Gary K. Rice, RPh, MS, MBA

From its creation, Diplomat University at Diplomat Specialty Pharmacy has been structured around its primary objective to provide a high-level of ongoing education to enable staff and partners to take the best possible care of patients.

Specialty pharmacy is expected to grow at double digit rates annually over the next few years, fueled by a rich drug pipeline, expanded indications of existing medications, and the introduction of biosimilars. Given the growth and innovation anticipated in the upcoming years, specialty pharmacies will continue to expand their services and capabilities to provide specialty medications in ways that promote safety, convenience, and quality care for patients who need the medications and to physicians who dispense them.

Diplomat Specialty Pharmacy provides patient-centric, clinically driven programs and services that promote patient safety, clinical outcomes, and economic value. The establishment of Diplomat University in October 2010 set the stage to expand the educational capabilities to address both industry and company growth. In 2012, the organization’s quality assurance program was incorporated into Diplomat University to expand the program from an operations perspective to a corporatewide initiative. From its inception, Diplomat University has been structured around its primary objective—to provide a high level of ongoing education in order to enable staff and partners to take the best possible care of patients. Directed by a previous college of pharmacy associate professor, this department provides Diplomat employees with a true academic-like learning environment. Contributing to the Diplomat University team is a group of individuals who educate employees on clinical, leadership, adjudication/ patient care systems, and quality improvement topics. Training programs are assigned to staff based on their role, department, and/or disease state specialty area. In addition, Diplomat University offers educational support during new product and program launches, which may include training staff on new or updated processes or newly approved specialty pharmaceuticals.

The educational opportunities at Diplomat begin immediately after employment. Internal education commences with a 2-week comprehensive New Employee Orientation Program. It is within this time frame that a new hire will learn about the company’s history and growth, customer service practices, prescription processing techniques, and important clinical aspects (eg, specialty disease states, pharmaceuticals, and assessment surveys). After successfully completing this mandatory introductory training, a new hire will transition into additional job-specific training within the department.

During times of rapid company growth, the need for front-line management intensifies. As such, there may be opportunities for employees to step into these roles who have minimal management experience and training. Identifying this as an educational opportunity, Diplomat University created an ongoing leadership training program to provide a learning foundation for leadership growth.

In addition to live training sessions, Diplomat University offers clinical staff the opportunity to acquire continuing education (CE) credits by successfully completing self-paced modules. Through collaboration with Ferris State University College of Pharmacy, Diplomat University is able to offer CE free to employees. Understanding that clinicians (nurses and pharmacists) and technicians require different levels of detail, separate modules are created for each group and tailored to meet the needs of their specific role. These self-paced modules focus on a specialty disease state (eg, hepatitis C virus or rheumatoid arthritis) and may include sections ranging from etiology and pathophysiology to treatment regimens and adverse effect mitigation strategies.

In addition to the internal education, Diplomat University also serves as a training ground for selected Diplomat partners. As more companies are becoming involved in specialty pharmacy through Diplomat’s innovative Retail and Hospital-Specialty Network programs, the need for specialty pharmacy education in these settings has escalated. Diplomat University has provided individualized and diverse education and training programs for its pharmacy partners, ranging from Specialty Pharmacy 101 to comprehensive multi-day specialty pharmacy clinical training programs.

Given the expansive amount of information that today’s pharmacy students need to acquire in order to become competent practitioners, specialty pharmacy is an area often overlooked within the curriculum. To help expose students to this fastgrowing segment of pharmacy, Diplomat works with various colleges to provide advanced pharmacy practice experiences to fourth-year pharmacy students. Diplomat also offers a unique post-graduate year 1 pharmacy residency program with a focus in specialty pharmacy. By providing hands-on training to pharmacy students and residents, Diplomat is able to actively support the development of the next generation of specialty pharmacists. Within a growing industry like specialty pharmacy, the need for a companywide quality management (QM) program becomes increasingly important. Diplomat’s QM program is patient-centric.

The goals and objectives of the QM program are to promote and build quality into Diplomat’s organizational activities, identify and investigate opportunities for improvement in a timely manner with implementation of actions and follow-up, encourage patient safety, and maintain compliance with local, state, and federal regulatory and accreditation standards.

