Royce Burruss, RPh, MBA, FASCP

The clinical assessment has long been a cornerstone of patient-centric specialty pharmacy care. As the health care industry focuses on outcomes, accountability, and cost control, a demand is growing for increasingly sophisticated clinical assessment instruments. Numerous concomitant variables are associated with this demand, including more advanced, complex, and very expensive drug therapies, as well as growing requirements from payers and pharmaceutical manufacturers for greater quantity and quality of patient-specific data. In the current health care environment, specialty pharmacies are tasked more than ever to provide specific data to qualify for in-network status with payers and secure access to limited-distribution medications.

The patient management standards of accreditation agencies appear to be changing in concert with payer and manufacturer requirements, thereby increasing the need to monitor, assess, intervene, and accurately report outcomes to obtain and maintain specialty pharmacy accreditation. The resulting emerging expectation is for specialty pharmacies to use validated, disease-specific, health quality survey instruments to capture detailed pharmacy interventions and related outcomes. Clinical assessments—also referred to as patient questionnaires, survey instruments, survey tools, and health quality assessments&mdash;are a primary component of every patient-centered care model. Specialty pharmacy assessments are designed to capture data necessary for patient-centric pharmaceutical care that is safe, efficacious, and individually tailored. Traditionally, clinicians administer specialty pharmacy assessments at the start of care and repeat them at timely intervals, with the frequency of reassessments determined by patient need, disease state/medical condition, and medication regimen.

In general, specialty pharmacy assessments are designed to monitor adverse effects, drug interactions, and patient-reported adherence to prescribed drug therapy. The requirements of the modern health care system are challenging specialty pharmacies to rethink traditional assessments, and those ahead of the curve are using increasingly sophisticated instruments to engage patients, capture data, and implement interventions.

Disease- and medication-specific assessments provide a more complete picture of patient response to therapy, allowing the clinician to deliver focused care plans for patients and quality data for manufacturers, medical providers, and payers.

Specialty pharmacies are also incorporating validated survey instruments to demonstrate outcomes and the quality of their care. Sequence is a proprietary, web-based data management and analytics program that can help specialty pharmacies effectively collect and share data before and after patients undergo solid organ transplant. This includes a transplant-specific, weighted clinical assessment tool that helps identify patient adherence and lifestyle or other challenges that may disrupt therapy. The platform combines pharmacy assessments, dispensation, and therapy interventions with transplant center, home nursing, and laboratory data.

The result is a comprehensive picture of therapeutic impact and efficacy at the individual patient and aggregate transplant center levels. A study published in the Journal of Managed Care Pharmacy found that transplant patients followed by a specialty pharmacy with a specific transplant program had higher adherence rates and lower overall medical costs than patients followed by a traditional retail pharmacy.

 Provision of transplant-specific assessments and singular access to multiple patient touch points are helping specialty pharmacies and transplant professionals work together to improve adherence, speed time to transplant, and reduce the risk of organ rejection.

Specialty pharmacies are also using new ways to encourage patients to share self-reported data. Mobile, digital health, and business intelligence tools are changing the way patients record and share information with their specialty pharmacy. These data are particularly valuable in complex, high-cost therapies. According to a 2017 Express Scripts report, patients with hemophilia can have an annual prescription drug cost of more than $700,000.

 Patients with severe hemophilia typically self-infuse medication in their home. With more than 20 factor products, a new subcutaneous treatment option, and gene therapy preparing to enter the market, tracking infusions and recording bleeding episodes will become increasingly important.

Health care technology company Audaire Health focuses on facilitating transparency and accountability among payer, provider, pharmacy, and patient. Audaire has partnered with the National Hemophilia Foundation and several leading specialty pharmacies to provide patients with hemophilia a near passive platform to record and instantly share drug utilization information. The system also provides a nearly passive data input solution designed to ease reporting burden for both patients and pharmacy providers.

