DOCSLIB.ORG

Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry1

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry1 Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) July 2018 Procedural Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: [email protected] https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002 Phone: 800-835-4709 or 240-402-8010 Email: [email protected] https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication and Education CDRH-Division of Industry and Consumer Education Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Ave., Bldg. 66, Room 4621 Silver Spring, MD 20993-0002 Phone: 800-638-2041 or 301-796-7100; Fax: 301-847-8149 Email: [email protected] https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) July 2018 Procedural Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. SCOPE ............................................................................................................................... 2 III. BACKGROUND ............................................................................................................... 4 IV. INTEROPERABILITY AND INTEGRATION OF SYSTEMS .................................. 4 A. Data Standards ............................................................................................................................... 5 B. Structured and Unstructured Data .............................................................................................. 5 C. Validation ....................................................................................................................................... 6 D. Data From Multiple EHR Systems ............................................................................................... 6 V. BEST PRACTICES FOR USING EHRs IN CLINICAL INVESTIGATIONS ......... 6 A. Use of Health Information Technology Certified by ONC......................................................... 7 B. Use of EHR Systems Not Certified by ONC ................................................................................ 7 C. eSource Principles for EHRs ......................................................................................................... 8 1. Data Originator ............................................................................................................................... 8 2. Data Modifications .......................................................................................................................... 9 D. Blinded Study Designs ................................................................................................................... 9 E. Informed Consent .......................................................................................................................... 9 VI. INSPECTION, RECORDKEEPING, AND RECORD RETENTION REQUIREMENTS ...................................................................................................................... 10 GLOSSARY................................................................................................................................. 11 Contains Nonbinding Recommendations Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry1 This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations.2 For the purposes of this guidance, electronic health record (EHR) systems3are electronic platforms that contain individual health records for patients. EHR systems are generally maintained by health care providers, health care organizations, and health care institutions and are used to deliver care. EHR systems can be used to integrate real-time electronic health care information from medical devices and multiple health care providers involved in the care of patients. For the purposes of this guidance, an EHR is an individual patient record contained within the EHR system. A typical individual EHR may include a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and laboratory and test results. This guidance uses broad definitions of EHRs and EHR systems to be inclusive of many different types of EHRs and EHR systems.4 1 This guidance has been prepared by the Office of Medical Policy and the Office of Translational Sciences in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health at the Food and Drug Administration. This guidance was developed in consultation with the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS). 2 For FDA’s regulatory definitions of a clinical investigation, see 21 CFR 50.3(c), 56.102(c), and 312.3(b). For FDA’s regulatory definition of an investigation, see 21 CFR 812.3(h). 3 See the Glossary for definitions and usage of specific terms used throughout this guidance. Words and phrases in bold italics are defined in the Glossary. 4 We note that this definition of EHRs may not be consistent with the definition for EHRs published in other guidance documents. 