events. METHODS: We systematically reviewed the experience of a clinical pharmacist on the cardiology wards between September 1, 1995, and February 18, 2000. We classified medication errors according to the type of error, medications involved, personnel involved, stages of drug administration involved, and time of year most frequently associated with errors. RESULTS: Among 14983 pharmacist interventions, 4768 were related to medication errors, or 24 medication errors per 100 admissions. The most common errors involved the wrong drug (36.0%) or wrong dose (35.3%), and cardiovascular medications were involved in 41.2% of the errors. Prescribers were associated with most of the errors, and the transition from outpatient to inpatient was the most common point in the system for the occurrence of these medication errors. Higher numbers of errors were also identified during the transition period of house staff, and the total number of errors increased during the study period. CONCLUSIONS: Through the clinical pharmacist's identification and correction of medication errors, 2 areas of improvement that may reduce medication errors were identified. The first is ensuring accurate knowledge of a patient's outpatient medication regimen. The second involves improving the education and support of new interns during their initial months of training. This work exemplifies the approach recommended by the Institute of Medicine to reduce medical errors through systematic analyses rather than ascribing fault to individuals.

What clinicians should know about the QT interval.

CONTEXT: Of the several factors implicated in causing QT interval prolongation and torsades de pointes, errors in the use of medications that may prolong this interval deserve special attention. OBJECTIVE: To systematically summarize the available clinical data on the QT interval and to offer improved recommendations for the use of QT-prolonging medications. DATA SOURCES: We searched MEDLINE from 1966 through 2002 for all English-language articles related to the QT interval. Additional data sources included bibliographies of articles identified on MEDLINE, a survey of experts, and data presented at a meeting of experts on long QT syndrome. STUDY SELECTION: We selected for review registries and case series examining clinical outcomes of patients with prolonged QT interval and the effect of different methods of measurement of the QT interval on patient outcomes. Ten studies were identified, of which 6 were included in the analysis. DATA EXTRACTION: Data quality was determined by publication in the peer-reviewed literature. DATA SYNTHESIS: Optimal measurement of the QT interval is problematic because of lack of standardization and lack of data regarding the best way to adjust for heart rate. Reliable information on the proper use of QT-prolonging medications is scarce. Although a QT interval of at least 500 milliseconds generally has been shown to correlate with a higher risk of torsades de pointes, there is no established threshold below which prolongation of the QT interval is considered free of proarrhythmic risk. The risk of torsades de pointes should be assessed in patients who are about to begin taking a QT-prolonging medication. Although inadequate clinical studies preclude prediction of absolute risk for individual patients, particularly high-risk situations can be defined based on clinical variables. We propose recommendations on proper monitoring of the QT interval in patients receiving QT-prolonging medications. CONCLUSION: Although the use of QT-prolonging medications can predispose to torsades de pointes, there is a relative paucity of information that can help clinicians and patients make optimal informed decisions about how best to minimize the risk of this serious complication.

Aspirin use post-acute coronary syndromes: intolerance, bleeding and discontinuation.

BACKGROUND: While aspirin's secondary prevention benefit is clear, prior reports indicate that 19-83% of eligible patients may not use aspirin chronically. METHODS: We investigated intolerance and bleeding while on aspirin and aspirin discontinuation using 5337 post-acute coronary syndrome patients considered appropriate for chronic antiplatelet therapy who were randomly assigned to aspirin in SYMPHONY and 2nd SYMPHONY and followed for 94 (64,157) days. Multivariable logistic regression models tested associations between baseline characteristics and aspirin discontinuation and bleeding. RESULTS: Nearly 18% of patients discontinued study aspirin; 48% subsequently used open-label aspirin and 5% other antiplatelet or anticoagulant therapy. Black race, recurrent ischemia, hypertension, chronic obstructive pulmonary disease, lighter weight, shorter time to treatment and use of non-steroidal anti-inflammatory agents, diuretics, and digitalis were independently associated with early discontinuation. Early discontinuation was less likely in Eastern Europe, Latin America and Asia. Although major or minor bleeding was common (12.6%), only 1.0% of aspirin-treated patients were reported to discontinue due to bleeding. Gastrointestinal (10.5%) and puncture site (7.6%) were the most common bleeding locations. Bleeding risk was associated with lower estimated creatinine clearance, shorter time to treatment, smoking, Killip class >II, higher systolic blood pressure, and use of aspirin or heparin prior to starting study aspirin. CONCLUSIONS: Despite early initiation and close follow-up, more than 9% of aspirin-treated patients discontinued therapy early and remained off treatment. Addressing the factors associated with both bleeding and discontinuation during chronic therapy is necessary to improve adherence to this inexpensive, life-saving therapy.