Impact of Infectious Diseases Consultation in Patients With Candidemia at a Multisite Health Care System With Established Antimicrobial Stewardship and Telemedicine Services.

Background: Infectious diseases consultation improves outcomes in patients with candidemia, although some facilities lack access to consultation. This multisite health care system study compared in-hospital mortality in patients with candidemia across 3 groups-those who received on-site consultation, telemedicine consultation, or no consultation. All patients were reviewed by an antimicrobial stewardship pharmacist. Methods: A retrospective observational cohort study was performed of adult hospitalized patients with candidemia from January 2018 to October 2021. The primary outcome was in-hospital mortality. Secondary outcomes included receipt and duration of antifungals, removal of central venous lines if present, ophthalmologic examination, echocardiography, and determination of infection source. Results: A total of 265 patients were evaluated: 187 in the on-site consultation group, 49 in the telemedicine consultation group, and 29 in the nonconsultation group. Although in-hospital mortality did not differ significantly between the on-site and nonconsultation groups, it was significantly lower in the telemedicine group when compared with the nonconsultation group (10.2% vs 34.5%, P = .009). Patients who received on-site or telemedicine consultation had significantly more antifungal therapy initiated, appropriate therapy duration, central lines removed, and echocardiography performed, as well as fewer unknown candidemia sources, vs those in the nonconsultation group. Conclusions: This is the first study of a multisite health care system providing telemedicine services to evaluate the impact of infectious diseases consultation on candidemia mortality. These findings suggest that when on-site consultation is unavailable, infectious diseases telemedicine consultation and antimicrobial stewardship can improve outcomes and should be considered for all patients with candidemia at resource-limited sites.

New Drugs Approved in 2022.

In 2022, the US Food and Drug Administration (FDA) approved 37 novel drugs. Twenty-four of the 37 (65%) novel drug approvals were reviewed and approved through an expedited review pathway and 20 of the 37 (54%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2022.

Tricyclic Antidepressant Overdose Manikin Simulation in Student Pharmacists.

Background: Pharmacists must be knowledgeable of medication use within the scope of both typical dosing and atypical dosing. In the United States, antidepressants are the fourth most common substance in overdose situations and are ranked first for serious exposures per year. Objective: The purpose of this study is to design, implement, and assess the efficacy of an antidepressant overdose simulation using a high-fidelity manikin. Methods: This was a single-center, prospective, observational, cross-sectional study of third-year student pharmacists in spring 2021. This study was determined to be exempt by the institutional review board. Students who did not participate in the manikin simulation or complete both the pre- and postsimulation surveys were excluded. Student pharmacists were expected to identify the type of overdose, identify probable offending agent, and evaluate the hemodynamic status. Primary objectives compared student pharmacist knowledge, confidence in recognizing overdose, and confidence in managing overdose pre- and post-antidepressant overdose manikin simulation. Results: Twenty-three students completed both surveys and participated in the simulation. The knowledge total score was 2.1 ± 1.3 in the presimulation and 2.9 ± 0.9 in the postsimulation (P < 0.001). The recognition confidence was 2.0 ± 1.3 in the presimulation and 3.7 ± 0.7 in the postsimulation (P < 0.001). The management confidence was 1.8 ± 1.0 in the presimulation and 3.5 ± 0.5 in the postsimulation (P < 0.001). Limitations in this study were small sample size, lack of rubric, and a case prompt. Conclusion: The outcomes were statistically significant postsimulation. Manikin simulations may have a larger impact on a pharmacy curriculum.

Beyond the Classroom: An Observational Study to Assess Student Pharmacists' Confidence and Perception of a High-Fidelity Manikin Chemotherapy Infusion Reaction Simulation.

