The feasibility and effect of pharmacist new medication counseling on HCAHPS scores
Tolulope Akinbo, Pharm.D., MPH; Jacqueline Ewald, Pharm.D., BCPS; Susan Fosnight , RPh, CGP, BCPS; Jessica
Cather, Pharm.D., BCPS, BCPP.
Akinbot@Summahealth.org
PGY-1 Pharmacy Practice Residency
Summa Health System- Akron City Hospital, 525 East Market Street, Akron, OH, 44309
Background: In 2006, the Centers of Medicare and Medicaid services (CMS) and the Agency for Healthcare Research
and Quality(AHRQ) implemented the Hospital Consumer Assessment of HealthCare Providers and Systems (HCAHPS)
survey as a means of standardizing and publicly reporting data assessing patients’ satisfaction with healthcare providers
and health systems1. HCAHPS is the first national, standardized, publicly reported survey of patients' perspectives of
hospital care2. The goals of the HCAHPS survey are to provide comparable data by which hospitals can be assessed
based on domains deemed important to consumers, to serve as an incentive for hospitals to improve quality of provided
care and to improve public accountability of hospitals by providing transparency with the publicly reported data 3.
At Summa Akron City, pharmacists have been involved in patient education on new and discharge medications whenever
schedules permit. Recent Summa Akron City HCAHPS survey results suggest that to achieve the institutional goal for the
communication about medications domain of the HCAHPS survey, one of every 20 surveyed patients would need to
change their HCAHPS survey responses. Due to this, decentralized pharmacists have been charged with a goal to
educate at least 2 patients per day. Although, the pharmacy department set this goal, on many units it is not being met.
This project plans to evaluate the feasibility of this goal and its effect on HCAHPS scores using currently available
resources.
Objectives: (1) To evaluate the impact of pharmacist-provided new medication education on medication communicationrelated HCAHPS scores and overall HCAHPS scores of the educated cohort of patients and the targeted patient care
units. (2) To evaluate the impact of pharmacist-provided new medication education on HCAHPS survey response rates of
the educated cohort of patients and the specific patient care units. (3) To determine the time spent providing the new
medication education service daily including time spent identifying patients on new medications, providing counseling, and
documenting each education intervention in the electronic health record.
Methodology: The principal investigator will use a standardized method to consistently provide new medication education
to up to four patients daily, 2 patients per targeted unit, for one month. Patients will be provided with hospital approved
supplemental education leaflets, and emphasis of the education will be placed on medication indication and side effects,
the specific areas targeted on the medication communication section of the HCAHPS survey. This impact will be
evaluated by comparing the 3 month average of the HCAHPS scores for these units prior to the intervention to HCAHPS
scores for each unit the month of the intervention. The primary outcomes measured will be medication communicationrelated HCAHPS scores and overall HCAHPS scores for the educated cohort of patients and the targeted patient care
units. The secondary outcomes measured will be the HCAHPS survey response rates for the educated cohort of patients
and the targeted patient care units and the time spent to provide this new medication education service daily. Data
collected from this quality improvement project will be deidentified and deemed exempt by Summa Health System from
Institutional Review Board as not meeting the federal definition of research or clinical investigation.
Results and Conclusions: To be determined.
References:
1. "Survey of patients' experiences." Hospital Patients' Survey Data. Medicare. Web. 7 Oct. 2014.
<http://www.medicare.gov/hospitalcompare/Data/Overview.html?AspxAutoDetectCookieSupport=1>.
2. "HCAHPS - Hospital Survey." HCAHPS - Hospital Survey. Web. 23 Sept. 2014.
<http://www.hcahpsonline.org/home.aspx>.
3. "HCAHPS: Patients' Perspectives of Care Survey." - Centers for Medicare & Medicaid Services. Web. 23 Sept.
2014. <http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessmentinstruments/HospitalQualityInits/HospitalHCAHPS.html>.
OCCP Fall Meeting 2014
1
Evaluation of oral antipsychotic supplementation of long-acting antipsychotic injections in an acute-care
psychiatric setting
Jennifer Alastanos, PharmD; Chris Paxos, PharmD, BCPP, BCPS, CGP; Jessica Boss, PharmD, BCPS, CGP
jennifer.alastanos@akrongeneral.org
PGY-1
Akron General Medical Center 1 Akron General Avenue, Akron, OH 44307
Background: Long-acting antipsychotic injections were developed in an effort to increase adherence. 1
The United States Food and Drug Administration package inserts for aripiprazole, risperidone, and paliperidone have
specific recommendations for oral antipsychotic supplementation when initiating long-acting injectable therapy. After the
recommended supplementation, oral antipsychotics should be discontinued to avoid polypharmacy. It is recommended to
supplement aripiprazole long-acting injection with oral aripiprazole (10 or 20 mg) or another oral antipsychotic for 14
consecutive days to maintain a therapeutic concentration. Risperidone long-acting injection is recommended to be
supplemented with oral risperidone (or another oral antipsychotic) during the first 3 weeks of treatment due to the delayed
release phase of the long-acting injection. Paliperidone long-acting injection does not require oral antipsychotic
supplementation.2 Previous studies concluded rates of co-prescribing of oral and long-acting injections require further
investigation.3,4,5
Objectives: (1) To describe the frequency of oral antipsychotic supplementation according to recommendations among
patients receiving long-acting injections. (2) To identify predictors of oral antipsychotic supplementation inconsistent with
recommendations.
Methodology: Upon approval by the Institutional Review Board, pharmacy records will identify patients admitted to an
inpatient psychiatric unit that received at least one dose of aripiprazole, risperidone, or paliperidone long-acting injection
between July 2009 and June 2014. Exclusion criteria include age less than 18 years or pregnancy. The following data will
be collected: demographics, third party insurance, prescriber, psychiatric diagnoses, long-acting injection, trial of oral
antipsychotic prior to initiation of long-acting injection, and total number of antipsychotics prescribed. The primary
outcome of this study is the percentage of patients receiving oral antipsychotic supplementation according to
recommendations (new initiation or maintenance treatment) and the percentage of patients that do not (oral
supplementation less than recommendations, greater than recommendations, or during maintenance treatment).
Secondary outcomes include identifying predictors in patients that receive oral supplementation inconsistent with
recommendations. Patient identifiers will be removed prior to data analysis to maintain confidentiality. A statistician will aid
in analysis of data.
Results and conclusions: To be determined.
References:
1. Bera RB. Patient outcomes within schizophrenia treatment: a look at the role of long-acting injectable
antipsychotics. J Clin Psychiatry. 2014; 75: 30-3.
2. Meyer JM. Understanding depot antipsychotics: an illustrated guide to kinetics. CNS Spectr. 2013; 18: 58-67.
3. Pabis DJ, e al. Evaluation of inpatient depot antipsychotic prescribing. Ann Pharmacother. 1996; 30(12): 1381-6.
4. Wheeler A, et al. Explicit review of risperidone long-acting injection prescribing practice. J Clin Pharm Ther. 2011;
36(6): 651-63.
5. Affarwal NK, et al. Prevalence of concomitant oral antipsychotic drug use among patients treated with long-acting,
intramuscular, antipsychotic medications. J Clin Psychopharmacol. 2012; 32(3): 323-8.
OCCP Fall Meeting 2014
2
Development and initiation of a pharmacy-led medication reconciliation program in an ambulatory solid tumor
oncology patient population
Matthew J Arango, PharmD; Kelley D Carlstrom, PharmD, BCOP; Marc Earl, PharmD, BCOP; Erika M Gallagher,
PharmD, BCOP; Jame Abraham, MD
arangom@ccf.org
PGY-2 Oncology Resident
Cleveland Clinic Main Campus, 9500 Euclid Avenue, Cleveland, OH 44195
Background: Medication reconciliation is a core component of Drug Therapy Management services which helps healthsystem departments of pharmacy comply with national standards.1 Multiple studies have demonstrated the value of
medication reconciliation services in terms of decreasing medication errors and decreasing readmission rates. 2-3 Patients
with cancer represent an optimal target for medication reconciliation services due to their complex treatment regimens,
potential comorbidities and supportive care needs, and interactions with many different specialized healthcare providers.
Despite this, few medication reconciliation programs have been targeted specifically at ambulatory oncology patients. 4 At
the Cleveland Clinic Taussig Cancer Institute (TCI) a new, pharmacist-led medication reconciliation service has been
developed for ambulatory patients receiving treatment for breast cancer. This study will assess this novel pharmacy
service in terms of clinical benefit and sustainability.
Objectives: (1) To determine the number of patients who meet with a pharmacist for medication reconciliation and the
number of medication lists which require modification (2) To determine the types of modifications made to medication lists,
pharmacist time investment, and effect of the service on emergency department (ED) visits and hospital admissions for
treatment complications.
Methodology: The study will be submitted to the Institutional Review Board for approval. Patients will be identified
through the institution’s electronic medical record (EMR) and TCI treatment schedule. A pharmacist will perform
medication reconciliation and provide education on anti-emetics and calcium supplementation during patients’ treatment
infusion. Completion of medication reconciliation and any findings will be documented in a note and the medication list will
be updated in the EMR. Study data collected from the EMR will include demographic data (age, gender, comorbid
conditions, insurance status, and race), modifications made to the medication list (omission, discontinuation, updated
dose/frequency, and classification of affected medication), time spent performing the service, and number of ED visits or
hospital admissions for treatment complications within 30 days of medication reconciliation. Data will be analyzed using
descriptive statistics.
Results and conclusions: To be determined.
References:
1. The Joint Commission. 2014 National Patient Safety Goals. <http://www.jointcommission.org/>. Accessed 09/11/14
2. Pronovost P, Weast B, Schwarz M, et al. Medication reconciliation: a practical tool to reduce the risk of medication
errors. J Crit Care 2003;18:201-5
3. Coleman EA, Smith JD, Raha D, and Min S. Posthospital medication discrepancies. Arch Intern Med 2005;165:18427
4. Weingart SN, Cleary A, Seger A, et al. Medication reconciliation in ambulatory oncology. Joint Comm J Qual Patient
Saf 2007;33:750-7
OCCP Fall Meeting 2014
3
Implementation of a weight-based enoxaparin dosing protocol for venous thromboembolism prophylaxis in acute
burn patients
Heidi Aston, PharmD; Nilam Patel, PharmD, BCPS; Anjay Khandelwal, MD; Tammy Coffee, CNP; Charles Yowler, MD;
Christopher Brandt, MD
haston@metrohealth.org
PGY-1
MetroHealth System 2500 MetroHealth Drive, Cleveland, OH 44109
Background: Enoxaparin is commonly used for venous thromboembolism (VTE) prophylaxis in acute burn patients.
LMWH anticoagulation effectiveness can be monitored by drawing anti-Xa levels. Previous research has demonstrated
that more than 50% of acute burn patients have subtherapeutic anti-Xa levels when using the traditionally recommended
prophylaxis dose of LMWH.3-5 The target anti-Xa level for VTE prophylaxis is 0.2-0.4 IU/mL. This study evaluates the use
of a weight based dosing protocol of enoxaparin for acute burn patients.
Objectives: Primary objective: to determine if the use of a weight based dosing protocol for enoxaparin achieves target
anti-Xa levels in acute burn patients. Secondary objective: to determine if there is a difference in the dosing requirement
of enoxaparin based on weight, burn size, burn depth, and type of burn injury.
Methodology: This study will be submitted to the Institutional Review Board for approval. This will be a single center,
observational study at a 14 bed certified American Burn Association intensive care unit (BICU). The hospital’s electronic
medical record system will be used to identify patients admitted to BICU and for data collection. Patients will be included if
they are admitted to BICU and expected to be non-ambulatory for ≥ 48 hours. Patients will be excluded if there is a known
contraindication of enoxaparin, intracranial hemorrhage or neurotrauma, heparin induced thrombocytopenia (HIT), known
bleeding disorder, active bleeding, epidural analgesia, or suspected or proven hematoma. Patients with CrCl ≥ 30 mL/min
will be given enoxaparin 0.5 mg/kg subcutaneously (SC) every 12 hours. If CrCl < 30 mL/min enoxaparin 0.5 mg/kg SC
every 24 hours will be administered. Actual body weight will be used for dose calculations and doses will be rounded to
nearest 10 mg. Anti-Xa levels will be drawn 4 hours after the 3rd consecutive dose with goal range of 0.2-0.4 IU/mL.
Enoxaparin doses will be held the morning of surgery unless otherwise directed. The following demographic criteria will be
collected: age, gender, etiology of burn injury, burn size, burn depth, presence of inhalation injury, weight, height, body
mass index, and creatinine clearance. The following treatment criteria will also be collected: anti-Xa levels, enoxaparin
dose, number of doses held for surgery, time to first dose of enoxaparin, time to goal anti-Xa, and adverse events
including unexpected bleeding, need for blood transfusions, hematoma associated graft loss requiring surgical
intervention, thrombocytopenia, HIT, and VTE. Data will be collected until patients are discharged from BICU. All data will
be recorded without patient identifiers and be maintained confidentially. Education of the dosing nomogram and
monitoring parameters will be provided to all nurses and physicians before initiation of the study.
Results and conclusions: To be determined.
References:
1. Guyatt GH, Akl EA, Crowther M, et al. Antithrombotic therapy and prevention of thrombosis, 9 th ed: American College
of Chest Physicians evidence-based clinical practice guidelines. Chest. 2012;141;7S-47S.
2. Van Haren R, Thorson C, Valle E, et al. Hypercoagulability after burn injury. J Trauma Acute Care Surg.
2013;75(1):37-43.
3. Lin H, Faraklas I, Saffle J, Cochran A. Enoxaparin dose adjustment is associated with low incidence of venous
thromboembolic events in acute burn patients. J Trauma. 2011;71:1557-61.
4. Faraklas I, Ghanem M, Brown A, Cochran A. Evaluation of an enoxaparin dosing calculator using burn size and
weight. J Burn Care Res. 2013;34(6):621-7.
5. Droege ME, Mueller EQ, Besl KM et al. Effect of a dalteparin prophylaxis protocol using anti-factor Xa concentrations
on venous thromboembolism in high-risk trauma patients. J Trauma Acute Care Surg. 2014;76(2):450-6.
OCCP Fall Meeting 2014
4
Cleveland Clinic Health System Extravasation Management Guidelines: Evaluating Adherence
Della Bahmandar, Pharm.D., MBA; Amy Martin, Pharm.D., BCPS; Mandy Leonard, Pharm.D., BCPS; Joseph Hooley,
BSPS, CPPS; Stephanie Bass, Pharm.D., BCPS:
bahmand@ccf.org
PGY-1 Pharmacy Practice
Cleveland Clinic Health System – Main Campus
Background:
Extravasation of IV medication is considered a medical emergency that can lead to serious outcomes if not treated
appropriately.1 As many as 25% of extravasations can lead to serious injury; causing a burden of disease more severe
than the principal admitting diagnosis.2 Despite these implications, there is a lack of high quality evidence based literature
regarding management of extravasation injuries. Various nursing organizations have compiled guidelines based on the
limited evidence and expert opinion; however, discrepancies in recommendations and limited information within the
guidelines lead to the need for development of institutional protocols. Development of institution specific
recommendations necessitates strategies to monitor and assess such recommendations. A retrospective study identified
42 patients experiencing extravasation, of which 50% were managed appropriately according to the institution’s protocol.3
Evaluating and understanding adherence to an institution’s protocol can give rise to better understanding about
discrepancies between protocol and practice and determine areas for improvement, education, and awareness. The goal
of the study is to describe the adherence to the Cleveland Clinic Health System (CCHS) Extravasation Management
Guidelines (EMG) at the Cleveland Clinic Main Campus.
Objectives: (1) To determine the percent of documented extravasations receiving appropriate management. (2) To
evaluate compliance with the nursing procedure for extravasation management, determine the percent of extravasation
antidotes administered within the correct timeframe specified by the CCHS EMG, and calculate the percentage of
pharmacologic antidote orders entered into the EPIC system using the specifically designed antidote drug files.
Methodology:
The hospital’s safety event reporting system will be utilized to identify patients who have experienced an extravasation
event. Adult patients who experienced an extravasation injury will be included in the analysis if admitted to inpatient,
outpatient or the emergency department at the Cleveland Clinic Main Campus. The following data will be collected: age,
gender, height, weight, service and shift during which the extravasation occurred, and the type of personnel that was
notified. The agent causing the extravasation will be recorded. Use of antidote or compress and appropriateness
according to the CCHS EMG will be identified. The components of the nursing procedure for extravasation management
will be evaluated and recorded. All data will be recorded without patient identifiers and maintained confidentially.
Results and conclusions: To be determined.
References:
1. Perez Fidalgo JA, Garcia Fabregat L, Cervantes A, et. al. Management of chemotherapy extravasation: ESMO-EONS
Clinical Practice Guidelines. Annals of Oncology 2012;23(7):167-173.
2. MacCara, M. Extravasation: A hazard of intravenous therapy. Drug Intell Clin Pharm 1983:17:713-7.
3. Paquette V, McGloin R, Northway T, et al. Describing Intravenous Extravasation in Children (DIVE Study). Can J
Hosp Pharm 2011;64(5):340-345.
OCCP Fall Meeting 2014
5
Tranexamic acid use in the hip and knee arthroplasty population at an academic medical center: a retrospective
analysis of postoperative outcomes
Sheena Burwell, PharmD; Todd Gundrum, PharmD, BCPS; Daniel Gehling, MD
sheena.burwell@utoledo.edu
PGY-1
University of Toledo Medical Center, 3000 Arlington Ave, Toledo, OH 43614
Background: Hip and knee arthroplasties are becoming increasingly more frequent procedures in the United States.
These procedures require appropriate blood management as blood transfusions generally increase healthcare costs and
hospital length of stay. Subsequently, intravenous tranexamic acid use has been investigated in a number of studies to
reduce blood loss, blood transfusion requirements, hospital length of stay, and overall costs for orthopedic surgeries,
including hip and knee arthroplasty.1-4
Objectives: (1) To determine if the use of tranexamic acid in hip and knee arthroplasty will decrease the incidence of
perioperative blood transfusion compared to the control group. (2) To determine if the use of tranexamic acid in hip and
knee arthroplasty will decrease perioperative hemoglobin levels, thromboembolic complications, and hospital length of
stay.
Methodology:
This study will be submitted to the Institutional Review Board for approval before commencement. All adult patients who
underwent hip or knee arthroplasty by a single orthopedic surgeon between September 30, 2013 and September 30, 2014
will be retrospectively screened utilizing historical medical records. Tranexamic acid was added to the formulary in April
2014 and has been used in orthopedic surgeries since that date. Hip and knee arthroplasty performed prior to the
formulary addition will act as a control for the procedures performed after the addition. The following data will be collected:
date of admission, date of surgery, date of discharge, patient age, height, weight, and gender. Additionally, data involving
surgery type, use of tranexamic acid, amount of blood loss during surgery, units of blood transfused, tourniquet time,
change in hemoglobin levels, and the incidence of venous thromboembolism will be collected. Tranexamic acid and
control groups will be matched using propensity scoring and will be analyzed using a t-test and chi-square statistical test.
Results and conclusions: To be determined.
References:
1. Iorio R et al. Impact of the economic downturn on adult reconstruction surgery. J Arthroplasty. 2010;25:1005–14.
2. Rana AJ et al. Hospital economics of primary THA decreasing reimbursement and increasing cost, 1990 to 2008.
Clin Orthop. 2011;469:355–61.
3. Poeran J et al. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee
arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ. 2014;349:g4829.
4. Bidolegui F et al. Tranexamic acid reduces blood loss and transfusion in patients undergoing total knee
arthroplasty without tourniquet: a prospective randomized controlled trial. Open Orthop J. 2014;8:250-254.
OCCP Fall Meeting 2014
6
Optimization of Medication Alerts seen during Order Entry and Verification
Jenny Bute, Pharm.D.; Jeffrey Chalmers, B.S., Pharm.D.; David Stowe, R.Ph.; Joseph Gagliardi, Clinical Analyst
butej@ccf.org
PGY-2 Pharmacy Informatics
Cleveland Clinic 9500 Euclid Avenue, JJN1-200, Cleveland, Ohio, 44195
Background: The benefits of clinical decision support (CDS) within computerized provider order entry systems in
reducing the rate medication errors have been shown in numerous studies 1-3. Certain elements of CDS, such as
medication related alerts, are amongst the most common alerts generated during the ordering and verification process in
the electronic medical record (EMR). While some alerts have value, too many alerts increase the risk of desensitizing the
user to clinically significant alerts that may prevent medication errors and patient harm 4. Currently, the Cleveland Clinic
health system does not have a formalized procedure to identify and optimize these alerts. This study aims to evaluate the
clinical appropriateness of the medication alerts currently in place and to define a systematic framework for the
optimization of these alerts in the future.
Objectives: (1) To determine if a decrease in clinically insignificant alert volume will lead to a decrease in override rate
among prescribers and/or pharmacists. (2) To characterize the frequency and distribution of the different types of
medications alerts currently seen at the Cleveland Clinic. (3)To evaluate the impact of a monthly alert review and
optimization on the number of significant alerts identified.
Methodology: Prior to commencement, this study has been granted exemption by the Institutional Review Board. Five
different types of medication alerts will be included in this study, which are duplicate therapy, drug-drug interaction, drugallergy interaction, dosing range, and drug-pregnancy interaction alerts. For the five month duration of this study, a
monthly Alert Summary Report (ASR) will be generated to characterize all medication alerts triggered in the electronic
medical record (EMR) over the previous two weeks. The primary investigator will review and summarize the ASR
spreadsheet and determine candidates for intervention, utilizing four different methods to determine the clinical
significance of each different type of alert. Approved interventions will then be implemented in the EMR. This cycle will
be repeated monthly and results will be trended in order to address the study objectives. All data will be recorded without
patient identifiers and maintained confidentially.
Results and conclusions: To be determined.
References:
1. Bobb A, Gleason K, Husch M, Feinglass J, Yarnold PR, Noskin GA. The epidemiology of prescribing errors: the
potential impact of computerized prescriber order entry. Arch Intern Med 2004;164:785-92.
2. Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order entry and clinical decision support
systems on medication safety: a systematic review. Arch Intern Med 2003;163:1409-16.
3. Schedlbauer A, Prasad V, Mulvaney C, et al. What evidence supports the use of computerized alerts and prompts to
improve clinicians' prescribing behavior? J Am Med Inform Assoc 2009;16:531-8.
4. van der Sijs H, Aarts J, Vulto A, Berg M. Overriding of drug safety alerts in computerized physician order entry. J Am
Med Inform Assoc 2006;13:138-47.
OCCP Fall Meeting 2014
7
Evaluation of adherence in patients prescribed long-acting injectable antipsychotics: a comparison of bi-weekly
versus monthly administered neuroleptics
Chelsea Carr, Pharm.D., Jennifer Roche, Pharm.D., BCPP, Colleen Hall, Pharm.D., BCPP, Christopher Burant, Ph.D.,
Matthew Fuller, Pharm.D., BCPS, BCPP, FASHP
chelsea.carr@va.gov
PGY-2 Psychiatric Pharmacy Practice Resident
Louis Stokes Cleveland VA Medical Center 10701 East Boulevard, Cleveland, Ohio 44106
Background: Antipsychotics, both first- and second-generation, are the mainstay of treatment for patients with schizophrenia and other
disorders of thought. Although continuous treatment with antipsychotics is required to prevent relapse, adherence to these medications
is often dismal. It is thought that patients are non-adherent due to a number of reasons. Intolerable adverse effects, negative stigma
associated with the indication for therapy, and feeling as though symptoms have resolved are just a few of the reasons for patients
discontinuing therapy.1 It has been reported that nearly half of the patients prescribed antipsychotics take less than 70% of their
medication.1 With a large portion of patients non-adherent to their antipsychotic regimens, one option that is becoming more common
is to initiate a long-acting injectable antipsychotic (LAIA).2 Literature has shown that long-acting injectable antipsychotics may have
additional benefit in adherence for patients non-adherent to oral antipsychotics.3 There are currently six LAIAs on the market, two are
first-generation (or typical) antipsychotics, fluphenazine decanoate and haloperidol decanoate, and four second-generation (or atypical)
antipsychotics, risperidone, paliperidone palmitate, aripiprazole, and olanzapine pamoate. Depending on the LAIA selected, the agent
may be administered every two weeks (fluphenazine, risperidone, and olanzapine) or every month (haloperidol decanoate, paliperidone
palmitate, and aripiprazole). To date, there is no known literature evaluating differences in adherence in LAIAs administered bi-weekly
vs. LAIAs administered monthly.
Objectives: Assess possible adherence differences in patients prescribed bi-weekly administered long-acting injectable antipsychotics
(LAIAs) versus patients prescribed monthly administered LAIAs. Subsequent secondary objectives include differences in adherence
between typical and atypical LAIAs, adherence differences in patients prescribed paliperidone palmitate versus long-acting injectable
risperidone, reasons for non-adherence, number of VA psychiatric hospitalizations after LAIA initiation, as well as adherence
differences in patients on concurrent oral antipsychotics versus patients on only a LAIA.
Methodology: This study has been sent to the Institutional Review Board for approval. Once approval is granted, patients will be
identified by utilizing the Veteran Affairs electronic medical record and pulling any prescriptions for a LAIA administered between
September 1, 2009 and September 1, 2014 to identify eligible patients. Patients will then be evaluated using inclusion and exclusion
criteria to determine if they will be evaluated. Patients will not be included if they are ≤18 years of age, given a short-acting injectable
antipsychotic for agitation purposes without history of receiving a LAIA, have received less than three doses of paliperidone palmitate or
less than two doses of all other LAIAs. Patients will not be included if they are on olanzapine pamoate, as this LAIA is not used at our
facility. The following data will be collected: age, sex, diagnosis, LAIA prescribed, dose, initiation/administration/discontinuation dates
of LAIA, concurrent medication, dosage, and date(s) of oral antipsychotics, reason for discontinuation (if applicable), and psychiatric
hospitalizations after LAIA initiation. Medication Possession Ratios (MPRs) will be calculated for each patient to determine adherence
to the individual LAIAs for comparison between bi-weekly and monthly administered LAIAs. All patient information will be de-identified.
Results and conclusions: To be determined.
References:
1.
2.
3.
Goff DC, et al. Strategies for improving treatment adherence in schizophrenia and schizoaffective disorder. J Clin Psychiatry.
2010;71 Suppl 2:20-6
Hasan A, et al. World Federation of Societies of Biological Psychiatry (WFSBP) Task Force on Treatment Guidelines for
Schizophrenia. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of
Schizophrenia, part 1: update 2012 on the acute treatment of schizophrenia and the management of treatment resistance.
World J Biol Psychiatry. 2012 Jul; 13(5):318-78.
Olivares JM; e-STAR Spanish Study Group. Long-term outcomes in patients with schizophrenia treated with risperidone longacting injection or oral antipsychotics in Spain: results from the electronic Schizophrenia Treatment Adherence Registry (eSTAR). Eur Psychiatry. 2009 Jun; 24(5):287-96.
OCCP Fall Meeting 2014
8
A comparison of cefazolin and ceftriaxone for the treatment of methicillin-susceptible Staphylococcus aureus
(MSSA) bacteremia
Dustin Carr, PharmD; Usha Stiefel, MD; Robert Bonomo, MD; Sharanie Sims, PharmD, BCPS (AQ-ID)
Dustin.Carr@va.gov
PGY-1
Louis Stokes Cleveland VA Medical Center
Background: Anti-staphylococcal penicillins (ASP) are the traditional first-line therapy for MSSA bacteremia; however,
the use of cefazolin and ceftriaxone has become more frequent due to more convenient dosing, especially when used as
outpatient parenteral antimicrobial therapy (OPAT).1,2 Cefazolin has had favorable results when compared against ASPs
although recent literature suggests more treatment failures suspected secondary to hydrolysis by β-lactamase of MSSA,
which has been referred to as the cefazolin inoculum effect (CIE), although studies evaluating clinical outcomes have not
shown a profound effect.3 A more recent alternative to the use of cefazolin and ASPs involves using ceftriaxone, which
offers a favorable pharmacokinetic profile and more cost containment in comparison; however, it is a broader spectrum
antimicrobial.2,4 To date, there has only been one comparator trial of cefazolin versus ceftriaxone which found similar
favorable clinical outcomes between the two antimicrobials.4 Currently, there are no studies comparing the treatment
outcomes of ceftriaxone and cefazolin in the Veteran population with MSSA bacteremia.
