A Comprehensive Review of Methods to Measure Oral Oncolytic Dose Intensity Using Retrospective Data.

BACKGROUND: Understanding the real-world use of oral oncolytics is essential to assess drug effectiveness. Retrospective analyses using medical and pharmacy claims data allow observation of drug use patterns and health outcomes. However, studies of medication adherence to oral oncolytics may not be sufficient in characterizing exposure because they typically measure refill frequency, not the administered dose or dose changes. Patients who appear fully adherent by traditional measures may be receiving different doses and experiencing differing effectiveness. Relative dose intensity (RDI) is a measure that has been used for intravenous drugs to capture the amount of a particular chemotherapeutic agent administered per unit of time (dose intensity), expressed as the fraction of the amount recommended in evidence-based guidelines. Such a measure would be useful for real-world studies of comparative effectiveness to characterize patient exposure to oral oncolytics. OBJECTIVE: To identify studies that used administrative claims data to measure real-world oral oncolytic dose intensity, RDI, or similar constructs. METHODS: Two health sciences librarians conducted a literature search (PubMed, January 1, 1809-February 6, 2018) including terms in each of the following concept areas: oncology drugs, dosage, and retrospective data sources. At least 2 reviewers scanned each title and abstract of publications retrieved from PubMed. Abstracts that indicated the study reported dose or related concepts and oral oncolytics using retrospective data sources were marked for full-text review. During full-text review, papers were excluded if they did not study oral oncolytics (i.e., only described intravenous chemotherapy); if they did not report drug dosage; or if the study was not retrospective. Resulting studies were included for full-text data extraction. RESULTS: Of the 1,640 publications returned from the search, 41 were marked for full-text review. Full-text review established that 17 studies addressed a concept related to dose of oral oncolytics using retrospective data. Twenty-four studies were excluded: 11 did not measure dose; 9 did not study oral oncolytics; and 4 were not retrospective studies. Among the 17 articles marked for extraction, 5 articles reported dose intensity or RDI using medical records or electronic health record (EHR) data. CONCLUSIONS: This study reveals not only the need for a claims-based measure of dose intensity for oral oncolytics, but also provides a basis for the development of such a measure based on previous EHR-based studies. While several claims data studies have characterized oral oncolytic dosing and duration, we found that no studies combined these dimensions into a single measure such as dose intensity. Methods using EHR data may be translatable to a claims data study. Future research is needed to develop and validate such measures. DISCLOSURES: Novartis Pharmaceuticals provided funding for this study and is a manufacturer of oral onalytics, which is under study in this article. Arcona and Zacker are employees of Novartis. Slejko reports grants from PhRMA, PhRMA Foundation, and Takeda Pharmaceuticals and consulting fees from Pfizer, outside the submitted work. Stuart reports consulting fees from the University of Maryland during the study. The other authors have nothing to disclose. The preliminary findings of this study were presented in a poster at AMCP Nexus 2018, October 22-25, 2018, in Orlando, FL.

Cluster analysis and its application to healthcare claims data: a study of end-stage renal disease patients who initiated hemodialysis.

