Journal of Pharmacy Technology最新文献

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: Heparin is a high-risk medication with significant variability across patients. Systematic data analysis can help hospitals improve heparin management, ensuring safe and effective anticoagulation. An opportunity exists to create a more efficient data collection process, allowing hospitals to streamline quality assurance programs. Objective: To assess the agreement between manual and electronic data abstraction for heparin quality assurance. Methods: This is a single-center, observational cohort study that evaluated patients who received therapeutic unfractionated heparin from September to November 20, 2023. Patients treated for less than 24 hours were excluded. Data were collected manually from pharmacist monitoring forms and the electronic medical record; electronic data abstraction was queried from an institutional data warehouse. The primary outcome was agreement in percentage of patients achieving a therapeutic aPTT within 24 hours. Secondary outcomes included agreement on time to therapeutic aPTT, agreement on time to therapeutic or supratherapeutic aPTT, and clinical outcomes. Results: The study included 288 patients. Manual data collection indicated 44.1% of patients were therapeutic within 24 hours, whereas electronic data collection showed 46.9% (kappa = 0.86). The kappa value for agreement of therapeutic or supratherapeutic aPTT within 24 hours was substantial (kappa = 0.69), with manual data showing 61.5% of patients therapeutic within 24 hours compared with 73.3% in electronic data. However, poor agreement was found when identifying subsequent heparin boluses (kappa = 0.13) and new venous thromboembolism cases (kappa = -0.01). Conclusions and Relevance: The metrics from the 2 data collection methods varied in reliability, ranging from highly consistent to poorly aligned. A hybrid approach, integrating manual and reliable electronic methods, has been implemented at our institution to improve efficiency. Further studies are needed to assess generalizability, and enhance electronic data capture for clinical outcomes.

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.

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.

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.