Journal of Pharmacy Technology最新文献

Introduction: Previous studies have shown that the manufacturer's standard fixed dosing of enoxaparin for venous thromboembolism (VTE) prophylaxis leads to sub-prophylactic anti-Xa levels in medicine patients with obesity. Yet, there is limited literature describing higher dosing strategies in this patient population, and an optimal dosing regimen has not been well-established. Objective: The primary objective was to evaluate mean doses (mg/kg/d) of prophylactic enoxaparin that are associated with goal anti-Xa levels in medicine patients with obesity across 3 body mass index (BMI) groups (40-49 kg/m², 50-59 kg/m², ≥60 kg/m²). Methods: This is a single-center, retrospective cohort study of adult patients (age ≥18 years) with BMI ≥40 kg/m² admitted to a medicine team with at least 1 appropriately drawn anti-Xa level between January 2018 and July 2023. The institution's goal anti-Xa level for VTE prophylaxis was 0.2 to 0.4 units/mL. The primary outcome was the comparison of mean dose between those within anti-Xa at goal and not at goal. Secondary outcomes included the percentages of initial anti-Xa levels below, within, or above goal range and the incidence of new VTE and major bleeding events during hospitalization while on enoxaparin. All outcomes were stratified into 3 BMI groups: 40-49 kg/m², 50-59 kg/m², and ≥60 kg/m². Results: Median dose of those with final anti-Xa level at goal was significantly higher than that of those not in goal anti-Xa range across all 3 BMI groups (0.57 vs 0.50 mg/kg/d; P < 0.05). The majority of the initial anti-Xa levels were subprophylactic, with only 35.7% of patients (or 75 of 210 patients) had initial anti-Xa within the goal range. There were no statistically significant differences in the number of blood transfusions or VTE events between the groups. Conclusion: Findings suggest that medicine patients with BMI ≥40 kg/m² may require enoxaparin doses higher than 0.5 mg/kg/d to reach goal prophylactic anti-Xa level. However, more robust data are necessary to further validate these results and the clinical implications.

Background: During the coronavirus disease 2019 (COVID-19) pandemic, many clinical practices shifted to using virtual platforms to care for patients. After in-person visits resumed, many patients continued to participate in virtual care. Objective: This study evaluated the impact of hybrid care (virtual and in-person visits) on diabetes control in patients seen by clinical pharmacists operating under collaborative drug therapy management (CDTM). Methods: A retrospective chart review was completed for adult (18+) patients with type 2 diabetes (T2D) managed under CDTM protocols in clinical pharmacy ambulatory care clinics. Patients were included if they were discharged between January 2018 to December 2019 (pre-video) or January 2022 to December 2023 (post-video) and had documented baseline and post-intervention hemoglobin A1c (HgbA1c) values. Results: Of the 528 patients that met the inclusion/exclusion criteria, 290 were in the pre-video group and 238 were in the post-video group. There was a non-statistically significant trend toward a greater average decline in HgbA1c in the post-video period (-1.7) compared with the pre-video period (-1.5) (P = 0.239). Secondary outcomes showed the percentage of no-show appointments to be less in the post-video group (7.1 vs 5.2; P = 0.0178) and the mean number of visits to be similar (6.4 vs 6.3; P = 0.5753). Conclusions: A hybrid visit-type model that incorporates video appointments into clinical pharmacy practice provided similar outcomes to traditional in-office/telephone visits. These results demonstrate the importance of ambulatory care pharmacists continuing to offer virtual visit types despite no longer being in a state of emergency.

Background: Clinicians often use parenteral lead-in regimens prior to direct oral anticoagulants (DOACs) for venous thromboembolism (VTE) in hospitalized patients due to shorter half-life and the ability to use laboratory monitoring. Objective: This study evaluates the effectiveness and safety of different apixaban lead-in durations for hospitalized adults with newly diagnosed VTE. Methods: Retrospective review of patients with one of the following lead-in regimens: (1) parenteral anticoagulation ≥ 48 hours with abbreviated course of apixaban lead-in, (2) parenteral anticoagulation ≥ 48 hours with full apixaban lead-in, or (3) no parenteral anticoagulation with full apixaban lead-in. All followed by maintenance apixaban for at least 6 months. Primary outcomes were incidences of recurrent VTE (rVTE) or bleeding events, in accordance with International Society on Thrombosis and Hemostasis (ISTH) definitions, within 6 months of the index visit. Data are presented descriptively and univariate analyses between groups performed. Results: Sixty-eight patients were included; rVTE (all deep vein thrombosis (DVT)) occurred in 2 patients (2.9%) and bleeding events (all clinically relevant non-major bleeding) occurred in 3 patients (4.4%) overall. There were no differences between groups; one patient in the parenteral group had full lead-in and one patient in the full-lead apixaban group had rVTE. One patient in the parenteral with full lead-in and 2 patients in the full lead-in apixaban group had a bleeding event (P = 0.99). Mean time to rVTE or bleeding event was 46 and 158 days, respectively. Conclusions: Similar safety and effectiveness were noted between the 3 apixaban lead-in regimens. These findings suggest that all 3 regimens provide similar outcomes, warranting further investigation to optimize lead-in strategies.