BACKGROUND: Cluster analysis (CA) is a frequently used applied statistical technique that helps to reveal hidden structures and "clusters" found in large data sets. However, this method has not been widely used in large healthcare claims databases where the distribution of expenditure data is commonly severely skewed. The purpose of this study was to identify cost change patterns of patients with end-stage renal disease (ESRD) who initiated hemodialysis (HD) by applying different clustering methods. METHODS: A retrospective, cross-sectional, observational study was conducted using the Truven Health MarketScan® Research Databases. Patients aged ≥18 years with ≥2 ESRD diagnoses who initiated HD between 2008 and 2010 were included. The K-means CA method and hierarchical CA with various linkage methods were applied to all-cause costs within baseline (12-months pre-HD) and follow-up periods (12-months post-HD) to identify clusters. Demographic, clinical, and cost information was extracted from both periods, and then examined by cluster. RESULTS: A total of 18,380 patients were identified. Meaningful all-cause cost clusters were generated using K-means CA and hierarchical CA with either flexible beta or Ward's methods. Based on cluster sample sizes and change of cost patterns, the K-means CA method and 4 clusters were selected: Cluster 1: Average to High (n = 113); Cluster 2: Very High to High (n = 89); Cluster 3: Average to Average (n = 16,624); or Cluster 4: Increasing Costs, High at Both Points (n = 1554). Median cost changes in the 12-month pre-HD and post-HD periods increased from $185,070 to $884,605 for Cluster 1 (Average to High), decreased from $910,930 to $157,997 for Cluster 2 (Very High to High), were relatively stable and remained low from $15,168 to $13,026 for Cluster 3 (Average to Average), and increased from $57,909 to $193,140 for Cluster 4 (Increasing Costs, High at Both Points). Relatively stable costs after starting HD were associated with more stable scores on comorbidity index scores from the pre-and post-HD periods, while increasing costs were associated with more sharply increasing comorbidity scores. CONCLUSIONS: The K-means CA method appeared to be the most appropriate in healthcare claims data with highly skewed cost information when taking into account both change of cost patterns and sample size in the smallest cluster.

Assessing the importance of predictors in unplanned hospital readmissions for chronic obstructive pulmonary disease.

PURPOSE: The all-cause readmission rate within 30 days of index admissions for chronic obstructive pulmonary disease (COPD) was approximately 21% in the United States in 2008. This study aimed to examine patient and clinical characteristics predicting 30-day unplanned readmissions for an initial COPD hospitalization and to determine those predictors' importance. PATIENTS AND METHODS: A retrospective study was conducted in patients with COPD-related hospitalizations using commercial claims data from 2010 to 2012. The primary outcome was all-cause unplanned readmission, with secondary outcomes being COPD as primary diagnosis and COPD as any diagnosis unplanned readmissions. Factors predicting unplanned readmissions encompassed demographic, pharmacy, and medical variables identified at baseline and during the index hospitalization. Dominance analysis was conducted to rank the predictors in terms of importance, defined as the contribution to change in model fit of a predictor by itself and in combination with other predictors. RESULTS: After applying the inclusion and exclusion criteria, 18,282 patients with index COPD-related admissions were identified. Among them, the rates of unplanned readmissions with COPD as primary diagnosis, COPD as any diagnosis, and all-cause were 2.6%, 5.6%, and 7.3%, respectively. For each outcome, the readmission group was slightly older, had a greater COPD severity score, and required a longer length of stay. Moreover, the readmission group had larger proportions of patients with comorbidities, dyspnea/shortness of breath, intensive care unit stay, or ventilator use, compared to the non-readmission group. Dominance analysis revealed that the three most important predictors - heart failure/heart disease, anemia, and COPD severity score - accounted for 56% of the predicted variance in all-cause unplanned readmissions. CONCLUSION: Overall, COPD severity score and heart failure/heart disease emerged as important factors in predicting 30-day unplanned readmissions across all three outcomes. Results from dominance analysis suggest looking beyond COPD-specific complications and focusing on comorbid conditions highly associated with COPD in order to lower all-cause unplanned readmissions.

