Breaking Out of Isolation: The Value of Clinical Integration in Health System Specialty Pharmacy

THE BENEFITS OF INTEGRATED clinical care are undeniable. In a specialty context, pharmacy integration acquires additional meaning and urgency for its impact on individual patient health, population health, and organizational efficiency. The ASHP Specialty Pharmacy Resource Guide notes these factors as contributing to successful clinical integration:

• Complete and timely information about the patient and the services they are receiving
• Access to the electronic medical record (EMR)
• Adequate resources for patient education and self-management support
• The ability to measure and report on the quality of care
• A culture of teamwork among staff and physicians1

Health systems and their in-house specialty pharmacies are uniquely positioned to leverage these factors, whether the pharmacy staff is located within specialty clinics or a centralized approach is used. The specialty pharmacy can help deliver a seamless patient experience,reduce the administrative workload on clinics, and collaborate with physicians to develop and refine treatment protocols. Specialty pharmacies also provide comprehensive counseling, follow-up, and intervention that can improve patient outcomes.

Specialty Pharmacy Integration in the Care Process
Specialty pharmacy integration relies on communication among providers and the inclusion of pharmacists and other pharmacy staff on the care team. In an integrated system, the pharmacist—often board-certified and residency-trained—has access to the EMR and the ability to review diagnoses, lab results, discharge notes, and other information.

The pharmacist can recommend treatment and document interventions in the EMR, so that the physician and other providers can stay up-to-date without relying on the patient to communicate information accurately. Under ideal circumstances, the pharmacist and pharmacy technicians are embedded in the process.

Vanderbilt University Medical Center (VUMC) has been a pioneer in embedding pharmacy staff inside specialty clinics. Currently, Vanderbilt Specialty Pharmacy (VSP) has 26 pharmacists rooted in 20 specialty clinics across the enterprise.

“We feel that the hands-on, team-based approach to specialty pharmacy care within the clinic is providing a superior service, patent experience, and outcomes, and allowing us to really leverage our position as an integrated delivery network,” said Jerry Buller, DPh, director of specialty pharmacy services at VUMC.

The clinic-based Vanderbilt pharmacy team conducts specialty benefits investigations, obtains prior authorizations (PAs), and handles any manufacturer-funded co-pay assistance upstream in the clinic. They also work with providers to draft appeals and letters of medical necessity.

“The fact that clinical pharmacists are steps away from the physician and communicating instantly within their EMR ensures patient care issues can be addressed real time,” Buller said. “We bring the clinic to the patient.”

According to Buller, 60% to 65% of patients typically are qualified to use VSP, and most choose to have the pharmacy fill their medications. For patients whose insurance requires them to use an outside specialty pharmacy, Vanderbilt still performs initial assessments, patient education, and injection training, and obtains the PA in an effort to increase the speed to therapy.

Even patients who are required to use an outside specialty pharmacy receive the benefit fostered by this clinic-based model. These patients experience a significantly reduced time to therapy compared with that experienced at a typical outside specialty pharmacy. VSP’s average time to process a clean claim is 1.01 days, according to Buller.

Clinical metrics are also bolstered by Vanderbilt’s in-house pharmacy model, as shown in patients receiving hepatitis C virus (HCV) therapy. A recent poster presented at last year’s National Association of Specialty Pharmacy annual meeting2 demonstrated that every HCV patient referred to VSP was able to start therapy. Additionally, a statistically significant number of those patients completed their entire course of HCV therapy compared with an outside pharmacy (97% vs 93%; P = .02).

Issues that Arise in Traditional or Coordinated Care Processes
Clinically integrated care, such as Vanderbilt’s, stands in contrast to traditional, or coordinated, care. In a traditional care process, patients receive their specialty medications from a pharmacy that is not linked to their hospital or clinic. Reimbursement assistance, adverse effect (AE) management protocols, and patient education are fragmented or lacking, so that patients fall between the cracks of the system, sometimes failing to begin therapy and rarely being adequately monitored.

Although an individual patient may have a good experience if there is a close relationship between the prescriber, the pharmacist, and the patient, all parties must perform their due diligence. The payer must be willing to authorize a charge and the patient must be able to afford the medication; however, traditional care is still fraught with obstacles for most specialty patients. The lack of integration in the traditional care process is compounded, as manufacturers limit distribution of new specialty pharmaceuticals.

