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Direct Patient Care in an Ambulatory Setting Bernadette Asias-Dinh, PharmD, BCPS, BCACP, CDCES PHAR5371 [email protected] October 3, 2023 Lecture Objectives • Given information from the “research phase” and/or needs assessment, select the most appropriate design of an ambulatory care pharmacy service...

Direct Patient Care in an Ambulatory Setting Bernadette Asias-Dinh, PharmD, BCPS, BCACP, CDCES PHAR5371 [email protected] October 3, 2023 Lecture Objectives • Given information from the “research phase” and/or needs assessment, select the most appropriate design of an ambulatory care pharmacy service • Summarize the legal requirements to participate in collaborative drug therapy management as outlined by the Texas State Board of Pharmacy (TSBP) • Recognize the purpose of recommended administrative tasks and documents necessary to manage direct patient care services in an ambulatory care setting Overview Ambulatory care pharmacy practice – intro and review Establishing an ambulatory care pharmacy practice Managing an active ambulatory care pharmacy practice Ambulatory Care Pharmacy Practice Introduction and Review We’re going back, back to P1 year…. Review: Ambulatory Care Pharmacy Practice “Ambulatory care pharmacy practice is the provision of integrated, accessible health care services by pharmacists who are accountable for addressing medication needs, developing sustained partnerships with patients, and practicing in the context of family and community. This is accomplished through direct patient care and medication management for ambulatory patients, long-term relationships, coordination of care, patient advocacy, wellness and health promotion, triage and referral, and patient education and selfmanagement. The ambulatory care pharmacists may work in both an institutional and community-based clinic involved in direct care of a diverse patient population” --Board of Pharmacy Specialties (developed by joint task force represented by APhA, ASHP, and ACCP) Image source: https://www.google.com/imgres?imgurl=https%3A%2F%2Fmedia.giphy.com%2Fmedia%2FrambtrormFyWQ%2Fgiphy.gif&imgrefurl=https%3A%2F%2Fgiphy.com%2Fgifs%2Fanimation-love-disneyrambtrormFyWQ&docid=lVkhZjeUBc6HZM&tbnid=7zliGCG_sXwc4M%3A&vet=10ahUKEwir7PLF8ZLeAhUDZawKHWReB9YQMwhPKAEwAQ..i&w=500&h=280&bih=771&biw=1368&q=confused%20gif&ved=0ahUKEwir7PLF8ZLeAhUDZawKHWReB9YQMwhPKAEwAQ&iact=mrc&uact=8 Review: What are some examples of ambulatory care pharmacy services? • Medication therapy management • Patient education / Disease state selfmanagement education • Interdisciplinary team visits* • Comprehensive medication management* • Disease state management* *may include collaborative drug therapy management (prescriptive authority) What is required for a pharmacist to have prescriptive authority in Texas? Other Value-Added Outpatient/Ambulatory Care Services • Immunizations • Travel health • Test and Treat • Contraception • Tobacco Cessation • Opioid antagonist • HIV PrEP/PEP https://naspa.us/wp-content/uploads/2022/12/Texas.pdf Establishing an Ambulatory Care Pharmacy Practice Steps to Developing an Ambulatory Care Pharmacy Practice Research Focus the service idea Develop a program proposal Scope of practice and policy/procedure Marketing Steps to Developing an Ambulatory Care Pharmacy Practice Research Focus the service idea Research Develop a program proposal Scope of practice and policy/procedure Marketing Research – Collaborator / Practice Site • What is the mission, vision, and values? How do we best implement this service to ensure success? • What are the goals? • What previous experience does my collaborator have with pharmacists? • What services do other practitioners provide? (don’t compete!) • What resources are potentially available to me? • Pharmacist expertise or opportunities for training • Support staff • Who are key decision-makers & who will advocate for my services? • Physician champions • Pharmacy administration Research – Collaborator / Practice Site Practice: What disease state(s) can the ambulatory care pharmacy service target to help achieve the goals in this aim of the collaborator/ practice site’s strategic plan? Research – Needs Assessment Analysis • What conditions lead to frequent hospitalizations or emergency care? • ICD-10 codes • E codes • Medications prescribed • How well does current care adhere to standardized guidelines? • Medical chart review • Pharmacy records • What quality measures need improvement by the practice site? What are the needs of the population I’m serving? Research – Needs Assessment Analysis Practice: what disease state(s) should be targeted by the ambulatory care service? Diagnosis % of all 30-day readmissions I50.33 Acute on chronic diastolic (congestive) heart failure 35% I21.9 Acute myocardial infarction 15% D57.219 Sickle cell disease – pain crisis 16% J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation 34 % **Don’t target something your organization already excels in** Research - Review of the Literature • Similar pharmacy practice • Process and structure • Patient outcomes • Financial sustainability Victor, RG et al. NEJM 2018; 378: 1291-1301 What has