Pharmacists practicing in academic medical centers and university health systems routinely address complex disease states, complicated medication regimens, and payer challenges, while medications assigned to limited distribution pathways and narrow pharmacy networks make delivering care increasingly difficult. Implementing specialty pharmacy services within the health system is an effective strategy to ensure that patients with complex diseases and intricate regimens can access the medications they need. Although the definition of a specialty pharmacy has evolved and expanded in recent years, a specialty pharmacy generally encompasses drug distribution and patient care related to potentially toxic, expensive, and/or medications that involve complicated treatment regimens.
The University of Alabama Birmingham (UAB) Hospital is the largest academic medical center in Alabama, consisting of over 1,100 inpatient beds, 10 intensive care units, and the only adult level 1 trauma center in the state. Our numerous inpatient programs are complemented by a number of ambulatory clinics that provide longitudinal patient care. Recently, the health system began expanding into the arena of outpatient specialty pharmacy, with the goal of facilitating medication access for UAB patients with disease states that traditionally require high-cost, complex medication regimens and significant clinical involvement in order to ensure appropriate medication use and optimal medication-related outcomes.
One such disease state is solid-organ transplantation. The UAB health system identified opportunities to improve patient safety and wellness, and perhaps reduce overall health-system costs relating to solid-organ transplant as well, by developing individualized therapy plans, improving communication throughout transitions of care, and maintaining a complete and continuous health record. To attain these goals, UAB developed a strategy for implementing a specialty pharmacy. The first service line to benefit from specialty pharmacy services was transplantation.
The Early Stages of Specialty Pharmacy
Solid-organ transplant patients had historically been treated by UAB Hospital’s multipurpose, multidisciplinary outpatient pharmacy. UAB has been utilizing pharmacists in ambulatory clinics since the 1980s; these pharmacists quickly established themselves as valued members of the solid-organ transplant clinic team. Pharmacist responsibilities include overseeing immunosuppressive regimens, facilitating access to medications, and performing in-depth patient medication education. These pharmacists also play a pivotal role in managing drug therapy; this service is particularly beneficial for patients who are discharged from the hospital with a number of new prescriptions.
For example, due to the narrow therapeutic index and pharmacodynamic profiles of these medications, each patient receives their own unique cocktail and dosage. Upon discharge, the patient must fully understand the medications they are taking, the correct dosage regimen and timing for each medication, and they must be able to fill these prescriptions. Because drug regimens change frequently during the initial post-transplantation period, the patient must stay current with their medications, despite changing doses. Involving a pharmacist during this process ensures that each prescription is filled correctly and that the patient understands the regimen. Moreover, the pharmacist can monitor patients for compliance to these complex regimens as well as any adverse effects. UAB pharmacists operating in the clinic document any issues in the patient’s EHR and subsequently communicate this information to the patient’s physician. A key outcome of this involvement is that UAB pharmacists are able to add all pertinent information to the EHR—data that would have remained unknown had the patient been cared for by a pharmacist outside of the UAB health system. The ability to access this information enhances communication and facilitates data sharing between noncontiguous disciplines for the entire time the patient remains in the health system. The success derived from the efforts of these pharmacists is a tremendous example of how pharmacy departments can directly impact patient care in the ambulatory arena. In addition, their success laid the groundwork for further expansion of the specialty pharmacy model.
In 2009, our organization established an additional outpatient pharmacy that focused specifically on treating patients receiving solid-organ transplants. This initiative was undertaken to isolate these patients and medication regimens from the generalized patient population for which UAB had been dispensing and to provide specialized training to the pharmacists handling and adjudicating these prescriptions. Because UAB already had a pharmacy presence in solid-organ transplant, making the leap to establish a specialty pharmacy presence was not a significant stretch. Assuming proper departmental and institutional support, organizations with a structure similar to UAB may be able to establish a specialty pharmacy presence in the solid-organ transplant area as well.
Expanding Service Lines
Building on the established track record of pharmacists in the solid-organ transplant clinic, it was a small step to expand to the hepatology department, caring for patients following liver transplant or patients infected with the hepatitis C virus (HCV). With the advent and refinement of direct-acting antivirals for the treatment of HCV, our physicians determined that treating the infection was superior to watchful waiting. Therefore, the prescription volume for these agents increased as well, which resulted in a corresponding increase in paperwork, social service, and payer challenges. Our previous process of asking the patient which pharmacy they preferred or which pharmacy was closest to their primary residence was ineffective in helping patients access their medications, given that oftentimes these pharmacies were out of network. Thus, prescriptions had to be rerouted to in-network pharmacies. Some prescriptions went unfilled, especially by patients with high copayments. At best, patients experienced delays in obtaining their prescribed therapies due to prior authorization steps or other payer requirements. Turnaround times at large retail pharmacies often stretched several weeks.
