Journal of Pharmacy Technology最新文献

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.

Objective: Provide real-world data on switching from adalimumab biosimilar MSB11022 to GP2017 related to persistence, adherence, and safety in adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). Methods: Retrospective cohort study that used registries and medical records from a single hospital (June 2022 to April 2024). Adult patients with RA, PsA, and axSpA treated with adalimumab biosimilar MSB11022 who switched to biosimilar GP2017 were identified and followed up until April 2024, or disenrollment. Baseline demographic and clinical characteristics studied included sex, age, diagnosis, and previous treatment. Adherence was measured using medication possession ratio (MPR); patients with MPR ≥85% were considered adherent. Persistence, cause of discontinuation, safety, and dosage regimen were collected. Results: A total of 63 patients with chronic inflammatory rheumatic diseases, of whom 36 (57.1%) were women, with an average age of 53.9 years were included. In total, 24 had axSpA, 21 had RA, and 18 had PsA. A total of 58 patients (92.1%) were biologic-naïve, and 27 (42.3%) received methotrexate. A total of 63 patients switched from adalimumab biosimilar MSB11022 to GP2017. After 12 months, 53 (84.1%) continued; 9 (14.3%) discontinued due to lack of effectiveness, side effects, or change of health department. The total persistence of patients who switched from MSB11022 to GP2017 was 12.4 ± 3.1 months. Non-naïve patients had a persistence of 13.7 ± 0.5 months, and naïve patients had 9.5 ± 3.0 months, with no significant differences. The retention rate at 12 months was 84%, with an adherence rate of 88.2%. Conclusions: Switching from adalimumab biosimilar MSB11022 to biosimilar GP2017 in patients with chronic inflammatory rheumatic diseases did not lead to signs of safety or loss of efficacy over 12 months other than those already known in the literature for the class of drugs.

Background: Fluoroquinolones (FQs) are associated with potential tendon injury but comparative risk versus other antibiotic (non-FQ) options for the same indication has rarely been evaluated.

Objective: Describe the incidence (relative risk) of any tendon injury in patients receiving FQs compared with other (non-FQ) antibiotics for treatment of urinary tract infections (UTIs).

Methods: A retrospective propensity score-weighted cohort study was performed to evaluate the association between FQ antibiotics and tendon injury at two time points (within one month and within six months of use) compared with non-FQ regimens for treatment of UTI. The evaluation was performed using the Merative™ MarketScan^® Research Databases from 2014 to 2020. Adult patients with International Classification of Diseases (ICD)-9/10 coding for UTI were included. Patients with a history of tendon injury or those who received both FQ and non-FQ regimens during the study period were excluded. Propensity score weighting was used to adjust for selection bias due to contributing risk factors, including demographics (age, sex), comorbidities (diabetes mellitus, chronic kidney disease), and concurrent medications (corticosteroids).

Results: Both the 1-month and 6-month cohorts were predominately female and less than 50 years of age. At one month, the incidence of tendon injury was 0.2% in the FQ group and 0.1% in the non-FQ group, and the odds of tendon injury were not estimated to be significantly different between groups (odds ratio [OR] = 1.03, 95% confidence interval [CI] 0.93, 1.32). Odds of tendon injury were also not estimated to be significantly different in the 6-month cohort (OR = 0.98, 95% CI 0.84, 1.05).

Conclusion and relevance: In this population of predominantly young female patients without high incidence of potentially contributing comorbidities, increased risk of tendon injury was not associated with FQ use. Future research is needed to determine whether demographic differences between this and other previously studied populations account for this discordant result.

Background: Infliximab is an anti-tumor necrosis factor agent used to treat rheumatologic disease. Evidence on the safety of switching to biosimilars and the associated risk factors for flares/loss of disease control within rheumatology is limited. Objective: The primary objective is to evaluate nonmedical switches from reference infliximab to biosimilars in rheumatology on risks and level of disease control. Methods: This retrospective analysis of data was conducted on all adult patients at our institution's rheumatology clinics with a rheumatologic diagnosis who were stable on reference infliximab and switched to the formulary biosimilars infliximab-dyyb or infliximab-abda, during the study period. Patient demographics as well as concomitant rheumatologic medications, markers of disease control, and hospitalization data were collected. Results: Of the 317 patients screened, 48 patients met inclusion criteria. A total of 29 patients (60.4%) were on reference infliximab and 19 patients (39.6%) were switched to biosimilar. Eight patients (42.1%) flared after a switch to biosimilar. Of the biosimilar patients, all patients were on infliximab-dyyb and were mandated to switch by insurance. Two patients who flared after switch to biosimilar (25%) had a delay in treatment due to attempts to receive prior authorization for reference infliximab. Conclusions: In the patients who switched to biosimilar, almost half experienced a flare. Two of these eight patients (25%) had a delay in treatment after the switch, which may be a risk factor for flaring/loss of disease control. Pharmacists should be following patients who switch to biosimilar closely during the transition period, to monitor for signs of flares/loss of disease control.

