Standards proposed for community Rx accreditation

Abstract

Draft standards for accreditation of community pharmacy practices have been issued by the Center for Pharmacy Practice Accreditation (CPPA) with a deadline of August 15 for comments.The standards were developed by a working committee whose members are on listed on page 54. More information is available at http://cppa.pharmacist.com.CPPA, a Joint effort of APhA and the National Association of Boards of Pharmacy, has contracted with APhA to develop consensus-based standards. APhA's effort is led by Thomas R. Temple, BSPharm, MS, past CEO of Iowa Pharmacists Association."These standards represent a watershed moment for community pharmacy practices," Temple said. "Only by ensuring that our services are taken to the next level will we succeed in the future."CPPA is asking reviewers to consider these questions about the draft standards:1.Will the standards create value for those receiving services through pharmacy practices ?2.Are the standards appropriate and achievable by current community pharmacy practices over the next 1 to 5 years?3.Will the standards result in improved pharmacy practice?4.Do the standards promote positive service outcomes in pharmacy practices?5.Do the standards reflect contemporary community pharmacy practice?6.Do the standards serve to facilitate innovation in community pharmacy practice?Reviewers will also be asked to provide suggestions for additions, deletions, and other modifications, and to comment on specific draft standards and how they should be assessed during surveys.Community Pharmacy Practice StandardsDRAFT for Public CommentVision for Center for Pharmacy Practice Accreditation (CPPA) ProgramsAdopted May 2,2012, by the CPPA BoardPharmacy practice accreditation standards should facilitate a pharmacy practice that provides quality, safe, and effective dispensing and/or pharmacist-provided health-related services to both patients and consumers in general. The accreditation process facilitates innovation, recognition, and viable operations for participating pharmacy practices.Community Pharmacy Practice StandardsOverarching Statement for Community Pharmacy Practice StandardsPatient care and dispensing services provided in the practice setting demonstrate compliance with any applicable state and national regulatory requirements and/or standards established by a recognized organization appropriate for the services provided.STANDARD 11.0Practice Management: The pharmacy practice is appropriately managed to allow for efficient, safe, and effective delivery of services.1.1The practice has:1.1.1a mission statement that reflects the services provided1.1.2a well-defined organizational structure1.1.3job descriptions for each category of staff1.1.4annual performance appraisal system and performance management system aligned to the duties and roles required for each staff member1.1.5descriptions of services provided1.1.6goals established for each service1.1.7current policies and procedures for hiring and credentialing personnel, operations, and services that are readily available and used by appropriate pharmacy staff in everyday practice1.1.8adequate and appropriate facilities to deliver quality services1.1.9sufficient and appropriate professional, technical, and support staff to deliver quality services1.1.10resources to deliver the level of services provided in the practice1.1.11systems to document pharmacy workload, financial performance, and patient care outcomes data of the practice1.1.12a process in place for preventing and dealing with fraud, waste, and abuseSTANDARD 22.0Patient Counseling: Every patienti has an understanding and expectation of what the medication is, what it does, how to optimally use it, the potential risks, and the intended outcome of the therapy.2.1Pharmacists and/or pharmacy internsii provide effective counseling to patients.2.1.1Pharmacist(s) and/or pharmacy interns are approachable and accessible to develop ongoing relationships with patients.2.2Pharmacy practiceiii provides resources and information to encourage patient-initiated questions, including phone numbers, e-mails, or websites, that connect the patient with a pharmacist to receive patient counseling.2.3Appropriate pharmacy practice staffiv makes an ongoing attempt to gather complete medication history, including data from multiple health care providers.2.4Pharmacists and/or pharmacy interns evaluate the patient's medication use history, perform drug-utilization review as defined within the National Association of Boards of Pharmacy's model act, and take appropriate action to address patient consultation needs.2.5Pharmacists and/or pharmacy interns determine the patient's level of understanding of medication therapy and provide counseling upon every first fill, upon any change to medication therapy, upon need determined by the pharmacist, or upon request of the patient.2.6Pharmacy practice provides an environment for patient counseling that secures