Adaptable, Consultative, Respected
ASHP pharmacy practice accreditation applies ASHP specialty standards in an accreditation process that brings ASHP’s pharmacy knowledge and accreditation expertise in to your pharmacy organization. These standards reflect national quality initiatives and contemporary and future practices of specialty pharmacy. The process is designed to be easy to understand, flexible, and consultative in nature. The accreditation process can be tailored to different models of care.
Accreditation focuses on optimal care delivery through evaluation of:
- Effective patient care plans to achieve desired medication therapy outcomes
- Patient-specific assessments and optimal collection, use, and documentation of information
- Inclusion of specialty drug-specific assessment and disease state-specific assessment requirements
- Comprehensive review of the patient’s medication history and medication list prior to each fill
- Documentation of all pharmacy case management activities
- Patient consultation and education
- Quality metrics and quality improvement plans
Successful accreditation signifies to payers, patients, and other healthcare providers that the pharmacy provides an advanced level of high-quality, safe, and efficient patient care in a predictable and measurable way.
The ASHP Accreditation Standard for Specialty Pharmacy Practice is designed to create a consensus around the practice of specialty pharmacy and guide the accreditation process. Specialty pharmacy practice is defined as pharmacy practice created:
- to manage the medication access and handling requirements of specialty pharmaceuticals, including dispensing and distribution, and
- to provide clinical management services for patients with chronic, serious, life-threatening and/or rare diseases or conditions receiving specialty medications aimed toward achieving the desired patient therapeutic and economic outcomes.
While specialty pharmacy continues to evolve, best practices inclusive of patient management and support, product management, medication therapy management, healthcare provider relationships, manufacturer relationships, and continuous quality improvement should remain contiguous and be readily supported by its practitioners. Established standards help to guide, describe, and gain recognition for innovative, high-quality, safe, and effective specialty pharmacy practices. The development of a standards-based accreditation process is critical for continuous quality improvement, consistency, medication safety and effectiveness, and achieving desired health outcomes. These standards seek to provide clarity to the key metrics that effectively support patients, healthcare providers, manufacturers, payers, and peers engaged in specialty pharmacy practice.
Scope of Standards
The Standard for Specialty Pharmacy Practice addresses four primary areas of specialty pharmacy practice, which encompass the overall provision of pharmacy care for patients receiving specialty 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 Standard is organized under the following Domains:
1.0 Organizational Infrastructure
2.0 Medication Access Support
3.0 Clinical Management Services
4.0 Quality Improvement
Within each Standard Domain are key elements that demonstrate competency in the identified area of specialty pharmacy practice. The accompanying narrative for each standard element describes the specific criteria for ASHP evaluation of the specialty pharmacy practice to determine consistency with the standard for accreditation within the overall management of specialty pharmaceuticals and clinical pharmacy management of patients.
It is expected for ASHP accreditation that patient care, dispensing services, and support services provided by the specialty pharmacy practice and as described in the 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 standard elements are required for accreditation except those designated as "Goal." Accredited practices will be expected to be working towards these "Goals." As practices evolve, standard elements currently designated as goals will be required for accreditation.
Accreditation is the process by which ASHP will assess your pharmacy’s level of performance in relation to the established accreditation standard and will create ways to continuously improve. It takes roughly 8 to 10 months, and consists of the following steps:
Review the accreditation standard and other materials on the ASHP website. A conference call will be scheduled to review the standard and discuss the accreditation process. ASHP will send a proposed timeline for the accreditation process and a pricing proposal for the specialty pharmacy practice accreditation based on the needs and the structure of the organization.
A self-assessment is provided to interested specialty pharmacies. Specialty pharmacies may also choose to seek consultation to assess pharmacy department readiness for accreditation. ASHP Consulting provides an on-site readiness assessment that includes advice on how to improve pharmacy services and prepare for the accreditation survey. Consultation can include a mock accreditation survey. Please contact ASHP Consulting by email at [email protected], and view its complement of services.
