Many patients who use specialty medications to treat their disease states have complex conditions that are best managed by an interdisciplinary team. Mail-order pharmacies are not well positioned to provide comprehensive pharmacy services as part of the health-system care team.1-3 Specialty pharmacy programs aim to enhance their care and improve outcomes. Integrated health-system specialty pharmacies are able to provide high-quality services that have the potential to exceed those offered by traditional nonsystem specialty pharmacies, all while serving to financially benefit the health system. Yet resources to help overcome the new, unique set of challenges faced by integrated health-system specialty pharmacy are scarce. What follows are strategies used by the University of Rochester Specialty Pharmacy (URSP) in New York to overcome common challenges.

Launching URSP
The University of Rochester started an integrated specialty pharmacy program in 2011 for patients with employer-sponsored insurance. The program was staffed by a pharmacist and a pharmacy technician. As of 2019, URSP has expanded to include all patients of the health system in multiple therapeutic areas, such as cardiology, dermatology, gastroenterology, hepatology, neurology, oncology, pulmonology, and rheumatology, and is now staffed by 18 pharmacists and 23 pharmacy technicians. Each patient is assigned a dedicated clinical pharmacist and an advanced care technician.

All clinical pharmacists must become board certified through the Board of Pharmacy Specialties in the area most pertinent for their area of practice. Additional pharmacist credentialing is supported and encouraged, such as the Multiple Sclerosis Certified Specialist through the Consortium of Multiple Sclerosis Centers. Twelve of the 15 clinical pharmacy specialists completed an American Society of Health-System Pharmacists (ASHP)–accredited postgraduate year 1 pharmacy residency program, and 3 completed a second-year residency program. All technicians must become certified through the Pharmacy Technician Certification Board within a year of hire.

Overcoming Challenges

Financial Justification
Revenue generated by dispensing specialty prescriptions uniquely positions health-system pharmacies to support the development of robust clinical pharmacy programs that, in turn, enhance patient care. Although many departments struggle to provide long-term financial justification to hire additional staff for interdisciplinary teams, specialty pharmacies are able to support rapid growth and expansion.

Unnecessary Referrals
Specialty prescriptions for patients within the health system are preferentially filled with URSP. An unanticipated challenge has been referral to outside (nonintegrated) specialty pharmacies by manufacturer assistance programs, insurances, and pharmacy benefit managers, which can negatively affect patient safety. Medications have been delivered to patients before optimal baseline screening or before other monitoring parameters were completed, or a wrong formulation has been dispensed. Despite patient preference to fill at URSP, this can result in patients or providers being contacted by the outside specialty pharmacy. This adds to significantly more time to manage patient care. Communication via email and over the phone with contacts at the manufacturer, as well as in-person meetings, email, and phone contact with administrative staff from our clinics, led to workflow optimization that clarifies when a patient prefers to use URSP. The multiple sclerosis team adopted a process of specifying that a benefits investigation was completed, and URSP is the preferred pharmacy on the manufacturer patient assistance program enrollment form.

Payer Restrictions and Limited-Distribution Drugs
Insurance restrictions and limited distribution of medications prohibit health-system specialty pharmacies from providing comprehensive pharmacy services to all patients. Obtaining accreditation through URAC or similar organizations is often required as part of the contract agreement for specialty pharmacies to gain access to limited-distribution drugs. URAC is an independent, nonprofit accreditation entity that provides accreditation and certification programs for health plans, health care management, health care operations, pharmacy quality management, provider integration and coordination, and organizational management. URSP employees took an active role in the process of creating policies and procedures to prepare for URAC accreditation, and no consulting services were used. Full specialty pharmacy URAC accreditation was obtained in 2016 and took less than 2 years. Involving our own employees in the accreditation process allowed URSP to develop policies and procedures that best meet our health system’s unique needs, obviating the need for outside resources that are less familiar with current workflows.

The inability to fill each patient’s specialty prescriptions within the health system has at times led to challenges in establishing clear roles and responsibilities for the URSP teams. Strategies to overcome such difficulties include improved communication and mutual support from the respective departments at the university. Meetings are held to introduce the team to the respective department and other interdisciplinary team members. URSP teams establish integrated specialty pharmacy services through regular communication via in-person meetings, phone calls, emails, and the electronic medical record (EMR) with administrative staff, social workers, nursing, advanced practice providers, and physicians. Workflow efficiency across the interdisciplinary team is continually reviewed in the format best suited to individual clinic needs and availability.