privacy and security of patient data.2.7Patient counseling is individualized to meet the needs of the patient.2.7.1Appropriate pharmacy practice staff addresses the special communication needs of patients including, but not limited to, those with low health literacy, with cultural influences relevant to medication therapy, or those who do not speak English, and has a documented protocol on this process.2.7.2Appropriate pharmacy practice staff provides and informs patients about appropriate or required written educational information, including but not limited to, medication leaflets, MedGuides, REMS information, and appropriate warning labels.2.8Pharmacists and/or pharmacy interns use a variety of communication mechanisms for providing patient counseling tailored to the needs of the patient.2.9Pharmacy practice uses available delivery formats to provide additional sources of information that may supplement and support patient counseling, including, but not limited to, printed patient information, e-mail and telephone communication, reliable and accurate websites, text messages, real-time Internet communication, or other means of communication.2.10Pharmacy practice has a process for documenting the counseling session to facilitate internal and external continuity of care.2.10.1Pharmacist or appropriate pharmacy staff documents in the patient record (patient profile and/or electronic medical record) important or pertinent information from the patient counseling session.2.11Pharmacy practice has a process for evaluating the effectiveness of patient counseling activities.2.11.1Pharmacist or appropriate pharmacy staff uses established metrics to monitor the outcome of counseling activities. This could include, but not be limited to:•Adherence metrics (30-, 60-, 90-day evaluation points)•Improved therapeutic outcomes•Reduction of adverse drug eventsSTANDARD 33.0Patient Care Services: Pharmacy practice develops, implements, and oversees sustainable patient-centered services focused on improving patient medication use, health, and wellness.3.1Patient care services are developed and delivered based on analyses of need in the practice's patient population and using evidence-based guidelines or best practices when available.3.2Pharmacists and/or pharmacy interns deliver medication therapy management services that include both:•Comprehensive medication reviews: conducted to obtain a complete medication history, assess the appropriateness of medication therapy, and create a reconciled medication list and a care plan for the patient.•Targeted medication reviews: conducted for ongoing monitoring of medications and interventions to address specific medication-related problems.3.3Pharmacy practice provides at least two of the following patient care services consistent with laws and regulations:•Health and wellness program(s) (e.g., blood pressure screenings, cholesterol screenings, osteoporosis screenings, smoking cessation programs, weight loss programs)•Immunization program(s)•Programs to monitor and improve patients' medication adherence•Care transitions program(s)•Chronic disease education program(s)•Chronic disease management program(s)3.4Pharmacy practice actively seeks collaboration with physicians and other health care providers.3.5Patient care services in the practice are enabled by collaborative practice agreements with prescribers where feasible.3.6Patient education and training are provided in an effective manner based on the needs of the patient.3.6.1Pharmacy practice staff evaluates gaps in care, medication history, lab results, medication adherence, and other factors to identify patient medication, therapeutic, and consultation needs.3.7Pharmacists or appropriate staff effectively and efficiently documents and communicates patient care.3.7.1Systems facilitate documentation of care to enhance continuity of care among practice providers.3.7.2Pharmacy practice has systems in place to communicate appropriate information to physicians and other health care professionals, including consultation on the selection of medications, recommendations to address identified medication problems, services provided, updates on the patient's progress, and recommended follow-up.3.8Pharmacy practice evaluates competency and facilitates continuous professional development of staff involved in patient care service delivery based on the complexity of services and needs of patients.3.9Pharmacy practice operates a quality improvement program for patient care services.3.9.1Pharmacy practice collects data for analysis and uses recognized quality measures to monitor and improve patient care outcomes.STANDARD 44.0Technology: Pharmacy practice information systems and technology operate properly and support patient care services, medication safety, and medication fulfillment if applicable.4.1Pharmacy practice information systems support effective and efficient documentation into the patient's medication (or pharmacy practice) and/or medical