Pharmacy technician involvement in community pharmacy medication therapy management.

OBJECTIVES: To assess the impact of technician involvement on the completion of medication therapy management (MTM) services in a community pharmacy setting and to describe pharmacists' and technicians' perceptions of technician involvement in MTM-related tasks and their satisfaction with the technician's role in MTM. DESIGN: Prospective observational study. SETTING AND PARTICIPANTS: In the fall of 2015, pharmacists and selected technicians from 32 grocery store-based community pharmacies were trained to use technicians within MTM services. MAIN OUTCOME MEASURES: Completed MTM claims were evaluated at all pharmacies for 3 months before training and 3 months after training. An electronic survey, developed with the use of competencies taught in the training and relevant published literature, was distributed via e-mail to trained employees 3 months after training. RESULTS: The total number of completed MTM claims at the 32 pharmacy sites was higher during the posttraining time period (2687 claims) versus the pretraining period (1735 claims). Of the 182 trained participants, 112 (61.5%) completed the survey. Overall, perceived technician involvement was lower than expected. However, identifying MTM opportunities was the most commonly reported technician MTM task, with 62.5% of technicians and 47.2% of pharmacists reporting technician involvement. Nearly one-half of technicians (42.5%) and pharmacists (44.0%) agreed or strongly agreed they were satisfied with the technician's role in MTM services, and 40.0% of technicians agreed that they were more satisfied with their work in the pharmacy after involvement in MTM. CONCLUSION: Three months after initial training of technicians in MTM, participation of technicians was lower than expected. However, the technicians involved most often reported identifying MTM opportunities for pharmacists, which may be a focus for future technician trainings. In addition, technician involvement in MTM services may increase satisfaction with many aspects of work for actively involved technicians.

SMN Blood Levels in a Porcine Model of Spinal Muscular Atrophy.

BACKGROUND: Spinal Muscular Atrophy (SMA) is an autosomal recessive motor neuron disease that results in loss of spinal motor neurons, muscular weakness and, in severe cases, respiratory failure and death. SMA is caused by a deletion or mutation of the SMN1 gene and retention of the SMN2 gene that leads to low SMN expression levels.The measurement of SMN mRNA levels in peripheral blood samples has been used in SMA clinical studies as a pharmacodynamic biomarker for response to therapies designed to increase SMN levels. We recently developed a postnatal porcine model of SMA by the viral delivery of a short-hairpin RNA (shRNA) targeting porcine SMN (pSMN). scAAV9-mediated knockdown of pSMN mRNA at postnatal day 5 results in denervation, weakness and motor neuron and ventral root axon loss that begins 3-4 weeks after viral delivery, and this phenotype can be ameliorated by subsequent viral delivery of human SMN (hSMN). OBJECTIVE: To determine if the effect of modulating SMN levels using gene therapy can be measured in blood. METHODS: We measured expression of pSMN mRNA and hSMN mRNA by quantitative droplet digital PCR (ddPCR). RESULTS: We found that the endogenous expression of pSMN mRNA in blood increases in the first month of life. However, there were no significant differences in blood levels of pSMN mRNA after knock-down or of human SMN mRNA after gene therapy. CONCLUSIONS: Our results, obtained in a large animal model of SMA that is similar in size and anatomy to human infants, suggest that measurement of SMN mRNA levels in blood may not be informative in SMA clinical trials involving intrathecal delivery of SMN-modulating therapies.

Pharmacotherapy in Conjunction with a Diet and Exercise Program for the Treatment of Weight Recidivism or Weight Loss Plateau Post-bariatric Surgery: a Retrospective Review.