Costs and health care resource utilization among chronic obstructive pulmonary disease patients with newly acquired pneumonia.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are at increased risk for lung infections and other pathologies (eg, pneumonia); however, few studies have evaluated the impact of pneumonia on health care resource utilization and costs in this population. The purpose of this study was to estimate health care resource utilization and costs among COPD patients with newly acquired pneumonia compared to those without pneumonia. METHODS: A retrospective claims analysis using Truven MarketScan(®) Commercial and Medicare databases was conducted. COPD patients with and without newly acquired pneumonia diagnosed between January 1, 2004 and September 30, 2011 were identified. Propensity score matching was used to create a 1:1 matched cohort. Patient demographics, comorbidities (measured by Charlson Comorbidity Index), and medication use were evaluated before and after matching. Health care resource utilization (ie, hospitalizations, emergency room [ER] and outpatient visits), and associated health care costs were assessed during the 12-month follow-up. Logistic regression was conducted to evaluate the risk of hospitalization and ER visits, and gamma regression models and two-part models compared health care costs between groups after matching. RESULTS: In the baseline cohort (N=467,578), patients with newly acquired pneumonia were older (mean age: 70 versus [vs] 63 years) and had higher Charlson Comorbidity Index scores (3.3 vs 2.6) than patients without pneumonia. After propensity score matching, the pneumonia cohort was nine times more likely to have a hospitalization (odds ratio; 95% confidence intervals [CI] =9.2; 8.9, 9.4) and four times more likely to have an ER visit (odds ratio; 95% CI =4.4; 4.3, 4.5) over the 12-month follow-up period compared to the control cohort. The estimated 12-month mean hospitalization costs ($14,353 [95% CI: $14,037-$14,690]), outpatient costs ($6,891 [95% CI: $6,706-$7,070]), and prescription drug costs ($1,104 [95% CI: $1,054-$1,142]) were higher in the pneumonia cohort than in the control cohort. CONCLUSION: This study demonstrated elevated health care resource use and costs in patients with COPD after acquiring pneumonia compared to those without pneumonia.

Enteric-coated mycophenolate sodium versus mycophenolate mofetil maintenance immunosuppression: outcomes analysis of the United Network for Organ Sharing/Organ Procurement and Transplantation Network database.

BACKGROUND: A large, retrospective database analysis was conducted to evaluate the long-term outcomes of patients who received enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) maintenance immunosuppression at the time of discharge. METHODS: All primary kidney transplant patients who received either EC-MPS or MMF at time of discharge in the United Network for Organ Sharing/Organ Procurement and Transplantation Network database from 2004 to 2007 were included. Patients were excluded if they had received a previous kidney transplant, multiple organs, or combination therapy with everolimus at the time of discharge. Outcomes included graft failure, death-censored graft failure, and death with functioning graft, biopsy-proven acute rejection (BPAR), new-onset diabetes mellitus, and renal function. The propensity score method was used to adjust for nonrandomized treatment selection. A total of 48,458 patients were included in the analysis. RESULTS: At time of discharge, 10.4% of patients received EC-MPS (n=5057) and 89.6% received MMF (n=43,401). Propensity score-adjusted regression analysis showed that patients who received EC-MPS were at increased risk of BPAR (hazards ratio, 1.167; 95% confidence interval, 1.056-1.129; P=0.002). CONCLUSIONS: The adjusted BPAR rate difference at 3 years posttransplantation was less than 2% (13.6% vs. 11.7%); statistically significant because of the large number of patients included in the analysis, but a difference that may not be clinically meaningful. No differences in graft survival, new-onset diabetes mellitus, or renal function were observed between the treatment groups.

Comparing outcomes associated with dose manipulations of enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients.

BACKGROUND: This study assessed the incidence of reported gastrointestinal (GI) complications in patients treated with enteric-coated mycophenolate sodium (EC-MPS) versus mycophenolate mofetil (MMF) and to examine the impact of dose manipulations on biopsy-proven acute rejection (BPAR). METHODS: A retrospective study was conducted in 379 renal transplant recipients initiated on EC-MPS or MMF through 3-months posttransplant between the years of 2001 to 2007. Descriptive univariate analyses were used for comparisons of baseline characteristics and outcome measures between the cohorts. A Cox proportional hazards model was used to evaluate the time to a first BPAR event. RESULTS: GI complications occurred at an incidence of 52.8% and 48.9% in the EC-MPS and MMF cohorts, respectively (NS). Patients requiring dose manipulations due to GI complications were 19.7% with EC-MPS and 25.3% with MMF (NS). The mean equimolar dose reduction below 2000 mg was 930+/-292.13 mg with EC-MPS and 933+/-173.95 mg with MMF (NS). Patients treated with EC-MPS experienced significantly fewer BPAR episodes than those treated with MMF (14% EC-MPS vs. 23.1% MMF; P =0.0221). CONCLUSIONS: In this study, EC-MPS had a similar incidence of GI complications and dose manipulations compared with MMF. Despite similar GI complication rates and dose manipulations, treatment with EC-MPS seemed to result in a lower incidence of BPAR. Based on these observations, more studies need to be conducted to evaluate risks for BPAR relating to mycophenolic acid product.