The platform captures multiple data points, including prescription, dispensation, pharmacy/clinic touch points, reported bleeds, and other medication administration information. Utilization is recorded and shared instantly, providing the opportunity for early interventions, preventing costly emergency department visits or hospitalizations, and identifying trends in bleeding episodes. This type of dynamic, real-time reporting allows the pharmacy clinician to step beyond static assessments to track utilization, pinpoint adherence or other therapy issues, and provide resources to help patients experience better outcomes.

The specialty pharmacy industry has and will continue to face increasing challenges associated with capturing, analyzing, and reporting greater amounts of patient-reported data, including interventions and outcomes. The future of specialty pharmacy as an industry is contingent on clinical data capture, analysis, interpretation, and reporting on both the patient-specific and aggregate bases to better meet patient-centric needs as well as to respond to the growing demands from payers, manufacturers, and health care accreditation agencies.

		Tschida S, Aslam S, Khan T, Sahli B, Shrank W, Lal L. Managing specialty medication services through a specialty pharmacy program: the case of oral renal transplant immunosuppressant medications. 

		Super spending U.S. trends in high cost medication use. Express Scripts website. 

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Articles

The clinical assessment has long been a cornerstone of patient-centric specialty pharmacy care.

The Changing Clinical Assessment: An Overview and Next-Level Challenges

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.

The Demand for Outcomes Data

In the rapidly changing specialty oncology space, accreditation, technology, data reporting, and customer service are some of the keys to staying ahead.

The specialty pharmacy market has become increasingly challenging, and this is forecasted to continue into the foreseeable future. Reasons for this include increasing competition for distribution of specialty oncology medications (SOMs) in particular. Additionally, more of these SOMs are being relegated to limited channels of distribution (LCD) to relatively few specialty pharmacy providers (SPPs), and profit margins for SOMs at the SPP level are decreasing. The body of scientific and clinical knowledge pertaining to oncology has grown in volume and complexity and this growth is expected to continue exponentially. Increasing reporting requirements for metrics associated with patient care, fulfillment turnaround time, and SRx utilization are also part of the challenge. SPPs must implement dynamic strategic and operational plans which will result in the SPP being top-in-class for provision of patient-centric care and pharmaceutical manufacturer satisfaction while generating adequate profitability.

The strategic and operational plans must be adaptable to the rapidly changing specialty oncology marketplace. Yet, even though some of the content of these plans may need to change (primarily the “how to get things done” parts), the context should not. The SPP must maintain its focus on providing the highest levels of satisfaction for internal and external customers. The following characterize SPP oncology practices which have demonstrated sustained success over their competition:

		Most SPP oncology practices have achieved or are pursuing specialty pharmacy accreditation by one of several nationally recognized accreditation organizations, with URAC accreditation being the most common. This is a testament to their commitment to the highest level of oncology practice, particularly given how resource intensive achieving and maintaining accreditation is.

		They have state-of-the-art information technology (IT) systems which integrate all aspects of pharmacy operations, including central intake, clinical services, fulfillment, delivery, continuous quality improvement (CQI), on-demand custom report generation, and management support functions.

		They periodically report their key operational and financial metrics for both management consumption and use in the SPP’s CQI programs. The reports are typically customizable to satisfy internal (eg, finance and accounting) and external (eg, managed care organizations [MCOs], pharmaceutical manufacturers) customer specifications and SPP contractual obligations.

		SPP oncology practices have centralized customer service operations that seamlessly and simply handle all customer and patient care needs, including connecting patients to appropriate patient support services whenever needed (eg, patient assistance programs [PAP] with customer service centers [CSCs] maintaining communication with patientsthroughout this process). Patients should never be left feeling as though they are on their own to overcome obstacles and access SPP services. Besides capturing patient demographics, doing benefit determinations, and guiding patients to and through PAPs, their CSCs also capture key clinical data which are referred to the clinical pharmacist for evaluation and use in patient counseling.

		Each respective staff member is experienced in and committed to oncology pharmacy practice. This includes having registered, even nationally certified, pharmacy technicians performing in CSC, prescription fulfillment, and supporting the clinical pharmacists. Some of their clinical pharmacists are board certified in oncology and have medication therapy management (MTM) certification from the American Pharmacists Association (APhA).

