Denosumab treatment lapses, discontinuation, and off-treatment fracture risk: A retrospective study of patients with osteoporosis in a real-world clinical setting.

INTRODUCTION: The purpose of this study was to retrospectively examine predictors of fracture risk when adult patients experienced a denosumab treatment lapse or discontinuation in a real-world clinic setting. MATERIALS AND METHODS: Eligible patients were adults who had received ≥2 doses of denosumab at an academic health center in the United States. Demographics, treatment doses, reasons for missed doses, and fractures, were collected retrospectively from electronic health records, from an 8-year period (2010-2018). The number of times each patient incurred a treatment lapse, defined as ≥240 days between two doses (excluding lapse due to discontinuation, death, or transfer of care) was computed. The occurrence of denosumab discontinuation (excluding discontinuation due to death or transfer of care), whether the patient initiated alternative therapy, and the reason for each lapse and discontinuation were collected. Cox proportional hazards models assessed characteristics associated with risk of fracture and treatment discontinuation. A logistic regression model was used to determine if cumulative amount of time off medication (i.e., cumulative lapse time) was associated with a higher likelihood of incurring a fracture. RESULTS: We included 534 patients: 95 % White, 86 % women, 33 % tobacco users, 13 % diagnosed with diabetes, median age 69 years (Interquartile Range (IQR): 62-77), and median Body Mass Index (BMI) 25 kg/m2 (IQR: 22-28). Thirty-six percent of patients incurred 250 lapses; 10 % discontinued therapy. Dental problems/procedures and logistical barriers were the most common reasons for lapses and discontinuations. Nineteen percent (n = 103) incurred a total of 190 fractures; of these, 121 were osteoporotic, 50 were vertebral. Risk of any, osteoporotic, and vertebral fractures were associated with off-treatment status (hazard ratio [HR] = 1.7, p = 0.043; HR = 2.0, p = 0.026; and HR = 4.2, p = 0.001, respectively) and older age (HR = 1.3, p = 0.015; HR = 1.5, p = 0.001; and HR = 1.8, p = 0.005, respectively). Older age was associated with higher risk of discontinuation (HR = 1.4, p = 0.022). There was a non-significant trend of a nonlinear association between incurring a fracture and cumulative lapse time (p = 0.087). CONCLUSION: Denosumab treatment lapses are common, and off-treatment status may be associated with a higher risk of fractures. Clinical teams should proactively identify and address adverse effects and potential logistical barriers to reduce the risk of treatment lapses.

Prevalence of fear of hypoglycemia in adults with type 1 diabetes using a newly developed screener and clinician's perspective on its implementation.

INTRODUCTION: Fear of hypoglycemia (FoH) affects quality of life, emotional well-being, and diabetes management among people with type 1 diabetes (PwT1D). American Diabetes Association's (ADA) guidelines recommend assessing FoH in clinical practice. However, existing FoH measures are commonly used in research and not in clinical practice. In this study, prevalence of FoH was assessed in PwT1D using a newly developed FoH screener for clinical practice; its association with established measures and outcomes was also determined. In addition, healthcare providers' (HCPs) perspectives on implementing FoH screener into real-world practice were explored. RESEARCH DESIGN AND METHODS: This multiphase observational study used mixed methods in two phases. First, we collected a cross-sectional survey (including the screener) from PwT1D (≥18 years) from T1D Exchange Quality Improvement Collaborative adult clinics. Pearson correlations and regression analyses were performed on diabetes outcome measures using screener scores. Second, we conducted focus groups among HCPs who treat PwT1D and descriptive analysis to summarize results. RESULTS: We included 553 PwT1D. Participants had a mean±SD age of 38.9±14.2 years and 30% reported a high FoH total score. Regression analyses showed that higher A1c and higher number of comorbidities were significantly associated with high FoH (p<0.001). High FoH worry and behavior scores were significantly associated with 8-Item Patient Health Questionnaire and 7-Item Generalized Anxiety Disorder Scale scores. Participants with ≥1 severe hypoglycemia event(s) and impaired awareness of hypoglycemia had higher odds of high FoH. Eleven HCPs participated in focus group interviews; they expressed that the FoH screener is clinically necessary and relevant but poses implementation challenges that must be addressed. CONCLUSIONS: Our results demonstrate FoH is common in PwT1D and affects their psychosocial well-being and diabetes management. In alignment with ADA position statement, HCP focus group results emphasize importance of screening for FoH. Implementing this newly developed FoH screener may help HCPs identify FoH in PwT1D.