Objectives: To compare rates of treatment failure at the end of therapy in Veteran patients treated with cefazolin or
ceftriaxone for methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. Secondary objectives include
antimicrobial susceptibilities, occurrence of relapse, duration of treatment, source of infection, treatment setting,
concomitant antimicrobials, adverse drug reactions, presence of subsequent Clostridium difficile or recurrent bacteremia
within 90 days of treatment, overall 90-day mortality, and cost of therapy.
Methodology: This study is currently pending Institutional Review Board (IRB) approval. Upon IRB approval, patients will
be identified from the microbiology blood culture database and the OPAT registry who have been diagnosed with MSSA
bacteremia from January 2009 to August 2014. Patients will be included if they were diagnosed with MSSA bacteremia
and treated with at least 14 days of parenteral cefazolin or ceftriaxone from January 2009 to September 2014. Patients
will be excluded if they received OPAT with another concomitant anti-staphylococcal antibiotic, had a documented
polymicrobial infection, received empiric antibiotics for >72 hours after cultures were finalized, or it OPAT was not meant
to be curative.
Results and conclusions: To be determined
References:
1. Li J, Echevarria KL, Hughes DW, Cadena JA, Bowling JE, Lewis JS 2nd. Comparison of cefazolin versus oxacillin
for the treatment of complicated bacteremia caused by methicillin-susceptible Staphylococcus aureus. Antimicrob
Agents Chemother. 2014 Jun 16.
2. Wieland BW, Marcantoni JR, Bommarito KM, Warren DK, Marschall J. A retrospective comparison of ceftriaxone
versus oxacillin for osteoarticular infections due to methicillin-susceptible Staphylococcus aureus. Clin Infect Dis.
2012 Mar 1;54(5):585-90.
3. Lee S, Kwon KT, Kim HI, Chang HH, Lee JM, Choe PG, Park WB, Kim NJ, Oh MD, Song DY, Kim SW. Clinical
Implications of Cefazolin Inoculum Effect and β-Lactamase Type on Methicillin-Susceptible Staphylococcus
aureus Bacteremia. Microb Drug Resist. 2014 Jul 7.
4. Winans SA, Luce AM, Hasbun R. Outpatient parenteral antimicrobial therapy for the treatment of methicillinsusceptible Staphylococcus aureus: a comparison of cefazolin and ceftriaxone. Infection. 2013 Aug;41(4):769-74.
OCCP Fall Meeting 2014
9
Optimization of discharge prescriptions by emergency medicine pharmacists in an academic emergency
department
Jesse Castillo, PharmD; Matthew Campbell, PharmD, BCPS; Erick Sokn, PharmD, MS, BCPS; Stephen Meldon, MD,
FACEP; Seth Podolsky, MD, MS, FACEP; Michael Spinner, PharmD, BCPS
castil2@ccf.org
PGY-1 Pharmacy Practice
Cleveland Clinic 9500 Euclid Ave, Cleveland, Ohio 44106
Background: Transitions of care can be a significant source of medication errors and/or adverse effects, especially for
patients discharged from healthcare facilities.1 The Emergency Department (ED) has been described as one of the
highest areas in the hospital for preventable adverse drug events.2 A 2013 national survey showed only 16.4% of
hospitals utilized pharmacists in the emergency department to provide drug therapy management.3 Specifically related to
the ED, only two studies have examined the frequency and characteristics of ED discharge prescription review by ED
pharmacists.4-5 Although these two studies demonstrated pharmacist intervention rates ranging from 3.2 % to 10.1 %,
neither study evaluated the significance of interventions or patient-related outcomes. This study seeks to evaluate the
impact of discharge prescription review by emergency medicine pharmacists to improve patient safety and optimize
medication therapy
Objectives: (1) Determine the rate, type, and clinical significance of interventions associated with emergency medicine
pharmacist review of emergency department discharge prescriptions. (2) Evaluate the impact of emergency medicine
pharmacist review of discharge prescriptions on ED and/or hospital re-admission rates. (3) Develop criteria to identify
“high-risk” patients for discharge medication review by emergency medicine pharmacists.
Methodology: Prior to commencement, this retrospective observational study will be submitted to the Institutional Review
Board for approval. The hospital’s electronic medical record system will be utilized to identify ED patients with at least 1
discharge prescription written during daily hours of ED pharmacist coverage from 0700 to 2300. ED patients will be
excluded if discharge prescriptions were written outside the daily hours of ED pharmacist coverage. ED prescription
intervention rate is defined as the percentage of ED discharge prescriptions that required ED pharmacist intervention
relative to all ED prescriptions reviewed. ED and/or hospital re-admission rates within 30 days of index ED discharge will
be compared between ED patients discharged with and without ED pharmacist prescription review. Patient demographics,
details of discharge prescriptions, and pharmacist interventions will be captured from electronic medical records. All data
will be recorded without patient identifiers and maintained confidentially.
Results and conclusions: To be determined.
References:
1. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med.
2003;138(3):161-7.
2. Aspden P, Institute of Medicine (U.S.). Committee on Identifying and Preventing Medication Errors. Preventing
medication errors. Washington, DC: National Academies Press; 2007.
3. Pedersen CA, et al. ASHP national survey of pharmacy practice in hospital settings: Prescribing and transcribing-2013.
Am J Health Syst Pharm. 2014;71(11):924-42.
4. Cesarz JL, et al. Emergency department discharge prescription interventions by emergency medicine pharmacists.
Annals of emergency medicine. 2013;61(2):209-21.
5. Stasiak P, et al. Detection and correction of prescription errors by an emergency department pharmacy service. CJEM.
2014;16(3):193-206.
OCCP Fall Meeting 2014
10
Effect of a Multidisciplinary Pharmacy and Nursing Committee on Hospital Consumer Assessment of Healthcare
Providers and Systems (HCAHPS) Scores Relating to Communication about Medications
Spencer R. Crook, PharmD, Lawrence A. Frazee, PharmD, BCPS, Kathleen Donley, RPh, MBA, FASHP
spencer.crook@akrongeneral.org
PGY2 Health System Pharmacy Administration
Akron General Medical Center
Background:
The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey directly affects an
organization’s reimbursement from government payers. Those hospitals that receive consistently high scores or that
improve their scores substantially over time can increase their payments from Medicare by up to 2% in 2017. Improving
HCAHPS also has the potential to save institutions on costs associated with readmission. There is anecdotal evidence
suggesting that focused pharmacy initiatives improve scores for HCAHPS medication questions, particularly initiatives
placing the pharmacist face-to-face with patients and multidisciplinary initiatives. Published literature is mostly descriptive
with limited analysis to determine the statistical significance of HCAHPS performance improvement with the implemented
initiatives. There is also little discussion of sustainability for these initiatives using formal pharmacoeconomic analysis.
Objectives:
The objective of this innovation project is to convene a multidisciplinary committee that will meet consistently over 18
months and work collaboratively to implement sustainable quality improvements within Akron General Medical Center
(AGMC). The quality improvements will focus on improving HCAHPS medication question scores for patients discharged
from an HCAHPS-eligible service line at AGMC. The target questions will be questions16, 17, and 25 on the HCAHPS
survey.
Methodology:
The Pharmacy and Nursing HCAHPS Committee (PhNHC) consists of 2 nurse and 6 pharmacist volunteers. A complete
literature search was first conducted to generate a list of ideas and processes that have been implemented in other
institutions with reported successful improvement in HCAHPS medication question scores. Each idea was rated by
committee members in terms of feasibility, return on investment, and quality. These ideas directed initial committee
efforts. Through the process of systematic discussion and implementation, the PhNHC will continue to meet for 18
months. The affected policies, procedures, systems, and services will be limited only by the creativity and innovation of
the committee. Each intervention will be described and discussed in terms of process, effectiveness, and sustainability.
Effectiveness will be described as effect on HCAHPS scores. Sustainability will be described as cost-effectiveness
analysis, return on investment, FTEs required, or qualitative feedback from stakeholders.
Results and conclusions:
A discharge medication concierge service was effective in improving HCAHPS medication question scores. The service
was also found to be sustainable with a neutral return on investment. Initiatives pending results include a medication
information hotline for patients, HCAHPS-targeted medication database training for nurses, quick-reference patient
education cards for nursing units, and standardized patient interaction training for pharmacy interns.
References:
1. Boulding W, Glickman SW, Manary MP, Schulman KA, Staelin R. Relationship between patient satisfaction with
inpatient care and hospital readmission within 30 days. Am J Manag Care. 2011; 17: 41-48.
2. Buckley B. Tales of success in boosting HCAHPS scores. Pharmacy Practice News. 2012; 39. Available at
www.pharmacypracticenews.com. Accessibility verified April 9, 2014.
3. Erickson AK. Pharmacists survey report. Pharmacy today. 2013. Available from: www.pharmacist.com/pharmacytoday. Accessibility verified April 9, 2014.
4. HCAHPS Hospital Survey. HCAHPS Mail Survey Materials (English). 2013. Available at www.hcahpsonline.org.
Accessibility verified April 9, 2014.
5. Traynor K. Pharmacists work to boost patient satisfaction scores. Am J Health-Syst Pharm. 15 May 2013; 70: 836-9.
OCCP Fall Meeting 2014
11
Identification of Risk Factors for Hypersensitivity Reactions to PEG-asparaginase in Pediatric Patients with Acute
Lymphoblastic Leukemia
Elizabeth Dahl, PharmD; Anthony Zembillas, PharmD, BCPS; Karissa Kusick, PharmD, BCOP; Jeffrey Ketz, PharmD, BCPS
dahle@ccf.org
PGY-1 Pediatric-focused
Cleveland Clinic Children’s Hospital
Background:
PEG-asparaginase is a pegylated formulation of E. coli L-asparaginase and is a standard component in the treatment of
pediatric acute lymphoblastic leukemia (ALL). Since PEG-asparaginase preparations are bacterially derived, they are highly
immunogenic and can cause mild to severe hypersensitivity reactions. Prophylaxis for these hypersensitivity reactions may
be ineffective and could potentially decrease the efficacy of the drug. 1,2 PEG-asparaginase has traditionally been
administered intramuscularly (IM), but over the last several years it has been given intravenously (IV) in order to reduce pain and
provide a more convenient means of administration. Interest has developed in evaluating hypersensitivity rates between the
IV and IM routes of administration and there are a few published studies and case studies available. The most recent
study conducted by Petersen et al. compared the incidence of hypersensitivity reactions in pediatric patients with ALL who
received IV vs. IM PEG-asparaginase.3 Of 318 patients, 159 received IV and 159 received IM PEG-asparaginase. Thirtyone (19.5%) patients in the IV group developed an allergic reaction compared to 17 (10.7%) patients in the IM group (P =
.028). Since the switch from IM to IV PEG-asparaginase in many of the protocols at the Cleveland Clinic, the incidence of
hypersensitivity reactions in pediatric patients appears to have increased. If patients experience a hypersensitivity reaction
to PEG-asparaginase they are switched to Erwinia asparaginase to finish their treatment and Erwinia is approximately ten
times the cost of PEG-asparaginase per treatment course.
Objectives:
(1) To determine the difference in hypersensitivity reaction rates between PEG-asparaginase IV and IM administration. (2)
To describe the incidence and severity of hypersensitivity reactions in pediatric patients with ALL treated at the Cleveland
Clinic Children’s Hospital. (3) To identify additional risk factors associated with hypersensitivity reactions to PEGasparaginase in pediatric patients with ALL.
Methodology:
This study will be reviewed by the Institutional Review Board prior to initiation of data collection. Patients will be identified
through a database query and be included if they received IV or IM PEG-asparaginase and were enrolled on study or
treated per a COG protocol. Patients will be divided into two groups based on whether or not they experienced a
hypersensitivity reaction to PEG-asparaginase. The data will be extracted from the shared medical record Epic® and
uploaded on to the REDCap database. Data points that will be collected include: age, MRN/study ID, gender,
diagnosis/cell lineage, route of administration, risk stratification pre- and post-induction, IV flow rate, allergic reaction
grade and onset of symptoms, concomitant steroids, number of PEG-asparaginase doses, treatment phase of occurrence
of hypersensitivity reaction, hospital or ICU admission and length of stay, Erwinia administration and number of cycles
received. Baseline characteristics will be analyzed with descriptive statistics and χ 2. Potential confounders will be
analyzed using logistic regression. No patient identifiers will be recorded within the database and all information will be
kept confidential.
Results and conclusions: To be determined.
References:
1. Sahiner UM, Yavuz ST, Gokce M, Buyuktiryaki B. Anaphylactic reaction to polyethylene-glycol conjugatedasparaginase: Premedication and desensitization may not be sufficient. Pediatrics International. 2013;55:531-33.
2. Shinnick SE, Browning ML, Koontz SE. Managing Hypersenstivity to Asparaginase in Pediatrics, Adolescents, and
Young Adults. Journal of Pediatric Oncology Nursing. 2013;30(2):63-77.
3. Petersen WC, Clark D, Senn SL, Cash WT. Comparison of Allergic Reactions to Intravenous and Intramuscular
Pegaspargase in Children with Acute Lymphoblastic Leukemia. Pediatric Hematology and Oncology. 2014;31:311-17.
OCCP Fall Meeting 2014
12
The Use of Anti-Factor Xa Monitoring in Select Patients Receiving Enoxaparin at the Cleveland Clinic
Gretchen D’Arcangelo, PharmD; Jeff Ketz, PharmD, BCPS; Katie Greenlee, PharmD, BCPS
darcang@ccf.org
PGY-1
Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195
Background: Enoxaparin is a low molecular weight heparin (LMWH) with a more predictable anticoagulant doseresponse effect than heparin, and, as such, anticoagulation monitoring is generally unnecessary.1,2 However, studies have
shown that dose-response effects are variable in patients who are either overweight, underweight or have renal
dysfunction.1-5 In these patient populations, anticoagulant monitoring with anti-factor Xa levels may be necessary to
ensure therapeutic response and minimize the risk of bleeding. However, specific recommendations regarding appropriate
anti-factor Xa monitoring and interpretation is currently not available. 1,2 This study aims to determine the best practice
regarding therapeutic enoxaparin use in patients <45 kg,>150 kg, or with renal dysfunction through anti-factor Xa
monitoring at a large academic institution.
Objectives: (1) To evaluate the use of anti-factor Xa monitoring in patients <45 kg, >150 kg, or with renal dysfunction
receiving therapeutic enoxaparin. (2) Evaluate the dosing of enoxaparin in patients > 150 kg, < 45 kg or renal dysfunction
(CrCl < 30 mL/min). (3) Assess the frequency of enoxaparin monitoring with anti-factor Xa levels at the Cleveland Clinic in
patients who are <45 kg, >150 kg, or with renal dysfunction. (4) Evaluate enoxaparin dose adjustments based on antifactor Xa levels. (5) Determine percent of patients at target anti-factor Xa levels, as well as supratherapeutic and
subtherapeutic levels and the associated dose. (6) Determine rate of enoxaparin bleeding events in patients <45 kg, >150
kg, or with renal dysfunction. (7) Formulate protocol/best practice for the use of enoxaparin in patients <45 kg, >150 kg, or
with renal dysfunction.
Methodology: This study has been approved by the Institutional Review Board and is ready for commencement. The
hospital’s electronic medical record system will be utilized to identify adult inpatients that received therapeutic enoxaparin
and were either < 45 kg, > 150 kg, or had CrCl < 30 mL/min. Patients who received prophylactic doses of enoxaparin will
be excluded. The following information will be collected for each patient: age, gender, weight, height, BMI, serum
creatinine, creatinine clearance, enoxaparin indication and initial dose, any subsequent enoxaparin dose changes and the
indication for the change, and the presence and results of anti-factor Xa monitoring. To determine the presence of
bleeding events the following information will be collected: ICD-9 codes indicating bleeding, daily hemoglobin levels, and
the presence of packed red blood cell transfusions. Data will be collected for the duration of enoxaparin therapy while
inpatient, or until a bleeding event occurs and enoxaparin therapy was discontinued. All data will be recorded without
patient identifiers and maintained confidentially.
Results and conclusions: To be determined.
References:
1. Product Information. Lovenox (enoxaparin sodium injection). Bridgewater, NJ: sanofi-aventis US LLC, Oct 2013.
2. Garcia DA, Baglin TP, Weitz JI, Samama MM. Parenteral anticoagulants: Antithrombotic therapy and prevention of
thrombosis, 9th ed: american college of chest physicians evidence-based clinical practice guidelines. Chest.
2012;141(2_suppl):e24S-e43S.
3. Lim W, Dentali F, Eikelboom JW, Crowther MA. Meta-analysis: low-molecular-weight heparin and bleeding in patients
with severe renal insufficiency. Annals of internal medicine. May 2 2006;144(9):673-684.
4. Deal EN, Hollands JM, Riney JN, Skrupky LP, Smith JR, Reichley RM. Evaluation of therapeutic anticoagulation with
enoxaparin and associated anti-Xa monitoring in patients with morbid obesity: a case series. Journal of thrombosis
and thrombolysis. Aug 2011;32(2):188-194.
5. Lalama JT, Feeney ME, Vandiver JW, Beavers KD, Walter LN, McClintic JR. Assessing an enoxaparin dosing
protocol in morbidly obese patients. Journal of thrombosis and thrombolysis. Aug 3 2014.
OCCP Fall Meeting 2014
13
Application of new cholesterol guidelines and health care provider survey: knowledge, attitudes, and cholesterol
management post-guideline release
Lauren DiBenedetto, PharmD; Alexander Hoffman, PharmD, Mary Ann Dzurec, PharmD, BCACP, Amy Kramer,
PharmD
ladibenedetto@healthspan.org
PGY-1
HealthSpan, 12301 Snow Road, Parma Ohio 44130
Background:
The American College of Cardiology and the American Heart Association (ACC/AHA), in collaboration with the National Heart, Lung,
and Blood Institute (NHLBI) and other specialty societies released new guidelines in November 2013 for the prevention of
cardiovascular disease and management of blood cholesterol. 1 These new guidelines replaced the Adult Treatment Panel III (ATP III)
guidelines for the detection, evaluation, and treatment of high blood cholesterol in adults that guided clinical practice for over 10 years. 2
The 2013 guidelines substantially modify the previous recommendations. The new guidelines no longer recommend titrating HMG-CoA
reductase inhibitor (statin) dose to a specific low-density lipoprotein (LDL) cholesterol target and instead shift focus to treating
cardiovascular risk.3 Patients’ 10-year atherosclerotic cardiovascular disease risk is determined using the new Pooled Cohort Risk
Assessment Equations or risk calculator (http://my.americanheart.org/cvriskcalculator). 4,5 Another significant change from the previous
guidelines includes recommendations regarding non-statins that are either added to statin therapy or used in statin-intolerant
individuals. Randomized control trials evaluating the atherosclerotic cardiovascular disease event reductions from non-statins were
reviewed by the Expert Panel. It was concluded that addition of a non-statin has not been proven to further reduce cardiovascular risk;
therefore, non-statins are no longer routinely recommended.2
Objectives:
(1) To assess how many HealthSpan Integrated Care patients are eligible for a statin based on their 10-year atherosclerotic
cardiovascular disease risk. (2) To evaluate the current prescribing rate of non-statins and compare these results with what is
recommended by the most recent guidelines. (3) To evaluate physician knowledge and utilization of the updated guidelines and allow
for targeted education and support.
Methodology:
Application for investigational review board (IRB) approval has been submitted to St. Rita’s Hospital for review. Upon approval, data will
be collected via retrospective chart review from January 1 st 2013 through December 31st 2014 and entered in a database. HealthSpan
Integrated Care of Northeast Ohio members who are between the ages of 40 and 75 years of age will be included in this study.
Exclusion criteria include patients who are pregnant, patients who are younger than 40 years of age, and patients older than 75 years of
age. Patients with diabetes and patients with clinical atherosclerotic cardiovascular disease (ASCVD) will also be excluded because
HealthSpan has an internal model of care that verifies that these patients are prescribed a statin unless medically inappropriate.
Patients will be categorized by primary care provider and primary health facility. Ten year atherosclerotic cardiovascular disease risk
will be calculated using the atherosclerotic cardiovascular disease risk calculator. Non-statin medications will be defined as any of the
following medications: gemfibrozil, fenofibrate, cholestyramine, colestipol, colesevelam, ezetimibe, ezetimibe/simvastatin, and omega-3
acid ethyl esters. The data for the primary and secondary objectives are descriptive or count data with no comparator groups. No power
analysis or comparative statistical analyses are needed. The healthcare provider survey will be distributed at healthcare provider
meetings and includes adult primary care practitioners: family practice and internal medicine physicians; nurse practitioners; and
physician assistants.
Results and conclusions: To be determined.
References:
1.
2.
3.
4.
5.
Stone NJ et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in
adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am
Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934.
Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third
report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults (Adult Treatment Panel III) JAMA. 2001 May 16;285(19):2486-97.
Montori et al. Patient-centered and practical application of new high cholesterol guidelines to prevent cardiovascular disease.
JAMA. 2014 Feb 5;311(5):465-6.
American Heart Association. Prevention Guidelines. http://my.americanheart.org/cvriskcalculator. Accessed September 1,
2014.
Goff DC Jr et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2935-59.
OCCP Fall Meeting 2014
14
Implementation of psychiatric clinical pharmacy services in an adult inpatient psychiatry unit
Angela Dimos, PharmD, Joshua Unsworth, PharmD, BCPS
adimos@swgeneral.com
PGY-1
Southwest General Health Center 18697 Bagley Rd. Middleburg Heights, Ohio 44130
Background:
With the many treatment modalities for mental health conditions, there remains a lack of continuity with the management
of depression and other mental health conditions such as schizophrenia, bipolar disorder and generalized anxiety
disorder.1 Current literature supports the benefits of a pharmacist in an inpatient psychiatry unit such as drug monitoring,
patient education, treatment recommendations and providing guidance for prescribing. Medication compliance is one of
the major clinical implications to overcome in this population. Literature has determined that 80% of patients treated for
schizophrenia will relapse within 5 years; with the most common cause of relapse being poor adherence to antipsychotic
medications.2 This study is designed to implement clinical pharmacy services in an inpatient psychiatry unit to assess
improvement in patient care and decrease healthcare costs.
Objectives:
The purpose of this study is to assess the clinical outcomes of implementing pharmacy services in an adult inpatient
psychiatry unit. This study will implement clinical services including a discharge service that will allow patients to fill the
first 30 days of all new prescriptions upon discharge from the unit.
Methodology:
This single centered prospective, randomized trial will assess the impact of implementing psychiatric pharmacy services
within an inpatient psychiatric unit. The primary endpoint of this study will assess pharmacy clinical interventions. These
clinical interventions will be determined through discharge medication reconciliation upon implementation of a bedside
medication delivery service. The opportunity to intervene will be concentrated in the following categories: drug
interactions, untreated conditions, inappropriate medication therapy, adverse events, and duplicate medication therapy.
The following data will be collected for each intervention: acceptance or declination, recommendation category, notable
changes in prescribing patterns, and the amount of time expended. The primary endpoints will be analyzed using a MannWhitney U test. Pharmacotherapy recommendations will be provided to the psychiatrist and clinical nurse practitioner
when appropriate. Secondary endpoints will incorporate clinical pharmacy services that encompass admission medication
reconciliation, patient education and discharge counseling. Medications will be reviewed for participants during the study
period, including necessary labs to evaluate proper medication use. When applicable a chi-squared test or Fisher’s exact
test will be used for nominal data and a student’s t-test will be used to analyze continuous data. This study will be
submitted to the Institutional Review Board to receive approval.
Results and conclusions: To be determined.
References:
1.) Finley P, Crismon L, Rush J. Evaluating the impact of pharmacists in mental health: A systematic review.
Pharmacotherapy. 2003;23(12):1634-44.
2.) Kaplan, G, Casoy, J, Zummo, J. Impact of long-acting injectable antipsychotics on medication adherence and
clinical, functional, and economic outcomes of schizophrenia. Patient Preference and Adherence. 2013;7:117180.
OCCP Fall Meeting 2014
15
Liposomal Bupivacaine versus Conventional Bupivacaine: An Analysis to Determine Hospital Utility to Provide
Optimal Patient Care
Patrick Divoky, PharmD; Mate Soric, PharmD, BCPS
patrick.divoky@uhhospitals.org
PGY-1 Pharmacy Practice Resident
University Hospitals Geauga Medical Center 13207 Ravenna Rd, Chardon, OH 44024
Background:
Liposomal Bupivacaine is an analgesic used perioperatively to reduce pain. Its purpose is to inhibit the initiation and
transmission of nociceptive pain to and from the surgical site which would allow for reduced pain scores and a shortened
duration of hospital stay post-surgery. Studied against placebo in bunionectomy and hemorrhoidectomy, liposomal
bupivacaine found an overall reduction in pain scores and overall length of hospital stay. 1 When compared against
conventional bupivacaine in total knee patients, no statistical difference in overall opioid consumption, pain scores, or
length of hospital stay was found.2,3 No studies have taken into account the potential confounding variable of adductor
canal blocks performed in addition to the liposomal bupivacaine injection. Cost effectiveness remains among the highest
priorities within every hospital system.
Objectives: The purpose of the study is a retrospective chart review to compare the overall effectiveness and net clinical
benefit of liposomal bupivacaine to conventional bupivacaine in total knee replacement patients. The primary objective will
be to reduce overall length of stay by 0.5 days. This will be achieved through an analysis with respect to time to length of
hospital stay, first opioid given for pain relief, total opioid consumption, and if readmission rates secondary to surgical
procedure performed play a factor in overall efficacy of one formulation over the other.
Methodology: An electronic medical record query will be done to find all patients who meet inclusion and exclusion
criteria in the University Hospitals Geauga Medical Center from 1/1/2014-9/31/2014 to determine patients who will be in
the control group (did not receive treatment with liposomal bupivacaine). This data will be analyzed to compare the net
clinical benefit of liposomal bupivacaine in patients undergoing total knee replacement surgery with a primary endpoint of
overall length of hospital stay. Secondary endpoints will include time to first opioid relief, total oral morphine equivalent
used, initial pain scores following procedure, average pain score at 24hrs post-surgery, average pain score throughout
entire hospitalization, average time to first ambulation/physical therapy session, adductor canal block influence on pain
score at 24hrs, adductor canal block influence on pain score throughout entire hospitalization, rate of readmission
secondary to surgical procedure.
Results and conclusions: To be determined.
References:
1. Gorfine SR, Onel E, et al. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia
in patients undergoing hemorrhoidectomy: A mulitcenter, randomized, double-blind, placebo-controlled trial. Dis
Colon Rectum. 2011;54:1552-1559.
2. Bagsby DT, et al, Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee
arthroplasty, J Arthroplasty (2014)
3. Noviasky J et al, Bupivacaine Liposomal Versus Bupivacaine: Hosp Pharm 2014;49(6):539-543
OCCP Fall Meeting 2014
16
Impact of a pharmacist-driven discharge prescription delivery program on 30-day hospital readmission rates in
an academic medical center
Yana A. Doughty, PharmD; Erin L. Thompson, PharmD, BCPS, Annissa K. Green, PharmD; Valerie M. Householder,
PharmD, BCACP; Cindy S. Puffer RPh
yana.steklova@utoledo.edu
PGY-1 Managed Care Resident
The University of Toledo Medical Center, 3000 Arlington Ave. MS 1060, Toledo, OH 43614
Background:
Medication non-adherence has a direct impact on patient 30-day hospital readmissions. Studies show that nearly onethird of patients do not fill their prescriptions1. Nearly 24-28% of patients do not fill their prescriptions upon hospital
discharge2. This in turn leads to decreased adherence and accounts for 11% of readmission rates 3. Therefore, nonadherence is a critical area to address to help improve hospital readmissions. The purpose of a bedside prescription
delivery at discharge program is to improve patient access to medications and help reduce hospital 30-day readmissions.
Objectives:
(1) To determine whether a pharmacist-driven bedside prescription delivery program contributes to a reduction in 30-day
hospital readmissions.
(2) To track patient readmissions based on diagnosis and individual risk category for patient readmission. (3) To track
pharmacist interventions.