Study objectives: Zolpidem is a widely prescribed medication for treating insomnia due to its effectiveness as a sedative-hypnotic. This study aimed to estimate the incidence of potential adverse effects associated with the use and misuse of zolpidem.

Methods: Retrospective cohort study. Participants were selected from consumers who had purchased zolpidem in a commercial pharmacy in Brazil and submitted an interviewed. Descriptive analysis was used to present the results. Pearson's chi-square tests were used to compare adverse reactions to zolpidem with categorical variables, and Student's t-tests were used to compare means. The significance level adopted was 5%.

Results: The study involved 65 participants, with a mean age of 52.7 years, 76.9% of whom were women. Of the total sample, 69.2% used zolpidem for the treatment of long-term insomnia, and 77.4% used it continuously. Among the interviewees, 55.4% reported experiencing adverse reactions, with amnesia, insomnia, and sleepwalking being the most reported. A statistically significant association was found between the occurrence of adverse reactions and continuous use (P value = 0.048), as well as among those with lower mean age (P value = 0.042).

Conclusion: Despite being a prescription-controlled medication, zolpidem was used excessively and inappropriately in the studied sample. Given the high prevalence of adverse effects identified in this study, the risk/benefit ratio of pharmacological treatments for insomnia warrants careful evaluation during prescription and dispensing. Incidence of adverse effects and misuse of zolpidem.

Objective: To evaluate the evidence for the use of ascorbic acid, thiamine, or a combination of both agents without corticosteroids in the management of sepsis and septic shock.

Data sources: A review of the literature was conducted through August 2023 on PubMed, MEDLINE, Web of Science, and CINAHL using the following terminology: "ascorbic acid" OR "vitamin C" OR "thiamine" OR "vitamin B" OR "vitamin B 1" AND "sepsis" OR "septic shock" NOT "steroid" OR "hydrocortisone" OR "corticosteroid."

Study selection and data extraction: Trials that described patient outcomes, medication efficacy, and medication safety data were considered for inclusion, while reports describing the use of either or both thiamine and ascorbic acid for a non-sepsis indication and reports that were not readily translatable to English were excluded. Studies that allowed corticosteroid use in both the intervention and control cohorts as part of a standard-of-care protocol were eligible for inclusion.

Data synthesis: Heterogeneity of data exists, marked by divergent quantifications for successful pharmacotherapy interventions. Whereas some data support changes in patient outcome scores or critical illness indices, others have failed to demonstrate any meaningful benefit to ICU length of stay, ventilator status, or mortality.

Conclusion: Exploring the individual and synergistic effects of ascorbic acid and thiamine on key pathways implicated in sepsis pathophysiology has not yielded unequivocal evidence supporting their use without concomitant corticosteroids.

Objective: The objective of the study is to review the characteristics, efficacy, safety, and clinical relevance of sotatercept in pulmonary arterial hypertension (PAH). Data Sources: A literature search containing search terms related to sotatercept and PAH was conducted. Embase via Elsevier, MEDLINE via Ovid, the medRxiv preprint server, Cochrane Library CENTRAL trials registry, and ClinicalTrials.gov were searched from inception through October 31, 2024. The package insert was utilized to obtain drug information and additional data. Study Selection and Data Extraction: Phase II-III clinical trials investigating sotatercept for PAH were included. Articles written in English were extracted while animal studies and phase I clinical trials were excluded. Data Synthesis: In patients with WHO Group 1, functional class II-III PAH, adding sotatercept to background therapy increased 6-minute walk distance in phase II-III trials. Pooled analysis from PULSAR (phase II) and STELLAR (phase III) showed improvements in pulmonary vascular resistance and NT-proBNP. Exploratory data from PULSAR revealed that BMPR2 genetic variant status was not associated with significant differences in treatment effects. SPECTRA (phase IIb) demonstrated improved right ventricular structure and function. Interim analysis from SOTERIA showed that treatment effects persist at 1 year. Conclusions: Sotatercept is a viable add-on therapy for patients with PAH Group 1 and functional class II-III. Additional data are needed to assess long-term outcomes among treatment-naïve patients and those with the most severe symptomatology.