These objectives are accomplished by employing leadership and staff to support the operations of the QM Program (Table). The QM program is led by the vice president of clinical services, who has authority and responsibility for the overall operational structure of the QM program and serves on the QM committee. The organization supports the program through the establishment of a variety of resources including the:

		Quality Department (includes a full-time quality assurance manager and technicians)

The activities performed by the quality team and within all departments are chronicled annually in the 

. Both annual reports demonstrate that the success of the QM program is sustained by proper organization, skillful planning, and continued organization support. 

The Quality Management Program Description

 provides a brief description of the program’s structure, devoted resources, leadership, and the annual work plan. 

 provides a brief description and quality indicator results over the previous 12 months. For instance, one of the QM initiatives is an annual patient satisfaction survey. Overall patient satisfaction rates over the last 3 years have ranged from 98% to 99%.

Diplomat Specialty Pharmacy’s commitment to education and training combined with the QM program was recognized on December 17, 2012, when the organization received specialty pharmacy accreditation status from URAC. While Diplomat was already accredited by the Accreditation Commission for Health Care and Community Health Accreditation Program, it was decided that adding URAC Specialty Pharmacy accreditation was an important marker for Diplomat’s best-in-class specialty pharmacy services.

The delivery of specialty pharmacy services and care is a complex process involving all types of integrated and interdependent processes. The establishment of Diplomat University, coupled with the corporate QM program, has allowed Diplomat Specialty Pharmacy to optimally deliver patient-centric care in a growing industry, while promoting patient safety and convenience and demonstrating highquality patient care.

Gary K. Rice, RPh, MS, MBA; Stephanie L. Freed, PharmD; and Jennifer K. Hagerman, PharmD, AE-C, are part of the Diplomat Specialty Pharmacy team in Flint, Michigan. Diplomat Specialty Pharmacy, founded in 1975, serves patients nationwide as the country’s largest privately held specialty pharmacy and focuses on complete medication management programs for patients with serious and chronic conditions. Key programs include oncology, HIV/AIDS, hepatitis C, multiple sclerosis, rheumatoid arthritis, Crohn’s, hemophilia/ IVIG, growth hormone, and psoriasis. Other specialty areas include transplant, fertility, and bio-identical hormone therapy.

Articles

Raising the Bar Through Education and Quality Initiatives

Specialty pharmacies are becoming more involved in programs that focus on the management of oral oncolytics. The role of health care workers, including pharmacists, physicians, and nurses, is being defined as this therapeutic class grows.

While the escalating number of oral oncolytics offers many cancer patients more convenient and less invasive treatment options compared with infused therapy, oral drugs also demand a new model for patient education, monitoring, and support. This trend is driven by a rising number of novel oral oncology agents in the marketplace, a robust pipeline, and increasing expanded indications for already approved therapies. The health care world has witnessed a remarkable paradigm shift from acute, limited treatment to maintenance therapies and an eventual chronic care model requiring advanced, ongoing care.

With infused oncology regimens, physicians and their nurses interact with patients more often, increasing the ease of monitoring. But with oral oncolytics, providers may often see patients less frequently, only for follow-up appointments. Many patients reason that because the medications are taken by mouth, they lack significant adverse effects. In reality, many oral oncolytics have toxicities as bad as or worse than their infused counterparts.

For these reasons, management programs that focus specifically on the oral oncolytics are becoming more common across the industry, and many managed care organizations are implementing protocols to manage this therapeutic class. Payers are asking specialty pharmacies to support their patients in at least 3 areas:

Educate patients about medication tolerance and adverse effects 

Actively monitor regimen adherence, persistency, and length of therapy 

Ideal candidates for oral oncolytics possess good communications skills (or have responsible, committed family members to communicate on their behalf) and a demonstrated willingness, ability, and discipline to adhere to the medication regimen and recommendations made by their extended health care team, including clinical pharmacy staff. Additionally, patients should be assessed with regard to their:

Understanding of the importance of their therapy to their disease outcomes 

Potential for adverse effects and agreement to minimization strategies 

Ability to integrate their therapy into their daily routine 

Equally essential are additional levels of cooperation and integration among physicians, pharmacists, and other health care providers responsible for patients’ overall care. Role allocation should seek to minimize costs while maximizing job capabilities and skill sets. The challenges surrounding oral oncolytics present unique opportunities for nursing teams to promote and facilitate medication adherence. As integral members of the health care team, nurses are renowned for their patient advocacy, teaching skills, and high-touch care. These qualities can be optimized in the specialty pharmacy setting through a variety of strategies targeting education, communication, and technology (Figure 1).

