Granisetron Transdermal System
Page 4 Volume 17; Issue 2 Granisetron Transdermal System for the Prevention of Chemotherapy-Induced Nausea and Vomiting (continued from page 3) etc. Safety and efficacy has not been established in pediatric patients. 3,6 Granisetron transdermal patch was recently added to the formulary at the Johns Hopkins Hospital with restrictions. It is restricted to oncology inpatients who have not responded to or are intolerant to at least 2 different agents (one of which must be a 5-HT3 antagonist) with optimized dosing and frequency each for at least 24 hours, or who respond to 5HT‐3 antagonists but are unable to transition from IV to PO antiemetics. References 1. Basch E, Prestrud AA, Hesketh PJ, et al; American Society of Clinical Oncology. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 2011;29:4189-98. 2. Granisetron [monograph]. In: LexiComp Online [online database]. Hudson, OH: Lexi-Comp. Accessed December 2016. 3. Food and Drug Administration. SANCUSO (Granisetron Transdermal System) prescribing information (September 2015). http:// w w w . a c c e s s d a t a . f d a . g o v / d r u g s a t f d a _ d o c s / label/2015/022198s003lbl.pdf . Accessed December 2016. 4. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Antiemesis (updated 2016). https:// www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf Accessed December 2016. 5. Boccia, R.V., Gordan, L.N., Clark, G. et al. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer 2011; 19:1609-17. 6. Chabner B, A., Thompson E. C. Management of Adverse Effects of Cancer Therapy. Merck Manual Professional Version. https:// www.merckmanuals.com/professional/hematology-and-oncology/ principles-of-cancer-therapy/management-of-adverse-effects-ofcancer-therapy. Access January 2017. NINJAs in the Children’s Center Bethany Sharpless, PharmD, PGY2 Pediatric Pharmacy Resident When one thinks of the word “ninja,” pediatric acute kidney injury (AKI) is generally not the first thing that comes to mind. “NINJA,” or Nephrotoxic Injury Negated by Just-in-time Action, is a multi-center quality improvement project with the goal of early identification of non-critically ill pediatric patients at risk for medication-induced AKI and reduction of the incidence and intensity of medication-induced AKI. The initiative, based out of Cincinnati Children’s Hospital Medical Center, began after a retrospective analysis of hospitalized children showed that rates of AKI increased from 16% to 45% in pediatric patients with exposure to ≥ 3 nephrotoxic medications. 1 In addition, pediatric evidence has shown that 5 or more days of aminoglycoside exposure was an independent risk factor for AKI, with rates of kidney injury increasing with days of therapy. 2 AKI is sometimes more easily missed in pediatric patients, as a quantitatively small change in serum creatinine (for example an increase from 0.3 to 0.6) represents an increase of two times baseline, which qualifies as AKI per the KDIGO (Kidney Disease Improving Global Outcomes) criteria. 3 Johns Hopkins was the 13 th institution to join the NINJA collaborative and implemented the program in 2016. The criteria to identify patients who need closer renal monitoring are patients on ≥ 3 concomitant nephrotoxic medications or an aminoglycoside for ≥ 3 days. 4 The group intentionally excluded critically ill patients as those patients often have risk factors for nephrotoxicity beyond medications. In 2015, the Cincinnati project team reported 3.5 years of data. 5 During the period, decreases in AKI rate (2.96 to 1.06 AKI episodes per 1000 patient-days) as well as nephrotoxic medication exposure rate (11.64 to 7.24 exposures per 1000 patient-days) were observed. Multicenter collaborative data have not yet been published. While each institution has different workflows, the common goal is to decrease the intensity of AKI through increased awareness and monitoring. At JHH, Elys Bhatia of Clinical Analytics created Image source: Johns Hopkins Children Center (continued on page 5)
Page 5 Volume 17; Issue 2 NINJAs in the Children’s Center (continued from page 4) Acyclovir Cidofovir NINJA 61 Medication List = Therapeutic Monitoring Recommended Gadopentetate dimeglumine (Magnevist) Ioxaglate meglumine and ioxaglate sodium Valacyclovir Ambisome Cisplatin Ganciclovir Ioxilan Pentamidine Valganciclovir Amikacin* Colistimethate Gentamicin* Ketorolac Piperacillin Valsartan Amphotericin B Cyclosporine* Ibuprofen Lisinopril Pamidronate disodium Piperacillin/Tazobactam Vancomycin* Aspirin Dapsone Ifosfamide Lithium* Sirolimus* Zoledronic acid Captopril Carboplatin Cefotaxime Diatrizoate meglumine Diatrizoate sodium Enalapril Indomethacin Losartan Sulfasalazine Zonisamide Iodixanol (Visipaque) Iohexol (Omnipaque) Mesalamine Methotrexate* Ceftazidime Enalaprilat Iopamidol (Isovue) Mitomycin Tacrolimus* Tenofovir Ticarcillin/ Clavulanic Acid Cefuroxime Foscarnet Iopromide Nafcillin Tobramycin* Celecoxib Gadoextate disodium (Eovist) Ioversol Naproxen Topiramate a Qlikview dashboard that provides the rest of the NINJA team (Jeff Fadrowski, MD, Elizabeth Goswami, PharmD, and Emma Sexton, RN) a daily report of patients exposed to nephrotoxic medications, as well as patients meeting criteria for AKI. If a patient meets the criteria for increased risk of AKI, the NINJA team visits the patient’s primary team on the floor with a “NINJA Alert”. During the conversation, the NINJA team recommends daily serum creatinine monitoring as well as minimization of nephrotoxic medications as clinically appropriate. The NINJAs make the team aware of the patient’s baseline serum creatinine and tell the team if the patient has AKI. Patients are followed for the duration of nephrotoxic medication exposure, and patients with AKI are followed until AKI has resolved for 48 hours. Although this project currently impacts only our non-critically ill pediatric patients, awareness of medication-associated AKI risk is important regardless of patient age. Acute kidney injury is a cause of patient morbidity and has been shown to have long-term implications on a patient’s renal function. 6 Pharmacists have an opportunity to promote early detection of patients with medication risk factors for AKI, and early intervention by pharmacists can result in reduction in nephrotoxic medication exposure as well as incidence of AKI. References: 1. Moffett B, Goldstein S. Acute kidney injury and increasing nephrotoxic-medication exposure in noncritically-ill children. Clinical Journal of the American Society of Nephrology. 2011;6:856-63. 2. Zappitelli M, Moffett B, Hyder A, Goldstein S. Acute kidney injury in non-critically ill children treated with aminoglycoside antibiotics in a tertiary healthcare centre: a retrospective cohort study. Nephrology Dialysis Transplantation. 2010;26:144-50. 3. Summary of Recommendation Statements, KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney International Supplements. 2012;2:8-12. 4. Goldstein S, Kirkendall E, Nguyen H et al. Electronic health record identification of nephrotoxin exposure and associated acute kidney injury. Pediatrics. 2013;132:e756-67. 5. Goldstein S, Mottes T, Simpson K et al. A sustained quality improvement program reduces nephrotoxic medication-associated acute kidney injury. Kidney International. 2016;9:212-21. 6. Menon S, Kirkendall E, Nguyen H, Goldstein S. Acute kidney injury associated with high nephrotoxic medication exposure leads to chronic kidney disease after 6 Months. The Journal of Pediatrics. 2014;165:522-7.