Planning and Developing a Clinical Pharmacy Practice

Issues of Concern

The foundation of a successful ambulatory care pharmacist-led clinic involves meticulous planning, starting with a comprehensive needs assessment. Initially, an internal institutional needs assessment identifies available resources to start the practice. The pharmacist must also perform an external environmental scan. An external environmental scan includes a thorough investigation of the literature to compare similar practice models and identify key aspects integral to the practice's success on a local, statewide, and national level. Understanding the healthcare landscape, patient demographics, and prevalent disease burden within the community is essential for tailoring pharmacy services to meet patient needs. 

Once the needs are determined, the pharmacist can develop their practice mission, vision, and goals, drawing input from key stakeholders pivotal to their success. For instance, a physician plays a central role in advocating for the pharmacist-led clinic within the healthcare system. Other stakeholders include a billing specialist, a compliance officer, and a practice manager.[3] Furthermore, collaboration from pharmacy managers, colleagues, physicians, nurses, administrators, and patients is indispensable for garnering support and fostering interprofessional teamwork. 

The next steps include determining the specific practice model and emphasizing scalability and reproducibility. This may entail conducting a SWOT (strengths, weaknesses, opportunities, threats) analysis and a comprehensive financial assessment.[8] Furthermore, assessing billing practices and staffing needs further solidifies the foundation, ensuring the model is financially stable and operationally efficient. 

Clinical Significance

Operations  

Clinic workflow and staffing 

The standard operations should be seamless and efficient for patients and staff. Before accepting new patients, several workflow components need to be addressed. These include incorporating technology, optimal staffing, and a conducive workspace environment. Technology integration is a crucial element to optimize workflow within the clinic. An electronic medical record (EMR) is pivotal to streamline operations and facilitate comprehensive care delivery. EMR facilitates better clinical documentation, efficient lab ordering, results retrieval, and prescribing.[9]

Through the EMR, pharmacists can identify specific clinic times to schedule patients, ensuring streamlined appointment management tailored to patient needs. For instance, a new patient visit may necessitate a more extended duration, typically around 1 hour, whereas a follow-up appointment could suffice with a 15- to 30-minute visit, contingent upon patient complexity. Pharmacists should allocate time for pre-visit workup, documentation, and administrative responsibilities (eg, meetings, billing coordination, professional development, student or resident precepting).[10][11]

In addition to managing clinic scheduling, ambulatory care pharmacists should identify a space for a conducive workspace environment. When outlining the workspace, identifying private consultation areas ensures optimal conditions for patient assessments, maintains privacy, and facilitates consultations. Investing in a well-equipped private consultation space with adequate medical equipment and comfortable seating arrangements fosters an environment for open communication and optimal patient-centered care. 

Staffing requirements constitute another critical facet of ambulatory care practice management. Pharmacists must collaborate with clinic leadership to delineate expectations and metrics essential for staffing. Engaging support staff such as receptionists can streamline visit registration, paperwork management, and clinic upkeep, enhancing operational efficiency and patient satisfaction. Other care team members, such as medical assistants, pharmacy technicians, nurses, and pharmacy learners, may also play a role.[12] 

Outcomes assessment and financial sustainability

A crucial element of an ambulatory care pharmacy practice's operations is assessing outcomes such as clinical, humanistic, and productivity measures. Benchmarks will vary by practice site and disease state. These outcomes may be tied to direct or indirect reimbursement, which can support the pharmacist’s position within the clinic. However, in many ambulatory care practices, demonstrating the direct impact of the pharmacist’s role may be challenging, especially since pharmacists often work within multidisciplinary care teams.

Although challenging, a method for efficient evaluation of ambulatory care pharmacist services is needed to ensure the sustainability of the practice. The use of a clinical performance dashboard is one example of evaluation. Many ambulatory care pharmacists manually extract chart data to demonstrate outcomes and therapeutic improvements initially. However, most institutions have a developed dashboard portal that can be adapted to pharmacy metrics. Common clinical indicators more easily adaptable to a dashboard include improving hemoglobin A1c, blood pressure, and lipid levels in the primary care setting. These outcomes are usually assessed over 6 to 12 months.[13][14][15]

In addition to identifying institutional or practice-based strategic priorities, national organizations that influence ambulatory care practice include the Agency for Healthcare Research and Quality (AHRQ), American Society of Health-System Pharmacists (ASHP), Accountability Measures Work Group, National Quality Forum (NQF), National Committee for Quality Assurance (NCQA), and Pharmacy Quality Alliance (PQA).[16] These organizations focus on healthcare performance, which is useful in guiding outcomes assessments and potential revenue.

Reimbursement presents a significant challenge for pharmacists in ambulatory care settings. When devising compensation strategies for pharmacy services, factors such as service location (face-to-face or telehealth), billing provider, supervision requirements, and reimbursement rates must be considered. Before initiating billing, reviewing billing and documentation prerequisites with relevant stakeholders, including medical billing personnel, supervising clinicians, and third-party payers, is imperative. These requirements may encompass mandatory courses or training, both initially and continuously.