been done before, and what outcomes would be expected? Research – Business Model What is the financial justification for this service? • What is my practice site’s business model? • • • • Fee-for-service Incentives for “best practices” or meeting quality outcome goals Increase in prescription or store product sales Cost avoidance Research – Regulatory Considerations What legal & regulatory framework is required? • State board of pharmacy & state board of medicine laws related to pharmacists’ clinical privileges • Are there legal or regulatory requirements for certain clinical activities? • Collaborative practice agreement or statewide protocol for prescriptive authority • TSBP rules - signing of prescription drug orders by a pharmacist through collaborative drug therapy management is limited to specific settings • Federally qualified healthcare center, hospital, hospital-based clinic, or academic health center • A pharmacist in any setting can enter into a collaborative practice agreement but may not be able to have their name on the prescription Research – Regulatory Considerations What legal & regulatory framework is required? • Clinical Laboratory Improvement Amendments (CLIA) • Ensures quality laboratory testing and procedures • Consider application as a CLIA-waived testing site and limit to CLIA-waived tests (point-of-care) if no laboratory already available in your practice • CDC best practices • Limit to CLIA-waived tests (usually point-of-care) • What is required to be reimbursed for your service? • Example – 2023 Medicare Part D requirements for Medication Therapy Management Reimbursement • Minimum of 2-3 chronic disease states • Minimum of 2-8 medications • Annual medication costs ≥ $4,935 Steps to Developing an Ambulatory Care Pharmacy Practice Research Focus the service idea Focus the service idea Develop a program proposal Scope of practice and policy/procedure Marketing Focus the service idea • What is the optimal design based on the information gathered? • Considerations • Disease states targeted • Goals • Resources • Patient education materials • Protocol • Ability to demonstrate impact Needs assessment Research Resources Develop a program proposal • Purpose • Background • Service Structure • Implications • Assessment • Billing • Financial Summary • Resources Steps to Developing an Ambulatory Care Pharmacy Practice Research Focus the service idea Develop a program proposal Scope of practice and policy/procedure Marketing Program Proposal – Service Structure What processes will the patient go through when enrolled in your service? Referral (?) Follow-up visits Scheduling Discharge from service Initial visit What access to the electronic medical record is needed to provide care and document interventions? Program Proposal – Service Structure Referral process • TSBP Patient Eligibility Requirements for Collaborative Drug Therapy Management: • Initial diagnosis, patient assessment, and drug therapy order by physician • Maintains a physician-patient relationship • How are patients selected for your service? • Patient or provider initiated • Standardized eligibility requirements – who would benefit most from the service? Program Proposal – Service Structure New patient enrollment • How are patients enrolled / referred to your service? • Electronic medical record • Paper Program Proposal – Service Structure Scheduling • Independent, shared, or walk-in appointments • When is your service available to see patients? Consider…. Duration of appointments Administrative tasks Breaks Patient workup Documentation (progress notes / charting) Precepting Meetings Employee leave Program Proposal – Service Structure Clinic visit flow • • • • Patient intake forms Initial vs. follow-up visits Group vs. individual patient education Documentation process & note templates • TSBP requirements: Document all interventions when practicing under DTM within a “reasonable time of each intervention” • Communication with referring physician • Faxing or electronically sending note • Verbal discussions - routine vs. urgent situations • Refer to best practices, literature, or similar successful services in the same institution Program Proposal – Service Structure Visit flow - Example Registration check-in Education provided throughout Discuss Assessment Medication & Social History Basic Physical Assessment / Vitals Review of physical assessment, laboratory, and self-monitoring results Discuss & implement patient-centered goals and therapeutic plan Adherence Assessment Review of Systems (Evaluate disease state control, medication tolerability) Document & communicate with physician! Lifestyle Assessment Health Maintenance Assessment How will students or residents be incorporated? What are your “downtime” procedures? Program Proposal – Service Structure What happens when a patient is meeting their goals? • Discharge from service • Less frequent follow-up What are other reasons a patient may be discharged from the service? • Unable to contact • Frequent no-show to appointments • Patient refusal • Patient no longer eligible Program Proposal – Service Structure Tips to optimizing the service structure: • Ensure all components included are truly