Adherence and discontinuation of prescription cannabidiol for the management of seizure disorders at an integrated care center.

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). Patients were included in the PDC analysis if they had at least 3 fills during the study period. Non-adherence was defined as a PDC < 0.8. Descriptive statistics were used to summarize data with categorical variables represented as frequencies and percentages and continuous variables as medians and interquartile ranges (IQRs). RESULTS: We included 136 patients with a median age of 14 years (IQR 9 - 21). Most patients were white (n = 115, 85%), with a diagnosis of intractable epilepsy (n = 100, 74%). Among the 128 patients with 3 or more fills, the median PDC was 0.99 (IQR 0.95 - 1.00) with non-adherence seen in 6% (n = 8) of patients. The most common reason for non-adherence was side effects (n = 2, 25%). Prescription CBD was discontinued by 23% (n = 31) of patients with a median time to discontinuation of 117 days (IQR 68 - 216). The most common reason for discontinuation was major side effects (n = 12, 39%). The most common side effects leading to discontinuation were agitation/irritability (n = 4), mood changes (n = 4), aggressive behavior (n = 3), and increased seizure frequency (n = 3). CONCLUSION: Adherence to prescription CBD at an integrated care center was high with approximately 94% of patients considered adherent. Providers and pharmacists may improve adherence and discontinuation rates by educating patients on the timeline of response, potential side effects, and potential for dose adjustments.

Therapy outcomes associated with prescription cannabidiol use at 12 months post-initiation.

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. Secondary outcomes included prescription CBD discontinuation rate and reason and concomitant anti-seizure medication (ASM) use. A multiple logistic regression model evaluated the odds of EHS use, adjusting for initial concomitant ASM count, age, and insurance type. RESULTS: The 136 patients included were 85% white, 50% female, and 68% pediatric. EHS utilization occurred in 37% (n = 50) of patients; 29 patients (21%, n = 20 pediatric, n = 9 adult) had at least one emergency department (ED) visit, 9 patients (7%) had two or more; 30 patients (22%, n = 22 pediatric, n = 8 adult) had at least one hospitalizaion. Median time to first ED and hospitalization was 69 (IQR 31-196) and 104 (IQR 38-179) days, respectively. Prescription CBD was discontinued in 31 patients (23%, n = 18 pediatric, n = 13 adult), due to major side effects (n = 12, 39%), common side effects (n = 11, 36%), and unsatisfactory response (n = 11, 36%). There was no significant change in concomitant ASM use. CONCLUSION: Despite potential benefits of prescription CBD, many patients utilize EHSs in the first 12 months of treatment with minimal changes in concomitant ASM use.

Insurance Approval Delay of Biologic Therapy Dose Escalation Associated with Disease Activity in Patients with Inflammatory Bowel Disease.

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. AIMS: This study measured time from decision to dose escalate to insurance approval and evaluated impact of approval time on disease activity. METHODS: This was a single-center retrospective analysis of adult patients with IBD prescribed an escalated dose of biologic therapy at an academic center with an integrated specialty pharmacy team from January to December 2018. Outcomes included time to insurance approval and the association between approval time and follow-up C-reactive protein (CRP) and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores. Associations were tested using linear regression analyses. RESULTS: 220 patients were included, median age 39, 53% female, and 96% white. Overall median time from decision to dose escalate to insurance approval was 7 days [interquartile range (IQR) 1, 14]. Approval time was delayed when an appeal was required [median of 29 days (IQR 17, 43)]. Patients with a longer time to insurance approval were less likely to have CRP improvement (p = 0.019). Time to insurance approval did not significantly impact follow-up SIBDQ scores. CONCLUSION: Patients who had a longer time to insurance approval were less likely to have improvement in CRP, highlighting the negative clinical impact of a complex dose escalation process.

Specialty pharmacy integration and the role of an advanced certified pharmacy technician in prescription cannabidiol access.