In an attempt to mitigate these challenges, in 2015 the UAB specialty pharmacy began dispensing medications for patients infected with HCV. The clinic pharmacist participates in the care experience by providing patient education, medication reconciliation, drug utilization review, and patient safety oversight. Working in conjunction with pharmacists and technicians from the UAB specialty pharmacy, clinic pharmacists supplemented social services by adjudicating the prescriptions, completing prior authorizations, enrolling patients in grant programs, and seeking copay assistance where applicable. If the UAB specialty pharmacy is unable to fill the prescription due to network restrictions, the physician is notified and the prescription transferred to an appropriate pharmacy.
In addition to coordinating workflow, filling patients’ HCV treatment at UAB outpatient pharmacies allows us to partner with the medical team to provide an environment that optimizes the likelihood of treatment success. For example, we have developed an intensive specialty pharmacy services patient-management program. Under this program, patients receive follow-up care from the same UAB pharmacy staff that was involved in the initial decision to begin therapy. The program provides standardized documentation that facilitates education, adherence training, and any required patient or physician interventions. Patients receive refill reminders and regular follow-up by pharmacy staff to ensure compliance with their regimen, to ascertain any adverse effects from the medication, and to verify that their health information has not changed. The pharmacist can also double-check clinically relevant information, such as physician notes or new laboratory data.
Using the hepatology model as a template, specialty pharmacy services have recently expanded into additional specialty practice areas, such as rheumatology, oncology, and neurology. Often, our best marketing occurs through word of mouth between physicians currently practicing in clinics where our pharmacists are established and those practicing in clinics without embedded pharmacists.
Identifying Customers and Pharmacy Staffing
The mission of UAB Specialty Pharmacy is to achieve optimal therapeutic outcomes for UAB patients by taking personal responsibility for their specialty medication needs in a safe and professional environment. As such, our customers are the patients seen by UAB providers in our clinics. Fortunately, many of these patients have insurance that allows them to not only see UAB providers but also be treated through our outpatient pharmacy. One of the easier insurance partners to work with is the commercial health plan available for our facilities’ employees. As the second largest employer in the state of Alabama, this gave us a large pool of patients that we could treat while working with an insurer that understood our health system.
Our staffing model involves dedicating a pharmacist and a patient-care coordinator (PCC) to each medical group that receives specialty pharmacy services. A PCC is a pharmacy technician who works to the top of their license with additional training in prior authorizations, documentation, and direct patient care. For large physician groups, such as oncology, our team works in collaboration with a few physicians within the group.
It is useful to begin with a physician champion who understands the need for a multidisciplinary team approach and the value pharmacy adds to the patient care experience. Working together with a physician champion helps staff learn the clinic’s processes, workflow, and needs in a controlled environment, and sets appropriate expectations for collaboration. As the other partners in the practice discover the benefits of utilizing specialty pharmacy services, we expand to include them as well.
The pharmacist is embedded in the clinic with the providers, while the pharmacy technician is located in the business office. The technician is responsible for adjudicating prescriptions, providing financial assistance, and calling patients with refill reminders. Prescription fill rates and patient follow-up begin slowly due to limits in clinic appointment slots or ability to process claims; as the demand for services increases, we will request additional staff for both the clinic and the outpatient pharmacy. Oftentimes, prescription volumes are useful to justify our staffing requests.
Establishing specialty pharmacy services has not been without challenges. One limitation to providing medications to patients are the narrow networks established by certain pharmacy benefit managers (PBMs). When we are unable to fill a prescription due to our out-of-network status, the patient’s prescription then must be transferred to an in-network pharmacy. Becoming an authorized provider for certain PBMs can be a time-consuming process.
Limited distribution networks (LDNs) pose another challenge for many specialty medications. This becomes challenging because a PBM may allow us to fill a patient’s medication, but the manufacturer may restrict the pharmacies that can dispense their medications. In this situation, we assist the patient in routing the appropriate information to a pharmacy that is not only contracted with the appropriate PBM, but that also has access to the LDN.
Gaining access to these LDNs can prove challenging, as networks often may be closed to new member pharmacies. Because we provide medications to many patients and UAB employees, encompassing a large number of individuals with a variety of disease states and health benefits, it is advantageous to be contracted with multiple PBMs and to be included in as many LDNs as possible. Taking a proactive approach ensures we are able to fill as many prescriptions for as many individuals as possible.