Assessing Pharmacist Interventions at an Outpatient Renal Transplant Clinic Under a Collaborative Pharmacy Practice Agreement.

Background: Collaborative pharmacist practice agreements (CPPAs) advance the role of pharmacists by granting prescriptive authority without direct oversight from participating physicians. Objective: To assess the quantity of prescriptions authorized by pharmacists and frequency and types of interventions performed under a CPPA in an outpatient renal transplant clinic. Practice description: Clinical pharmacists in the outpatient renal transplant clinic began prescribing medications under a CPPA in March 2017. Practice innovation: Under the CPPA, pharmacists perform interventions to improve medication management. After identifying gaps in medication therapy, pharmacists tracked their interventions to improve patient care. Methods: An ambispective cohort study evaluated the number of prescriptions and interventions performed under a CPPA. Patients with a prescription generated by pharmacists between January 2019 through June 2019 were included. Pharmacists prospectively collected the number and types of interventions performed; the number of pharmacist-generated prescriptions was retrospectively collected. Interventions were categorized into three groups: medical record assessments, medication counseling, and resolution of barriers to medication continuation. Results: Pharmacists under a CPPA placed 5793 prescriptions and performed 3852 interventions for 1233 patients. The most common intervention categories were medical record assessments, medication counseling, and resolution of barriers to medication continuation. Conclusion: Pharmacists within a CPPA performed medical record assessments to identify untreated or under treated health conditions, eliminate duplicate therapy, and monitor narrow therapeutic drugs. Expanding pharmacists' prescriptive authority within the renal transplant clinic is a successful strategy to ensure patients are taking medications correctly and to avoid barriers to medication persistence.

Individual and Community-Level Characteristics and Adherence to Specialty Medications.

Background: Understanding risk factors for nonadherence can help specialty pharmacies optimize resources to prevent nonadherence and inform risk-stratification processes. Objective: To determine which individual and community-level characteristics are associated with nonadherence to specialty medications. Methods: We analyzed a cohort of patients enrolled in a prospective randomized controlled trial having filled a specialty medication at least 4 times in the previous 12 months with a proportion of days (PDC) covered < 0.90. We collected patient age, gender, race, medication administration type, therapy start date, home address, insurance type, and online patient portal status from the electronic health record. An ordinal logistic regression model was used to assess the association of nonadherence with individual and community-level patient characteristics. Results: Most patients were female (68%), white (82%), and held commercial insurance (58%) with a median age of 53 (interquartile range [IQR] 40, 64) years. Patients were mostly from the adult rheumatology (35%), multiple sclerosis (20%) and lipid (17%) clinics. Given a 10-year increase in age, patients had lower odds of having lower PDC (odds ratio [OR] = 0.82, 95% confidence interval [CI] = 0.71-0.94, P = 0.005). Patients on therapy greater than or equal to 1 year had half the odds of having lower PDC relative to patients on therapy less than 1 year (OR = 0.52, CI = 0.35 - 0.75, P < 0.001). No statistically significant associations were found between PDC and gender, race, insurance type, route of administration, clinic type, patient portal status, median income, percent receiving government assistance, or percent with no health insurance. Conclusion: Patients with younger age and shorter duration on treatment may be at-risk for lower adherence. Specialty pharmacies may benefit from targeting adherence interventions to these groups.

Exploring healthcare providers' experiences with specialty medication and limited distribution networks.