1 Contains Nonbinding Recommendations This guidance provides recommendations on: Deciding whether and how to use EHRs as a source of data in clinical investigations Using EHR systems that are interoperable with electronic data capture (EDC) systems in clinical investigations Ensuring the quality and integrity of EHR data collected and used as electronic source data in clinical investigations Ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements5 In an effort to modernize and streamline clinical investigations, the goals of this guidance are to: Facilitate the use of EHR data in clinical investigations Promote the interoperability of EHR and EDC systems In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. SCOPE The recommendations outlined in this guidance apply to the use of EHR data in: Prospective clinical investigations of human drugs and biological products, medical devices, and combination products, including clinical investigations conducted in clinical practice settings6 5 For inspection requirements and principal recordkeeping requirements for clinical investigators who develop human drugs and biological products, see 21 CFR 312.62 and 312.68. For medical devices, see 21 CFR 812.140 and 812.145. 6Conclusions about the risks and benefits of medical products drawn from data, including EHR data, collected in routine clinical practice settings (i.e., outside of typical clinical research settings) are sometimes referred to as real world evidence. Such conclusions may be used to inform regulatory decision making, specifically in the approval of new indications for approved drugs and to satisfy post-approval study requirements. This guidance, which is intended to assist interested parties on the use of EHR data in FDA-regulated clinical investigations, satisfies, in part, the mandate under the 21st Century Cures Act (Cures Act) (Public Law 114-255) to issue guidance about the use of real world evidence in regulatory decision making. See Section 3022 of the Cures Act. See also 21 U.S.C. 2 Contains Nonbinding Recommendations Foreign clinical studies not conducted under
Load more

Recommended publications
  • Patient Care Through Telepharmacy September 2016
    Patient Care through Telepharmacy September 2016 Gregory Janes Objectives 1. Describe why telepharmacy started and how it has evolved with technology 2. Explain how telepharmacy is being used to provide better patient care, especially in rural areas 3. Understand the current regulatory environment around the US and what states are doing with regulation Agenda ● Origins of Telepharmacy ● Why now? ● Telepharmacy process ● Regulatory environment ● Future Applications Telepharmacy Prescription verification CounselingPrescription & verification Education History Origins of Telepharmacy 1942 Australia’s Royal Flying Doctor Service 2001 U.S. has first state pass telepharmacy regulation 2003 Canada begins first telepharmacy service 2010 Hong Kong sees first videoconferencing consulting services US Telepharmacy Timeline 2001 North Dakota first state to allow 2001 Community Health Association in Spokane, WA launches program 2002 NDSU study begins 2003 Alaska Native Medical Center program 2006 U.S. Navy begins telepharmacy 2012 New generation begins in Iowa Question #1 What was the first US state to allow Telepharmacy? a) Alaska b) North Dakota c) South Dakota d) Hawaii Question #1 What was the first US state to allow Telepharmacy? a) Alaska b) North Dakota c) South Dakota d) Hawaii NDSU Telepharmacy Study Study from 2002-2008 ● 81 pharmacies ○ 53 retail and 28 hospital ● Rate of dispensing errors <1% ○ Compared to national average of ~2% ● Positive outcomes, mechanisms could be improved Source: The North Dakota Experience: Achieving High-Performance
    [Show full text]
  • Preventive Health Care
    PREVENTIVE HEALTH CARE DANA BARTLETT, BSN, MSN, MA, CSPI Dana Bartlett is a professional nurse and author. His clinical experience includes 16 years of ICU and ER experience and over 20 years of as a poison control center information specialist. Dana has published numerous CE and journal articles, written NCLEX material, written textbook chapters, and done editing and reviewing for publishers such as Elsevire, Lippincott, and Thieme. He has written widely on the subject of toxicology and was recently named a contributing editor, toxicology section, for Critical Care Nurse journal. He is currently employed at the Connecticut Poison Control Center and is actively involved in lecturing and mentoring nurses, emergency medical residents and pharmacy students. ABSTRACT Screening is an effective method for detecting and preventing acute and chronic diseases. In the United States healthcare tends to be provided after someone has become unwell and medical attention is sought. Poor health habits play a large part in the pathogenesis and progression of many common, chronic diseases. Conversely, healthy habits are very effective at preventing many diseases. The common causes of chronic disease and prevention are discussed with a primary focus on the role of health professionals to provide preventive healthcare and to educate patients to recognize risk factors and to avoid a chronic disease. nursece4less.com nursece4less.com nursece4less.com nursece4less.com 1 Policy Statement This activity has been planned and implemented in accordance with the policies of NurseCe4Less.com and the continuing nursing education requirements of the American Nurses Credentialing Center's Commission on Accreditation for registered nurses. It is the policy of NurseCe4Less.com to ensure objectivity, transparency, and best practice in clinical education for all continuing nursing education (CNE) activities.
