Publications by authors named "Nisha B Shah"

Objective: Evaluate adherence, discontinuation rates, and reasons for non-adherence and discontinuation of prescription CBD during the 12-months post-initiation period at an integrated care center.

Methods: This was a prospective study of patients prescribed CBD by a neurology clinic provider with initial prescription fulfillment through the center's specialty pharmacy from January 2019 through April 2020. Baseline demographics and reasons for non-adherence and/or discontinuation were collected from the electronic health record and pharmacy claims history was used to calculate adherence using proportion of days covered (PDC).

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Background: Dose escalation of self-injectable biologic therapy for inflammatory bowel diseases may be required to counteract loss of response and/or low drug levels. Payors often require completion of a prior authorization (PA), which is a complex approval pathway before providing coverage. If the initial PA request is denied, clinic staff must complete a time and resource-intensive process to obtain medication approval.

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Objective: This study evaluated prescription cannabidiol (CBD) outcomes during the first 12 months of therapy.

Methods: A single-center, prospective cohort study was performed including patients prescribed CBD from January 2019 - April 2020, excluding clinical trial patients and those using external specialty pharmacy services. The primary outcome wasepilepsy-related emergency healthcare service (EHS) use within 12 months of initation.

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Article Synopsis
  • The study evaluated how well patients with inflammatory bowel disease (IBD) adhered to biologic therapy and examined the factors affecting their adherence at academic centers with integrated specialty pharmacies.
  • Researchers analyzed data from 608 patients aged ≥18, measuring medication possession ratio (MPR) and the impact of factors like smoking, narcotic use, and psychiatric history on adherence.
  • Results showed high adherence rates (68%-70%), but more risk factors increased the likelihood of nonadherence, which was linked to a higher risk of emergency department visits and hospitalizations.
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Background: Insurance requirements that limit access to prescription cannabidiol (CBD), an adjunct therapy for uncontrolled seizure disorders, may lead to treatment initiation delays. Integrated health-system specialty pharmacies (IHSSPs) use pharmacists and advance certified pharmacy technicians (CPhTs) to help navigate prescription CBD access requirements.

Objective(s): Evaluate time from initial specialty pharmacy referral to prescription CBD shipment.

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Background: Droxidopa, indicated for the treatment of symptomatic neurogenic orthostatic hypotension, can be challenging for patients to access owing to manufacturer and payer restrictions, and requires close monitoring to ensure safety and effectiveness.

Objective: This practice report describes the development and outcomes of an integrated neurology specialty pharmacy team for droxidopa management.

Practice Description: An integrated health-system specialty pharmacy (HSSP) connected to an academic institution with integrated specialty pharmacists working in collaboration with the providers in both the neurology and autonomic disfunction clinic.

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Purpose: To describe the presence, type, and management of drug-drug interactions (DDIs) at prescription cannabidiol (CBD) therapy initiation.

Methods: We conducted a single-center, retrospective study of patients prescribed CBD from a medical center's neurology clinic for seizure management from January 2019 through April 2020. Patients were excluded if they were enrolled in a CBD clinical trial or the insurance approval or medication fulfillment process was not completed by the center's specialty pharmacy.

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Background: Patients with relapsing multiple sclerosis (RMS) are maintained on disease-modifying therapy (DMT) to prevent disease progression. Reported persistence rates to DMTs are varied and concerningly low. Limited data exists on long-term persistence rates and reasons for DMT discontinuation in patients with RMS.

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Background: Patients prescribed specialty oncology medications face logistical and financial challenges to medication procurement, leading to primary medication nonadherence (PMN). Limited research has evaluated rates and reasons for PMN within a specialty oncology population. Addressing PMN is essential to ensuring patient access and uptake and realizing benefits of these therapies.

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Background: Tofacitinib has been approved for moderate-to-severe ulcerative colitis and studied in Crohn's disease. Understanding medication adherence to oral medications in severe disease is essential.

Methods: We retrospectively reviewed adherence and real-world outcomes of inflammatory bowel disease patients who initiated tofacitinib at a single care center.

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Introduction: Access to pimavanserin, the only Parkinson disease-related psychosis treatment approved by the FDA, is restricted by insurance requirements, a limited distribution network, and high costs. Following initiation, patients require monitoring for safety and effectiveness. The primary objective of this study was to evaluate impact of specialty pharmacist (SP) integration on time to insurance approval.

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Background: Previous literature has illustrated a wide range of primary medication nonadherence (PMN) rates due to inconsistent calculation methods and parameters, but the impact of parameter specifications on PMN rates has not been assessed.

Objectives: The objective of this study was to evaluate the impact of lookback window (LBW), duplicate window (DW), and fill window (FW) specifications on PMN rates in patients prescribed specialty self-administered oncology medications.

Methods: This was a single-center, retrospective cohort analysis.

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Purpose: Health-system specialty pharmacies (HSSPs) provide high-quality, efficient, and collaborative care to patients receiving specialty therapy. Despite proven benefits of the integrated model, manufacturer and payer restrictions challenge the viability and utility of HSSPs. Vanderbilt Specialty Pharmacy developed a health outcomes and research program to measure and communicate the value of this model, drive improvement in patient care delivery, and advocate for recognition of HSSP pharmacists' role in patient care.

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Background: The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence.

Objective: This study aims to determine whether pharmacist interventions improve specialty medication adherence.

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Background: The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence.

Objective: This study aims to determine whether pharmacist interventions improve specialty medication adherence.

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Background: Tyrosine kinase inhibitors, commonly prescribed for non-small cell lung cancer, are efficacious but pose safety risks that can diminish quality of life. Quality measures to ensure appropriate utilization and monitoring of tyrosine kinase inhibitors are needed to reduce unnecessary healthcare costs and maximize therapeutic benefit. With integrated clinical and pharmaceutical care services, a health-system specialty pharmacy is the ideal setting for quality measures development.

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Background: In inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), nonadherence to biologic therapy increases risk of disease flare. The aim of this study was to identify risk factors for nonadherence.

Methods: This was a single-center retrospective study evaluating patients with IBD treated at a tertiary care center and prescribed self-injectable biologic therapy using the center's specialty pharmacy.

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Purpose: The development of a tool to measure medication safety, therapeutic efficacy, and other quality outcomes in patients receiving self-injectable biologic therapy for the management of inflammatory bowel disease (IBD) at a health-system specialty pharmacy is described.

Summary: Through a collaborative initiative by pharmacists, gastro-enterologists, and representatives of a pharmacy benefit manager and a pharmaceutical company, a set of clinical and specialty pharmacy quality measures was developed. The clinical measures are intended for use in assessing patient safety, disease status, treatment efficacy, and healthcare resource utilization during 3 assessments (pre-treatment, on-treatment, and longitudinal).

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Phosphodiesterase-5 inhibitors (PDE-5I) have demonstrated improvement in disease symptoms and quality of life for patients with pulmonary arterial hypertension (PAH). Despite these benefits, reported adherence to PDE-5I therapy is sub-optimal. Clinical pharmacists at an integrated practice site are in a unique position to mitigate barriers related to PAH therapy including medication adherence and costs.

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Dopamine (DA) neurons in the ventral tegmental area (VTA) and substantia nigra (SNc) encode reward prediction errors (RPEs) and are proposed to mediate error-driven learning. However, the learning strategy engaged by DA-RPEs remains controversial. RPEs might imbue predictive cues with pure value, independently of representations of their associated outcome.

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