necessary. Consider: • Purpose of the service • Aforementioned research (regulatory or reimbursement requirements, structure outlined in previous studies, available resources) • Needs and resources available to your target population • Consider published standards of care for the disease state or type of service you are providing • Prioritize structure components that will have the most impact to show your service’s worth Program Proposal – Assessment • What is the criteria to demonstrate success? • Initially choose short-term measures (demonstrate benefit in 6-12 months) that are meaningful, feasible, and actionable • Should be validated - consider health care quality measures • Can include clinical, humanistic (quality of life, patient satisfaction), and economic outcomes • Include provider satisfaction • Incorporate feedback from key stakeholders • How often will assessment occur? • Ex: quarterly, monthly, etc. • How will results be disseminated? • Ex: Committee meetings, standing reports Program Proposal - Assessment Examples of Healthcare Quality Measures: Organization / Payer Measures Population Examples CMS Valued-based Program: Hospital Readmission Reduction Program Medicare Beneficiaries 30-day risk standardized readmission measures: -Acute myocardial infarction -COPD -CHF -Pneumonia -Coronary artery bypass graft surgery -Elective primary total hip arthroplasty and/or total knee arthroplasty CMS 2017 star measures (Ranking from 1-5, 1 star=poor and 5 stars = excellent) Medicare Part C and D beneficiaries Medication adherence by proportion of days covered (triple weighted!): -Diabetes medications -Renin-angiotensin-aldosterone system antagonists -Statins Steps to Developing an Ambulatory Care Pharmacy Practice Research Scope of practice and policy/procedure Focus the service idea Develop a program proposal Scope of practice and policy/procedure Marketing Scope of Practice • Can be included in the program proposal • Delineates specific clinical privileges the pharmacist has been authorized to practice • Collaborative Practice Agreement (CPA) • Protocol • State board of pharmacy dictates components required • Legally binding - consider having risk management review Scope of Practice – Types of Pharmacist Prescriptive Authority in the US Adams AJ, Weaver KK. The Continuum of Pharmacist Prescriptive Authority. Ann Pharmacother. 2016 Sep;50(9):778-84. doi: 10.1177/1060028016653608. Epub 2016 Jun 15. PMID: 27307413. Delegated Prescriptive Authority: TSBP Requirements • AKA Collaborative Drug Therapy Management (DTM) • What are pharmacist requirements to participate? • Notify the board via application • Signed by pharmacist and delegating physician • Includes copy of the collaborative practice agreement • Information is posted online • Initial Training: 6 hours of continuing education related to DTM offered by the pharmacist Delegated Prescriptive Authority: TSBP Requirements • What are physician requirements to participate? • Review services provided to a patient • Maintains a physician-patient relationship • Geographically located to be able to be physically present daily to provide medical care and supervision • Available through direct telecommunication for consultation, assistance, and direction Delegated Prescriptive Authority: TSBP Requirements • What activities are included? • Collecting and reviewing patient drug use histories • Ordering or performing routine drug therapy related patient assessment procedures • Ordering drug therapy related laboratory tests • Implementing or modifying drug therapy following diagnosis, initial patient assessment, and order of drug therapy by a physician as detailed in the protocol • Any other drug therapy related act delegated by the physician TSBP Requirements for Delegated Prescriptive Authority • What information is required in a collaborative practice agreement per TSBP? • • • • • • • What physicians are delegating DTM? What pharmacists are authorized to engage in DTM? What types of DTM decisions can the pharmacist make? Which ailments or conditions? Which drugs can be prescribed? How will the pharmacist make decisions regarding DTM? What activities will the pharmacist perform for DTM including communication of therapeutic plans and clinical outcomes? Collaborative Practice Agreement Example PRO TIP: Don’t make this too detailed PRACTICE - TSBP Requirements Mrs. Jones is referred to you by Dr. Sneed for diabetes management after recent hospitalization for DKA and is newly diagnosed with Type 1 diabetes. She didn’t have an established physician prior to the hospitalization. An appointment is requested by the end of the week since she won’t be able to see Dr. Sneed for initial visit for another month. • Pharmacist: • PGY1-trained • Academic health system practice setting in Texas Medical Center • Has an established collaborative practice agreement for diabetes management, approved by the Texas State Board of Pharmacy • Physician – Dr. Sneed • Endocrinologist • Practices in the Heights location of the same Academic health system • Signed collaborative practice agreement Think – pair – share: Per TSBP rules, can you prescribe using collaborative drug therapy management services