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Objectives: The American Pharmacists Association (APhA) convened the Biologics and Biosimilars Stakeholder Conference on November 30, 2016, in Washington DC. The objectives of the Conference were to determine the key issues and challenges within the marketplace for biologics, follow-on biologics (FOBs), and biosimilars, identify potential roles and responsibilities of pharmacists regarding biologic and biosimilar medications, and identify actions or activities that pharmacists may take to optimize the safe and cost-effective use of biologics and biosimilars.Data Sources: National thought leaders and stakeholder representatives, including individuals from the Food and Drug Administration, Centers for Medicare and Medicaid Services, a private third-party payer, manufacturers, and several national organizations of health care professionals, participated in the conference. Information shared by this group was supplemented with relevant legal and regulatory information and published literature.Summary: Biologics play a valuable role in the treatment of numerous health conditions, but their associated costs, which tend to be greater than those of small-molecule drugs, place a burden on the health care system. Biosimilars (both noninterchangeable and interchangeable) are highly similar copies of the originator biologic and offer the potential to reduce costs and improve patient access to biological products by increasing treatment options and creating a more competitive market. Despite the potential benefits of biosimilars, certain factors may limit their uptake. The conference participants explored issues that different stakeholders think influence the use of biologics, including biosimilars, in the United States. Barriers included technology, prescriber-pharmacist communication, legislation and regulations, limited patient and health care practitioner knowledge of biological products, patient and health care practitioner perceptions of biosimilars, and evolving science or lack of long-term data. After participants identified issues, they discussed strategies to address these concerns, including the need to enhance the education of pharmacists, prescribers, and patients regarding biologic products, including biosimilars and FOBs; the passage of state laws and regulations that do not impede the use of biosimilars, including interchangeable biosimilars; the use of product-specific tracking information in electronic health records and surveillance systems; bidirectional communication among pharmacists, prescribers, and other members of the care team to support pharmacovigilance and the maintenance of accurate patient records; and the development of evidence-based third-party payer policies.Conclusion: Patient access to safe and cost-effective treatments is an important goal for the health care system. As the availability and use of biosimilars, including those determined to be interchangeable, increases, their potential to lower costs and improve patient access to treatment grows. However, the extent of such growth is, in part, dependent on various stakeholders' decisions to provide, pay for, or use these products in a safe and thoughtful manner. Ongoing stakeholder collaboration, educational activities, and review of current government or payer policies are required to optimize the uptake of biological products, including biosimilars. [ABSTRACT FROM AUTHOR]