Methodology:
This study was submitted to the institutional review board (IRB). Data collection will begin upon IRB approval. This
retrospective cohort study will be conducted through medical chart review of patients admitted January 1-June 30, 2014.
Patients will be offered to participate in the prescription bedside delivery program during their inpatient stay. If enrolled in
the program, pharmacists, nurses, and physicians will coordinate care of the patient to ensure prescription needs are
addressed. Prior to discharge, the outpatient pharmacy will fill any prescriptions written for the patient by the physician
and then deliver the prescription to their bedside. If a patient chooses not to participate in the medication delivery
program, existing hospital discharge protocols and procedures will be followed. Patients will retrospectively be enrolled
into the study based on whether or not they participated in the bedside medication delivery program. Those who opt out of
the discharge delivery program will serve as the control group. Patients will be followed for 30 days after their initial
discharge date to monitor for any readmission. Pharmacist interventions will be tallied and reported. These interventions,
along with patient diagnoses and risk factors will be assessed to determine impact on 30-day readmissions.
Results and Conclusions:
To be determined.
References:
1. Peterson AM, Takiya L, Finley R. Meta-analysis of trials of interventions to improve medication adherence. Am J
Health-Syst Pharm. 2003;60(7):657–665.
2. Fallis BA, Dhalla IA, Klemensberg J, Bell CM. Primary medication non-adherence after discharge from a general
internal medicine service. PLoS ONE. 2013;8(5):e61735.
3. Osterberg, L., Blaschke, T. (2005). Adherence to medication. N Engl J Med, 353(5), 487-497.
OCCP Fall Meeting 2014
17
Procalcitonin guided antimicrobial stewardship for suspected upper respiratory tract infections in a small,
community hospital.
Lukas Everly, PharmD ; Mate Soric, PharmD, BCPS
lukas.everly@uhhospitals.org
PGY-2 Internal Medicine & Academia Resident
University Hospitals Geauga Medical Center 13207 Ravenna Road, Cleveland, OH 44024
Background: Procalcitonin testing has been studied extensively over the past several years as a useful biologic marker
for the presence of a bacterial infection. While large clinical trials have shown benefits in reducing the use of unnecessary
antibiotics, adverse impacts have not been observed regarding patient outcomes (length of stay, 30 day readmission, or
mortality) 1, 2, 3. Traditionally procalcitonin testing has been restricted to cases of severe sepsis in patients admitted to the
intensive care unit, but growing evidence is available supporting a role for testing in less severe situations, such as
community acquired pneumonia4 and COPD5 exacerbations. As more health systems have adopted procalcitonin testing
to guide antibiotic use, little evidence is available from the perspective of small, community hospitals that typically lack this
resource.
Objectives: (1) To determine if the utilization of procalcitonin testing on patients admitted with suspected upper
respiratory tract infections will decrease inappropriate antibiotic use; (2) To evaluate the impact of procalcitonin guided
antibiotic use on drug costs, length of stay, 30 day readmission rate, and 30 day mortality.
Methodology: Prior to commencement, this prospective observational study will be submitted to the Institutional Review
Board for approval. The hospital’s electronic medical record system will be utilized to identify patients at least 18 years of
age admitted with a diagnosis of pneumonia, CHF, or COPD with an additional sign of infection (cough, sputum
production, dyspnea, tachypnea, pleuritic pain, rales, crepitation, temperature greater than 38 degrees Celsius, WBC
greater than 10,000 cells/ µL, or chest x-ray suggestive of infection). These patients will be matched to patients who
received procalcitonin guided antibiotic utilization based upon age, gender, diagnosis, and Charlson comorbidity index.
Patients will be excluded from analysis if there is a concurrent medical condition leading to possible imminent death, are
pregnant, are severely immunocompromised including neutropenia, or have a condition that requires immediate antibiotic
treatment for an extended duration (suppressive therapy, osteomyelitis, endocarditis, etc). The following data will be
collected: age, gender, admitting diagnosis, Charlson comorbidity index, procalcitonin level, date of admission, start date
of antibiotic therapy, stop date of antibiotic therapy, discharge date, and the presence of 30 day readmission or mortality
from inpatient discharge. Antibiotic use will be characterized as days on therapy. All data will be recorded, linked, and
maintained according to the documentation approved by the Institutional Review Board.
Results and Conclusions: To be determined
References
1) Schuetz et al. Effect of Procalcitonin-Based Guidelines vs. Standard Guidelines on Antibiotic Use in Lower
Respiratory Tract Infections (ProHOSP). JAMA 2009;302(10):1059-66.
2) Boudama et al. Use of procalcitonin to reduce patients’ exposure to antibiotics in intensive care units (PRORATA
trial): a multicentre randomized controlled trial. Lancet 2010;375:-463-74.
3) Wacker et al. Procalcitonin as a diagnostic marker for sepsis: a systematic review and meta-analysis. Lancet Infect
Dis. 2013;13:426-35.
4) Menedez R, Sahuquillo-Arce J, Reves S et al. Cytokine activation patterns and biomarkers are influenced by
microorganisms in community-acquired pneumonia. Chest 2011; 11: 1–28.
5) Stolz D, Christ-Crain M, et al. Antibiotic Treatment of Exacerbations of COPD: a randomized, controlled trial
comparing procalcitonin-guidance with standard therapy. Chest. 2007;131(1):9-19.
OCCP Fall Meeting 2014
18
Evaluation of a clinical pharmacist-facilitated multidisciplinary pain, agitation, and delirium protocol for
mechanically-ventilated intensive care unit (ICU) patients
Mary Elizabeth Fredrickson, PharmD; Dawn Miller, PharmD, BCPS
Resident’s email address: mefredrickson@mercy.com
PGY1mailto:rdmitchell@hmis.org
Research Site: St. Elizabeth Health Center
1044 Belmont Ave, Youngstown, OH 44501
Background: Previous literature has demonstrated a reduction in the duration of mechanical ventilation through
implementation of and adherence to pain, agitation, and delirium protocols. 1-3 In 2013, the Society of Critical Care
Medicine (SCCM) incorporated this evidence into revised guidelines outlining strategies for the management of adult ICU
patients.4 The guidelines define best practices and encourage ICU practitioners to implement multifaceted, patientcentered protocols in their own institutions.
Objective: To evaluate the impact of a clinical pharmacist-facilitated, multidisciplinary pain, agitation, and delirium
protocol on clinical outcomes of mechanically-ventilated ICU patients.
Methodology: This study was reviewed by the Institutional Review Board and informed consent was requested. A new
protocol, developed in accordance with the revised SCCM guidelines, will be utilized at St. Elizabeth Health Center to
manage pain, agitation, and delirium in mechanically-ventilated ICU patients. The protocol emphasizes analgesia-first
sedation with active down-titration, use of validated bedside behavioral assessment tools, daily sedation interruptions, and
implementation of delirium screening and prevention strategies. Patients will be prospectively enrolled in the study if they
are admitted to the medical intensive care unit and require mechanical ventilation for ≥ 12 hours. Exclusion criteria for this
study includes: age ≤ 18 years, pregnancy, chronic tracheostomy, and cardiac arrest undergoing therapeutic
hypothermia. A clinical pharmacist will be consulted to evaluate each patient and recommend an initial analgesic and
sedative regimen. The pharmacist will also complete daily follow-up assessments, participate in daily sedation
interruptions, and coordinate screenings for delirium. Recommendations will be communicated to the critical care team on
patient rounds and through progress notes in the electronic medical record. Baseline retrospective data will be collected
for patients who received care without pharmacist intervention over a three month period prior to protocol initiation. This
data will be compared to data collected during the intervention phase of the study. The primary outcome is duration of
mechanical ventilation. Secondary outcomes include length of ICU stay, length of hospital stay, protocol adherence, and
mean total daily doses of analgesic and sedative medications. Safety outcomes will also be documented, including
number of self-extubations, reintubations, and tracheostomies.
Results and conclusions: To be determined.
References:
1. Kane S, Weber R, and Dasta J. The impact of critical care pharmacists on enhancing patient outcomes. Intensive
Care Med. 2003; 29 (5): 691-8.
2. Girard T, Kress J, Fuchs B et al. Efficacy and safety of a paired sedation and ventilatory weaning protocol for
mechanically ventilated patients in intensive care (awakening and breathing controlled trial): a randomized
controlled trial. Lancet. 2008; 371: 126-134.
3. Mehta S, Burry L, Cook D et al. Daily sedation interruption in mechanically ventilated critically ill patients cared for
with a sedation protocol: a randomized control trial. JAMA. 2012; 308 (19): 1985-92.
4. Barr J, Fraser G, Puntillo K et al. Clinical practice guidelines for the management of pain, agitation, and delirium in
adult patients in the intensive care unit. Crit Care Med. 2013; 41 (1): 263-306.
OCCP Fall Meeting 2014
19
Analgesic effect of scheduled tramadol in patients with concomitant strong cytochrome 2D6 inhibitors
Authors: Derek Frost, Pharm.D., Mate Soric, Pharm.D. BCPS
Derek.frost@uhhospitals.org
PGY1
University Hospitals – Geauga Medical Center
Background: Tramadol requires metabolism via O-demethylation by Cytochrome 2D6 to an active metabolite.1 Previous
research has shown patients who are poor CYP2D6 metabolizers have decreased metabolism to the active metabolite. 1, 2
Some small pharmacokinetic studies have shown decreased metabolism when combined with paroxetine, a strong
CYP2D6 inhibitor and escitalopram, a weak CYP2D6 inhibitor.3, 4
Objectives: (1) To determine if the use of a strong CYP 2D6 inhibitor with scheduled tramadol decreases patients’ mean
pain scores. (2) To determine if the use of a strong CYP 2D6 inhibitor with scheduled tramadol increases the need for
breakthrough opioid use.
Methodology: This will be a retrospective chart review that will evaluate hospitalized patients with an order for scheduled
tramadol with and without a concurrent strong CYP2D6 inhibitor. Inclusion criteria for participants includes those at least
18 years of age or older, receiving concurrent scheduled tramadol and a strong CYP2D6 Inhibitor for at least 24 hours,
admitted as inpatient or observation for at least 24 hours, and pain scores assessed utilizing the 0-10 numerical pain
scale during use of scheduled tramadol. Exclusion criteria for participants include patients receiving suboptimal therapy,
and patients receiving scheduled ondansetron without a 24-hour ondansetron-free period. A study population of 64
participants will be needed to provide 80% power to find a 1 point difference in mean pain score for patients receiving
concurrent strong CYP2D6 inhibitors to the control using a student t-test. Secondary endpoints to be evaluated include
use of breakthrough opioid medications, length of stay, daily dose of tramadol, and discontinuation rate of tramadol. Data
analysis for secondary endpoints will utilize a student t-test for any continuous data, a chi-squared test for nominal data,
and Fisher’s exact test for any nominal data with <5 occurrences. A query of electronic health medical record for patients
meeting inclusion and exclusion criteria within the University Hospitals Health System from 1/1/2012- 9/30/2014. This
study is currently waiting for Institutional Review Board Approval.
Results and Conclusions: To Be Determined
References
1. The hypoalgesic effect of tramadol in relation to CYP2D6. Poulsen L1, Arendt-Nielsen L, Brøsen K, Sindrup SH.
Clin Pharmacol Ther. 1996 Dec;60(6):636-44.
2. Genetic predictors of the clinical response to opioid analgesics: clinical utility and future perspectives. Lötsch J1,
Skarke C, Liefhold J, Geisslinger G. Clin Pharmacokinet. 2004;43(14):983-1013.
3. Paroxetine, a cytochrome P450 2D6 inhibitor, diminishes the stereoselective O-demethylation and reduces the
hypoalgesic effect of tramadol. Laugesen S1, Enggaard TP, Pedersen RS, Sindrup SH, Brøsen K. Clin
Pharmacol Ther. 2005 Apr;77(4):312-23.
4. Escitalopram is a weak inhibitor of the CYP2D6-catalyzed O-demethylation of (+)-tramadol but does not reduce
thehypoalgesic effect in experimental pain. Noehr-Jensen L1, Zwisler ST, Larsen F, Sindrup SH, Damkier P,
Brosen K. Clin Pharmacol Ther. 2009 Dec;86(6):626-33. doi: 10.1038/clpt.2009.154. Epub 2009 Aug 26.
OCCP Fall Meeting 2014
20
Does dexmedetomidine use in patients undergoing ETOH withdrawal lead to a decrease in benzodiazepine
requirements?
Kristen Funelli, CNMT, RT(N)(MR), PharmD; Melissa Lagzdins, PharmD, BCPS; Mary Temple-Cooper, MS, PharmD,
BCPS, FCCP
funellk@ccf.org
PGY-1
Hillcrest Hospital 6780 Mayfield Road, Mayfield Heights, OH 44124
Background:
Approximately 500,000 Americans suffer from severe alcohol withdrawal which requires pharmacologic treatment. Benzodiazepines
are currently the standard of care1, particularly when status epilepticus and delirium tremens are present. Phenobarbital and propofol
are used as adjunctive therapy when excessive doses of benzodiazpeines are required. However, these medications often result in
respiratory depression and excessive sedation, which increases risk of patient complications 2. Thus, dexmedetomidine is an attractive
agent for alcohol withdrawal syndrome. It is a highly selective, central acting alpha-2 agonist, and is not associated with clinically
significant respiratory depression. Dexmedetomidine decreases benzodiazepine requirements in patients with alcohol withdrawal
syndrome2. The goal of this study is to validate findings of prior studies at our institution, and to add to the sparse literature currently
available.
Objectives: This study aims to determine if dexmedetomidine use decreases benzodiazepine requirements in patients with severe
alcohol withdrawal syndrome.
Methodology: This study was submitted to the Cleveland Clinic Institutional Review Board for approval. This will be a single center,
retrospective chart review conducted at Hillcrest Hospital. Charts will be reviewed via EPIC™, which is our electronic medical records
database. All data will be recorded without patient identifiers and maintained confidentially in a secured RedCap™ database. The
primary outcome will be change in total benzodiazepine dosage expressed in milligrams of oral lorazepam equivalents. Secondary
outcomes will include: length of stay in critical care unit, average CIWA-Ar score per day, use of adjunctive agents and duration (i.e.
propofol, haloperidol, etc.), incidence of adverse effects (i.e. hypertension, hypotension, and bradycardia). Patients will be divided into
two groups, based on presence of an order for benzodiazepines with and without concomitant dexmedetomidine therapy. Pertinent
charts will be identified for review by ICD-9 code for alcohol withdrawal syndrome and compared to an EPIC™ report on patients
receiving dexmedetomidine since 2011. The following data will be collected: age, gender, race, location/unit, intubation status,
admitting diagnosis, blood alcohol level upon admission, average dose of dexmedetomidine, duration of dexmedetomidine therapy,
length of ICU stay, use of adjunctive agents and duration, and incidence of adverse effects. A RASS score will be recorded upon
admission. The primary outcome will be evaluated using a student’s t-test. If the data is non-parametric with respect to means,
medians and non-parametric analysis will be evaluated. Secondary outcomes will be evaluated using Chi square or Fisher’s exact,
Wilcoxon rank sum test, and student’s t-test. Non-parametric data will be analyzed using medians with the Wilcoxon rank sum test and
parametric data will be analyzed using means with the student’s t-test, as appropriate for the type of data. Alpha will be set at 0.05 and
power at 80%. The difference to detect will be a 10 mg per day reduction in benzodiazepine dose over 7 days (total of 70 mg), based
upon previous literature. Standard deviation is set at 45 mg of oral lorazepam equivalents. Our sample size is set at 66 patients per
group. Sample sizes of similar studies have found a difference in benzodiazepine dose between groups of 1.5 standard deviations or
more. We would require only 10 patients per group to detect a difference of this size or larger with at least 80% power at the 0.05 level
using a two-sample t-test. However, we plan to adjust for additional variables in our statistical analysis and following the common
guideline of 10 patients per variable for multivariable analysis, we plan to collect data on 50-60 patients total (25-30 per group). We will
re-evaluate our statistical power at that point using multivariable regression power analysis to confirm it is adequate based on that initial
data collection, and review additional patient records if our expected power is less than 80%.
Results and conclusions: To be determined.
References:
1.
2.
3.
4.
5.
Hoffman, Robert S., M.D., Weinhouse, Gerald L., M.D. Management of moderate and severe alcohol withdrawal syndromes.
In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. (Accessed on July 8, 2014.)
Frazee, Erin, Pharm.D., Personett, Heather, PharmD, Leung, Jonathan, PharmD, Nelson, Sara, PharmD, Dierkhising, Ross,
MS, Bauer, Phillipe, MD. “Influence of dexmedetomidine therapy on the management of severe alcohol withdrawal syndrome
in critically ill patients." Journal of Critical Care 29 (2014): 298-302.
Lexi-Comp OnlineTM , Lexi-Drugs OnlineTM , Hudson, Ohio: Lexi-Comp, Inc.; July 21, 2014.
DeMuro et al. Use of dexmedetomidine for the treatment of alcohol withdrawal syndrome in critically ill patients: a retrospective
case series. J Anesth. 2012;26:601-605
Muzyk et al. The use of dexmedetomidine in alcohol withdrawal. J Neuropsychiatry Clin Neurosci. 2012;24(3):E45-46.
OCCP Fall Meeting 2014
21
Pharmacist based outpatient diabetes interventions utilizing continuous glucose monitoring
Jeremy Hall, PharmD, Joshua Unsworth, PharmD, BCPS
jhall@swgeneral.com
PGY-1
Southwest General Health Center 18697 Bagley Road, Middleburg Heights, OH 44130
Background: Diabetes mellitus (DM) continues to be one of the leading diagnosed health issues within the United States,
with approximately 17.9 million Americans diagnosed and as many as 5.7 million more with undiagnosed and unmanaged
diabetes.1 The overall management of diabetes contributes to approximately one out of every five dollars spent within
healthcare on direct costs alone.1 Pharmacist involvement within healthcare teams, collaborative practice settings, and
outpatient clinics have been shown to decrease diabetes related healthcare expenses, improve HgbA1c and blood
glucose control, prevent emergency department visits and inpatient hospitalizations, improve medication adherence, and
decrease diabetes related cardiovascular outcomes.2,3,4 In conjunction with the outpatient interventions, continuous
glucose monitoring (CGM) has shown to be beneficial in the management of uncontrolled diabetes in patients utilizing
insulin therapy, patients with newly diagnosed type 1 diabetes, and patients with nocturnal hypoglycemic episodes.5 The
use of CGM has has yet to be utilized in the setting of a pharmacist based service.
Objectives: The objective of this prospective and retrospective study is to evaluate the utility of a pharmacist based
outpatient diabetes management service. The service is targeted at patients with uncontrolled diabetes to utilizing
continuous glucose monitoring in maximizing the patients’ medication regimen and reduce adverse events.
Methodology: Prior to initiation of the study, IRB approval will be obtained. The primary endpoint of the study will be
interventions provided by the pharmacist. Secondary endpoints will be improvements in diabetes control measures,
increased medication adherence rates, and management of drug therapy problems. Patients identified as uncontrolled or
newly diagnosed DM will be reviewed for eligibility for CGM as set by the appropriate insurance provider coverage
requirements. Inclusion criteria include a combination of the following: diagnosis of Type 1 or Type 2 DM, documented
daily blood glucose testing, above goal A1c measurements, uncontrolled blood glucose measurements, multiple daily
insulin injections, self-adjusted insulin regimens, repeated episodes of hyperglycemia or hypoglycemia, hypoglycemia
unawareness, and/or frequent hospitalizations potentially related to uncontrolled DM. After written informed consent is
obtained, patients will have the CGM sensor placed and calibrated upon discharge. After seventy-two hours of
continuous monitoring, the sensor will be collected to extract and analyze the data. Other information to be collected
includes daily point of care blood glucose testing results, insulin therapy utilized over the seventy-two hour period, diet
information, medication information for diabetes related complications, and medication adherence. The glucose
monitoring data will be interpreted by a pharmacist, and recommendations in relation to medication adjustments provided
to the patient’s physician. Initial follow-up with the pharmacist will provide education about medication regimen changes,
medication counseling, and answer therapy related questions. Additional follow up will be obtained to assess the safety
and efficacy of the medication regimen. The primary endpoint will be analyzed using the fisher’s exact test, chi-square
test, and student’s t-test, and secondary endpoints being analyzed using the fisher’s exact test and chi-Square test for
nominal data and the student’s t-test for continuous data.
Results and conclusions: To be determined
References:
1.
2.
3.
4.
5.
Fera T, Bluml B, Ellis W. Diabetes Ten City Challenge: Final economic and clinical results. J Am Pharm Assoc. 2009;49:383–91.
Collier IA, Baker DM. Implementation of a pharmacist-supervised outpatient diabetes treatment clinic. Am J Health-Syst Pharm.
2014;71:27-36.
Pepper MJ, Mallory N, Coker TN. Pharmacists’ Impact on Improving Outcomes in Patients with Type 2 Diabetes Mellitus. Diabetes
Educ. 2012;38(3):409-16.
Cranor CW, Bunting BA, Christensen DB. The Asheville Project: Long-Term Clinical and Economic Outcomes of a Community
Pharmacy Diabetes Care Program. J Am Pharm Assoc. 2003;43:173–84.
Nardacci EA, Bode BW, Hirsch IB. Individualizing Care for the Many: The evolving role of professional continuous glucose
monitoring systems in clinical practice. Diabetes Educ. 2010; 36(1):4s-19s.
OCCP Fall Meeting 2014
22
CLARIFICATION OF DRUG ALLERGY INFORMATION USING A STANDARDIZED PATIENT INTERVIEW
Amy Harig, PharmD, Amy Rybarczyk, PharmD, BCPS, Amanda Benedetti, PharmD, Jacob Zimmerman, PharmD
amy.harig@akrongeneral.org
PGY-1 Pharmacy Practice Resident
Akron General Medical Center, 1 Akron General Avenue , Akron, Ohio 44307
Background: Vague, incomplete or inaccurate allergy histories can be detrimental to patient safety and affect the care of
the patient. There is an increased chance of medication error if details of a drug allergy are not documented, or if there is
no documentation of the allergy at all. Lack of clear information about a patient’s drug allergies may result in a change in
drug therapy for the patient that may be unnecessary, less efficacious or more costly. Incomplete or inaccurate allergy
histories may also result in increased time spent by healthcare providers, in particular pharmacists, to clarify an order in
question. This is especially true if the patient is ordered the medication for the first time and no documentation of the
nature or severity of an allergy is available.
Previous studies researching this were performed a decade ago or longer and many lack the patient interview component,
which is necessary for clarification. Review of the literature found the three studies that have utilized a patient interview
component. Tripp et al. found a documented drug allergy was able to be removed for 169 out of the 606 drug allergies
reported (28%) after a pharmacist-conducted patient interview1. Pilzer et al. also conducted a prospective interview that
found beta -lactam antibiotics and opioids were the two most common drug classes that had patient reported drug
allergies, which accounted for half of the reported allergies overall2. Finally, Cantrell et al. conducted a one day chart audit
which found 36% of drug allergies reported were not documented on the patient’s chart3.
No research similar to that described above has been conducted at our facility. Currently an allergy assessment is
conducted when a patient is admitted. However there is no standardized process, which can lead to the allergy
information not always being complete. It has also been observed that our facility utilizes several different sources where
drug allergies are documented, which may increase the chance for a discrepancy and further confusion. This study would
determine if using a standardized allergy questionnaire for a patient interview provides more clinically useful information
compared to the current approach used to documented allergy histories.
Objectives: (1) To determine the proportion of patients with a clinically relevant change in allergy history after a
standardized allergy interview compared to documentation prior to the interview. (2) Assess the number of drug allergies
that can be categorized after a standardized drug allergy interview compared to documentation prior to the interview. (3)
Identify patient characteristics that are associated with the need for an updated drug allergy history after a drug allergy
interview. (4) Identify the percentage of patients that will have documented allergies that are discrepant from one AGMC
drug documentation source to another.
Methodology: This study will be submitted to the Institutional Review Board for review. Patients that are admitted and
have at least one documented drug allergy will be included. Patient’s who decline participation, are admitted to nongeneral medical/surgical floors, are not A&Ox3 or have a history of or present cognitive impairment and patients
previously interviewed during the study period will be excluded. A drug allergy interview will be conducted utilizing a
standardized drug allergy questionnaire. Collected data includes the medication name, the symptoms, time course and
treatment of the reaction that occurred. The primary outcome is the number of patients with a need for an updated drug
allergy history after a standardized patient interview. Secondary outcomes include the number of allergies per category
before and after patient interview, the association of defined patient characteristics and the need for a clinically relevant
change to the documented allergy history after patient interview and the proportion of documented allergies prior to
interview that are discrepant between sources.
Results and conclusions: To be determined
References:
1. Tripp D., Brown G. Pharmacist assessment of drug allergies. Am J Hosp Pharm. 1993;(50):95-8.
2. Pilzer J., Burke T., Mutnick A., Drug allergy assessment at a university hospital and clinic. Am J Health-Syst Pharm.
1996;(53):2970-5.
3. Cantrill J., Cottrell W. Accuracy of drug allergy documentation. Am J Health-Syst Pharm. 1997;(54):1627-9.
OCCP Fall Meeting 2014
23
Evaluation of hemoglobin A1c before and after population management with an interdisciplinary team
Chelsea Harrison, PharmD; Susan Cotey, RN, CDE; Cari Cristiani, PharmD, BCPS; Andrea Harris, RN, CDE; Megan
Huebner, PharmD; Nana Kobaivanova, MD; Jennifer Luxenburg, PharmD, BCACP
Contact Information: Harrisc6@ccf.org
PGY2 Ambulatory Care Resident
Research Site: Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH, 44195
Background:
Diabetes is a devastating disease for both individual patients and the entire health care community. The American
Diabetes Association (ADA) recommend a hemoglobin (Hgb) A1c <7%, or <8% in select patients, while the American
Association for Clinical Endocrinologists (AACE) guidelines recommend a slightly lower goal Hgb A1c of <6.5%.1,2 The
Centers for Medicare and Medicaid outline similar recommendations for Accountable Care Organizations (ACO), with a
benchmark goal of Hgb A1c <8%.3 It is challenging for primary care physicians to meet these goals of care, but with the
help of interdisciplinary teams and population management the goals are more attainable.4 The Cleveland Clinic Medicine
Institute target benchmark goal for 2014 is 80% of patients with diabetes to achieve a Hgb A1c <8%, which aligns with the
goals outlined in the ACO metrics.3 At the Cleveland Clinic Stephanie Tubbs Jones (STJ) Family Health Center this
benchmark is currently not being met. In an effort to improve care for patients, the interdisciplinary team of physicians,
pharmacists, certified diabetes educators, and other healthcare providers initiated a new population management service
to specifically identify patients that were not meeting goals of care. The purpose of this project is to evaluate the new
population management process developed at STJ Family Health Center.
Objectives:
(1) To evaluate the change in Hgb A1c in patients with diabetes that had at least two clinical interactions by a member of
the interdisciplinary team at STJ with an initial Hgb A1c >8%. (2a) To evaluate the change in Hgb A1c in patients who had
clinical interactions by both pharmacist and diabetes educator versus only pharmacist or only diabetes educator; (2b) To
compare the percentage of patients with Hgb A1c of <7%, <8%, and <9% before and after interaction with interdisciplinary
team.
Methodology:
This study will be a retrospective chart review with pre-post design in which both the primary and secondary endpoint data
will be retrieved through review of study subjects’ charts within the EPIC database. Patients will be identified from a list of
patients that underwent population management by the clinical team at STJ. The list identified patients with either a Hgb
A1c >8% or those without a Hgb A1c measured within the last year. Included patients will be 18 to 75 years of age with
diabetes mellitus type 2, an A1c of >8% at baseline, and at least two interactions with the interdisciplinary team. Patients
will be excluded if they were pregnant, on dialysis, on chronic steroids, or had extended hospitalization during the study
period. Patients will be reviewed from April 1, 2014 through February 28, 2015. Patients’ Hgb A1c will be compared
before and after the clinical interaction with the interdisciplinary team.
Results and conclusions: To be determined.
