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.

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.

Does interaction occur between risk factors for revision total knee arthroplasty?

INTRODUCTION: Several risk factors for revision TKA have previously been identified, but interactions between risk factors may occur and affect risk of revision. To our knowledge, such interactions have not been previously studied. As patients often exhibit multiple risk factors for revision, knowledge of these interactions can help improve risk stratification and patient education prior to TKA. MATERIALS AND METHODS: The State Inpatient Databases (SID), part of the Healthcare Cost and Utilization Project (HCUP), were queried to identify patients who underwent TKA between January 1, 2006 and December 31, 2015. Risk factors for revision TKA were identified, and interactions between indication for TKA and other risk factors were analyzed. RESULTS: Of 958,944 patients who underwent TKA, 33,550 (3.5%) underwent revision. Age, sex, race, length of stay, Elixhauser readmission score, urban/rural designation, and indication for TKA were significantly associated with revision (p < 0.05). Age was the strongest predictor (p < 0.0001), with younger patients exhibiting higher revision risk. Risks associated with age were modified by an interaction with indication for TKA (p < 0.0001). There was no significant interaction between sex and indication for TKA (p = 0.535) or race and indication for TKA (p = 0.187). CONCLUSIONS: Age, sex, race, length of stay, Elixhauser readmission score, urban/rural designation, and indication for TKA are significantly associated with revision TKA. Interaction occurs between age and indication.

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.

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.

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.

Low rates of primary medication nonadherence in patients prescribed oral oncology agents across health system specialty pharmacies.

BACKGROUND: New oral oncology medications bring novel challenges when patients are initiating treatment. Rates of primary medication nonadherence (PMN), the rate at which a medication is prescribed but not obtained, of up to 30% have been reported for oral oncology medications. More research is needed to identify causes and develop strategies for health system specialty pharmacies (HSSPs) to improve cancer treatment initiation rates. OBJECTIVE: To evaluate the rate and reasons for PMN to specialty oral oncology medications in an HSSP setting. METHODS: We performed a multisite retrospective cohort study across 7 HSSP sites. Patients were included if they had an orally self-administered oncology medication referral generated by the health system of the affiliated specialty pharmacy between May 1, 2020, and July 31, 2020. Data collected at each site using pharmacy software and the electronic health record were deidentified and aggregated for analysis. After identifying unfilled referrals within a 60-day fill window, a retrospective chart review was performed to identify final referral outcomes and reasons for unfilled referrals. Referral outcomes were categorized as unknown fill outcomes (because of being referred to another fulfillment method or if received for benefits investigation only), filled by the HSSP, or not filled. The primary outcome was PMN for each PMN-eligible referral and secondary outcomes included reason for PMN and time to fill. The final PMN rate was calculated by dividing the number of unfilled referrals by total referrals with a known fill outcome. RESULTS: Of 3,891 referrals, 947 were PMN eligible, representing patients with a median age of 65 years (interquartile range = 55-73), near equal distribution between male and female (53% vs 47%), and most commonly with Medicare pharmacy coverage (48%). The most referred medication was capecitabine (14%), and the most common diagnosis was prostate cancer (14%). Among PMN-eligible referrals, 346 (37%) had an unknown fill outcome. Of the 601 referrals with known fill outcome, 69 referrals were true instances of PMN, yielding the final PMN rate of 11%. Most referrals were filled by the HSSP (56%). Patient decision was the most common reason for not filling (25%; 17/69 PMN cases). The median time to fill after initial referral was 5 days (interquartile range = 2-10). CONCLUSIONS: HSSPs have a high percentage of patient initiation of new oral oncology medication treatments in a timely manner. More research is needed to understand patient reasons for deciding not to start therapy and to improve patient-centered cancer treatment planning decisions. DISCLOSURES: Dr Crumb was a planning committee member with Horizon CME for the Nashville APPOS 2022 Conference. Dr Patel received funding and support for attending meetings and/or travel from the University of Illinois Chicago College of Pharmacy.