Integrated health-system specialty pharmacies (IHSSP) have shown high medication access, adherence, and provider satisfaction. The goal of this study was to explore healthcare providers' experiences with specialty medications distributed via Limited Distribution Networks (LDN) that do not include IHSSPs. We investigated healthcare providers' perceived impact of LDNs on clinic workflow, clinical practice, and patient outcomes. Interviews and focus groups were conducted with fourteen healthcare providers from four outpatient specialty clinics at an academic health system with an IHSSP. Qualitative analysis using an iterative inductive/deductive approach of coded transcripts was used to identify themes. Participants discussed requirements and barriers to communicating with insurance providers, drug manufacturers, and external pharmacies; time and effort required to navigate LDNs and impact on workload and clinic workflow; financial awareness of medication costs and methods for communication about financial information with patients; and advocating for patients to ensure access to necessary therapy and avoid missed doses or treatment lapse. Participants reported barriers to navigating LDNs that can interfere with clinic workflow and patient care. IHSSPs may reduce clinic burden by helping patients access, afford, and remain on therapy.

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.

Access to hepatitis C direct-acting antiviral therapy in hepatitis C-positive donor to hepatitis C-negative recipient solid-organ transplantation in a real-world setting.

BACKGROUND: Emerging data supports expanding the solid organ donor pool with transplantation from hepatitis C virus (HCV)-positive donors into HCV-negative recipients. However, concerns exist regarding the ability to access direct-acting antivirals (DAAs) post-transplant in a real-world setting. METHODS: This single-center, retrospective study evaluated DAA access rates, time to first dose, and patient cost in donor-derived HCV solid-organ transplant recipients utilizing an integrated specialty pharmacy process. RESULTS: Among 91 patients, all accessed DAAs through prescription insurance (97%) or patient assistance programs (3%). Of those who received DAAs through insurance, only 65% received approval on initial insurance submission. Median time from transplant to first dose was 45d [IQR 34-66]. The on-site specialty pharmacy was used by 69% of patients. Copay assistance programs reduced the median monthly patient cost from $1914 [range $7-7536] to $0 [range $0-5]. CONCLUSION: Our findings indicate that access to DAAs in donor-derived HCV post-transplant is achievable and affordable; however, significant added administrative efforts may be required for insurance approval as well as obtaining copay assistance, which is a limited resource.

Integrating pharmacists into a kidney transplant clinic: Developing and implementing a collaborative pharmacy practice agreement.

BACKGROUND: Collaborative pharmacy practice agreements (CPPAs) grant patient care authorities to pharmacists (PharmDs) under a scope of practice without direct physician supervision. OBJECTIVES: The aim of this study was to discuss steps for developing and implementing a CPPA in an outpatient renal transplant clinic and assess changes in physician and nurse burden, integrated pharmacy growth, and patient safety. PRACTICE DESCRIPTION: A CPPA was developed between physicians and pharmacists and implemented into a renal transplant clinic and the integrated pharmacy over the course of several years. PRACTICE INNOVATION: CPPA execution in a post-transplant clinic has not been previously described and is needed to help advance patient care delivery models. EVALUATION METHODS: This single center, retrospective study compared immunosuppressant prescriptions generated by each authorizer type (nurse, physician, pharmacist) across 3 time periods: before pharmacist integration, during CPPA development, and after CPPA implementation. Pharmacy manpower and patient safety concerns post-CPPA implementation were also reviewed. RESULTS: Results show that prescription authorization migrated from either a nurse or physician (57% and 43% respectively) in pre-PharmD period, to mostly by physicians (72%) in PharmD pre-CPPA period, and largely by pharmacists (85%) in PharmD post-CPPA period. Quarterly prescription volume increased (6019 in quarter 3 of 2015 vs. 14,806 in quarter 4 of 2018) and integrated pharmacy staff grew from 8 employees (Pre-PharmD period) to 20 in PharmD post-CPPA period. No safety concerns were reported in any time period. CONCLUSION: CPPAs have the advantage of reducing physician and nurse workload related to prescribing and advancing the role of the pharmacist by utilizing their expertise to take over certain tasks. Lessons learned during the CPPA implementation process include identifying needs, promoting maximal utility of pharmacists, and maintaining optimal communication between the health care team.

Adherence and persistence in patients with rheumatoid arthritis at an integrated health system specialty pharmacy.

