Specialty Pharmacy Practice Accreditation Program

Standards Development Process:

The CPPA Specialty Pharmacy Standards Development Committee members, representing the broad range of specialty pharmacy stakeholders – small and large specialty pharmacy practice including chain, independent and health systems, and payer and manufacturer – began their work in January 2014. This group reviewed the characteristics of a specialty pharmaceutical and the elements of specialty pharmacy practice which make it unique from other pharmacy practice. The committee also defined specialty pharmacy practice as a practice that

(1) manages the medication access and handling requirements of specialty pharmaceuticals, including dispensing and distribution, and
(2) provides clinical management services for patients with rare and/or chronic disease who receive specialty medications designed to achieve the desired patient therapeutic and economic outcomes.

These draft standards were vetted in mid-2014 to gain perspectives from pharmacists, healthcare system stakeholders, payers, specialty medication manufacturers, consumer groups, and patients to assure consensus in the standards and value in the marketplace for payers and patients. These comments were then considered by the committee in late 2014 and the final version was published in early 2015.  Version II, with addition of a code of conduct standard, was published in December 2016.

As specialty pharmacy practice has evolved, CPPA found it imperative to conduct a full evaluation of the standards. CPPA’s panel of specialty pharmacy experts conducted a full evaluation of standards in order to reflect contemporary and future practices of specialty pharmacy and align with national quality initiatives.  In addition, clinical pharmacy expertise, across the country, assisted with the revisions to the Minimum Requirements for Patient Case Management Protocols (Appendix I).  

The Standards:

CPPA Specialty Pharmacy Practice Standards are designed to create a consensus around the practice of specialty pharmacy and guide the accreditation process. They address four primary areas of specialty pharmacy practice, which encompass the overall provision of pharmacy care for patients receiving these medications. These areas of focus include the organizational infrastructure to support the provision of specialty pharmacy care, patient medication access support via manufacturer requirements and benefits investigation, clinical management of the patient, and quality. Specifically, the standards are organized under the following Standard 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 standards that demonstrate competency in the identified area of specialty pharmacy practice. An accompanying narrative for each standard describes 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.

The Accreditation Program:

The accreditation process, which typically takes 8-10 months, consists of an application, submission of documents, a site survey, and determination of accreditation status. The process is intended to be consultative in nature and best practices will be shared.