A comprehensive understanding of the challenges associated with implementing a specialty pharmacy is imperative to success. While each academic medical center will encounter its own unique set of challenges, it is helpful to recognize some of the more common issues. For example, the logistical challenges of starting a new service line should not be underestimated. The number of employees, workspaces, and workflow of the service should be thoroughly discussed. Gaining the support of the institution’s C-suite will be vital to operational success. Recognizing potential limitations from the outset of starting the service will improve the trajectory of the specialty pharmacy.
While we encountered many challenges when starting our specialty pharmacy journey, implementing services has been exciting and rewarding on many levels. Our organization has taken another step to ensure patients receive quality care by providing pharmacy services in the clinic setting. Prior to launching this service line, few of our clinics offered clinical pharmacy services. This service has brought more pharmacists, and their significant skill sets, to the frontline of patient care. By continually focusing on improving patient care and outcomes, our specialty pharmacy services have become a valued part of the comprehensive pharmacy services provided at UAB Hospital.
Factors Driving Success
We attribute the success of our specialty pharmacy initiatives to several factors:
- Sufficient Resources. The outpatient pharmacies have the bandwidth to absorb increased prescription volume, as well as the expertise to properly store, handle, and distribute these complex agents. As many biologic products have specific handling requirements, sufficient floor space for refrigerators, robust inventory management, and reliable shipping partners with expertise in cold chain distribution are necessary. For example, the amount of time, expertise, and effort required to procure the appropriate number of gel ice packs for a week’s worth of dispensing will surprise most new practitioners.
- Staff Collaboration. Positive interaction and collaboration between clinicians and clinic pharmacists enhances the continuum of patient care, driving successful outcomes. Our PCCs follow up with every patient every time a specialty medication is prescribed, which improves medication adherence and compliance. Furthermore, a clinic pharmacist follows a reassessment schedule to speak with each patient and is always available to answer patient questions.
- A Measured Approach. Our leadership group made it a priority to expand the program into only one clinic at a time, which has allowed us to focus on each clinic’s specific workflow needs prior to venturing on to the next clinic. When evaluating which areas would benefit most from specialty pharmacy services, we quickly learned that each clinic’s needs are unique. Although there often is a natural tendency to attempt to create uniformity across systems, due to the differences in disease states, prescriber habits, medication regimens, and patient population needs, we made the decision to individualize clinic workflows. Such an approach demonstrates a commitment to patient care and stewardship of complex medication regimens, making UAB specialty pharmacy services an attractive partner for specific PBMs and LDNs.
Lessons Learned and Tips for Success
UAB specialty pharmacy services could not have experienced the growth and success it has without a commitment to its guiding principles, which are broadly applicable across a variety of health care settings and can aid other hospitals in establishing their own specialty pharmacy strategy. Our specialty pharmacy strategy includes three main themes:
- Institutions should seek to prioritize specific specialties and practices as the focus of future specialty pharmacy expansion.
- Institutions must identify physician champions embedded within these specialty practice areas.
- Pharmacies and health systems must develop a strategy for gaining access to PBM networks and LDN products.
Judiciously identifying which specialty practice areas will be the focus of creation and/or expansion of specialty pharmacy services is perhaps the most critical aspect of implementing a specialty pharmacy strategy. The chosen specialty practice area is ideally one that will yield a noticeable financial return on investment in a short time period and without significant effort. Success in this area is crucial to building credibility and demonstrating the potential financial impacts of the program. While many institutions have had success filling prescriptions for hepatology patients, myriad other opportunities and specialty areas may be pursued.
Networking with a physician champion in a particular specialty practice area is useful to help identify which areas would benefit from the implementation of specialty pharmacy efforts. By pursuing a clinic or specialty practice where strong pharmacy-physician relationships already exist, the pharmacy department can bypass the initial step of building rapport with physicians. Once those relationships are in place, physicians will be more likely to refer patients to the internal specialty pharmacy. Build relationships and a prescribing base by focusing on the higher level of customer service and direct patient care that the pharmacy can provide over traditional mail order or other specialty pharmacies. Ready accessibility ensures the specialty pharmacist can quickly respond to patient and physician needs. This creates a positive experience for both the physician and the patient, resulting in a greater awareness of provided services and increasing the likelihood the pharmacy will be utilized again in the future.
