Financial impact of integrated specialty pharmacy efforts to avoid oral anticancer medication waste.

BACKGROUND: The growing number of oral anticancer medications represents a significant portion of pharmacy spending and can be costly for patients. Patients taking oral anticancer medications may experience frequent treatment changes following necessary safety and effectiveness monitoring, often resulting in medication waste. Strategies to avoid medication waste could alleviate the financial burden of these costly therapies on the payer and the patient. OBJECTIVE: To evaluate the impact on waste and cost avoidance of reviewing the amount of medication patients have on hand and the presence of upcoming follow-up (ie, provider visit, laboratory testing, or imaging) before requesting a prescription refill renewal for patients taking oral anticancer medications through an integrated health system specialty pharmacy. METHODS: We performed a retrospective review of patients filling oral anticancer medications prescribed by a Vanderbilt University Medical Center provider and dispensed by Vanderbilt Specialty Pharmacy between January 1, 2020, and December 31, 2020. Specialty pharmacists received a system-generated refill renewal request for oral anticancer medications when the final prescription refill was dispensed, prompting the pharmacist to review the patient's medical record for continued therapy appropriateness and to request a new prescription. If the patient had a sufficient supply on hand to last until an upcoming follow-up (ie, provider visit, imaging, or laboratory assessment), the pharmacist postponed the renewal until after the scheduled follow-up. Patients were included in the analysis if the refill renewal request was postponed after review of the amount of medication on hand and the presence of an upcoming follow-up. Medication outcomes (ie, continued, dose changed, held, medication changed to a different oral anticancer medication, or discontinued) resulting from the follow-up were collected. Cost avoidance in US dollars was assigned based on the outcome of follow-up by calculating the price per unit times the number of units that would have been unused or in excess of what was needed if the medication had been dispensed before the scheduled follow-up. The average wholesale price minus 20% (AWP-20%) and wholesale acquisition cost (WAC) were used to report a range of costs avoided over 12 months. RESULTS: The total cost avoidance over 12 months associated with postponing refill renewal requests in a large academic health system with an integrated specialty pharmacy ranged from $549,187.03 using WAC pricing to $751,994.99 using AWP-20% pricing, with a median cost avoidance per fill of $366.04 (WAC) to $1,931.18 (AWP-20%). Refill renewal requests were postponed in 159 instances for 135 unique patients. After follow-up, medications were continued unchanged in only 2% of postponed renewals, 56% of follow-ups resulted in medication discontinuations, 32% in dose changes, 5% in medication changes, and 5% in medication holds. CONCLUSIONS: Integrated health system specialty pharmacist postponement of refill requests after review of the amount of medication on hand and upcoming follow-up proved effective in avoiding waste and unnecessary medication costs in patients treated with oral anticancer medications at a large academic health system.

Cost avoidance from health system specialty pharmacist interventions in patients with multiple sclerosis.

BACKGROUND: Specialty pharmacists monitor patients taking multiple sclerosis (MS) disease-modifying therapies (DMTs) to evaluate response to therapy and intervene on adverse effects. These interventions have the potential to avoid health care costs by discontinuing inappropriate therapies and avoiding downstream health care utilization. OBJECTIVE: To calculate the costs avoided by specialty pharmacist interventions in MS. METHODS: A retrospective observational cohort study including patients at the Vanderbilt MS Clinic who received a specialty pharmacist intervention between February 1, 2022, and July 31, 2022, was performed. A panel of 3 investigators categorized each intervention based on the potential for cost avoidance: (1) no cost avoidance, (2) direct cost avoidance, and (3) indirect cost avoidance. A single intervention may have one or both cost avoidance types. Direct costs avoided included the cost of the potential service or medication avoided due to the intervention. Medication costs were calculated using the range of the average wholesale price and average wholesale price - 20%. For indirect costs avoided, the range of costs of a consequence (self-care, ambulatory visit, emergency department visit, hospitalization, or death) occurring had the intervention not been performed were multiplied by the range of probabilities for the consequence occurring (from zero [0] to very likely [0.5]). Self-care indirect cost savings equated to $0. Descriptive statistics summarized types of pharmacist interventions, the patients impacted, and costs avoided. In patients with an intervention that resulted in cost avoidance, chart review was performed to collect patient demographics, disease history, and MS-related health care usage during the 12 months prior to the pharmacist intervention. RESULTS: 485 pharmacist interventions in 354 individual patients were included. Fifty interventions in 38 individual patients (76% female, median age 51 years, 68% White) resulted in cost avoidance. The total estimated costs avoided in 6 months ranged from $123,733 to $156,265. In total, $138,410 were direct costs and $1,890 were indirect costs. Reasons for direct costs avoided (n = 13) were often safety monitoring (69%) or common side effects management (23%). Indirect costs avoidance (n = 37) resulted primarily from interventions on common side effects management (57%) and safety monitoring (22%). Self-care was the most common type of indirect cost avoided (n = 27). Interventions resulting in costs avoided were commonly seen in patients with relapsing-remitting MS (82%). The median time from MS diagnosis was 15 years and 42% of patients had previously trialed 1 other MS DMT. CONCLUSIONS: There is a potential for significant health care savings after specialty pharmacist interventions in MS, primarily from preventing the dispensing of inappropriate therapies.

