Lynnae M. Mahaney, BSPharm, MBA, FASHP

Pharmacy accreditation programs can improve health care by providing standards by which to evaluate the quality of patient care services and by setting requirements for patient consultation, education, and documentation.

One of the pertinent findings in the 9th edition of the EMD Serono Specialty Digest is that less than 50% of health plans utilize the therapy management programs offered by their specialty pharmacy providers.

As the spending on specialty pharmaceuticals continues to rise at a rate close to 20% per year,

payers have increased their focus on therapy management programs and health outcomes for patients receiving these medications.

Clearly, getting patients to cost-effective and positive medication therapy outcomes is critical given the expenditures for specialty medications. So how does a health plan evaluate the availability and quality of the patient care services delivered by their specialty pharmacy providers? Specialty pharmacy practice accreditation provides that evaluative tool.

Accreditation as a tool for improvement of health care systems and quality of services has a long history. According to a publication on hospital accreditation produced by the United States Agency for International Development, “Successful accreditation programs have been a significant factor in improving health care systems and care provision, supporting rationalization of reimbursement mechanisms, enhancing public trust in the quality of care and in the institutions providing it, and reducing the variation in quality between different health care organizations.”

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, and to ensure the safety and effectiveness of medications and the quality of medication use for desired health outcomes.

Standards help to provide clarity to the key metrics that effectively support patients, health care providers, manufacturers, payers, and peers engaged in specialty pharmacy practice.

The Center for Pharmacy Practice Accreditation (CPPA) is a nonprofit organization established in 2012 by the American Pharmacists Association, the National Association of Boards of Pharmacy, and the American Society of Health-System Pharmacists to recognize pharmacy practices for providing patient care services that improve health outcomes and contribute to lower health care costs. These 3 organizations saw a need to establish standards to meet the public’s need for specific, predictable, and measurable pharmacist clinical services across the medication use continuum. The CPPA’s mission, unique among accreditors, is to raise the level of pharmacy-delivered patient care services through accreditation and thus serve the public health.

The organization has a board of directors with representatives from each of the owner organizations. The committees are composed of volunteer pharmacist experts, appointed by the owner organizations. The standards oversight committee is responsible for the coordination of the development and ongoing revisions of consensus-based standards for CPPA’s accreditation program. There are currently 2 committees for development and draft changes of standards: community and specialty. The accreditation process oversight committee provides direction for accreditation programs including review of all accreditation program documents and consideration of the accreditation status of pharmacy practices.

In 2013, CPPA published standards for community pharmacy practice accreditation and began accrediting community pharmacies in 2014. In 2014, the organization also began the development of specialty pharmacy practice standards.

Specialty Pharmacy Practice Accreditation Program 

The CPPA specialty pharmacy standards development committee members, representing the broad range of specialty pharmacy stakeholders—small and large chain, independent, and health-system specialty pharmacy practices; payers; and manufacturers&mdash;began their work in January 2014. This group reviewed the current characteristics of a specialty pharmaceutical and the elements of specialty pharmacy practice that make it different from other pharmacy practice. The committee defined specialty pharmacy practice as a practice that:

		Manages the medication access and handling requirements of specialty pharmaceuticals, including dispensing and distribution, and

		Provides clinical management services for patients with rare and/or chronic diseases who receive specialty medications designed to achieve the desired patient therapeutic and economic outcomes.

The first draft of the standards was vetted by more than 25 specialty pharmacy organizations and then revised for publication. These draft standards were further vetted in September and October 2014 so that additional perspectives from pharmacists, health care system stakeholders, payers, specialty medication manufacturers, consumer groups, and patients could be gained to assure consensus in the standards and value in the marketplace for payers and patients. These comments were then considered by the committee in November 2014, and the final version will be published in early 2015.

CPPA Specialty Pharmacy Practice Standards are designed to create a consensus around the practice of specialty pharmacy and guide the accreditation process. They address 4 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 access to medications via manufacturer requirements and benefits investigation, clinical management of the patient, and quality. Specifically, the standards are organized under the following standard domains:

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 practice to determine consistency with the standards for accreditation within the overall management of specialty pharmaceuticals and clinical pharmacy management of patients.

Alongside the development of the standards, CPPA developed the specialty pharmacy practice accreditation program. The accreditation process, which takes about 6 to 9 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. The application, detailed information, and resources are available on CPPA’s website at www.pharmacypracticeaccredit.org.

Duke University Medical Center and Diplomat Specialty Pharmacy are the CPPA accreditation beta sites. The accreditation program will be open to all applicants in early 2015.

What Makes the CPPA Specialty Standards and Program Unique? 

CPPA standards were developed by the medication use experts. They are intended to evaluate the delivery of specialty pharmacy care, which enables safe and cost-effective patient care outcomes. Within the standards, CPPA defines pharmacy patient case management, its components, and the patient-specific assessments and information that must be obtained, incorporated, and documented as part of the patient case management process.

Consistent communication between prescribers and patients results in better care coordination and more cost-effective care. Multiple standards for communication between the specialty pharmacy practice, other health care providers, and patients are included. Patient education and understanding are critical to medication therapy adherence and acceptance. For this purpose, the standards require patient consultation, education, and documentation regarding expectations for therapy, anticipated duration of treatment, expected outcome and clinical goals of therapy, adverse event management, time to benefit, and role of adherence and persistence in expected outcome for each of these concepts.

The standards also incorporate manufacturer and payer requirements, the provision and documentation of comprehensive benefits investigation, prior authorization assistance and benefits coordination, and extensive quality improvement documentation and reporting.

The CPPA standards are comprehensive and practical and can be applied to any model within the channels providing specialty pharmacy care, eg, channel partners. CPPA has created an accreditation program which is easy to understand, flexible, and can be bundled with the other types of CPPA accreditation. 

For more information about the accreditation programs, standards, resources, and application materials, visit www.pharmacypracticeaccredit.org.

. 9th ed. Rockland, Mass.:EMD Serono, Inc; 2013. www.amcp.org/EMDSeronoSpecialtyDigest9th.pdf. Accessed October 17, 2014.

. May 2014. www.firstreportnow.com/articles/results-emd-serono-specialty-digest%E2%84%A2-10th-edition.

		Schwark T. Concept for a hospital accreditation system in Georgia. Washington, DC: United States Agency for International Development; 2005. www.abtassociates.com/reports/0858_Concept_Hospital_Accreditation_Georgia_ENG.pdf. Accessed October 21, 2014.

		Nahata MC, Beck DE, Draugalis JR, Flynn AA, Kerr RA, Wells BG. The academy’s agenda for improving the safety of medication use: report of the 2006-2007 Argus Commission. 

 is the executive director of the Center for Pharmacy Practice Accreditation. She previously served as vice president of hospital and health system services at Visante Inc and as assistant chief of pharmacy services at William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin.

Lynnae M. Mahaney, BSPharm, MBA, FASHP

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