BACKGROUND: Disease-modifying anti-rheumatic drugs (DMARDs) improve symptoms and delay progression of rheumatoid arthritis (RA), but adherence is often sub-optimal and many patients change medication (either "switching" to a medication with a different mechanism of action or "cycling" to a medication with the same mechanism of action) during the first year of therapy. Some integrated health-system specialty pharmacies embed pharmacists in clinics to help patients access and adhere to specialty medication. OBJECTIVE: This study assessed DMARD switching, cycling, adherence, and persistence at an outpatient rheumatology clinic with an integrated health-system specialty pharmacy. METHODS: We conducted a retrospective cohort study of adults with RA, naïve to biologic or targeted synthetic DMARDs, who filled ≥ 2 biologic or targeted synthetic DMARD prescriptions within 12 months. Adherence was measured using proportion of days covered (PDC); persistence was computed at 12 months. Univariate analyses compared adherence and persistence between patients with and without a medication change. Ordinal logistic regression examined whether PDC was associated with patient age, gender, race, insurance type, and medication change. RESULTS: We included 772 patients: 79% female/21% male, 89% White/11% non-White, median age 56 years (interquartile range = 48-63). Most patients (84%) did not change medication during the study period, 5% cycled medication one or more times (but did not switch), 9% switched medication one or more times (but did not cycle), and 2% of patients both switched and cycled during the study period. Median PDC of the sample was 0.94 and 73% of patients were persistent. Patients with a medication change had lower PDC than those without (0.89 vs 0.95, P = 0.004), but rate of persistence did not significantly differ between groups (77 vs 72%, P = 0.300). Odds of higher PDC was more likely for men (Odds ratio [OR] = 1.82, 95% confidence interval [CI]: 1.34-2.48, P < 0.001) and less likely for patients who changed medication (OR = 0.65, CI: 0.47-0.91, P = 0.011); age, race, and insurance type were not significant. CONCLUSIONS: Patients with RA demonstrated high medication adherence and persistence, and low rates of switching and cycling. Findings support evidence that integrated health-system specialty pharmacies with clinical pharmacists embedded in outpatient clinics help patients overcome barriers to medication adherence to persist on therapy. DISCLOSURES: This study was funded by Sanofi, Inc. James and J. Choi were employed by Sanofi, Inc., at the time of this study. Peter, Zuckerman, DeClercq, L. Choi, and Tanner, received research funding from Sanofi, Inc., for work on this study. Tanner has also received advisory board/speaker bureau fees from Pfizer, Regeneron, and Sanofi-Aventis. This study was presented as a poster at AMCP Nexus in October 2019 at National Harbor, MD.

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.

Comparison of provider satisfaction with specialty pharmacy services in integrated health-system and external practice models: A multisite survey.

PURPOSE: The purpose of this study is to obtain insight into providers' satisfaction with services offered by health-system integrated specialty pharmacies and to determine whether providers' perceptions of services offered under an integrated model differ from perceptions of external specialty pharmacy services. METHODS: A multi-site, cross-sectional, online survey of specialty clinic healthcare providers at 10 academic health systems with integrated specialty pharmacies was conducted. The questionnaire was developed by members of the Vizient Specialty Pharmacy Outcomes and Benchmarking Workgroup and was pretested at 3 pilot sites prior to dissemination. Prescribers of specialty medications within each institution were identified and sent an email invitation to participate in the study that included a link to the anonymous questionnaire. Respondents were asked to rate their agreement with 10 statements regarding quality of services of integrated and external specialty pharmacies on a 5-point scale (1 = strongly disagree, 5 = strongly agree). An analysis to determine differences in providers' overall satisfaction with the integrated and external specialty pharmacy practice models, as well as differences in satisfaction scores for each of the 10 statements, was performed using paired-samples t tests. RESULTS: The mean (SD) score for overall satisfaction with integrated specialty pharmacies was significantly higher than the score for satisfaction with external specialty pharmacies: 4.72 (0.58) vs 2.97 (1.20); 95% confidence interval, 1.64-1.87; P < 0.001. Provider ratings of the integrated specialty pharmacy model were also higher for all 10 items evaluating the quality of services (P < 0.05 for all comparisons). CONCLUSION: The study results confirm that the health-system integrated specialty pharmacy practice model promotes high rates of provider satisfaction with services and perceived benefits.

Inclusion in limited distribution drug network reduces time to dalfampridine access in patients with multiple sclerosis at a health-system specialty pharmacy.

