Predictors of Serious Opioid-Related Adverse Drug Events in Hospitalized Patients.

OBJECTIVE: Opioids are high-risk medications in the inpatient setting because of their potential for significant patient harm. The primary objective was to identify risk factors that predispose inpatients to develop opioid-related adverse drug events (ORADE) requiring the use of naloxone. METHODS: In a retrospective case-control study, patients were included according to the following criteria: 18 years or older, 1 administered opioid doses or more, and admitted for 24 hours or more. Patients were excluded if they had a prehospital drug overdose, other indications for naloxone use, or were admitted to an intensive care unit, psychiatric medical unit, or in the emergency department. Patients were classified as cases if naloxone was administered and a selection of controls were frequency matched 2:1 based on medical or surgical status. A logistic regression model was used to evaluate for risk factors for ORADE. RESULTS: A total of 275 cases and 592 control patients were included into the final analysis. Variables that were associated with greater odds of naloxone administration included age of 65 years or older, female, length of stay, pulmonary diagnoses, use of gabapentinoids, and patient-controlled analgesia use. Antihistamines, continuous infusion, and intermittent nurse administered intravenous bolus routes had a negative association with naloxone use. CONCLUSIONS: Several risk factors were found to be associated with ORADE supporting many of the previously described risk factors, and the discovery of potential new ones, such as gabapentinoid use. Health care providers should consider the risk factors for hospitalized patients receiving opioids who may warrant lower doses, additional monitoring, or alternative agents.

Treatment of Narcolepsy with Sodium Oxybate While Breastfeeding: A Case Report.

BACKGROUND: Sodium oxybate is used in the treatment of narcolepsy. Currently no published literature supports its safety during breastfeeding, although it has a favorable pharmacokinetic profile for minimizing exposure. MATERIALS AND METHODS: We report a case of a 27-year-old primigravida with narcolepsy who was taking sodium oxybate for symptom control and contacted our Lactation Study Center for advice. Based on our current pharmacokinetic knowledge, she was advised to avoid breastfeeding 4 hours after a dose. RESULTS: Follow-up phone interviews were done and the patient reported that the feeding schedule was manageable, and she was able to exclusively breastfeed for 6 months of her infant's life. Based on pediatric records, her infant's growth and development were excellent. There were no noted side effects of the medication for the infant. CONCLUSIONS: This is the first report to our knowledge of breastfeeding during maternal therapy with sodium oxybate, which appears to be compatible with safe, exclusive breastfeeding when managed appropriately.

Patiromer: a clinical review.

IMPORTANCE: Patiromer FOS (for oral suspension), formerly known as RLY5016, is pending FDA approval for the treatment of hyperkalemia. Once approved, patiromer, as well as a second agent known as sodium zirconium cyclosilicate (ZS-9), will be among the new therapeutic options available to treat hyperkalemia in over 50 years. OBJECTIVE: The primary objective of this review is to analyze the efficacy and safety of patiromer to treat hyperkalemia and compare its pharmacokinetics to currently available sodium polystyrene sulfonate (SPS) therapy. Patiromer was studied in patients with chronic kidney disease and/or heart failure for both acute and chronic therapy. EVIDENCE REVIEW: Studies of patiromer were obtained via a literature search of PubMed database and Google Scholar (2000 to the present) using 'patiromer', 'RLY5016', and 'hyperkalemia management' as keywords. Additional references were identified from fda.gov, clinicaltrials.gov, and the pharmaceutical manufacturer, Relypsa Inc. FINDINGS: Three published clinical trials, ten posters, one clinical trial commentary, three editorials and one oral presentation were obtained. The materials discussed three main clinical trials (PEARL-HF, OPAL-HK and AMETHYST-DN) and examined the safety and efficacy of patiromer in patients with hyperkalemia or at risk for hyperkalemia who have chronic kidney disease (CKD), type 2 diabetes mellitus (T2DM), hypertension and/or heart failure (HF) while receiving renin-angiotensin-aldosterone system inhibitors (RAASis). All three studies achieved their primary endpoints and reduced serum potassium. The PEARL-HF study increased the proportion of patients able to titrate their spironolactone dose from 25 mg/day to 50 mg/day in patients with normokalemia who had a history of hyperkalemia or an estimated glomerular filtration rate of <60 mL/min. The OPAL-HK study allowed patients receiving patiromer to remain on their RAASi therapy. The AMETHYST-DN study demonstrated that patiromer reduced and maintained mean serum potassium ≤5.0 mEq/L for up to 1 year, with a low rate of hypokalemia. Adverse events (AEs) were similar between studies. The most commonly reported adverse event was constipation. CONCLUSIONS AND RELEVANCE: Patiromer is effective in decreasing serum potassium, preventing recurrence of hyperkalemia, and reducing RAASi discontinuation. Compared to current SPS therapy, patiromer may be the preferred option to treat hyperkalemia, once approved. Patiromer is well tolerated and is not associated with serious AEs.