Journal of Pharmacy Technology最新文献

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: Pharmaceutical waste represents a major burden to the health care system and environment. Proper drug waste disposal devices are vitally needed, especially for propofol solutions that inherently carry a high risk of microbial contamination. Objectives: The aims of this study were to compare the capabilities of 2 drug disposal systems for decontamination of propofol solutions inoculated with medical pathogens and assess chemical degradation of propofol after treatment with Fenton reagents. Methods: Standard microbiological assays were used to assess survival and growth of Escherichia coli and Candida albicans inoculated into propofol solutions. Both a prototype instrument and a commercially marketed disposal device were tested for their ability to kill microbial growth. Furthermore, a propofol bioanalytical assay utilizing high-performance liquid chromatography (HPLC) was developed to measure propofol concentrations before and after treatment with a Fenton reagent cocktail (iron and hydrogen peroxide). Results: Propofol emulsion and diluted solutions lack antimicrobial properties and support the growth of microbes. The prototype instrument effectively killed E. coli and C. albicans inoculated into propofol solutions, while the commercial product did not kill or inhibit the growth of the microorganisms. Finally, propofol was chemically degraded to undetectable quantities (< 0.13 ppm) upon exposure to Fenton reagents in a prototype instrument. Conclusions: We show for the first time that propofol solutions inoculated with microbes are decontaminated upon exposure to Fenton reagents. Treatment with Fenton reagents also chemically destroys the propofol molecule. These results will support the development of novel drug disposal devices for real-time application in the pharmacy setting.

Objective: To cultivate caregiver perspectives and empathy through computer-based simulations in the ambulatory care setting. Methods: A total of 46 third-year students were enrolled in the 2-week ambulatory care elective at the University of Florida College of Pharmacy. Students were assigned 5 computer-based simulated scenarios, each created to encompass elements regarding social determinants of health from a caregiver perspective. After each scenario, students were required to complete a post scenario assessment where students were tasked with reporting their emotional response by providing 3 adjectives upon completion. After completing all caregiver scenarios, students completed a postsimulation reflection connecting their experience with caring for their future ambulatory care patients. Both individual and final reflections were analyzed and assigned to the themes of emotional strife, compassion/understanding, self-reflection, resilience, and/or other to determine proportion of identified themes. Results: For the individual caregiver scenarios, the most identified theme was emotional strife amongst all scenarios (45%-68%). Regarding the final reflection, most of the theme identified were compassion/understanding (46%) followed by self-reflection (29%). Emotional strife was the least identified theme in the final reflection (7%). Conclusion: After students completed all the caregiver scenarios, students reported higher levels of compassion/understanding and self-reflection when compared with other identified themes. Through this computer-based simulation, students gained a better understanding and empathy toward the caregiver perspective when faced with common health care disparities in an ambulatory care patient population.

Background: Heparin infusions are used to treat and prevent thromboembolic complications in neurocritical care, but optimal dosing in patients with acute intracranial pathology or recent neurosurgery is uncertain, due to elevated risk of hemorrhage. Many institutions customize heparin nomograms for such patients but fail to methodically evaluate their effectiveness. Context: Neurocritical care unit in an academic medical center in the United States. Problem: Several incidents of heparin infusions failing to reach their partial thromboplastin time (PTT) goal within 24 hours of initiation occurred. This created a concern that existing heparin dosing protocol should be adjusted to attain goal PTT more rapidly to better treat thrombotic events. Objective: To reduce time to therapeutic effectiveness of weight-based heparin in neurocritical care patients at high risk of bleeding. Study Design: Quality improvement initiative, comparing data from a retrospective chart review (historical comparison cohort) and a prospective observational quality improvement initiative (QI cohort). Patients: Adult patients with acute intracranial pathology and acute indications for therapeutic anticoagulation but considered at high risk of intracranial hemorrhage. Interventions: Increase heparin dosing nomogram from 12 units/kg/h (historical cohort) to 18 units/kg/h (quality improvement cohort), without an initial bolus in either. Measurements: Primary endpoint was time to therapeutic activated partial thromboplastin time (aPTT) in hours, assessed with a Kaplan-Meier curve. Any known bleeding or thrombotic complications were recorded. Results: Time to reach therapeutic target aPTT was shorter in quality improvement cohort than in historical cohort (see Figure 1 in full text for details). Bleeding complications occurred in 3 of 21 patients in each cohort. Conclusions: Quality improvement initiatives such as this can make documented improvements in health care provided to neurocritical care patients.

