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Specialty Pharmacy Accreditation

ASHP accreditation is formal recognition of the high quality of services and care provided by your specialty pharmacy.

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 Standards

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:

  1. to manage the medication access and handling requirements of specialty pharmaceuticals, including dispensing and distribution, and
  2. 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.