record.4.1.1Pharmacy practice information systems allow for documentation of prescription medications, over-the-counter medications, dietary supplements, laboratory values, diagnoses, and other information required to deliver available patient care services.4.2Pharmacy practice information systems contain clinical decision support programs that facilitate the delivery of patient care services.4.3Pharmacy practice implements strategies to facilitate bidirectional flow of clinical and medication-related information.4.3.1Pharmacy practice has capability for e-prescribing transmissions.4.3.2Pharmacy practice is exploring strategies for interfacing with electronic health records (EHR).4.4The patient electronic medication/medical record is stored and accessible in a manner that facilitates effective pharmacist communication with other pharmacists in the practice, patients, caregivers, prescribers, or other appropriate health care professionals or organizations.4.5Pharmacy practice has systems in place to allow access to appropriate evidence-based references, including the primary literature.4.6Pharmacy practice information systems support the pharmacist performing effective prospective and retrospective drug-use review.4.6.1Pharmacy practice information systems assist the pharmacist in checking the prescription drug order for, at a minimum, proper and/or reasonable dosage, duplicate medication therapy, drug interactions, rational therapy contraindications, patient allergies, and/or potential or actual adverse drug reactions.4.7Pharmacy practice uses technology that supports safe medication distribution processes and facilitates patient safety.4.7.1Pharmacy practice implements bar-coding technology or other tools to ensure patient safety.4.8Pharmacy practice implements policies and procedures to validate that information systems and technology maintain the privacy and security of patient information.4.9Quality assurance mechanisms are in place to monitor performance of pharmacy information systems and technology.4.9.1Pharmacy practice information systems and technology are tested, validated, and updated on a routine basis.4.9.1.1Pharmacy practice information systems are routinely updated to include recent medication information.4.9.1.2Pharmacy practice has systems in place to appropriately manage drug recalls.4.9.1.3Pharmacy practice information systems have routine maintenance, back-up, cyber-security, and data- retrieval systems in place.4.9.1.4Pharmacy practice has a continuity plan in place should pharmacy practice information systems fail.5.0Quality Improvement: Pharmacy practice operates a continuous quality improvement (CQI) program, with the intended goal of enhancing patient safety.5.1Pharmacy practice operates a CQI program.5.1.1Pharmacy practice staff documents quality-related events (QREs) and conducts periodic audits of medication errors and QREs.5.1.2QREs are communicated to appropriate persons internally, national databases, peer-review committees, or patient safety organizations, as appropriate or required.5.1.3QRE analysis by pharmacist and pharmacy staff lead to appropriate actions such as modification of workflows or procedures, so as to prevent similar QREs in the future.5.1.4Quality self-audits or peer-review staff meetings are held to review pharmacy workflows and systems to support clinical pharmacy services and safe medication distribution processes.5.1.5Pharmacy practice staff identifies trends in QREs and develops plans to address identified trends.5.2Pharmacy practice conducts performance measurement activities to develop and implement plans that improve performance, where appropriate, and to address the effectiveness of the CQI program.5.3Pharmacy practice conducts and encourages routine training and education of pharmacy staff on quality improvement initiatives.5.4Pharmacy practice employs patient satisfaction or consumer surveys regarding pharmacy staff and patient care services with the intent of improving patient satisfaction and outcomes of care.i.Patient: includes the patient, caregivers, and authorized representatives of a patient who have responsibility for ensuring appropriate use of medications by a patient. For purposes of these Standards, "patient" also includes other consumers who use the services of a pharmacy practice.ii.Pharmacy Intern: means an individual who is currently licensed to engage in the Practice of Pharmacy while under the supervision of a Pharmacist and is enrolled in a professional degree program of a school or college of pharmacy that has been approved by the Board and is satisfactorily progressing toward meeting the requirements for licensure as a Pharmacist; or a graduate of an approved professional degree program of a school or college of pharmacy or a graduate who has established educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee (FPGEC) Certificate, who is currently licensed by the Board of Pharmacy for the purpose of obtaining practical experience