April 15, 2013
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Specialty pharmacy is a significant pharmacy practice area and stakeholders now have a new advocate with the recent formation of a new pharmacy association representing the interests of specialty pharmacy supporters. The Specialty Pharmacy Association of America (SPAARx) will be formally unveiled during the 2013 Armada Specialty Pharmacy Summit in Las Vegas, taking place May 7–10, but it is already building a substantial membership.
As part of its early efforts, SPAARx seeks to more clearly define the term “specialty pharmacy.” It is important to note that the proper use of the term can impact provider and payer issues, supply-chain routing, transmission of data related to specialty drugs, and state pharmacy laws/regulations, as well as FDA requirements pertaining to REMS, such as clinical outcomes, compliance/adherence, and storage/handling. Therefore, the new definition serves as a benchmark for many stakeholders.
The original definition of “specialty pharmacy” was drafted in 2006 with input from more than 20 leading specialty pharmacies. The most recent definition, by SPAARx, was released on February 26, 2013, and again reflects input of numerous specialty pharmacy stakeholders and thought leaders. Public comment was sought through March 2013.
Specialty pharmacy defined
According to SPAARx, “specialty pharmacy is a unique class of professional pharmacy practice that includes a comprehensive and coordinated model of care for patients with chronic illnesses and complex medical conditions. Specialty pharmacies provide expert therapy management services, coupled with patient education and counseling, that collectively drive adherence, compliance, and persistence, manage dosing, and monitor appropriate medication use. This unparalleled, patient-centric model is organized to dispense/distribute typically high cost, injectable/infusible/oral and other hard-to-manage therapies within a collaborative framework designed to achieve superior clinical, humanistic, and economic outcomes.”
Three core elements
Three core elements are included in the SPAARx definition.
The specialty pharmacy service model. The specialty pharmacy service model is “high touch” and has the primary differentiating goal of monitoring and positively impacting adherence, compliance, and persistence. Clinical pharmacists develop clinically based, disease-specific care plans and disease therapy management (DTP) programs. They also minimize adverse events and optimize patient safety and clinical, economic, and humanistic outcomes, as well as advocating for patients and providing patient education.
Specialty pharmacies have developed the technical expertise required to obtain data necessary to determine adherence to defined quality management standards. Core data reporting allows specialty pharmacies to gauge the effectiveness of their programs at the patient level as well as that of the population.
Satisfaction with the experience. Satisfaction in specialty pharmacy includes satisfaction for the patient and family members, as well as for the total healthcare team. Quality- and service-driven standards are part of DTM programs, giving specialty pharmacy a noteworthy profile. Satisfaction in specialty pharmacy also includes expediting access to care.
The specialty pharmacy business model. Clinical, operational, and essential administrative activities are unique to specialty pharmacy.
Clinical considerations include access to pharmacists and nurses at any time to support both routine and emergent patient issues, including patient-safety issues.
Operational considerations include proper product procurement and authentication, as well as inventory controls to ensure drug availability. In addition, tracking medication and proper handling of specialty drugs are key factors.
Administrative considerations include resolution of benefit issues such as prior authorizations and drug utilization review, along with investigation of patient financial hardship and patient-assistance programs. Finally, specialty pharmacies record data essential to generation of information that gauges performance, quality improvement initiatives, and the needs of patients, providers, payers, and drug manufacturers.