Background Adults with autism spectrum disorder ( ASD ) frequently experience polypharmacy. However, there is limited understanding of how to quantify medication complexity in this vulnerable population. Objectives This study examined medication administration difficulty using the Medication Regimen Complexity Index ( MRCI ) tool in adolescents and adults with ASD . The outcomes compared the mean total MRCI score with the medication count, described MRCI contributions for over‐the‐counter medication ( OTC ), and compared MRCI scores by patient characteristics. Methods This was a retrospective chart review of patients aged 7–45 years (mean = 20.1) enrolled in a primary care ASD transitions program. Each patient's listed medications were counted and then scored using the validated MRCI tool. Results For the 142 patients studied, mean total MRCI was 14.6 ± 14.6 (range 0–89) and mean medication count was 6.3 ± 5.4 (range 0–38). For patients on 0–4 medications (66 of 142; 46.5%), the mean MRCI was 5.5 ± 4.2, 5–9 medications (50 of 142; 35.2%) the mean MRCI was 15.2 ± 6.8, and 10–38 medications (26 of 142; 18.3%) the mean MRCI was 36.5 ± 18.9 (p<0.001). Sixty percent (85 of 142) reported OTC use, which contributed 26.6% to the mean total MRCI . Reported benzodiazepine (mean MRCI 25.8 ± 17.2), antiepileptic (mean MRCI 23.7 ± 16.9), antipsychotic (mean MRCI 19.7 ± 15.9), or antidepressant (mean MRCI 17.0 ± 14.8) use received higher MRCI scores compared to nonuse (p<0.001 for all except antidepressants [p=0.004]). Total MRCI did not differ significantly by age group, sex, or attention‐deficit‐hyperactivity disorder ( ADHD ) medication use (stimulant or nonstimulant). Conclusions Medication regimen complexity in adolescents and adults with ASD was increased significantly for individuals taking ≥ 5 medications. Central nervous system agent use, other than ADHD therapy, identified patients with higher regimen complexity. The related clinical effects of these findings warrant further investigation.
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.
Various findings of the Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers (IMPROVE) study are reviewed. Suggestions for future methodologies that will enhance this study are discussed. The IMPROVE study is one of the largest pharmaceutical care studies conducted. Although it was an intervention study that examined global outcomes following management by pharmacists, it was designed as an effectiveness study. Several new practice and research methods were developed, including a method to identify patients at high risk for drug-related problems utilizing pharmacy databases, a method to identify chronic diseases using pharmacy databases, a method to evaluate the structure and process for delivering pharmaceutical care in Veterans Affairs medical centers (VAMCs), and guidelines for providing care to patients in the IMPROVE study. Nine VAMCs participated in the study, and 1054 patients were randomized to either an intervention group (n = 523) or a control group (n = 531). Pharmacists documented a total of 1855 contacts with the intervention group patients and made 3048 therapy-specific interventions over the 12-month study period. There was no meaningful difference in patient satisfaction or quality of life in the two groups. Selected disease-specific indicators found an improved rate of measurement of hemoglobin A1c tests and better control of total and low-density-lipoprotein (LDL) cholesterol levels in the intervention group compared with the control group. Total health care costs increased in both groups over the 12-month period. The mean increase in costs in the intervention group was $1020, which was lower than the control group's value of $1313. The lessons learned from the IMPROVE study suggest to future investigators how to study and measure the effects of clinical pharmacy services on patient outcome.
An ongoing study of the impact of ambulatory care clinical pharmacists on patient outcomes at selected Veterans Affairs medical centers (VAMCs) is described. The IMPROVE (Impact of Managed Pharmaceutical Care on Resource Utilization and Outcomes in Veterans Affairs Medical Centers) study will examine the effects of referring patients at high risk for drug-related problems to a pharmacist-managed monitoring program. Nine study sites from diverse geographic locations and small and large urban areas have been selected. Investigators visited each site to evaluate the structure of care, observe pharmacist-patient interactions, and assess the level and documentation of pharmacists' activities. A coordinating center will collect and process patient-specific data from the study sites to identify high-risk patients. It is expected that 500 intervention patients and 500 control patients from the nine VAMCs will complete all portions of the study. Intervention patients will be scheduled for medication assessments by ambulatory care pharmacists and will be monitored by pharmacists for at least 12 months. The coordinating center will track refill histories for intervention patients. Investigators will assess the activities performed by ambulatory care pharmacists to determine predictors of successful patient outcomes. The two groups will be compared with respect to change from baseline in quality of life and satisfaction with health care providers. A cost-benefit analysis will be undertaken to determine the impact of pharmaceutical care relative to total patient care costs. The main outcome results of the IMPROVE study are expected to be available in 1999. The IMPROVE project will be the first study of the impact of ambulatory care clinical pharmacists on patient outcomes.