Retraining transplant pharmacy staff to reduce Medicare Part B prescription billing errors post-transplant.

BACKGROUND: Medicare Part B (MedB) imposes penalties for certain errors in prescription billing of post-transplant medications, which can greatly affect pharmacy revenue. To prevent MedB billing fines, pharmacy staff must be cognizant of specific MedB requirements. OBJECTIVE: This quality improvement project aimed to retrain certified pharmacy technicians (CPhTs) on common billing errors and evaluate changes in error rates and potential fines after retraining. We aimed to determine whether retraining CPhTs minimizes MedB prescription billing errors and reduces potential fines owed by the Vanderbilt Transplant Pharmacy (VTP) to the Centers for Medicare and Medicaid Services (CMS). METHODS: This was a single-center, quality improvement study including post-transplant patients with at least one MedB prescription billing error who filled prescriptions through VTP. All CPhTs involved in MedB prescription billing received retraining focused on the top 3 errors in MedB billing identified at VTP: early refills, missing relationship of caller to patient and residence of patient on order documentation, or no day supply remaining recorded on the order file. Retraining consisted of developing a training checklist, testing current knowledge levels, individualized nonpunitive coaching based on technician specific errors, and retesting for knowledge retention. Outcomes included the number of prescriptions with at least one MedB prescription billing error and the projected amount of dollars fined owing to errors recorded during the 3 months before and 3 months after retraining. RESULTS: Fourteen CPhTs received retraining. Average refill too soon errors decreased by 37.5% (10.7% vs. 6.7%), average missing relationship by 21.7% (7.7% vs. 6%), and day supply errors by 39.7% (1.7% vs. 1%). Error reductions equaled a 28.2% decrease (approximately $12,700) in potential fines. CONCLUSION: Retraining focused on MedB billing error successfully reduced error frequency and fines from CMS. MedB billing error fines can be costly for pharmacies dispensing high-cost medications; therefore, identifying common errors and training staff can be useful and financially prudent.

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.

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.

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.

Patient-reported outcomes and pharmacist actions in patients with multiple sclerosis managed by health-system specialty pharmacies.