    [Show full text]
  • A Tool to Help Clinicians Do What They Value Most
    Health Information Technology: a Tool to Help Clinicians Do What They Value Most Health care professionals like you play a vital role in improving the health outcomes, quality of care, and the health care experience of patients. Health information technology (health IT) is an important tool that you can use to improve clinical practice and the health of your patients. Health IT can help health care professionals to do what you do best: provide excellent care to your patients. Research shows that when patients are Health IT encompasses a wide range of electronic tools that can help you: engaged in their health care, it can lead to • Access up-to-date evidence-based clinical guidelines and decision measurable improvements in safety and support quality. • Improve the quality of care and safety of your patients Source: Agency for Healthcare Research and Quality (AHRQ) • Provide proactive health maintenance for your patients • Better coordinate patients’ care with other providers through the secure and private sharing of clinical information. Health IT can help you to solve clinical problems with real-time data Quality improvement and clinical decision support rely on information about your patient population being readily available in digital form. Health IT can help you monitor your patients’ health status and make specific and targeted recommendations to improve your patients’ health. Access to real-time data through electronic health records and health IT will help you: A MAJORITY OF PROVIDERS • Use clinical decision support to highlight care options tailored to believe that electronic health information your patients has the potential to improve the quality of patient care and care coordination.
    [Show full text]
  • Enhancing Personal Health Record Adoption Through the Community Pharmacy Network: a Service Project Michael Veronin
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by INNOVATIONS in pharmacy (Iip - E-Journal) Volume 6 | Number 4 Article 221 2015 Enhancing Personal Health Record Adoption Through the Community Pharmacy Network: A Service Project Michael Veronin Follow this and additional works at: http://pubs.lib.umn.edu/innovations Recommended Citation Veronin M. Enhancing Personal Health Record Adoption Through the Community Pharmacy Network: A Service Project. Inov Pharm. 2015;6(4): Article 221. http://pubs.lib.umn.edu/innovations/vol6/iss4/3 INNOVATIONS in pharmacy is published by the University of Minnesota Libraries Publishing. Idea Paper INSIGHTS Enhancing Personal Health Record Adoption Through the Community Pharmacy Network: A Service Project Michael Veronin, PhD, RPh Department of Pharmaceutical Sciences, Ben and Maytee Fisch College of Pharmacy, The University of Texas at Tyler Key words: Personal Health Record, PHR, community pharmacy, ADDIE, health care quality No potential conflicts of interest or competing interests to disclose. No financial support or funding to disclose. Abstract Personal Health Records, or PHRs, are designed to be created, maintained and securely managed by patients themselves. PHRs can reduce medical errors and increase quality of care in the health care system through efficiency and improving accessibility of health information. Adoption of PHRs has been disappointingly low. In this paper a project is described—essentially a call for action—whereby the skills, expertise, and accessibility of the community pharmacist is utilized to address the problem of poor PHR adoption. The objective of this proposed project is to promote the expansion of PHR adoption directly at the consumer level by utilizing the existing infrastructure of community pharmacies.
    [Show full text]
  • Health Information Technology
    Published for 2020-21 school year. Health Information Technology Primary Career Cluster: Business Management and Technology Course Contact: [email protected] Course Code: C12H34 Introduction to Business & Marketing (C12H26) or Health Science Prerequisite(s): Education (C14H14) Credit: 1 Grade Level: 11-12 Focused Elective This course satisfies one of three credits required for an elective Graduation Requirements: focus when taken in conjunction with other Health Science courses. This course satisfies one out of two required courses to meet the POS Concentrator: Perkins V concentrator definition, when taken in sequence in an approved program of study. Programs of Study and This is the second course in the Health Sciences Administration Sequence: program of study. Aligned Student HOSA: http://www.tennesseehosa.org Organization(s): Teachers are encouraged to use embedded WBL activities such as informational interviewing, job shadowing, and career mentoring. Coordinating Work-Based For information, visit Learning: https://www.tn.gov/content/tn/education/career-and-technical- education/work-based-learning.html Available Student Industry None Certifications: 030, 031, 032, 034, 037, 039, 041, 052, 054, 055, 056, 057, 152, 153, Teacher Endorsement(s): 158, 201, 202, 203, 204, 311, 430, 432, 433, 434, 435, 436, 471, 472, 474, 475, 476, 577, 720, 721, 722, 952, 953, 958 Required Teacher None Certifications/Training: https://www.tn.gov/content/dam/tn/education/ccte/cte/cte_resource Teacher Resources: _health_science.pdf Course Description Health Information Technology is a third-level applied course in the Health Informatics program of study intended to prepare students with an understanding of the changing world of health care information.
