Framework for Pharmacy Services Quality Improvement-A Bridge to Cross the Quality Chasm.

OBJECTIVE: To review the literature on the subject of quality improvement principles and methods applied to pharmacy services and to describe a framework for current and future efforts in pharmacy services quality improvement and effective drug therapy management. BACKGROUND: The Academy of Managed Care Pharmacy produced the Catalog of Pharmacy Quality Indicators in 1997, followed by the Summary of National Pharmacy Quality Measures in February 1999. In April 2002, AMCP introduced Pharmacy's Framework for Drug Therapy Management in the 21st Century. The Framework documents include a self-assessment tool that details more than 250 specific "components" that describe tasks, behaviors, skills, functions, duties, and responsibilities that contribute to meeting customer expectations for effective drug therapy management. FINDINGS: There are many opportunities for quality improvement in clinical, service, and cost outcomes related to drug therapy management. These may include patient safety; incidence of medical errors; adverse drug events; patient adherence to therapy; attainment of target goals of blood pressure, glucose, and lipid levels; risk reduction for adverse cardiac events and osteoporotic-related fractures; patient satisfaction; risk of hospitalization or mortality; and cost of care. Health care practitioners can measure improvements in health care quality in several ways including (a) a better patient outcome at the same cost, (b) the same patient outcome at lower cost, (c) a better patient outcome at lower cost, or (d) a significantly better patient outcome at moderately higher cost. Measurement makes effective management possible. A framework of component factors (e.g., tasks) is necessary to facilitate changes in the key processes and critical factors that will help individual practitioners and health care systems meet customer expectations in regard to drug therapy, thus improving these outcomes. CONCLUSIONS: Quality improvement in health care services in the United States will be made in incremental changes that rely on a structure-process-outcome model. The structure is provided by evidence created from controlled randomized trials and other studies of care and system outcomes that are based on the scientific method. The process portion is created by the application of evidence in the form of clinical practice guidelines, clinical practice models, and self-assessment tools such as Pharmacy's Framework for Drug Therapy Management. Incremental changes in structure and process will result in the desirable outcome of meeting customer needs for more effective drug therapy and disease management. DISCLOSURES: Authors Richard N. Fry and Steven G. Avey are employed by the Foundation for Managed Care Pharmacy, a nonprofit charitable trust that serves as the educational and philanthropic arm of the Academy of Managed Care Pharmacy; author Frederic R. Curtiss performed the majority of work associated with this manuscript prior to becoming editor-in-chief of the Journal of Managed Care Pharmacy. This manuscript underwent blinded peer review and was subject to the same standards as every article published in JMCP.

Evolution of the AMCP Format for Formulary Submissions.

DISCLOSURES: No funding was required for this project. The authors are or have been members of the Format Executive Committee.

Reflections on the Formulary System from 1997 to the Present.

DISCLOSURES: No funding was received for the writing of this reflection. Avey is a member of the AMCP Foundation and has recently retired from MedImpact Health Systems, where he served as Vice President of Specialty Clinical Solutions.

The Challenge of Variable Costs in Decisions Based on Cost-Effectiveness Evidence: A Case Study for Brodalumab.

BACKGROUND: Payers often consider cost-effectiveness studies for new drugs when making decisions on coverage, formulary position, and budgets; however, cost-effectiveness studies are often calculated using estimated pricing before a drug's launch. If the drug's price changes on or after launch, or if rebate programs are initiated, cost-effectiveness studies need to be updated to prevent payers from making decisions using inaccurate value assumptions, which can lead to unexpected financial impacts and potentially delay patient access to drugs. OBJECTIVE: To evaluate how lower at-launch drug pricing versus initial estimated pricing affects cost-effectiveness ratios and potentially influences treatment decisions, using the case study of brodalumab, a biologic drug indicated for the treatment of moderate-to-severe plaque psoriasis. METHODS: We compared the estimated cost-effectiveness of brodalumab, which was published in a December 2016 Institute for Clinical and Economic Review (ICER) report based on estimated pricing, with the drug's cost-effectiveness based on its actual pricing after its approval. DISCUSSION: The 2016 ICER report on the cost-effectiveness of targeted immunomodulators indicated for the treatment of moderate-to-severe plaque psoriasis, brodalumab's price was estimated to be $4267 by averaging the cost of its likely competitors. Brodalumab's effectiveness as a treatment for moderate-to-severe plaque psoriasis is high in clinical trials, but its estimated cost placed it as the fourth most cost-effective targeted immunomodulatory drug in the ICER report. On its approval in February 2017, brodalumab's newly estimated base price was $3900, based on its prelaunch price. Calculations using this base price placed brodalumab as the most cost-effective option among targeted immunomodulators in this setting. At the time this current article was written, brodalumab's cost was $3500, making it even more cost-effective. CONCLUSION: Because payers, providers, and patients are all concerned with achieving better outcomes for the often painful and disfiguring disease of plaque psoriasis, while controlling costs, updating cost-effectiveness data when new pricing information becomes available may reveal significant cost differences to help stakeholders make better decisions about their population's healthcare outcomes and costs.