as a requirement for licensure as a Pharmacist; or a qualified applicant awaiting examination for licensure or meeting Board requirements for relicensure; or an individual participating in a residency or fellowship program. (Source: NABP Model Act)iii.Pharmacy Practice: is the entity where services are directly provided to patients focused on improving medication use and advancing patient safety.iv.Pharmacy Practice Staff: includes Pharmacists, Pharmacy Interns, and support staff within the Pharmacy Practice who directly provide services based upon their scope of authority.APhA Community Pharmacy Practice Standards Development Working Committee Participant ListChair: Marialice Bennett, BSPharm, FAPhAOhio State University College of Pharmacy Jose Cervantes, PharmacyH-E-B Grocery Company, LP BJ Cobb, BSPharmWinn-Dixie Stores, Inc. Tracy Furgiuele, BSPharmMedco Health Solutions, Inc. Margherita R. Giuliano, BSPharm, CAE Connecticut Pharmacists Association Jeff Goad, PharmD, MPH University of Southern California School of Pharmacy Stuart Haines, PharmD, BCPS, BCACP University of Maryland School of Pharmacy Brian C. Jensen, BSPharm, FACA Lakeshore Apothacare Inc./Pharmacy SolutionsDan Kennedy, BSPharm, FAPhAOregon Health and Science University Brian K. Komoto, PharmDKomoto Healthcare Winnie Landis, BSPharm, CDE, FAPhACVS/pharmacy Debbie Mack, BSPharm, CHCWalmart Stores, Inc. Lynnae Mahaney, MBA, BSPharm, FASHP, VHA-CM William S. Middleton Memorial Veterans Hospital Sandy Markwood National Association of Area Agencies on Aging Bill Osborn, PharmD Osborn Drugs, Inc. Mike Podgurski, BSPharm Rite Aid Corp.John Thornton, BSPharmBlue Cross Blue Shield Association Laura White, BSPharm Humana, Inc.Staff:Anne Burns, BSPharm Elizabeth Cardello, BSPharm Thomas E. Menighan, BSPharm, MBA,ScD (Hon), FAPhA Mitchel C. Rothholz, BSPhsarm, MBA Margaret H. Tomecki, PharmD, FAPhAAmerican Pharmacists Association Thomas R. Temple, BSPharm, MS Temple and AssociatesObservers:Melissa Madigan, PharmD, JD Eileen Lewalski, PharmD, JD National Association of Boards of Pharmacy Draft standards for accreditation of community pharmacy practices have been issued by the Center for Pharmacy Practice Accreditation (CPPA) with a deadline of August 15 for comments. The standards were developed by a working committee whose members are on listed on page 54. More information is available at http://cppa.pharmacist.com. CPPA, a Joint effort of APhA and the National Association of Boards of Pharmacy, has contracted with APhA to develop consensus-based standards. APhA's effort is led by Thomas R. Temple, BSPharm, MS, past CEO of Iowa Pharmacists Association. "These standards represent a watershed moment for community pharmacy practices," Temple said. "Only by ensuring that our services are taken to the next level will we succeed in the future." CPPA is asking reviewers to consider these questions about the draft standards:1.Will the standards create value for those receiving services through pharmacy practices ?2.Are the standards appropriate and achievable by current community pharmacy practices over the next 1 to 5 years?3.Will the standards result in improved pharmacy practice?4.Do the standards promote positive service outcomes in pharmacy practices?5.Do the standards reflect contemporary community pharmacy practice?6.Do the standards serve to facilitate innovation in community pharmacy practice? Reviewers will also be asked to provide suggestions for additions, deletions, and other modifications, and to comment on specific draft standards and how they should be assessed during surveys. Community Pharmacy Practice StandardsDRAFT for Public CommentVision for Center for Pharmacy Practice Accreditation (CPPA) ProgramsAdopted May 2,2012, by the CPPA BoardPharmacy practice accreditation standards should facilitate a pharmacy practice that provides quality, safe, and effective dispensing and/or pharmacist-provided health-related services to both patients and consumers in general. The accreditation process facilitates innovation, recognition, and viable operations for participating pharmacy practices.Community Pharmacy Practice StandardsOverarching Statement for Community Pharmacy Practice StandardsPatient care and dispensing services provided in the practice setting demonstrate compliance with any applicable state and national regulatory requirements and/or standards established by a recognized organization appropriate for the services provided.STANDARD 11.0Practice Management: The pharmacy practice is appropriately managed to allow for efficient, safe, and effective delivery of services.1.1The practice has:1.1.1a mission statement that reflects the services provided1.1.2a well-defined organizational structure1.1.3job descriptions for each category of staff1.1.4annual performance appraisal system and performance management system aligned to the duties and roles required for each staff member1.1.5descriptions of services provided1.1.6goals established for each