Objectives: The APhA Stakeholder Conference on Improving Patient Access to Injectable Medications was convened to foster national dialogue to advance the pharmacist's role in the provision of injectable medication administration services (MAS) and related patient care services, and to establish pharmacy as a site of care for these injections. Participants discussed the distinct opportunities to maximize pharmacist scope of services, expand patient access to care, improve medication adherence, and enhance outcomes for patients on injectable medication therapies for a range of conditions. These elements were framed in terms of the practice model, the business model, and the necessary training and resources to support these activities. Data sources: National thought leaders within pharmacy practice, pharmacist employers, national pharmacy associations, and pharmaceutical companies were invited to participate in the conference on December 15, 2016. Participants provided perspectives on a series of structured questions around administrative and patient care issues associated with the expansion of pharmacy-based MAS. Outcomes from the discussions were supplemented with related information from the literature. Summary: The APhA Stakeholder Conference on Improving Patient Access to Injectable Medications explored how the pharmacy profession could advance a broad-based, profession-wide practice model for MAS across a wide spectrum of therapeutic classes. There is a significant public health need to expand access to patients and make MAS a widely available, predictable, measurable, and scalable service provided by pharmacists. Conference participants discussed scope of practice, service delivery, and business model barriers. They also identified tools and resources that are necessary to overcome those barriers to advance opportunities and develop long-term, sustainable strategies to increase access to MAS from community-based pharmacist practitioners. Conclusion: Conference outcomes provided specific guidance around the need to develop practice support to address public health needs and effectively advance pharmacist provision of MAS and related patient care services. Key recommendations included the development of national practice guidance, standardized education and training, practice-level tools and resources, and enhanced technology solutions. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this Initiative was to establish a Coordinating Council to Improve Collaboration in Supporting Patients with Alzheimer's Disease. The Council convened on March 5-6, 2008, in Washington, DC. The American Pharmacists Association (APhA) Foundation, in conjunction with leading national experts in Alzheimer's disease (AD), assessed the level of care and services currently provided by pharmacists to AD patients and developed this "blueprint document" for how they might be more effective in helping patients and family caregivers manage the burden of this devastating disease. Data source: A premeeting survey of Council members was conducted to elicit their perceptions regarding the needs and challenges facing AD patients and their family caregivers and to gain insights as to what roles pharmacists could and should be playing to help manage drug therapy and enhance the quality of life in patients with AD. Summary: AD is one of the most significant health crises that will be faced in the United States over the next 30 years. Currently, it Is the sixth leading cause of death In the country. The findings of the Council confirmed that pharmacists are, playing Important roles In the management of AD but can expand these roles. Conclusion: Pharmacists are accessible, trusted, and respected resources. Increased pharmacist involvement in the care of Individuals with AD could improve clinical outcomes and family caregiver quality of life. With the expected increase in the number of individuals diagnosed with AD, the resources and services to care for and support this population will be even further taxed. Innovative approaches for expanding pharmacist involvement in AD should be developed to maximize the difference pharmacists can make in the lives of those who suffer from the disease. [ABSTRACT FROM AUTHOR]

Over the last four decades, the expanded patient care roles of pharmacists in the United States (U.S.) have increased focus on ensuring the implementation of processes to enhance continuing professional development within the profession. The transition from a model of continuing pharmacy education (CPE) to a model of continuing professional development (CPD) is still evolving. As pharmacists assume more complex roles in patient care delivery, particularly in community-based settings, the need to demonstrate and maintain professional competence becomes more critical. In addition, long-held processes for post-graduate education and licensure must also continue to adapt to meet these changing needs. Members of the pharmacy profession in the U.S. must adopt the concept of CPD and implement processes to support the thoughtful completion of professional development plans. Comprehensive, state-of-the-art technology solutions are available to assist pharmacists with understanding, implementing and applying CPD to their professional lives. [ABSTRACT FROM AUTHOR]

Objective: To improve key indicators of diabetes care by expanding a proven community-based model of care throughout high-risk areas in the United States., Design: Observational, multisite, pre-post comparison study., Setting: Federally qualified health centers, free clinics, employer worksites, community pharmacies, departments of health, physician offices, and other care facilities in 25 communities in 17 states from June 2011 through January 2013., Participants: 1,836 patients disproportionately affected by diabetes representing diverse ethnicities, insurance statuses, and social and economic backgrounds., Intervention: Pharmacists were integrated into local, interdisciplinary diabetes care teams and provided customized diabetes education and medication consultations to patients., Main Outcome Measures: Clinical measures included glycosylated hemoglobin (A1C), body mass index, systolic and diastolic blood pressures, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides, and total cholesterol. Process measures included smoking status, eye examination status, foot examination status, and influenza vaccine status., Results: Pharmacist patient care services for those underserved or disproportionately affected by diabetes resulted in a statistically significant and clinically relevant decrease in mean A1C levels (-0.8%). Other outcome indicators were below target levels at baseline and decreased significantly but not by clinically relevant amounts (LDL-C, -7.1 mg/dL; triglycerides, -23.7 mg/dL, and total cholesterol, -8.8 mg/dL). The mean increase in HDL-C (+0.6 mg/dL) was not statistically significant or clinically relevant. Among evaluable patients who were not at target for process measures at baseline, 51.7% of 453 patients received eye examinations, 72.0% of 271 patients received foot examinations, 41.7% of 307 patients received influenza vaccinations, and 9.3% patients of 270 quit smoking during the project. Of the communities involved in the study, 92% intend to sustain pharmacists' services., Conclusion: Project, Impact: Diabetes results show significant improvement in patients' clinical outcomes and demonstrate that all patients, even those with tremendous barriers to appropriate diabetes care, benefit from patient-centered, interdisciplinary health care teams that include pharmacists.

