Development and Implementation of Clinical Outcome Measures for Automated Collection Within Specialty Pharmacy Practice

BACKGROUND: Johns Hopkins Specialty Pharmacy Services recognized the need to identify and develop standardized collection methods for clinical outcome measures (COMs) to demonstrate program quality and value to third-party payers, manufacturers, and internal stakeholders. OBJECTIVE: To define specialty COMs and develop a framework for standardized data collection and reporting. METHODS: COMs for specialty pharmacy disease states (cystic fibrosis; hepatitis C; inflammatory conditions in dermatology, gastroenterology and rheumatology; and multiple sclerosis) were identified through a literature search, collaboration with specialty pharmacists, and committee review. Once identified, these measures were distributed to internal and external stakeholders that included specialty clinic team members, drug manufacturers, and third-party payers for input and validation. A standardized process for discrete documentation and data collection of these measures was implemented using case management software, electronic medical record integration, and informatics support. RESULTS: 28 COMs were identified. The various data sources used to collect the COMs were incorporated into an automated virtual dashboard to allow for regular review and sharing with clinicians, leadership, and other key stakeholders. The virtual dashboard included COMs with data derived from electronic medical records (n = 9), patient-reported outcomes based on responses to pharmacist-delivered questions (n = 11), and pharmacist assessment of outcomes (n = 8). The completed virtual dashboard was further refined to allow for reporting of both population and patient-level outcome results on a quarterly basis. CONCLUSIONS: This project describes methods to standardize documentation, data collection, and reporting of clinical outcomes data for multiple specialty conditions in a health system-integrated specialty pharmacy program. Through literature review and stakeholder consultation, a variety of potential COMs were identified for further evaluation of feasibility and value considering documentation and data collection requirements. Incorporation of COMs into a virtual dashboard will help facilitate the evaluation of program effectiveness, quality improvement planning, and sharing with stakeholders. Additional opportunities exist to further standardize COMs across the pharmacy industry to allow for future benchmarking and standardized evaluation of patient care programs.