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. METHODS: This was a single-center, retrospective analysis of patients prescribed CBD from January 2019 to April 2020 by the outpatient neurology clinic and dispensed by the center's IHSSP. The primary outcome was the time to prescription CBD access, defined as days between the specialty pharmacy completing an initial patient assessment and first medication shipment. Secondary outcomes were percentage of patients requiring financial assistance and days between key steps in the access pathway. Data were collected from electronic health records and the specialty pharmacy patient management database. The CPhT was responsible for completing most portions of the access pathway under supervision of the clinical pharmacist. RESULTS: After screening, 136 patients were included: 50% male, 85% white, 60% insured by Medicaid, and median age 14 years (interquartile range [IQR] 9-21). The most common indication was Lennox-Gastaut syndrome (n = 117, 86%). Of the 129 patients (95%) who required a prior authorization (PA), 92% were approved (n = 119). Median time from initial assessment to first shipment was 7 days (IQR 4-13). Of patients for whom the CPhT helped obtain financial assistance (n = 14, 10%), all had $0 costs after assistance. Median times for secondary outcomes led by the CPhT in days were as follows: initial assessment completion to benefits investigation (BI) = 0 (IQR 0-0), BI to PA submission = 0 (IQR 0-0), and PA denial to appeal submission = 4 (IQR 1-7). CONCLUSION: IHSSP teams, particularly advanced CPhT roles, helped patients afford and initiate prescription CBD quickly.

Droxidopa management by an integrated health-system specialty pharmacy team.

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. PRACTICE INNOVATION: In May 2017, the integrated HSSP developed droxidopa management services. Based on clinic-identified needs, the specialty pharmacy team completed droxidopa access requirements (insurance approval and affordability), provided comprehensive medication education at droxidopa initiation, and developed and executed droxidopa titration and monitoring plans in collaboration with providers. While patients were on droxidopa therapy, specialty pharmacist staff (pharmacists and technicians) monitored patients for safety and response to therapy and communicated with the health care team through the shared electronic health record. EVALUATION METHODS: We performed a retrospective cohort analysis of adult patients with at least 3 fills of droxidopa using the integrated specialty pharmacy services from May 2017 to April 2020. Outcomes included persistence (defined as lack of 60-day gap in treatment), adherence (calculated using pharmacy claims and proportion of days covered [PDC]), and number and type of pharmacist interventions after droxidopa initiation. RESULTS: Of the 83 patients reviewed, 60 patients (72%) were persistent on droxidopa therapy over the study period. The median PDC was 0.98 (interquartile range 0.90-1.00). Over 36 months, the specialty pharmacist performed 60 interventions after droxidopa initiation, most related to dose changes, drug-drug interaction management, and medication reconciliation. CONCLUSION: The development of integrated specialty pharmacy services for patients prescribed droxidopa resulted in high droxidopa persistence and adherence. Interventions from the specialty pharmacist ensured droxidopa remained safe and appropriate for patients.

Prescription cannabidiol for seizure disorder management: Initial drug-drug interaction management by specialty pharmacists.

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. The primary outcomes were the numbers, types, and management of DDIs identified at the time of CBD prescribing. RESULTS: Of the 136 patients included, 109 (80%) had a DDI identified at baseline. Of the 260 DDIs, 71% (n = 184) were pharmacodynamic and 29% (n = 76) were pharmacokinetic in nature. Management of the 260 DDIs detected included counseling only (89% [n = 232 interactions]), discontinuation of the interacting agent [9% (n = 22 interactions]), and dosage change for the interacting agent [2% (n = 6 interactions]). Clobazam was the most commonly identified interacting medication (n = 63, 24%), while valproic acid accounted for 10% (n = 26) of the DDIs. The population was predominantly white (n = 115, 85%), 18 years of age or younger (n = 92, 68%), and had an indication for prescription CBD treatment of Lennox-Gastaut syndrome (n = 117, 86%). CONCLUSION: This study provides new information on the role that integrated specialty pharmacists can play in identifying and managing initial DDIs in patients starting prescription CBD.

A cross-sectional analysis of persistence to disease-modifying therapies in treatment naïve and experienced patients with relapsing multiple sclerosis at a health-system specialty pharmacy.