References:
1. American Diabetes Association. Standards of Medical Care in Diabetes – 2014. Diabetes Care 2014;37(1):S14S80
2. American Association of Clinical Endocrinologists’ Comprehensive Diabetes Management Algorithm Consensus
Statement. Endocr Pract. 2013;19 (Suppl 1):1-48.
3. Centers for Medicare & Medicaid Services. Accountable Care Organization 2014 Program Analysis Quality
Performance Standards Narrative Measure Specifications. June 30, 2014;
http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/sharedsavingsprogram/Quality_Measures_Standards.html. Accessed Sept 9, 2014.
4. Grant RW, Gesmundo J, Cagliero E, et al. A controlled trial of population management. Diabetes Care.
2004;27(10):2299-2305.
OCCP Fall Meeting 2014
24
Evaluation of Pharmacist-Physician Collaborative Management of Hypertension
Libby Herman, PharmD; Cari Cristiani, PharmD, BCPS; Giavanna Russo-Alvarez, PharmD, BCACP
hermanl2@ccf.org
PGY-1 Pharmacy Practice
Cleveland Clinic 9500 Euclid Avenue, Cleveland, OH 44195
Background: Hypertension (HTN) is an important risk factor for cardiovascular disease and is reported to be the leading
cause of preventable death.1 Several guidelines recommend implementing a team-based approach to achieve and
maintain blood pressure (BP) control.2-5 The pharmacy consult service for management of HTN has not been formally
evaluated as an independent effector of outcomes in the Internal Medicine Clinic at Cleveland Clinic Main Campus. Given
the increasing importance of attaining the core measures to maximize reimbursement, an evaluation of pharmacistphysician collaborative management of hypertension would be beneficial.
Objectives: (1) The primary endpoint is the mean difference in recorded BP at baseline and at the next encounter after
the last pharmacy visit. (2) Secondary endpoints include the following: (a) The proportion of patients who achieved a BP
of < 140/90 mmHg at the first encounter after the last pharmacy visit; (b) the proportion of patients who achieved a BP of
< 140/90 mmHg at a follow-up encounter one year after the initial pharmacy visit; (c) the mean difference in recorded BP
at baseline and one year after the initial pharmacy visit.
Methodology: The study has been submitted for IRB approval. The institution’s electronic medical record will be utilized
to identify patients and collect data. All data will be recorded without patient identifiers and maintained confidentially. The
study is a retrospective, non-interventional cohort conducted at the Internal Medicine Clinic at Cleveland Clinic Main
Campus. Patients will be identified for inclusion between January 1st and December 31st, 2013. Patients aged 18-79 years
with existing uncontrolled HTN (BP ≥ 140/90 mmHg), an ordered consult to pharmacy for management of hypertension,
and an initial pharmacy visit within that time frame will be included and followed until December 31st, 2014. Patients will be
excluded if they have any of the following: end-stage renal disease requiring chronic hemodialysis, hyperthyroidism,
hyperaldosteronism, Cushing’s disease, white coat hypertension, are pregnant, have an existing consult to nephrology or
prior nephrology visits, or have previous pharmacy visits for management of hypertension. The following data will be
collected: age, gender, weight, height, body mass index, ethnicity, smoking status, relevant comorbidities, BP, number
and type of antihypertensives, and time frame between recorded BPs.
Results and conclusions: To be determined.
References:
1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, et al. Heart disease and stroke statistics –
2014 update: a report from the American Heart Association. Circulation. 2013; 127(1): e77-286.
2. The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. The
seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood
pressure (JNC VII). Hypertension 2003;42(1): 1206-1252.
3. U.S. Preventive Services Task Force. Screening for High Blood Pressure: U.S. Preventive Services Task Force
Reaffirmation Recommendation Statement. Ann Intern Med 2007:147-783-786.
4. Go AS, Bauman MA, King SM, Fonarow GC, Lawrence W, Williams KA, et al. An effective approach to high blood
pressure control: a science advisory from the American Heart Association, the American College of Cardiology, and
the Centers for Disease Control and Prevention. Hypertension 2014;63: 878-885.
5. Weber MA, Schiffrin EL, White WB, Mann S, Lindholm LH, Kenerson JG, et al. Clinical practice guidelines for the
management of hypertension in the community: a statement by the American Society of Hypertension and the
International Society of Hypertension. J Clin Hypertension 2014;16(1): 14-26.
OCCP Fall Meeting 2014
25
A pilot study comparing hospital readmission rates in patients that received rivaroxaban versus enoxaparin after
orthopedic surgery
Melissa A. Herschman, PharmD; Frank S. Rigelsky, PharmD, BCPS; Sandra S. Axtell, PharmD, BCPS
herschm@ccf.org
PGY-1
Hillcrest Hospital 6780 Mayfield Rd, Mayfield Heights, OH 44124
Background: Venous thromboembolism (VTE) is a potential complication after undergoing a total hip arthroplasty (THA)
or total knee arthroplasty (TKA). The American College of Chest Physicians recommends low molecular weight heparin
(LMWH) as the standard of care therapy for VTE prophylaxis following a THA or TKA. LMWH is recommended for its
efficacy in thromboprophylaxis, combined with little risk of bleeding, and extensive clinical experience.1 Investigators
found rivaroxaban 10mg by mouth daily to be significantly more effective than enoxaparin 40mg subcutaneous daily with
similar safety outcomes for deep vein thrombosis (DVT) prophylaxis after THA. 2 In another study, investigators used
equivalent dosing and showed similar results for DVT prophylaxis after TKA. 3 Therefore, rivaroxaban can be utilized as an
effective alternative to enoxaparin for DVT prophylaxis after THA or TKA.
Objectives: The primary endpoint is to determine whether rivaroxaban decreases 30-day, all-cause readmission rates
compared to enoxaparin at Hillcrest Hospital. The null hypothesis states that a significant difference does not exist
between 30-day readmission rates for patients taking rivaroxaban versus enoxaparin for VTE prophylaxis after THA or
TKA. The alternative hypothesis states that rivaroxaban results in significantly less 30-day readmission rates compared to
enoxaparin. The secondary endpoint includes 30-day readmission rates due to VTE or any bleeding. The purpose of this
study is to evaluate readmission rates following THA or TKA based on the use of rivaroxaban and enoxaparin at Hillcrest
Hospital.
Methodology: A retrospective chart review will be performed on patients who underwent a THA or TKA from May 2013
until May 2014. The electronic medical record charts will be obtained through a quality management database and deidentified using REDcapTM. All patients who received a single prophylactic dose of rivaroxaban 10mg by mouth daily or
enoxaparin subcutaneous 30mg twice daily or 40mg once daily after THA or TKA during the study period will be included.
The exclusion criteria include patients with a history of heparin-induced thrombocytopenia, allergy associated with heparin
or rivaroxaban, requiring treatment dose anticoagulation, inherent hypercoaguable conditions, creatinine clearance less
than 30 mL/min, or death within 30 days of surgery. We will record 30-day, all-cause readmission rates and 30-day
readmission rates due to VTE or any bleeding. Additional data to be collected include: age; patient demographics;
comorbidities; reason for readmission; weight; serum creatinine; creatinine clearance; drug interactions; concomitant
anticoagulant or antiplatelet administration; total length of stay; post-operative length of stay; use of an intermittent
pneumatic compression device; incorrect dose prescribed; history of smoking or VTE; active or history of malignancy; time
to first dose administration of rivaroxaban or enoxaparin after surgery; and surgeon. We will also review the direct cost of
rivaroxaban and enoxaparin. We will use the chi-squared statistical test for categorical variables, wilcoxon-rank sum test
for non-parametric continuous data, student’s t-test for parametric continuous data, and perform a logistical regression to
address confounding variables.
Results and conclusions: To be determined
References:
1. Falck-Ytter Y, Francis C, Johanson N, Curley C, Dahl O, Schulman S, et al. Prevention of VTE in orthopedic surgery
patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American college of clinical practice guidelines.
Chest. 2012;141:e278S-e325S.
2. Eriksson B, Borris L, Friedman R, Haas S, Huisman M, Kakkar A, et al. Rivaroxaban versus enoxaparin for
thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358:2765-75. (RECORD 1)
3. Lassen M, Ageno W, Borris L, Lieberman J, Rosencher N, Bandel T, et al. Rivaroxaban versus enoxaparin for
thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358:2776-86. (RECORD 3)
OCCP Fall Meeting 2014
26
Expanding the Role: The Impact of Unit-based Pharmacists on Patient and Nursing Education in the Cardiac Care
Step-Down Unit
Aleksandra Hiznay, PharmD, Rachana Patel, PharmD, BCPS
aleksandra.hiznay@csauh.com
PGY-1
St. John Medical Center 29000 Center Ridge Road, Westlake, OH 44145
Background: As the financial impact of institution-specific data (Core Measures, Hospital Consumer Assessment of
Healthcare Providers and Systems (H CAHPS) survey, and re-admissions) continues to grow, it is vital to maximize each
provider’s skill sets. Pharmacists providing education to not only patients, but also nurses, can help patients better
understand their medications and overall health. When medication therapy is involved, hospital pharmacists have the
opportunity to serve as a valuable resource to patients and nurses for drug information. It is the pharmacist’s role to verify
that patients have sufficient understanding, knowledge and skill to follow their pharmacotherapeutic regimens and
monitoring plans.1 Studies have shown that pharmacist involvement in medication reconciliation and the discharge
process have improved patient outcomes through decreasing re-admission rates and increasing the H CAHPS Survey
scores.2,3 A unit-based pharmacy model where pharmacists perform profile reviews and bedside rounds allows
pharmacists to be involved with both medication reconciliation and the discharge process. Unit-based pharmacists also
serve as a resource to nursing staff for medication related questions. Expanding this model will optimize the use of
pharmacists’ medication expertise, increase pharmacist-patient and pharmacist-nursing communication, and thus,
increase patients’ knowledge on medications and their overall health.
Objectives: (1) To measure pharmacists’ impact on the Care Transition Domain of the H CAHPS survey scores through
medication education in the Cardiac Care Unit (CCU). (2) To determine if the presence of a pharmacist in the CCU will
increase the quality of communication by nursing of new medications and indirectly increase the corresponding H CAHPS
survey scores.
Methodology: The study will be submitted to the Institutional Review Board for approval before initiation. The pharmacist
will complete patient rounds on all the patients in the CCU. During these rounds the pharmacist will review medication
profiles and assess the patient’s current understanding of their medications after nurses have administered medications.
The pharmacist will provide education on medication purposes and disease states to improve overall understanding of
their health. The impact of the pharmacist-patient interaction will be assessed through two patient discharge survey
questions and the Care Transitions Domain of the H CAHP survey score. These will be recorded weekly and the change
in average score before and after implementing pharmacist daily rounds will be evaluated. Nursing’s communication of
medication usage and side effects will also be assessed through patient rounds through a patient questionnaire and check
list. If nursing did not provide accurate information about a medication pharmacy will educate nursing on proper
medication usages and side effects. Nursing will be given a survey before and after the initiation of pharmacist rounds to
evaluate the effectiveness of pharmacist-provided nursing education. The Communication of Side Effects and Reasons
New Medication Domain of the H CAHP survey score will be recorded weekly and the change in average score before
and after implementing pharmacist daily rounds will be evaluated.
Results and conclusions: To be determined.
References:
1. American Society of Health-System Pharmacists. ASHP guidelines on pharmacist-conducted patient education
and counseling. Am J Health-Syst Pharm. 1997;54:431-4.
2. Fera T, et al. Role of a care transition pharmacist in a primary care resource center. Am J Health Syst Pharm.
2014;71:1585-90.
3. Murphy ME, et al. Medication reconciliation at an academic medical center: Implementation of a comprehensive
program from admission to discharge. Am J Health Syst Pharm. 2009;66:2126-31.
OCCP Fall Meeting 2014
27
Evaluation of albumin usage pre-guideline implementation at a large academic medical center
Yumi Honda, PharmD; Weston Bush, PharmD, BCPS; Andreea Popa, PharmD, BCPS; Paul Eisenberg, MD; Steven
Strausbaugh, MD
Yumi.Honda@uhhospitals.org
PGY-2 Critical Care
University Hospitals Case Medical Center,11100 Euclid Ave, Cleveland, OH 44106
Background: Albumin is a human colloid blood product used for various indications1,2,3,4. Although many of these
indications have valid research available to support albumin dose and frequency, many of them do not. Albumin
continues to be dosed in these circumstances based largely on preconceived clinical benefits of colloids compared to
crystalloid. Albumin is a limited resource that carries a high cost, therefore the appropriate use of albumin needs to be
established and reserved for patients who can benefit the most from its use. Currently, there are no formally enforced
usage guidelines with regard to ordering albumin at University Hospitals Case Medical Center (UHCMC). Based on
similar size institutions experiences and published data, inappropriate usage of albumin can be decreased by the
introduction of institutional usage guidelines along with targeted education. 5 UHCMC has recently approved institution
wide albumin usage guidelines along with an implementation plan that includes clinical decision driven orderset via the
electronic medical record and education. The target date for initiation is the first quarter of 2015. The purpose of this
study is to evaluate the usage of albumin at UHCMC before guideline implementation and to identify the clinical
indications for which targeted education will have most impact.
Objectives: (1) To describe the use of albumin across the health system based on location and frequency. (2) Identify the
most frequent clinical indications for albumin use.
Methodology: Prior to commencement, this study will be submitted to the Institutional Review Board for approval. The
hospital’s electronic medical record system, omnicell data, anesthesia work station data, and direct billing data will be
utilized to identify all patients who have received albumin between April 1, 2014 and September 30, 2014. The following
patient demographic data will be collected: age, weight, and location of albumin administration. The following albuminspecific data will be collected: dose, indication, and formulation. We will use descriptive statistics to analyze all data. All
data will be maintained confidentially through the UH REDCapTM Database program.
Results and conclusions: to be determined.
References:
1. Finfer S, Bellomo R, Boyce N, SAFE study investigators, et al. A comparison of albumin and saline for fluid
resuscitation in the intensive care unit. N Eng J Med. 2004;350(22):2247-56.
2. Sort P, Navasa M, Arroyo V et al. Effect of intravenous albumin on renal impairment and mortality in patients with
cirrhosis and spontaneous bacterial peritonitis. N Engl J Med. 1999;341:403-409.
3. Annane D et al. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting
with hypovolemic shock: The CRISTAL randomized trial. JAMA. 2013; 310: 1809-17.
4. Dellinger RP et al. Surviving sepsis campaign: International guidelines for management of severe sepsis and septic
shock: 2012. Crit Care Med. 2013; 41(2): 580-637.
5. King W et al. Introduction of guidelines for the use of albumin and the effect on albumin prescribing practices in British
Columbia. BC Medical Journal. 2012; 54(1): 34-38.
OCCP Fall Meeting 2014
28
Evaluation of the incidence and risk factors of propofol-associated hypertriglyceridemia
Mackenzie Horning, PharmD; Jodi Dreiling, PharmD, BCPS; Nancy Berry, PharmD
mackenzie.horning@akrongeneral.org
PGY-1
Akron General Medical Center 1 Akron General Avenue, Akron, OH 44307
Background: Propofol is a lipophilic, intravenous general anesthetic utilized for sedation during mechanical ventilation. 1 It
is formulated in a 10% fat emulsion, providing 1.1 kcal/mL from fat. Hypertriglyceridemia is a reported side effect ranging
from 3-10% in pre-marketing trials.2 However, neither the package insert, nor the 2013 Clinical Practice Guidelines for the
Management of Pain, Agitation, and Delirium in Adult Patients in the Intensive Care Unit make recommendations
regarding triglyceride (TG) monitoring.1,2 On the other hand, the previous sedation guidelines published in 2002 suggest
TG monitoring after two or more days of propofol therapy, with a moderate degree of evidence (Grade B). 3 Additionally,
there have been limited published studies evaluating propofol-associated hypertriglyceridemia risk factors and
monitoring.4,5 This study investigates the incidence, risk factors, and clinician response of propofol-associated
hypertriglyceridemia.
Objectives: (1) To investigate the incidence of propofol-associated hypertriglyceridemia. (2) To evaluate risk factors
linked with developing propofol-associated hypertriglyceridemia. (3) To describe clinician response to propofol-associated
hypertriglyceridemia.
Methodology: This is a retrospective, cohort study from January 2009 to December 2014 evaluating the incidence, risk
factors, and clinician response of propofol-associated hypertriglyceridemia. Upon approval of the Institutional Research
Review Board, patients will be identified via pharmacy dispensing records. Patients eligible for inclusion are those 18
years of age or older who were administered propofol for at least 24 hours and had a TG level drawn while receiving
propofol. Pregnant patients will be excluded. Data collection will include: demographic data, hypertriglyceridemia history,
type of critical care patient (medical, surgical, cardiac, neurology, trauma), TG level while on propofol, average propofol
dose per day, number of days administered propofol at the time of TG level draw, and clinician response to
hypertriglyceridemia. Hypertriglyceridemia will be conservatively defined as a TG ≥ 300 mg/dL. The primary endpoint will
be incidence of propofol-associated hypertriglyceridemia. Secondary endpoints will include an evaluation of risk factors
linked to propofol-associated hypertriglyceridemia and a description of clinician response. All data will be recorded without
patient identifiers and maintained confidentially within a password-protected electronic database. A statistician will aid in
the analysis of the data.
Results and conclusions: To be determined.
References:
1. Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for the management of pain, agitation, and delirium in
adult patients in the intensive care unit. Crit Care Med 2013 Jan; 41(1): 263-306.
2. Propofol [package insert]. Lake Forest, IL: Hospira; 2009.
3. Jacobi J, Fraser GL, Coursin DB, et al. Clinical practice guidelines for the sustained use of sedatives and analgesics
in the critically ill adult. Crit Care Med 2002; 30: 119-41.
4. Devlin JW, Lau AK, Tanios MA. Propofol-associated hypertriglyceridemia and pancreatitis in the intensive care unit:
an analysis of frequency and risk factors. Pharmacotherapy 2005; 25(10): 1348-52.
5. Devaud JC, Berger MM, Pannatier A, et al. Hypertriglyceridemia: a potential side effect of propofol sedation in critical
illness. Intensive Care Med 2012; 38(12): 1990-8.
OCCP Fall Meeting 2014
29
Evaluation of systemic corticosteroids and incidence of delirium in critically ill patients with chronic lung disease
Ellen Immler, PharmD; Mariana Petrozzi, MD; Andreea Popa, PharmD
ellen.immler@uhhospitals.org
PGY-2 Critical Care
University Hospitals – Case Medical Center, 11100 Euclid Ave, Cleveland, OH 44106
Background: Treatment guidelines for patients with exacerbations of chronic lung diseases, such as asthma or chronic
obstructive pulmonary disease (COPD), recommend administration of systemic corticosteroids. 1,2 However, the optimal
dose, especially in critically ill patients, is unknown and multiple dosing regimens may be utilized. Corticosteroid use,
particularly in the ICU, has been associated with numerous adverse effects such as increased incidence of infection,
hyperglycemia, and neuromuscular sequelae.3 Corticosteroids are also a recognized risk factor for developing psychiatric
disturbances, such as delirium; furthermore, recent studies have linked corticosteroids to the development of ICU
delirium.4 The aim of the current study is to characterize dosing strategies for systemic corticosteroids in ICU patients with
exacerbations of chronic lung disease and evaluate the incidence of delirium in this patient population.
Objectives: (1) To determine the incidence of delirium with systemic corticosteroid use in exacerbations of asthma and
COPD in a medical ICU population. (2) To characterize corticosteroid use and to determine length of ICU and hospital
stay, and duration of mechanical ventilation in critically ill patients treated with systemic corticosteroids for exacerbations
of asthma and COPD.
Methodology: The current study is a single-center, retrospective chart review. Prior to commencement, this study will be
submitted to the Institutional Review Board for approval. The hospital’s electronic medical record system will be utilized to
identify patients admitted to the medical ICU with exacerbations of asthma or COPD receiving one or more doses of
systemic corticosteroid. Patients receiving corticosteroids outside of acute exacerbations of asthma or COPD will be
excluded. Data collection will include patient demographics, corticosteroid use (route of administration, dose, frequency,
and duration of therapy), length of stay, ventilator days, and development of delirium. All data will be recorded without
patient identifiers and maintained confidentially utilizing REDCapTM database system.
Results and conclusions: To be determined.
References:
1. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive
Lung Disease (GOLD) 2014. Available from: http://www.goldcopd.org.
2. U.S. Department of Health, National Institutes of Health, National Heart, Lung, and Blood Institute. Expert Panel
Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma - Summary Report 2007.
http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.htm.
3. Rady MY, Johnson DJ, Patel B, Larson J, Helmers R. Corticosteroids influence the mortality and morbidity of
acute critical illness. Critical Care 2006;10(4): R101.
4. Schreiber MP, Colantuoni E, Bienvenu OJ, et al. Corticosteroids and transition to delirium in patients with acute
lung injury. Crit Care Med 2014;42:1480-1486.
OCCP Fall Meeting 2014
30
Effect on diabetes care by a nurse Certified Diabetes Educator with pharmacist support within a primary care
clinic in a Veterans Affairs Hospital
Amy James, PharmD; Kathryn Leciejewski, PharmD, BCACP, CDE; Kristina Pascuzzi, PharmD, BCPS, CDE
Amy.James1@va.gov
PGY-2 Ambulatory Care Resident
Louis Stokes Cleveland Veterans Affairs Medical Center 10701 East Blvd Cleveland, Ohio 44106
Background: Within the VA 500,000 veterans receive care annually for diabetes. 1 It has become important to develop
strategies to improve effectiveness and reduce the cost of managing diabetes. Case management or disease state
management using nurses has emerged as a new method to meet the needs of patients with complex conditions or high
disease burdens, such as diabetes.2 Using nurse certified diabetes educators (CDE) and specific diabetes algorithms,
studies have shown a reduction in HbA1C by 1.7%.3 A growing approach to case management is the pharmacist-nurse
collaboration. The SCRIP-HTN study concluded that when nurses and pharmacists work together systolic blood pressure
can decrease by 10.1mmHg.4 With clinically significant outcomes seen with the SCRIP-HTN study, the thought is diabetes
outcomes could be effected with this collaboration. A novel clinic was created at The Louis Stokes Cleveland Department
Veteran Affairs Medical Center (LSCDVAMC) called the Nurse CDE/PharmD disease management clinic in 2011 to
improve diabetes outcomes utilizing the pharmacist and nurse collaboration. This service was initiated to alleviate nurse
CDE frustration surrounding the logistics of precepting all patients with a provider prior to initiating or changing therapy. At
the VA, clinical pharmacists have scopes of practice allowing them to serve as the preceptor for this clinic.
Objectives: The primary objective of this project is to determine the change in HbA1C at 1 year or at discharge for
patients referred to a nurse CDE/PharmD disease management clinic compared to the last HbA1C received while
managed by usual care. Using patients as their own control, the study will determine the following secondary objectives
comparing patients after referral to the nurse CDE/PharmD disease management clinic to when managed by usual care
a) number of overall medication changes b) average number of HbA1C tests c) percentage of patients with a last
documented HbA1C <8% d) percentage of patients with a last documented HbA1C <7% e) average number of patient
visits f) determine provider referring patient to clinic
Methodology: Prior to commencement, this study will be submitted to the Institutional Review Board for approval.
Patients referred to the Nurse CDE/PharmD disease management clinic between January 1, 2011 to December 31, 2013
will be evaluated for inclusion in the study through a CPRS® generated list. For patients included in the study, data will be
collected during two separate time periods (pre and post) and compared, using patients as their own control. Pre period
(or usual care) data collection will begin 730 days (2 years) prior to the first Nurse CDE/PharmD disease management
clinic appointment. Post period data will be collected for no longer than one year during enrollment in the nurse
CDE/PharmD disease management clinic, starting the day of the first appointment. Patients will be included if they are 18
years or older, had at least 2 visits during that specified time frame, had an HbA1C upon referral of >8%, and had at least
1 HbA1C recorded during each time period. Patients will be excluded if they are not followed by a VA primary care
provider or resident for at least 2 years prior to being referred to the clinic, had less than 2 visits to the nurse
CDE/PharmD disease management clinic, were referred or followed by endocrinology, and had an HbA1C<8% upon
referral. Differences in continuous outcome variables will be assessed with a one sided paired t-test. A sample size of
200 patients will be sufficient to detect a difference in HbA1C from the pre to post time frame with a power of 0.80 and
alpha=0.05.
Results and conclusions: To be determined
References:
1. Miller DR, Safford MM, Pogach LM. Who has diabetes? Best estimates of diabetes prevalence in the Department of
Veterans Affairs based on computerized patient data. Diabetes Care 2004;27:B10-21.
2. DeBusk R, West J, Miller N, at al. Chronic disease management: treating patient with disease(s) vs treating disease(s)
in the patient. Arch Intern Med. 1999;159:2739-2742
3. Aubert RE, Herman WH, Waters J, et al. nurse case management to improve glycemic control in diabetic patients in a
health maintaince organization. Ann intern med. 1998;129:605-612
4. McLean DL, Mcalister FA, Johnson JA, et al. A randomized trial of the effect of community pharmacist and nurse care
on improving blood pressure management in patients with diabetes mellitus. Arch intern med. 2008;1686(21):2355-2361
OCCP Fall Meeting 2014
31
A comparison of abnormal involuntary movements in patients receiving clozapine monotherapy
vs. patients receiving clozapine plus a second antipsychotic.
Eric Johnson, PharmD, Colleen Hall, PharmD, BCPP, Jennifer Roche, PharmD, BCPP, George Jaskiw,
MD, Matthew Fuller, PharmD, BCPP
Eric.johnson9@va.gov
PGY-2 Psychiatric Pharmacy Practice Resident
Louis Stokes Cleveland VA Medical Center
Background: Clozapine is often utilized for patients who are intolerant of motor side effects caused by
typical antipsychotics. Clozapine possesses activity at the serotonin 5-HT2A, muscarinic, histaminergic,
cholinergic and adrenergic receptors and also has a weak affinity for D2 receptors which may lead to
fewer extrapyramidal side effects.
Objectives: (1) To compare abnormal movements in patients receiving clozapine monotherapy versus
patients receiving clozapine plus a second antipsychotic. (2) To compare the mean clozapine dosage
between the clozapine monotherapy arm versus the clozapine plus a second antipsychotic.
Methodology: A retrospective chart review will conducted on 387 patients enrolled in the hospital’s
clozapine database. Name, age, sex, medication, clozapine dosage, and diagnosis will be collected from
the computerized patient record system (CPRS). Patients will be divided into two groups, “clozapine
monotherapy” or “clozapine + typical antipsychotics”. In each group, AIMS scores at baseline, 6
months, and 1 year will be recorded. A 2x3 repeated measures ANOVA will be used to: 1) compare the
mean AIMS scores between the two groups overall 2) compare AIMS scores between the two groups at 3
specific time points during treatment 3) detect which treatment had the greatest effect on AIMS scores.
An independent t-test will be utilized to compare the mean clozapine dose between groups. Descriptive
statistics will be used to account for other medications that may also affect AIMS scores, exploratory data
for time points at 3 and 5 years, and for mean dose of typical antipsychotics. This study will be submitted
to the Institutional Review Board for approval.
Results and conclusions: To be determined
References:
1. Bhidayasiri, R., & Boonyawairoj, S. Spectrum of tardive syndromes: clinical recognition and
management. Postgrad Med J. 2011;87:132-141
2. Baldessarini, R., Cole, J. O., & Davis, J. M. Summary of a taskforce report of the american
psychiatric association. JAMA Psychiatry.1980;137:1163-1172.
3. Egan, M., Apud, J., & Wyatt, R. Treatment of Tardive Dyskinesia. Schizophr Bull
(Bp).1997;23(4):583-609.
4. Bassitt, D. P., & Neto, M. R. Clozapine efficacy in tardive dyskinesia in schizophrenic
patients. Eur Arch Psychiatry Clin Neurosci.1998;248(4):209-211
OCCP Fall Meeting 2014
32
An evaluation of physician acceptance of pharmacist-based interventions in a physician practice setting
Tom Kahle, Pharm D; Rachana Patel, PharmD, BCPS; Julie Falk, PharmD
Thomas.kahle@csauh.com
PGY-1
Westshore Primary Care 26908 Detroit Rd, Suite 201 Westlake, OH 44145
Background: The role of clinical pharmacists in the physician practice setting is not yet well defined. As national
pharmacy organizations push for provider-status, an evidence-based role for pharmacists in this setting will be required.