service1.1.7current policies and procedures for hiring and credentialing personnel, operations, and services that are readily available and used by appropriate pharmacy staff in everyday practice1.1.8adequate and appropriate facilities to deliver quality services1.1.9sufficient and appropriate professional, technical, and support staff to deliver quality services1.1.10resources to deliver the level of services provided in the practice1.1.11systems to document pharmacy workload, financial performance, and patient care outcomes data of the practice1.1.12a process in place for preventing and dealing with fraud, waste, and abuseSTANDARD 22.0Patient Counseling: Every patienti has an understanding and expectation of what the medication is, what it does, how to optimally use it, the potential risks, and the intended outcome of the therapy.2.1Pharmacists and/or pharmacy internsii provide effective counseling to patients.2.1.1Pharmacist(s) and/or pharmacy interns are approachable and accessible to develop ongoing relationships with patients.2.2Pharmacy practiceiii provides resources and information to encourage patient-initiated questions, including phone numbers, e-mails, or websites, that connect the patient with a pharmacist to receive patient counseling.2.3Appropriate pharmacy practice staffiv makes an ongoing attempt to gather complete medication history, including data from multiple health care providers.2.4Pharmacists and/or pharmacy interns evaluate the patient's medication use history, perform drug-utilization review as defined within the National Association of Boards of Pharmacy's model act, and take appropriate action to address patient consultation needs.2.5Pharmacists and/or pharmacy interns determine the patient's level of understanding of medication therapy and provide counseling upon every first fill, upon any change to medication therapy, upon need determined by the pharmacist, or upon request of the patient.2.6Pharmacy practice provides an environment for patient counseling that secures privacy and security of patient data.2.7Patient counseling is individualized to meet the needs of the patient.2.7.1Appropriate pharmacy practice staff addresses the special communication needs of patients including, but not limited to, those with low health literacy, with cultural influences relevant to medication therapy, or those who do not speak English, and has a documented protocol on this process.2.7.2Appropriate pharmacy practice staff provides and informs patients about appropriate or required written educational information, including but not limited to, medication leaflets, MedGuides, REMS information, and appropriate warning labels.2.8Pharmacists and/or pharmacy interns use a variety of communication mechanisms for providing patient counseling tailored to the needs of the patient.2.9Pharmacy practice uses available delivery formats to provide additional sources of information that may supplement and support patient counseling, including, but not limited to, printed patient information, e-mail and telephone communication, reliable and accurate websites, text messages, real-time Internet communication, or other means of communication.2.10Pharmacy practice has a process for documenting the counseling session to facilitate internal and external continuity of care.2.10.1Pharmacist or appropriate pharmacy staff documents in the patient record (patient profile and/or electronic medical record) important or pertinent information from the patient counseling session.2.11Pharmacy practice has a process for evaluating the effectiveness of patient counseling activities.2.11.1Pharmacist or appropriate pharmacy staff uses established metrics to monitor the outcome of counseling activities. This could include, but not be limited to:•Adherence metrics (30-, 60-, 90-day evaluation points)•Improved therapeutic outcomes•Reduction of adverse drug eventsSTANDARD 33.0Patient Care Services: Pharmacy practice develops, implements, and oversees sustainable patient-centered services focused on improving patient medication use, health, and wellness.3.1Patient care services are developed and delivered based on analyses of need in the practice's patient population and using evidence-based guidelines or best practices when available.3.2Pharmacists and/or pharmacy interns deliver medication therapy management services that include both:•Comprehensive medication reviews: conducted to obtain a complete medication history, assess the appropriateness of medication therapy, and create a reconciled medication list and a care plan for the patient.