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. This study evaluated long-term DMT persistence, rates and reasons for DMT discontinuation or switch, specialty pharmacist involvement in DMT treatment transitions, and predictors associated with non-persistence in treatment naïve and experienced patients. METHODS: We performed a single-center retrospective, cross-sectional review of patients with RMS and ≥3 fills of DMT from a health-system specialty pharmacy (May-October 2017). Patients were followed for 3 years to determine DMT persistence, defined as the time a patient remained on index DMT. Descriptive statistics were used to summarize sample characteristics and outcomes. The Kaplan-Meier estimation method was used to estimate the probability of remaining persistent and we used the Cox proportional hazards regression model to analyze the primary outcome. Rates and reasons for DMT discontinuation were identified via pharmacy claims and confirmed via chart review of the electronic health record. RESULTS: The study included 540 patients, of which 41 (7.6%) were treatment naïve. Over 3 years, 193 (36%) patients remained on index DMT. The probability of remaining persistent for 3 years was 0.51 (95% confidence interval [CI] 0.47-0.56) and median time on index DMT was 642 days (interquartile range 317-1096). For the 347 patients that did not continue index DMT: 91 (26%) discontinued, 136 (39%) switched to a new DMT, 92 (27%) transferred care to a new specialty pharmacy or provider, 21 (6%) were lost to follow-up, and 7 (2%) died. Common reasons for DMT discontinuation or switch were insurance formulary change, side effects, clinical decline, and stable disease. Specialty pharmacists initiated 6 (7%) DMT discontinuations and 49 (36%) DMT switches. A strong non-linear relationship existed between age and risk of non-persistence (p = 0.003). Patients on an injectable index DMT were 1.5 times more likely to be non-persistent than those on an oral DMT (95% CI 1.1-2.1, p = 0.012) and patients with non-commercial insurance were 1.4 times more likely to be non-persistent (95% CI 1.02-2.0, p = 0.040). CONCLUSIONS: Long-term persistence to DMTs is low, with many patients switching or discontinuing DMT treatment. Specialty pharmacists identify the need for DMT discontinuation or switch and are uniquely positioned to assist during therapy transitions.

Primary medication nonadherence to oral oncology specialty medications.

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. OBJECTIVES: The objectives of this study were to compute the rates of and reasons for PMN in patients prescribed oral oncology medications at an integrated health-system specialty pharmacy (IHSSP). METHODS: We performed a single-center, retrospective analysis of specialty oncology prescriptions electronically prescribed between January and December 2018. Data were extracted from electronic health record (EHR) and pharmacy claims databases. Prescriptions were PMN eligible if none of the following were met: fill of any cancer medication within the previous 180-day lookback window, duplicate prescription, cancellation within 30 days, rerouting to an external pharmacy within 30 days of prescribing, filled through alternate method, or nononcology or hematology condition. PMN was calculated by dividing eligible prescriptions unfilled during the study period by all eligible prescriptions. Reasons for a lack of prescription fulfillment were assessed via EHR review. Data were analyzed using descriptive statistics. RESULTS: We evaluated 4482 prescriptions from 1422 patients, resulting in 861 PMN-eligible prescriptions. Most PMN-eligible prescriptions (n = 668, 78%) were filled within 30 days, leaving 193 prescriptions as potential instances of PMN. After EHR review, 158 prescriptions met the exclusion criteria, resulting in a PMN rate of 4%. Of PMN prescriptions (n = 35), most were caused by clinical reasons (n = 22, 63%); however, 10 prescriptions were unfilled owing to patient decision, 2 owing to unaffordable treatment, and 1 owing to inability to reach the patient. Patients with PMN had a median age of 72 years and were mostly male (60%), with a median Charlson comorbidity index score of 7. CONCLUSION: Low rates of PMN to prescribed anticancer medications were found among electronic prescriptions intended to be filled at an IHSSP.

Primary medication nonadherence calculation method specifications impact resulting rates.

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. Patients receiving a new electronic specialty oncology prescription January-December 2018 were included; excluded if re-routed to an external pharmacy within 2 days, fell within a DW, or cancelled within a FW. Twenty-four methods were used to calculate PMN based on combinations of the following parameters: (i) absence of prior specialty self-administered oncology medication fill within LBW (90, 180 days); (ii) absence of a duplicate prescription within DW (2, 7, 30 days); and (iii) sold status within FW (14, 30, 60, 90 days). For each method, PMN was calculated as the number of unsold prescriptions within the FW divided by all eligible prescriptions. RESULTS: We evaluated 4,482 prescriptions, resulting in PMN ranging from 16% to 23%. Patients were commonly male (53%) and white (83%), with a median age of 64 years (interquartile range, IQR, 54, 72). Increasing the LBW from 90 to 180 days resulted in exclusion of 72 (2%) prescriptions and minimally impacted PMN rates. Most duplicate prescriptions (87%) occurred within two days of original prescription and PMN rates were minimally affected by DW. Most fulfilled prescriptions were filled within FW 30 days, 98% with a method of LBW 180, DW 2, and FW 30. Adjusting the FW consistently impacted PMN rates. CONCLUSIONS: Because various PMN definitions can significantly impact results, a thorough explanation of all parameter specifications should be reported in research using PMN.