In a coordinated care process, pharmacies with extensive specialty business, such as large mail order pharmacies, provide more comprehensive services. Depending on the pharmacy, reimbursement specialists, patient care coordinators, and pharmacists provide PA assistance, standardized case management, patient education, ongoing monitoring, and other support.

However, much of the administrative burden still falls on physicians to provide letters of medical necessity and other paperwork, and pharmacists must rely on patient-reported information because they do not have access to the EMR. Abandonment of therapy is often not reported to the physician.

Implementing Specialty Pharmacy Integration
Simply having an in-house specialty pharmacy, of course, does not guarantee clinical integration within a health system. Establishing workflow and building trust can be a slow process. Clinics may already be receiving competent, coordinated support from outside specialty pharmacies, but it is impossible for this type of support to be fully clinically integrated and collaborative.

An outside pharmacy cannot match the advantage of a shared EMR for clinicians and local convenience for patients. A single point of referral also makes staff workflows more efficient.

In conversations with clinics, questions about what the specialty clinic is struggling with can uncover the most urgent integration needs. If PAs and other administrative tasks are burdensome, as they often are, the pharmacy can offer a staff member to take on these tasks, perhaps operating as an on-site liaison. These staffers can also advise patients on the value of using the in-house pharmacy, if a patient’s insurance allows it.

Taking on the task of follow-up phone calls is also a common way to increase integration; formally instituting a therapy management protocol for each specialty is a best practice. The clinic and pharmacy work together to develop protocols and improve them over time. Specific steps and staff vary, but typically, a specialty pharmacist counsels patients before or upon initiation of therapy and a pharmacist or nurse follows up at defined intervals. Patients build rapport with their care team, facilitating proactive problem solving that may prevent therapy abandonment and hospitalizations.

At Fairview Health Services, all specialty clinics have been integrated with Fairview’s specialty pharmacy. In the oral oncology program, for example, pharmacists who specialize in oncology medicines monitor patients’ lab values to ensure they are in the normal range, determine whether drug therapy is appropriate, help manage AEs, and adjust the dosage of the oncology drug or other medications, if needed. For example, an elderly diabetic patient was taking the oral chemotherapy drug palbociclib (Ibrance) to treat metastatic breast cancer.

The therapy management program meant that the pharmacist was aware the patient was taking metformin for her diabetes. With access to the patient’s labs, the pharmacist noticed that the patient’s creatinine level had risen precipitously over the course of 7 days, indicating severe renal impairment.

The oncologist was informed immediately and a decision was made to hold the metformin. The patient was given intravenous fluids, her primary care provider was informed, and the metformin was stopped permanently. Communicating stories like this is helpful in expanding specialty pharmacy integration to more clinics within the health system.

While having high-level buy-in at the senior level, such as the medical director, can be useful, it is usually more effective to work directly with the providers at the clinic. Along with sharing individual stories, sharing metrics is also important, and if these metrics can be communicated by providers, all the better.

If the persistency rate has increased at the cystic fibrosis clinic as a result of therapy management, those physicians might be enlisted to contact doctors at the rheumatology clinic to discuss the improvement, along with other benefits, of greater integration.

Reducing waste while improving the odds of successful treatment is also a persuasive point for clinicians. When counseling occurs before initiation of therapy, the pharmacy can uncover factors that might call for a delay. This could be as simple as waiting until after a patient’s upcoming vacation or as challenging as addressing mental health issues. Either of these factors could cause interruptions in therapy that would not only have a clinical impact, but would result in the waste of thousands of dollars of medication.

Fairview’s HCV patient onboarding process considers short-term concerns such as surgery, vacation, moving, and changing jobs or insurance. Also considered are factors such as confusion or cognitive impairment, previous history of nonadherence, and missing appointments, as noted in the medical record. The onboarding process team includes a patient financial advocate, a specialty care coordinator, and an HCV-trained clinical pharmacist.

Some nursing staff and physician assistants may be skeptical of integration initiatives, but the benefits become clear when integration provides them with more time for hands-on patient care, frees them from administrative burdens, improves medication adherence and AE management, and enhances the overall patient experience.

Conclusion
A specialty pharmacy that operates in a bubble within the health system is not reaching its full potential. The pharmacy needs to become fully integrated with the health system and its specialty clinicians to compete in the marketplace and benefit from optimal patient outcomes and operational efficiencies. Clinical integration is important and achievable in this era of health care disruption and transformation. 




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