•Targeted medication reviews: conducted for ongoing monitoring of medications and interventions to address specific medication-related problems.3.3Pharmacy practice provides at least two of the following patient care services consistent with laws and regulations:•Health and wellness program(s) (e.g., blood pressure screenings, cholesterol screenings, osteoporosis screenings, smoking cessation programs, weight loss programs)•Immunization program(s)•Programs to monitor and improve patients' medication adherence•Care transitions program(s)•Chronic disease education program(s)•Chronic disease management program(s)3.4Pharmacy practice actively seeks collaboration with physicians and other health care providers.3.5Patient care services in the practice are enabled by collaborative practice agreements with prescribers where feasible.3.6Patient education and training are provided in an effective manner based on the needs of the patient.3.6.1Pharmacy practice staff evaluates gaps in care, medication history, lab results, medication adherence, and other factors to identify patient medication, therapeutic, and consultation needs.3.7Pharmacists or appropriate staff effectively and efficiently documents and communicates patient care.3.7.1Systems facilitate documentation of care to enhance continuity of care among practice providers.3.7.2Pharmacy practice has systems in place to communicate appropriate information to physicians and other health care professionals, including consultation on the selection of medications, recommendations to address identified medication problems, services provided, updates on the patient's progress, and recommended follow-up.3.8Pharmacy practice evaluates competency and facilitates continuous professional development of staff involved in patient care service delivery based on the complexity of services and needs of patients.3.9Pharmacy practice operates a quality improvement program for patient care services.3.9.1Pharmacy practice collects data for analysis and uses recognized quality measures to monitor and improve patient care outcomes.STANDARD 44.0Technology: Pharmacy practice information systems and technology operate properly and support patient care services, medication safety, and medication fulfillment if applicable.4.1Pharmacy practice information systems support effective and efficient documentation into the patient's medication (or pharmacy practice) and/or medical record.4.1.1Pharmacy practice information systems allow for documentation of prescription medications, over-the-counter medications, dietary supplements, laboratory values, diagnoses, and other information required to deliver available patient care services.4.2Pharmacy practice information systems contain clinical decision support programs that facilitate the delivery of patient care services.4.3Pharmacy practice implements strategies to facilitate bidirectional flow of clinical and medication-related information.4.3.1Pharmacy practice has capability for e-prescribing transmissions.4.3.2Pharmacy practice is exploring strategies for interfacing with electronic health records (EHR).4.4The patient electronic medication/medical record is stored and accessible in a manner that facilitates effective pharmacist communication with other pharmacists in the practice, patients, caregivers, prescribers, or other appropriate health care professionals or organizations.4.5Pharmacy practice has systems in place to allow access to appropriate evidence-based references, including the primary literature.4.6Pharmacy practice information systems support the pharmacist performing effective prospective and retrospective drug-use review.4.6.1Pharmacy practice information systems assist the pharmacist in checking the prescription drug order for, at a minimum, proper and/or reasonable dosage, duplicate medication therapy, drug interactions, rational therapy contraindications, patient allergies, and/or potential or actual adverse drug reactions.4.7Pharmacy practice uses technology that supports safe medication distribution processes and facilitates patient safety.4.7.1Pharmacy practice implements bar-coding technology or other tools to ensure patient safety.4.8Pharmacy practice implements policies and procedures to validate that information systems and technology maintain the privacy and security of patient information.4.9Quality assurance mechanisms are in place to monitor performance of pharmacy information systems and technology.4.9.1Pharmacy practice information systems and technology are tested, validated, and updated on a routine basis.4.9.1.1Pharmacy practice information systems are routinely updated to include recent medication information.4.9.1.2Pharmacy practice has systems in place to appropriately manage drug recalls.4.9.1.3Pharmacy practice information systems have routine maintenance, back-up, cyber-security, and data- retrieval systems in place.4.9.1.4Pharmacy practice has a continuity plan in place should pharmacy practice information systems fail.5.0Quality Improvement: Pharmacy practice operates a continuous quality improvement (CQI) program, with the intended goal of enhancing patient safety.5.1Pharmacy practice operates a CQI program.5.1.1Pharmacy practice staff documents quality-related events (QREs) and conducts periodic audits of medication errors and QREs.5.1.2QREs are communicated to appropriate persons internally, national database