		These SPPs have sophisticated clinical practice support tools integrated into their respective pharmacy IT systems. These tools are designed to be patient specific and are regularly and routinely applied to each oncology patient and provide prompts to the clinical pharmacists for when to do clinical assessments. The more sophisticated SPPs have a tool that provides quantification of the risk of a given patient being nonadherent to their oncology prescriptions. Determining this risk factor drives the frequency and nature of the clinical follow-up reassessments, bringing particular focus on mitigation of medication-related problems and maintaining adherence to oncology prescriptions. Lastly, each member of the clinical pharmacy team is knowledgeable in and credentialed to perform risk evaluation mitigation strategies related to requirements for SOMs.

		In addition to having the above-mentioned clinical tools, most of these SPPs have a comprehensive MTM program. These MTM tools usually contain the APhA’s recommended documents. However, the more sophisticated of these tools are computer-based and also contain a nonadherence risk assessment instrument and an instrument to identify, assess severity of, and provide solutions to medication-related problems.

		All have clinical pharmacists available to any customer 24 hours a day, 7 days a week via toll-free telephone access.

		Most SPPs concentrating on oncology, which have moderately high volumes of oncology-related medications, also have a fulfillment system that is fully integrated into the pharmacy IT system. The fulfillment systems incorporate patient-specific radio frequency tags, conveyor systems, and state-of-art bar-code generation and scanning technology. All these are necessary to operate a perpetual drug inventory system, fill prescriptions, check fulfillment for accuracy and completeness, and facilitate delivery to the patient’s residence or prescriber’s office. The latter includes being able to print a copy of the proof-of-delivery document. The higher volume specialty oncology pharmacies also utilize reliable robotic prescription-filling technology (eg, ScriptPro), which is also integrated into the SPP’s IT system.

		Many SPPs concentrating on specialty oncology medications provide support services to MCOs by assisting them with driving patients to preferred drugs on the plan’s formulary. The more advanced SPPs specializing in oncology specialty drugs provide an outsourcing program via a service agreement with an MCO’s department of pharmacy. Here specially trained and often statecredentialed/ certified programs allow the SPP to provide prior authorization (PA) services for specialty oncology drugs that are on-formulary, using the MCO’s drug coverage criteria and PA forms. A minority of these types of contracts provide an opportunity for the SPP to recommend oncology drug coverage criteria for consideration by the MCO’s Pharmacy and Therapeutics Committee and assisting with developing and testing of MCO-sponsored PA systems, eg, PA websites for physician and pharmacy providers.

These plans, programs, and resources are either in daily use or are being developed for future use by successful specialty oncology pharmacies. It is, therefore, incumbent on SPP leadership to closely monitor these practice-critical trends and to implement those that make good business sense.

Royce Burruss, RPh, MBA, FASCP, has practiced full time in a variety of settings, having concentrated on specialty pharmacy for the past 14 years in clinical and senior management roles. He currently practices at OncoSource Rx as the director of clinical services. Prior to this he practiced clinical and administrative pharmacy in managed care, home infusion, retail, and hospital pharmacy. He has 11 active pharmacist licenses (Virginia, Maryland, Kentucky, Tennessee, Arizona, Louisiana, Nebraska, Oregon, Arkansas, Mississippi, and North Carolina) and he has led practices to successful JACHO and URAC accreditation. Since 1999, Mr. Burruss has been an assistant clinical professor of the University of Maryland School of Pharmacy. He is an active member of the American Pharmacists Association, American Society of Health-System Pharmacists, Academy of Managed Care Pharmacy, American College of Clinical Pharmacy, Fellow of the American Society of Consultant Pharmacist, and other professional societies. He has published in peerreviewed journals and has taught numerous courses on varied topics to pharmacy students. He graduated from Virginia Commonwealth University, Medical College of Virginia, School of Pharmacy with a BS in pharmacy and from the University of Richmond with an MBA.