Mary G. Amato

The Treatment of Chronic Constipation in Adults

OBJECTIVE:To evaluate whether laxatives and fiber therapies improve symptoms and bowel movement frequency in adults with chronic constipation.DATA SOURCES:English language studies were identified from computerized MEDLINE (1966-1995), Biological Abstracts (1990-1995), and Micromedex searches; bibliographies; textbooks; laxative manufacturers; and experts.STUDY SELECTION:Randomized trials of laxative or fiber therapies lasting more than 1 week that evaluated clinical outcomes in adults with chronic constipationMEASUREMENTS AND MAIN RESULTS:Two independent reviewers appraised each trials characteristics including methodologic quality. There were 36 trials involving 1,815 persons from a variety of settings including clinics, hospitals and nursing homes. Twenty-three trials were 1 month or less in duration. Several laxative and fiber preparations were evaluated. Twenty trials had a placebo, usual care, or discontinuation of laxative control group, and 16 directly compared different agents. Laxatives and fiber increased bowel movement frequency by an overall weighted average of 1.4 (95% confidence interval [CI] 1.1-1.8) bowel movements per week. Fiber and bulk laxatives decreased abdominal pain and improved stool consistency compared with placebo. Most nonbulk laxative data concerning abdominal pain and stool consistency were inconclusive, though cisapride, lactulose, and lactitol improved consistency. Data concerning superiority of various treatments were inconclusive. No severe side effects for any of the therapies were reported.CONCLUSIONS:Both fiber and laxatives modestly improved bowel movement frequency in adults with chronic constipation. There was inadequate evidence to establish whether fiber was superior to laxatives or one laxative class was superior to another.

Clinical and Economic Impact of Ambulatory Care Clinical Pharmacists in Management of Dyslipidemia in Older Adults: The IMPROVE Study

We examined the impact of ambulatory care clinical pharmacist interventions on clinical and economic outcomes of 208 patients with dyslipidemia and 229 controls treated at nine Veterans Affairs medical centers. This was a randomized, controlled trial involving patients at high risk of drug‐related problems. Only those with dyslipidemia are reported here. In addition to usual medical care, clinical pharmacists were responsible for providing pharmaceutical care for patients in the intervention group. The control group did not receive pharmaceutical care. Seventy‐two percent of the intervention group and 70% of controls required secondary prevention according to the National Cholesterol Education Program guidelines. Significantly more patients in the intervention group had a fasting lipid profile compared with controls (p=0.021). The absolute change in total cholesterol (17.7 vs 7.4 mg/dl, p=0.028) and low‐density lipoprotein (23.4 vs 12.8 mg/dl, p=0.042) was greater in the intervention than in the control group. There were no differences in patients achieving goal lipid values or in overall costs despite increased visits to pharmacists. Ambulatory care clinical pharmacists can significantly improve dyslipidemia in a practice setting designed to manage many medical and drug‐related problems.

An economic analysis of a randomized, controlled, multicenter study of clinical pharmacist interventions for high-risk veterans: The IMPROVE study

Study Objective. To determine if clinical pharmacists could affect economic resource use and humanistic outcomes in an ambulatory, high‐risk population.

Can clinical pharmacists affect SF-36 scores in veterans at high risk for medication-related problems?

Background.An objective of pharmaceutical care is for pharmacists to improve patients’ health-related quality of life (HRQOL) by optimizing medication therapy. Objectives.The objective of this study was to determine whether ambulatory care clinical pharmacists could affect HRQOL in veterans who were likely to experience a drug-related problem. Research Design. This was a 9-site, randomized, controlled trial involving Veterans Affairs Medical Centers (VAMCs). Patients were eligible if they met ≥3 criteria for being at high risk for drug-related problems. Enrolled patients were randomized to either usual medical care or usual medical care plus clinical pharmacist interventions. HRQOL was measured with the SF-36 questionnaire administered at baseline and at 6 and 12 months. Results.In total, 1,054 patients were enrolled; 523 were randomized to intervention, and 531 to control. After patient age, site, and chronic disease score were controlled for, the only domain that was significantly different between groups over time was the bodily pain scale, which converged to similar values at the end of the study. Patients’ rating of the change in health status in the past 12 months was statistically different between groups, intervention patients declining less (−2.4 units) than control subjects (−6.3 units) (P <0.004). This difference was not considered clinically meaningful. However, a dose-response relationship was observed for general health perceptions (P = 0.004), vitality (P = 0.006), and change in health over the past year (P = 0.007). Conclusions.These results suggest that clinical pharmacists had no significant impact on HRQOL as measured by the SF-36 for veterans at high risk for medication-related problems.

