P = .04) at independents. A number of erroneous statements were made by respondents, including that naloxone was a controlled substance, that a tablet formulation was available, and that injectable formulations not appropriate for layperson use were available.Discussion | Two years after implementation, only 23.5% of a representative sample of California retail pharmacies were furnishing naloxone to patients without a physician prescription. Reasons the practice was not being implemented may include lack of knowledge of legislation, lack of required training, stigma about substance use disorder, and time. 4,5 With only 50.6% of pharmacies stocking nasal naloxone, patients may face a delay in access to the drug.Limitations include low rural pharmacy representation, inclusion of nonpharmacist respondents, absence of data on reasons why pharmacies were not furnishing naloxone, and restriction to California, although most states have some form of pharmacy-based naloxone distribution. Over the last 2 years, the Board of Pharmacy has provided naloxone training to more than 700 of California's 40 000 pharmacists. Whether naloxone will become more available with training of additional pharmacists and implementation of standardized policies by pharmacy chains needs to be studied.
Precision pharmacotherapy encompasses the use of therapeutic drug monitoring, evaluation of liver and renal function, genomics, and environmental and lifestyle exposures; and analysis of other unique patient or disease characteristics to guide drug selection and dosing. This paper articulates real‐world clinical applications of precision pharmacotherapy, focusing exclusively on the emerging field of clinical pharmacogenomics. Precision pharmacotherapy is evolving rapidly, and clinical pharmacists now play an invaluable role in the clinical implementation, education, and research applications of pharmacogenomics. This paper provides an overview of the evolution of pharmacogenomics in clinical pharmacy practice, together with recommendations on how the American College of Clinical Pharmacy (ACCP) can support the advancement of clinical pharmacogenomics implementation, education, and research. Commonalities among successful clinical pharmacogenomic implementation and education programs are identified, with recommendations for how ACCP can leverage and advance these common themes. Opportunities are also provided to support the research needed to move the practice and application of pharmacogenomics forward.
The Letters column is a forum for rapid exchange of ideas among readers of AJHP. Liberal criteria are applied in the review of submissions to encourage contributions to this column. The Letters column includes the following types of contributions: (1) comments, addenda, and minor updates on previously published work, (2) alerts on potential problems in practice, (3) observations or comments on trends in drug use, (4) opinions on apparent trends or controversies in drug therapy or clinical research, (5) opinions on public health issues of interest to pharmacists in health systems, (6) comments on ASHP activities, and (7) human interest items about life as a pharmacist. Reports of adverse drug reactions must present a reasonably clear description of causality. Short papers on practice innovations and other original work are included in the Notes section rather than in Letters. Letters commenting on an AJHP article must be received within 3 months of the article's publication. Letters should be submitted electronically through http://ajhp.msubmit.net. The following conditions must be adhered to: (1) the body of the letter must be no longer than 2 typewritten pages, (2) the use of references and tables should be minimized, and (3) the entire letter (including references, tables, and authors' names) must be typed double-spaced. After acceptance of a letter, the authors are required to sign an exclusive publication statement and a copyright transferal form. All letters are subject to revision by the editors.