Specialty pharmacist integration into an outpatient neurology clinic improves pimavanserin access.

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. Additionally, we describe a pharmacist-led monitoring program. METHODS: This was a single-center, retrospective study of adults prescribed pimavanserin by the neurology clinic from June 2016 to June 2018. Patients receiving pimavanserin externally or through clinical trials were excluded. Pre- (June 2016 to December 2016) and post-SP integration (January 2017 to June 2018) periods were assessed. Proportional odds logistic regression was performed to test association of approval time with patient characteristics (age, gender, insurance type) postintegration. Interventions were categorized as clinical care, care coordination, management of adverse event, or adherence. RESULTS: We included 94 patients (32 preintegration, 62 postintegration), 80% male (n = 75) and 96% white (n = 90) with a mean age of 73 years. Median time to approval was 22 days preintegration and 3 days postintegration. Higher rates of approval (81% vs 95%) and initiation (78% vs 94%) were observed postintegration. Proportional odds logistic regression suggested patients with commercial insurance were likely to have longer time to approval compared with patients with Medicare/Medicaid (odds ratio 7.1; 95% confidence interval: 1.9, 26.7; P = .004). Most interventions were clinical (51%, n = 47) or care coordination (42%, n = 39). CONCLUSION: Median time to approval decreased postintegration. The SP performed valuable monitoring and interventions.

Development, implementation, and evaluation of a health outcomes and research program at an integrated health-system specialty pharmacy.

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. The purpose of this descriptive report is to describe the development and results of this program. SUMMARY: The health outcomes and research program began as an initiative for pharmacists to evaluate and convey the benefits they provide to patients, providers, and the health system. Early outcomes data proved useful in communicating the value of an integrated model to key stakeholders and highlighted the need to further develop research efforts. The department leadership invested resources to build a research program with dedicated personnel, engaged research experts to train pharmacists, and fostered internal and external collaborations to facilitate research efforts. As of March 2021, the health outcomes and research program team has published 33 peer-reviewed manuscripts, presented 88 posters and 7 podium presentations at national conferences, and received 4 monetary research awards. Further, the program team engages other HSSP teams to initiate and expand their own health outcomes research in an effort to empower all HSSPs in demonstrating their value. CONCLUSIONS: The health outcomes and research program described has pioneered outcomes research among HSSPs nationwide and has proven valuable to specialty pharmacists, the health system, and key specialty pharmacy stakeholders.

Tofacitinib Adherence and Outcomes in Refractory Inflammatory Bowel Disease.

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. Adherence was measured by proportion of days covered. Results: Sixty-three patients were identified. All patients failed at least one prior biologic therapy. Mean proportion of days covered was 95.7% for ulcerative colitis and 93.1% for Crohn's disease. Significant clinical and endoscopic response was seen. Conclusion: Adherence was high in a cohort with highly refractory disease.

Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.

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. METHODS: This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients' electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum. DISCUSSION: This trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent. REGISTRATION: The trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on 17 October 2018.

Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.

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. METHODS: This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients' electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum. DISCUSSION: This trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent. REGISTRATION: The trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on 17 October 2018.

Development of a quality measures tool for the utilization of tyrosine kinase inhibitors in non-small cell lung cancer: An integrated specialty pharmacy initiative.

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. PURPOSE: The purpose of this initiative was to develop a tool to assess quality in the utilization of tyrosine kinase inhibitors in non-small cell lung cancer by engaging multiple key stakeholder perspectives to identify the fundamental elements of high-quality clinical and specialty pharmacy care. SUMMARY: Quality measures for the utilization of tyrosine kinase inhibitors in non-small cell lung cancer were developed by conducting package insert, guideline, and literature review followed by integrating feedback from key stakeholder groups through individual conversations and a structured assessment. The finalized guide assesses safety, efficacy, persistence, and patient-reported outcomes using defined clinical and specialty pharmacy measures. Most stakeholders agreed that the proposed measures were relevant as well as accurate and expressed support for implementation. CONCLUSIONS: The proposed tool provides a framework for specialty pharmacies to deliver quality care in the use of tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. Further work is needed to implement and validate this tool.

