APhA Academy of Student Pharmacists – House of Delegates Report of the 2014 APhA-ASP Resolutions Committee PROPOSED RESOLUTIONS AND BACKGROUND STATEMENTS 2014.1 – Pharmacogenomics 1. APhA-ASP supports the utilization of evidence-based pharmacogenomic testing and services to enhance individualization of patient care and improve clinical outcomes. 2. APhA-ASP promotes pharmacists as the primary member of the health care team responsible for pharmacogenomic services, including but not limited to, interpreting and applying test results, developing individualized medication treatment plans in collaboration with prescribers, and serving as a resource to prescribers, patients, and other members of the health care team. 3. APhA-ASP supports continued research, development and implementation of clinical standards and guidelines regarding the use of pharmacogenomics to improve patient care. 4. APhA-ASP supports ongoing vigilance by all stakeholders with access to pharmacogenomic information to maintain the confidentiality and ensure the appropriate use of the information. 5. APhA-ASP encourages all schools and colleges of pharmacy to incorporate pharmacogenomics throughout the curriculum. 6. APhA-ASP encourages the development of continuing education and training programs to support existing practitioner understanding of pharmacogenomics. 7. APhA-ASP encourages all stakeholders, including but not limited to, employers, pharmacies, healthsystems, and third party payers, to develop a compensation model for pharmacist-provided pharmacogenomic services that is both financially viable and in the best interest of patients. Background Statement: Pharmacogenomics, the study of how genetic information may influence an individual’s response to a medication, has become of increasing importance in the practice of pharmacy. According to the Food and Drug Administration, there are now over 100 drugs that carry pharmacogenomic information within the label, and around 40% of medications in the drug pipeline are targeted therapies.1 For several commonly used medications such as clopidogrel, codeine, abacavir, and numerous oncology agents, clinical response and/or outcomes are linked to a patient’s genotype. Pharmacogenomic testing, whereby a patient’s genetic information is sequenced and analyzed to reveal variations in metabolic enzymes and drug targets, can impact clinical decisions, allow for dose optimization, and reduce toxicities, adverse effects, and treatment failures. As a member of the health care team, pharmacists are uniquely able to provide pharmacogenomic services due to their extensive knowledge of and experience in pharmacotherapy and pharmacokinetics. Pharmacogenomic services would include interpreting test results, applying knowledge of pharmacogenomic parameters to a patient’s therapy, and making recommendations regarding medication selection and dosing. Report of the 2014 APhA-ASP Resolutions Committee – Page 1 of 4 The APhA-ASP Resolutions Committee believes pharmacogenomics will play a large role in the future of pharmacy, but as a developing field, there are several challenges that need to be addressed. First among these challenges is a need for continued research to translate laboratory discovery into clinical practice guidelines to assist practitioners in making decisions based on pharmacogenomic results. Additionally, as the use of genetic information becomes more prevalent in health care, efforts to safeguard the confidentiality of a patient’s genetic information should be expanded. Furthermore, schools and colleges of pharmacy should integrate the study of pharmacogenomics into coursework so future practitioners will have a baseline understanding of how such knowledge may be used to improve patient care. A final challenge to the increased use of pharmacogenomics will be developing a financially viable model for pharmacist-provided pharmacogenomic services. Although clinical usage of pharmacogenomic information is currently in its early stages, the APhA-ASP Resolutions Committee feels that embracing pharmacogenomic services and continuing to learn and research this field is an important step toward advancing personalized medicine. References: 1. Table of Pharmacogenomic Biomarkers in Drug Labels. U.S. Food and Drug Administration. 2013. Access at: http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm. January 9, 2014. 2. Pharmacogenomics: Increasing the safety and effectiveness of drug therapy. American Medical Association. 2011. Accessed at: http://www.ama-assn.org//resources/doc/genetics/pgx-brochure2011.pdf. January 9, 2014. 3. Integrating pharmacogenomics into pharmacy practice via medication therapy management. American Pharmacists Association. J AmPharm Assoc. 2011;51:e64-e74. 2014.2 – Dispensing and Administering Medications in Life-Threatening Situations 1. APhA-ASP supports pharmacists’ authority to dispense and administer medications without a prescription in an emergency or life-threatening situation. 