One of the most significant challenges every specialty pharmacy faces is obtaining the medications required to serve patients. Whether the difficulty is due to the drug being restricted to certain distribution channels by the manufacturer, or limited to dispensing from a closed network of pharmacies based on the patient’s pharmacy benefit, health systems endeavoring to establish a specialty pharmacy are sure to encounter situations where it is all but impossible to serve an available patient. Thus, health systems must pursue deliberate channels to ensure access to medications in a systematic fashion. Oftentimes, success can be achieved by focusing on a single specific disease state and/or medication at a time. Once pharmacy has demonstrated success in one area, those lessons learned can be translated to other areas as the program expands.
By focusing our initial efforts on solid-organ transplant patients, UAB has been able to grow our service in exponential fashion, and this growth continues today as more specialty service lines are launched. Above all, a demonstrated commitment to providing excellent patient care is vitally necessary in the endeavor to establish successful specialty pharmacy services.
Continued expansion to involve more providers and patients in our intensive management program is an ongoing goal of our program. Additional goals include collecting the patient care data necessary to quantify the value added by our pharmacy services. Anecdotally, we believe our interventions have a positive impact on individual patient results, such as increased adherence and cure rates, as well as larger population outcomes, such as reduced emergency room visits and avoided inpatient admissions.
Finally, as noted previously, the costs incurred in both staff and technology to provide these services are not insubstantial. Soon we hope to be able to perform the studies necessary to prove that the benefits of providing this level of quality far exceed their cost.
Matthew Malachowski, PharmD, BCPS, is the supervising pharmacist for specialty pharmacy services at UAB Medicine in Birmingham, Alabama. His professional responsibilities include oversight of ambulatory care pharmacy involvement in the solid-organ transplant program. Matthew graduated from the University of Rhode Island in 2006 and completed a general practice residency at the University of Alabama Birmingham in 2007.
David A. South, PharmD, MS, is the supervising pharmacist for inpatient general medicine services at UAB Medicine in Birmingham, Alabama. His responsibilities include oversight of acute-care pharmacy involvement in the solid-organ transplant program. David graduated from Samford University in 2014 and completed a 2-year health-system pharmacy administration residency at the University of North Carolina Hospitals and Clinics in Chapel Hill, North Carolina.
Michael James, PharmD, is the supervising pharmacist for The Kirklin Clinic outpatient pharmacy at UAB Medicine in Birmingham, Alabama. His duties include oversight of treatment for clinic procedural areas and specialty pharmacy products. Michael graduated from Lake Erie College of Osteopathic Medicine School of Pharmacy in 2009 and has previous managerial experience with Rite Aid Pharmacy prior to joining the UAB team.
Joshua Whitley, PharmD, is the supervising pharmacist for the specialty transplant outpatient pharmacy at UAB Medicine in Birmingham, Alabama. His responsibilities include oversight of treatment for solid-organ transplant and hepatology patients. Joshua graduated from Samford University in 2014 and has previous managerial experience with Rite Aid Pharmacy prior to joining the UAB team.
Specialty Pharmacy Accreditation
Specialty pharmacy accreditation, which can be obtained from several organizations, has been an important goal for our institution from the initiation of the program. Having one or multiple accreditations demonstrates that the specialty pharmacy meets specific industry standards for effective practice. In addition, many drug manufacturers and PBMs require certain accreditations in order to be considered for inclusion in their networks. Obtaining these accreditations will ensure the pharmacy has implemented and follows the practices and policies and procedures (P&Ps) necessary to care for patients appropriately.
Nevertheless, pursuing accreditation is not without challenges, and organizations must carefully consider the requirements before making a commitment. Specific P&Ps must be developed in order to meet the appropriate standards. Constructing an effective workflow and detailed P&Ps requires many hours of process evaluation and analysis. Because P&Ps are only as successful as their execution, educating staff is paramount for ensuring operational workflow.
The UAB outpatient pharmacies described herein are currently in the midst of URAC accreditation and our organization is in the process of evaluating additional accrediting bodies for further certifications. Before embarking on such an adventure, institutions should carefully evaluate the benefits obtained from such accreditation and determine where gaps exist in their current program.
Additional Guidance on Developing Specialty Pharmacy Services:
Ask the Expert: What is the process for facilitating access to specialty medications?
Building a Specialty Pharmacy Call Center
A How-To Guide for Specialty Pharmacy Accreditation
Top 10 Checklist for Launching a Specialty Pharmacy
The Increasing Impact of High-Cost Specialty Therapies
Evaluating Biosimilars for Formulary Inclusion
Managing High-Risk Biologics with MUEs
Cost-Effective Approaches to Biologics Procurement
Comparison of USP <800> Gap Analysis Tools
Constructing an Oncology Pharmacy
Establishing and Expanding Specialty Pharmacy Services
Maximizing Central Pharmacy Dispensing Technology
Overcoming Challenges in IV Workflow Software Use
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