Patterns of psychotropic drug prescription for U.S. patients with diagnoses of bipolar disorders.

OBJECTIVE: Bipolar disorders are prevalent major illnesses with high rates of morbidity, comorbidity, disability, and mortality. A growing number of psychotropic drugs are used to treat bipolar disorder, often off-label and in untested, complex combinations. METHODS: To quantify utilization rates for psychotropic drug classes, this study used the 2002-2003 U.S. national MarketScan research databases to identify 7,760 persons with ICD-9 bipolar disorder subtypes. Survival analysis was used to estimate times until initial monotherapies were augmented, changed, or discontinued. RESULTS: The most commonly prescribed first drug class was antidepressants (50% of patients), followed by mood stabilizers (25%: anticonvulsants, 17%, and lithium, 8%), sedatives (15%), and antipsychotics (11%). At study midpoint only 44% of patients were receiving monotherapy. Those receiving monotherapy were ranked by initial drug prescribed and percentage of patients (bipolar I and bipolar II): antidepressants (55% and 65%), lithium (51% and 41%), antipsychotics (32% and 31%), anticonvulsants (28% and 29%), and sedatives (28%, 25%). Median time to adding another psychotropic was 2.5-times less than median time to changing the initial treatment (16.4 compared with 40.9 weeks), and stopping was rare. Median weeks until therapy was changed in any way for 25% of patients was as follows: lithium, 29 weeks; antidepressants, 13; anticonvulsants, 13; antipsychotics, 13; and sedatives, 9. CONCLUSIONS: Antidepressants were the first-choice agent twice as often as mood stabilizers. Lithium was sustained longer than monotherapy with other mood stabilizers. Time to augmentation was much shorter than time to change or discontinuation.

Drug persistency of two cholinesterase inhibitors: rivastigmine versus donepezil in elderly patients with Alzheimer's disease.

OBJECTIVES: To compare persistency rates and persistency days in patients with Alzheimer's disease (AD) who initiated therapy with either rivastigmine or donepezil, and to identify factors influencing persistency in a real-world setting. DESIGN AND METHODS: This study used data collected by MarketScan from 1 January 1999 to 31 December 2002. Patients were included if they were newly diagnosed with AD and filled at least one prescription for rivastigmine or donepezil between 1 July 2000 and 30 June 2001, were > or =65 years of age on the index prescription date, and had continuous health and prescription insurance during the entire study period. Patients were excluded if they filled a prescription for any cholinesterase inhibitor during the 18 months prior to initiation of the study drugs. Patients who refilled their initial cholinesterase inhibitor prescription within a permissible gap of 60 days after depleting the drug supply from the prior prescription were considered to be persistent. Sensitivity analysis was performed to test the robustness of the persistency definition. The Kaplan-Meier method was used to determine persistency rates across time and Cox proportional hazards models were used to estimate relative risks of discontinuation or switch with adjustment for other covariates, and to identify factors significantly influencing persistency of the study drugs. RESULTS: Of the newly treated AD patients, the proportion of rivastigmine and donepezil patients who continued their medication was the same (47%; p = 0.5). On average, rivastigmine users continuously used their medication for 234 days (median 312 days) while those taking donepezil used their medication for 235 days (median 315 days) [p = 0.91]. Patients were more likely to discontinue or switch their initial cholinesterase inhibitor if they used a central nervous system (CNS) medication before initiation of therapy (relative risk [RR] = 1.23; 95% CI 1.01, 1.51 without adjustment for study variables; RR = 1.30; 95% CI 1.05, 1.60 with adjustment for study variables). On the other hand, patients were less likely to discontinue their cholinesterase inhibitor if they visited their physician office frequently (RR = 0.24; 95% CI 0.18, 0.32 without adjustment; RR = 0.23; 95% CI 0.17, 0.30 with adjustment) or if they were hospitalised after initiation of their cholinesterase inhibitor therapy (RR = 0.60; 95% CI 0.39, 0.91 without adjustment; RR = 0.65; 95% CI 0.42, 0.99 with adjustment). CONCLUSION: Patients who were newly diagnosed with AD and initiated therapy with either rivastigmine or donepezil had similar levels of persistency with their initial AD therapy in a real-world setting.