Objective: To assess the impact of a high-fidelity manikin chemotherapy infusion simulation on student pharmacists' confidence in applying clinical knowledge and perception of oncology pharmacy practice. Methods: One cohort of third professional year student pharmacists completed a high-fidelity manikin simulation during the last week of their didactic training. The 10-minute manikin experience simulated an acute paclitaxel infusion reaction, requiring students to apply their knowledge on how to provide patient care during a chemotherapy-induced infusion reaction. A pre- and post-survey was administered to determine whether there was a change in students' confidence and perception. Results: Thirty-three student pharmacists (62%) completed the pre- and post-surveys and manikin simulation. A statistically significant improvement was seen in median confidence scores when comparing pre- and post-questions of all 10 survey items (P < 0.001). Students' perception of oncology pharmacy and the manikin simulation had mean of 4.4 on a 0- to 5-point Likert scale. Conclusion: The high-fidelity manikin experience improved student pharmacists' post-survey confidence of applying clinical skills. In addition, students' perception of oncology pharmacy improved and the use of a manikin simulation to support didactic learning was seen as an additional avenue for delivering didactic curriculum. This study explored the feasibility of introducing a manikin simulation into the oncology pharmacy curriculum and the benefit of providing hands-on application of clinical skills to support didactic concept-based learning.

Optimization of Antibiotic Selection in the Emergency Department for Adult Skin and Soft Tissue Infections.

Objectives: Emergency department (ED) order sets that include skin and soft tissue infections (SSTI) stratification and antimicrobial selection criteria may improve clinical outcomes and appropriateness of initial antibiotic selection. The purpose of this study was to optimize and evaluate antimicrobial prescribing for SSTI in the ED by implementing an institution specific Infectious Diseases Society of America (IDSA) guideline directed computerized provider order entry (CPOE) order set. The primary outcome was the rate of appropriate antibiotic prescribing for SSTI in the ED before and after order set revision. Secondary outcomes were length of hospital stay, rate of continuity of antibiotics from the ED to hospital admission orders, and frequency of order set utilization. Methods: This was a single-centered, retrospective, cohort study. The ED SSTI order set revision reflected current IDSA guidelines, institution formulary, and institution antibiogram. Results: A total of 180 patients were included in the study. The rate of appropriate antibiotic prescribing was 74.4% and 78.9% (P = .60) in the pre-revision and post-revision groups, respectively. Length of hospital stay of admitted patients was 4.93 and 4.32 days (P = .61). Rate of antibiotics continued from the ED to admission was 62.1% and 59.4% (P = .99). Order set utilization was 17.8% and 24.4% (P = .36). A subgroup analysis found appropriateness increased with order set use in admitted patients (50% vs 88.2%; P = .0382) and total patients (50% vs 81.8%; P = .037). Conclusion: An order set reflective of current IDSA guidelines and institution specific antibiogram showed a similar rate of appropriate antibiotic selection compared to provider's clinical judgment. Provider awareness of SSTI management could have been a limitation to the study.

New Drugs Approved in 2021.

In 2021, the US Food and Drug Administration (FDA) approved 50 novel drugs. Thirty-seven of the 50 (74%) novel drug approvals were reviewed and approved through an expedited review pathway, and 26 of the 50 (52%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2021.

Albumin Utilization in Spontaneous Bacterial Peritonitis.

BACKGROUND: Albumin has been shown to decrease the incidence of mortality and acute kidney injury (AKI) in patients with spontaneous bacterial peritonitis (SBP). Albumin administration in SBP is recommended within 6 hours of diagnosis and for reserved use in high-risk patients with the following baseline laboratory tests: serum creatinine >1 mg/dL, blood urea nitrogen >30 mg/dL or total bilirubin >4 mg/dL. OBJECTIVE: We aimed to assess the impact of an albumin order set restricted to high-risk SBP. METHODS: A retrospective cohort study was conducted between Jan 1, 2013 to Feb 28, 2018. The albumin order set was implemented on Sep 20, 2016. Patients were included if they were diagnosed with SBP and had an ascitic fluid polymorphonuclear count ≥ 250 cells/mm3. RESULTS: Out of a total of 137 patients reviewed, 88 met the inclusion criteria. The incidence of AKI in the pre-order set and post-order set were 63.93% and 33.33% (p = 0.01), respectively. The incidence of mortality in the pre-order set and post-order set were 36.07% and 7.41% (p = 0.005), respectively. The percentage of patients administered albumin within 6 hours were 24.59% to 40.74% (p = 0.14) in the pre-order set and post-order set, respectively. The percentage of patients who received the recommended albumin dosing regimen ordered was 42.62% vs 96.30% (p < 0.001), in the pre-order set and post-order set, respectively. CONCLUSION: The albumin order set restricted to high-risk SBP patients significantly reduced the incidence of AKI and mortality, and improved the appropriateness of albumin regimen ordered.

