Evaluation of a Pharmacist-Developed, Nurse-Driven Protocol for Management of Parenteral Anticancer Therapy Infusion Reactions in an Ambulatory Infusion Center.

PURPOSE: Intravenous anticancer therapy can be associated with hypersensitivity- and/or infusion-related reactions (IRRs) which may result in life-threatening symptoms. As part of a quality improvement project, oncology pharmacists developed and implemented a nurse-driven, symptom-based IRR protocol. The objective of the evaluation was to evaluate IRR treatment failure after implementation of a symptom-based protocol in an ambulatory infusion center. Secondary objectives included determining the most common anticancer agents requiring IRR treatment, documentation of ED visits or hospital admissions within 72 h of treatment, documentation of mortality due to an IRR, and evaluating whether there were multiple documented IRRs to the same medication. METHODS: A total of 456 patients, who received an infusion of anticancer therapy at Grady Health System (GHS) between February 2014 and March 2018, were retrospectively evaluated. Patients were included if they received a protocol-specific medication for infusion reaction management of a parenterally administered anticancer agent. The primary outcome was the rate of treatment failure within 72 h of treatment for an IRR. RESULTS: Seventy-eight patients experiencing 108 IRRs were included in the analysis. Five percent of IRRs consisted of rigors only, 57% of IRRs were mild/moderate severity, 31% of IRRs were severe/anaphylactic severity and 7% of IRRs were rigors in addition to a mild/moderate/severe reaction. Of the 108 IRRs, treatment failure within 72 h was observed in eight reactions; six were evaluated in the emergency department and two required a hospital admission. Overall, 93% of reactions resolved in the infusion center and patients were discharged home; there were no patient deaths. The most common offending agents were paclitaxel and oxaliplatin. CONCLUSION: Following implementation of a novel pharmacist-developed, symptom-based nurse-driven protocol, infusion reaction treatment failure occurred in 7% of IRRs evaluated. Although the failure rate was low, additional nurse education and improved access to protocol-directed medications may optimize use of the protocol.

Evaluation of Treatment-Dose Enoxaparin in Acutely Ill Morbidly Obese Patients at an Academic Medical Center: A Randomized Clinical Trial.

BACKGROUND: Enoxaparin dosing recommendations for morbidly obese patients are lacking. Retrospective and observational studies reported goal anti-Xa levels with a median dose of 0.8 mg/kg using total body weight. Further studies are needed to determine if a more conservative dosing strategy is warranted. OBJECTIVE: To determine if reduced dose enoxaparin was more effective than standard dose at achieving goal anti-Xa levels in morbidly obese patients. METHODS: A prospective, randomized, controlled study was conducted in patients with a body mass index (BMI) ≥40 kg/m2. Patients were randomized to standard (1 mg/kg) or reduced dose (0.8 mg/kg) enoxaparin every 12 hours. The primary outcome was the proportion of patients with an initial anti-Xa at goal (0.5-1.1 IU/mL). RESULTS: A total of 62 patients were enrolled and randomized to 1 mg/kg (n = 32) or 0.8 mg/kg (n = 30), and 54 patients completed the study. The study did not meet accrual for 80% power. Goal anti-Xa levels were achieved in a similar proportion for the reduced-dose (n = 25/28) and standard dose arms (n = 20/26; 89.3% vs 76.9%; P = 0.29). Overall, 9 patients required dose adjustments, of which 6 were in the 1-mg/kg arm, and all were above goal. No documented bleeding or thrombotic events were reported. CONCLUSIONS AND RELEVANCE: This was the first randomized, controlled trial of enoxaparin dosing in patients with a BMI ≥40 kg/m2. Overall, 89% of patients had a goal anti-Xa when initiated on 0.8 mg/kg. Based on the results, reduced dose enoxaparin may be a reasonable dosing strategy in morbidly obese patients.

Analysis of Opioid Use Following Curative Cancer Treatment at a Large Urban Safety-net Hospital.

OBJECTIVES: This study examined the pattern of use and factors predicting prolonged prescription opioid medications among cancer patients following treatment with curative intent. MATERIALS AND METHODS: Patients diagnosed with cancer over a 3-year period at a large urban safety-net hospital were included. Univariate and multivariate analyses was used to identify factors associated with continued opioid use. RESULTS: Of the 199 patients included in the study, 38% continued to receive an opioid prescription well beyond the acute diagnosis and treatment phase. Mean age was 60.3 years, with a female preponderance (63%). Surgical resection only (31.6%) and the combination of surgery, chemotherapy, and radiation (19.7%) were the commonest treatment modalities. Pain-related comorbidities predating cancer diagnosis were reported in 53.3% of the patients, and about 33% were also on pain-modifying medications (odds ratio [OR], 3.58; 95% confidence interval [CI], 1.92-6.77; Fisher exact test P<0.001). Average number of prescriptions received per patient was 4.8 (range, 1 to 31), over an average of 9.5 months (range, 1.2 to 28.1 mo). Mean morphine milligram equivalents prescribed per prescription was 319 mg (range, 48 to 2475 mg). According to multivariate model, patients who received chemotherapy (OR, 7.25; 95% CI, 2.09-25.17; P=0.0018), or pain-modifying medications (OR, 4.61; 95% CI, 2.25-9.44; P<0.0001) were significantly more likely to continue to receive prescriptions for opioids. DISCUSSION: Treatment with chemotherapy, pain-modifying medications, cancer stage, and interval between diagnosis and treatment are the best predictors for continuous opioid use. The current epidemic of opioid misuse and abuse makes examination current practices and identifification of areas of improvement imperative.

Antibiotic allergies in the medical record: effect on drug selection and assessment of validity.

STUDY OBJECTIVES: To determine the frequency with which reported antibiotic allergies alter drug selection and to assess the validity of these allergies. DESIGN: Retrospective medical record review, with concurrent interviews conducted in a selected subgroup of patients. SETTING: Tertiary care academic medical center. PATIENTS: Three hundred patients with at least one documented antibiotic allergy and who received an antibiotic while hospitalized. MEASUREMENTS AND MAIN RESULTS: Data were collected to determine the patients' allergies documented in the medical record. The first antibiotic regimen that each patient received while hospitalized was evaluated for deviation from the standard of care as determined from institutional protocols, recommendations in the literature, and expert opinion. A total of 416 allergies to antibiotics were reported. Penicillins were the agents most commonly reported (198 reports), followed by sulfonamides, cephalosporins, macrolides, and fluoroquinolones. The reported allergies altered antibiotic therapy in 91 (30.3%) patients. Report of a penicillin or cephalosporin allergy and use of antibiotics for prophylaxis were strong predictors of altered therapy. The subgroup consisted of 100 patients who were interviewed to determine the specific details of their reported allergic reactions. For 22 of the 100 patients, major discrepancies were found between their verbal reports and medical record documentation. The Naranjo adverse drug reaction probability scale was used to determine the validity of their reactions. Among these 100 patients, 109 (78.4%) of 139 reported reactions to antibiotics were deemed to be allergic in nature. For 55 (50.5%) of the 109 allergic reactions, the Naranjo score was 5 or greater, which correlates with probable to definite validity. CONCLUSION: Discrepancies between the medical record and in-depth allergy histories are common, and the validity of reported allergic reactions is frequently questionable. Because documentation of an antibiotic allergy frequently alters therapy, increased effort to verify these reactions may be beneficial.