Optimal follow-up schedule for patients taking PCSK9 monoclonal antibodies in a health system: Analysis of specialty pharmacy clinical interventions.

PURPOSE: The objective of this study was to determine if and when it is clinically appropriate to consider a reduction in the frequency of health-system specialty pharmacy (HSSP) clinical pharmacist assessments for patients taking a proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody (mAb) after they are deemed clinically stable on therapy. METHODS: A single-center, retrospective, observational study of adult patients on PCSK9 mAb therapy enrolled in the University of Rochester Specialty Pharmacy Cardiology Patient Management Program was performed between October 24, 2016, and April 30, 2022. The primary outcome was the number of clinical pharmacist interventions per interval within the baseline 12 months compared to 12-month intervals for up to 72 months after initiation of PCSK9 mAb therapy. RESULTS: A total of 368 patients on PCSK9 mAb therapy were included in the study. A significantly lower percentage of patients had more than 2 interventions during the 12- to 24-month interval (24.3%) as compared to the baseline 12-month interval (80.2%) (P < 0.001); this represented a 70% reduction in the chance of a patient requiring more than 2 interventions (relative risk, 0.30; 95% CI, 0.24-0.38). A similar trend was demonstrated in the 24- to 36-month and 36- to 48-month intervals when compared to the first year of therapy. The most commonly documented clinical pharmacist interventions were in the categories of safety (29.2%), effectiveness (28.4%), and adherence (19.9%). CONCLUSION: Patients beyond 1 year of PCSK9 mAb therapy required less clinical pharmacist interventions. Therefore, stable patients receiving a PCSK9 mAb may be considered for less frequent clinical assessments to allow for HSSP growth to nontraditional clinical areas.

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.

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.

Pneumococcal Vaccination Practices in Patients With Multiple Sclerosis Receiving Anti-CD20 Monoclonal Antibodies After Pharmacy and Nursing Collaboration.

BACKGROUND: It is recommended that patients taking immunosuppressive anti-CD20 monoclonal antibodies (mAbs) receive pneumococcal vaccinations before their first dose to ensure optimal immune response. An initial medication use evaluation reviewed adherence to Centers for Disease Control and Prevention (CDC) pneumococcal immunization recommendations at the study site, and room for improvement was identified. The nursing team implemented workflow changes to increase nursing involvement in vaccination coordination, education, tracking, and administration. We sought to evaluate the impact of a nursing intervention on optimal pneumococcal vaccination administration rates in patients receiving anti-CD20 mAbs at a multiple sclerosis (MS) center. METHODS: We performed a single-center, retrospective, pre/post medication use evaluation. Inclusion criteria were older than 18 years with a diagnosis of MS and received their first anti-CD20 mAb infusion at the study site during the preintervention or postintervention time frame. RESULTS: We included 406 and 73 patients in the preintervention and postintervention studies, respectively. The nursing intervention significantly improved the percentage of patients receiving optimal pneumococcal vaccination before their first infusion from 58% to 84% and significantly reduced the number with unknown vaccination status from 17% to 3%. Patients who received optimal follow-up vaccination with 23-valent pneumococcal polysaccharide vaccine after optimal 13-valent pneumococcal conjugate vaccine administration improved from 9% to 56%. CONCLUSIONS: A nursing team intervention improved adherence to CDC pneumococcal immunization recommendations for patients receiving anti-CD20 mAb therapy. This project highlights the value of interdisciplinary team collaboration between health system specialty pharmacies and specialized nursing teams in the care of patients with MS.

A Retrospective Study of Patient Factors That Indicate Provider Nonadherence to an Institutional Clostridium difficile Treatment Guideline.

