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NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives
Zelenetz, Andrew D; Ahmed, Islah; Braud, Edward Louis; Cross, James D; Davenport-Ennis, Nancy; Dickinson, Barry D; Goldberg, Steven E; Gottlieb, Scott; Johnson, Philip E; Lyman, Gary H; Markus, Richard; Matulonis, Ursula A; Reinke, Denise; Li, Edward C; DeMartino, Jessica; Larsen, Jonathan K; Hoffman, James M
Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with cancer. The potential for biosimilars to reduce the cost of biologics, which are often high-cost components of oncology care, was the impetus behind the Biologics Price Competition and Innovation Act of 2009, a part of the 2010 Affordable Care Act. In March 2011, NCCN assembled a work group consisting of thought leaders from NCCN Member Institutions and other organizations, to provide guidance regarding the challenges health care providers and other key stakeholders face in incorporating biosimilars in health care practice. The work group identified challenges surrounding biosimilars, including health care provider knowledge, substitution practices, pharmacovigilance, naming and product tracking, coverage and reimbursement, use in off-label settings, and data requirements for approval.
PMID: 21976013
ISSN: 1540-1413
CID: 1608942
Predictors of relapse of methicillin-resistant Staphylococcus aureus bacteremia after treatment with vancomycin
Welsh, Kerry J; Skrobarcek, Kimberly A; Abbott, April N; Lewis, Cole T; Kruzel, Mark C; Lewis, Evan M; Gardiner, Jeanelle M; Mohr, John F; Armitige, Lisa Y; Wanger, Audrey
The risk factors for relapse of methicillin-resistant Staphylococcus aureus (MRSA) bacteremia after vancomycin treatment are unknown. Diversilab typing was used to classify recurrent bacteremia as relapse or reinfection. Bacteremia for >7 days and staphylococcal cassette chromosome mec element (SCCmec) type II were independently associated with relapse of MRSA bacteremia after vancomycin treatment.
PMCID:3187311
PMID: 21865420
ISSN: 1098-660x
CID: 1571492
The impact of a behavioral intervention on weight gain during pregnancy [Note]
Kaplan, R; Jay, M
EMBASE:2011589794
ISSN: 1079-6533
CID: 1463562
Impact of VA weight management program for veterans [Note]
Jay, M
EMBASE:2011408284
ISSN: 1079-6533
CID: 1463572
Can cognitive behavioral therapy prevent recurrent cardiovascular events? Commentary [Note]
Jay, M
EMBASE:2011207500
ISSN: 1079-6533
CID: 1463582
Capacity building of nursing human resources: How do we get it right?
Squires, Allison
[New York : NYU Global Institute of Public Health], 2011
Extent: 32 p.
ISBN: n/a
CID: 1460202
Medication adherence for 90-day quantities of medication dispensed through retail and mail order pharmacies
Khandelwal, Nikhil; Duncan, Ian; Rubinstein, Elan; Ahmed, Tamim; Pegus, Cheryl; Murphy, Patricia; Kudrak, Kenneth E
OBJECTIVES: To examine relative medication adherence of patients filling 90-day supplies of maintenance medications using retail and mail order channels. It was hypothesized that adherence rates would not differ across the 2 channels. STUDY DESIGN: A cross-sectional retrospective analysis was conducted using de-identified pharmacy claims data from a large pharmacy benefit manager (PBM) database over a 2-year period (January 2008 to August 2010). Patients who were continuously eligible for at least 12 months during this time frame, with benefit plan designs that allowed filling of 90-day supplies either at retail or by mail order pharmacy, were selected. METHODS: Adherence was measured by medication possession ratio (MPR) within a 1-year period. Propensity score matching was employed to minimize differences between the Retail-90 group and Mail Order-90 group. RESULTS: Overall, patients filling 90-day prescriptions for 9 therapeutic groups (antiasthmatics and bronchodilators, antidepressants, antidiabetics, antihyperlipidemics, antihypertensives, beta blockers, calcium channel blockers, diuretics, and thyroid agents) at retail pharmacies demonstrated a propensity score-matched average MPR that was statistically higher than for patients filling prescriptions via mail order (77.0% vs 76.0%). There were no significant differences in MPR (post-matching) between 90-day retail and mail order channels for individual therapeutic groups, except for antidiabetics (80.2% vs 83.1%). CONCLUSIONS: On a propensity-matched basis, patients who fill maintenance prescriptions at retail have a slightly, but statistically significantly, higher MPR than patients who fill their prescriptions by mail
PMID: 22200059
ISSN: 1088-0224
CID: 1293122
Pharmacists as providers: targeting pneumococcal vaccinations to high risk populations
Taitel, Michael; Cohen, Ed; Duncan, Ian; Pegus, Cheryl
BACKGROUND: Older adults and persons with chronic conditions are at increased risk for pneumococcal disease. Severe pneumococcal disease represents a substantial humanistic and economic burden to society. Although pneumococcal vaccination (PPSV) can decrease risk for serious consequences, vaccination rates are suboptimal. As more people seek annual influenza vaccinations at community pharmacies, pharmacists have the ability to identify at-risk patients and provide PPSV. OBJECTIVES: The objective of this study was to evaluate the impact of pharmacists educating at-risk patients on the importance of receiving a pneumococcal vaccination. METHODS: Using de-identified claims from a large, national pharmacy chain, all patients who had received an influenza vaccination between August 1, 2010 and November 14, 2010 and who were eligible for PPSV were identified for the analysis. Based on the Advisory Committee on Immunization Practices recommendations, at-risk patients were identified as over 65 years of age or as aged 2-64 with a comorbid conditions. A benchmark medical and pharmacy claims database of commercial and Medicare health plan members was used to derive a PPSV vaccination rate typical of traditional care delivery to compare to pharmacy-based vaccination. Period incidence of PPSV was calculated and compared. RESULTS: Among the 1.3 million at-risk patients who were vaccinated by a pharmacist during the study period, 65,598 (4.88%) also received a pneumococcal vaccine. This vaccination rate was significantly higher than the benchmark rate of 2.90% (34,917/1,204,104; p<.001) representing traditional care. Patients aged 60-70 years had the highest vaccination rate (6.60%; 26,430/400,454) of any age group. CONCLUSIONS: Pharmacists were successful at identifying at-risk patients and providing additional immunization services. Concurrent immunization of PPSV with influenza vaccination by pharmacists has potential to improve PPSV coverage. These results support the expanding role of community pharmacists in the provision of wellness and prevention services.