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.

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.

Renin-Angiotensin System Modulation With Synthetic Angiotensin (1-7) and Angiotensin II Type 1 Receptor-Biased Ligand in Adults With COVID-19: Two Randomized Clinical Trials.

Importance: Preclinical models suggest dysregulation of the renin-angiotensin system (RAS) caused by SARS-CoV-2 infection may increase the relative activity of angiotensin II compared with angiotensin (1-7) and may be an important contributor to COVID-19 pathophysiology. Objective: To evaluate the efficacy and safety of RAS modulation using 2 investigational RAS agents, TXA-127 (synthetic angiotensin [1-7]) and TRV-027 (an angiotensin II type 1 receptor-biased ligand), that are hypothesized to potentiate the action of angiotensin (1-7) and mitigate the action of the angiotensin II. Design, Setting, and Participants: Two randomized clinical trials including adults hospitalized with acute COVID-19 and new-onset hypoxemia were conducted at 35 sites in the US between July 22, 2021, and April 20, 2022; last follow-up visit: July 26, 2022. Interventions: A 0.5-mg/kg intravenous infusion of TXA-127 once daily for 5 days or placebo. A 12-mg/h continuous intravenous infusion of TRV-027 for 5 days or placebo. Main Outcomes and Measures: The primary outcome was oxygen-free days, an ordinal outcome that classifies a patient's status at day 28 based on mortality and duration of supplemental oxygen use; an adjusted odds ratio (OR) greater than 1.0 indicated superiority of the RAS agent vs placebo. A key secondary outcome was 28-day all-cause mortality. Safety outcomes included allergic reaction, new kidney replacement therapy, and hypotension. Results: Both trials met prespecified early stopping criteria for a low probability of efficacy. Of 343 patients in the TXA-127 trial (226 [65.9%] aged 31-64 years, 200 [58.3%] men, 225 [65.6%] White, and 274 [79.9%] not Hispanic), 170 received TXA-127 and 173 received placebo. Of 290 patients in the TRV-027 trial (199 [68.6%] aged 31-64 years, 168 [57.9%] men, 195 [67.2%] White, and 225 [77.6%] not Hispanic), 145 received TRV-027 and 145 received placebo. Compared with placebo, both TXA-127 (unadjusted mean difference, -2.3 [95% CrI, -4.8 to 0.2]; adjusted OR, 0.88 [95% CrI, 0.59 to 1.30]) and TRV-027 (unadjusted mean difference, -2.4 [95% CrI, -5.1 to 0.3]; adjusted OR, 0.74 [95% CrI, 0.48 to 1.13]) resulted in no difference in oxygen-free days. In the TXA-127 trial, 28-day all-cause mortality occurred in 22 of 163 patients (13.5%) in the TXA-127 group vs 22 of 166 patients (13.3%) in the placebo group (adjusted OR, 0.83 [95% CrI, 0.41 to 1.66]). In the TRV-027 trial, 28-day all-cause mortality occurred in 29 of 141 patients (20.6%) in the TRV-027 group vs 18 of 140 patients (12.9%) in the placebo group (adjusted OR, 1.52 [95% CrI, 0.75 to 3.08]). The frequency of the safety outcomes was similar with either TXA-127 or TRV-027 vs placebo. Conclusions and Relevance: In adults with severe COVID-19, RAS modulation (TXA-127 or TRV-027) did not improve oxygen-free days vs placebo. These results do not support the hypotheses that pharmacological interventions that selectively block the angiotensin II type 1 receptor or increase angiotensin (1-7) improve outcomes for patients with severe COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04924660.

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.

Risk of Revision Shoulder Arthroplasty After Anatomic and Reverse Total Shoulder Arthroplasty.