    [Show full text]
  • Health Care Informatics Keng Siau
    IEEE TRANSACTIONS ON INFORMATION TECHNOLOGY IN BIOMEDICINE, VOL. 7, NO. 1, MARCH 2003 1 Health Care Informatics Keng Siau Abstract—The health care industry is currently experiencing a fundamental change. Health care organizations are reorganizing their processes to reduce costs, be more competitive, and provide better and more personalized customer care. This new business strategy requires health care organizations to implement new tech- nologies, such as Internet applications, enterprise systems, and mo- bile technologies in order to achieve their desired business changes. This article offers a conceptual model for implementing new in- formation systems, integrating internal data, and linking suppliers and patients. Index Terms—Bioinformatics, data mining, enterprise systems, health informatics, information warehouse, internet, mobile tech- nology, patient relationship management, telemedicine. I. INTRODUCTION Fig. 1. Health care supply chain. NFORMATION technology has expanded to encompass I nearly every industry in the world from finance and banking to universities and nonprofit organizations. The health placement for the physician–patient relationship; instead it is care industry, which is composed of hospitals, individual meant to enhance this relationship, by making both physicians physician practices, specialty practices, as well as managed and patients better informed. care providers, pharmaceutical companies, and insurance companies, is no exception. The industry’s expanded interest II. CURRENT USE OF IT IN HEALTHCARE in information systems implementation has primarily been Current literature on the deployment of information systems fueled by needs for cost efficiency, increased competition, as in the health care sector shows that most organizations are al- well as a fundamental change in the health care industry, in locating a relatively small amount of resources toward informa- which providers have changed their focus from reactive care tion systems.
    [Show full text]
  • Telepharmacy Rules and Statutes: a 50-State Survey
    American Journal of Medical Research 5(2), 2018 pp. 7–23, ISSN 2334-4814, eISSN 2376-4481 doi:10.22381/AJMR5220181 TELEPHARMACY RULES AND STATUTES: A 50-STATE SURVEY GEORGE TZANETAKOS Department of Health Management and Policy, College of Public Health, The University of Iowa FRED ULLRICH Department of Health Management and Policy, College of Public Health, The University of Iowa KEITH MUELLER [email protected] Department of Health Management and Policy, College of Public Health, The University of Iowa (corresponding author) ABSTRACT. There has been a significant decline in the number of independently owned rural pharmacies serving non-metropolitan areas, thereby limiting access to pharmaceutical services for rural residents, particularly for those most vulnerable and in need of these services. The use of telepharmacy is one potential solution to this problem. Telepharmacies deliver pharmaceutical care to outpatients at a distance via telecommunication and other advanced technologies. This study identifies rules and laws enacted by states authorizing the use of community telepharmacy initiatives within their respective jurisdictions. As of August 2016, the use of telepharmacy was authorized, in varying capacities, in 23 states (46%). Pilot program development that could apply to telepharmacy initiatives was authorized by six states (12%). Waivers to administrative or legislative pharmacy practice requirements that could allow for telepharmacy initiatives were permitted in five states (10%). Nearly one-third of the states (16, or 32%) did not authorize the use of telepharmacy, nor did they authorize the pursuit of telepharmacy initiatives via pilot programs or waivers. Keywords: telepharmacy; rule; statute; rural; community; outpatient How to cite: Tzanetakos, George, Fred Ullrich, and Keith Mueller (2018).