Current and emerging treatments for hypercholesterolemia: A focus on statins and proprotein convertase subtilisin/kexin Type 9 inhibitors for perioperative clinicians.

Statins are a mainstay of hyperlipidemia treatment. These drugs inhibit the enzyme 3-hydroxy-3-methylglutaryl coenzyme A reductase and have beneficial effects on atherosclerosis including plaque stabilization, reduction of platelet activation, and reduction of plaque proliferation and inflammation. Statins also have a benefit beyond atherosclerotic plaque, including anticoagulation, vasodilatation, antioxidant effects, and reduction of mediators of inflammation. In the perioperative period, statins appear to contribute to improved outcomes via these mechanisms. Both vascular and nonvascular surgery patients have been shown in prospective studies to have lower risk of adverse cardiac outcomes when initiated on statins preoperatively. However, not all patients can tolerate statins; the search for novel lipid-lowering therapies led to the discovery of the proprotein convertase subtilisin/kexin Type 9 (PCSK9) inhibitors. These drugs are fully-humanized, injectable monoclonal antibodies. With lower PCSK9 activity, low-density lipoprotein cholesterol (LDL-C) receptors are more likely to be recycled to the hepatocyte surface, where they serve to clear plasma LDL-C. Evidence from several prospective studies shows that these new agents can significantly lower LDL-C levels. While PCSK9 inhibitors offer hope of effective therapy for patients with familial hyperlipidemia or intolerance of statins, several important questions remain, including the results of long term cardiovascular outcome studies. The perioperative effects of new LDL-C-lowering drugs are unknown at present but are likely to be similar to the older agents.

Effects of benefit design change across 5 disease states.

OBJECTIVE: To assess the effects of benefit design change (BDC) on medication adherence and persistence (including switch in therapy), drug costs, and total healthcare costs. STUDY DESIGN: A retrospective study was performed using administrative claims data from an integrated healthcare system between January 2001 and December 2002. METHODS: Continuously enrolled patients in 2001 and 2002 with allergic rhinitis, asthma, diabetes mellitus, hypertension, or osteoarthritis belonged to employer groups with or without a pharmacy BDC as of January 1, 2002. Prescription status (same, switch, or discontinue), adherence among patients receiving therapy, and differences in drug costs and total healthcare costs for each disease state were measured between groups. Bivariate and multivariate statistics were used to test differences in outcomes between groups. RESULTS: Compared with the group without BDC, the proportion of patients who discontinued drug therapy was significantly greater in the BDC group among those with allergic rhinitis (67% vs 54%), asthma (66% vs 50%), osteoarthritis (61% vs 36%), and hypertension (39% vs 18%) (P < .05 for all). Medication compliance was not affected by BDC. The year-to-year pharmacy costs per patient in the BDC group decreased $305 for patients with osteoarthritis (P < .001) and $95 for patients with allergic rhinitis (P = .03). There was no significant effect on overall healthcare costs in any disease state during the year following the BDC. CONCLUSION: A pharmacy BDC may result in decreased pharmacy costs, with no effect on overall healthcare costs within 1 year for patients with allergic rhinitis, asthma, hypertension, or osteoarthritis.

Challenges facing employers in the treatment of depression.

OBJECTIVE: To review the challenges of treating depression in the workplace in the environment of increased health care costs. SUMMARY: The cost of health care is on the rise, and employers and employees are at odds over who will share the burden of these costs. The focus of cost containment has been to minimize drug cost; however, employers need to be aware of indirect costs of medical illness. Due to its prevalence and rate of undertreatment, depression is one of the main disease states that employers should target in their disease management efforts. CONCLUSION: In order to treat depression appropriately, we must consider the social stigma, treatment barriers, and health care structure that exist to treat depression. Additional outcomes data is needed to demonstrate to employers, the largest purchasers of health care, the benefit of managing depression in the workplace.

AMCP's Framework for Quality Drug Therapy.

