Journal of managed care & specialty pharmacy
-
J Manag Care Spec Pharm · Oct 2017
Optimization of Medication Use at Accountable Care Organizations.
Optimized medication use involves the effective use of medications for better outcomes, improved patient experience, and lower costs. Few studies systematically gather data on the actions accountable care organizations (ACOs) have taken to optimize medication use. ⋯ This research was sponsored and funded by the National Pharmaceutical Council (NPC), an industry funded health policy research group that is not involved in lobbying or advocacy. Employees of the sponsor contributed to the research questions, determination of the relevance of the research questions, and the research design. Specifically, there was involvement in the survey and interview instruments. They also contributed to some data interpretation and revision of the manuscript. Leavitt Partners was hired by NPC to conduct research for this study and also serves a number of health care clients, including life sciences companies, provider organizations, accountable care organizations, and payers. Westrich and Dubois are employed by the NPC. Wilks, Krisle, Lunner, and Muhlestein are employed by Leavitt Partners and did not receive separate compensation. Study concept and design were contributed by Krisle, Dubois, and Muhlestein, along with Lunner and Westrich. Krisle and Muhlestein collected the data, and data interpretation was performed by Wilks, Krisle, and Muhlestein, along with Dubois and Westrich. The manuscript was written primarily by Wilks, along with Krisle and Muhlestein, and revised by Wilks, Westrich, Lunner, and Krisle. Preliminary versions of this work were presented at the following: National Council for Prescription Drug Programs Educational Summit, November 1, 2016; Academy Health 2016 Annual Research Meeting, June 27, 2016; Accountable Care Learning Collaborative Webinar, June 16, 2016; the 21st Annual PBMI Drug Benefit Conference, February 29, 2016; National Value-Based Payment and Pay for Performance Summit, February 17, 2016; National Accountable Care Congress, November 17, 2015; and American Journal of Managed Care's ACO Emerging Healthcare Delivery Coalition, Fall 2015 Live Meeting, October 15, 2015.
-
J Manag Care Spec Pharm · Oct 2017
Observational StudyThe FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.
Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs. ⋯ This project was not supported by any external grants or funds. Gupta was supported by the Yale University School of Medicine Office of Student Research at the time of this study. Dhruva is supported by the Department of Veterans Affairs as part of the Robert Wood Johnson Foundation Clinical Scholars program. Ross reports receiving research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing; from Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; from the FDA to establish the Yale-Mayo Clinic Center of Excellence in Regulatory Science and Innovation; from the Blue Cross Blue Shield Association to better understand medical technology evidence generation; from the Centers for Medicare & Medicaid Services to develop and maintain performance measures that are used for public reporting; and from the Laura and John Arnold Foundation to support the Collaboration on Research Integrity and Transparency at Yale. Fox reports travel support from Oklahoma Society of Health System Pharmacists, Premier Oncology Hematology Management Society, and SEHA-United Arab Emirates. Vizient provides some financial support to the University of Utah Drug Information Service to provide summaries of drug shortage information. Gupta and Ross were responsible for the conception and design of this work, drafted the manuscript, and conducted the statistical analysis. Gupta and Fox were responsible for acquisition of data. Ross provided supervision. All authors participated in the analysis and interpretation of the data and critically revised the manuscript for important intellectual content.