BACKGROUND: Bariatric surgery is an effective therapeutic option for management of obesity. However, weight recidivism (WR) and weight loss plateau (WLP) are common problems. We present our experience with the use of two pharmacotherapies in conjunction with our standard diet and exercise program in those patients who experienced WR or WLP. METHODS: From June 2010 to April 2014, bariatric surgery patients who experienced WR or WLP after undergoing Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), and who were treated with phentermine (Ph) or phentermine-topiramate (PhT), were reviewed retrospectively. Generalized estimating equations were used to compare patient weights through 90 days between initial surgery type and medication type. Patient weights, medication side effect, and co-morbidities were collected during the first 90 days of therapy. RESULTS: Fifty-two patients received Ph while 13 patients received PhT. Overall, patients in both groups lost weight. Among those whose weights were recorded at 90 days, patients on Ph lost 6.35 kg (12.8% excess weight loss (EWL); 95% confidence interval (CI) 4.25, 8.44) and those prescribed PhT lost 3.81 kg (12.9% EWL; CI 1.08, 6.54). Adjusting for baseline weight, time since surgery, and visit through 90 days, patients treated with Ph weighed significantly less than those on PhT throughout the course of this study (1.35 kg lighter; 95% CI 0.17, 2.53; p = 0.025). There were no serious side effects reported. CONCLUSIONS: Phentermine and phentermine-topirimate in addition to diet and exercise appear to be viable options for weight loss in post-RYGB and LAGB patients who experience WR or WLP.

Prevalence of antipsychotic prescriptions among patients with anxiety disorders treated in inpatient and outpatient psychiatric settings.

BACKGROUND: An increasing number of prescribers are using antipsychotics for treatment of anxiety disorders, despite lack of FDA-approved indications and mixed efficacy results from clinical trials. The objective of this study was to examine the prevalence of antipsychotics prescription in psychiatric inpatients and outpatients with anxiety disorders. METHODS: This is a retrospective study of de-identified data from patients with a DSMIV-TR anxiety disorder diagnosis in an academic psychiatric setting in 2013. The final cohort of patients, after exclusion of bipolar/psychotic comorbidity, includes 1699 patients. Logistic regression models were used to explore associations between antipsychotic prescription and patient characteristics. RESULTS: Among non-psychotic/non-bipolar patients with anxiety disorder, 53.6% of inpatients and 16.6% of outpatients received antipsychotic medication. Rates varied with the disorder. Outpatients with post-traumatic stress disorder (OR: 2.24, 95% CI: 1.66-3.01) and obsessive compulsive disorder (OR: 2.80, 95% CI: 1.86-4.19) received antipsychotic prescriptions more often than those without these diagnoses. Comorbidity with depression was common while comorbidity with borderline personality disorder was rare; both increased odds of receiving prescription of antipsychotics (OR: 1.57, 95% CI: 1.16-2.12 for depression; OR: 2.63, 95% CI 1.42-4.88 for borderline personality disorder, respectively). Additionally, age was significantly associated with increased odds of being on an antipsychotic. Quetiapine and aripripazole were the most prescribed antipsychotics and very few patients received rescue medication for extrapyramidal symptoms. LIMITATIONS: Lack of specific indications for the psychotropic prescriptions. CONCLUSIONS: A substantial percentage of patients with anxiety disorders are prescribed antipsychotics, especially among inpatients. This practice may reflect the severity of the anxiety disorder or the high prevalence of comorbidity. Based on frequency of rescue medication prescription, treatment seemed well tolerated for extra-pyramidal neurological side-effects.

Magnetic resonance imaging fluid-attenuated inversion recovery sequence signal reduction after endoscopic endonasal transcribiform total resection of olfactory groove meningiomas.