PMID: 21864625
ISSN: 0264-410x
CID: 1293132
Impact of clinical oral chemotherapy program on wastage and hospitalizations
Khandelwal, Nikhil; Duncan, Ian; Ahmed, Tamim; Rubinstein, Elan; Pegus, Cheryl
OBJECTIVE: The oral chemotherapy cycle management program (CMP) provides clinical management support to patients receiving certain oral chemotherapies. The CMP includes a dose-monitoring (ie, split-fill) plan for early identification and management of adverse effects. If serious adverse effects are identified mid cycle, the remainder of the monthly supply is withheld, thus avoiding potential waste associated with early therapy discontinuation. This study investigated medication wastage and estimated potential cost savings for patients who were enrolled in the CMP, as compared with those who were not enrolled in the program. STUDY DESIGN: Retrospective test-control study. PATIENTS AND METHODS: Patients whose oral chemotherapy was initiated between June 2008 and February 2010 and who were enrolled in the CMP were included as the test group. Patients whose oral chemotherapy was initiated between June 2007 and May 2008 and who were not part of the CMP were included as the control group. RESULTS: Medication wastage associated with early therapy discontinuation was found to be lower in the CMP group. Approximately 34% of patients in the CMP group could have avoided medication wastage if split-fill plans had been available, potentially realizing savings of approximately $934.20 per patient. Linear probability regression models showed that the CMP group had a 2.9% probability for reduction in hospital admissions (P <.05), resulting in additional savings of approximately $440.00 per patient. Combined savings resulting from reduced wastage and hospital admissions was approximately $1374 per patient. CONCLUSION: Dose-monitoring programs such as the CMP effectively reduce wastage and serious adverse effects associated with oral chemotherapeutic agents, realizing potential cost savings for both payers and patients.
PMID: 21711067
ISSN: 1088-0224
CID: 1293142
Impact of clinical oral chemotherapy program on wastage and hospitalizations
Khandelwal, Nikhil; Duncan, Ian; Ahmed, Tamim; Rubinstein, Elan; Pegus, Cheryl
PURPOSE: The oral chemotherapy cycle management program (CMP) provides clinical management support to patients receiving certain oral chemotherapies. The CMP includes a dose-monitoring (ie, split-fill) plan for early identification and management of adverse effects. If serious adverse effects are identified mid cycle, the remainder of the monthly supply is withheld, thus avoiding potential waste associated with early therapy discontinuation. This study investigated medication wastage and estimated potential cost savings for patients who were enrolled in the CMP, as compared with those who were not enrolled in the program. STUDY DESIGN: Retrospective test-control study. PATIENTS AND METHODS: Patients whose oral chemotherapy was initiated between June 2008 and February 2010 and who were enrolled in the CMP were included as the test group. Patient whose oral chemotherapy was initiated between June 2007 and May 2008 and who were not part of the CMP were included as the control group. RESULTS: Medication wastage associated with early therapy discontinuation was found to be lower in the CMP group. Approximately 34% of patients in the CMP group could have avoided medication wastage if split-fill plans had been available, potentially realizing savings of approximately $934.20 per patient. Linear probability regression models showed that the CMP group had a 2.9% probability for reduction in hospital admissions (P < .05), resulting in additional savings of approximately $440.0 per patient. Combined savings resulting from reduced wastage and hospital admissions was approximately $1,374 per patient. CONCLUSION: Dose-monitoring programs such as the CMP effectively reduce wastage and serious adverse effects associated with oral chemotherapeutic agents, realizing potential cost savings for both payers and patients.
PMCID:3092454
PMID: 21886508
ISSN: 1554-7477
CID: 1293152