Marilyn R. Stebbins

A Population Study of the Frequency of High-Dose Acetaminophen Prescribing and Dispensing

Background: Recurrent intake of 4 g/day or more of acetaminophen has been associated with elevation of serum alanine aminotransferase (ALT) levels in 30–40% of the exposed population and may result in hepatotoxicity. Objective: To describe the frequency that patients are prescribed acetaminophen doses that exceed 4 g/day across a large population. Methods: Using Californias Medicaid (MediCal) fee-for-service population, pharmacy claims including over-the-counter (OTC) medications were examined for prescriptions that could result in acetaminophen doses of 4 g/day or more. The period studied, October 2004 through September 2005, was before the Part D pharmacy benefit was available to dually eligible Medicare patients when all prescriptions were covered by the MediCal claims process. Results: During the pre-Part D evaluation period, approximately 3.27 million beneficiaries were enrolled in the fee-for-service MediCal program. A total of 192,716 (5.9%) were potentially exposed to at least 1 day of 4 g/day or more of acetaminophen. Of those, 769 patients were potentially exposed to at least 1 day of 16 g/day or more. A total of 2664 beneficiaries were dispensed prescriptions and OTC products that, if taken as directed, would have resulted in more than 100 days of acetaminophen doses of 4 g/day or more during the study year. Conclusions: Despite electronic systems designed to warn dispensing pharmacists of duplications of drug class and cumulative excessive doses, potentially toxic amounts of acetaminophen are commonly prescribed and dispensed to this population. Better systems, increased awareness, and education of patients, prescribers, and pharmacists are needed to reduce this potential toxic exposure.

Promoting access and reducing expected out-of-pocket prescription drug costs for vulnerable Medicare beneficiaries: a pharmacist-directed model.

BackgroundThe Medicare Part D benefit is complicated and may be costly, especially for vulnerable low-income populations where lack of resources and limited English proficiency may be barriers to optimal plan selection. ObjectivesTo identify vulnerable Medicare beneficiaries and lower their expected annual out-of-pocket (OOP) prescription drug costs through one-on-one prescription drug plan counseling by pharmacists and trained pharmacy students. Research DesignBetween October 2008 and January 2010, a cross-sectional study was performed throughout California. Using Medicares Prescription Drug Plan Finder tool, expected annual OOP costs for each beneficiarys current prescription drug plan were compared with the lowest-cost plan. SubjectsThe study sample included vulnerable Medicare beneficiaries with annual incomes ⩽300% of the Federal Poverty Level. ResultsThere were 1300 vulnerable beneficiaries who received counseling at 94 outreach events. Only 29% of beneficiaries with a stand-alone Part D prescription drug plan were enrolled in the lowest-cost plan. On the basis of counseling recommendations, 390 beneficiaries changed to the lowest-cost Part D plan on site, reducing their expected OOP costs by 68%. Additionally, 72 beneficiaries were identified as eligible for but not receiving low-income subsidy benefits and 55 received assistance with the online application for the subsidy. ConclusionsFindings show that targeted outreach by trained pharmacy advocates can identify vulnerable Medicare populations in need of Part D counseling and reduce their expected annual OOP prescription drug costs.

