Veronica Arikian, RN, PhD, MA

Assessment, interventions, and outcomes information is vital to specialty pharmacy stakeholders.

	The demand for outcomes data, reported in numerous ways (eg, by patient, drug therapy, drug class, payer, etc), continues to grow. This demand has particularly impacted specialty oncology pharmacies (SOPs), which routinely generate patient-specific clinical assessments, interventions, and outcomes (AIOs). These outcomes are critical for diverse consumers of this data, for example, health care insurers (Medicare, Medicaid, commercial, and self-insured groups), pharmaceutical manufacturers, accreditation agencies, and academic institutions. SOPs and prescribers primarily deal with patients as individuals, with each developing precise treatment/ interventional plans that when implemented in concert with patients result in improved outcomes and associated metrics—directly benefiting patients by providing them with the opportunity for improvement in the sense of well-being.

	The demand for intervention and outcomes data by the larger consumers has evolved from needing data primarily pertaining to medication errors and adverse drug reactions to wanting an array of patient-specific interventional and associated outcomes metrics from which they can proactively develop/revise their own patient outreach programs, with the goal of optimizing ongoing clinical outcomes. These outcomes are measured at both the individual patient level and the sub-population-based level, with the intent to reduce health care costs across all levels.

	The broad consumers of outcomes data typically aggregate patient-specific outcomes data (eg, by disease state, specific drug therapy, physician practice type, general geographic location, common patient demographics, specific type of medication error, etc) or group them into larger, more generalized populations (eg, by cancer of any type, all-cause vascular disease, drug therapy category, all-cause medication error, etc). However, the data received from SOPs by these consumers are typically provided to them in various formats that are often difficult to consolidate in a single, easy to use database. The main reason for the multiplicity of formats is that the information technology platforms used by each SOP, including their data output and clinical AIO applications, are very different from one SOP to another, ie, the systems and respective data formats are nonstandard from the larger consumer perspective. This results in a significant challenge to larger data consumers to further consolidate such data into a database that has the desired usability and utility.

	Because all health care practitioners have the primary goal of providing health care safely—

, or first do no harm—the development of computerized information technology systems (ITSs) for these providers, beyond basic practice management support, was based primarily on reducing the potential for communicating medical data that could result in errors, including medication errors. Examples of such systems currently in place are electronic medical/health records (eMRs or eHRs) and electronic prescription intermediaries (ePIs), neither of which are currently used by all practitioners, but which nevertheless are being adopted with increasing frequency. Generally speaking, very few ITSs have the capability of providing a broad spectrum of AIO data/information beyond prescription data from prescribers/practices to designated larger data consumers. One of the health care industry’s earliest examples and the currently leading example of such ITSs capable of transmitting AIO data is Pathware and its companion, Pathways. (Note: Pathware and Pathways are products owned by Cardinal Health.) These have been successfully implemented in the oncology market space for 4 years; however, newer ITS products have recently emerged.

	Another gap in communicating AIO data/information, perhaps of greater significance than the gap in ITS uptake, exists in prescriber-to-SOP bidirectional communication of relevant AIO data/information. Most communications initiated by SOPs to prescribers consist of prescription-related requests (new prescription needed, refill needed, clarification of an existing prescription, reporting a suspected adverse drug event or drug error, etc), and most communications originating with prescribers to SOPs typically involve inquiries about prior authorization—what needs prior authorization and how to obtain/complete forms, when will a new/changed/refilled prescription be delivered to and started by a patient, and drug information requests. However, unless the SOP and the prescriber are operating on a common, shared ITS, AIO data generated by either practice are not shared between the SOP and prescriber and vice versa, resulting in potential lost opportunity to improve quality of care to their shared patients.

	A critical aspect of the development, implementation, and ongoing operation of ITS with bidirectional AIO data flow is the need to ensure that there exists between the SOP pharmacy staff and the prescriber, including their respective information gatekeepers (for the prescriber it is typically a registered nurse [RN], an advanced practice nurse [APN], or physician assistant [PA], and for SOPs it is typically a pharmacy technician or customer service representative), the following:

			Mutual trust of the shared information, and between the respective practitioners

			Commonly accepted medical language/jargon

			AIO information that is both useful and relevant to the respective practices

			Assurance that the shared information is confidential, shared, and used in a timely manner

			Frequent and transparent communication.

	As demand for AIO data/information continues to grow, so must the ITS infrastructure used by both SOPs and prescribers. The attendant challenges of some incremental higher cost, as well as trust and acceptance of shared AIOs, will have to be addressed sooner rather than later. In addition, the current ITS vendors will be challenged to continuously improve their respective product/service offerings. These will include bi-directional AIO data/information sharing capability with the large health care data consumers and between prescriber and SOP practices. 

 has been engaged in the full-time practice of pharmacy in a variety of settings, having concentrated on specialty pharmacy for the past 14 years, and currently is director of clinical services and pharmacist-in-charge of Cardinal Health Specialty Pharmacy, OncoSource Rx. Prior to this he practiced clinical and administrative pharmacy in managed care, home infusion, retail, and acute care hospital settings. He has active pharmacist licenses in 12 states. Royce has led practices to successful JACHO (hospital and home infusion, and Disease Specific Care Certification for Hepatitis B/C) and URAC (specialty pharmacy) accreditations. He is assistant clinical professor of the University of Maryland, School of Pharmacy. He is an active member of APhA, ASHP, AMCP, and ACCP, a fellow of ASCP, NASP, and other professional societies, and he has published in peer-reviewed journals and taught university-level courses on various topics. He graduated from Virginia Commonwealth with a BS in pharmacy and the University of Richmond with an MBA. 

 is associate professor of nursing at the State University of New York Downstate Medical Center in Brooklyn, New York, teaching both undergraduate and graduate nursing students, with a concentration on teaching research and mentoring graduate students. She earned a BA in English and education from St. Joseph’s College, a BS in nursing from Columbia University, an MA in nursing from New York University, and a PhD in nursing systems from Virginia Commonwealth University. Her primary area of expertise is nursing research and leadership/administration; however, she has significant nursing practice experience in acute care settings, including respiratory intensive care, general medical/surgical nursing, nursing administration, and public health nursing. In addition, Veronica serves as expert witness in malpractice cases. She has published extensively in peer-reviewed publications on various health care topics, including nursing and pharmacy.

Veronica Arikian, RN, PhD, MA

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