PURPOSE: This study evaluated patient-reported outcomes (PROs) and pharmacist actions for patients on disease-modifying therapies (DMTs) for multiple sclerosis (MS) through health-system specialty pharmacies (HSSPs). METHODS: A multisite, prospective cohort study of patients utilizing an HSSP for DMT fulfillment was performed. Primary outcomes were affirmative answers to PRO questions regarding impacted productivity, hospitalization, and relapse and pharmacist actions. Rates of pharmacist actions were reported as the number of person-years of treatment per action. Univariate and multivariate logistic regression were used to evaluate the association between each PRO and covariates, including the number of pharmacist actions performed, age, sex, insurance, site, and route of administration. RESULTS: The 968 patients included had 10,562 fills and 6,946 PRO assessments. The most common affirmative PRO was impacted productivity (14.6%). Pharmacists performed 3,683 actions, most commonly general medication education (42.6%) and safety (33.3%). Rates of general medication education and nonfinancial coordination of care actions were similar across medication classes; other pharmacist actions varied by medication class. Insurance type was significantly associated with reporting impacted productivity; patients with Medicare and Medicaid were 2.2 and 3.1 times more likely to have reported impacted productivity, respectively (P < 0.001) than commercially insured patients. Patients who reported impacted productivity had more pharmacist actions (P < 0.001). CONCLUSION: Patients on DMTs through an HSSP reported low rates of impacted productivity, relapse, and hospitalization due to MS, although patients with noncommercial insurance were more likely to have impacted productivity. Patients reporting impacted productivity and those taking certain DMTs may require more frequent pharmacist actions.

Primary medication nonadherence rates to specialty disease-modifying antirheumatic drugs for rheumatoid arthritis within a health system specialty pharmacy.

BACKGROUND: Assessing primary medication nonadherence, the rate at which a medication is prescribed for a patient but is not obtained or replaced with an alternative medication within a reasonable time period, can provide a better understanding of the frequency and impact of these barriers to medication access. Previous literature has reported high rates of primary medication nonadherence, ranging from approximately 20% to 55% in patients with rheumatoid arthritis (RA) treated with specialty disease-modifying antirheumatic drugs (DMARDs). The high primary medication nonadherence rate may reflect the difficulties associated with obtaining specialty medications, such as high costs, extended prior authorizations, and pretreatment safety requirements. OBJECTIVE: To evaluate reasons for and rates of primary medication nonadherence to specialty DMARDs in patients with RA referred to an integrated health systems specialty pharmacy. METHODS: We conducted a retrospective cohort study examining eligible patients with a specialty DMARD referral from a health system rheumatology provider to the health system specialty pharmacy. Initially, pharmacy claims were used to identify primary medication nonadherence, defined as the lack of a fill event within 60 days following the medication referral for patients without a specialty DMARD claim in the 180 days prior. Referrals from July 1, 2020, to July 1, 2021, were eligible. Exclusion criteria included duplicate referrals, use for non-RA indications, switches to clinic-administered therapies, and alternate filling methods. Medical record reviews were conducted to confirm referral outcomes. Outcomes included rate of and reasons for primary medication nonadherence. RESULTS: We included 480 eligible patients, 100 of whom had no documented fill event. After medical record review, 27 patients were removed due to having a non-RA diagnosis and 65 patients were removed due to having alternative fill methods, most due to external prescription routing (83.1%). The final primary medication nonadherence rate was 2.1%. Out of the 8 cases of true primary medication nonadherence, 3 patients held specialty DMARD therapy because of other existing disease states, 3 patients were unreachable, and 2 patients were unable to afford medication. CONCLUSIONS: Rates of primary medication nonadherence to specialty DMARDs were low in patients with RA managed by a health system specialty pharmacy. A total of 8 primary medication nonadherence cases were related to safety concerns in non-RA diseases states, patient unreachability, and affordability. However, the limited number of primary medication nonadherence cases limits the generalizability of reasons for primary medication nonadherence found in this study. Key elements of the health systems specialty pharmacy model that likely contribute to low primary medication nonadherence include dedicated financial assistance navigation services, in-clinic pharmacist availability, and open communication between provider offices.

Optimizing HIV PrEP Persistence: Does Your Pharmacy Matter?

Persistence to human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is integral to preventing new HIV infections. Previous studies have shown real-world PrEP persistence is low and insight is needed into PrEP delivery strategies that improve persistence. This single-center, retrospective, cohort study measured persistence in patients filling PrEP through an integrated health-system specialty pharmacy (HSSP) compared to those filling at external pharmacies. The Kaplan-Meier estimates for persistence probability at 6, 12, and 18 months were 0.87 (95% CI 0.79-0.95), 0.75 (95% CI 0.66-0.86), and 0.64 (95% CI 0.53-0.76) for the HSSP cohort compared to 0.65 (95% CI 0.51-0.83), 0.41 (95% CI 0.28-0.62), and 0.32 (95% CI 0.2-0.53), respectively, for the non-HSSP cohort (log-rank p < 0.001, [Formula: see text] = 11.2). Cox PH modeling showed that patients using a non-HSSP were 2.7 times more likely to be non-persistent than HSSP patients (HR 2.7, 95% CI 1.6-4.7, p < 0.001, [Formula: see text] = 12.61), demonstrating patients were better maintained on PrEP therapy when their prescriptions were filled with the HSSP.

