The CPPA Specialty Pharmacy Standards address four primary areas of specialty pharmacy practice, which encompass the overall provision of pharmacy care for patients receiving pharmaceuticals. These areas of focus include the organizational infrastructure to support the provision of specialty pharmacy care, patient access to medications via manufacturer requirements and benefits investigation (BI), clinical management of the patient, and quality. Specifically, the standards are organized under the following Standard Domains:
1.0 Organizational Infrastructure
2.0 Access to Medications
3.0 Clinical and Patient Management Services
4.0 Quality Improvement
Within each Standard Domain are key standards that demonstrate competency in the identified area of specialty pharmacy practice. These standards represent the specific criteria for CPPA evaluation of the specialty pharmacy practice to determine consistency with the standards for accreditation within the overall management of specialty pharmaceuticals and clinical pharmacy management of patients.
It is expected for accreditation that the patient care, dispensing services, and support services provided by the specialty pharmacy practice and as described in their Scope of Services demonstrate compliance with applicable state and national regulatory requirements and/or standards established by a recognized organization appropriate for the services provided.
All standards are required for accreditation except those designated as “Goal.” Accredited practices will be expected to be working toward these “Goals.” As best practices evolve and become more prevalent, “Goal” standards will eventually be required for accreditation.
Standard Domain 1.0: Organizational Infrastructure
The specialty pharmacy practice has an organizational infrastructure to support the provision of specialty pharmacy care.
• Appropriate documents and current licensure required of the specialty pharmacy practice
• Has a) a clear organizational structure including a mission statement, b) a policy and procedure process, and c) a process for the delegation of organizational oversight and leadership to allow for safe and effective delivery of services.
• Describes the scope of specialty pharmacy services offered
• Defines and manages internal and external delegated services
• Appropriate professional and support staff to deliver services
• Maintains a structure to ensure appropriate fiscal management
• Protocols for medication procurement, storage, preparation, and distribution for medication integrity and timely delivery
• Appropriate environment to maintain patient privacy and deliver patient care services
• Uses systems and technology that support safe medication distribution processes and facilitate patient safety
• Uses information systems and technology for documentation and support of the delivery of patient care services
• Information systems provide access to appropriate evidence-based references and clinical decision support programs that facilitate the delivery of patient care services
• Supports the interoperability of information systems
• Ensures the integrity, security, and privacy of patient information and other data
• Maintains policies and procedures to ensure compliance with HIPAA and HITECH regulations
• A contingency plan in order to maintain patient care services during unplanned events
Standard Domain 2.0: Access to Medications
The specialty pharmacy practice provides services that enable patient access to medications.
• Provides comprehensive benefits investigation, prior authorization assistance, and benefits coordination on behalf of the patients it serves
• Implements mechanisms to support patient safety and compliance with manufacturer and payer requirements
• Facilitates patient access to care through the transparent provision of financial information to the patient and prescriber
Standard Domain 3.0: Clinical Management Services
The specialty pharmacy practice provides clinical management services
• Facilitates coordinated patient management through enrollment communications to patients and prescribers
• Communicates with healthcare providers to facilitate coordination of patient care
• Maintains internal policies and procedures for collaboration with other pharmacy providers included in the patient’s care
• Maintains a comprehensive patient profile for all patients
• Provides patient-centered consultation and education regarding expectations of therapy
• Provides and monitors pharmacy patient case management services.
• Modifies patient case management based on patient-specific factors when needed
• Evaluates and documents competency and facilitates continuing professional development of staff involved in patient care service delivery based on the complexity of services and needs of patients
• Maintains consistent procedures for patient notification of interventions and delays in therapy
• Prohibits the use of refill protocols whereby specialty medications are filled without direct patient contact.
Standard Domain 4.0: Quality Improvement
The specialty pharmacy practice implements a continuous quality improvement program.
• Reports and evaluates quality outcomes and quality metrics to assess the effectiveness of patient care services and promote continuous quality improvement.
• Implements continuous quality improvement projects based on quality metric reports
• Provides accurate data reports