Risk Factors for Medication Nonadherence to Self-Injectable Biologic Therapy in Adult Patients With Inflammatory Bowel Disease.

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. Adherence was defined using medication possession ratio (MPR). Nonadherence was defined as MPR <0.86. RESULTS: Four hundred sixty patients (n = 393 with CD and n = 67 with UC) were evaluated with mean MPR (interquartile range) equaling 0.89 (0.48-1). Overall, 69% of patients were adherent (defined as MPR ≥0.86), 66% of patients with CD and 87% of patients with UC. In univariate analysis, several factors increased risk of nonadherence: CD diagnosis, insurance type, psychiatric history, smoking, prior biologic use, and narcotic use (P < 0.05). In multivariable analysis, Medicaid insurance (odds ratio [OR], 5.5; 95% confidence interval [CI], 1.85-15.6) and CD diagnosis (OR, 2.8; 95% CI, 1.3-6.0) increased risk of nonadherence. In CD, as the number of risk factors increased (narcotic use, psychiatric history, prior biologic use, and smoking), the probability of nonadherence increased. Adherence was 72% in patients with 0-1 risk factors, decreasing to 62%, 61%, and 42% in patients with 2, 3, and 4 risk factors, respectively (P < 0.05). CONCLUSIONS: This study identified risk factors for nonadherence to biologic therapy. In patients with CD, the probability of nonadherence increased as the number of risk factors increased.

Development of quality measures for use of self-injectable biologic therapy in inflammatory bowel disease: An integrated specialty pharmacy initiative.

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). The specialty pharmacy measures can be used to assess medication adherence, medication persistence, specialty pharmacy accreditation, and patient satisfaction. The proposed quality measures provide a foundation for evaluating the quality of IBD care and improving patient outcomes within a health-system specialty pharmacy. Future efforts to validate and implement the tool in clinical practice are planned. CONCLUSION: The proposed quality measures provide a foundation for future inquiry regarding the appropriateness and feasibility of integrating the measures into clinical care. Further work is needed to implement and validate these quality measures and determine their impact in optimizing health outcomes.

High rates of medication adherence in patients with pulmonary arterial hypertension: An integrated specialty pharmacy approach.

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. The primary objective of this study was to assess medication adherence to PDE-5I therapy within an integrated care model at an academic institution. The secondary objective was to assess the impact of out-of-pocket (OOP) cost, frequency of dosing, adverse events (AE) and PAH-related hospitalizations on medication adherence. We performed a retrospective cohort analysis of adult patients with PAH who were prescribed PDE-5I therapy by the center's outpatient pulmonary clinic and who received medication management through the center's specialty pharmacy. We defined optimal medication adherence as proportion of days covered (PDC) ≥ 80%. Clinical data including AEs and PAH-related hospitalizations were extracted from the electronic medical record, and financial data from pharmacy claims. Of the 131 patients meeting inclusion criteria, 94% achieved optimal adherence of ≥ 80% PDC. In this study population, 47% of patients experienced an AE and 27% had at least one hospitalization. The median monthly OOP cost was $0.62. Patients with PDC<80% were more likely to report an AE compared to patients with PDC≥ 80% (p = 0.002). Hospitalization, OOP cost, and frequency of dosing were not associated with adherence in this cohort. Patients receiving PDE-5I therapy through an integrated model achieved high adherence rates and low OOP costs.

Ventral Tegmental Dopamine Neurons Participate in Reward Identity Predictions.

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. Alternatively, RPEs might promote learning about the sensory features (the identity) of the rewarding outcome. Here, we show that, although both VTA and SNc DA neuron activation reinforces instrumental responding, only VTA DA neuron activation during consumption of expected sucrose reward restores error-driven learning and promotes formation of a new cue→sucrose association. Critically, expression of VTA DA-dependent Pavlovian associations is abolished following sucrose devaluation, a signature of identity-based learning. These findings reveal that activation of VTA- or SNc-DA neurons engages largely dissociable learning processes with VTA-DA neurons capable of participating in outcome-specific predictive learning, and the role of SNc-DA neurons appears limited to reinforcement of instrumental responses.