Goals of patient and/or caregiver consultations are the provision of individualized training and verification of the ability to implement drug and non-drug recommendations. Effective medication education incorporates the pill description, prescribed dosage, storage, disposal, safe handling, and other precautions. Administration and scheduling instructions, such as food requirements, treatment cycles, missed dose protocols, and concomitant therapies, have a high impact potential for the nursing team. Trained oncology nurses can also assist patients in developing realistic expectations, particularly the anticipation of adverse effects, monitoring requirements, and potential dosage changes or treatment interruptions.

Nursing contributions to adverse effect identification, prevention, and management are essential. With fewer office visits for monitoring, oral oncology patients may be hesitant to report adverse effects, believing that a dose decrease or treatment interruption could compromise efficacy.

 Nurses can reinforce minimization strategies and advise patients when and how to contact their providers or seek emergency care.3 In addition, when an adverse event is identified nurses will obtain details of the event and report back to the physician as well as complete the required FDA MedWatch form which tracks reported events.

While many specialty pharmacies have protocols in place to monitor adherence, an often overlooked topic is patient understanding of the importance of adherence. In a self-reported survey, 33% of breast cancer patients reported that their health care provider discussed the importance of taking their oral oncolytics as directed only once. When asked to select factors that could have increased their adherence, 89% of patients selected knowledge that it might improve clinical outcomes and 60% cited improved side effect management. 

 In a survey of 42 comprehensive United States cancer centers, 9 lacked standardized processes to evaluate adherence at office visits.

Scheduled proactive contact can help fill this void, allowing nurses to establish therapeutic relationships, provide ongoing adherence messaging, and encourage disclosure of treatment difficulties.

 Interventions can be designed to coincide with the medication’s adverse effect profile and at other time points when patients may be more likely to discontinue therapy. If the peak incidence of rash is during treatment week 3, a nursing call 10 to 14 days after patients start therapy would be more valuable than a discussion at the first refill. Drug rescue calls, in which nurses seek to identify and resolve reasons for treatment discontinuation, can minimize drug abandonment and increase persistency. During regularly scheduled follow-up calls, nurses can also collect accurate health and medication histories, including prescription, over-the-counter (OTC), and herbal products. These calls provide an opportunity to verbally assess adherence and treatment response, and collect other valuable outcome measures for pharmaceutical hubs, managed markets clients, and prescribing offices.

Should nurses identify barriers beyond their scope or program protocols, such as drug interactions or inappropriate weight-based dosing, patients can be triaged to pharmacists for resolution. Direct nurse-to-prescriber communication, such as notifications regarding adverse effects, nonadherence, disease status changes, and interventions completed, is essential for continuity of care. Potential additional roles for the nursing team include improving medication access through patient assistance programs or non-profit funding organizations and promoting enrollment into manufacturer support programs, which often provide an abundance of clinical resources and support services. Aside from manufacturer-provided materials, nurses can author newsletters and easyto- understand patient guides which serve to reinforce and provide additional education.

As an illustrative example, Diplomat Specialty Pharmacy determines the timing and frequency of patient assessments based on the oral oncolytic's adverse effect profile. A "yes" response to questions, such as those regarding episodes of nausea, vomiting, or diarrhea, triggers an additional series of questions that follow a drug-specific algorithm to determine severity, management, and next steps for triage and prescriber communication. Diplomat also distributes Oncology Care Kits exclusive to each medication with drug and non-drug adverse effect management techniques and OTC samples such as antidiarrheals or stool softeners. Nursing interventions are also timed in accordance with oncology cycles to ensure patient understanding and compliance with scheduled treatment breaks and phasic dosing.