2. APhA-ASP supports protection from civil and criminal prosecution of medically trained personnel, including pharmacists, for actions taken in the best interest of the patient during an emergency or life-threatening situation. Background Statement: There are many inconsistencies among state regulations regarding pharmacists’ authority to dispense and administer medications (without a prescription) during an emergency or life-threatening situation. While Good Samaritan Laws provide legal protection to persons who assist an individual during an emergency or life-threatening situation, the extent of the protection varies from state to state when “medically trained personnel” are involved. Furthermore, pharmacists may not be included as “medically trained personnel” within such laws. Report of the 2014 APhA-ASP Resolutions Committee – Page 2 of 4 The APhA-ASP Resolutions Committee believes that pharmacists should legally be authorized to act in the best interest of an individual in an emergency or life-threatening situation, as well as be protected from prosecution or loss of license for such actions. References: 1. State Laws & Legislation. HeartSafe America Inc. 2013. Accessed at: http://www.heartsafeusa.com/forum/99/state-laws-legislation. January 11, 2014 2014.3 – Pharmacist-led Clinics 1. APhA-ASP supports the expansion of pharmacist-led clinics—in collaboration with other members of the health care team—that serve unmet health needs and facilitate increased access to patient care. These clinics may include, but not be limited to, anticoagulation, international travel, tobacco cessation, rural, underserved, and mobile health clinics. 2. APhA-ASP encourages all schools and colleges of pharmacy to incorporate entrepreneurship, business development, and practice management training in the curriculum to provide future pharmacists with the tools to operate and manage financially viable pharmacist-led clinics. 3. APhA-ASP encourages the expansion of residency, fellowship, and other postgraduate training programs within pharmacist-led clinics. 4. APhA-ASP encourages the development of grants or financial assistance programs to aid in the establishment and management of pharmacist-led clinics. Background Statement: APhA-ASP Resolution 1997.4 encourages pharmacists to establish collaborative drug and non-drug therapy protocols. Moreover, clinical evidence from pharmacist-directed anticoagulation and diabetes clinics demonstrates improved patient outcomes and satisfaction.1,2,3 Based upon this evidence, the APhA-ASP Resolutions Committee supports the advancement of pharmacist-led clinics to broaden the scope of pharmacy practice, expand entrepreneurial opportunities, and improve patient access to clinical services. The proposed resolution addresses multiple outlets in which pharmacist-led clinics can be implemented. For example, mobile health clinics may provide an opportunity for pharmacist-led interdisciplinary teams to increase access for vulnerable and medically underserved populations. 4 Mobile health clinics offering disease state management and other clinical services may lead to an improvement in patient outcomes, a reduction in emergency department visits, and a decrease in overall health care costs. To better prepare student pharmacists, we encourage all schools and colleges of pharmacy to offer didactic and experiential opportunities focusing on entrepreneurship and clinic management. While student pharmacists receive excellent clinical training, we believe there is room for further improvement in the curriculum in the areas of entrepreneurship, strategic direction, and business management. In addition, the committee believes that residency and other postgraduate training is important, as reflected in APhA-ASP Resolution 2008.3. Report of the 2014 APhA-ASP Resolutions Committee – Page 3 of 4 The APhA-ASP Resolutions Committee feels this proposed resolution highlights pharmacists’ ability to serve patients on a more personal level through pharmacist-led interdisciplinary clinics that increase access to patient care and expand pharmacy practice. References: 1. Makowski C, Jennings D, Nemerovski C, et al. The impact of pharmacist-directed patient education and anticoagulant care coordination on patient satisfaction. The Annals of Pharmacotherapy 2013; 47: 805-810. 2. Verret L, Couturier J, Rozon A, et al. Impact of a pharmacist-led warfarin self-management program on quality of life and anticoagulation control: A randomized trial. Pharmacotherapy 2012; 32: 871879. 3. Davidson M. The effectiveness of nurse- and pharmacist-directed care in diabetes disease management: A narrative review. Current Diabetes Reviews 2013; 3: 280-286. 4. Wlodarczyk D and Wheeler M. The Home visit: Mobile outreach. In: Medical Management of Vulnerable and Underserved Patients: Principles, Practice, and Populations. New York, NY: McGrawâHill; 2007. Report of the 2014 APhA-ASP Resolutions Committee – Page 4 of 4