Emergency preparation and mitigation for COVID-19 response in an integrated pharmacy practice model.

PURPOSE: The purpose of this descriptive report is to share experiences in crisis response planning and risk mitigation at a university health system department of pharmacy with an integrated clinical practice model in the early months of the coronarvirus disease 2019 (COVID-19) pandemic. SUMMARY: The department of pharmacy's COVID-19 pandemic response included successful planning and implementation of measures to maintain pharmacy operations and minimize COVID-19 exposure of patients and staff. These measures included ensuring adequate personnel staffing using flexible staffing solutions, ongoing assessment of supply chain integrity, and continuation of integrated clinical pharmacy services 24/7 throughout the initial phase of the COVID-19 pandemic. Information technology (IT) and educational program modifications are also discussed. CONCLUSION: This report describes successful crisis planning and risk mitigation in the setting of COVID-19, which was facilitated by the department of pharmacy's integrated clinical practice model. This model enabled uninterrupted personnel scheduling, supply chain integrity, continued provision of 24/7 integrated clinical services, adaptive use of IT tools, and continuation of educational programs. The experiences described may be instructive to other pharmacy departments in evaluating their response to the COVID-19 pandemic and in planning for similar pandemic or other emergency scenarios.

Impact of a Plan of Care Protocol on Patient Outcomes in People Who Inject Drugs With Infective Endocarditis.

BACKGROUND: People who inject drugs (PWID) are at increased risk of deleterious sequelae due to infective endocarditis (IE). A standardized, hospital-wide drug use-associated infection protocol targeting medication safety, pain management, and limiting external risk factors was implemented at an academic medical center to improve outcomes in PWID with IE. METHODS: A quasi-experimental study included patients with active injection drug use and definite IE from January 2013 to July 2017 (preintervention group) and from September 2017 to January 2019 (intervention group). The primary outcome of interest was the 90-day all-cause readmission rate. Secondary outcomes included infection-related readmission rates, in-hospital and all-cause mortality rates, and the frequency of patients leaving against medical advice. RESULTS: A total of 168 patients were included, in the 100 preintervention and 68 in the intervention group. Patients in the intervention group had reduced odds of 90-day all-cause readmission (adjusted odds ratio, 0.2; 95% confidence interval, 0.08-0.6) after adjustment for confounding variables. The 12-month all-cause mortality rate was also significantly reduced in the intervention group (adjusted odds ratio, 0.25; 95% confidence interval, .07-.89). The intervention group had a higher proportion of patients leaving against medical advice (6% for the preintervention group vs 35% for the intervention group, P < .001). CONCLUSIONS: A drug use-associated infection protocol demonstrated reduced 90-day all-cause readmission and 12-month all-cause mortality rates in PWID with IE. This study highlights the importance of standardized care processes for improving care in this specialized patient population.

Safety outcomes of apixaban in patients with nonvalvular atrial fibrillation and severe renal impairment.

Apixaban is prescribed for stroke prevention in nonvalvular atrial fibrillation (NVAF) in patients with varying degrees of renal dysfunction. While pharmacokinetic data support apixaban in severe renal impairment, clinical safety outcomes data are limited. This retrospective cohort analysis was conducted to evaluate the safety of apixaban in patients with NVAF and renal impairment. A total of 340 patients with NVAF receiving apixaban 5 mg or 2.5 mg twice daily were included for analysis; 287 preserved renal function (pRF: CrCl ≥ 25 ml/min and SCr ≤ 2.5 mg/dl) and 53 impaired renal function (iRF: CrCl < 25 ml/min and/or SCr > 2.5 mg/dl). The primary endpoint was major bleeding in patients taking apixaban 5 mg. Secondary endpoints included major bleeding with apixaban 2.5 mg and minor bleeding in both groups. There was no difference in major bleeding events in the 5 mg pRF group (4.41%) versus iRF group (3.57%) (P = 0.66). Similar rates occurred between the 2.5 mg pRF and iRF groups. Minor bleeding events were similar regardless of renal function. The incidence of bleeding in the 5 mg group was 11.45% with pRF versus 10.71% with iRF (P = 0.6). In the 2.5 mg group, bleeding incidence was 10% with pRF versus 16% with iRF (P = 0.47). There were no observed differences in bleeding between groups with pRF or iRF, regardless of apixaban dose. Because patients with severe renal impairment were excluded from original trials, this study contributes clinical safety outcomes to the limited data for use of apixaban in this patient population.

Tobramycin-induced hepatotoxicity.

OBJECTIVE: To report a case of tobramycin-induced hepatotoxicity. CASE SUMMARY: A 20-year-old female was hospitalized for treatment of Pseudomonas aeruginosa bacteremia and osteomyelitis. Empiric intravenous antibiotic therapy with piperacillin/tazobactam, vancomycin, and ciprofloxacin was started, and based on the results of culture and sensitivity testing, was changed to intravenous ceftazidime and tobramycin 70 mg every 8 hours on hospital day 3. Liver enzyme levels then increased over days 3-6. Tests for hepatitis A, B, and C were all nonreactive, and HIV testing was negative. On day 8, therapy was changed from ceftazidime to piperacillin/tazobactam and the tobramycin dose was increased to 100 mg every 8 hours. Due to a continued increase in total bilirubin, aspartate aminotransferase, and alanine aminotransferase, piperacillin/tazobactam was discontinued and aztreonam was started on day 10. All antibiotics were stopped on day 12 and the elevated liver parameters began to decrease. Aztreonam and ciprofloxacin were restarted on day 16, and most laboratory test results returned to baseline levels by day 19; total bilirubin and alkaline phosphatase decreased to lower than baseline values. DISCUSSION: This case illustrates a possible occurrence of tobramycin-induced hepatotoxicity. Liver enzymes rose when tobramycin therapy was initiated, markedly increased when the tobramycin dose was increased, then resolved upon discontinuation of therapy. Other medication-related causes were ruled out by temporal relationship or rechallenge (aztreonam). Use of the Naranjo probability scale indicated a possible relationship between hepatotoxicity and tobramycin therapy. Other adverse reaction scales specific for evaluation of drug-induced liver disease were also used. Both the Council for International Organizations of Medical Sciences and Maria and Victorino scales indicated a probable likelihood of tobramycin-induced hepatotoxicity. This patient was not rechallenged with tobramycin due to the highly suggestive timeline present, lack of specific symptoms, and unnecessary risk to the patient. CONCLUSIONS: Although no other case reports on this interaction have been published through October 9, 2007, historical data from tertiary sources reveal the possibility of aminoglycoside-induced hepatotoxicity; therefore, tobramycin-induced hepatotoxicity cannot be ruled out in this patient. Clinicians should be aware of this adverse event.