Health Insurer Strategies to Reduce Specialty Drug Spending-Copayment Adjustment and Alternative Funding Programs.

This Viewpoint describes programs intended to help patients with commercial insurance that, instead, employers, health plans, and other payers use to reduce their spending on specialty drugs.

Adherence and persistence to self-administered disease-modifying therapies in patients with multiple sclerosis: A multisite analysis.

BACKGROUND: Though there are several disease-modifying therapy (DMT) options for patients with multiple sclerosis (MS), treatment outcomes rely on patient adherence and persistence. Previous studies have demonstrated suboptimal adherence rates and high rates of early treatment discontinuation. Health-system specialty pharmacies (HSPPs) are a growing practice model that have demonstrated adherence and persistence benefits through single site evaluations. Research is needed across multiple HSSPs to understand and validate the outcomes of this practice model. METHODS: A multisite prospective cohort study was performed including patients with at least three fills of a DMT between January 2020 and June 2021 at an HSSP. Patients were excluded due to pregnancy or death. Enrollment occurred for 6 months followed by 12 months of follow-up. Adherence was measured using pharmacy claims to calculate proportion of days covered (PDC) during the follow-up period. Time to non-persistence was calculated as the time from an index DMT fill to the first date of a gap of >60 days between medication exhaust and fulfillment dates. Adherence and persistence calculations were assessed at the therapeutic class level (any self-administered DMT dispensed by the HSSPs). The Kaplan-Meier method was used to present the probability of being persistent, and Cox proportional hazards regression analysis was used to estimate hazard ratios of factors associated with non-persistence, which included age, sex, study site, insurance type, and whether the patient switched medication as potential factors. RESULTS: The most common self-administered DMTs filled among 968 patients were glatiramer acetate (32%), fingolimod (18%), and dimethyl fumarate (18%). Most patients (96%) did not switch DMT during the study period. The median PDC was 0.97 (interquartile range 0.90-0.99), which was similar across all sites. Patients who had at least one DMT switch were 76% less likely to have a higher PDC than those who did not have any switch after adjusting for other covariates (Odds ratio: 0.24, 95% confidence interval [CI]: 0.14-0.40, p<0.001). Most patients (86%) were persistent to DMT over the 12-month study period. Among those non-persistent, median time to non-persistence was 231 (IQR 177-301) days. Patients who switched medications were 2.4 times more likely to be non-persistent (95% CI: 1.3 - 4.5, p = 0.005). The most common reasons for non-persistence were discontinuation/medication held for an extended period (30%), often due to patient or prescriber decision (75%). CONCLUSION: High rates of DMT adherence and persistence were seen among patients serviced by HSSPs, indicating potential benefits of this model for patients with MS. Switching DMTs was associated with lower adherence and persistence and may be an opportunity for added care coordination or resources to optimize therapy transitions.

Patient-Tailored Interventions to Improve Specialty Medication Adherence: Results from a Prospective Randomized Controlled Trial.