- Self-Assessment Document (.docx)
ASHP will prepare a Letter of Agreement (LOA), including the accepted pricing proposal, and provide a Business Associate Agreement (BAA) for signature by the specialty pharmacy and ASHP.
ASHP will also send an invoice for the fees according to the following schedule:
- A one-time application fee
- A one-time accreditation fee
- Year One participation fee(s)
Complete the application and supplemental documentation. Supplemental documentation includes business and ownership information and personnel and facility licensure. Email your completed application and supplemental documentation to [email protected] ASHP will review the application and verify receipt of signed LOA/BAA, and payment of invoice. After your application and supplemental documentation have been processed, you will receive a welcome letter signifying the beginning of the accreditation process.
A surveyor or surveyor team will be assigned to your pharmacy and you will receive the Document Assessment Checklist. The Document Assessment Checklist is a tool provided for self-reporting policies and procedures and demonstrating compliance with the standard. It will assist you in collecting and organizing policies and procedures for submission.
- The completed Document Assessment Checklist and the referenced policies and procedures should be submitted to our secure electronic location specific to your pharmacy within 120 days of receiving the assessment checklist.
- The checklist, your policies and procedures, and other supporting documentation will be reviewed by the survey team within 4-6 weeks, and you will receive a written report noting whether any policies, procedures, or other documentation are missing or require clarification.
- Your surveyor(s) will schedule a conference call with you and your team to discuss the report and any questions, as well as to plan for the on-site survey.
Your surveyor notifies you of survey readiness. Your survey will occur within six weeks of this notification. The survey is unannounced. You may request dates to be avoided for the site survey. These requests must be submitted as early in the accreditation process as possible to be given consideration. When possible, these requested dates will be avoided; however, this cannot be guaranteed. (For multisite organizations, a headquarters survey is scheduled followed by unannounced surveys at additional sites).
You will receive a general survey plan from your surveyor. The surveyor will be a pharmacist, and will arrive at the pharmacy during normal business hours. Surveyors are sensitive to the business of the pharmacy practice, recognizing your need to take care of patients. Surveyors typically avoid Monday mornings and the day immediately before or after a holiday.
During the on-site survey, the survey team will:
- review and tour all pharmacy operations and patient care areas
- review patient records for compliance with policies, procedures, and documentation
- observe patient care services being performed (where appropriate)
- interview senior hospital management and other staff members (where appropriate)
- ask questions of personnel concerning their duties and responsibilities relating to their roles in the delivery of pharmacy services to patients and other health care professionals, and their adherence to policies and procedures.
The survey team will converse with you throughout the survey and at the close of the survey will provide a verbal report of your best practices, consultative suggestions, and any areas of partial and/or non-compliance with the standard.
A written survey report will be sent to the Specialty Pharmacy Manager within 30 days following the on-site survey. The report will reiterate your best practices, consultative suggestions, and state either that your survey is complete or that there are outstanding items to address for compliance with the standard. Within 30 days of receipt of the report, a written response with a plan of corrective action and timeline for any non-compliant standard elements is required. The action plan and timeline will be reviewed by the survey team and may require additional information, with evidence of completion, as determined by the survey team. Any required action plan reports must be provided, according to the accepted timeline, until all plans are complete. You will be notified when your pharmacy department is eligible for an accreditation decision.
The programs' survey findings and final action plan with responses and timeline will be reviewed by the survey team and the ASHP Accreditation Commission. If appropriate, the Commission will recommend accreditation of the program to the ASHP Board of Directors. The ASHP Board of Directors will consider the recommendation and make their decision regarding accreditation of the specialty pharmacy practice. The accreditation term is three years.
You are notified of the accreditation decision in writing. When you achieve accreditation status, you will receive a formal accreditation letter, certificate of accreditation, digital files with the accreditation seal, and guidelines for use of the seal.
Ongoing Accreditation Requirements
Annual reports are required for every accredited pharmacy practice and reviewed by the ASHP Accreditation Commission and Office of Practice Advancement. More frequent reports may be requested in the judgement of the Commission.
Reaccreditation occurs every three years, repeating the accreditation process as described.