There are a variety of interventions that could be performed by pharmacists in a physician practice. Medication therapy
management and collaborative practice arrangements are already being utilized to fill current voids. Interventions like
these have been proven to improve monitoring, medication adherence, time to therapeutic goals and cost savings in many
chronic disease states.1,2 Gaining the support of physicians will be necessary for the successful integration of pharmacists
in this capacity. Based on current literature, physician acceptance of pharmacists’ interventions ranges from 77 to
92.8%.3,4 An average of $1,057 can be avoided by each pharmacists’ intervention. 4 This study evaluates the potential
interventions a pharmacist could have in a physician practice, physician acceptance of pharmacists’ interventions and the
potential cost-avoidance of these interventions.
Objectives: (1) To determine the types of interventions pharmacists can have in a physician practice.
(2) To determine the overall physician acceptance of pharmacists’ interventions. (3) To determine the potential costavoidance of these interventions.
Methodology: Prior to commencement, this study will be submitted to the Institutional Review Board for approval. A
pharmacist will be present at the physician practice for 8 hours each week. Outside of the time in the practice, the
pharmacist will be responsible for evaluating patient profiles for medication-related problems. While in the practice, the
pharmacist will be able to ask the patients questions relating to their medications. Recommendations will be made to the
physician based on the findings. The pharmacist will also serve as a resource to the physicians by answering drug
information questions and providing educational presentations. All data will be recorded, in a confidential manner without
patient identifiers, utilizing a web-based platform.
Results and conclusions: To be determined.
References:
1. Kiel PJ, McCord AD. Pharmacist impact on clinical outcomes in a diabetes disease management program via
collaborative practice. Ann Pharmacother. 2005 Nov;39(11):1828-32.
2. Debenito JM, Billups SJ, Tran TS, et. al. Impact of a clinical pharmacy anemia management service on
adherence to monitoring guidelines, clinical outcomes, and medication utilization. J Manag Care Pharm. 2014
Jul;20(7):715-20.
3. Ginzburg R. Impact of pharmacy student interventions in an urban family medicine clinic. Am J Pharm Educ. 2014
Jun 17;78(5):90.
4. Lee AJ, Boro MS, Knapp KK, et. al. Clinical and economic outcomes of pharmacist recommendations in a
Veterans Affairs medical center. Am J Health Syst Pharm. 2002 Nov 1;59(21):2070-7.
OCCP Fall Meeting 2014
33
Pneumococcal vaccination rates in an urban outpatient clinic before and after implementation of a clinical
reminder initiative
David Koren, Pharm.D., Andrea Pallotta, Pharm.D., BCPS, Elizabeth Neuner Pharm.D., BCPS (AQ-ID), Marc Wilner,
Pharm.D., Jeffrey Clark, R.Ph., Susan Rehm, M.D.
korend@ccf.org
PGY-2 Infectious Diseases
Cleveland Clinic 9500 Euclid Avenue, Cleveland, OH 44195
Background: With over 90 serotypes, Streptococcus pneumoniae causes invasive and noninvasive infections. As of
2014, two different vaccines against prevalent serotypes are available in the United States, the Pneumococcal
Polysaccharide Vaccine (PPSV-23) and the Pneumococcal Conjugate Vaccine (PCV-13).1 Adult (19-64 years) guidelines
by the Advisory Committee on Immunization Practice and the Centers for Disease Control and Prevention were revised in
October 2012 for prevention of pneumococcal disease in patients with immunocompromising conditions or
functional/anatomical asplenia. Three risk-categories of patients were created, each with differing vaccine
recommendations.2 Given these complex prescribing recommendations and 2012 reported national pneumococcal
vaccination rate of 20%, Clinical Decision Support (CDS) was implemented within our Electronic Health Record (EHR) to
assist in determining eligibility and increasing vaccination rates.3 The current study serves to assess the impact of CDS
implementation on pneumococcal vaccination rates at an outpatient infectious diseases clinic.
Objectives: (1) To evaluate pneumococcal vaccination rates amongst vaccine eligible patients in an outpatient ID clinic
pre/post CDS implementation. (2) To describe indications amongst patients for receiving pneumococcal vaccination. (3)
To describe vaccination rates based on provider type. (4) To characterize administration of PCV-13 versus PPSV-23.
Methodology: This study is under review by the Institutional Review Board as a pre/post implementation retrospective
medical chart review. The hospital’s EHR will identify adult patients with completed appointments by a licensed
independent practitioner between ages of 19-64 years and qualifying diagnoses warranting pneumococcal vaccination
between September 1 and December 31, 2013 (pre-group) and September 1 through December 31 2014 (post-group).
Vaccination rates will be determined as the percent of eligible patients receiving pneumococcal vaccines at an Infectious
Diseases appointment. With an estimated baseline vaccination rate of 20%, 362 patients per group are necessary at an
alpha-level of 0.05 to provide 80% power to discern a 46% change. 3,4 Gender, date of birth, race, date of appointment,
indication for pneumococcal vaccination, previous pneumococcal vaccinations (type and month/year), vaccine eligibility at
current visit, provider type, and type of vaccine ordered (ordering date, administered date, and identification by CDS date
for post-group) will be collected. Data will be maintained confidentially and analyzed by descriptive or inferential statistics
as appropriate.
Results and conclusions: To be determined
References:
1. Centers for Disease Control and Prevention. Manual for the Surveillance of vaccine-preventable diseases. Centers for
Disease Control and Prevention, Atlanta , GA 2012
2. Advisory Committee on Immunization Practices. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent
Pneumococcal Polysaccharide Vaccine for Adults with Immunocompromising Conditions: Recommendations of the
Advisory Committee on Immunization Practices (ACIP). MMWR. 2012:61(40);816-819
3. Advisory Committee on Immunization Practices. Noninfluenza vaccination rates among adults – 2012. MMWR.
2014:63(5);95-102
4. Klatt, TE and Hopp, E. Effect of a best-practice alert on the rate of influenza vaccination of pregnant women. Obstetrics
and Gynecology. 2012:119(2);301-305
OCCP Fall Meeting 2014
34
Incidence and clinical impact of serum creatinine rise with integrase inhibitors in HIV-1 infected adults
Tara Lindeman, PharmD, Eric Sahloff, PharmD, Joan Duggan, MD
tara.lindeman@utoledo.edu
PGY-1 Pharmacy
University of Toledo Medical Center, 3000 Arlington Ave. Toledo, OH 43614
Background: Dolutegravir, raltegravir, and elvitegravir are HIV integrase inhibitors, when combined with other
antiretroviral agents, are approved for the treatment of HIV-1 positive treatment-naïve and treatment-experienced
patients.1 A rise in serum creatinine has been shown to be a side effect of second generation integrase inhibitors, such as
dolutegravir and the single tablet regimen consisting of tenofovir/emtricitabine/cobicistat/elvitegravir (Stribild®), in clinical
trials. This rise in serum creatinine is due to decreased tubular secretion, not nephrotoxicity. 2,3,4 There is limited postmarketing data on the clinical significance of this increase in serum creatinine on patients receiving treatment with an
integrase inhibitor. The purpose of this study is to evaluate the incidence and clinical significance of this change in serum
creatinine in a real world population.
Objectives: (1) To determine the change in serum creatinine from baseline in HIV-infected subjects after initiation of an
integrase inhibitor in combination with a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbone
(tenofovir/emtricitabine, abacavir/lamivudine, or zidovudine/lamivudine). (2) To determine the change in creatinine
clearance, the effect of tenofovir and sulfamethoxazole/trimethoprim on serum creatinine in patients on integrase
inhibitors, and discontinuation rates due to changes in renal function after initiating an integrase inhibitor-based regimen.
Methodology: This is a single-center, retrospective study. Medical records of all HIV positive male and female adult
patients attending the clinic will be screened. Patients will be included if 18 years of age or older, HIV-1 infected, and
initiated on or switched to a regimen containing dolutegravir, raltegravir or elvitegravir/cobicistat and a
nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbone. Patients will be excluded if they are pregnant,
have an active AIDS defining illness, viral hepatitis, severe hepatic impairment, or HIV-associated nephropathy, or a
baseline creatinine clearance less than 50 mL/min. Medical records will be reviewed and demographic data, CD4 count,
viral load, current and previous antiretroviral regimens and concurrent medications, serum creatinine, estimated creatinine
clearance, and comorbidities will be collected. The primary endpoint is to determine the absolute change in serum
creatinine from baseline to 48 weeks after starting an integrase inhibitor-based regimen. Secondary endpoints include
absolute and percent change in creatinine clearance from baseline; impact of other potentially nephrotoxic agents on
changes in serum creatinine or creatinine clearance; and discontinuation rates due to renal insufficiency. This study has
been submitted to the Institutional Review Board for approval.
Results and conclusions: To be determined
References:
1.
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of
antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and
Human Services. Available at http://aidsinfo.nih.gov/ContentFiles/Adultand
AdolescentGL.pdf. Accessed 8 September 2014.
2.
Raffi F, Jaeger H, Quiros-Roldan E, et al. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviralnaïve adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority
trial. Lancet Infect Dis. 2013 Nov;13(11):927-35
3.
Lepist EI, Zhang X, Hao J, et al. Contribution of the organic anion transporter OAT2 to the renal active tubular
secretion of creatinine and mechanism for serum creatinine elevations caused by cobicistat. Kidney Int. 2014
Aug;86(2):350-7.
4.
Koteff J, Borland J, Chen S, et al. A phase 1 study to evaluate the effect of dolutegravir on renal function via
measurement of iohexol and para-aminohippurate clearance in healthy subjects. Br J Clin Pharmacol. 2013
Apr;75(4):990-6.
OCCP Fall Meeting 2014
35
Quantification of labor and material costs associated with internal pre-packing of medications in a community
hospital.
Nicole McCorkindale, PharmD; Rebecca Taylor, PharmD, MBA, BCPS
mccorkn@ccf.org
PGY-1
Marymount Hospital, 12300 McCracken Rd, Garfield Heights, OH 44125
Background: Pharmacy technicians may be required to spend significant time and resources pre-packing medications
into unit dose depending on the volume of medications repackaged at an institution. The alternative pre-packing bulk
medication into unit dose form is to purchase unit-dose packaging from an outside vendor, which can be complicated by
delayed deliveries by the vendor and increased cost compared to in-house pre-packing. A review conducted by Doraci
examined a 335-bed hospital which utilized an outside packing vendor for 75-80% of its total oral-solid medications.1
Points of interest included medication safety, label and packaging options, pharmacy infrastructure changes, efficiency,
shelf-life, and cost. Comparative cost information was obtained from the results of a survey sponsored by McKesson
showing a range of $0.08 to $0.20 per unit-dose.2 In order to calculate costs of in-house prepacking of bulk medications,
the following were considered: cost of packaging materials, maintenance and depreciation of packaging machines, and
labor costs. Results displayed, while it is not possible to completely eliminate in-house pre-packing due to inability to unitdose some medications, reducing the volume of medications that must be pre-packed in-house showed to be an effective
strategy to reduce costs and improve efficiency within the pharmacy.
Objectives: (1) To compare the cost of an inpatient pharmacy pre-packing their own medication and purchasing from an
outside vendor. (2) To quantify the time used for the inpatient pharmacy to pre-pack its own medications. (3) To
characterize the most commonly pre-packed medications.
Methodology: This is a prospective cost-minimization analysis over a 6-month period from September 1, 2014 to
February 28, 2015. The study was approved by the health-system’s institutional review board. A video camera will be
utilized to record and analyze the time of each step of the process, from the beginning of the pre-packing by the
technicians to the completion of the process by pharmacist verification. Technicians will print the list of all daily pre-packed
medications for pharmacist verification purposes. The technician responsible for pre-packing the medications will assign a
number next to the medications on the printed list to show which medication was pre-packed and in which order for video
recording purposes. A limited number of technicians will be involved in the pre-packing process in an attempt to decrease
variation for the purposes of this study. Cost data will be retrieved from medication supplier invoices and commonly prepacked medications will be reviewed from reports pulled from the pre-packing program.
Results and conclusions: To be determined.
References:
1. Unit Dose vs. Bulk Oral Solid Medication Purchasing Patterns and Repackaging: Sampling and Analysis (White Paper).
McKesson Corporation; Cranberry Township, PA, 2010.
http://www.mckesson.com/uploadedfiles/mckessoncom/content/pharmacies/_body_components/_right_rails/whitepaperunitdose-vsbulkoralsolidmedpurchasing/pdf. Accessed: 1 Oct 2014
2. Doraci B. Maximize Use of Pre-Packaged Unit-Dose Products. Pharmacy Purchasing Products. 2014;11(5):30-43
OCCP Fall Meeting 2014
36
Review of anticoagulation in veterans on chronic warfarin therapy with an ACS event (RAVE Study)
Ashley McDonald, PharmD; Jonathan Goldberg, MD; Amanda Miller, PharmD, BCPS; Sharron LeForest, PharmD,
BCPS
Ashley.McDonald2@va.gov
PGY-2 Geriatric Pharmacy Practice Resident
Louis Stokes Cleveland VA Medical Center 10701 East Boulevard, Cleveland, OH 44106
Background: It is estimated that over 1 million hospitalizations are required for acute coronary syndrome (ACS) in the
United States annually1. Acute coronary syndrome is a general term that is used to describe clinical manifestations
consistent with unstable angina (UA), non-ST segment elevation myocardial infarction (NSTEMI), and ST-segment
elevation myocardial infarction (STEMI)1. Evidence based guidelines for the treatment of ACS are well established and
are determined from clinical trials2-3. However, patients who are being treated with chronic warfarin therapy prior to ACS
presentation, have been excluded from clinical trials assessing ACS management2-3. Many clinicians withhold, or delay
parenteral anticoagulation management due to increased bleeding risk concerns in those on current warfarin therapy,
especially in the geriatric population4-5. The purpose of this study is to evaluate the relationship between age and
parenteral anticoagulation for ACS in veterans on chronic warfarin therapy that present to Louis Stokes Cleveland
Veterans’ Affairs Medical Center (LSCVAMC).
Objectives: (1) Primary: To compare the number of younger veterans (18-64 years of age) to elderly veterans (65 years
of age and older) that received therapeutic treatment doses of enoxaparin or heparin who presented to the LSCVAMC
with acute coronary syndrome while on chronic warfarin therapy. (2) Secondary: Evaluate if parenteral anticoagulation
treatment is influenced by the patient’s International Normalizes Ratio (INR) on presentation. (3) Secondary: Assess if use
of parenteral anticoagulation in patients on chronic warfarin therapy with ACS is associated with bleeding adverse events.
Methodology: Prior to commencement, this study will be submitted to the Institutional Review Board for approval. A
single-center retrospective chart review will be conducted of patients ≥ 18 years of age, on chronic warfarin therapy who
have a discharge diagnosis of ACS (identified by ICD-9 codes). Patients who are on anticoagulants such as, apixaban,
rivaroxaban, and dabigatran at any point during ACS admission, anticoagulated with fondaparinux, bivalirudin, or
argatroban prior to cardiac catheterization procedure and after admission to medicine floor, developed ACS as an
inpatient, have had surgery or trauma within 30 days of admission, and have a documented discharge diagnosis of STEMI
(defined by having 3 consecutive elevated troponin levels >0.5 ng/ml) will be excluded. Patient demographics, past
medical history, provider type, cardiac home medications, timing of anticoagulation given upon admission, and bleed
adverse events within 48 hours of ACS admission will be obtained through chart review of the CPRS and VISTA database
Patients 65 years of age and older will be matched with a patient meeting inclusion criteria who is under 65 years of age
by time of admission going in reverse chronological order.
Results and conclusions: To be determined.
References:
1. Kumar A, Cannon C. Acute coronary syndromes: diagnosis and management, part I. Mayo Clin Proc. Oct 2009;
84(10):917-938.
2. O’Gara P et al. American College of Cardiology; American Heart Association. 2013 ACCF/AHA guideline for the
management of ST-elevation myocardial Infarction: a report of the American College of Cardiology
Foundation/American Heart Association Task for on Practice Guidelines. Circulation 2013;127:1524-4539.
3. Anderson J et. al. American College of Cardiology; American Heart Association. 2012 ACCF/AHA focused update
incorporated into the ACCF/AHA 2007 guidelines for the management of patients with unstable angina/non -STelevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart
Association Task Force on Practice Guidelines. Circulation 2013;127(23):e663-828.
4. Alonso A et. al. Management and outcomes of patients presenting with STEMI by use of chronic oral
anticoagulation: results from the GRACE registry. Eur Heart J Acute Cardiovasc Care 2013;2(3):280-291.
5. Alexander K et. al. Acute coronary in the elderly, part I: Non-ST-segment-elevation acute coronary syndromes: a
scientific statement for healthcare professionals from the American Heart Association Council on Clinical
Cardiology: In collaboration with the Society of Geriatric Cardiology. Circulation 2007;115(19)2549-2569.
OCCP Fall Meeting 2014
37
Impact of Pharmacist Management of Dyslipidemia in Patients with Type 2 Diabetes Mellitus
Sarah Milkovich, PharmD; Nathan Stuckey, PharmD, BCPS; Lori Rose, PharmD, BCPS; Courtney Pearson, MD
milkovs@ccf.org
PGY-1
Cleveland Clinic – Fairview Hospital, 18101 Lorain Road Cleveland, OH 44111
Background: Diabetes is a chronic disease affecting approximately 25.8 million Americans. Diabetes leads to many
complications including cardiovascular disease. According to the 2013 ACC/AHA Update on the Treatment of Blood
Cholesterol in Adults, statin therapy is preferred to reduce the risk of atherosclerotic cardiovascular disease (ASCVD) in
diabetic patients.1 Several retrospective and observational studies demonstrate the positive impact of pharmacist
intervention to decrease cardiovascular risk using previous NCEP/ATP-III guidelines.2,3,4,5 To date, studies evaluating
pharmacist-managed dyslipidemia using current guidelines have not been published. The objective of this study is to
evaluate the change in the number of type 2 diabetes mellitus patients with appropriate statin therapy after pharmacist
management of dyslipidemia according to the 2013 ACC/AHA Prevention Guidelines.
Objectives: (1) To evaluate the efficacy and safety of optimization of statin therapy in type 2 diabetes patients according
to 2013 ACC/AHA Prevention Guidelines. (2) To compare optimization of statin therapy by a pharmacist to usual care. (3)
To improve adherence to Center for Family Medicine’s Accountable Care Organization measure for dyslipidemia in
diabetes.
Methodology: Pharmacist management of dyslipidemia in type 2 diabetic patients will be evaluated using a pilot program
in a family medicine clinic. Diabetic patients are enrolled in the program if they are age 20 years and older and referred to
the program by a physician. Patients are excluded if contraindications to statin therapy are documented. The initial
standardized pharmacy appointment will include a comprehensive medication review, baseline lipid panel, treatment
goals, drug therapy initiation or modification, and education. The baseline lipid panel includes total cholesterol, LDL
cholesterol, HDL cholesterol, and triglycerides. After the initial pharmacy appointment, the pharmacist will contact
patients via telephone within two weeks if therapy is initiated or medication changes occurred, and if necessary at six
weeks and ten weeks. Patients will return for a follow up visit with the pharmacist after 12 weeks to assess changes in
lipid panel, risk factors, medication adherence, and adverse effects. Patients receiving pharmacist intervention will be
compared to a control group of diabetic patients receiving usual care by a physician, and differences will be assessed.
Results and Conclusions: To be determined.
References:
1. Goff DC, et al. 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk. Circulation Epub 12
November 2013.
2. Smith MC, et al. Effectiveness of a pharmacy care management program for veterans with dyslipidemia.
Pharmacotherapy 2013;33(7):736-743.
3. Cripps RJ, et al. An evaluation of diabetes-related measures of control after 6 months of clinical pharmacy
specialist intervention. Journal of Pharmacy Practice 2011(24):332.
4. Ip EJ, et al. Enhancing diabetes care by adding a pharmacist to the primary care team. AJHP 2013; 70:877-86.
5. Sease JM, et al. Pharmacist management of patients with diabetes mellitus enrolled in a rural free clinic. AJHP
2013; 70:43-7.
OCCP Fall Meeting 2014
38
Effect of a pharmacist lead intervention on patient satisfaction with pain management
Andrea Miller, PharmD; Christina Wadsworth, PharmD, BCPS; Matthew Hoover, PharmD, BCPS
Millera6@ccf.org
PGY-1
Marymount Hospital
Background:
The Joint Commission of on Accreditation of Healthcare Organizations (JACHO) made pain the “fifth vital sign” in 2001. 1
This placed new emphasis on individualized patient pain control plans, assessment of pain, frequent reassessment of
pain, and a multifaceted approach to pain relief. Inadequate pain control can lead to delayed wound healing and is a risk
factor for the development of chronic pain syndromes.2,3 Although measures have been put into place by JACHO to help
manage pain, satisfaction with pain management has an increased prominence with the implementation of the Hospital
Consumer Assessment of Health Providers and Systems (HCAHPS). Numerous studies have assessed the level of pain
control and patient satisfaction. One study found a negative association between a high level of patient satisfaction with
poor pain control as well as no association between patient satisfaction and a patient’s pain score. 2,4 A study by Reich and
colleagues sought to identify demographic, clinical and administrative predictors of pain scores that were secondarily
predictive of HCAHPS pain satisfaction results.5 The results showed a greater likelihood of moderate/severe pain was
associated with younger age, female gender, longer length of stay, department of the primary physician, the principal
diagnosis, and use of antipsychotic medications.
Objectives:
(1) To determine if a pharmacist lead intervention consisting of a conversation about pain with the patient throughout their
stay and follow-up with the physician and/or nursing staff will improve the patient’s satisfaction with their pain
management compared to the current standard of practice. (2) To assess if any patient demographics contribute to lower
satisfaction with pain management.
Methodology:
This is a pre-post analysis of pain HCAHPS scores. The study was approved by the health-system’s institutional review
board. Patients admitted to the general medical floors who completed an HCAHPS will be included in the analysis. The
control group will be the patients admitted during November 2013 and the intervention group will consist of patients
admitted during November 2014.The intervention will consist of a daily conversation regarding the patient’s pain with a
pharmacist/pharmacy resident/pharmacy student (pharmacy team). After discussion with the patient, the pharmacy team
will determine if follow-up with the patient’s attending physician is necessary for dose modification(does the patient need
an increase in dose, different medication, what works for the patient, what worked for the patient in the past, etc.). The
pharmacy team will follow-up with the nursing staff to ensure the patient’s pain is being evaluated as per hospital policy
(one hour after administration of pain medication) as well as letting the nursing staff know of any nonpharmacologic
methods the patient finds helpful to relieve pain.
Results and Conclusions: To be determined
References:
1. Joint Commission on Accrediation of Healthcare Organizations. Implementing the New Pain Management Standards.
Oakbrook Terrace, IL: JACHO; 2000.
2. Gupta A, Daigle S, Mojica J, Hurley RW. Patient perception of pain care in hospitals in the United States. J Pain
Research. 2009; 2: 157-64.
3. Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoractomy
pain. Clin J Pain. 1996; 12:50-5.
4. Phillips S, Gift M, Gelot S, Duong M, Tapp H. Assessing the relationship between the level of pain control and patient
satisfaction. J Pain Research. 2013 Sep; 6: 683-89.
5. Reich DL, Porter C, Levin MA et al. Predictors of maximal inpatient pain severity score and relationship with postdischarge satisfaction survey results. Anesthesiology. 2010; 33(Suppl. 1): S233-34.
OCCP Fall Meeting 2014
39
Fosfomycin for the Treatment of Urinary Tract Infections Caused by Gram-negative Organisms
LeAnne Moore, Pharm.D.; Federico Perez, M.D.; Sharanie Sims, Pharm.D., BCPS (AQ ID)
Leanne.Moore2@va.gov
PGY-2 Infectious Diseases
Louis Stokes Cleveland VA Medical Center (LSCVAMC) 10701 East Boulevard, Cleveland, Ohio 44107
Background:
Urinary tract infections (UTI) remain the most common nosocomial infection. 1 There has been an increased emergence of
multidrug resistant organisms that are causative pathogens for urinary tract infections, limiting therapeutic options.2
Extended spectrum beta-lactamase (ESBL) producing organisms such as Escherichia coli, Klebsiella pneumoniae, and
Proteus mirabilis have become a primary concern.2 The antimicrobials of choice for the ESBL organisms are
carbapenems, however this class of antimicrobials are available only as intravenous products. 2 Fosfomycin is an
antimicrobial agent that was discovered in 1969 with a broad spectrum of activity against Gram-positive and Gramnegative organisms.3 The mechanism of action and chemical structure of fosfomycin is unlike other known classes of
antimicrobials and thus it has retained susceptibility against many of the multidrug resistant organisms. 2 These
susceptibility rates have primarily been proven in in vitro models. 1 Oral fosfomycin is only approved in the United States
for the treatment of uncomplicated urinary tract infections.4 However, due to the complexity of treating urinary tract
infections with highly resistant organisms, it is often used for additional indications. 3
There are limited studies evaluating the susceptibility of fosfomycin to multidrug resistant organisms in the United States. 4
Outside of the United States, susceptibility rates have been reported to be 96-100% in urinary community-acquired
isolates.1 Recent reports have indicated the emergence of fosfomycin resistance due to increased use secondary to
fosfomycin’s utility in drug-resistant infections.5 The susceptibility testing of fosfomycin is not routinely completed at the
LSCVAMC , however it is one of the agents commonly prescribed for multi-drug resistant UTIs. The aim of this study is to
determine clinical success of patients treated with fosfomycin for a urinary tract infection caused by a Gram-negative
organism. The results of this study will help provide a framework for development of an evidence-based protocol for
fosfomycin use.
Objectives:
The primary objective is to determine the clinical response of patients treated with fosfomycin for a urinary tract infection
caused by a Gram-negative organism. Secondary objectives include microbiological response, fosfomycin susceptibility,
duration of therapy, rate of reinfection or recurrence, and all-cause mortality
Methodology:
A retrospective chart review will be conducted on patients who received at least one dose of fosfomycin for a urinary tract
infection caused by a Gram-negative organism at the LSCVAMC. Patients who had a concomitant bacteremia or
received combination therapy to treat urinary tract infection will be excluded. Patient demographics, characteristics of
urinary tract infection, and co-morbid conditions (including urological co-morbidities), will be obtained through chart
review. Patients will be identified through the computerized patient record system (CPRS) from January 2005 to August
2014. Clinical response will be defined as positive, negative or uncertain, whereas microbiological response will be
defined as positive, presumed or negative.
Results and conclusions: To be determined
References:
1. Pullukcu H, Tasbakan M, Sipahi OR, Yamazhan T, Aydemir S, Ulusoy S. Fosfomycin in the treatment of extended
spectrum beta-lactamase producing Escherichia coli-related lower urinary tract infections. Int J Antimicrob Agents.
2006;29:62-65.
2.
Reffert JL, Smith WJ. Fosfomycin for the treatment of resistant gram-negative bacterial
infections. Pharmacotherapy. 2014;34(8):845-857.
3.
Raz R. Fosfomycin: an old-new antibiotic. Clin Microbiol Infect 2011; 18:4-7.
4.
Neuner EA, Sekeres J, Hall GS, van Duin D. Experience with fosfomycin for treatment of
urinary tract infections due to multidrug-resistant organisms. Antimicrob Agents Chemother. 2012;56(11):57445748.
5. Oteo J, Bautista V, Lara N et al. Parallel increase in community us of fosfomycin and resistance to fosfomycin in
extended-spectrum B-lactamase (ESBL)-producing Escherichia coli. J Antimicrob Chemother. 2010;65:245—
2463.