BACKGROUND: Specialty medication nonadherence results in poor clinical outcomes and increased costs. This study evaluated the impact of patient-tailored interventions on specialty medication adherence. METHODS: A pragmatic, randomized controlled trial was conducted at a single-center health-system specialty pharmacy from May 2019 to August 2021. Participants included recently nonadherent patients prescribed self-administered specialty medications from multiple specialty clinics. Eligible patients were stratified by historical clinic rates of nonadherence and randomized 1:1 to usual care or intervention arms. Intervention patients received patient-tailored interventions and 8 months of follow-up. A Wilcoxon test was used to analyze the difference in 6-, 8-, and 12-month post-enrollment adherence, calculated using proportion of days covered, between the intervention and usual care arms. RESULTS: Four hundred and thirty eight patients were randomized. Baseline characteristics were similar between groups: mostly women (68%), white (82%), with a median age of 54 years (interquartile range, 40, 64). The most common reasons for nonadherence in the intervention arm were memory (37%) and unreachability (28%). There was a significant difference in median proportion of days covered between patients in the usual care and intervention arms at 8-months (0.88 vs 0.94, P < .001), 6-months (0.90 vs 0.95, P = .003), and 12-months post-enrollment (0.87 vs 0.93, P < .001). CONCLUSIONS: Patient-tailored interventions resulted in significant specialty medication adherence improvement compared with standard of care. Specialty pharmacies should consider targeting nonadherent patients for adherence interventions.

2022 ASHP Survey of Health-System Specialty Pharmacy Practice: Clinical Services.

PURPOSE: Results of the first ASHP national survey of clinical services provided by health-system specialty pharmacies (HSSPs) are presented. METHODS: A survey questionnaire was developed by 26 HSSP contacts after reviewing available literature on the role and services of HSSPs. After pilot and cognitive testing resulting in a final questionnaire of 119 questions, a convenience sample of 441 leaders in HSSPs was contacted using email and invited to participate in the survey. RESULTS: The survey response rate was 29%. Almost half of respondents (48%) had offered pharmacy services for 7 years or more, and most (60%) dispensed more than 15,000 prescriptions annually. Respondents most commonly (42%) reported a specialist model wherein staff are dedicated to specific specialty disease states. Over half of respondents reported providing several medication access, pretreatment assessment, and initial counseling services to patients referred to them, regardless of whether the HSSP was used for medication fulfillment. All HSSP activities were noted to be documented in the electronic health record and visible to providers frequently or always. Almost all respondents noted that HSSP pharmacists have a role in specialty medication selection. Disease-specific outcomes were tracked in 95% of responding HSSPs, with 67% reporting that outcomes were used to drive patient monitoring. HSSPs were often involved in continuity of care services such as transitions of care (reported by 89% of respondents), referral to other health-system services (53%), and addressing social determinants of health (60%). Most respondents (80%) reported providing clinical education to specialty clinic staff, including medicine learners (62%). Though only 12% of respondents had dedicated outcomes research staff, many reported annually publishing (47%) or presenting (61%) outcomes research. CONCLUSION: HSSPs are a clinical and educational resource for specialty clinics and have developed robust patient care services that encompass the patient journey from before specialty medication selection through treatment monitoring and optimization.

Development and implementation of a laboratory monitoring dashboard to reduce treatment gaps in inflammatory bowel disease.

PURPOSE: Patients receiving biologic therapy for inflammatory bowel disease (IBD) require routine laboratory monitoring to ensure the safety and efficacy of therapy. The purpose of this quality improvement project was to evaluate the implementation of a dashboard to prevent treatment gaps by prospectively identifying patients with IBD and outdated laboratory results receiving biologics. METHODS: We performed a pre/post analysis of dashboard implementation to assess the number of patients with overdue laboratory work resulting in treatment gaps. The dashboard combined data from the electronic health record (EHR) and pharmacy claims database to identify patients on a biologic with laboratory tests (white blood cell count, liver transaminases, C-reactive protein, and erythrocyte sedimentation rate) completed 5 or more months ago and/or a tuberculosis screen completed 11 or more months ago. After implementation, specialty pharmacists reviewed the dashboard and communicated via EHR if a new prescription and laboratory tests were needed. Messages were sent 4 weeks in advance of the next refill-eligible date. Mixed methods were used for analysis of qualitative data, including surveys, and quantitative data, assessing treatment gap length. RESULTS: A total of 40 patients who had outdated laboratory values and required a new prescription (15 before dashboard implementation and 25 after implementation) were included in the analysis. The frequency of a treatment gap decreased from 80% (n = 12) in the preimplementation phase to 32% (n = 8) in the postimplementation phase. The median gap length was shorter after dashboard implementation, decreasing from 21 days (range, 3-97 days) to 11 days (range, 2-23 days). CONCLUSION: Utilization of a quality measures dashboard decreased treatment gaps in patients with IBD receiving biologic therapy. Integrated specialty pharmacists are uniquely positioned to monitor adherence to laboratory monitoring parameters for patients on biologics.