Types of Interventions Made by Clinical Pharmacists in the IMPROVE Study

The purpose of this study was to describe and evaluate the activities and interventions provided by ambulatory care clinical pharmacists during the IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study. A total of 523 patients were randomized into the intervention arm at nine Veterans Affairs medical centers if they were considered to be at high risk for drug‐related problems. Patients randomized to the control group had no interventions and they are not reported. Using a standard form, pharmacists were asked to document the length of visit, method of contact, medical conditions addressed, and drug‐related problems addressed and resolved during each contact. Seventy‐eight ambulatory care clinical pharmacists documented 1855 contacts over 12 months, an average of 3.54 ± 2.31/patient. The length of visits was 15 minutes or more for 73% of contacts. In‐person contacts accounted for 1421 visits (76.6%), with the remainder being telephone contacts. During each contact the average number of drug‐related problems addressed and resolved were 1.64 ± 1.16 and 1.14 ± 0.98, respectively. More drug‐related problems were addressed and resolved when visits were 15 minutes or longer (p= 0.001) and when the contact was in person (p= 0.001). These data may provide information to clinical pharmacists developing pharmacy‐managed clinics for patients at high risk for drug‐related problems. The information may be a benchmark for types of interventions that can be made, as well as the time commitments required to make them.

Computerised physician order entry-related medication errors: analysis of reported errors and vulnerability testing of current systems

Importance Medication computerised provider order entry (CPOE) has been shown to decrease errors and is being widely adopted. However, CPOE also has potential for introducing or contributing to errors. Objectives The objectives of this study are to (a) analyse medication error reports where CPOE was reported as a ‘contributing cause’ and (b) develop ‘use cases’ based on these reports to test vulnerability of current CPOE systems to these errors. Methods A review of medication errors reported to United States Pharmacopeia MEDMARX reporting system was made, and a taxonomy was developed for CPOE-related errors. For each error we evaluated what went wrong and why and identified potential prevention strategies and recurring error scenarios. These scenarios were then used to test vulnerability of leading CPOE systems, asking typical users to enter these erroneous orders to assess the degree to which these problematic orders could be entered. Results Between 2003 and 2010, 1.04 million medication errors were reported to MEDMARX, of which 63 040 were reported as CPOE related. A review of 10 060 CPOE-related cases was used to derive 101 codes describing what went wrong, 67 codes describing reasons why errors occurred, 73 codes describing potential prevention strategies and 21 codes describing recurring error scenarios. Ability to enter these erroneous order scenarios was tested on 13 CPOE systems at 16 sites. Overall, 298 (79.5%) of the erroneous orders were able to be entered including 100 (28.0%) being ‘easily’ placed, another 101 (28.3%) with only minor workarounds and no warnings. Conclusions and relevance Medication error reports provide valuable information for understanding CPOE-related errors. Reports were useful for developing taxonomy and identifying recurring errors to which current CPOE systems are vulnerable. Enhanced monitoring, reporting and testing of CPOE systems are important to improve CPOE safety.

