Drug-induced exanthem following dabigatran.

OBJECTIVE: To report an incident of a drug-induced exanthem during treatment with dabigatran in a patient without prior exposure to the drug. CASE SUMMARY: A 20-year-old white male was prescribed oral dabigatran 150 mg twice daily for thromboembolic prevention because of nonvalvular atrial fibrillation. After 2 weeks of dabigatran therapy, a raised, pruritic, erythematous rash developed on the patient's inner thigh and forearm. Upon discontinuation of dabigatran and initiation of oral corticosteroid treatment, the rash resolved. Dabigatran therapy was not readministered and thromboembolic prevention therapy with warfarin was instituted. DISCUSSION: The clinical evidence for efficacy of dabigatran was derived largely from the RE-LY trial, which provided an open-label comparison with warfarin for the reduction of stroke and systemic embolism in nonvalvular atrial fibrillation. The most frequent adverse reactions leading to discontinuation of dabigatran were bleeding and gastrointestinal events. In the RE-LY study, drug hyper-sensitivity, allergic edema, anaphylactic reaction, and anaphylactic shock were reported in <0.1% of patients receiving dabigatran. Despite the low incidence of hypersensitivity reported in the RE-LY trial, the use of the Naranjo probability scale indicated a probable relationship between the rash and dabigatran therapy in this patient. CONCLUSIONS: Upon initiation of dabigatran therapy, surveillance for hyper-sensitivity reactions should be included as part of routine drug monitoring.

COVID-19 pandemic: Challenges and solutions from the cardiology pharmacist's perspective.

The recent coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) challenges pharmacists worldwide. Alongside other specialized pharmacists, we re-evaluated daily processes and therapies used to treat COVID-19 patients within our institutions from a cardiovascular perspective and share what we have learned. To develop a collaborative approach for cardiology issues and concerns in the care of confirmed or suspected COVID-19 patients by drawing on the experiences of cardiology pharmacists across the country. On March 26, 2020, a conference call was convened composed of 24 cardiology residency-trained pharmacists (23 actively practicing in cardiology and 1 in critical care) from 16 institutions across the United States to discuss cardiology issues each have encountered with COVID-19 patients. Discussion centered around providing optimal pharmaceutical care while limiting staff exposure. The collaborative of pharmacists found for the ST-elevation myocardial infarction patient, many institutions were diverting COVID-19 rule-out patients to their Emergency Department (ED). Thrombolytics are an alternative to percutaneous coronary intervention (PCI) allowing for timely treatment of patients and decreased staff exposure. An emergency response grab and go kit includes initial drugs and airway equipment so the patient can be treated and the cart can be left outside the room. Cardiology pharmacists have developed policies and procedures to address monitoring of QT prolonging medications, the use of inhaled prostacyclins, and national drug shortages. Technology has allowed us to practice social distancing, while staying in close contact with our teams, patients, and colleagues and continuing to teach. Residents are engaged in unique decision-making processes with their preceptors and assist as pharmacist extenders. Cardiology pharmacists are in a unique position to work with other pharmacists and health care professionals to implement safe and effective practice changes during the COVID-19 pandemic. Ongoing monitoring and adjustments are necessary in rapidly changing times.

Safety of Twice Daily Sotalol in Patients with Renal Impairment: A Single Center, Retrospective Review.

BACKGROUND: The class III antiarrhythmic sotalol is renally eliminated with a dose-related propensity to cause adverse drug reactions (ADR) potentially leading to life-threatening arrhythmias. Although product labeling recommends once daily dosing in patients with renal impairment, twice daily dosing is commonly utilized. This study evaluates the safety of this practice. METHODS: This retrospective, observational study examined renally impaired patients with atrial fibrillation or atrial flutter admitted for sotalol initiation from July 1, 2012 - December 31, 2014, then for up to 20 months after initiation. Primary endpoints included rates of ADR and therapy changes due to ADR. Secondary endpoints included therapy changes due to arrhythmia recurrence, admissions due to arrhythmia recurrence, and therapy changes for any cause. RESULTS: Analysis included 134 patients with an average creatinine clearance of 51 ml/min, followed over a median of 170 days. Length of stay averaged 3 days withADR occurring in 53.7% of patients, most commonly QT prolongation or bradycardia. Therapy change due to ADR occurred in 45.5% of patients (n=61). Therapy change due to arrhythmia recurrence occurred in 23.1% (n=31), admission due to arrhythmia recurrence occurred in 24.6% (n=33), and therapy change for any cause occurred in 74.6% (n=100). CONCLUSION: Initiating sotalol twice daily in renally impaired patients results in ADR and therapy change rates consistent with rates seen in clinical practice for non-renally impaired patients, with minimal length of stay.This practice may be reasonable when initiated in the acute care setting with subsequent outpatient monitoring, however further study is needed.