INTRODUCTION: The objective of this study was to determine the survivorship of anatomic total shoulder arthroplasty (aTSA) and reverse TSA (rTSA) over a medium-term follow-up in a large population-based sample and to identify potential risk factors for revision surgery. METHODS: The State Inpatient Database from the Healthcare Cost and Utilization Project was used to identify patients who underwent aTSA or rTSA from 2011 through 2015 using ICD9 codes. We modeled the primary outcome of time to revision or arthroplasty using the Cox proportional hazards model. The predictors of revision surgery in the model include aTSA versus rTSA, indication for surgery, age, sex, race, urban versus rural residence, hospital length of stay zip code-based income quartile classification, and Elixhauser comorbidity readmission score. RESULTS: Among 43,990 patients in this study, 1,141 (4.0%) underwent revision or implant removal over the 4-year study period. The median age was 71 years, and 57% of patients were female. Indications for the index surgery included primary osteoarthritis (75.2%), cuff tear (8.5%), acute fracture (7.0%), malunion/nonunion (1.4%), and other (7.8%). Among these indications for surgery, the risk of revision or removal was greatest in patients who underwent the primary procedure for malunion/nonunion (hazard ratio [HR] 2.39, 95% confidence interval [CI] 1.69 to 3.39) compared with the reference of primary osteoarthritis. Male patients who underwent aTSA were less likely to need revision surgery than male patients who underwent rTSA (HR: 0.59, 95% CI 0.49 to 0.71), and the opposite relationship was observed in female patients (HR: 1.41, 95% CI 1.18 to 1.69). Age, length of stay, and Elixhauser comorbidity score were predictive of revision surgery (P < 0.0001, P = 0.0005, P < 0.0001, respectively), whereas race, urban versus rural, and zip code-based income quartile were not. DISCUSSION: aTSA and rTSA showed excellent 4-year survivorship of 96.0% in a large population-based sample. aTSA and rTSA survivorships were similar at the 4-year follow-up.

Understanding Patient and Clinician Reported Nonroutine Events in Ambulatory Surgery.

OBJECTIVE: Nonroutine events (NREs, i.e., deviations from optimal care) can identify care process deficiencies and safety risks. Nonroutine events reported by clinicians have been shown to identify systems failures, but this methodology fails to capture the patient perspective. The objective of this prospective observational study is to understand the incidence and nature of patient- and clinician-reported NREs in ambulatory surgery. METHODS: We interviewed patients about NREs that occurred during their perioperative care using a structured interview tool before discharge and in a 7-day follow-up call. Concurrently, we interviewed the clinicians caring for these patients immediately postoperatively to collect NREs. We trained 2 experienced clinicians and 2 patients to assess and code each reported NRE for type, theme, severity, and likelihood of reoccurrence (i.e., likelihood that the same event would occur for another patient). RESULTS: One hundred one of 145 ambulatory surgery cases (70%) contained at least one NRE. Overall, 214 NREs were reported-88 by patients and 126 by clinicians. Cases containing clinician-reported NREs were associated with increased patient body mass index ( P = 0.023) and lower postcase patient ratings of being treated with respect ( P = 0.032). Cases containing patient-reported NREs were associated with longer case duration ( P = 0.040), higher postcase clinician frustration ratings ( P < 0.001), higher ratings of patient stress ( P = 0.019), and lower patient ratings of their quality of life ( P = 0.010), of the quality of clinician teamwork ( P = 0.010), being treated with respect ( P = 0.003), and being listened to carefully ( P = 0.012). Trained patient raters evaluated NRE severity significantly higher than did clinician raters ( P < 0.001), while clinicians rated recurrence likelihood significantly higher than patients for both clinician ( P = 0.032) and patient-reported NREs ( P = 0.001). CONCLUSIONS: Both patients and clinicians readily report events during clinical care that they believe deviate from optimal care expectations. These 2 primary stakeholders in safe, high-quality surgical care have different experiences and perspectives regarding NREs. The combination of patient- and clinician-reported NREs seems to be a promising patient-centered method of identifying healthcare system deficiencies and opportunities for improvement.

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.