New Drugs Approved in 2020.

In 2020, the US Food and Drug Administration approved 53 novel drugs. Thirty-six of the 53 (68%) drugs were reviewed and approved through an expedited review pathway, and 31 of the 53 (58%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the US Food and Drug Administration in 2020.

Factors Influencing Prescribers' Decision for Extending Venous Thromboembolism Prophylaxis in the Medical Patient Population following Hospitalization.

Introduction Venous thromboembolism (VTE) prophylaxis during hospitalization has clearly defined metrics for risk stratification and practice policy employed to ensure processes of adherence. However, acceptance for practice or even the level and timeline of risk is less clear during the immediate time after hospitalization. With emerging new oral anticoagulant agents, data are available that may influence prescribing in the outpatient setting following hospitalization. A survey was created to determine the level of acceptance or influences for practice surrounding continuation of anticoagulation following hospitalization. Methods This study was designed as a single-center survey of hospitalist and family medicine physician to assess influences to the physician's impression for risk of VTE prophylaxis and knowledge of therapy options. Results Physicians reported depending heavily on medical center protocols for determining anticoagulation at hospital discharge. Prescribing postdischarge anticoagulation was reported to be affected by lack of comfort with prescribing oral medications and concerns with risk of bleeding for all types of anticoagulation outweighing the perceived benefit. Additionally, the decision whether to prescribe these medications at discharge was reported to be related to perceived cost and other patient barriers such as concerns over route of administration. Conclusion Concerns for bleeding were an influence and likely resulted in shorter duration for VTE prophylaxis being prescribed posthospitalization.

Ciprofloxacin/dexamethasone precipitate formation in the ear canal of a paediatric patient.

This case report describes a paediatric patient diagnosed with otitis externa and treated with topical ciprofloxacin/dexamethasone. The patient completed the course of therapy and then developed precipitate formation from the pharmacological treatment. Laboratory testing of the precipitate confirmed the presence of a large quantity of ciprofloxacin. Removal of the precipitate required the use of an elephant ear washer system and removal with surgical tweezers. This case report investigated a probable topical ciprofloxacin/dexamethasone-induced ear precipitate formation in the ear canal, which, subsequently, was successfully removed from the patient's ear canal.

New Drugs Approved in 2019.

In 2019, the US Food and Drug Administration (FDA) approved 48 novel drugs. Thirty of the 48 (62.5%) novel drug approvals were reviewed and approved through an expedited review pathway while 20 of the 48 (41.7%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2019.

Intravenous unfractionated heparin dosing in obese patients using anti-Xa levels.

There is limited guidance on intravenous dosing of unfractionated heparin in obese patients. The purpose of this study was to determine the efficacy and safety of a standard unfractionated heparin (UFH) protocol in obese patients based on total body weight (TBW) or adjusted body weight (ABW) to reach two consecutive therapeutic anti-Xa levels. This was a retrospective observational cohort study conducted in a large academic medical center. Adults received a standard UFH protocol between January 1, 2013 to December 31, 2015. Inclusion criteria included age ≥ 18 years of age, weight ≥ 100 kg with a BMI ≥ 30 kg/m2, and received intravenous UFH. Patients were excluded if they received an alternative UFH protocol, received < 24 h of the standard UFH protocol, or had inadequate compliance to protocol. Out of the 131 patients included, 109 patients reached two consecutive therapeutic UFH levels within 96 h. The average time to two consecutive therapeutic UFH levels was 29.4 h and 27.6 h in patients dosed by TBW and ABW, respectively (95% CI - 4.63 to 8.11; P = 0.93). Safety outcomes included major bleeding, overt bleeding, or death events between patients dosed by TBW compared to ABW, (p = 0.61, p = 1.0, p = 1.0, respectively). Dosing intravenous UFH based on TBW or ABW resulted in similar times to therapeutic anti-Xa levels and safety outcomes. The data provided suggests using either TBW or ABW in obese patients is as effective and safe to use.

