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

Specialty Pharmacy TimesJuly/August
Volume 10
Issue 5

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

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—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.1 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 $700,000.2 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. J Manag Care Pharm. 2013;19(1):26-41. doi: 10.18553/jmcp.2013.19.1.26.
  • Super spending U.S. trends in high cost medication use. Express Scripts website. file:///D:/Express%20Scripts%20Super%20Spending%20Report%20October%202017.pdf. Accessed May 12, 2019.

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