Study Objective. To determine if clinical pharmacists could affect economic resource use and humanistic outcomes in an ambulatory, high‐risk population. Design. Prospective, randomized, controlled study. Setting. Nine Veterans Affairs medical centers. Patients. Patients who were at high risk for medication‐related problems. Intervention. Patients were randomized to usual medical care with input from a clinical pharmacist (intervention group) or just usual medical care (control group). Measurements and Main Results. Of 1054 patients enrolled, 523 were randomized to the intervention group and 531 to the control group. The number of clinic visits increased in the intervention group (p=0.003), but there was no difference in clinic costs. Mean increases in total health care costs were $1020 for the intervention group and $1313 for the control group (p=0.06). Conclusion. Including the cost of pharmacist interventions, overall health care expenditures were similar for patients randomized to see a clinical pharmacist versus usual medical care.
The pharmacokinetic actions, bioequivalence, and cardiovascular effects of two verapamil products were studied in a randomized, double‐blind, crossover study in eight elderly hypertensive patients (median age, 69.5 years; range, 60–79 years) given brand‐name or generic immediate‐release verapamil in 120‐mg twice‐daily doses for 14 days. Blood pressures, heart rates, P—R intervals, and serum concentrations of R‐/S‐verapamil and norverapamil were measured multiple times in patients during the last day of each therapy. Median blood pressure decreased more with generic verapamil than with the brand‐name drug, with the largest difference occurring at 0.5 hours (137/74 mmHg versus 144.5/80.5 mmHg; P = 0.05 and 0.091, respectively). Pharmacokinetic parameters were not different for the two products (P < 0.10). However, the generic product, compared with the brand‐name drug, had mean area under the concentration—time curve (time 0 to 12 hours) ratios (90% CI) of 1.09 (0.78–1.52), 1.16 (0.87–1.55) and 1.11 (0.81–1.52) for R‐, S‐, and total verapamil. Seventy concentration peaks (31 with the brand‐name drug, 39 with the generic drug) appeared between 8 and 24 hours. Median percentages of increase of these peaks, compared with those of previous concentrations, were 48.3% and 36.3% for brand‐name and generic drugs, respectively. Fifty of the 70 peaks (71%) were associated with a stereospecific concentration peak of norverapamil and, temporally, with meals. Our findings suggest that whereas the two verapamil products may not be bioequivalent by Food and Drug Administration criteria, the observed differences in effects were not clinically significant in this elderly population. Multiple concentration peaks after absorption were observed in all patients with both verapamil products and were perhaps related to enterohepatic recirculation.
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.
Pharmacogenomic testing: aiding in the management of psychotropic therapy for adolescents with autism spectrum disorders Seuli Bose-Brill,1 Jinming Xing,2 Debra J Barnette,1,2 Christopher Hanks1 1Internal Medicine and Pediatrics at Grandview, Wexner Medical Center, 2Department of Practice and Science, College of Pharmacy, The Ohio State University, Columbus, OH, USA Abstract: Adolescents with autism have higher rates of anxiety than the general adolescent population. They often struggle to express psychological symptoms verbally where their symptoms may manifest as withdrawal and agitation. Adolescent patients with autism have higher rates of polypharmacy and high-risk psychiatric medication use (eg, atypical antipsychotics) than other patients with psychiatric illness. Primary care pediatricians are at the front lines of psychiatric management for patients with autism. Yet, they have inadequate access to pediatric psychiatry for complex medication management. Pharmacogenomic testing can provide personalized drug metabolism profiles for a majority of psychotropic medications. Primary care based pharmacogenomic testing for adolescents with autism on one or more psychiatric medications may help individualize and optimize complex medication regimens, while promoting drug safety. Keywords: autism, pharmacogenomic, pharmacogenetic, pharmacotherapy, anxiety, depression, psychiatry, pediatrics