The use of the occupational disruptiveness scale of the neuropsychiatric inventory-nursing home version to measure the impact of rivastigmine on the disruptive behavior of nursing home residents with Alzheimer's disease.

OBJECTIVES: The Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) was used to study the impact of rivastigmine (Exelon; Novartis Pharmaceuticals Corporation, East Hanover, NJ), on occupational disruptiveness (OD), a proxy measure for professional caregiver burden. METHODS: The study was a prospective, multicenter, open-label, single-arm trial with NH residents prescribed rivastigmine (up to 6 mg bid) for Alzheimer's disease (AD) treatment. The NPI-NH was completed by NH staff caregivers at time of initiation of treatment with rivastigmine (T1), at treatment weeks 10 to 14 (T2), at treatment weeks 24 to 28 (T3), and at treatment weeks 50 to 54 (T4). RESULTS: Observations ranged from 173 at baseline to 73 at week 52. All but one patient had either moderate or severe dementia. Total OD score means were 4.7 +/- 6.1, 3.9 +/- 5.0, 4.19 +/- 5.6, and 2.79 +/- 2.8 at baseline, and weeks 12, 26, and 52 (T1-T4), respectively, with significant difference found between T1 and T4. Except for euphoria and disinhibition at T3 and T4, all correlations between OD scores and the domain scores of the NPI, were significant. Rivastigmine dose was an independent variable that affected OD change. CONCLUSION: Treatment with rivastigmine was associated with a reduction in the self-reported professional caregiver burden, as assessed by the NPI-NH OD scale.

Impact of rivastigmine use on the risk of nursing home placement in a US sample.

INTRODUCTION: Although numerous studies have evaluated predictors of nursing home placement (NHP), few have focused on the effects of cholinesterase inhibitor (ChEI) use on NHP. The objective of this study was to compare the risk of NHP between rivastigmine patients versus no-ChEI patients (control group), and secondly, between rivastigmine versus donepezil patients. METHODS: A retrospective analysis of a large US medical claims database was performed. Eligible subjects were identified from those who had continuous medical coverage from 1 April 2000 to 30 June 2002. Rivastigmine and donepezil subjects were new users, defined as having received no ChEI treatment during the initial 6 months of the study. Control subjects were diagnosed with Alzheimer's disease (AD) at some point after the initial 6-month period. All subjects were followed from baseline (initiation of ChEI therapy or initial AD diagnosis) to the date of NHP or 30 June 2002, whichever occurred first. RESULTS: In the rivastigmine (n=1181), donepezil (n=3864), and control (n=517) groups, 3.7%, 4.4% and 11.0% of subjects, respectively, had an NHP (p <0.001 for rivastigmine versus control). A Cox proportional hazard model, controlling for age, gender, comorbidities and behavioural disorders, showed that the control subjects were almost 3-fold more likely to have NHP than rivastigmine subjects (hazard ratio [HR]=2.71; 95% CI 1.82, 4.03). The difference in the risk of NHP was not significant between the rivastigmine and donepezil groups (HR=1.23; 95% CI 0.89, 1.71). DISCUSSION: This study demonstrated that rivastigmine decreased the risk of NHP in a large insured population.

Correlates of hypertension control in a primary care setting.