    [Show full text]
  • Benefits of Using an Electronic Health Record
    Tech Talk Benefits of using an electronic health record By Robin Hoover, MSN-HCI, RN Since the passage of the Health Information duplicate tests and improving overall efficiency.7 Technology for Economic and Clinical Health The EHR also stores radiology results, which can (HITECH) Act in 2009, advancements in technology be accessed from within the application if clini- for electronic health records (EHRs) have dramati- cians need to view the actual X-ray or the report cally increased.1 HITECH includes incentives that from the radiologist.8 All reports are accessible to provide reimbursements to hospitals and health- all clinicians involved in the patient’s healthcare care provider practices for adopting certified and can be viewed at any time. EHR technology and meeting meaningful use It is important to note that not all EHRs provide requirements.2 the same features. Some features, such as the abil- Despite these incentives, nurses, healthcare ity to view X-rays in the EHR, represent an addi- providers, and hospitals have been slow to adopt tional design and development cost for the facility. any comprehensive EHR. Potential barriers include a lack of computer skills, high cost, Involving the patient security concerns, workflow issues, and time.3 The Health Insurance Portability and However, as this article will show, adopting EHRs Accountability Act of 1996 requires that all pro- has many more benefits than drawbacks, and tected health information be secure.9 Keeping this implementation is worth the upfront time and information safe is a major challenge for all mem- cost commitment. bers of the healthcare team.
    [Show full text]
  • Health Care Transactions Basics (PDF)
    ABOUT ADMINISTRATIVE SIMPLIFICATION Health Care Transactions Basics What is a Health Care Transaction? Administrative Simplifcation Standard A health care transaction is an Transactions exchange of information between To help guide the health care industry, the two parties to carry out financial Department of Health and Human Services (HHS) adopted or administrative activities. When standardized implementation specifications for electronic electronic health care transactions transactions used in the electronic exchange of health care data. are used effectively, they: These adopted transactions include: • Increase efficiencies in operations • Health care claim X12N 837 transaction • Improve the quality and accuracy • Health care claim payment advice X12N 835 transaction of information • Health care claim status request/notifcation X12N 276/277 transaction • Reduce the overall costs to the • Eligibility, coverage, or beneft inquiry/information X12N 270/271 health care system transaction Widespread use of Healthcare • Beneft enrollment and maintenance X12N 834 transaction Insurance Portability and • Health care service review information X12N 278 transaction Accountability Act of 1996 • Payment order/remittance advice X12N 820 transaction (HIPAA) adopted transactions— HIPAA-covered entities—health plans, clearinghouses, and covered where everyone uses the same health care providers—must use the adopted standards when language, format, and code sets— conducting these transactions using an electronic format. can lead to substantial savings For several of these transactions, HHS has also adopted across the health care industry. operating rules that support the use of transactions. To realize these benefits, however, all organizations need to be using the same adopted standards for their health care transactions. Enforcement The National Standards Group (NSG) enforces compliance with Administrative Simplification standards and operating rules on behalf of the Department of Health and Human Services.
    [Show full text]
  • Health Information Technology Program Guide Fall 2021
    Health Information Technology Program Guide Fall 2021 Table of Contents INTRODUCTION 4 Mission 4 WELCOME 5 What Is Health Information? 6 What Do Health Information Technicians Do? 8 Duties 8 Work Environment 9 Work Schedules 9 Why Choose a Career in Health Information? 11 Versatile Education 11 Dynamic Career Opportunities and Opportunities for Advancement 11 How Do I Become a Registered Health Information Technician? 12 Education 12 Important Qualities 12 Licenses, Certifications, and Registrations 13 Advancement 13 Accreditation 13 Money and Outlook 14 HEALTH INFORMATION TECHNOLOGY PROGRAM AT CCCC 16 Faculty 16 Admissions Process 23 Program Details 25 AHIMA Code of Ethics 26 AHIMA Student Membership 26 Background Check 27 Credit by Examination 27 Credit by Experience 28 Computer Skills 29 Distance Program 29 Program Technology Requirements 29 General Education Options for Communication, Humanities, and Social Science Electives 30 Professional Practice Experience (PPE) 31 CCCC HIT PROGRAM GUIDE FALL 2021 2 Office of Student Accessibility Services 31 Syllabus 31 Expectations for Online Students 32 Technical Standards 33 Student Learning Outcomes 37 How Do I Get Started? 41 What Can I Do While Waiting to Begin? 42 APPENDIX 43 Appendix A – Admissions for Health Science Programs 43 Appendix B- Program Planning Guide 43 PROGRAM GUIDE ACKNOWLEDGMENT FORM 44 TECHNICAL STANDARDS ACKNOWLEDGEMENT FORM 45 CCCC HIT PROGRAM GUIDE FALL 2021 3 INTRODUCTION This program guide is for students in the Health Information Technology (HIT) program at Central Carolina Community College. This guide contains information about the administrative and academic policies of this program. It is essential for all students to become familiar with this guide to successfully complete this program.
