Review of Dual Biologics in Specialty Pharmacy Practice.

OBJECTIVE: To describe and review the published evidence on use of multiple biologics within specialty pharmacy practice. DATA SOURCES: A search of PubMed and Embase was conducted from October 2021 through September 2022. Keywords included biologics for immune-mediated conditions along with the terms "dual," "add-on," and "combination." STUDY SELECTION AND DATA EXTRACTION: All human studies in the English language were considered. Published abstracts, case reports, case series, randomized controlled trials, systematic reviews, and meta-analyses were included. DATA SYNTHESIS: Although evidence is limited, there are published meta-analyses of combined biologic use within gastroenterology and rheumatology. There are also numerous case reports within dermatology. Clinical trials of dual biologics for severe rheumatologic conditions and inflammatory bowel disease are in progress. Existing evidence for use in pulmonology and allergy suggest dual biologic therapy can be safe and effective, but data are limited. Literature describing use of monoclonal antibodies for other overlapping conditions is lacking. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: This article reviews the evidence describing combination biologic use and outlines remaining knowledge gaps. It also describes the essential role that specialty pharmacists play in managing therapeutic mAbs. CONCLUSIONS: High-quality evidence describing combination biologic use is limited and long-term safety data are lacking. Pharmacists should utilize their specialized training to assess appropriateness of therapy, provide patient counseling and monitor for safety and efficacy.

Evaluation of a specialty hepatitis C virus telephone pharmacy service.

PURPOSE: Direct-acting antivirals (DAAs) used to treat hepatitis C virus (HCV) infection are associated with significant drug-drug interactions (DDIs). Pharmacists are well positioned to identify and mitigate these DDIs. Data to guide assessment of the impact of HCV specialty pharmacy services on identifying and addressing DDIs with DAAs are lacking. The overall purpose of the study described here was to determine the incidence and severity of DDIs identified by specialty pharmacists among patients treated with DAAs prior to and 1 month into therapy. METHODS: An observational, retrospective study was conducted to evaluate the impact of specialty pharmacy services in mitigating DDIs associated with use of DAAs. Adult patients with HCV infection (n = 200) who received DAAs and were enrolled with a specialty pharmacy service over a 1-year period were included. Endpoints included number, severity, and type of DDIs and DDIs per patient at baseline and 1 month into therapy, pharmacists' interventions, and safety and clinical outcomes. RESULTS: Fifty-nine percent of patients had at least 1 DDI. A total of 170 DDIs were identified (137 at baseline and 33 at 1-month follow-up), and the mean number of DDIs per patient significantly decreased from baseline to 1-month follow-up (from 1.38 to 0.16, P < 0.0001). The rate of "potentially clinically significant" or "critical" interactions was significantly lower at 1-month follow-up vs baseline assessment (69.6% vs 81.7%, P < 0.0001). The most commonly identified DDIs involved acid suppressive medications (49.6% and 66.6% of DDIs at baseline and follow-up assessment, respectively) and cardiovascular medications (26.2% and 21.2%, respectively). Total number of DDI interventions was 131, with an acceptance rate of 85%. Most common intervention was patient education and monitoring. CONCLUSION: Approximately 60% of patients had DDIs with DAAs. Implementing HCV specialty pharmacy services significantly decreased DDIs while maintaining SVR12.

Management of anticoagulation in patients with human immunodeficiency virus/acquired immunodeficiency virus.

PURPOSE: Limited guidance is available to assist practitioners in managing complex human immunodeficiency virus (HIV) related pharmacotherapy. Management recommendations of oral anticoagulation (warfarin and direct oral anticoagulants [DOACs]) and highly active antiretroviral therapy (HAART) based on drug-drug interactions (DDI) studies and pharmacokinetic (PK) data are provided. METHODS: Search of PubMed, EMBASE, and Google Scholar (01/1985 to 12/2018) using the terms "HIV," "DDI," and names of HAART. PK information and DDI screening were obtained from medication package inserts and drug information resources: Micromedex, Lexicomp, HIV-DDI Checker- University of Liverpool. All English literature on DDI or PK interactions was considered for inclusion. In the absence of data, PK principles were used to predict the likelihood of interactions. RESULTS: No clinically significant DDI are expected to occur between DOACs and nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs), maraviroc, enfuvirtide, or integrase strand inhibitors (INSTIs) that do not include a pharmacologic booster. Potent cytochrome P (CYP) 450 enzyme inhibition by protease inhibitors (PIs) or pharmacologic boosters may lead to higher concentrations of the DOAC and potentially increase the risk of bleeding. CYP450 enzyme induction by non-nucleoside reverse transcriptase inhibitors (NNRTIs) may lower concentrations of DOACs, which may lead to treatment failure. Warfarin DDIs are variable, therefore close monitoring of the INR is recommended. CONCLUSIONS: The potential for DDIs between HAART and oral anticoagulation exists based on PK profiles. Management of these interactions should involve careful selection based on patient characteristics and HAART and anticoagulants with a low potential for DDI should be selected.

Assessment of mental health in doctor of pharmacy students.

INTRODUCTION: Pharmacy student mental health is of increasing concern to faculty, administrators, and students. The objectives of this study were to investigate the mental health of doctor of pharmacy (PharmD) students at a four-year college of pharmacy (COP), compare components of mental health of PharmD students to the general university campus students, and examine the relationship between academic distress and specific components of mental health. METHODS: The mental health status of PharmD students was measured using the Counseling Center Assessment of Psychological Symptoms (CCAPS-62), a validated survey tool assessing eight subscales of mental health. Comparisons were made within the PharmD student population and to the general campus population at the same university, who were surveyed during the same time period. Statistical analysis included a series of univariate regressions and chi square testing. RESULTS: Fifty-eight percent of PharmD students (193/332) voluntarily participated in the study. Over 25% of PharmD students scored in the high severity range for depression, generalized anxiety, academic distress, and eating concerns. Academic distress scores were significantly worse for second-year PharmD students, while hostility scores were significantly worse for third-year PharmD students. Correlations were identified between academic distress and depression, generalized anxiety, and social anxiety. PharmD scores in several subscales were significantly worse than the general campus population. CONCLUSION: High academic stress levels and poor mental health outcomes were observed in PharmD students. Identification and implementation of methods to reduce the psychological distress of PharmD students are needed.