BACKGROUND: Dalfampridine improves walking speed in patients with multiple sclerosis (MS), but accessing specialty medications such as dalfampridine can be hindered by insurance restrictions, high costs, and limited distribution networks (LDNs) imposed by manufacturers. Some integrated health-systems specialty pharmacies (HSSPs) embed pharmacists in clinics and dispense medications from their internal pharmacies if included within the LDN. OBJECTIVE: To assess access to dalfampridine in patients at an HSSP before and after gaining admission to the LDN. METHODS: This study was conducted at Vanderbilt Specialty Pharmacy (VSP), an integrated HSSP at Vanderbilt University Medical Center (VUMC) with 2 clinical pharmacists embedded in the MS clinic. VSP gained access to the dalfampridine LDN on May 1, 2018, at which time the embedded pharmacists began to manage the comprehensive therapy initiation process. We performed a retrospective review of adult patients with MS who were prescribed dalfampridine from March 2010 to December 2018. Eligible prescriptions were new starts (no previous use) or restarts (after previous use and discontinuation). Prescriptions were classified as pre-VSP and post-VSP, which differentiates before and after VSP gained access to dispense dalfampridine. Study outcomes were insurance approval, initiation of therapy, and time from treatment decision to medication access. We used a proportional odds logistic regression model for time to medication access using the following covariates: pre-VSP versus post-VSP time period, insurance prior authorization (PA) denied versus approved/not needed, and baseline timed 25-foot walk. RESULTS: We included 262 patients and 290 prescriptions (260 pre-VSP and 30 post-VSP). In pre-VSP and post-VSP prescriptions, 97% were approved by insurance, and 93% of patients started therapy. Median time to medication access was 22 days (IQR = 11-45) for pre-VSP prescriptions and 1 day (IQR = 0-3) for post-VSP prescriptions. In the proportional odds logistic regression model, the odds of having a longer medication access time were significantly higher for pre-VSP prescriptions (OR = 83.219, P < 0.001) and prescriptions whose PA was initially denied (OR = 9.50, P < 0.001); 25-foot walk time was not significant (OR = 0.95, P = 0.277). CONCLUSIONS: After obtaining access to dispense dalfampridine, the time to access therapy was reduced, suggesting that LDNs delay patient access to therapy at HSSPs. DISCLOSURES: No funding was provided for this study. The authors have no conflicting interests to disclose. Preliminary results have been previously presented at the American Society of Health-Systems Pharmacy Midyear Meeting in December 2019, the Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit in August 2020, and the National Association of Specialty Pharmacy Annual Meeting in September 2020.

Rheumatoid arthritis medication adherence in a health system specialty pharmacy.

OBJECTIVES: To assess adherence to specialty medications for rheumatoid arthritis (RA) at an integrated health system specialty pharmacy (HSSP) and identify characteristics associated with adherence. STUDY DESIGN: Single-center, retrospective cohort study. METHODS: Study patients were adults with RA who filled at least 3 prescriptions for biologic disease-modifying antirheumatic drugs (bDMARDs) between July 1, 2016, and June 30, 2017, at an integrated HSSP. Data were collected from pharmacy claims and electronic health records. The primary outcome, adherence, was measured using proportion of days covered (PDC). Proportional odds logistic regression was used to test association between PDC and age, gender, race, insurance type, and out-of-pocket costs. RESULTS: We included 675 patients: 77% were female, 90% were White, 29% were naive to treatment at initial dispensing, 60% held commercial insurance, and the median age was 56 years. Median (interquartile range [IQR]) patient out-of-pocket cost per fill was $1.50 ($0-$5). Median (IQR) PDC was 0.95 (0.84-1.00); 80% of patients achieved PDC of 0.80 or higher. Higher adherence was more likely in patients who were male (odds ratio [OR], 1.58; 95% CI, 1.15-2.18; P = .005], naive to specialty medication treatment (OR, 3.04; 95% CI, 2.21-4.18; P < .001), and older in age (per 10 years: OR, 1.17; 95% CI, 1.04-1.32; P = .008), and adherence had a significant nonlinear association with average cost per fill (P = .006); associations with race and insurance type were not significant. CONCLUSIONS: At an integrated HSSP, patients with RA paid low out-of-pocket costs for bDMARD therapy and achieved high treatment adherence. Data suggest that integrated HSSPs assist patients in removing financial barriers to treatment.