BACKGROUND: Numerous clinical trials have demonstrated reduction in cardiovascular events as a result of lowering blood pressure (BP). Despite these findings, BP control rates, especially in primary care settings, remain suboptimal. This study describes hypertension control and its predictors, using data from a sample of 631 adult patients drawn from an established primary care practice. METHODS: Data were obtained through chart review and patient survey during a 3-month period. The BP control was the outcome in a logistic regression model identifying demographic and clinical predictors of control. RESULTS: Compared to patients with low Framingham Risk Scores (FRS), individuals with moderate and high scores had reduced odds of achieving control (69% reduction, 95% confidence interval [CI] 0.19-0.65; 82% reduction, 95% CI 0.10-0.36, respectively). Being female reduced the odds of control by 61% (95% CI 0.26-0.66). Having diabetes mellitus (DM) (95% CI 0.21-0.79) or impaired fasting glucose (IFG; fasting glucose >109 but <126 mg/dL) (95% CI 0.10-0.40) reduced the odds of control by 64% and 82%, respectively. For each additional point on a physician-rated patient knowledge scale, the odds of having controlled BP increased 78% (95% CI 1.44-2.56). Each additional co-morbid condition positively associated with control (34% increase in odds, 95% CI 1.15-1.86). Age (95% CI 0.98-1.02) and body mass index (BMI) (95% CI 0.97-1.04) had no effect. CONCLUSIONS: Higher FRS, female sex, DM, and IFG negatively correlated with control. Patient knowledge and number of co-morbid conditions correlated positively. Age and BMI did not correlate with control. The most disturbing finding in our study was that higher risk patients who stand to benefit most from BP control were least likely to be controlled, despite being on more antihypertensive medications. These findings may be helpful to primary care providers in reaching patient hypertension control goals.

Risk of antipsychotic drug use in patients with Alzheimer's disease treated with rivastigmine.

BACKGROUND AND OBJECTIVE: Cholinesterase inhibitors may offer some improvement in the behavioural symptoms of Alzheimer's disease. The dual inhibitory mechanism of action of rivastigmine (inhibition of acetylcholinesterase and butyrylcholinesterase) may improve behavioural symptoms and may delay the need for antipsychotics. This study was conducted to investigate the effect of rivastigmine on the time to first antipsychotic drug use among patients with Alzheimer's disease, compared with patients with Alzheimer's disease not treated with a cholinesterase inhibitor. DESIGN AND METHODS: This study used MarketScan research databases from 1 January 1999 to 31 March 2002. Patients were included if they: (a). were diagnosed with Alzheimer's disease on two occasions or filled a prescription for rivastigmine for the first time during the index period from 1 July 2000 to 31 December 2001; (b). were 65 years of age and older; (c). had continuous health and prescription insurance coverage during the entire study period; and (d). had not used an antipsychotic medication within 18 months prior to their index Alzheimer's disease prescription or diagnosis. The 'no cholinesterase inhibitor' group included patients who were newly diagnosed with Alzheimer's disease, but did not use any cholinesterase inhibitors. Chi-square, Student's t-, and log-rank tests were used to test differences in study variables between groups. Cox proportional hazards models were used to estimate predicted risk of first antipsychotic drug use. RESULTS: The study included 497 patients in the rivastigmine group and 749 patients in the 'no cholinesterase inhibitor' group. The rivastigmine group patients were younger compared with the 'no cholinesterase inhibitor' group patients (p < 0.01). The overall usage of antipsychotics was considerably lower for patients taking rivastigmine (9.8%) compared with those not taking cholinesterase inhibitors (25.6%). Patients taking rivastigmine were 64% less likely (relative risk = 0.36; p < 0.0001) to take antipsychotics compared with patients not taking cholinesterase inhibitors, after adjusting for demographic covariates, comorbid conditions, and use of other CNS drugs and anticonvulsants. Age was the only other factor that influenced antipsychotic use; older patients were significantly more likely to start antipsychotics than younger patients. CONCLUSION: This study provides initial evidence that patients with Alzheimer's disease treated with rivastigmine have a reduced risk of initiating therapy with an antipsychotic drug compared with patients who receive no cholinesterase inhibitor treatment. These findings may imply that rivastigmine use could delay the onset of behavioural symptoms that require treatment with antipsychotic medications.

Gastrointestinal adverse events in a general population sample of nursing home residents taking cholinesterase inhibitors.