Evaluation of Occipital Nerve Blocks for Acute Pain Relief of Migraines.

Migraines are a debilitating neurological disease affecting as many as 1 of 6 adults in the United States. Occipital nerve block, consisting of a local anesthetic and/or corticosteroid, has shown to be an effective treatment for the management of migraines. Occipital nerve block has been reported to reduce migraine pain scores, frequency, and duration. We aimed to evaluate the impact of occipital nerve block for acute pain relief in patients with migraines. This was a single-center retrospective observational study conducted at a 1162-bed academic medical center in Gainesville, Florida. Included patients were ≥18 years old, diagnosed with migraine with or without aura, and received at least 1 occipital nerve block. Excluded patients received nerve blocks not specific to the occipital region. The outcomes observed were migraine pain before and after administration within the same initial encounter of receiving an occipital nerve block using a numeric pain rating scale, injection direction, medications used, duration of effect and frequency of additional injections, and adverse reactions. A total of 190 patients met the inclusion criteria, with 63% rating their pain to be 6-8 of 10 prior to an occipital nerve block. After receiving an occipital nerve block, 27% of patients reported significant or immediate relief, and 42% experienced reduced pain scores of 0-2. The majority of injections were bilateral using lidocaine with dexamethasone. Only 3% of patients reported an adverse reaction. Occipital nerve block as adjunctive therapy has shown safety and efficacy in treating patients with migraines, measured by the reduction in pain.

New Drug Approvals in 2018 - Another Record Year!

In 2018, the US Food and Drug Administration approved 59 novel drugs. This all-time record was due primarily to the expedited review pathways; 43 of the 59 (73%) novel drug approvals were designated in an expedited review pathway, and 34 of the 59 (58%) were approved for treatment of rare diseases. A review of these novel drugs is summarized.

Influenza-induced rhabdomyolysis.

Rhabdomyolysis is characterised by muscle breakdown with release of damaging proteins that can have devastating consequences. Acute influenza infection is being increasingly recognised as an underlying aetiology. We report an unusual case of severe rhabdomyolysis with acute renal failure due to influenza A infection that improved with high-dose oseltamivir and intravenous fluids. In our case, we also noticed a temporal relation between fever spikes and subsequent increase in serum creatine kinase. The precise mechanism between the rise in temperature and creatine kinase is unclear but it could be due to direct viral invasion of myocytes or due to release of new viral progeny following replication in the myocyte.

2017 Is Banner Year for Drug Approvals by the Food and Drug Administration.

In 2017, the US Food and Drug Administration approved 46 novel drugs, and 29 drugs received newly approved indications. This record setting year was due in part to the new expedited review pathways. A review of these drugs is summarized.

Continuous Lidocaine Infusion as Adjunctive Analgesia in Intensive Care Unit Patients.

Despite a paucity of data, the role of intravenous lidocaine (IVLI) as adjunctive analgesia in the intensive care unit (ICU) seems promising due to a low potential to contribute to respiratory depression. A retrospective chart review was conducted to evaluate the safety and effectiveness of IVLI for the treatment of pain in ICU patients with varying degrees of organ dysfunction from March 2014 to March 2016. The primary outcomes included the time to a ≥20% reduction in pain scores after the initiation of IVLI and the difference in opioid requirements as well as pain scores prior to and during IVLI therapy. Other variables included the presence of IVLI-related adverse events and the dosage and duration of IVLI. A total of 21 ICU patients were included from 2 different hospitals. The mean time to a ≥20% reduction in pain scores from the start of IVLI was 3.3 hours (SD = 2.2). The median morphine dose equivalents required during 6, 12, and 24 hours pre-IVLI were significantly higher compared to the same time periods after IVLI (18.3 vs 10 mg, P = .002; 41.8 vs 18.3 mg, P = .002; 93.5 vs 30.5 mg, P = .037). Neurological adverse effects of lidocaine were noted in 3 patients, but the effects were reversed on IVLI discontinuation. This report suggests that IVLI as an adjunctive agent in the treatment of acute pain may be a potential option in ICU patients who are refractory to opioids or those in whom opioid-induced respiratory depression is a concern.