Comprehensive Medication Management programs: 2015 status in Southern California

Comprehensive medication management (CMM) is an evidence-based, physician approved, pharmacistled, preventive clinical service ensuring optimal use of medications that is effective at improving health outcomes for high-risk patients while decreasing health care costs. Pharmacistprovided medication management, such as CMM pilot programs have been successfully implemented in six health care systems within Southern California resulting in improvements in clinical, fiscal, and quality measures. In response to Governor Brown’s 2012 call for improved health of Californians and the resulting Let’s Get Healthy California Task Force Report (December, 2012), the California Department of Public Health (CDPH) drafted the California Wellness Plan (CWP), California’s chronic disease prevention and health promotion plan. Goal 2 of the CWP aims for health system interventions and efforts to be linked with community programs and clinical services in order to meet the needs of populations with the largest health disparities. When used safely, appropriately, and with proper education, medications can contribute to better health and longer, improved quality of life. Health care models that incorporate clinical pharmacy services, such as comprehensive medication management (CMM), have been able to improve similar objectives to those under CWP Goal 2. Several national organizations have published guidance on medication therapy management (MTM) and Medicare includes MTM as a Part D benefit; however, CMM, which fully leverages the pharmacist’s scope of practice, is not as widely known. CMM is an evidence-based preventive clinical service demonstrated to decrease health care costs and improve chronic disease treatment outcomes by ensuring optimal prescribing, monitoring, education, and use of medications that engages physicians and patients. When directed at complex highrisk patients, CMM is proven to improve: quality of life, access to other health care providers, patients’ health literacy and decision making, physician and other non-pharmacist provider satisfaction, and continuity of care. Complex high-risk patients tend to account for the majority of health care costs and require significantly more time, focus, and follow-up than relatively lowerrisk patients. The pharmacy profession can contribute to providing high quality, high value, and patient-centered care in an interprofessional collaborative practice in health care. This paper seeks to describe the current landscape, including the delivery, use, outcomes, benefits and challenges of CMM in Southern California as of May 2015. In 2010, CMM was first defined and described by the Patient Centered Primary Care Collaborative (PCPCC) to provide a framework for a “whole-patient approach” to medication management as an integral component of patientcentered medical homes (PCMH) and coordinated care systems, including Accountable Care Organizations (ACO). CMM “is defined as the standard of care that ensures each patient’s medications (whether they are prescription, nonprescription, alternative, traditional, vitamins, or nutritional supplements) are individually assessed to determine that each medication is appropriate for the patient, effective for the medical condition, safe given the comorbidities and other medications being taken, and able to be taken by the patient as intended. CMM includes an individualized care plan that achieves the intended goals of therapy with appropriate follow-up to determine actual patient outcomes. This all occurs because the patient understands, agrees with, and actively participates in the treatment regimen, thus optimizing each patient’s medication experience and clinical outcomes.” In 2012, the second edition of the PCPCC Guide to Integrating Comprehensive Medication Management to Optimize Patient Outcomes was updated to include guidelines for practice and documentation consistent with PCMH and ACO integration. This has served as a quick reference to distinguish CMM levels of care from those of other MTM services such as single disease state interventions (e.g., diabetes or anticoagulation clinics) and drug only (drug silo) interventions [e.g., Medicare Part D MTM Targeted Interventions (TIPs), Comprehensive Medication Reviews (CMR) or medication reconciliation at hospital discharge]. Today’s health care system is fragmented due to a lack of care coordination, poorly-integrated health information, and misaligned fiscal incentives; these derive from a payment system that is transitioning from fee-for-service to an outcomes-driven value-based design. As health care for patients with chronic disease consumes a growing proportion of overall expenditures, better disease management and education are crucial. With the shortage of primary care physicians there is a need for comprehensive and 65 Butler et al. / Research in Social and Administrative Pharmacy 13 (2017) 63–87 collaborative health care services that meet patient care needs. Not only should health care delivery improve access to skilled professional resources, but services should be evidencebased, and result in better health outcomes. The abstract now combines the original manuscript’s abstract þ the material previously within the Executive Summary. Introduction and Background Advances in pharmacy education, training, and credentialing uniquely position pharmacists to offer CMM as part of a quality interprofessional collaborative practice in health care. A typical CMM program systematically identifies high-risk and/or high-cost patients for enrollment. These patients are high utilizers of medications and health care services and have pre-diagnosed, established chronic illnesses that are persistently not at provider and patient defined medication treatment goals. Pharmacists evaluate patients to identify barriers to treatment success including performance of point-of-care testing if indicated, measurement of vital signs, and application of basic medication-related physical assessment, all part of pharmacist education and training, and supported by California State Pharmacy Law. Pharmacists formulate and implement a medication care plan aligned with the primary care provider’s plan for the patient to overcome treatment-related barriers to varying degrees across the United States of America (U.S.). In California, one of six states in the nation that recognizes pharmacists as health care providers, under physician authorized collaborative practice agreements pharmacists are able to adjust medication doses, discontinue or initiate medications, order tests related to monitoring medication safety and efficacy, educate the patient and caregiver if available, and communicate all actions to the primary care provider and other health care team members working with the patient. This process differs between institutions and can be modified to meet the needs of each health care organization. Several resources are available for developing and sustaining CMM programs (see Appendix E). CMM services are not currently reimbursed by most public or private third party payers in the U.S. (see Appendix H). Since pharmacists are not recognized as providers at the Federal level; as a result, few avenues are available for pharmacists to receive payment for clinical services. Financial support for CMM programs is limited to full-risk health plans/systems such as staff model health maintenance organizations (e.g., Kaiser Permanente) and medical groups participating in “at-risk” contracts (i.e., Accountable Care Organizations and Integrated Delivery Networks). California will participate in the Medicaid Health Home State Plan Option, authorized under the Affordable Care Act Section 2703, beginning 2016 (http://www.dhcs.ca.gov/services/ Pages/HealthHomesProgram.aspx). Materials in this paper were collected as a result of the efforts of the CWP Goal 2 CMM Statewide Implementation Work Group (see Appendix K). The following six programs in Southern California were contacted and agreed to share CMM pilot program descriptions and information (Appendix L). University of Southern California (USC) School of Pharmacy/AltaMed Health Services Over a three-year period, pharmacy teams enrolled more than 6000 high-risk and/or high-cost patients. Outcomes are being evaluated in comparison to a “usual care” cohort of propensity-matched patients who received care at AltaMed locations that did not offer CMM. CMM clearly outperformed usual care in the management of common chronic conditions. In addition, the CMM program was able to maintain treatment success over time, in large part due to “check-ins” provided every two months by the pharmacy technicians for discharged patients. An average of 10 medication-related problems were identified and resolved for each enrolled patient. Preliminary return on investment analysis suggests that the program costs are outweighed by cost savings in Altamed. The CMM program using pharmacy technicians was associated with a 50% increase in daily patient visits. Greater Newport Physicians Ambulatory Care Clinics On average, ACTIVE Diabetes Program participants were able to meet their diabetes treatment goals within the first 180 days of enrollment. They were also able to meet quality measure goals for blood pressure control, high cholesterol, and nephropathy screening. 66 Butler et al. / Research in Social and Administrative Pharmacy 13 (2017) 63–87 As a result of the pharmacist-led Anticoagulation Center, there were 53% fewer inpatient admissions and 41% fewer emergency department visits. The 30-day readmission rate for Special Care Center participating seniors was 60% lower than the national average. Additionally, all three programshadhigh-marks in patient satisfaction. When compared to a cohort of diabetes patients with hemoglobin A1c baseline above 8%, medical costs for ACTIVE program participants was approximately