OCCP Fall Meeting 2014
40
Ketamine and Propofol for Pediatric Procedural Sedation in the Emergency Department
Theresa Nerone, PharmD, Kara Sink, RPh, Matthew Campbell, PharmD, BCPS, Stephanie Bass, PharmD, BCPS
neronet@ccf.org
PGY-1 Pharmacy Practice Resident
Cleveland Clinic
Background: Children often require diagnostic or therapeutic procedures in the emergency department that require some
level of sedation or analgesia. Procedural sedation is the use of pharmacologic agents to effectively minimize discomfort,
pain, and anxiety while controlling movement in order to safely and effectively complete a procedure or diagnostic exam. 1
Patients undergoing procedural sedation should not require intubation and are ideally ready for discharge shortly after
completion of the procedure. Medication choice in procedural sedation can vary by provider experience and type of
procedure. Ketamine and propofol are commonly used agents for procedural sedation in the pediatric population,
Studies have compared the impact of these agents on time to sedation resolution, however these studies either compared
ketamine and propofol used concomitantly with other sedatives or in the adult population. 2,3 To our knowledge, there
have been no studies comparing ketamine or propofol alone on the time to sedation resolution in the emergency
department for pediatric procedural sedation.
Objectives: (1) Compare the impact of ketamine and propofol on time to sedation resolution in pediatric patients
undergoing procedural sedation in the emergency department. (2) Assess the rate of adverse events associated with
administration of ketamine and propofol during procedural sedation in the emergency department.
Methodology: This study was approved by the Institutional Review Board. The hospital’s electronic medical record
system will be utilized to identify pediatric patients who received ketamine or propofol in the emergency department for
procedural sedation. Patients will be excluded from the study if they are greater than 18 years old or were given any
sedative for intubation and have not undergone procedural sedation. The following data will be collected: age, weight,
gender, location, diagnosis, procedure type, level of consciousness, sedative given (number of doses, initial dose,
cumulative dose), opioids given, length of procedure, adverse reactions, and time to sedation resolution. All data will be
recorded without patient identifiers and maintained confidentially.
Results and conclusions: To be determined.
References:
1. American Academy of Pediatrics; American Academy of Pediatric Dentistry, Coté CJ, Wilson S; Work Group on
Sedation. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic
and therapeutic procedures: an update. Pediatrics. 2006 Dec;118(6):2587-602.
2. Godambe SA, Elliot V, Matheny D, Pershad J. Comparison of propofol/fentanyl versus ketamine/midazolam for
brief orthopedic procedural sedation in a pediatric emergency department. Pediatrics. 2003 Jul;112(1 Pt 1):11623.
3. Gorchynski J, Wang S, Anderson C, Montano J. Conscious sedation and emergency department length of stay: a
comparison of propofol, ketamine, and fentanyl/versed. Cal J Emerg Med. 2006 Jan;7(1):4-7.
OCCP Fall Meeting 2014
41
A Retrospective Comparison of Medication Administration Error Rates Between Patients Prescribed Traditional
Infusion Vs. Extended-Infusion Piperacillin-Tazobactam
Ethan Osborn, PharmD; Todd Gundrum, PharmD, BCPS; Kelli Cole, PharmD
ethan.osborn@utoledo.edu
PGY-1
The University of Toledo Medical Center, Toledo, OH 43614
Background:
Piperacillin-tazobactam, like all beta-lactam antibiotics, are time-dependent bactericidal agents. Recently, researchers
have undertaken the task of finding a way to take full advantage of this pharmacodynamic property to yield greater
efficacy through the use of extended infusions over 4 hours. A pharmacokinetic study showed through both population
pharmacokinetics and Monte Carlo simulations that maintaining the serum concentration of the drug above the MIC for
50% of the dosing interval maximizes bactericidal activity, which is achieved in extended infusion. 1 Clinically, this has
shown to lead to decreased 14-day and 30-day mortality in critically ill individuals in two retrospective studies. 2,3 The
adoption of these results into practice hospital-wide across the nation may lead to an increased risk of medication
administration errors because of limited IV access in patients as well as IV incompatibilities. This study aims to look at the
rate of errors between patients receiving 30 minute and 4 hour piperacillin-tazobactam infusions.
Objectives:
(1) To evaluate the rate of medication administration errors between extended infusion and traditional infusion piperacillintazobactam treated patients (2) To assess the burden of extended infusion piperacillin-tazobactam on the nursing staff.
Methodology:
This research project is being submitted for approval by the facility’s Institutional Review Board. Patients will be identified
retrospectively through electronic medical records if they received piperacillin-tazobactam for >48 hours concomitantly
with other scheduled intravenous (IV) medications. Patients will be chosen both prior to and after the point in which the
facility implemented an automatic substitution policy for extended-infusion so as to create two comparator arms. From the
medical record, the number of times doses of scheduled IV medications other than piperacillin-tazobactam were charted
as given early/late (>1 hr from the scheduled time) will be documented for each patient. To more clearly evaluate whether
the administration error was likely correlated with the longer infusion time of piperacillin-tazobactam, the following data will
be collected to limit the influence of variables: The number and type of scheduled IV drugs each patient received, number
of errors per patient, number of IV lines placed in the patient, type of IV lines placed, frequency of switching extended
infusion orders to traditional infusion, and number of days of piperacillin-tazobactam therapy. Subgroup analyses of error
rates will be performed in specific sub-groups.
Results and conclusions: To be determined
References:
1. Lodise TP Jr, Lomaestro B, Rodvold KA, Danziger LH, Drusano GL. Pharmacodynamic Profiling of Piperacillin in the
Presence of Tazobactam in Patients through the Use of Population Pharmacokinetic Models and Monte Carlo
Simulation. Antimicrob Agents Chemother. 2004;48(12):4718-24.
2. Lodise TP Jr, Lomaestro B, Drusano LH. Piperacillin-Tazobactam for Pseudomonas aeruginosa Infection: Clinical
Implications of an Extended-Infusion Dosing Strategy. Clinical Infectious Diseases 2007;44:357-63.
3. Lee GC, Liou H, Yee R, Quan CF, Neldner K. Outcomes of Extended-Infusion Piperacillin-Tazobactam: A
Retrospective Analysis of Critically Ill Patients. Clinical Therapeutics 2012;34(12):2297-301.
OCCP Fall Meeting 2014
42
Evaluation of High Dose versus Low Dose Phenylephrine Infusions in Critically Ill Patients
Gina Paletta, Pharm.D., Kellie Buschor, Pharm.D., BCPS
gina.paletta@utoledo.edu
PGY-1
University of Toledo Medical Center 3000 Arlington Ave. Toledo, OH. 43615
Background:
Phenylephrine is a selective α1-adrenergic agonist and potent vasoconstrictor. It is used in the treatment of shock as
adjunct therapy to increase mean arterial pressure (MAP) after adequate volume replacement. Phenylephrine usage in
shock is limited due to potential adverse effects. Constriction of blood vessels can reduce tissue perfusion and oxygen
delivery resulting in peripheral ischemia. Continuous infusion doses of phenylephrine can range from 0.5-10mcg/kg/min.
As dosage increases the risk for potential adverse effects also increases, but with minimal added hemodynamic benefit.
Objectives:
(1) To determine the incidence of peripheral ischemia in high (> 5mcg/kg/min) versus low (≤ 5mcg/kg/min) dose
phenylephrine infusions in critically ill patients. (2) To determine the incidence of mortality in high (> 5mcg/kg/min) versus
low (≤ 5mcg/kg/min) dose phenylephrine infusions in critically ill patients.
Methodology:
This quasi-experiment has been submitted to the Institutional Review Board for approval. The electronic medical record
system will identify patients who were admitted to an intensive care unit and started on a phenylephrine infusion between
January 1, 2014 and December 31, 2014. Included patients will be divided into two groups based on the time frame in
which they received phenylephrine. Patients receiving phenylephrine infusions between January 1, 2014 and June 30,
2014, will be placed into the high dose group, while patients receiving phenylephrine infusions between July 1, 2014 and
December 31, 2014, will be placed into the low dose group. The primary outcome is incidence of peripheral ischemia and
the secondary outcome is incidence of mortality. The following data will be collected: identification code, group, patient
demographics including age, gender, BMI, and number of comorbidities, maximum phenylephrine infusion dosage,
duration of phenylephrine treatment in days, concomitant vasopressors, APACHE II score, peripheral ischemia, and
mortality. All data will be de-identified and maintained confidentially.
Results and conclusions: To be determined.
References:
1. Flancbaum L, Dick M, Dasta J, Sinha R, Choban P. A dose-response study of phenylephrine in critically ill, septic
surgical patients. Eur J Clin Pharmacol. 1997;51:461-465.
2. Gregory JS, Bonfiglio MF, Dasta JF, Reilley TE, Townsend MC, Flancbaum L. Experience with phenylephrine as a
component of the pharmacologic support of septic shock. Crit Care Med. 1991;10(11):1395-1400.
3. Morelli A, Ertmer C, Rehberg S, et al. Phenylephrine versus norepinephrine for initial hemodynamic support of patients
with septic shock: a randomized, controlled trial. Crit Care. 2008;12(6):143.
OCCP Fall Meeting 2014
43
Evaluation of patient acceptance and perceptions of recommendations made by a pharmacist-run travel clinic
Prerakkumar Parikh, PharmD; Shannon Just, PharmD, CACP; Matt Schneiderman, PharmD, BCACP, CACP; Amy
Kramer, PharmD
pparikh@healthspan.org
PGY-1
HealthSpan 12301 Snow Rd, Parma, OH 44130
Background: The number of international tourists have increased significantly from 528 million in 1995 to 1087 million in
2013 throughout the world.1 Residents of the United States (US) made nearly 62 million trips outside the US in 2013.2
Many travelers are unaware of the immunizations and preventative measures they should take prior to their travel and
therefore are at possible risk for developing dangerous diseases like Hepatitis A, yellow fever, rabies, typhoid and more.
World Health Organization recommends that travelers consult a travel medicine practitioner or physician prior to travel.3
Studies have shown that pharmacists have become more involved with providing travel medicine services through
establishment of pharmacist-run travel clinics but there is less evidence on how well their recommendations are
accepted.4,5 This study evaluates the patient acceptance of these pharmacist-made recommendations.
Objectives: (1) To measure the acceptance rates of the vaccination and medication based recommendations made by
travel clinic pharmacists for patients traveling internationally. (2) To evaluate the overall quality of service and patient
satisfaction with travel clinic, assess the amount of knowledge gained by patients about the travel related health issues
and understand the factors that led to refusal of pharmacist-made recommendations.
Methodology: This study has been approved by the Institutional Review Board. The electronic medical record system will
identify patients who used the travel clinic before their travel outside the United States. The study will enroll patients who
were referred to or requested service from the travel clinic between February 1 st 2014 and January 31st 2015. Patients
less than 18 years of age and the patients who did not complete their travel by February 28 th, 2015 will be excluded from
the study. The following data will be collected: patient age, gender, ethnicity, country of travel, duration of travel, and
travel related vaccinations and medications recommended by the travel clinic pharmacist. Patient charts will also be
reviewed to record if the patients received the recommended vaccinations and medications. The time of patient contact to
travel clinic before their travel date and the pharmacist response time will also be recorded. A voluntary survey about
travel clinic will be mailed to patients. All data will be recorded without patient identifiers and maintained confidentially.
The statistics involved in this study will be descriptive analysis and Cronbach’s alpha test for primary and secondary
objectives.
Results and conclusions: To be determined.
References:
1) United Nations World Tourism Organization. UNWTO Tourism Highlights, 2014 Edition. Madrid: United Nations World
Tourism Organization; 2014. Available from:
http://dtxtq4w60xqpw.cloudfront.net/sites/all/files/pdf/unwto_highlights14_en_hr_0.pdf
2) US Department of Commerce, Office of Travel and Tourism Industries. United States travel and tourism statistics,
2013 outbound analysis. Washington, DC: US Department of Commerce; 2014. Available from:
http://travel.trade.gov/outreachpages/download_data_table/2013_Outbound_Analysis.pdf
3) World Health Organization, International travel and health. (2014). Vaccine preventable diseases and vaccines.
Retrieved from World Health Organization website: http://www.who.int/ith/ITH_chapter_6.pdf?ua=1
4) Jackson AB, Humphries TL, Nelson KM, Helling DK. Clinical pharmacy travel medicine services: a new frontier. Ann
Pharmacother 1004; 38:2160–2165.
5) Gatewood SBS, Stanley DD, Goode JR. Implementation of a comprehensive pretravel health program in a
supermarket chain pharmacy. J Am Pharm Assoc 2009;49:660–669.
OCCP Fall Meeting 2014
44
Prophylactic extend-infusion carboplatin effect on the development of hypersensitivity reactions (HSRs) in
patients with gynecologic malignancies.
Amy Pasternak, Pharm.D.; Nicholas Link, Pharm.D., BCOP; Carolyn Richardson, Pharm.D., BCPS
pastera@ccf.org
PGY-1
Hillcrest Hospital A Cleveland Clinic hospital, 6780 Mayfield Rd, Mayfield Heights, OH 44124
Background: A large, retrospective analysis from Memorial Sloan Kettering Cancer Center demonstrated a statistically
significant decrease in the incidence of carboplatin HSRs in ovarian cancer patients that received extended-infusion
carboplatin compared to standard infusion carboplatin. One-hundred and seventeen patients out of 707 developed HSRs,
111(21%) in the standard group and 6 (3.4%) in the extended infusion group, p<0.001.1 Carboplatin HSRs are most
common in patients with ovarian cancer as carboplatin is used first line for primary occurrence and first line for disease
recurrence.2 The incidence of hypersensitivity becomes prominent at the 8th cumulative carboplatin cycle, occurring in
approximately 20% of patients, and the risk for HSR continues to increase with each subsequent carboplatin dose. 3
Objectives: The primary outcome is the difference in incidence of carboplatin HSR between standard and extended
infusion carboplatin. Secondary aims are to assess the relationship of the premedication regimen, allergy history, total
area under the curve carboplatin dose, number of prior carboplatin cycles, weight/ body-mass index, and length of
standard infusion with the incidence of HSR.
Methodology: Prior to the initiation of any data collection, this evaluation underwent review by the Institutional Review
Board and received approval as an exempt research evaluation. Patients will be identified within the electronic medical
record by medication order identification number, which is randomly generated at the time of order entry. Patient data will
be collected from Cleveland Clinic Main campus from 1/1/2007- 5/31/2010 and from Hillcrest Hospital from 1/1/20073/31/2015. Patients will be included in this evaluation if they have a diagnosis of ovarian, fallopian tube, or primary
peritoneal cancer and have received a minimum of eight cumulative carboplatin cycles. Patients will be excluded if a
definitive number of prior carboplatin infusions cannot be determined, carboplatin was discontinued or altered secondary
to a positive skin test, or the patient received standard infusion for primary reoccurrence but received extended-infusion
for later reoccurrence. Patients will be stratified to the standard infusion group if all cumulative lifetime carboplatin cycles
prior to developing a hypersensitivity reaction or changing therapy were infused over 30-60 minutes. Patients will be
stratified to the extended-infusion group if they were converted to a 3 hour carboplatin infusion at approximately the 7 th
cumulative carboplatin cycle prior to developing any hypersensitivity reaction. Assuming a 17% difference in incidence
between the two study groups, we need 65 patients in each group to meet an alpha= 0.05 and power=80%. However, in
order to maintain power if the difference in incidence between groups is lower, we will continue to accrue all patients at
Hillcrest hospital that meet the inclusion criteria within our investigatory time period from 1/1/2007- 3/31/2015. We
estimate the inclusion of approximately 100 patients per group. The primary outcome will be evaluated with the Fisher’s
exact test or a Chi-squared test if there are more than five primary outcome events. The correlation of the secondary
outcomes on the incidence of hypersensitivity will be evaluated with a logistic regression, for each dose of carboplatin
during and beyond the sixth cumulative cycle. Evaluation of differences between baseline patient characteristics will be
done with a t-test or Chi-squared test.
Results and Conclusions: To be determined.
References:
1. O’Cearbhaill et.al. The prophylactic conversion to an extended infusion schedule and use of premedication to prevent
hypersensitivity reactions in ovarian cancer patients during carboplatin retreatment. Gynecol Oncol. 2010;116:326331.
2. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Ovarian cancer including fallopian
tube cancer and primary peritoneal caner. Version 3.2014.
3. Sliesoraitis et. al. Carboplatin hypersensitivity. Int J Gynecol Cancer. 2005;15:13-18.
OCCP Fall Meeting 2014
45
Concomitant Proton Pump Inhibitor and Mycophenolate Mofetil Use in Renal Transplant Recipients
Kajal Patel, PharmD; Julie Barnes, PharmD; Seth Bauer, PharmD, BCPS; Michael Spinner, PharmD
patelk9@ccf.org
PGY2 Pharmacotherapy Resident
Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195
Background:
Mycophenolate mofetil (MMF) is a commonly used immunosuppressive agent after renal transplantation.1 Adequate
exposure to mycophenolic acid (MPA), the active moiety of MMF, is associated with decreased risk of acute rejection in
the early post-transplant period.2 Transplant recipients commonly require an acid-suppressing agent due to MMF
associated gastrointestinal side effects as well as long-term steroid therapy. While pharmacokinetic data show decreased
MPA exposure in patients taking MMF-proton pump inhibitor (PPI) co-therapy, two studies did not find a significant acute
rejection risk difference in patients taking MMF-PPI versus MMF-ranitidine.3-5 The Cleveland Clinic kidney transplant
immunosuppression regimen differs from those utilized in the two studies, specifically lower MMF doses. Determining the
clinical consequences of MMF-PPI concomitant use will bring to light potential renal transplant protocol changes that may
be necessary. This study aims to determine if renal transplant recipients at the Cleveland Clinic who receive a PPI plus
MMF have a higher risk of one-year acute rejection compared those on MMF without a PPI.
Objectives: (1) Compare one-year incidence of biopsy-proven acute rejection (BPAR)/treated suspected rejection (2)
Compare three-month incidence of BPAR/treated suspected rejection; describe time to rejection, rejection type, and stage
of rejection; compare one-year patient survival, graft survival, and graft function; compare incidence of Clostridium difficile
colitis; evaluate necessity for renal transplant protocol changes based upon clinical outcomes
Methodology:
A retrospective cohort study will be conducted to compare outcomes in renal transplant recipients receiving a PPI plus
MMF versus those on MMF without a PPI. The sample population will be identified using the renal transplant database.
Those who received a renal transplant at the Cleveland Clinic between January 1, 2009 and June 30, 2013 will be divided
into two groups defined by the post-transplant discharge medication list (with or without a PPI). Inclusion criteria consist of
adult (≥18 years of age) renal transplant recipients who received per protocol induction (basiliximab or anti-thymocyte
globulin) and maintenance (tacrolimus, mycophenolate mofetil 750 mg BID or less, and prednisone) immunosuppression.
The minimum follow-up time will be 12 months or up to patient death (if within 12 months post-transplant). Subjects will be
excluded if they received non-protocol immunosuppressive therapy, underwent multi-organ transplantation, or
experienced death or acute rejection prior to index hospital discharge. Demographics, transplant donor and recipient
characteristics, and post-transplant outcomes data will be collected from electronic medical records and the renal
transplant database. BPAR data (including rejection type and stage per Banff criteria) will be derived from protocol biopsy
results at 3, 6, and 12 months post-transplant and all clinically indicated interval biopsies. Treated suspected rejection will
be identified through documented administration of acute rejection therapy. Results will be reported in aggregate using
descriptive statistics (means, medians, and percentages) and comparisons between groups will be made using inferential
statistics.
Results and Conclusions: To be determined
References:
1. Cellcept (mycophenolate mofetil) [package insert]. San Francisco, CA; Genentech USA, Inc.; Revised September
2013. http://www.gene.com/download/pdf/cellcept_prescribing.pdf. Accessed August 19, 2014.
2. van Gelder T, Hilbrands L, Vanrenterghem Y, et al. A randomized double-blind, multicenter plasma concentration
controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after
kidney transplantation. Transplantation. 1999;68:261-66.
3. Gabardi S and Olyaei A. Evaluation of potential interactions between mycophenolic acid derivatives and proton
pump inhibitors. Ann Pharmacother. 2012;46:1054-64.
4. van Boekel G, Kerkhofs C, van de Logt F, et al. Proton pump inhibitors do not increase the risk of acute rejection.
Neth J Med. 2014;72:86-90.
5. Knorr J, Sjeime M, Braitman L, et al. Concomitant proton pump inhibitors with mycophenolate mofetil and the risk
of rejection in kidney transplant recipients. Transplantation. 2014;97:518-24.
OCCP Fall Meeting 2014
46
Retrospective evaluation of haloperidol loading dose versus haloperidol without loading dose on outcomes of
delirium in hospitalized elderly patients
Sunita Patel, PharmD; Susan M Fosnight, RPh, CGP, BCPS
patelsu@summahealth.org
PGY-1
Summa Health System – Akron City Hospital 525 E Market St, Akron, OH 44304
Background: Delirium is associated with increased morbidity and mortality, increased length of hospital stay, and
increased healthcare utilization, costing more than $8 billion per year.1 Haloperidol and atypical antipsychotics are
recommended if pharmacologic treatment is indicated. Despite lacking FDA approval for this indication, haloperidol is
often used because it targets one of the proposed pathogenesis pathways of delirium, has a rapid onset of action when a
loading dose is used, does not require dose adjustment in organ dysfunction, and has minimal adverse effects when used
at an appropriate dose, route, and duration. There have been no published randomized controlled trials to establish a
safe and effective dose of haloperidol for the management of delirium. Based on the pharmacokinetic properties of
haloperidol, the time to reach steady state (five half – lives) is appreciable. This makes it desirable to administer a loading
dose, to promptly raise the concentration of drug in the plasma. Since loading doses have not been well defined in elderly
patients, giving small doses, more frequently, may help to provide a rapid resolution of delirium symptoms and improve
overall outcomes in these patients.2-5
Objectives: To compare outcomes of delirium in patients that received a haloperidol loading dose versus those that
received haloperidol without a loading dose. The primary outcome is resolution of delirium, within 48 hours of haloperidol
administration. Secondary outcomes include the number of patient transfers to ICU, length of hospital stay, 30-day
readmission rate, total amount of haloperidol used, resolution of delirium at 24 hours, and mortality during admission.
Methodology: This study has received Institutional Review Board approval. A retrospective chart review will be
conducted. An analytical report has been formulated to perform quality improvement monitoring for delirium. This report
will be reviewed in reverse chronological order, starting from July 2014, to identify patients who meet inclusion criteria.
The following data will be collected: gender, age cohorts (65-69 years old, 70-74 years old, 75-79 years old, and greater
than 80 years old), Six-Item Screener (SIS) score on admission, Nursing Delirium Screening Scale (Nu-DESC) scores
and times, dose/route/time of haloperidol administration, whether patient required transfer to ICU, date of
admission/discharge, length of stay, readmission at 24 hours for delirium (if discharged with only one negative Nu-DESC
score), readmission at 30 days, and mortality during admission.
Results and conclusions: To be determined.
References:
1. Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-year health care costs associated with
delirium in the elderly population. Arch Intern Med 2008;168(1):27–32.doi: 10.1001/archinternmed.2007.
2. McCusker J, Cole M, Abrahamowicz M, Primeau F, Belzile E. Delirium predicts 12-month mortality. Arch Intern
Med. 2002;162(4):457–463.
3. American Psychiatric Association. Practice guideline for the treatment of patients with delirium. Am J Psychiatry
1999;156(5 suppl):1–20.
4. Cook IA. Guideline watch: practice guideline for the treatment of patients with delirium. Arlington, Va.: American
Psychiatric Association; 2004.
http://www.psychiatryonline.com/pracGuide/loadGuidelinePdf.aspx?file=Delirium.watch.
5. Inouye SK. Delirium in hospitalized older patients. Clinics in Geriatric Medicine 1998;14(4):745-64.
OCCP Fall Meeting 2014
47
Impact of Intravenous Acetaminophen in Cardiothoracic Surgery Patients
Rosemary Persaud, PharmD; Seth Bauer, PharmD, BCPS; Matthew Wanek, PharmD, BCPS
persaur@ccf.org
PGY-1 Pharmacotherapy
Cleveland Clinic 9500 Euclid Avenue, Cleveland, OH 44118
Background:
In November 2010, intravenous (IV) acetaminophen (APAP) was approved for use in the United States for the
management of mild to moderate pain as well as moderate to severe pain with adjunctive opioid analgesics.1 Compared
to other analgesic agents, several potential advantages of IV APAP exist due to the differences in side effect profiles.
Additionally, IV APAP has theoretical benefits compared to other formulations based on pharmacokinetic differences,
including higher peak concentrations and shorter time to maximal concentration.1 However, evidence correlating
pharmacokinetic advantages to benefits in outcomes including extent and onset of analgesic effects 2-4 is currently lacking.
Although reduction in opioid consumption with use of IV APAP has been suggested in prior studies, including a metaanalysis indicating a 9 mg reduction in IV morphine use during the first 24 hours postoperatively, consistent improvements
in patient pain scores, opioid-related adverse drug events, or ICU length of stay are lacking.5 To date, only one study has
shown a significant reduction in time to extubation in patients receiving IV APAP. 6 Of note, this study was in patients
undergoing major abdominal or pelvic surgery receiving meperidine, which is not widely used for pain control in the United
States. Furthermore, the cost of IV APAP is approximately 1000 times that of its oral formulation, leading to higher
medication costs. Considering the lack of consistent evidence for benefit in cardiothoracic surgery patients and higher
cost associated with the IV formulation, the clinical benefit of IV APAP in this population is unclear.
Objectives: (1) To assess the impact of IV APAP use in post-cardiothoracic surgery adults on intensive care unit (ICU)
length of stay. (2) To determine the effect of IV APAP on post-operative opioid requirements, the incidence of opioidrelated adverse drug events, the time to extubation and reintubation rates in post-cardiothoracic surgery adults.
Methodology:
This is a retrospective cohort study with a matched historical control. Data will be extracted from the Cleveland Clinic
Cardiothoracic Surgery Database. The study group will consist of patients at least 18 years old who receive at least one
dose of IV APAP post-operatively in the CVICU from October 2011 to September 2014. Excluded patients include heart
and lung transplant, left ventricular assist device (LVAD), and extracorporeal membrane oxygenation (ECMO) patients.
The study group will be matched to control patients admitted to CVICU post-operatively between October 2008 and
September 2011 based on age, gender, American Society of Anesthesiologists (ASA) Physical Status Score, type of
surgery, and opioid use prior to admission. The primary endpoint will be ICU length of stay. Additional endpoints include
opioid requirements within 48 hours post-surgery, incidence of opioid related adverse effects, time to extubation, and
reintubation rates. Prior to initiation, Institutional Review Board approval will be obtained.
Results and conclusions: To be determined.
References:
1. Ofirmev ® [package insert]. San Diego, CA: Cadence Pharmaceuticals Inc; 2010.
2. Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, et al. Plasma and cerebrospinal fluid
pharmacokinetic parameters after single-dose administration of intravenous, oral, and rectal acetaminophen. Pain
Practice. 2012. 12(70): 523-532.
3. Van Der Westhuizen J, Kuo PY, Reed PW, Holder K. Randomised controlled trial comparing oral and intravenous
paracetamol (acetaminophen) plasma levels when given as preoperative analgesia. Anaesth Intensive Care.
2011. 39(2); 242-246.
4. Seymour RA, Rawlins MD. Pharmacokinetics of parenteral paracetamol and its analgesic effects in post-operative
dental pain. Eur J Clin Pharmacol. 1981; 20: 215-8.
5. Remy C, Marret E, Bonnet F. Effects of acetaminophen on morphine side-effects and consumption after major
surgery: meta-analysis of randomized controlled trials. British J Anaesthesia. 2005; 94(4): 505-13.
6. Memis D, Inal MT, Kavalci G, Sezer A, Sut N. Intravenous paracetamol reduced the use of opioids, extubation
time, and opioid-related adverse effects after major surgery in the intensive care unit. J Crit Care Med. 2010.
25:458-462.