Lessons learned from implementation of computerized provider order entry in 5 community hospitals: a qualitative study

BackgroundComputerized Provider Order Entry (CPOE) can improve patient safety, quality and efficiency, but hospitals face a host of barriers to adopting CPOE, ranging from resistance among physicians to the cost of the systems. In response to the incentives for meaningful use of health information technology and other market forces, hospitals in the United States are increasingly moving toward the adoption of CPOE. The purpose of this study was to characterize the experiences of hospitals that have successfully implemented CPOE.MethodsWe used a qualitative approach to observe clinical activities and capture the experiences of physicians, nurses, pharmacists and administrators at five community hospitals in Massachusetts (USA) that adopted CPOE in the past few years. We conducted formal, structured observations of care processes in diverse inpatient settings within each of the hospitals and completed in-depth, semi-structured interviews with clinicians and staff by telephone. After transcribing the audiorecorded interviews, we analyzed the content of the transcripts iteratively, guided by principles of the Immersion and Crystallization analytic approach. Our objective was to identify attitudes, behaviors and experiences that would constitute useful lessons for other hospitals embarking on CPOE implementation.ResultsAnalysis of observations and interviews resulted in findings about the CPOE implementation process in five domains: governance, preparation, support, perceptions and consequences. Successful institutions implemented clear organizational decision-making mechanisms that involved clinicians (governance). They anticipated the need for education and training of a wide range of users (preparation). These hospitals deployed ample human resources for live, in-person training and support during implementation. Successful implementation hinged on the ability of clinical leaders to address and manage perceptions and the fear of change. Implementation proceeded smoothly when institutions identified and anticipated the consequences of the change.ConclusionsThe lessons learned in the five domains identified in this study may be useful for other community hospitals embarking on CPOE adoption.

Impact of Vendor Computerized Physician Order Entry in Community Hospitals

ABSTRACTBACKGROUNDIt is uncertain if computerized physician order entry (CPOE) systems are effective at reducing adverse drug event (ADE) rates in community hospitals, where mainly vendor-developed applications are used.OBJECTIVETo evaluate the impact of vendor CPOE systems on the frequency of ADEs.DESIGN AND PATIENTSProspective before-and-after study conducted from January 2005 to September 2010 at five Massachusetts community hospitals. Participants were adults admitted during the study period. A total of 2,000 charts were reviewed for orders, medication lists, laboratory reports, admission histories, notes, discharge summaries, and flow sheets.MAIN MEASURESThe primary outcome measure was the rate of preventable ADEs. Rates of potential ADEs and overall ADEs were secondary outcomes.KEY RESULTSThe rate of preventable ADEs decreased following implementation (10.6/100 vs. 7.0/100 admissions; p = 0.007) with a similar effect observed at each site. However, the associated decrease in preventable ADEs was balanced against an increase in potential ADEs (44.4/100 vs. 57.5/100 admissions; p < 0.001). We observed a reduction of 34.0% for preventable ADEs, but an increase of 29.5% in potential ADEs following implementation. The overall rate of ADEs increased (14.6/100 vs. 18.7/100 admissions; p = 0.03), which was driven by non-preventable events (4.0/100 vs. 11.7/100 admissions; p < 0.001).CONCLUSIONSAdoption of vendor CPOE systems was associated with a decrease in the preventable ADE rate by a third, although the rates of potential ADEs and overall ADEs increased. Our findings support the use of vendor CPOE systems as a means to reduce drug-related injury and harm. The potential ADE rate could be reduced by making refinements to the vendor applications and their associated decision support.

Workshop: Anticoagulation clinic care versus routine medical care: A review and interim report

The available data describing the impact of anticoagulation clinics (ACC) on complication rates is reviewed, and an interim report of an ongoing study is presented. Early reports of low complication rates with ACCs were uncontrolled descriptive reports. The findings of later controlled trials were limited because the prothrombin time ratio (PTR) rather than the International Normalized Ratio (INR) was used. Three of four INR-based studies found that the use of an ACC reduced complication rates by 70–90%. The study described in this report is an ongoing evaluation of the complication rates and associated health care costs among two inception cohorts in a university-based clinic. Patients started on warfarin during 20 months before the ACC opened are compared with patients started on warfarin (and enrolled in the ACC) after the ACC opened. Complication rates, hospitalisations, and emergency room visits appear to be reduced by 65–80% in the ACC group, and this equates to a saving in health care costs of approximately

Reduced Quality of Life in Veterans at Risk for Drug-Related Problems

1200 per patient per year.