Nursing team efficiency can be increased through a variety of technological innovations. Many specialty pharmacies calculate adherence based on refill dates to augment patient selfreport. Mobile and web technology is increasingly utilized for select patient contact points, surveys, and reminders. Nurses can facilitate participation in electronic medication monitoring programs and reminder packaging services.2 Diplomat examples include Oncology Medication CarePaks printed with the day, time, and week (Figure 2) and nurse calls to enroll patients in GlowCaps pilot programs, featuring electronic visual and audio medication reminders and progress reports of medication-taking events reviewed by the nursing staff.

Several barriers prevent the widespread implementation of successful nursing programs. Limited data has been published demonstrating the effectiveness of specialty pharmacy nursing interventions aimed to promote adherence. Strategies are often developed as initiatives to support manufacturer or managed markets clients and lack a scientific approach with a comparator group and research-driven protocol. This, coupled with insufficient data capture and reporting capabilities, makes it difficult for many to measure program impact. Intervention scheduling may become complex due to treatment interruptions and the need to collect true treatment initiation and restart dates. Patients are opted out of the program for a variety of reasons. Those reasons include regulatory limitations based on state mandates, off-label medication use, hospitalization, and patient choice based on quality of life concerns or disease progression. Some opt-out patients could receive nursing calls before they opt out, which makes data analysis between the 2 groups challenging.

A lack of validated tools, inaccurate recall, and the potential for distortion hinder patient self-reported adherence assessments. Adherence calculations using refill data vary among pharmacies, do not equate to medication ingestion, and cannot account for treatment interruptions or filling prescriptions elsewhere. Cycled oncology therapy may lead to inaccurate calculations and for some the expected duration of therapy due to life expectancy is simply too short for useful results.

Specialty pharmacy’s core values focus on patients, their families, and coordination of care among health care providers. Patient adherence is a key factor to optimize therapeutic outcomes, particularly in oncology, where increasing responsibility now falls to the patient. As the oncology landscape continues to evolve, the specialty pharmacy team must work together with a patientcentric vision to optimize patients’ therapeutic experience and clinical outcomes. The skill set of a nursing team is an invaluable asset in such a program— and its ability to impact adherence and other outcome measures is an area for further exploration. 

		Moore S. Nonadherence in patients with breast cancer receiving oral therapies. 

		Weingart SN, Brown E, Bach PB. NCCN task force report: oral chemotherapy. 

		Winkeljohn D. Adherence to oral cancer therapies: nursing interventions. 

		Wood L. A review on adherence management in patients on oral cancer therapies. 

		Kirk MC, Hudis CA. Insight into barriers against optimal adherence to oral hormonal therapy in women with breast cancer. 

		Weingart SN, Flug J, Brouillard D. Oral chemotherapy safety practices at US cancer centres: questionnaire survey. 

Gary K. Rice, RPh, MS, MBA, is the vice president of clinical services at Diplomat Specialty Pharmacy where he provides leadership, strategy, and planning for all clinical functions across the company. He works closely with operations, IT, business development, sales and marketing, and managed markets for tactical positioning and clinical service support from development through implementation, and oversees clinical initiatives and services. Gary has more than 30 years of pharmacy experience in PBM, managed markets, home infusion, DME, retail, and hospital pharmacy.

Heidi M. Hanna, PharmD, AAHIVP, is the manager of clinical services for Diplomat Specialty Pharmacy where she oversees the clinical pharmacist team and provides clinical support to all business segments, focusing on business development and sales and marketing. She also has experience in retail pharmacy and academia and continues to serve as an adjunct faculty member for the Ferris State University College of Pharmacy. Heidi has been credentialed through the American Academy of HIV Medicine since 2010.

Nila Carpenter, LPN, is the nurse manager of the adherence department at Diplomat Specialty Pharmacy. She has been actively involved in the development of disease management and adherence programs at Diplomat for the past 5 years. Nila provides leadership to the adherence staff and serves on multiple committees, including the Policy and Procedure Review Committee, Quality Improvement Committee and the First Responders Team. Nila attended the University of Michigan-Flint and received her nursing certification from C.S. Mott Community College. She is licensed in both Michigan and Ohio and maintains a NAPNES Pharmacology Certification.