OBJECTIVE: To assess the occurrence of gastrointestinal (GI) adverse events in a national sample of nursing home residents taking donepezil, galantamine, or rivastigmine. DESIGN: A retrospective analysis of the Minimum Data Set (MDS) was performed. SETTING: Four hundred-fifty-two nursing facilities across the United States. PARTICIPANTS/INTERVENTIONS: During 2000, 2001, and 2002, eligible residents began donepezil, galantamine, or rivastigmine monotherapy. Among these treatment groups, 5,846, 750, and 1,672 residents, respectively, were included in the analysis. All MDS assessments were analyzed if completed. Analyses were conducted at baseline and within one year of initiating therapy. MAIN OUTCOME MEASURES: Occurrence of vomiting, stomach pain, diarrhea, weight loss, and insomnia. RESULTS: Overall, GI adverse events ranged from 2% to 9% and were comparable among the groups. Residents taking galantamine were more likely to experience diarrhea relative to those taking rivastigmine or donepezil (8.9% versus 6.8% versus 6.4%, respectively; P = 0.035), and less likely to lose weight relative to these groups (15.6% versus 20.0% versus 20.3%, respectively; P = 0.01). GI adverse events were less frequent during the maintenance phase compared with the initial drug-titration phase. CONCLUSION: GI events generally occurred with similar frequency in a national sample of nursing home residents taking donepezil, galantamine, or rivastigmine in the usual clinical practice setting.

National prescribing patterns in the management of extrapyramidal symptoms among patients with schizophrenia.

PURPOSE: Antipsychotics, particularly typical agents, have been shown to cause extrapyramidal symptoms (EPS). We hypothesized a negative association between concomitant (at same visit) prescriptions for atypical antipsychotics and prescriptions for medications to manage EPS. METHOD: We combined National Ambulatory Medical Care Survey (NAMCS) data from 1993 through 1999 for visits by patients with a diagnosis of schizophrenia (ICD-9 295.0-295.9), that included a prescription for either an atypical or typical antipsychotic (but not both). We also constructed two, scale-weighted logistic regression models to separately estimate the odds and probabilities of receiving prescriptions for an antipsychotic and for a medication used to treat EPS. RESULTS: From 1993 through 1999, there were an estimated 10,475,507 office visits with schizophrenia as a diagnosis; 7,371,625 (70.4 percent) included a prescription for a conventional (typical) antipsychotic. Thirty-four percent of visits included a prescription for a medication used to treat EPS. Being in the older age group, having Medicaid as primary coverage, belonging to an HMO, and being female significantly reduced the probability of receiving an atypical antipsychotic by 12.6 percent, 10.9 percent, 15.1 percent and 10.2 percent, respectively. Caucasian patients were 14 percent more likely to be prescribed an atypical. Antipsychotic type had a clinically and statistically significant effect on EPS management prescribing. A prescription for an atypical antipsychotic reduced the probability of receiving a concomitant prescription for EPS management by 26.8 percent. CONCLUSION: As expected, we observed the hypothesized joint prescribing pattern. The results ofthis study suggest that atypical antipsychotic prescriptions strongly predict fewer prescriptions for EPS treatment, and, by implication, reduced need for EPS treatment in actual ambulatory care practices throughout the nation.

Improving guideline compliance: assessment of unit-based reminder for monitoring platelet counts post-PCI.

In assessing our institution's vascular access site bleeding complication rate, we found (anecdotally) that for many patients platelet count was not measured according to recommendations of the manufacturer of the predominantly used glycoprotein (GP) IIb/IIIa agents, in either the catheterization recovery unit (CRU) or the coronary care unit (CCU). We hypothesized that a unit-focused effort to remind cardiologists to order platelet counts after percutaneous coronary interventions GP IIb/IIIa would improve compliance. Findings indicated that a greater number of patients had platelet counts drawn after a reminder effort had been implemented. For both the first and second draws, the CCU had a higher pre-reminder rate than the CRU. Post-reminder, the CCU had no significant changes, whereas the CRU showed significant increases in both the first and second draws. For post GP IIb/IIIa platelet measurement, aggregate analysis (CRU and CCU) showed that, of those patients who had platelet counts drawn pre-reminder, only 18.2% met the first guideline and only 17.1% met the second. Post-reminder results showed no significant changes for the first or second draws. We concluded that the practical application of a standard operating procedure can have a secondary beneficial effect despite not meeting the stringent parameters set in prescribing guidelines.