Managing the unmanageable: the nature and impact of drug risk in physician groups.

1200 less per patient per year. When accounting for program costs, the savings is approximately

Evaluation of the Relationship Between a Chronic Disease Care Management Program and California Pay-for-Performance Diabetes Care Cholesterol Measures in One Medical Group

As drug costs rose in the 1990s, health maintenance organizations (HMOs) began transferring risk for prescription drug expenditures to physician groups. With principal-agent theory as a framework for understanding drug-risk transfer, we used a multiple case-study design to examine the relationship between the level of drug risk that a physician group accepts and the physician groups adoption of drug-use management strategies. The data demonstrated that adoption of drug-use management innovations was not related to level of risk for pharmacy costs and that factors other than drug-risk level (e.g., contracting and data issues, financial and market factors, and physician group assessments of the fairness and incentives of risk contracts) can influence the principal-agent relationship. The data also revealed a novel form of information asymmetry between physicians and HMOs and unexpected failures of HMOs to fully enable their physician-agents. We believe these observations reflect the complexity of relationships in the health care system and have implications for the use of incentives. Based on principal-agent theory and our findings, we offer an alternative approach to drug-risk contracting that reduces physicians responsibility for aspects of drug use that are beyond their control while maintaining the incentives to manage drug costs and use that were the original intent of drug-risk contracting.