Background: Sustained-release prostaglandin intracameral implants are new targeted treatment options for open-angle glaucoma or ocular hypertension that lower intraocular pressure (IOP) and reduce or eliminate the need for topical eye drops. Objective: To summarize evidence supporting prostaglandin intracameral implants for treatment of ocular hypertension or open angle glaucoma and identify patient populations most likely to benefit from these treatments. Data sources: A PubMed search (1/1/2016 to 10/1/2024) was conducted to identify randomized, controlled clinical trials for bimatoprost 10-μg and travoprost 75-μg intracameral implants. Manufacturer prescribing information, formulary dossiers, Food and Drug Administration (FDA) clinical reviews and glaucoma clinical treatment guidelines were also reviewed. Study selection and data extraction: English-language randomized controlled trials involving bimatoprost 10-μg or travoprost 75-μg intracameral implants were included. Data synthesis: Bimatoprost and travoprost intracameral implants demonstrated noninferior IOP reduction compared to timolol eye drops in phase 3 trials, with sustained effects up to 12 and 36 months, respectively. The FDA-approved implants are limited to a single administration to the affected eye to minimize corneal risks. The travoprost implant contains a titanium reservoir and requires surgical placement, while the bimatoprost implant is biodegradable and can be placed in a clinic setting. There are no studies directly comparing the safety and efficacy of the two intracameral implants. Conclusions: Prostaglandin intracameral implants are a novel approach to reducing medication burden while delivering sustained IOP reducing effects. Pharmacists should be aware of efficacy and safety considerations of these implants relative to available topical treatments for ocular hypertension or open angle glaucoma.

Objective: To compare the efficacy and safety of 12-24 hours versus 72 hours of intravenous terlipressin therapy in patients with acute esophageal variceal bleeding (AVB). Data sources: A systematic search was conducted using PubMed, Scopus, Cochrane Library, Google Scholar, Web of Science, VHL, and ClinicalTrials.gov for studies published up to February 24, 2024. The search terms included "terlipressin," "variceal bleeding," "short-course," and "72-hour treatment." Study selection and data extraction: Randomized controlled trials (RCTs) comparing 12 to 24 hours with 72 hours of terlipressin therapy in patients with AVB were included. Studies not meeting these criteria or focusing on unrelated outcomes were excluded. Two authors conducted data extraction and bias assessment independently, with discrepancies resolved by a third reviewer. Baseline characteristics and outcomes (rebleeding and mortality within 5 days) were recorded. Results: Four RCTs with 469 patients were included in the analysis. There were no significant differences observed in 5-day rebleeding rates (OR = 0.943; 95% CI [0.384, 2.317]; P = 0.898) or mortality rates (OR = 0.386; 95% CI [0.066, 2.260]; P = 0.291) between terlipressin treatment durations of 12 to 24 hours and 72 hours within the first 5 days posttreatment. In addition, no heterogeneity was found in both variables (P > 0.1). Conclusion: This meta-analysis indicates that there is no significant difference in rebleeding rates or mortality between 12 to 24 hours and 72 hours of terlipressin therapy for AVB within 5 days posttreatment. Shorter treatment durations may offer advantages in terms of resource utilization and adverse event risk but require further validation through studies involving larger patient populations.

Background: Community pharmacies have grown to be an increasingly important provider of CLIA-waived tests, just second to physician offices as the venue with the most waivers. Yet, individual variation is still observed across states with respect to the percentage of pharmacies holding a CLIA-waiver, with a reported range of 10.7% in Massachusetts to 87.9% in Delaware. Objective: To identify how state laws can either impede or enhance access to POCT services by pharmacies by comparing the percentage of pharmacies in each state holding a CLIA-waiver to the legal model for POCT services in each state. Methods: Data from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website reported on December 4, 2023, were used to determine the number of pharmacies holding CLIA-waivers in each state. This was then divided by the number of community pharmacies in each state, as reported in the 2023 National Community Pharmacy Association Digest, and then compared with 2 public reports on pharmacy CLIA laws. Results: States categorized as allowing pharmacists to independently perform CLIA-waived tests in public reports actually had a lower percentage of pharmacies with a CLIA-waiver (49.60%) than those categorized as not allowing CLIA-waived tests (60.19%). As many as 10 241 pharmacies hold a CLIA-waiver in states that did not affirmatively report that pharmacists ordering lab tests was allowed. Conclusion: The paradoxical finding is likely a result of the underreporting of pharmacist CLIA-waived testing authority given the complexity of pharmacy law relative to other professions. Simplifying pharmacy law through adoption of a "standard of care" regulatory approach may enhance patient access to POCT services moving forward.