Lung transplantation is the only definitive treatment for patients with end-stage lung diseases. Despite numerous advancements in transplantation, infection remains the most common complication after lung transplantation. Risk factors for infection post-lung transplantation include donor-derived bacterial transmission, lung allograft exposure to the external environment, diminished cough reflex, abnormal mucociliary clearance, interrupted lymphatic drainage, and immunosuppression. 1Perioperative infections can have short and long-term sequelae including increased rates of acute and chronic lung allograft rejection, impaired graft function, and increased mortality. [2][3][4] To decrease the risk of donor-derived bacterial infections, transplant centers utilize extended courses of perioperative antibiotics in the setting of positive donor cultures. 5 However, duration of perioperative antibiotic therapy remains controversial with reported treatment durations ranging from 7 to 14 days. [5][6][7][8][9] Lack of formal
BackgroundCefepime is a fourth-generation cephalosporin antibiotic used for the treatment of neutropenic fever, pneumonia, and urinary tract infections. The safety of cefepime is now being questioned as it has recently been implicated as a possible cause for lesser known adverse effects, including neurotoxicity. The objective of this study was to evaluate the association between cefepime and neurotoxicity.MethodsAdverse drug reactions (ADRs) reported to the U.S. Food and Drug Administration (FDA) from January 1, 2015 to September 30, 2017 were extracted from the FDA’s Adverse Event Reporting System (FAERS). The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify preferred terms that were subsequently used to create a neurotoxicity composite ADR. Reporting Odds Ratios (RORs) and corresponding 95% confidence intervals (95% CI) were calculated for the neurotoxicity composite ADR and for common preferred terms associated with neurotoxicity. An association was considered to be statistically significant if the 95% CI did not include 1.0.ResultsThe neurotoxicity composite ADR (consisting of 40+ MedDRA preferred terms) occurred in 13.9% (n = 209/1504) of cefepime reports. Cefepime was three times more likely to have a report of the neurotoxicity composite ADR as compared with other drugs in the FDA’s FAERS database (ROR, 2.90; 95% CI, 2.51–3.36). The most frequent individual MedDRA preferred terms for the neurotoxicity composite ADR included (in descending order): “confusional state” (3.1%, 46/1,504), “mental status changes” (2.8%, 42/1,504), “encephalopathy” (2.3%, 35/1,504), “seizure” (2.3%, 34/1,504), “myoclonus” (1.8%, 27/1,504), and “neurotoxicity” (1.2%, 18/1,504). The highest RORs with cefepime vs. other drugs were (in descending order): “myoclonus” 45.0 (30.6–66.1), “encephalopathy” 29.7 (21.2–41.6), “mental status changes” 27.8 (20.4–37.8), “neurotoxicity” 26.7 (16.7–42.6), “confusional state” 4.3 (3.2–5.7), and “seizure” 3.5 (2.5–4.9).ConclusionCefepime was associated with significantly higher odds of myoclonus, encephalopathy, mental status changes, neurotoxicity, confusional state, seizure, and a neurotoxicity composite ADR as compared with other drugs. Practitioners should use caution in initiating cefepime in those patients at risk of neurotoxicity and monitor closely for ADRs.Disclosures All authors: No reported disclosures.
Background Lung transplant recipients are at increased risk for infection in the early post-operative phase. Perioperative antibiotic (POA) practices are variable among transplant centers with sparse data regarding optimal antibiotic prophylaxis duration. This study aimed to evaluate the efficacy of short course (SC) (≤10 days) vs long course (LC) (≥11 days) POA in lung transplant patients. Methods This was a single-center, retrospective study of non-cystic fibrosis first time lung transplant recipients with donor positive cultures between Aug 2013 and Sept 2019. Patients who died within 14 days of transplant were excluded. Data collected included baseline characteristics, donor and recipient cultures, POA, and hospitalization details. The primary outcome was 30-day recipient freedom from donor-derived respiratory bacterial infection. Secondary outcomes included development of Clostridioides difficile infection (CDI), cumulative time on ventilator, post-op time to extubation, in-hospital all-cause mortality, and 30-day development of POA resistance. Descriptive statistics were used for analysis. Continuous variables were compared using the Wilcoxon rank sum test while categorical variables were compared using the chi-square or Fisher’s exact test. Statistical significance was defined as p< 0.05. Results A total of 147 patients were included (58 SC vs 89 LC). Median POA duration in the SC group was 6.5 days vs 13 days in the LC group (p< 0.0001). The primary outcome of 30-day freedom from donor-derived respiratory infection was present in 56 (97%) patients in the SC vs. 85 (96%) patients in the LC group (p= 1). There was no difference in development of CDI (p = 0.4), mortality (p = 1), or resistant organisms (p=0.28) while cumulative ventilator time and time to post-op extubation were longer in the LC group (p = 0.002 & 0.007, respectively). Methicillin-sensitive Staphylococcus aureus was the most common organism isolated from donors in the SC (23, 40%) and LC (48, 54%) groups. Conclusion Among lung transplant recipients with positive donor cultures, short course POA was as effective as long course in preventing donor-derived bacterial pneumonia. Further studies are needed to assess heterogeneity in POA practices and optimal duration among transplant centers. Disclosures Brian C. Keller, MD, PhD, CareDx, Inc. (Grant/Research Support) Bryan A. Whitson, MD, PhD, Abbott Laboratories (Consultant)TransMedics OCS (Other Financial or Material Support, Serves on the Clinical Events Committee)
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