For instance, in physician offices, billing for pharmacist services occurs through “incident to” billing, where services are billed under the clinician's name, particularly for comprehensive medication management (CMM) services provided under a collaborative practice agreement (CPA). In hospital-based clinics, reimbursement for CMM services generally involves a “technical or facility fee,” which considers the visit's duration and complexity using ambulatory payment classification codes. Medication therapy management (MTM) services can be billed directly by the pharmacist using current procedural terminology (CPT) codes: “initial,” “follow-up,” and “additional” at 15-minute increments.[17] Other billing codes may fall under Medicare annual wellness visits (AWV), transitional care management (TCM), chronic care management (CCM), diabetes self-management, continuous glucose monitor (CGM), provider-delivered care management (PDCM), and telehealth services codes.[3] Pharmacists can access information on reimbursement rates for specific billing codes via the Medicare physician fee schedule.    

Policies and procedures 

With the variability of ambulatory care practices, a policies and procedures manual describing the scope of practice and detailing the services provided should be developed in compliance with institutional department policies. The manual should be reviewed regularly and revised to stay consistent with changes in practice needs, scope of practice, and statewide policies.

Many state laws are ambiguous regarding ambulatory care practice beyond retail pharmacy settings. For example, in certain states, CPAs aren’t explicitly authorized. However, pharmacists may be granted prescriptive authority under physician supervision delegation, enabling them to enter into CPAs for ambulatory practice. Additionally, statewide policies will differ regarding the scope of practice and ambulatory care clinician responsibilities and privileges. Familiarity with state laws and regulations is important before developing the practice. This relates to prescriptive authority and billing and compliance requirements related to reimbursement. Statewide pharmacy associations and boards of pharmacy may be able to provide further guidance.[12]

Moreover, the criteria for pharmacists to practice in clinics should be well defined in the policies and procedure manual. Standardized benchmarks should be established for credentialing and training pharmacists, as they demonstrate qualifications to payers, with specialty board certification potentially serving as a means of recognition as direct patient care clinicians.[3][18] Most institutions favor a board-certified ambulatory care pharmacist to serve in their practice, although this recommendation is not uniform.[19] To obtain board certification, most pharmacists complete either an ambulatory care-focused postgraduate residency or a traditional pharmacy practice residency, followed by a second year of specialized ambulatory care training. Further information regarding pharmacy residency training could be obtained through the Board of Pharmacy Specialties.

Lastly, given practice variability, the Joint Commission of Pharmacy Practitioners (JCPP) is an excellent resource outlining the consistent delivery of patient care across the pharmacy profession.[20] To ensure standardized patient care, policies regarding documentation standards, emergency management, and patient education are important.

Marketing

When a robust business plan is finalized, the service should be marketed within the practice and/or institution. This can be accomplished using the 7 P’s of marketing, often applied in a business setting. Marketing nurtures trust and collaboration, fostering long-lasting relationships with patients and clinicians. The 7 P’s of marketing represent product, price, place, promotion, people, packaging, and process (see Table 1).[21][22][23][24]

Table 1. The The 7 P’s of marketing

Nursing, Allied Health, and Interprofessional Team Interventions

Interprofessional communication is vital to the success of an ambulatory care pharmacy. Using a patient-centered approach, a physician usually leads the care team, utilizing the support of other team members. Clinicians diagnose patients, refer them to the pharmacist and other support personnel for additional care, and then cosign medication orders prescribed by the ambulatory care pharmacist through a formal agreement.

Establishing Collaborative Practice Agreements (CPAs) between pharmacists and other clinicians is central to effective practice in the ambulatory care setting. The CDC defines a CPA as a formal arrangement where a licensed clinician diagnoses, supervises, and refers patients to a pharmacist, permitting them to assume professional responsibility for specific functions under a designated protocol. CPAs include disease-specific management and education to achieve favorable clinical outcomes. Different terms describe CPAs nationwide, and the practice laws vary from state to state. The agreement, contingent on state laws, extends the pharmacist’s scope to select, initiate, discontinue, continue, monitor, modify medication regimens, perform patient assessments, counsel, order laboratory tests, and administer drugs. CPAs foster trust between collaborating physicians and pharmacists, ensuring continuity of care, strengthening relationships, and streamlining workflows. Furthermore, they enable clinicians to effectively leverage their skills to deliver direct patient care.[25]

The National Association of Boards of Pharmacy outlines 8 essential elements of CPAs, including identification of involved parties, decision-making authority for pharmacists, monitoring mechanisms, provisions for agreement termination, and ability to override collaborative practice divisions as necessary, effective date, and signatures of all parties.[3] To optimize the ambulatory care practice’s overall efficiency and effectiveness, pharmacist extenders such as students, residents, and interns may be able to support clinical and non-clinical tasks.

The interprofessional team may assist in tasks ranging from care transitions, such as previsit medication history and completion of medication reconciliation processes, to disease state management activities, such as patient interviews, medication recommendations, and education. Additionally, they can handle tasks such as data collection, insurance formulary navigation, and prior authorization requests.