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.

Improving Documentation of Pain and Constipation Management Within the Cancer Center of a Large Urban Academic Hospital.

PURPOSE: Pain and constipation are common among patients with cancer and remain inadequately controlled in many. The Quality Oncology Practice Initiative assessment of pain and constipation at the Georgia Cancer Center for Excellence at Grady Health System identified documentation to be below benchmark levels. A quality improvement initiative to improve pain and constipation management was conducted. METHODS: Given the low baseline documentation rates for pain (60%) and constipation (20%), we aimed for an increase of 20 percentage points within 1 year. On the basis of cause-and-effect analysis and provider questionnaires to understand fully the causal factors, our multidisciplinary team developed a new provider note template to integrate nurse's assessment of pain and constipation into the provider's documentation. A new order panel was developed in the electronic medical record to link appropriate orders with the pain and constipation plan. RESULTS: The integration of the initial nursing assessment into the provider note template increased pain score documentation from 66.7% to 100% (P < .01), and the pain management plan improved from 65.3% to 86.4% (P = .06). Similarly, constipation assessment documentation improved from 20.4% to 100% (P < .01), and a documented constipation plan improved accordingly from 11.2% to 29.1% (P < .01). As a result of this intervention, pain control at the third clinic visit improved from 61.5% to 86.8% (P < .01). Emergency department visits related to pain and constipation decreased (16.2% to 14.9%; P = .19), and hospitalizations marginally increased (1.6% to 3.6%) during the study period (P =.28). CONCLUSION: A standardized visit template and hardwired assessment of pain and constipation exceeded the goal for improvement in documentation and positively affected outcomes.

Corrigendum to "Outcomes of Programmed Cell Death Protein 1 (PD-1) and Programmed Death-Ligand 1 (PD-L1) Inhibitor Therapy in HIV Patients with Advanced Cancer".

[This corrects the article DOI: 10.1155/2019/2989048.].

Outcomes of Programmed Cell Death Protein 1 (PD-1) and Programmed Death-Ligand 1(PD-L1) Inhibitor Therapy in HIV Patients with Advanced Cancer.

Due to HAART and consequent decline in mortality from infectious complications, HIV patients have an increasing burden of non-AIDS defining cancers. Data on their safety and efficacy is unknown as these patients were excluded from clinical trials due to concern of unforeseen side effects. Objectives. The main objective of our study was to evaluate the efficacy and safety profile of PD-1 and PD-L1 inhibitors in HIV patients being treated for advanced cancers and to assess the impact of these drugs on HIV status of the patients specifically CD4 count and HIV viral load. Materials and Methods. This was a retrospective analysis of data of 17 patients HIV treated with one of the PD-1/PD-L1 inhibitors (Nivolumab, Pembrolizumab, Atezolizumab, Durvalumab, or Avelumab) for advanced cancer. Results. 10 out of 17 patients responded to therapy. 7 patients, all of whom had shown response to therapy, were alive and 4 were still on checkpoint inhibitor. 10 patients including all 7 nonresponders had died. Responders had minimum of 15 weeks of response while one had ongoing continued response at 34 weeks. Side effects were seen in 7 patients and only one patient needed cessation of therapy. CD4 counts were stable on treatment while HIV RNA remained undetectable. Conclusion. PD-1 and PD-L1 inhibitors appear to have comparable efficacy and tolerable side effect profile and have no effect on HIV markers when used in HIV patients with advanced cancers.

Assessment of Provider Adherence to Recommended Monitoring Parameters for Oral Anticancer Medications.

INTRODUCTION: Oral anticancer medications (OAMs) offer convenient administration but create new challenges with unique toxicity profiles, specific monitoring parameters and non-continuous dosing schedules. We evaluated provider compliance with US Food and Drug Administration (FDA) drug labeling-specified monitoring parameters for commonly dispensed OAMs at a public academic health system. METHODS: A retrospective chart review of patients receiving OAMs was conducted at Grady Health System between July 2015 and June 2016. Patients included in the evaluation were dispensed one of the ten most common OAMs used in our cancer center. Laboratory data and provider documentation were collected and compared to FDA drug labeling-specified monitoring parameters, and the primary outcome was the percentage of fully-compliant cycles. Secondary outcomes included patient adherence assessed by provider documentation and fill history. Descriptive statistics were used to evaluate the data. RESULTS: The initial report comprised 422 patients, of which 77 patients with a total of 349 treatment cycles were included for final analysis. One hundred twenty-six (36.1%) of the treatment cycles were fully compliant with the FDA drug labeling-specified monitoring parameters. Sixty-four of the 199 (32.2%) applicable clinic notes documented patient adherence, and 15 (39.5%) of 38 patients were adherent based on fill history. CONCLUSION: This study revealed low compliance with FDA-recommended monitoring parameters for commonly dispensed OAMs at our institution. In addition, this study confirmed national concerns about adherence to oral regimens. It also suggests that provider compliance with monitoring parameters is an area that needs to be addressed in order to improve the ambulatory OAM process.