OCCP Fall Meeting 2014
48
Evaluation of piperacillin/tazobactam monotherapy compared to vancomycin and
piperacillin/tazobactam combination therapy for treatment of complicated intra-abdominal infections
Sarah Petite PharmD; Lisa Harinstein,PharmD, BCPS; Seth Bauer, PharmD, BCPS; Jessica Bollinger, PharmD, BCPS;
Christine Ahrens, PharmD, BCPS
Contact Information: petites@ccf.org
PGY-2 Pharmacotherapy Resident
Research Site: Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH
Background: Intra-abdominal infections are associated with significant mortality in intensive care unit (ICU) patients. 1
The Infectious Diseases Society of America (IDSA) recommends empiric antimicrobial therapy for complicated intraabdominal infections (cIAIs), including those that are community-acquired and healthcare-associated infections, that
targets facultative and aerobic gram-negative bacilli and anaerobic organisms.2,3 Depending on patient specific risk
factors, targeted empiric therapy against enterococcus and methicillin-resistant Staphylococcus aureus (MRSA) may be
added as the presence may be a predictor of treatment failure.4 The IDSA guidelines recommend empiric MRSA coverage
with vancomycin in patients with known colonization, who have failed other antimicrobial treatment or have had significant
antibiotic exposure.2 Empiric therapy against enterococcus is recommended for patients with a postoperative infection,
have previously received cephalosporins, are immunocompromised or have valvular heart disease or prosthetic
intravascular material. The recommended antimicrobial agents for enterococcal intra-abdominal infections include
ampicillin, piperacillin/tazobactam or vancomycin. It is unknown if monotherapy with a beta-lactam is sufficient for cIAIs or
if dual therapy is required with an additional agent, such as vancomycin. This study aims to determine if there is a clinical
benefit from combination therapy with vancomycin and piperacillin/tazobactam.
Objective: To determine the clinical benefit of the addition of vancomycin to piperacillin/tazobactam compared to
piperacillin/tazobactam monotherapy for treatment of cIAIs in surgical intensive care unit (SICU) patients.
Methodology: This study is an IRB-approved non-interventional retrospective chart review. Adult patients admitted to the
SICU with documented secondary peritonitis receiving at least 72 hours of piperacillin/tazobactam with or without
vancomycin will be included. Patients will be excluded if they have pancreatitis, primary peritonitis, neutropenia, a
concomitant infection at a site other than the abdomen, or if they are immunocompromised. Data describing baseline
characteristics, antimicrobial therapy, and clinical cure and failure will be collected. The primary endpoint will be clinical
cure rate at day 28, or at hospital discharge if discharged prior to day 28, in patients treated with vancomycin and
piperacillin/tazobactam versus piperacillin/tazobactam monotherapy. Secondary endpoints include comparing clinical cure
rate at day 7, hospital and ICU length of stay and mortality rates between piperacillin/tazobactam and vancomycin
combination therapy and piperacillin/tazobactam monotherapy.
Results and conclusions: To be determined.
References:
1. Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, et al. Incidence, risk factors, and
outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units.
French ICU Group for Severe Sepsis. JAMA 1995;274(12):968-974.
2. Solomkin JS, Mazuski JE, Bradley JS, Rodvold KA, Goldstein EJ, Baron EJ, et al. Diagnosis and management of
complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the
Infectious Diseases Society of America. Clin Infect Dis 2010;50(2):133-164.
3. Montravers P, Gauzit R, Muller C, Marmuse JP, Fichelle A, Desmonts JM. Emergence of antibiotic-resistant
bacteria in cases of peritonitis after intraabdominal surgery affects the efficacy of empirical antimicrobial therapy.
Clin Infect Dis 1996;23(3):486-494.
4. Sitges-Serra A, Lopez MJ, Girvent M, Almirall S, Sancho JJ. Postoperative enterococcal infection after treatment
of complicated intra-abdominal sepsis. Br J Surg 2002;89(3):361-367.
OCCP Fall Meeting 2014
49
Clinical outcomes and cost analysis of health-system wide conversion from poractant alfa to calfactant in the
neonatal intensive care unit
Michelle Poole, PharmD; Laurel Brown, PharmD, BCPS; Betsy Walters Burkey, PharmD, BCPS
poolem3@ccf.org
PGY-1
Cleveland Clinic – Fairview Hospital 18101 Lorain Avenue, Cleveland, OH 44111
Background:
Respiratory distress syndrome (RDS) is a common reason for admission into the neonatal intensive care unit (NICU).
Typically RDS affects neonates below 35 weeks of gestational age due to their immature lung development. A mainstay
of treatment includes surfactant replacement.1,2 Our institution recently changed our formulary surfactant product from
poractant alfa to calfactant. Currently there are no head-to-head, prospective trials comparing poractant alfa to calfactant,
but from a large comparative effectiveness study it was seen that poractant alfa and calfactant had similar efficacy when
prevention of air leak syndromes, bronchopulmonary dysplasia and death were considered. 3 Unfortunately redosing rates
were not analyzed. This study will compare redosing rates, clinical outcomes and cost for both products.
Objectives:
(1) Primary endpoint is to determine redosing rate of calfactant versus poractant alfa during NICU admission. (2)
Secondary endpoints include determining total ventilator days, oxygen requirements at 28 days or discharge, drug
acquisition costs to the health-system, complications (pulmonary hemorrhage or pneumothorax) within 24 hours of
surfactant administration, and mortality in both products.
Methodology:
This retrospective study, which will be approved by the Cleveland Clinic Institutional Review Board, will examine data from
the electronic medical record of three NICUs within the Cleveland Clinic Health System. Data for patients receiving
poractant alfa from September 1, 2013 through March 1, 2014, or calfactant from September 1, 2014 through March 1,
2015, will be collected without patient identifiers and stored securely. All infants meeting criteria and admitted to the NICU
will be included. Along with endpoints, data collection will include birth weight, gestational age, sex, race, antenatal steroid
administration, length of stay, FiO2 before surfactant administration, dose and volume surfactant.
Results and conclusions: To be determined.
References:
1. Polin RA, Carlo WA, Committee on Fetus and Newborn, American Academy of Pediatrics. Surfactant
replacement therapy for preterm and term neonates with respiratory distress. Pediatrics 2014 Jan;133(1): 156-63.
2. Ainsworth SB. Pathophysiology of Neonatal Respiratory Distress Syndrome. Treat Respir Med 2005;4(6):423437.
3. Trembath A, Hornik CP, Clark R, et al. Comparative effectiveness of surfactant preparations in premature infants.
J Pediatr 2013 Oct;163(4): 955-60.
OCCP Fall Meeting 2014
50
Retrospective EValuation of the Use of VANCOmycin in patients with febrile neutropenia (REVU-VANCO)
Zachary Post, Pharm.D.; Sharanie Sims, Pharm.D., BCPS (AQ-ID); Usha Stiefel, MD;
Candice Wenzell, Pharm.D., BCOP
zachary.post@va.gov
PGY-1
Louis Stokes Cleveland VA Medical Center (LSCDVAMC) 10701 East Boulevard, Cleveland, OH 44106
Background: Febrile neutropenia (FN) in oncology patients is considered a medical emergency with significant risks of
morbidity and mortality and typically requires hospitalization.1,3 Therefore, it is critical that these patients are managed
appropriately. Current literature and guidelines from the Infectious Diseases Society of America (IDSA) provide strict
recommendations for the empiric use of vancomycin in patients with FN.1 These guidelines describe instances in which
empiric vancomycin use is both recommended and discouraged. The indiscriminate administration of glycopeptides is
expensive and may lead to increased development of bacterial resistance.2 Despite the predominance of Gram-positive
organisms causing bacteremia during neutropenia and fever, randomized studies comparing initial empiric regimens with
and without vancomycin have failed to show significant reductions in duration of fever or overall mortality.1,4 Several
prospective, randomized studies and meta-analyses have compared empiric antimicrobial regimens for FN containing
vancomycin against those with placebo; consensus reveals a failure to demonstrate clinically significant beneficial
evidence for the empiric addition of vancomycin.2,4-5 For these reasons, evaluation of the empiric use of vancomycin in
accordance to current IDSA guidelines should be completed in hopes of influencing antimicrobial prescribing patterns and
potentially reducing morbidity and mortality while reducing cost, adverse events, and the development of bacterial
resistance.
Objectives: Assess the prescribing of empiric antimicrobial coverage with vancomycin in patients with FN at the
LSCDVAMC in accordance with the 2010 IDSA Clinical Practice Guidelines for the Use of Antimicrobial Agents in
Neutropenic Patients with Cancer. The primary objective is to assess the percentage of time vancomycin is used in
accordance with the aforementioned guidelines, and secondary objectives include: indication for vancomycin initiation, deescalation in accordance with the IDSA guidelines, initial vancomycin dosing in accordance with 2014 LSCDVAMC
Antimicrobial Guidelines, duration of therapy, hospital and ICU length of stay, and incidence of nephrotoxicity.
Methodology: A retrospective chart review will be conducted to assess the use of empiric vancomycin in FN patients.
The hospital’s computerized patient record system will be utilized to identify patients in which the prescriber used
‘Antibiotics for FN Treatment’ order set between 06/01/2011–10/31/2014. Patients will be included if they had a diagnosis
of FN upon admission or during hospital stay, with receipt of vancomycin as a component of FN treatment during the
same admission. If a patient has multiple occurrences of FN during the same admission, only the initial occurrence will be
included. Patients will be excluded if transferred from outside facility or receipt of IV antibiotics within 30 days prior to FN
episode (unless antibiotic course was for prior episode of FN). Descriptive statistics will be utilized to describe data
collected. Other measures to be collected include cancer type, administered chemotherapy, oral antibacterial prophylaxis,
colony stimulating factors, and external radiotherapy within the past 30 days, other antibiotic agents included in initial
regimen for FN, documented pneumonia infection and concurrent antimicrobial treatment during FN, and all-cause
mortality. All data will be recorded without patient identifiers and maintained confidentially.
Results and conclusions: To be determined.
References:
1.
2.
3.
4.
5.
Cometta A, Kern WV, de Bock R, et al. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients
with cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis 2011;52:e56-93.
Cometta A, Kern WV, de Bock R, et al. Vancomycin versus placebo for treating persistent fever in patients with neutropenic
cancer receiving piperacillin-tazobactam monotherapy. Clin Infect Dis 2003; 37:382-9.
Libuit J, Whitman A, Wolfe R, et al. Empiric vancomycin use in febrile neutropenic oncology patients. Open Forum Infect Dis
2014;1-3.
Wade JC, Glasmacher A. Vancomycin does not benefit persistently febrile neutropenic people with cancer. Cancer Treat Rev
2004;30:119-26.
Wright JD, Neugut AI, Anath CV, et al. Deviations from guideline-based therapy for febrile neutropenia in cancer patients and
their effect on outcomes. JAMA Intern Med 2013;173:559-68.
OCCP Fall Meeting 2014
51
Cost-benefit analysis of the treatment of status epilepticus secondary to anoxic brain injury beyond 48 hours
Matthew Reale, PharmD, Assad Amin MD, Kellie Buschor, PharmD, BCPS, Martin Ohlinger, PharmD, BCPS, FCCM
matthew.reale@utoledo.edu
PGY-2 Critical Care
University of Toledo Medical Center
Background
Electroencephalographic status epilepticus occurs in 9-35% of comatose patients following anoxic brain injury and is
associated with high mortality rates. Case fatality has been reported to be 90-100% despite adequate treatment with antiepileptic medications.1,2 Research suggests that status epilepticus is an independent predictor of mortality in patients
suffering from post-anoxic injury.3 With research suggesting that aggressive treatment has little effect on outcomes, this
study looks to evaluate the need for prolonged treatment of status epilepticus in patients with anoxic brain injury.
Objectives: 1.) To determine if there is a mortality benefit in treating status epilepticus in patients suffering from anoxic
brain injury beyond 48 hours if unresolved on EEG. 2.) To determine if there is a significant increase in hospital
associated cost related to treating patients beyond 48 hours
Methodology:
This retrospective study will be submitted to the Institutional Review Board for approval. The electronic medical record
system will identify patients who have electroencephalography (EEG) confirmed status epilepticus secondary to an anoxic
brain injury. The following data will be collected: patient demographics, EEG results, duration of status epilepticus,
whether the seizure activity was continuous or repetitive, past seizure history, anti-epileptic medications administered,
cost of treatment, duration of anti-epileptic treatment and discharge disposition. All data will be recorded without patient
identifiers and maintained confidentially. The data will be analyzed utilizing the appropriate statistical methods.
Outcomes to be analyzed include mortality and duration of status epilepticus. A cost benefit analysis will be conducted in
order to determine if treatment beyond 48 hours is of any benefit, clinically or economically.
Results and conclusions: To be determined
References:
1. Hofmeijer et al. Unstandardized treatment of electroencephalographic status epilepticus does not improve
outcome of comatose patients after cardiac arrest. Front Neurol. 2014;5:1-9
2. Rittenberger et al. Frequency and Timing of Nonconvulsive Status Epilepticus in Comatose Post-Cardiac Arrest
Subjects Treated with Hypothermia. Neurocrit Care. 2012;16:114-122
3. Rosetti et al. Status epilepticus: An independent outcome predictor after cerebral anoxia. Neurol. 2007;69:255260
OCCP Fall Meeting 2014
52
The impact of transitions-of-care clinic referral on the composite of 30-day readmission and emergency
department visitation.
Angela Righi, Pharm.D.; John M. Moorman, Pharm.D., BCPS; Lawrence A. Frazee, Pharm.D., BCPS; Carrie Caruso,
M.D.; Kimberly McBennett, M.D.
Angela.Righi@AkronGeneral.org
PGY-1
Akron General Medical Center, 1 Akron General Avenue, Akron, OH 44307
Background:
Care transitions from inpatient to the ambulatory setting are a high-risk time for medication errors and subsequent
readmission. Successful transitions of care (TOC) are important in light of the Centers for Medicare and Medicaid
Services denial to reimburse hospitals should readmission occur within 30 days 2. Studies implementing a variety of TOC
interventions have shown a positive impact on readmission rates, emergency department visitation, and mean hospital
costs.2-4 However, little research has been done on the predictors of readmission, especially medication-related
predictors. Extensive assessment of the TOC clinic at Akron General Medical Center has not been completed yet, and will
allow for a more standardized referral procedure. The primary objective of this study is to compare the rate of the
composite outcome of unplanned 30-day readmission and emergency department visitation between patients referred to a
TOC clinic and matched to historical controls. Predictors of the composite outcome among patients referred to the TOC
clinic will also be assessed.
Objectives:
(1) To compare the rate of the composite outcome of unplanned 30-day readmission and ED visitation among patients
referred to a TOC clinic to historical controls. (2) To describe the rate of the composite outcome of unplanned 30-day
readmission and ED visitation and identify predictors of the composite outcome among patients referred to a TOC clinic.
Methods:
Prior to commencement, this study will be submitted to the Institutional Research Review Board for approval. Patients in
the intervention group will be over 18 years old, discharged from the inpatient general medicine service within 30 days of
TOC clinic visit, establishing or continuing care at Internal Medicine Center of Akron, and discharge disposition to home.
Historical controls will be matched to the intervention group based on age, gender, length of stay, discharge season,
acuity of admission, and Charlson comorbidity index. Matching will be done via population percentages using data from
Akron General Medical Center’s electronic medical record system. Subsequent emergency room visitation and
readmission will be accessed to determine the primary objective. In addition, the following data on the intervention group
will be collected in order to be assessed as predictors of readmission: age, race, number of medications, comorbidities,
type of insurance, length of stay, acuity of admission, weekend discharge, specialist follow-up, TOC clinic failure to show,
length of time from discharge to clinic appointment, medication routes of administration, number of medication changes
during hospital stay, and whether the patient received medications at discharge
Results: To be determined.
References:
1. Centers for Medicare and Medicaid Services. Readmissions reduction program.
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS /Readmissions-ReductionProgram.html. Accessed August 1, 2014.
2. Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled
trial. Arch Intern Med. 2006;166(17):1822-8. Accessed August 7, 2014.
3. Naylor MD, et al. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J
Am Geriatr Soc. 2004;52(5):675-84. http://onlinelibrary.wiley.com.proxy.lib.ohio-state.edu/doi/10.1111/j.15325415.2004.52202.x/abstract. Accessed August 8, 2014.
4. Koehler BE, Richter KM, Youngblood L, Cohen BA, Prengler ID, Cheng D, Masica AL. Reduction of 30-day
postdischarge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients
through delivery of a targeted care bundle. J Hosp Med. 2009;4(4):211-8. doi: 10. 1002/jhm.427.
OCCP Fall Meeting 2014
53
A quality improvement project evaluating pharmacists’ role in transitions of care
Holly Robison, Pharm.D; Michelle Cudnik, Pharm.D, BCACP; Cynthia Brucato, Pharm.D
robisonh@summahealth.org
PGY-1 Pharmacy Resident
Summa Health System
525 East Market St, Akron, OH 44309
Background: With recent changes in reimbursement from the Centers for Medicare and Medicaid Services (CMS),
hospitals and medical institutions are required to deliver high quality care to patients in order to maintain reimbursement
for hospital admissions for patient lives covered by CMS. In March of 2010, the Affordable Care Act (ACA) was signed
into law which determined that hospital reimbursement from CMS will be justified based on the all-cause readmission
rates of patients with certain disease states (acute myocardial infarction, pneumonia, heart failure, chronic obstructive
pulmonary disease, and elective, primary total hip and/or total knee replacement) at each institution. If readmission rates
of an institution are below the national average, hospitals will be penalized accordingly. 1 One suggested strategy to
reduce these readmission rates and promote cost savings is pharmacist involvement within transitions of care. Within
transitions of care, pharmacist provided medication reconciliation, medication and disease state education, and chronic
disease state management services are valuable in identifying and addressing discrepancies.2,3 Recent studies have
shown that in some institutions more than half of all patients have at least one misunderstanding regarding discharge
medications, and care transition programs involving pharmacists decrease hospital readmissions.4-5
Objectives: The purpose of this study is to determine the impact of pharmacist involvement by evaluating 30-day
readmission rates and the number of recommendations made by the pharmacist. Secondary objectives include assessing
patient satisfaction, determining the amount of time necessary for a pharmacist to effectively provide this service,
determining the percentage of pharmacist recommendations accepted by the provider, and describing the financial billing
process associated with these services.
Methodology: This project has been approved by the Summa Health System (SHS) IRB Board as a quality improvement
(QI) initiative. For this QI initiative, a pharmacist will be involved in a scheduled post-hospital appointment for patients who
have been recently discharged from Akron City Hospital who also follow-up in the Internal Medicine Center (IMC) of SHS.
During the patient’s first post-discharge follow-up appointment, the patient will see their primary care physician (PCP) and
will also see a pharmacist. The pharmacist will provide education regarding medication indications, instructions for use,
and possible side effects. The pharmacist will complete medication reconciliations and detect any possible medication
errors, duplicate therapy, adverse drug reactions, non-adherence, or deficit of medication knowledge. Detection of any of
these findings, therapeutic recommendations provided to physicians, recommendations accepted by PCPs, and time
spent with each patient will be documented. Patients who have an encounter with a pharmacist will be given an
anonymous, optional survey after the visit to assess patient satisfaction. Patients will be included in the project if they
have a post-hospital visit in the IMC when a pharmacist is available to participate in the appointment. There will be no
exclusion criteria. Descriptive statistics for primary and secondary outcomes will be performed.
Results and conclusions: To be determined.
References:
1. Read the Law. U.S. Department of Health and Human Services. Internet. Accessed 11 Sept 2014. Available at:
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-ReductionProgram.html
2. McGaw J, Conner DA, Delate TM, Chester EA, Barnes CA. A multidisciplinary approach to transition care: a patient
safety innovation study. Perm J. 2007 Fall;11(4):4-9.
3. Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and economic outcomes of a community-based
long-term medication therapy management program for hypertension and dyslipidemia. J Am Pharm Assoc (2003).
2008 Jan-Feb;48(1):23-31.
4. Mixon AS, Myers AP, Leak CL, Lou Jacobsen JM, Cawthon C, Goggins KM, Nwosu S, Schildcrout JS, Schnelle JF,
Speroff T, Kripalani S. Characteristics associated with postdischarge medication errors. Mayo Clin Proc. 2014
Aug;89(8):1042-51.
5. Kirkham HS, Clark BL, Paynter J, Lewis GH, Duncan I. The effect of a collaborative pharmacist-hospital care
transition program on the likelihood of 30-day readmission. Am J Health Syst Pharm. 2014 May 1;71(9):739-45.
OCCP Fall Meeting 2014
54
Clopidogrel Reloading in Acute Coronary Syndrome in a VA Emergency Department (CRAVED study)
Ross Robison, PharmD, Amanda Miller, PharmD, BCPS, Jonathan Goldberg, MD, Steve Adoryan, RPh, BCPS
Ross.Robison@va.gov
PGY-1 Pharmacy Practice Resident
Louis Stokes VAMC, 10701 East Boulevard, Cleveland, OH 44106
Background: An increasing number of patients who present with acute coronary syndrome (ACS) are taking clopidogrel
at home as a result of prior ACS, stents or procedures. 1 The Non-ST Elevated MI (NSTEMI) guidelines recommend
initiation of dual antiplatelet therapy for invasive and medically managed patients but do not specifically address
individuals who are taking chronic clopidogrel.2 There is some evidence to suggest that reloading may be beneficial for
patients who present with non-ST elevated (NSTE) ACS and undergo percutaneous coronary intervention (PCI).
Clopidogrel loading dose practices in the Louis Stokes VA Medical Center Emergency Department (ED) have not been
evaluated. We hypothesize there are multiple factors that may influence the decision to load in the ED (home clopidogrel,
age, risk, etc).1,3,4
Objectives: The primary objective of this study is to compare the rate of clopidogrel loading dose administration in the
Emergency Department (ED) between veterans presenting with NSTE ACS who are taking chronic clopidogrel vs those
who are not. Secondary objectives include: (I) compare the rate of clopidogrel loading dose administration by age group
(<75 vs >75), (II) determine if other factors are associated with ED clopidogrel loading dose administration (race, previous
MI, smoking, TIMI risk >3, race, etc), (III) assess incidence of MACE, major bleed, GI bleed within 30 days of
presentation, (IV) assess location and timing of clopidogrel loading doses and (V) assess rates of aspirin, beta-blocker
and parenteral anticoagulation administration in the ED.
Methodology: Retrospective chart review following IRB approval. Veterans > 18 years of age who presented to the Louis
Stokes VA Medical Center Emergency Department, had a subsequent hospital admission and discharge diagnosis of
unstable angina or NSTEMI will be eligible for chart review. Charts will be reviewed sequentially and patients will be
divided into two groups: chronic clopidogrel (>10 days of therapy) or no chronic clopidogrel upon presentation (target 100
patients per group). Patients will be excluded if: they receive clopidogrel outside the VA, have a discharge diagnosis of
stable angina or STEMI, or are taking other antiplatelet/anticoagulant medications at home (warfarin, enoxaparin,
fondaparinux, dabigatran, apixaban, rivaroxaban). A chi-square test will be used to compare the rate of clopidogrel
administration between those taking chronic clopidogrel vs those who are not. While the target sample size is 200, a
sample size of 126 will be able to detect a moderately small effect size of 0.25 with a power of 0.80 and an α of 0.05
Logistic regression will be used to compare other categorical variables which may be associated with administration of
clopidogrel loading doses in the ED. Other secondary objectives will be reported with descriptive statistics.
Results and conclusions: To be determined
References:
1. Patti G, et al. ARMYDA-8 RELOAD-ACS Investigators. Efficacy of clopidogrel reloading in patients with acute
coronary syndrome undergoing percutaneous coronary intervention during chronic clopidogrel therapy (from the
Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty [ARMYDA-8 RELOAD-ACS] trial). Am J
Cardiol. 2013 Jul 15;112(2):162-8
2. Anderson JL, et al. 2012 ACCF/AHA focused update incorporated into the ACCF/AHA 2007 guidelines for the
management of patients with unstable angina/non-ST-elevation myocardial infarction: a report of the American
College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013
Jun 11;127(23):e663-828.
3. Di Sciascio G, et al. Clopidogrel reloading in patients undergoing percutaneous coronary intervention on chronic
clopidogrel therapy: results of the ARMYDA-4 RELOAD (Antiplatelet therapy for Reduction of MYocardial Damage
during Angioplasty) randomized trial. Eur Heart J. 2010 Jun;31(11):1337-43.
4. Mahmoudi M, et al. Safety and efficacy of clopidogrel reloading in patients on chronic clopidogrel therapy who present
with an acute coronary syndrome and undergo percutaneous coronary intervention. Am J Cardiol. 2011 Jun
15;107(12):1779-82.
OCCP Fall Meeting 2014
55
Effectiveness of Antioxidant Supplementation in Preventing Post-Operative Atrial Fibrillation in Cardiac Surgery
Patients
Kelly Rudd, PharmD; Vincent Mauro, PharmD; Thomas Schwann, MD, MBA
kelly.rudd@utoledo.edu
PGY-1
University of Toledo Medical Center. 3000 Arlington Ave, Toledo, OH 43614
Background: Atrial fibrillation (AF) is the most common complication associated with coronary artery bypass graft
(CABG) and is a major risk factor for morbidity and mortality in the surgical setting. Following CABG surgeries the
incidence of POAF is estimated to be approximately 30%, approximately 40% in valve replacement surgeries, and
approximately 50% in combined CABG and valve repair surgeries.1 POAF can also result in increased hospital cost, most
often a result of increased hospital length of stay. N-3 polyunsaturated fatty acids (PUFA’s) in combination with
antioxidants have recently been investigated as cheap, effective, and safe therapeutic options in preventing POAF in
patients undergoing CABG surgeries. More specifically, the combination of eicosapentaenoic acid (EPA) and
docosahexaenoic (DHA) in a ratio of 1:2 EPA/DHA, vitamin C at a dose of 1 g/day, and vitamin E at a dose of 100 IU/day.
Previous clinical trials that reported no benefit in POAF reductions with n-3 PUFA supplementation used an EPA/DHA
ratio of 1.24, whereas successful research used an EPA/DHA ratio of 0.5 and found benefit with supplementation.2,3
Objectives: (1) To determine if antioxidant supplementation peri-operatively in cardiac surgery decreases the rate of new
onset atrial fibrillation in CABG patients; (2) To determine if antioxidant supplementation peri-operatively in cardiac
surgery decreases hospital length of stay; and (3) evaluate the safety of the antioxidant supplementation in terms of
adverse effects
Methodology: Prior to patient selection, this study will be submitted to the Institutional Review Board for approval. The
hospital’s multiple electronic medical record programs will be utilized to identify patients admitted to the hospital and who
underwent CABG surgery. Patients will be divided into two groups, based on receipt of the antioxidant supplementation
protocol. Patients will be excluded from analysis if there is a prior diagnosis of atrial fibrillation and/or mitral/aortic valve
disease, age is ≤ 18 years old, or if they are pregnant. The following data will be collected: age, gender, race, allergies,
number of antioxidant dose peri-operatively, time to first episode of AF, hospital length of stay, number of hours on the
operating table, previous cardiothoracic surgery, smoking history, concomitant use of beta blockers, ACE-I/ARB, calcium
channel blocker, digoxin, statins, warfarin, rivaroxaban, apixaban, dabigatran, amiodarone, dofetilide, flecainide,
propafeone, ibutilide, aliskiren, aldosterone blocking diuretics, loop diuretics, aspirin, clopidogrel, ticagrelor, and prasugrel.
Data will be collected until hospital discharge. The primary endpoint is rate of new onset POAF in cardiac surgery
patients. POAF will be characterized using documented EKGs and additional use of antiarrhthymic medications.
Secondary objectives will be hospital length of stay and adverse events. Hospital length of stay will be characterized by
number of days between date of admission and date of discharge. All data will be recorded without patient identifiers and
stored on a password protected computer and kept in a locked office.
Results and conclusions: To be determined.
References:
1. Villareal RP, Hariharan R, Liu BC, Kar B, Lee VV, Elayda M, et al. Postoperative atrial fibrillation and mortality
after coronary artery bypass surgery. J Am Coll Card 2004;42:742-8.
2. Rodrigo R, Korantzopoulos P, Cereceda M, Asenjo R, Zamorano J, Villalabeitia E. A randomized controlled trial to
prevent post-operative atrial fibrillation by antioxidant reinforcement. J Am Coll Card 2013;62:1457-65.
3. Calo L, Bianconi L, Colivicchi F, Lamerti F, Loricchio ML, Meo A. N-3 fatty acids for the prevention of atrial
fibrillation after coronary artery bypass surgery, a randomized controlled trial. J Am Coll Card 2005;45:1723-28.
OCCP Fall Meeting 2014
56
Comparison of pharmacist- versus physician-managed vancomycin therapy.