Quality Improvement
Preparation for URAC accreditation led to the formation of a specialty pharmacy quality management committee and the development of a formal consumer safety quality improvement project. A clinical pharmacy specialist with an interest in quality improvement serves as chair of the committee, which agreed that an optimal project would provide information to help support the improvement of the patient management program. Adherence was considered as a potential metric of interest for a quality improvement project, as it is frequently used as an outcome of interest in pharmacy because of ease of capture. However, this was not pursued because of consistently high adherence rates, with medication possession ratios exceeding 90% for most drugs dispensed by URSP.

URSP performed a patient safety quality-improvement project to assess adherence to physician-recommended monitoring for fingolimod after the pharmacists identified the opportunity for interventions as follows: The pharmacist follow-up schedule was adjusted to coincide with lab monitoring due dates, lab requisitions were mailed with refill deliveries, and pharmacists directly placed appropriate lab orders as needed. After an initial evaluation identified potential for improvement, prior interventions were made with a postimplementation comparison in a second and third cohort to ensure the result was sustained. The results of the project were shared as 2 posters at the ASHP Midyear Clinical Meeting and Exhibition and led to recognition from our health system at a symposium highlighting teams overcoming barriers to providing the highest quality of care to patients.

Our current, ongoing patient safety project is designed to improve patient care documentation through the creation of a comprehensive navigator in the EMR to eliminate the need for duplicate documentation in a separate specialty pharmacy software system.

Standardization
URSP has consistently tried to standardize processes across therapeutic areas served while maintaining the necessary customization to meet the respective clinic workflows. Documentation in the EMR includes standardized templates with added customization components for different therapeutic areas.4-6 The format used within the EMR was designed to provide an optimal way to pull data for pharmacy outcomes research projects for both the overall program and specific disease states.

Because of the varied workflows of the ambulatory clinics, optimal integration of the clinical pharmacists into the team has required customization to add the most value to interdisciplinary teams we have joined. Standardization of clinical pharmacy services is detailed below.

Prior to and during therapy, a pharmacist provides medication education and counseling regarding adverse effect management and adherence, ensures the medication list is accurate, checks for drug interactions, and assesses for renal or hepatic dose adjustments. Initial medication teaching includes creation of a personalized adherence plan. The typical patient outreach timeline is prior to first fill, approximately 1 week after the anticipated start date, and at the time of scheduling the first refill, and then every 3 to 6 months for stable patients. The follow-up schedule is customized to meet patient-specific needs and regimens.

Customization is necessary to meet the needs of the different ambulatory clinics and provide the most value to the team. Clinical pharmacy services are provided in person at clinic visits as a separate pharmacist appointment or over the phone based on factors such as available space, frequency of patient follow-up, clinic schedules, and patient preference. Patient, provider, and employee satisfaction are evaluated annually and have been overwhelmingly positive with the program.

Conclusion
It is important to promote the ongoing development of best practices for integrated specialty pharmacies in academic health systems. Despite the challenges reviewed, we offer strategies to overcome these barriers. As specialty pharmacy continues to grow, we strongly encourage other programs to share best practices that help to optimize patient care within the unique area of specialty pharmacy.

References
  1. Bagwell A, Kelley T, Carver A, Lee JB, Newman B. Advancing Patient Care Through Specialty Pharmacy Services in an Academic Health System. J Manag Care Spec Pharm 2017 Aug;23(8):815-820.
  2. Habibi M, Kuttab HM. Management of multiple sclerosis and the integration of related specialty pharmacy programs within health systems. Am J Health Syst Pharm 2016 Jun 1;73(11):811-819.
  3. Zaepfel M, Cristofaro L, Trawinski A, McCarthy K, Rightmier E, Khadem T. Evaluation of a Hepatitis C Patient Management Program at a University Specialty Pharmacy. Ann Pharmacother 2017 Apr;51(4):307-314.
  4. American College of Clinical Pharmacy. Standards of practice for clinical pharmacists. Pharmacotherapy 2014 Aug;34(8):794-797.
  5. American Society of Hospital Pharmacists. ASHP guidelines on documenting pharmaceutical care in patient medical records. Am J Health Syst Pharm 2003 Apr 1;60(7):705-707. Reviewed in 2008.
  6. Zierler-Brown S, Brown TR, Chen D, Blackburn RW. Clinical documentation for patient care: models, concepts, and liability considerations for pharmacists. Am J Health Syst Pharm 2007 Sep 1;64(17):1851-1858.