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.

Adherence to Disease-Modifying Therapies at a Multiple Sclerosis Clinic: The Role of the Specialty Pharmacist.

BACKGROUND: Disease-modifying therapy (DMT) delays disease progression and improves quality of life for patients with multiple sclerosis (MS), but adherence to DMT is often suboptimal. Vanderbilt Specialty Pharmacy (VSP) embeds pharmacists within an outpatient MS clinic to provide medication management and address barriers to adherence. OBJECTIVE: We evaluated rates and predictors of adherence to DMT among patients with MS at an integrated specialty pharmacy. METHODS: We included patients with MS who filled ≥3 DMT prescriptions from VSP during the study period. Adherence was defined as medication possession ratio (MPR) or proportion of days covered (PDC) ≥0.8. Reasons for nonadherence were collected from pharmacy claims and electronic medical records. RESULTS: The study included 653 patients. Average MPR and PDC were 0.93 and 0.94, respectively. Eighty-eight percent of patients achieved MPR ≥0.8; 89% achieved PDC ≥0.8. Using financial assistance and having $0 out-of-pocket cost were associated with higher odds of achieving MPR and PDC ≥0.8 (P < .05). Of the 12% of patients who were nonadherent, most were unreachable for refills. CONCLUSIONS: Ensuring financial assistance and low out-of-pocket costs are associated with high adherence to DMT within an integrated specialty clinic, but more work is needed to address adherence in unreachable patients.

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.

Integrated specialty pharmacy yields high PCSK9 inhibitor access and initiation rates.

BACKGROUND: Access to proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors that lower low-density lipoprotein cholesterol in patients at high risk of atherosclerotic cardiovascular disease events has proven challenging. Methods to overcome access barriers are needed to fully realize the benefits of these novel agents. OBJECTIVE: This study evaluated medication access rates in patients prescribed a PCSK9 inhibitor at a health care system with integrated specialty pharmacy services. METHODS: We performed a single-center, ambispective cohort study of patients prescribed a PCSK9 inhibitor between September 2015 and December 2016 at Vanderbilt University Medical Center outpatient clinics. The primary end point was the percentage of PCSK9 inhibitor prescriptions resulting in access of the total prescriptions triaged to Vanderbilt Specialty Pharmacy. Secondary end points assessed among patients approved for therapy included time between benefits investigation and insurance approval, financial assistance use, and treatment initiation rates. RESULTS: Two hundred ninety-nine patients met inclusion criteria (average age = 63 years). Forty-six percent were female, 57% held commercial insurance, and 70% had an atherosclerotic cardiovascular disease indication. Overall, 96% of prescriptions resulted in access to a PCSK9 inhibitor. Most patients were approved with an initial prior authorization (58%) or after one appeal (29%). The median time to approval was 8 days. Among patients approved for therapy, 53% received financial assistance and 94% initiated therapy. CONCLUSION: An integrated specialty pharmacy service model in outpatient clinics produced high rates of PCSK9 inhibitor therapy access and initiation. This high level of access supports this model as a best practice for prescribing PCSK9 inhibitor therapy.

"You Need to Be a Good Listener": Recruiters' Use of Relational Communication Behaviors to Enhance Clinical Trial and Research Study Accrual.

Medical and research professionals who discuss clinical trials and research studies with potential participants face an often daunting challenge, particularly when recruiting from minority and underserved populations. This study reports on findings from a focus group study of 63 research coordinators, study nurses, professional recruiters, and other professionals in Indianapolis, IN and Miami, FL who work to recruit from minority and underserved populations. These professionals discussed the importance of creating a sense of connection with potential participants as part of the recruitment and retention process. Building a relationship, however fleeting, involved a number of concrete behaviors, including listening to personal information, expressing empathy, and then providing reciprocal self-disclosures; having repeated contact, usually by working in the same environment over an extended period of time; demonstrating respect through politeness and the use of honorifics; going the extra mile for participants; offering flexibility in scheduling follow-up appointments; and creating a sense of personal and community trust by being truthful. The implications of these findings for clinical trial and research study accrual are discussed.