Journal of Pharmacy Technology最新文献

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.

Objective: To evaluate the safety of utilizing multimodal analgesic regimens in critically ill, nonintubated patients. Data Sources: A systematic review was conducted using Embase, MEDLINE, Cochrane, SciELO, Web of Science, and the Korean Journal Index. Clinical trials of critically ill, nonintubated patients that contained complete safety outcomes date, including the incidence of specific adverse drug effects (ADE) associated with a multimodal analgesic medication or regimen, were included. Study Selection and Data Extraction: The primary outcome was the incidence of adverse drug effects associated with multimodal analgesics in comparison to standard-of-care analgesic strategies in our patient population. The secondary outcome was a subgroup analysis of adverse drug effect by type and by medication. Data Synthesis: 10 trials were included in this systematic review, of which 6 were randomized control trials that were evaluated in the meta-analysis. There was no statistically significant difference with respect to the primary outcome (mean difference = -0.11, P = 0.31, 95% CI = [-0.35, 0.13]). The subgroup analysis, which was conducted on randomized clinical control trials that documented a single adjunctive analgesic rather than a multimodal regimen, was stratified by the type of adverse effect encountered and the medication in question. There were no statistically significant findings regarding the incidence of specific ADE. Nonrandomized data included in this study support these findings. Conclusions: While concerns of the additive deleterious adverse effects commonly encountered in polypharmacy are valid, our findings support the use of multimodal analgesic regimens in the provision of analgesic in critically ill, nonintubated patients.

Background: Closed system transfer devices (CSTD) help to reduce the exposure of healthcare professionals to hazardous drugs. They may be used in stability studies conducted on anticancer drugs. During a stability study about polyolefin bags of gemcitabine, Tevadaptor® device was suspected of causing a bias in the evaluation of the concentrations of the first aliquots extracted from the bags.

Objective: The objectives are to determine whether the use of a CSTD to prepare a drug solution and to withdraw it from a bag can interfere on the measured concentration compared to the expected one and to suggest hypothesis to explain the phenomenon.

Method: In the first experiment, three polyolefin bags of gemcitabine (5.4 mg/mL) were prepared under aseptic conditions using the Tevadaptor Luer Lock Adaptor®. The day of preparation, five aliquots of 3.8 ml each were sequentially withdrawn from each polyolefin bag using the same device. After one day, a new aliquot was withdrawn from each bag. In the second experiment, three polyolefin bags of gemcitabine (5.4 mg/ml) were prepared under aseptic conditions using a needle. One aliquot was extracted using a needle after the preparation from each bag, and another aliquot was extracted after one day. The concentrations of all aliquots were measured by liquid chromatography coupled to a photodiode array detector during the same run.

Results and discussion: The concentrations of the first aliquots extracted on day zero from the polyolefin bags using the Tevadaptor Luer Lock Adaptor® exhibit an overestimation of 26% ([95%CI: 23%-29%] P<0.001) compared to the others. Overestimation is not found for subsequent aliquots, or while using a needle to bypass the Tevadaptor® device.

Conclusion: This case highlights the bias that may arise when using CSTDs in stability studies. They should be used with comprehensive understanding of their technical specifications.

Background: The ever-increasing complexity and demand for antineoplastic therapy necessitates innovative solutions to improve the accuracy and safety of drug preparation. Objective: To evaluate the utilization of an advanced robotic chemotherapy drug compounding system (APOTECAchemo) at a Community Cancer Center (CCC), examining accuracy, efficiency, and staff perceptions. Methods: This single-center, retrospective study evaluated the preparation of 7 intravenous (IV) antineoplastics at a CCC over a 1-year period. We compared manual methods with the APOTECAchemo system. The primary measure of accuracy was the absolute drug error percentage, with a comparison of pass and fail rates. Secondary endpoints included the overall use of APOTECAchemo for all IV antineoplastic preparations and average preparation times. An end-user satisfaction survey gathered feedback from pharmacists and pharmacy technicians. Results: A total of 8210 doses were prepared at the CCC, with 52.1% compounded by APOTECAchemo and 47.9% manually. Of these, the CCC prepared 5526 doses of the 7 routinely compounded antineoplastics. APOTECAchemo prepared 3851 (69.7%) doses, while manual compounding accounted for 1675 (30.3%) doses. The average absolute drug error was 1.44% (95% CI, 1.35-1.53) with robot compounding versus 1.17% (95% CI, 1.03-1.32) with manual (P < 0.001). The overall failure rate was 0.72%. There were 25 failed doses (0.45%), with 8 (0.2%) failures attributed to APOTECAchemo and 17 (1%) to manual compounding (P < 0.001). The average dose preparation time was longer with APOTECAchemo compared with manual methods. The end-user satisfaction survey indicated a positive reception toward APOTECAchemo. Conclusions: Our study demonstrates the successful implementation, extensive utilization, and high accuracy of both APOTECAchemo and manual compounding methods in the preparation of routinely administered antineoplastics at a CCC.