Background: Calls to poison centers involving exposure to glucagon-like peptide-1 receptor agonists (GLP-1 RA) have increased. Data from a statewide poison control system from 2017 to 2023 was analyzed to assess changes in GLP-1 RA exposure frequencies and reported clinical effects. Methods: Retrospective records review of all human exposure cases to GLP-1 RA reported to a statewide poison center from December 1, 2017 to December 31, 2023. Collected data were entered into REDCap (Research Electronic Data Capture). Changes in exposure frequency over time assessed with interrupted time series analysis (ITSA); the intervention was FDA approval of semaglutide (Wegovy) for chronic weight management in June 2021. Statistical analyses completed using Stata v17 or OpenEpi (v3.01). Results: One thousand forty-seven cases were included. Interrupted time series analysis identified an increase in reported GLP-1 RA exposures of 1.16 per month ([CI = 0.570, 1.802]; P < 0.001) and an increase in hospital utilization from exposures of 0.351 per month ([CI = 0.159, 0.544]; P = 0.001) following Wegovy approval. Common adverse effects were nausea (n = 295, 28.0%), vomiting (n = 267, 25.5%), dizziness (n = 63, 6.0%), abdominal pain (n = 54, 5.1%), and other gastrointestinal symptoms (n = 60, 5.7%). Most cases were managed at home (n = 696, 66.5%). Two hundred twenty (21.0%) patients were treated in the emergency department, and 46 (4.4%) were admitted. The most common reason for exposure was unintentional therapeutic error (n = 838, 80.0%). Five major (0.5%) and 72 moderate (6.9%) medical outcomes were reported. Hypoglycemia occurred in 40 (3.8%) patients. Thirty-six exposures involving compounded GLP-1 RA were identified; administration errors were the main reason for exposures among this subgroup (n = 33, 91.7%). Conclusion: Glucagon-like peptide-1 receptor agonist exposures and hospital utilization after exposure increased following Wegovy approval for weight management. Hypoglycemia, while infrequent, was reported; nondiabetic patients using GLP-1 RA should be educated on recognizing hypoglycemia. Additional patient education on GLP-1 RA administration and further study on the impact of compounded GLP-1 RA products are warranted.

Background: HIV treatment has advanced significantly with the introduction of simpler antiretroviral regimens, but adherence remains a challenge. In this context, the long-acting injectable combination cabotegravir/rilpivirine (CAB/RPV) emerges as a promising alternative to improve adherence and quality of life for patients. Objective: The purpose of this study was to determine the proportion of patients with HIV-1 on antiretroviral therapy (ART) who meet the criteria for the use of intramuscular CAB/RPV. Methods: A single-center, retrospective observational study was conducted on patients with HIV-1 receiving ART at a Spanish hospital. Adult patients with at least 6 months of stable ART and a viral load result in the previous 12 months were included. Pregnant women, patients with less than 6 months of ART, or those without a recent viral load were excluded. The primary endpoint was the proportion of patients meeting the criteria for intramuscular CAB/RPV: undetectable viral load, stable ART, adherence >90%, no resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs)/integrase strand transfer inhibitors (INSTIs), no enzyme inducers, no anticoagulants, and no hepatitis B virus (HBV) infection. We also measure the risk of virological failure. Costs and treatment complexity were analyzed. Results: A total of 194 patients were included. In total, 68% met the criteria for intramuscular CAB/RPV. The main reasons for ineligibility were a recent ART switch (16%) and lack of adherence (11.3%). The mean annual incremental cost per patient when switching to CAB/RPV was €651.51. Conclusion and Relevance: A considerable proportion of patients with HIV meet the criteria for intramuscular CAB/RPV. However, lack of adherence and the costs associated with intramuscular therapy represent barriers to its implementation. Strategies to improve adherence and cost-effectiveness studies are needed.

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.

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.

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.