Pharmacist Review of Chronic Inhaler Therapy Appropriateness for Hospitalized Patients with COPD or Asthma.

INTRODUCTION: Patients with asthma and chronic obstructive pulmonary disease rely on inhaler therapy to reduce disease progression and exacerbation risk. Patients admitted to the hospital are at an increased risk for exacerbations and readmission if their inhaler therapy upon discharge is not aligned with current guidelines and/or affordable. OBJECTIVE: Assess the appropriateness of the chronic inhaler regimen for patients admitted to the hospital based on clinical practice guidelines and insurance coverage. METHODS: A sub-study was designed to analyze a cohort of a single-center, pragmatic, prospective randomized controlled trial at a large academic medical center. Patients admitted to a medicine service with a pharmacist and prescribed a long-acting inhaler were included. Participants randomized to a pharmacist-led intervention were assessed for inhaler appropriateness based on clinical guidelines and patient insurance. The objective of this sub-study is to assess the number of inhalers identified as inappropriate based on the pharmacist's review. A patient was considered to have an inappropriate inhaler regimen if any of their inhalers were inconsistent with guideline recommendations or not covered by insurance. Descriptive statistics were used to characterize appropriate inhaler use. RESULTS: The study pharmacist reviewed 552 unique inhalers for 348 patients. Overall, 42% of inhalers were inappropriate, affecting 50.3% of participants. 20% of inhalers were inappropriate based on insurance, 26% were inappropriate based on guidelines, and 7% were inappropriate based on both criteria. Recommendations were placed via a pharmacy consult for 198 patients (57%), most recommending an inhaler initiation (55%), followed by inhaler discontinuation (38%). CONCLUSION: A pharmacist-led review of chronic inhaler therapy for patients admitted to the hospital identified the need for a change in therapy based on financial or clinical guidelines in over half of the patients reviewed. Interventions to increase the appropriateness of prescribed inhalers are needed to reduce disease progression and disease exacerbation.

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.

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.

Health-system specialty pharmacy role and outcomes: A review of current literature.

PURPOSE: Specialty medications can have life-altering outcomes for patients with complex diseases. However, their benefit relies on appropriate treatment selection, patients' ability to afford and initiate treatment, and ongoing treatment optimization based on patient response to therapy. Mounting research demonstrates the benefits of the health-system specialty pharmacies (HSSPs) in improving specialty medication access, affordability, and outcomes. The purpose of this rapid review is to describe the currently reported role and function of HSSP pharmacists and outcomes reported with use of the HSSP model, and to identify gaps in the literature where more information is needed to better understand the HSSP model and outcomes. SUMMARY: Current literature describes the role of HSSP pharmacists in facilitating patient access, affordability, and initiation and maintenance of specialty medications. Though it is clear HSSP pharmacists are involved in treatment monitoring, often through utilizing the electronic health record, more information is needed to elucidate the frequency, method, and extent of monitoring. Despite several valuable continuity of care services reported to be provided by HSSPs, the breadth and degree of standardization of these services remains unclear. There is minimal literature describing HSSP education and research involvement. HSSPs have reported significant benefits of this patient care model, as demonstrated by higher adherence and persistence; better clinical outcomes; financial benefits to patients, payers, and the health system; better quality of care; higher patient and provider satisfaction with services, and highly efficient specialty pharmacy services. More literature comparing clinical and diagnosis-related outcomes in HSSP versus non-HSSP patients is needed. CONCLUSION: HSSPs provide comprehensive, patient-centered specialty medication management that result in improved care across the continuum of the specialty patient journey and act as a valuable resource for specialty clinics and patients beyond medication management. Future research should build on the current description of HSSP services, how services affect patient outcomes, and the impact HSSP network restrictions.