Introduction: 12 chain community pharmacy sites located in two geographic areas with the United States implemented easy-to-administer memory screening assessments for patients with risk factors of cognitive memory decline and referred at-risk patients to their physicians., Aim of the Study: To evaluate the impact of a pharmacy-based cognitive memory screening and referral program, measure patient satisfaction with these advanced clinical services, and assess willingness to pay for cognitive memory screening services., Setting: 12 chain pharmacy sites located in two geographic areas--ten Fred Meyer Pharmacies located in the Portland, Oregon area and two Kerr Drug Pharmacies located in North Carolina., Method: Pharmacists were educated on Alzheimer's disease, trained on how to provide cognitive memory screening exams, and equipped with screening and documentation tools. Following each screening, pharmacist provided education and counseling to the patients and referred at-risk patients to physicians for follow-up as appropriate., Main Outcome Measures: Results of screenings; satisfaction of patients; willingness to pay., Results: Pharmacists delivered cognitive memory assessments to 161 patients from June to November 2008. 44.1 % of patients experienced at least one cognitive deficiency that required referral to a physician based on the screening conducted. The cognitive memory screening and referral program was highly regarded by patients who completed the satisfaction survey, with 98.4 % of respondents indicating that they were either very satisfied or satisfied with the program., Conclusion: Cognitive memory screening can be easily incorporated into clinical service offerings in community pharmacy practice and provides a valuable opportunity to identify patients at-risk and refer them to a physician for appropriate testing and diagnosis.

Objectives: To identify the current challenges and opportunities in compensation and recognition for pharmacist-provided immunizations across the lifespan and to establish guiding principles for pharmacist-provided immunization compensation and recognition., Data Sources: 22 stakeholders gathered on June 29, 2011, at the American Pharmacists Association (APhA) headquarters in Washington, DC, for a meeting on immunization compensation that was convened by APhA and the Academy of Managed Care Pharmacy. Participants included representatives from community pharmacy practices (chain, grocery, and independent), employers, national consumer health and advocacy organizations, national pharmacy and public health organizations, health plan representatives, pharmacy benefit managers, and health information technology, standards, and safety organizations. Key immunization leaders from TRICARE Management Activity, the Centers for Medicare & Medicaid Services, the National Vaccine Program Office of the Department of Health & Human Services, and the Centers for Disease Control and Prevention (CDC) also participated in the meeting., Summary: The increased numbers of pharmacists providing vaccination services and the availability of pharmacist-provided immunizations to populations in need of vaccines has continued to increase. This has resulted in a rise in the percentage of patients who receive vaccines at pharmacies. Pharmacists are now working to lever-age their ability to identify people with key risk factors (e.g., diabetes, heart disease or previous myocardial infarction), encourage them to receive their CDC-recommended vaccinations, and administer the required vaccine. Challenges and opportunities in compensation and recognition for pharmacist-provided immunizations across the adult lifespan persist. Variability in state practice acts, reimbursement and compensation processes and systems, and mechanisms for documentation of vaccine services create substantial differences in how pharmacist-provided immunizations are delivered throughout the United States., Conclusion: Pharmacist-provided immunizations are clinically sound, are cost effective, are readily accessible, and support our nation's public health goals. Pharmacists have demonstrated that patient vaccination rates have improved through expansion of pharmacist-provided immunizations. The profession should continue efforts to collaborate with other immunization stakeholders and expand a pharmacist scope of practice that is built around a uniform and recognized standard of immunization provision and that supports the provision of all CDC-recommended vaccines through pharmacy-provided immunizations.