    [Show full text]
  • Preventive Health Care
    PREVENTIVE HEALTH CARE Understanding what’s covered What is preventive care? What’s not considered preventive care? Preventive care is a specific group of services Once you have a symptom or your health care provider recommended when you don’t have any symptoms diagnoses a health issue, additional tests are not and haven’t been diagnosed with a related health considered preventive care. Also, you may receive issue. It includes your periodic wellness exam other medically appropriate services during a periodic (check-up) and specific tests, certain health wellness exam that are not considered preventive. screenings, and most immunizations. Most of these These services may be covered under your plan’s services typically can take place during the same visit. medical benefits, not your preventive care benefits. You and your health care provider will decide what This means you may be responsible for paying a preventive services are right for you, based on your: share or all of the cost. This may include your plan’s › Age deductible, copay or coinsurance amounts, depending on your plan. › Gender › Personal health history Which preventive services are covered? › Current health Many plans cover preventive care at no additional cost to you when you use a health care provider Why do I need preventive care? in your plan’s network. Use the provider directory on myCigna.com Preventive care can help you detect problems at early for a list of in-network health care stages, when they may be easier to treat. It can also providers and facilities. help you prevent certain illnesses and health conditions See the charts on the following pages for the services from happening.
    [Show full text]
  • Collaborative Practice Agreements and Pharmacists' Patient Care
    Collaborative Practice Agreements and Pharmacists’ Patient Care Services A RESOURCE FOR DOCTORS, NURSES, PHYSICIAN ASSISTANTS, AND OTHER PROVIDERS COLLABORATIVE PRACTICE AGREEMENTS AND PHARMACISTS’ PATIENT CARE SERVICES | A RESOURCE FOR HEALTH CARE PROVIDERS harmacists can improve patients’ health and the health care delivery system if they are part of the patient’s health care team. One way to achieve this Pharmacist Collaborative goal is with a collaborative practice agreement (CPA) Practice Agreement (CPA) Pbetween pharmacists and other health care providers.1 A formal agreement in which a licensed provider makes Patient care services provided by pharmacists can reduce a diagnosis, supervises patient care, and refers the fragmentation of care, lower health care costs, and improve patient to a pharmacist under a protocol that allows the health outcomes.1 A 2010 study found that patient health pharmacist to perform specific patient care functions. improves significantly when pharmacists work with doctors and other providers to manage patient care.2 The Community Preventive Services Task Force also found strong evidence that matter experts to identify evidence for effective policies, team-based care can improve blood pressure control when a practices, and key supports and barriers to expanding the role pharmacist is included on the team.3 of pharmacists in delivering patient care services and entering into CPAs.4 States regulate pharmacists’ patient care services through “scope of practice” laws and related rules, including boards Consistent with the findings of the Office of the Chief of pharmacy and medicine regulations. Depending on each Pharmacist 2011 Report to the U.S. Surgeon General,1 the state’s laws, pharmacists can work with other health care group found that broad access to patient care services deliv- providers through CPAs to perform an array of patient care ered by pharmacists is limited by policy and compensation services (Figure 1).
    [Show full text]