Minutes / Institutional Review Board - Englewood Hospital and ...

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March 14, 2013
NEW PROTOCOL
EHMC Protocol Number & Protocol Title
EHMC Protocol # E-13-487
Protocol Title: “ Implementation and impact of a multidisciplinary
penicillin allergy skin testing service within an antimicrobial stewardship
program”
Sponsor: N/A
Department/Section;
Principal & Sub-Investigator(s)
Departments:
- Anesthesiology & Critical Care Medicine
- Pharmacy
P: Carmine Gianatiempo, M.D.
Subs:
Stuart From, M.D.
Andrew Murgittroyd, PharmD
Description & Study Aim: The goal of this Study is to determine the legitimacy of patients’ self-reported allergy to
penicillin. Patients who claim to have an allergy to penicillin, and who are candidates for a beta-lactam antibiotic (a broad
class of antibiotics, consisting of all antibiotic agents that contains a β-lactam ring in their molecular structure) due to their
culture and sensitivity results, are denied treatment due to their self-reported allergy. These patients are candidates to receive
the Penicillin Allergy Skin Test. Through our Antimicrobial Stewardship Program, a negative test result will allow tailoring or
de-escalation to more appropriate antimicrobial therapy, thereby helping to minimize antimicrobial resistance and provide cost
effectiveness. This Study will monitor test results, any change in antibiotics, cost savings associated with the de-escalation of
medication, and tolerance to new medication if applicable.
NEW PROTOCOL
EHMC Protocol Number &
Protocol Title
EHMC Protocol # E-13-494
Protocol Title: CALGB C80803: “Randomized Phase II Trial of
PET Scan-Directed Combined Modality Therapy in Esophageal Cancer”
Sponsors: CALGB, NCI, CTSU
Department/Section:
Principal &
Sub-Investigator(s)
Department/Section:
Medicine / Oncology
P: Minaxi Jhawer, M.D.
Subs:
Lewis Attas, M.D.
Francis Forte, M.D.
Brian Kim, M.D.
Jill Morrison, M.D.
Michael Schleider, M.D.
Description & Study Aim: To determine if the outcome, for patients with esophageal cancer, can by improved by using
PET/CT Scans to determine whether or not a particular chemotherapy regimen is showing any effect on the tumor and, to
determine if PET/CT response can be used as a way to better direct therapy for tumors.

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March 14, 2013
EXPEDITED REVIEW
EHMC Protocol Number & Protocol Title
EHMC Protocol # E-13-482
Protocol Title: “Risk Stratification in Older Persons with Acute Myocardial Infarctions:
SILVER AMI”
Sponsor: National Heart, Lung, and Blood Institute
Department/Section;
Principal & Sub-Investigator(s)
Department/Section:
Medicine / Cardiology
P: Richard Goldweit, M.D.
Description & Study Aim: This is a minimal risk observational Study that uses a prospective cohort design to follow
older patients who are hospitalized for AMI (acute myocardial infarction). Study coordinators will screen men and
women age 75 and older, hospitalized with AMI. Enrollment and in-hospital assessments will be performed by local
Study Coordinators. Participants will be assessed at baseline, prior to AMI hospital discharge, through an interview,
physical assessment and medical record review. Research and medical records will be transmitted to the SILVER-AMI
Coordinating Center for data entry into a central, electronic database system with rigorous protection and quality controls.
One follow-up interview will be conducted approximately 6 months later by the Yale Follow-Up Center. Clinical
outcomes will be assessed for the follow-up period occurring 6 months post initial hospitalization via self-report and
medical record review. The overall objective of this Study is to develop and validate risk stratification tools for older
adults who have recently had an AMI. This is a multi-center, observational study designed to collect data about the
post-AMI recovery period which will be used to generate risk models for older patients with AMI. The intent is to use
the knowledge from the data collected in SILVER-AMI to ultimately design interventions to improve the care and
outcomes of older patients with AMI.
EXPEDITED REVIEW
EHMC Protocol Number & Protocol Title
EHMC Protocol # E-13-488
Protocol Title: “Implementation of a pharmacist-driven
drug-drug interaction evaluation and counseling program utilizing medication
reconciliation in an outpatient oncology infusion center”
Sponsor: N/A
Department/Section;
Principal & Sub-Investigator(s)
Department: Pharmacy Residency
Program
P: Meena Sugumaran, PharmD
Subs:
Jeffrey Nemeth, PharmD, MPA
Jacqueline Takere, PharmD
Description & Study Aim: Pharmacists will perform a thorough analysis to identify drug-drug interactions in patients
presenting to EHMC’s Infusion Center to receive IV medication. That sub-set of patients will also receive counseling to
improve safety and adherence to their therapy. All medical information will be obtained from the medication
reconciliation chart in the McKesson system. Patients younger then 18, or pregnant, will be excluded. Variables
collected will be: age, gender, diagnosis, prescription medications, nonprescription medications and medications
received at the Infusion Center. Patients will be counseled by a Pharmacist on Category “D” and “X” drug-drug
interactions, and interventions will be recorded. “Category “D” interaction is defined as “consider therapy modification”,
“Category “X” interaction is defined as “avoid combination”. Lexicomp Software will be used to analyze drug-drug
interactions, specifically Categories “D” and “X”.