BACKGROUND: Clostridium difficile infection (CDI) is treated most often with metronidazole or vancomycin. Both have been effective in treatment of mild to moderate infection. In more severe cases, vancomycin may be more effective. OBJECTIVES: The primary objectives were to quantify the severity of CDI and to describe overall adherence to the institutional CDI guideline. Secondary objectives were to assess factors associated with adherence to the guidelines. METHODS: Retrospective analysis of the electronic medical record was used to evaluate adherence to institutional guidelines. Data collected included demographics and other factors potentially contributing to adherence: Charlson comorbidity index, severity of infection, recurrence, intensive care unit (ICU) admission, infectious diseases (ID) consult, total duration and number of antibiotics, alternative therapies, and acid suppression. Descriptive statistics and bivariate analyses were used to describe and compare factors associated with guideline adherence; multivariate logistic regression assessed independent predictors of adherence. RESULTS: A total of 387 patients met the inclusion criteria. CDI severity was 55.8% mild/moderate cases, 42.4% severe, 0.5% fulminant, and 1.3% prophylaxis. Overall, institutional guideline adherence was 51.9%. In bivariate analyses, 5 factors were associated with nonadherence to guidelines: older age, ICU admission, duration of antibiotics, mild/moderate and severe infection (all P < .05). In the logistic regression model, severe infection ( P < .001) and longer duration of antibiotics ( P < .05) were independently associated with guideline nonadherence. CONCLUSION: In this study, 42.4% of the patients met criteria for severe infection. Providers for patients with severe infection and longer duration of antibiotic therapy were less likely to adhere to the institutional guideline.

Evaluation of a Hepatitis C Patient Management Program at a University Specialty Pharmacy.

BACKGROUND: The University of Rochester (UR) Specialty Pharmacy hepatitis C patient management program offers a unique advantage of being integrated within the same health system as the University of Rochester Medical Center (URMC) Gastroenterology and Hepatology division. OBJECTIVE: The primary purpose of this study was to assess treatment success through the incidence of achieving a sustained virological response (SVR) in patients served by the UR Specialty Pharmacy versus other nonintegrated pharmacies. METHODS: This was a single-center retrospective cohort study in adult patients of URMC Gastroenterology and Hepatology prescribed hepatitis C treatment between January 1, 2014, and July 15, 2015. The incidence of SVR, adherence, delay in therapy initiation, early treatment discontinuation, rate of attainment of viral load measurement post-therapy completion, and predictors associated with treatment outcome were assessed. RESULTS: A total of 414 patients were prescribed hepatitis C virus treatment during the study period; 137 did not initiate therapy. The rate of SVR was 93% among patients at the UR Specialty Pharmacy and 89% at nonintegrated pharmacies ( P = 0.357). Adherence to therapy was 100% and 97% at the UR Specialty Pharmacy and nonintegrated pharmacies, respectively ( P = 0.046). CONCLUSIONS: The UR Specialty Pharmacy was associated with a 93% SVR rate and significantly greater adherence compared with nonintegrated pharmacies. Larger studies are needed to determine if a significant difference in SVR exists between integrated and nonintegrated pharmacies. This study provides a framework for other institutions to justify developing integrated hepatitis C specialty pharmacy services and evaluate their success.

Streptococcus pneumoniae vaccination in older adults.

BACKGROUND: Streptococcus pneumoniae infections are a major cause of morbidity and mortality in older adults. Vaccination in older adults is intended to prevent S pneumoniae infections, yet little information is available regarding its efficacy in this patient population. OBJECTIVE: The aim of this article was to review the current literature to determine the efficacy and tolerability of S pneumoniae vaccination in older adults. METHODS: PubMed (1950-present) and EMBASE (1974-present) were searched using the search terms Streptococcus pneumoniae immunization, pneumococcus immunization, pneumococcus vaccine, and aged. Additional articles were identified from the reference lists of included studies. Studies were included if they reported information in older (55-<65 years) and elderly (≥65 years) adults and were related to at least 1 of the following topics: epidemiology of S pneumoniae, estimates of vaccine coverage, recommendations for vaccination, tolerability, and efficacy and/or effectiveness of vaccination against S pneumoniae. RESULTS: Six randomized controlled trials and 18 observational studies that evaluated the efficacy of pneumococcal vaccination in older and elderly adults were reviewed. Findings from evaluations of efficacy, as measured by clinical outcomes and immunogenicity, in older adults have been conflicting, with some subsets of prospective, well-controlled studies finding little benefit, whereas findings from several retrospective studies have suggested significant benefit. This discord may have been a result of the limited power of the prospective subanalyses to detect significant differences. CONCLUSIONS: In light of the potential clinical benefit and few reports of serious adverse events, vaccination in older adults is likely warranted. Prospective, well-controlled studies are needed to better quantitatively evaluate the benefit of pneumococcal vaccine in older adults.