BACKGROUND: Olfactory groove meningiomas grow insidiously and compress adjacent cerebral structures. Achieving complete removal without further damage to frontal lobes can be difficult. Microsurgical removal of large lesions is a challenging procedure and usually involves some brain retraction. The endoscopic endonasal approaches (EEAs) for tumors arising from the anterior fossa have been well described; however, their effect on the adjacent brain tissue has not. Herein, the authors utilized the magnetic resonance imaging fluid attenuated inversion recovery (FLAIR) sequence signal as a marker for edema and gliosis on pre- and post-operative images of olfactory groove meningiomas, thus presenting an objective parameter for brain injury after surgical manipulation. METHODS: Imaging of 18 olfactory groove meningiomas removed through EEAs was reviewed. Tumor and pre/postoperative FLAIR signal volumes were assessed utilizing the DICOM image viewer OsiriX(®). Inclusion criteria were: (1) No previous treatment; (2) EEA gross total removal; (3) no further treatment. RESULTS: There were 14 females and 4 males; the average age was 53.8 years (±8.85 years). Average tumor volume was 24.75 cm(3) (±23.26 cm(3), range 2.8-75.7 cm(3)), average preoperative FLAIR volume 31.17 cm(3) (±39.38 cm(3), range 0-127.5 cm(3)) and average postoperative change volume, 4.16 cm(3) (±6.18 cm(3), range 0-22.2 cm(3)). Average time of postoperative scanning was 6 months (range 0.14-20 months). In all cases (100%) gross total tumor removal was achieved. Nine patients (50%) had no postoperative FLAIR changes. In 2 patients (9%) there was minimal increase of changes postoperatively (2.2 cm(3) and 6 cm(3) respectively); all others demonstrated image improvement. The most common complication was postoperative cerebrospinal fluid leakage (27.8%); 1 patient (5.5%) died due to systemic complications and pulmonary sepsis. CONCLUSIONS: FLAIR signal changes tend to resolve after endonasal tumor resection and do not seem to worsen with this operative technique.

Effect of pulmonary hypertension on survival in patients with idiopathic pulmonary fibrosis after lung transplantation: an analysis of the United Network of Organ Sharing registry.

BACKGROUND: Pulmonary hypertension (PH) is a comorbidity associated with idiopathic pulmonary fibrosis (IPF). There is limited research regarding the effect on survival after lung transplantation (LTx). METHODS: To assess the effect of PH on survival in patients with IPF who received LTx, the United Network for Organ Sharing was queried for eligible patients with recorded mean (PAmean) and systolic (PAsystolic) pulmonary artery pressure. The analysis was restricted to the post-lung allocation scoring system starting May 1, 2005, to provide a cohort receiving present-day therapies and management. The last update of the data set was July 6, 2012, so a cutoff date of July 6, 2011, was chosen to allow for the possibility of at least 1 year of follow-up. Thresholds of ≥25 and ≥35 mm Hg were chosen for PAmean and PAsystolic, respectively, as indicators of PH. RESULTS: Of 23,951 LTxs in the UNOS data set, 2,542 met inclusion criteria, 1,234 (49%) with PAmean ≥ 25 mm Hg and 1,680 (66%) with PAsystolic ≥ 35 mm Hg. PAmean and PAsystolic were highly correlated, with an estimated correlation coefficient ρ = 0.93 (p < 0.001). Patients with PH (PAmean ≥ 25 mm Hg or PAsystolic ≥ 35 mm Hg) tended to have higher ischemic times, lung allocation score values, forced vital capacity percentage predicted at LTx, and supplemental oxygen requirement at rest values. In addition, a larger proportion of patients with PH was African American, male, had diabetes, and received bilateral LTx compared with single LTx. Comparing PAmean < 25 vs ≥ 25 mm Hg and PAsystolic < 35 vs ≥ 35 mm Hg, median survival in months was 60.4 (95% confidence interval [CI], 55.2-80.4) vs 61.4 (95% CI, 56.9-66.9; log-rank p = 0.876) and 57.6 (95% CI, 50.9-68.0) vs 64.3 (95% CI, 57.5-71.3; log-rank p = 0. 247), respectively. Hazard ratios for both definitions of PH from univariable and multivariable Cox proportional hazard models were close to 1 and none were statistically significant. CONCLUSIONS: On the basis of our models and despite PH being prevalent, there is no strong evidence suggesting that PH significantly alters the risk of death in IPF patients after LTx.

Survival benefit of induction immunosuppression in cystic fibrosis lung transplant recipients.