Background: Expansion of sodium-glucose cotransporter-2 inhibitor (SGLT2i) use in chronic kidney disease (CKD) prompted a pragmatic study of their safety and effectiveness in patients with type 2 diabetes mellitus (T2DM) and late-stage CKD. Objective: The primary clinical endpoint was change in HbA_1c. Secondary clinical endpoints included change in body weight and blood pressure. Safety endpoints included kidney function indices, mycotic or urinary tract infection, acute kidney injury, dehydration, and ketoacidosis. Methods: Adult patients with T2DM and late-stage CKD prescribed an SGLT2i between June 1, 2018 and June 1, 2023 were included in this retrospective cohort study. Late-stage CKD was defined as CKD stage G3b, G4, or G5, including requiring dialysis or kidney transplantation. Endpoints were compared between patients who continued an SGLT2i versus those who discontinued. Results: Fifty-nine patients were included. Short-term follow-up over 4.2 ± 1.7 months revealed no difference in HbA_1c between groups. Extended follow-up in a truncated sample over 10.4 ± 2.6 months showed modest, yet significantly lower HbA_1c with continuation (median: -0.3 vs 0.1%; P = 0.04). Weight loss was greater when treatment continued (median: -1.8 vs 0.2 kg; P = 0.01), whereas blood pressure did not differ. No differences in safety endpoints were observed. Kidney function mildly, but significantly worsened with continuation (median estimated glomerular filtration rate [eGFR]: -2.7 vs 0 mL/min/1.73 m²; P = 0.03). Conclusions: Patients with T2DM and late-stage CKD had similar glucose control and safety profiles irrespective of SGLT2i continuation or discontinuation. This may favor clinical decision-making toward benefits of SGLT2i reduction in weight, cardiovascular events, CKD progression, and hospitalizations over potential safety concerns in these patients.

Purpose: Prompt treatment of sepsis and septic shock is critical as delays increase mortality risk. Various tools, such as electronic alerts, standardized order sets, and rapid response teams, are used to expedite sepsis bundled care, yet their individual effects on outcomes and antimicrobial timing are unclear. This study evaluated the impact of an Inpatient Code Sepsis protocol, featuring an overhead page and order set, on mortality in hospitalized patients with sepsis and septic shock. Methods: A retrospective cohort study was conducted at a 371-bed hospital from July 1, 2020, to July 31, 2023. Hospitalized adults (≥18 years) diagnosed with sepsis and septic shock before and after the Inpatient Code Sepsis protocol implementation were included. The primary outcome was 30-day all-cause mortality; secondary outcomes were hospital length of stay, 30-day readmission, and time to antibiotic administration. Patients were excluded if they were identified for sepsis without infection, had sepsis due to non-bacterial causes, lost to follow-up within 30 days of admission, received empiric antibiotics in an emergency department or outside hospital, or were missing antibiotic administration time. Results: A total of 138 patients were included in the analysis. Mortality within 30 days did not significantly differ preprotocol and postprotocol (p = 0.381). However, a significant reduction in time to antibiotic administration was noted postimplementation (p < 0.05). Hospital length of stay and 30-day readmission showed no significant changes. Conclusion: The Inpatient Code Sepsis protocol did not impact 30-day mortality but did improve the time to antibiotic administration.

Retatrutide, a hormone receptor agonist targeting glucagon, glucagon-like peptide 1, and glucose-dependent insulinotropic polypeptide, is being developed to treat obesity. A literature review from April 2019 to April 2024 included such terms as "retatrutide," "LY3437943," "overweight," and "obesity." Phase I proof-of-concept studies led to phase II trials showing up to 24% body weight reduction and nearly 20 cm waist circumference reduction. The most common adverse effects were gastrointestinal. Ongoing phase II and III studies aim to further evaluate the safety and efficacy of retatrutide as a novel triagonist for obesity treatment.