OBJECTIVE: To describe AMCP's Framework for Quality Drug Therapy. SUMMARY: AMCP's Framework for Quality Drug Therapy was designed by a consortium of pharmacists and pharmacy organizations. It was built on customer assumptions and expectations, and it defined "customer" broadly. The document includes background information, a description of the process used, a list of customers' expectations, and a self-assessment grid. It can be applied in part or in its entirety in a wide variety of pharmacy settings. CONCLUSION: The scope of AMCP's Framework is unprecedented-it can help bridge the gap between the status quo and the ideal in drug therapy. The Framework is available at no charge from AMCP.

Framework for pharmacy services quality improvement--a bridge to cross the quality chasm. Part I. The opportunity and the tool.

OBJECTIVE: To review the literature on the subject of quality improvement principles and methods applied to pharmacy services and to describe a framework for current and future efforts in pharmacy services quality improvement and effective drug therapy management. BACKGROUND: The Academy of Managed Care Pharmacy produced the Catalog of Pharmacy Quality Indicators in 1997, followed by the Summary of National Pharmacy Quality Measures in February 1999. In April 2002, AMCP introduced Pharmacy's Framework for Drug Therapy Management in the 21st Century. The Framework documents include a self-assessment tool that details more than 250 specific "components" that describe tasks, behaviors, skills, functions, duties, and responsibilities that contribute to meeting customer expectations for effective drug therapy management. FINDINGS: There are many opportunities for quality improvement in clinical, service, and cost outcomes related to drug therapy management. These may include patient safety; incidence of medical errors; adverse drug events; patient adherence to therapy; attainment of target goals of blood pressure, glucose, and lipid levels; risk reduction for adverse cardiac events and osteoporotic-related fractures; patient satisfaction; risk of hospitalization or mortality; and cost of care. Health care practitioners can measure improvements in health care quality in several ways including (a) a better patient outcome at the same cost, (b) the same patient outcome at lower cost, (c) a better patient outcome at lower cost, or (d) a significantly better patient outcome at moderately higher cost. Measurement makes effective management possible. A framework of component factors (e.g., tasks) is necessary to facilitate changes in the key processes and critical factors that will help individual practitioners and health care systems meet customer expectations in regard to drug therapy, thus improving these outcomes. CONCLUSIONS: Quality improvement in health care services in the United States will be made in incremental changes that rely on a structure-process-outcome model. The structure is provided by evidence created from controlled randomized trials and other studies of care and system outcomes that are based on the scientific method. The process portion is created by the application of evidence in the form of clinical practice guidelines, clinical practice models, and self-assessment tools such as Pharmacy's Framework for Drug Therapy Management. Incremental changes in structure and process will result in the desirable outcome of meeting customer needs for more effective drug therapy and disease management.

The Academy of Managed Care Pharmacy Format for Formulary Submissions: an evolving standard--a Foundation for Managed Care Pharmacy Task Force report.

OBJECTIVE: The objective of this report is to provide, in detail, the evidentiary requirements contained in Version 2.0 of the Academy of Managed Care Pharmacy's (AMCP's) Format for Formulary Submissions and to elaborate on several key issues regarding the use of the Format that users, potential users, and pharmaceutical manufacturers have raised since AMCP published the first version of the guidelines in October 2000. BACKGROUND: The AMCP published its Format for Formulary Submissions in October 2000. The AMCP leadership and its members were motivated to develop these guidelines by a growing need to ensure that any increased utilization of medications, biopharmaceuticals, and vaccine products was appropriate and that newer products would bring added clinical and economic value to covered populations. Since publication of the Format, it has garnered nationwide publicity and attracted considerable positive and negative attention. As adoption of the AMCP Format has spread, manufacturers have begun to standardize the framework within which they present population-specific data. Since publication of the AMCP Format, the AMCP and the Foundation for Managed Care Pharmacy (FMCP) have continuously sought input from pharmaceutical manufacturers and health-system pharmacists through various venues to improve and clarify the process. Version 2.0 is the first attempt to address user's comments and concerns. METHODS: The majority of the article text is taken directly from Version 2.0 of the AMCP Format for Formulary Submissions published by the AMCP in October 2002. CONCLUSION: The AMCP and the FMCP believe that the AMCP Format is a tool that will help health systems establish a record of commitment to rational decision making, thus gaining the confidence of patients, clinicians, and members. While providing manufacturers a vehicle for communicating the scientifically based value of their product to a health system, the required evidence to substantiate that value argument allows a pharmacy and therapeutics committee to determine the clinical benefits of a drug, verify any cost savings the drug may generate, and determine the overall cost consequences to their health system. The AMCP Format for Formulary Submissions is an essential tool to evaluate medications, but requires thoughtful consideration as it is used.