BACKGROUND: Despite resistant microbes, induction immunosuppression is used in patients with cystic fibrosis (CF) undergoing lung transplantation (LTx). METHODS: To evaluate the effect of induction immunosuppression on survival, the United Network for Organ Sharing (UNOS) was queried restricting analysis to transplant patients 6-55years old from 2001 to 2012, who received induction agents (INDUCED) or did not (NONE). RESULTS: A total of 1721 CF patients who underwent LTx were included in the analysis; of these 791 (46%) were INDUCED. Of the INDUCED patients, 65% received basiliximab, 10% alemtuzumab, and 25% thymoglobulin/anti-lymphocyte globulin/anti-thymocyte globulin. Mean age was 28.0years (SD=9.7) and 28.5 (SD=9.5) for the INDUCED and NONE groups, respectively. The median survival in the INDUCED group was 93.8months (95% CI: 73.8, --) compared to 61.8months (95% CI: 55.8-73.8) for the NONE group (log rank p-value <0.001). CONCLUSIONS: Antibody-based induction immunosuppression had a survival benefit in CF patients undergoing LTx.

Impact of pulmonary hypertension on survival in patients with cystic fibrosis undergoing lung transplantation: an analysis of the UNOS registry.

BACKGROUND: Pulmonary hypertension (PH) is a comorbidity reported in patients with cystic fibrosis (CF) with research limited to single-center studies. METHODS: To assess the impact of PH in patients with CF who received a lung transplant (LTx), the United Network for Organ Sharing was queried from 1987 to 2012, restricting analysis to transplant patients 6-55 years old between 1/1/2005 and 7/6/2011. RESULTS: Of 23,951 lung transplants, 1177 met inclusion criteria with 831 having mean pulmonary artery pressure (mPAP) data available. For the entire cohort, mean age was 30.3 (SD=9.2, range 12-55), and mean mPAP was 26.5 (SD = 7.8, range 5-66) mmHg. A total of 470 (57%) had PH defined as mPAP ≥ 25 mmHg. Comparing PH to non-PH groups, mean forced expiratory volume in one second (FEV1) was 24.4 (SD = 13.8) vs. 26 (SD=13.9) % of predicted, mean supplemental oxygen requirement at rest was 4.5 (SD = 4.1) vs. 3.7 (SD = 3.0) liters per minute, and mean lung allocation score was 49 (SD = 16) vs. 43 (SD = 12), respectively. For the PH group, median survival was 84.4 months compared to 67.1 months for the non-PH group (log-rank p-value = 0.326). The adjusted hazard ratio for PH vs. non-PH was 0.862 (95% CI: 0.653-1.138; p = 0.293), thus indicating no statistically significant effect of PH on survival. CONCLUSIONS: A high prevalence of PH was found in CF patients prior to LTx. Based on our models despite PH being prevalent, there is no strong evidence suggesting that it significantly alters the risk of death in CF patients after LTx.

A contemporary analysis of induction immunosuppression in pediatric lung transplant recipients.

There is an increasing trend in the use of induction immunosuppression in children undergoing lung transplantation (LTx). To evaluate the effect of this practice on survival, the United Network for Organ Sharing (UNOS) was queried from 1987 to 2012, restricting analysis to transplant patients 6-17 years old from 2001 to 2012, who received no induction (NONE) or induction (INDUCED) with the contemporary agents of basiliximab, alemtuzumab, thymoglobulin, antilymphocyte globulin (ALG), or antithymocyte globulin (ATG). Of 23 951 lung transplants, 330 met inclusion criteria with 177 (54%) being INDUCED. Of the INDUCED agents, 121 (68%) were basiliximab, 3 (2%) alemtuzumab, and 53 (30%) ALG/ATG/thymoglobulin. The mean patient age was 13.6 (SD = 3.2) and 14 (SD = 3.0) years for the INDUCED and NONE groups, respectively. The median survival in the INDUCED group was 77.4 months (95% CI: 46.1, 125.6) compared with 50.8 months (95% CI: 42.9, 61.3) for the NONE (log-rank P-value = 0.3601). The most common cause of death was due to allograft failure or pulmonary complications with only one patient dying from post-transplant lymphoproliferative disorder. The estimated hazard ratio for INDUCED versus NONE was 0.859 (95% CI: 0.620, 1.191; P = 0.3618); there were no significant confounders or effect modifiers among the demographic and clinical variables. In conclusion, antibody-based induction immunosuppression with contemporary agents had a trend toward a protective, but not statistically significant, effect in 6- to 17-year-old patients.