for this patient by the end of the week? Policy & Procedure • Not legally binding • Can be included in the program proposal • Purpose: • Outlines administrative, operational, and clinical services • Includes details omitted from the collaborative practice agreement • Helps to standardize practice between multiple pharmacists • Required by Joint Commission on Accreditation of Healthcare Organizations Policy & Procedure Example Steps to Developing an Ambulatory Care Pharmacy Practice Research Focus the service idea Develop a program proposal Proposal approved, scope of practice & policy/procedure finalized! …now what? Scope of practice and policy/procedure Marketing https://contentscribblers.com/img/ser_sec1_left7.png Marketing • Who do you need to market to? • Physicians and other health care providers • Patients • Payers • Why market? • To know the service exists • Traditionally, the service may not be expected to be provided by pharmacists • Address concerns that other health care providers may have regarding competition Marketing to Physicians • Important – this is your referral base! • Determine which types of providers are targeted • Inservices • Personal visits • Fliers / emails with instructions for easy referral process • Physician champions • Find ways to establish relationships • Discuss mutual patients • Shadowing in clinic • Committee service Am I comfortable delegating prescriptive authority to this pharmacist? Why should I refer my patients to this service? Managing an Active Ambulatory Care Pharmacy Practice What is needed to maintain an ambulatory care pharmacy practice? Quality Improvement Review and update supporting documents Ensure staff competency Review and update patient care processes Planning for the future Quality Improvement • Continuous process that begins when researching & developing your program proposal • Use baseline data that supported implementation of your program • Measure data after implementation of the program • Evaluate patterns • Communicate results to the rest of the team • Collaborate to identify changes/initiatives for further improvement Review and Update Supporting Documents • Why would you need to update the initial documents? • • • • New regulatory / reimbursement requirements New clinical guidelines or best practices Institution-wide changes Quality improvement findings or feedback from stakeholders • Policy & Procedure • Updated regularly to reflect current practice/processes • Collaborative Practice Agreement • TSBP requirements: • Maintained by the pharmacist • Pharmacist + physician reviews at least annually • Pharmacist submits any changes to TSBP within 10 days Ensuring Staff Competency Credentialing & Privileging • Credentialing: process of obtaining, verifying, and assessing evidence of an individual’s professional qualifications to be approved to provide patient care services • Privileging: process of reviewing a practitioner’s credentials and performance to authorize a practitioner to provide specific patient care services under a defined scope of practice • Requirements (other than pharmacist licensure) can by established by the institution and/or third-party payers • Usually involves additional training and certifications Ensuring Staff Competency How is competence demonstrated? • Initial onboarding assessment and/or training for new employees • Continuing education / maintenance of certifications • TSBP Requirements: 6 hours per year of continuing education related to the DTM offered by the pharmacist • Consider a continuous professional development program • Institution-provided formal education programs • Peer evaluation • Appointment observation Example-Community Health Network: Planning for the future • Expansion of services • Feedback from stakeholders • Use data from quality measures or quality improvement process • New opportunities for reimbursement • Expand volume within the same service • New location • New physician relationships • Ensure there is adequate staff to support growth – financial considerations Key References • Snella, KA and GP Sachdev. A Primer for Developing Pharmacist-Managed Clinics in the Outpatient Setting. Pharmacotherapy 2003; 23(9):1153-1166 • Buxton JA, et al. ASHP guidelines: Minimum standard for ambulatory care pharmacy practice. Am J Health Syst Pharm 2015; 72(14): 1221-36 • Moczygemba LR, Coe AB. Value-added services as a component of enhancing pharmacists’ roles in public health. In: Zgarrick DP, Desselle SP, Moczygemba LR, Alston G. eds. Pharmacy Management: Essentials for All Practice Settings, 5e. McGraw Hill; 2020. • Hess KM. Implementing value-added pharmacist services. In: Zgarrick DP, Desselle SP, Moczygemba LR, Alston G. eds. Pharmacy Management: Essentials for All Practice Settings, 5e. McGraw Hill; 2020. Accessed September 26, 2023. https://accesspharmacy.mhmedical.com/content.aspx?bookid=2714&se ctionid=230770843 Key References Key References https://www.pharmacist.com/Practice/Practice-Resources/Team-based-Partnerships Direct Patient Care in an Ambulatory Setting Bernadette Asias-Dinh, PharmD, BCPS, BCACP, CDCES PHAR5371 [email protected] October 3, 2023

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