Elizabeth Scarpitti, PharmD, Tamara Trienski, PharmD
scarpittie@summahealth.org
PGY-1
Summa Health System: Akron City Hospital, 525 E. Market St., Akron, OH 44304
Background: Vancomycin is a glycopeptide antibiotic frequently used for treatment of penicillinase-producing strains of
Staphylococcus aureus.1,2 Despite its ubiquitous use in the United States for more than 50 years, the management of
vancomycin still confounds many practitioners today.1,2 As medication experts, pharmacists have been involved in
vancomycin monitoring and dose recommendations for years. Studies have shown that pharmacist involvement in
medication management is linked to better patient outcomes and reiterate the importance of clinical pharmacy services.3-5
Such services are quintessential for ensuring optimal patient care while maintaining cost effective therapy as the
healthcare environment transitions from fee-for-service to pay-for-performance. This study compares the effect of
vancomycin therapy managed by pharmacists versus physicians at a 446 bed teaching institution.
Objectives: (1) To compare the effect of pharmacist-managed vancomycin therapy to the institution’s current standard of
care (physician-managed vancomycin therapy) on appropriate vancomycin therapy management. (2) To determine the
effect of pharmacist- versus physician-managed vancomycin therapy on length of stay, duration of therapy, and 30-day
readmission rate for repeat infection. (3) To quantify the number of patients who experienced an adverse event related to
vancomycin therapy, received concurrent nephrotoxic medications, and/or had preexisting renal damage in instances
where a ≥ 25-50% increase in serum creatinine occurred from the patient-specific baseline after initiation of vancomycin
therapy without subsequent vancomycin adjustments.
Methodology: This study contains two arms: a prospective analysis of pharmacist-managed vancomycin therapy and a
retrospective analysis of historical standard of care with physician-managed vancomycin patients with pharmacist
recommendations as needed. The prospective arm will include patients of 1-2 specified physician groups for which
pharmacist consults to manage vancomycin are received. Consulting prescribers will be responsible for determining when
vancomycin is indicated in their patients. Consulted pharmacists will determine initial and subsequent dosing based on
patient specific parameters (age, weight, renal function, and vancomycin trough levels). The hospital’s electronic medical
record system will be utilized for the retrospective analysis of patients managed on vancomycin by the same physician
groups. Patients will be excluded from this study if they are < 18 years old, pregnant, have renal failure requiring
continuous renal replacement therapy or dialysis, receive < 3 doses of vancomycin, or were prescribed vancomycin
therapy by a provider outside of the physician groups defined in the study. Patients will additionally be excluded from the
retrospective group if the physician had ordered a consult to pharmacy for vancomycin dosing management or if
vancomycin therapy had been adjusted by the Antimicrobial Stewardship Team. The following data will be collected: age,
sex, renal function (blood urea nitrogen, serum creatinine, creatinine clearance), actual body weight, height, BMI, inpatient
location (ICU vs. non-ICU), prescriber, indication for vancomycin therapy/infection diagnosis, WBC, bands, cultures,
vancomycin regimen, dose (mg/kg), trough levels, random levels, timing of levels, duration of vancomycin therapy,
concurrent nephrotoxic agents, length of stay, and 30-day readmission rates for repeat infection. Data will be recorded
without patient identifiers and stored in a secured location. This study will be submitted to the Institutional Review Board
for approval prior to commencement.
Results and conclusions: To be determined.
References:
1. Therapeutic monitoring of vancomycin in adult patients: A consensus review of the American Society of HealthSystem Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists.
Am J Health-Syst Pharm. 2009;66:82-98.
2. Moellering RC Jr. Vancomycin: a 50-year reassessment. Clin Infect Dis. 2006;42(suppl 1):S3-4.
3. Bond CA, Raehl CL. Clinical and economic outcomes of pharmacist-managed aminoglycoside or vancomycin therapy.
Am J Health Syst Pharm. 2005 Aug 1;62(15):1596-605.
4. Touchette DR, Doloresco F, Suda KJ, Perez A, Turner S, et al. Economic evaluations of clinical pharmacy services:
2006-2010. Pharmacotherapy. 2014 Aug;34(8):771-93.
5. Welty TE, Copa AK. Impact of vancomycin therapeutic drug monitoring on patient care. Ann Pharmacother.1994 Dec;
28(12):1335-9.
OCCP Fall Meeting 2014
57
Evaluation of Weight Based Chemotherapy Dosing and Treatment Related Toxicities in Adult Females with
Breast Cancer Receiving AC
Nicholas Selle, PharmD; Nicole McMullen, PharmD, BCOP; James Reissig, PharmD, BCPS
Nicholas.Selle@akrongeneral.org
PGY-1
Akron General Medical Center 1 Akron General Avenue, Akron, OH 44307
Background: In April 2012, the American Society of Clinical Oncology (ASCO) published guidelines recommending
obese patients receive chemotherapy dosed on actual body weight (ABW). 1 This guideline was based on a substantial
amount of evidence that suggested neither short nor long term toxicity is increased among obese patients receiving ABW
dosing.2, 3 Additionally, there is compelling evidence that reductions in standard dose and dose intensity may compromise
disease survival and overall survival in the curative setting.4 The practice of ABW chemotherapy dosing in obese patients
has not been consistently observed at Akron General Medical Center (AGMC) since the release of the ASCO guideline.
Objectives: (1) To compare chemotherapy toxicity profiles in obese patients who receive ABW dosing with normal weight
patients receiving the same chemotherapy. (2) To determine the chemotherapy dosing patterns at AGMC before and after
the release of the ASCO guideline. (3) To compare chemotherapy toxicity profiles in obese patients who receive ABW
dosing with obese patients who get adjusted body weight dosing receiving the same chemotherapy.
Methodology: Prior to commencement, this study will be submitted to the Institutional Review Board for approval.
AGMC’s Outpatient infusion center’s electronic medical record system will be utilized to identify patients who received
cyclophosphamide and doxorubicin (AC) for treatment of breast cancer between 1/1/2011 and 8/31/2014. Subjects will be
excluded if they are pregnant, had received previous chemotherapy for breast cancer, received pegfilgrastim with the first
cycle of AC, or are <18 years of age. Patients will be assigned to categories based on the CDC's BMI classification.
Underweight (< 18.5 ), normal weight (18.5-24.9), overweight (25-29.9), obese (30-39.9), morbidly obese (>40). Data
collected will include rates of stage 4 neutropenia (primary), incidence of dose reductions, rates of chemotherapy delays,
and other chemotherapy related toxicities. All data will be recorded without patient identifiers and maintained
confidentially.
Results and conclusions: To be determined
References:
1. Griggs J, Mangu P, Anderson H, et al: Appropriate chemotherapy dosing for obese adult patients with cancer:
American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 212;30:1-10.
2. Lyman GH, Dale DC, Crawford J: Incedence and predictors of low density intensity in adjuvant breast cancer
chemotherapy: A nationwide study of community practices. J Clin Oncol 2003;21:4524-4531.
3. Rosner GL, Hargis GB, et al: Relationship between toxicity and obesity in woman receiving adjuvant
chemotherapy for breast cancer. J Clin Oncol 1996;14:3000-8.
4. Frei E, Canellos GP, et al: Dose: A Critical factor in cancer chemotherapy. Am J Med 1980;69:585-594.
OCCP Fall Meeting 2014
58
Inpatient management of hyperglycemia using an insulin sliding scale alone versus basal plus bolus insulin
Alexandra Serafino, PharmD
Anita Ridner, PharmD
Alexandra.serafino@utoledo.edu
PGY-1 Pharmacy Practice
University of Toledo Medical Center
Background:
Hyperglycemia is a prevalent issue in hospitalized patients due to diabetes, illness, stress on the body, and steroid use.
Research has shown that a basal plus bolus insulin management strategy results in significantly better glycemic control
and fewer hypoglycemic events than sliding scale insulin alone and is the preferred hyperglycemia management strategy
for non-critically ill inpatients. This study will demonstrate if non-critically ill inpatients with hyperglycemia are being
effectively controlled, determine if practices can be improved, and if the institution would benefit from an insulin ordering
protocol. Better in-hospital glycemic control will improve patient outcomes and possibly reduce hospital readmissions.
Objectives: (1) To compare glycemic control in hospitalized, non-critically ill, adult patients receiving sliding scale insulin
alone versus basal plus bolus insulin. (2) To determine rates of hypoglycemia between the two groups and differences in
glycemic control within specific populations.
Methodology:
This retrospective cohort study will be submitted to the Institutional Review Board for approval. Data will be collected
through chart review and will be immediately de-identified and confidentially maintained. Inpatients receiving any insulin
therapy will be identified through medication use reports. Through chart review, the following information will be obtained:
age, gender, weight, admitting diagnosis, dietary status, glucose point of care (POC), insulin regimen, steroid use,
surgeries, and home and discharge medications. Inclusion criteria consists of adult inpatients with hyperglycemia (at least
one fasting blood glucose greater than 140 mg/dL or one random POC greater than 180 mg/dL), and receiving insulin.
Patients will be excluded if they do not have at least 8 POCs, length of stay less than 48 hours or greater than 7 days, ICU
status, or were on a continuous infusion of insulin at any point in their stay. Patients will be grouped according to insulin
sliding scale therapy alone versus basal insulin plus any bolus or correctional insulin. The primary objective is to compare
glycemic control in non-critically ill inpatients receiving sliding scale insulin alone versus basal plus bolus insulin.
Secondary outcomes will compare rates of hypoglycemia and glycemic control in specific populations.
Results and conclusions:
To be determined.
References:
1. Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker
of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab 2002; 87:978-982.
2. McAlister FA, Majumdar SR, Blitz S, Rowe BH, Romney J, Marrie TJ. The relation between hyperglycemia and
outcomes in 2,741 patients admitted to the hospital with community-acquired pneumonia. Diabetes Care
2005;28:810-815.
3. Noordzij PG, Boersma E, Schreiner F, et al. Increased preoperative glucose levels are associated with
perioperative mortality in patients undergoing non-cardiac nonvascular surgery. Eur J Endocrinol 2007; 156:137142.
4. Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, et al. Randomized study of basal-bolus
insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 Trial). Diabetes Care
2007. 30(9):2181-6.
5. Maynard G, Lee J, Phillips G, Fink E, Renvall M. Improved Inpatient Use of Basal Insulin, Reduced
Hypoglycemia, and Improved Glycemic Control: Effect of Structured Subcutaneous Insulin Orders and an Insulin
Management Algorithm. Hospital Medicine 2009;4:3-15.
OCCP Fall Meeting 2014
59
Healthcare associated pneumonia (HCAP): treatment and evaluation at a tertiary medical center
Kane Shirkman, PharmD; Nina Naeger Murphy, PharmD, BCPS-AQ ID; Michelle Hecker, MD
Kshirkman@MetroHealth.org
PGY-1
MetroHealth Medical Center, 2500 MetroHealth Drive, Cleveland, Ohio 44109
Background: Guidelines for the management of HCAP were published in 2005 by the American Thoracic Society/Infectious Diseases
Society of America (ATA/IDSA) and are currently undergoing revision.¹ These guidelines recommend using two antipseudomonal
agents in addition to an agent for methicillin resistant Staphylococcus aureus in patients who are at risk for multidrug-resistant
organisms (MDRO).¹ Previous studies have shown that broad-spectrum antimicrobial coverage may not be needed to cover all
patients at risk for MDROs.2,3 One study showed that even though prescribers are aware and believe in following current HCAP
treatment guidelines, most do not actually practice that way. 4 Concern for drug resistant pathogens and a link to increased mortality
with inappropriate initial therapy are factors that continue to drive empiric broad spectrum antimicrobial prescribing in hospitalized
patients with HCAP.5 As the current ATS/IDSA guidelines are being re-evaluated and updated, we sought to describe our own
practice patterns, including microbiological evaluation of patients with HCAP diagnoses.
Objectives: (1) To describe antimicrobial prescribing patterns and microbiologic testing of patients diagnosed with HCAP. (2) To
describe patient clinical outcomes, including length of stay and readmission at 30, 60, and 90 days.
Methodology: Prior to commencement, this study will be submitted to the Institutional Review Board for approval. This is a
retrospective, descriptive chart review of patients diagnosed with HCAP at MetroHealth Medical Center from January 1, 2013
through January 1, 2014. Using the hospital’s electronic medical record system, a listing of patients with a primary or secondary ICD9 diagnosis code for pneumonia (codes 480-484 and 486-488) will be obtained. Inclusion criteria will consist of patients >17 years of
age admitted to the hospital meeting diagnostic criteria for HCAP based on current guidelines. Using a random number generator,
charts will be reviewed until 10 patients per month during the study period meet the inclusion criteria for a total of 120 patients.
Data collection will include patient demographics and any risk factors for multidrug-resistant pathogens, antimicrobial drug therapy
and duration, culture and sensitivity review of respiratory and blood isolates, urine legionella and pneumococcal antigen, respiratory
viral panel, development of Clostridium difficile infection, need for mechanical ventilation, oxygen requirements changed from
baseline, length of stay, and any readmissions within 90 days. Data will be collected on a standardized form without patient
identifiers and maintained in a secure database. Data will be displayed using descriptive statistics.
Results and Conclusions: To be determined
References:
1.
American Thoracic Society and Infectious Diseases Society of America. Guidelines for the management of adults with
hospital-acquired,ventilator-associated for the healthcare-associated pneumonia. Am J Respir Crit Care Med.
2005;171:388–416.
2.
Brito V, Niederman MS. Healthcare-associated pneumonia is a heterogeneous disease, and all patients do not need the
same broad-spectrum antibiotic therapy as complex nosocomial pneumonia. Curr Opin Infect Dis. 2009;12:316–325.
3.
Aliberti S, Cilloniz C, Chalmers JD, et al. Multidrug-resistant pathogens in hospitalised patients coming from the community
with pneumonia: a European perspective. Thorax. 2013;68:997–999.
4.
Seymann GB, Di Francesco L, Sharpe B, et al. The HCAP gap: differences between self-reported practice patterns and
published guidelines for health care-associated pneumonia.Clin Infect Dis. 2009;49:1868-1874.
5.
Gross AE, Van Schooneveld TC, Olsen KM, et al. Epidemiology and predictors of multidrug-resistant community-acquired
and health care-associated pneumonia. Antimicrob Agents Chemother. 2014;58:5262-5268.
OCCP Fall Meeting 2014
60
Performance of a CIWA-Ar Protocol
Sydney Smith, PharmD; Jeff Ketz, PharmD, BCPS, Elias Khawam, MD; Vicente Velez, MD
smiths9@ccf.org
PGY-1
Cleveland Clinic 9500 Euclid Avenue Cleveland, OH 44195
Background: The Clinical Institute Withdrawal Assessment for Alcohol – revised (CIWA-Ar) is a validated protocol in which a
clinician can quickly assess the severity of alcohol withdrawal symptoms and provide an appropriate medication, typically a
benzodiazepine, at a dose correlating with the CIWA-Ar score.1,2 Benzodiazepines have been shown to significantly reduce
seizures and delirium in alcohol withdrawal.3,4 Utilizing the CIWA-Ar for symptom-triggered therapy with short-acting
benzodiazepines rather than scheduled long-acting benzodiazepines may help to avoid overmedication and shorten treatment
duration, but may not always adequately control alcohol withdrawal symptoms.1,3,4 To our knowledge, only one study has
been published describing inappropriate use, but not performance, of a CIWA-Ar protocol implemented at a major academic
medical center.5 Our goal is to evaluate the CIWA-Ar protocol implemented at Cleveland Clinic Main Campus in order to
describe its utilization and evaluate effectiveness in the management of alcohol withdrawal.
Objectives: 1) To evaluate the effects of symptom-triggered benzodiazepine use on CIWA-Ar scores. 2) To describe the
patient population receiving the CIWA-Ar protocol. 3) To describe nursing assessment intervals, CIWA-Ar scores, and
benzodiazepine administration. 4) To describe inappropriate use of the CIWA-Ar protocol. 5) To describe pharmacologic
management in patients with an alcohol withdrawal diagnosis who did not receive the CIWA-Ar protocol.
Methodology: Adult patients who received the CIWA-Ar protocol or who had an alcohol withdrawal diagnosis will be identified
through the electronic medical record. Data will be collected to assess whether there are improvements in CIWA-Ar scores
with benzodiazepine administration, to characterize the patients who received the protocol and describe their subjective
alcohol consumption, and to describe the number and intervals of CIWA-Ar assessments and scores documented. We will
also describe appropriate and inappropriate benzodiazepine administration and use of the protocol in terms of patients who
are qualified to receive symptom-triggered therapy, as well as the management of alcohol withdrawal in patients who did not
receive the protocol. Student’s t-test or Mann-Whitney U will be used to compare total benzodiazepine use between patients
who received the protocol and those who did not. Descriptive statistics with measures of central tendency will be used for all
other endpoints. Patient-specific data will be kept confidential and accessible only to the investigators. This study was
submitted to the Institutional Review Board for approval.
Results and conclusions: To be determined.
References:
1. Reoux JP, Miller K. Routine Hospital Alcohol Detoxification Practice Compared to Symptom Triggered Management with an
Objective Withdrawal Scale (CIWA-Ar). Am J Addict 2000;9(2):135-44.
2. Sullivan JT, et al. Assessment of Alcohol Withdrawal: the revised clinical institute withdrawal assessment for alcohol scare
(CIWA-Ar). Br J Addict 1989;84:1353-7.
3. Mayo-Smith MF. Pharmacological Management of Alcohol Withdrawal. A Meta-analysis and Evidence-Based Practice
Guideline. JAMA 1997;278(2):144-51.
4. Maldonado JR, et al. Benzodiazepine loading versus symptom-triggered treatment of alcohol withdrawal: a prospective,
randomized clinical trial. Gen Hosp Psychiatry 2012;34(6):611-7.
5. Hecksel KA, et al. Inappropriate Use of Symptom-Triggered Therapy for Alcohol Withdrawal in the General Hospital. Mayo
Clin Proc 2008;83(3):274-9.
OCCP Fall Meeting 2014
61
Implementation of a medication therapy management service within a community hospital medical office building
Thomas Stanek, Jr., RPh, PharmD; Brandon Mottice, RPh, PharmD, BCPS; Allison Naso, RPh, PharmD, MBA, BCPS;
Michael Moran, RPh, MBA
stanekt@ccf.org
PGY-1
Medina Hospital, 1000 East Washington Street, Medina, OH 44256
Background:
Pharmacists have demonstrated enhanced positive impact on outcomes thru the service of Medication Therapy
Management (MTM). The purpose of MTM is to review and evaluate a patient’s drug regimen to identify and resolve any
medication-related issues. Multiple studies have shown that MTM can improve outcomes, increase patient safety,
decrease mortality, and provide cost savings for both parties.1 However, not enough has been done in the primary care
setting, as there is a lack of attention paid to medication work-flow in the medical office. Additionally, creating shared care
plans with an interdisciplinary team or improving collaboration between pharmacist and prescriber has not occurred within
regular daily practice.2 Consequently, even though there is a need to improve medication usage across the board in
healthcare, it is evident that the primary care setting remains a pivotal area for improvement of medication processes.3
Medina Hospital is a Cleveland Clinic regional community hospital with an adjoining Medical Office Building. The aim is to
develop and begin a pharmacist-driven MTM program within the Medical Office Building and integrate MTM into the
continuum of care.
Objectives:
Develop a patient-centered interdisciplinary MTM program at Medina Hospital medical office building; identify and collect
the number of Drug Therapy Problems (DTP) found to characterize the patient population of a new service; classify DTP
according to severity; resolve DTP and examine percentage of recommendations accepted by physicians; determine the
appropriate time needed for a MTM visit; investigate patient acceptance of the new service.
Methodology:
Patients will be included if they meet one of the following criteria: Medical Office Building patients with two or more chronic
conditions, including diabetes, heart failure, hyperlipidemia, hypertension, asthma, or COPD; take two or more
medications for a chronic condition; take five or more routine medications; or by physician referral. The primary outcome
will be the number and type of drug therapy problems (DTP) collected and analyzed at each visit. The DTP types are
those defined by the Pharmaceutical Care Practice: The Clinician’s Guide and include: unnecessary drug therapy; need
for additional drug therapy; ineffective drug; dosage too low/high; adverse drug reaction; and noncompliance. 4 Secondary
outcomes include: a ranking system from Low to High to rate the severity of the DTP seen in this patient population, the
percentage of recommendations accepted, and time allotted per visit. A patient experience survey will also be utilized to
investigate patient acceptance and views on MTM.
Results and conclusions:
To be determined.
References:
1. de Oliverira R, Brummel AR, and Miller DB. Medication therapy management: 10 years of experience in a large
integrated health care system. J. Managed Care Pharmacy. 2010; 16(3):185-95
2. Smith M, Giuliano MR, and Starkowski MP. In Connecticut: Improving Patient Medication Management in Primary
Care. Health Affairs. 2011; 30(4):646-654
3. Kennedy AG, Chen H, Corriveau M, et al. Improving Population Management through Pharmacist-Primary Care
Integration: A Pilot Study. Population Health Management. 2014: 1-7
4. Cipolle R.J., Strand L.M., Morley P.C. (2012). Chapter 5. Drug Therapy Problems. In Cipolle R.J., Strand L.M.,
Morley P.C. (Eds), Pharmaceutical Care Practice: The Patient-Centered Approach to Medication Management
Services, 3e. Retrieved September 26, 2014 from http://0accesspharmacy.mhmedical.com.crusher.neomed.edu/content.aspx?bookid=491&Sectionid=39674905.
OCCP Fall Meeting 2014
62
Incidence of positive culture results in patients treated with therapeutic hypothermia post out-of-hospital cardiac
arrest
Steven Stoyanov, PharmD; Jenna Schaffner, PharmD, BCPS; Jacob Zimmerman, PharmD; Jodi Dreiling, PharmD,
BCPS
Steven.Stoyanov@akrongeneral.org
PGY-1
Akron General Medical Center 1 Akron General Ave, Akron, OH 44307
Background: Out-of-hospital cardiac arrest (OHCA) occurs in over 400,000 people per year in the United States with less
than a 10% survival rate.1 It is the standard of care for patients to undergo therapeutic hypothermia in order to improve
neurological function. However, these patients are at an increased risk of infection due to immune system suppression.
There have been several studies showing that therapeutic hypothermia increases the rate of infection; nevertheless, there
has been no effect on mortality.2 Limited data suggests that early antibiotic therapy may reduce mortality in patients
treated with therapeutic hypothermia.3,4
Objectives: (1) To describe the incidence of positive cultures in patients undergoing therapeutic hypothermia post OHCA.
(2) To determine the relationship between antibiotic timing and mortality for the following time frames: <24 hours, 24-48
hours, and >48 hours post final ROSC. (3) To assess the effect of antibiotic therapy on hospital length of stay. (4) To
analyze the antibiotic choice based on susceptibility data.
Methodology: This is a retrospective, cohort study from July 2008 through November 2014 evaluating the incidence of
positive culture results in OHCA patients that received therapeutic hypothermia. Upon approval from the Institutional
Research Review Board, patients will be identified via billing records. All patients that received therapeutic hypothermia
post OHCA will be included in the primary and secondary objectives. Patients will then be divided into two groups, based
on antibiotic use, for the remainder of the objectives. Patients eligible for inclusion are those 18 years of age and older,
and treated with therapeutic hypothermia following OHCA surviving more than 24 hours. Patients will be excluded if they
received antibiotics prior to admission, had a hospital admission within 30 days, and pregnancy. Data collection will
include demographic information, cultures, antibiotic use, length of stay, and mortality. Patient identifiers will be removed
prior to data analysis to maintain confidentiality. A statistician will also aid in the analysis of data.
Results and conclusions: To be determined.
References:
1. Nichol G, Thomas E, Callaway CW, et al. Regional variation in out-of-hospital cardiac arrest incidence and outcome.
JAMA 2008; 300(12):1423–31.
2. Mongardon N, Perbet S, Lemiale V, et al. Infectious complications in out-of-hospital cardiac arrest patients in the
therapeutic hypothermia era. Crit Care Med 2011; 39(6): 1359-64.
3. Davies KJ, Walters JH, Kerslake IM, et al. Early antibiotics improve survival following out-of hospital cardiac arrest.
Resuscitation 2013; 84: 616-19.
4. Pabst D, Romer S, Samol A, et al. Predictors and outcome of early-onset pneumonia after out-of-hospital cardiac
arrest. Respiratory Care 2013; 58(9): 1514-20.
OCCP Fall Meeting 2014
63
Target specific oral anticoagulants (TSOACs) versus warfarin in patients undergoing radiofrequency ablation or
cardioversion for atrial fibrillation and flutter
Rachel Stulock, PharmD; Sharon Laforest, PharmD, BCPS; Carol Ingle, PharmD; Johnathan Goldberg, MS, MD,
Jayakumar Sahadevan, MD
Rachel.Stulock@va.gov
PGY-2 Ambulatory Care
Louis Stoke Cleveland VA Medical Center
Background: Conversion of atrial fibrillation (AF) or atrial flutter (AFL) to sinus rhythm with procedures such as
radiofrequency (RF) catheter ablation, electrical (ECV) or pharmacological cardioversion (PCV) can improve
cardiovascular hemodynamics, functional status, and quality of life. Patients are at an increased for thromboembolic
complications post procedure due to restored atrial contraction leading to dislodgment of left atrial thrombi. Therefore,
peri-procedural anticoagulation is recommended for three weeks prior to procedure and for four weeks post-procedure in
patients undergoing cardioversion1 or two months in cases of RF ablation2. Historically, warfarin was preferred for periprocedural anticoagulation, however target specific oral anticoagulants (TSOACs) have emerged as a potential
alternatives for this indication. There are several potential benefits of using TSOACs for peri-procedural anticoagulation
including their rapid onset of action, short half-life and wide therapeutic window, particularly for patients requiring only
temporary anticoagulation. Limited published literature is available describing the use of TSOACs for the express
indication of anticoagulation for cardioversion and ablation, and even fewer studies evaluating non-clinical outcomes such
as time-to-procedure and length of hospitalization.
Objectives: Primary objective of this study will be to evaluate time-to-procedure in patients receiving target specific oral
anticoagulants (TSOACs) compared to warfarin for peri-procedural anticoagulation for radiofrequency ablation or
cardioversion for AF and AFL. We hypothesize that patients who receive TSOACs for peri-procedural anticoagulation will
have shorter times-to-procedure. Secondary objectives will aim to evaluate possible clinical and financial implications of
prolonged time-to-procedure such as acute care encounters related to AF or AFL, cancelation of procedures, and hospital
utilization. Safety outcomes include frequency of thromboembolic and/or bleeding complications within 30 days postprocedure (or 30 days after transitioning to long term anticoagulation). Current practices will also be described,
particularly protocols when transitioning patients from a TSOAC to warfarin (or vice versa) in the peri-procedural period.
Methodology: This study is a retrospective, observational, single-center chart review. All patients ≥18 years of age
managed by the LSCVDAMC anticoagulation clinic who underwent E
CV, PCV, and RF ablation of atrial fibrillation or flutter during the study period will be included. Patients receiving
anticoagulation for any indication other than AF or AFL and those receiving non-approved doses of TSOACs will be
excluded. Patients will be screened for inclusion and exclusion criteria using data collected from the Computerized
Patient Record System (CPRS). The study group will include patients who received a TSOACs for peri-procedural
anticoagulation. TSOACs included are dabigatran, rivaroxaban and apixaban. The control group will consist of patients
who received warfarin for peri-procedural anticoagulation. Patients will be matched based on age, CHADS2 score and
date of procedure. A sample size of 200 patients (100 in each group) will be sufficient to detect a moderately small
decrease in effect size of 0.40 for differences in times-to-procedure using a paired t- test with a power of 0.80,
alpha=0.05.
Results and conclusions: Research in progress.
References:
1. Fuster V, Ryden LE, Cannom DS, Crijns HJ, et al. American College of Cardiology Foundation/American Heart
Association Task F, 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2014 guidelines for
the management of patients with atrial fibrillation: a report of the American College of Cardiology
Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2011 Mar 15;123(10):e269367.
2. Calkins H, Kuck KH, Cappato R, Brugada J et al. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter
and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient
management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606.
OCCP Fall Meeting 2014
64
Impact of a pharmacist driven discharge evaluation service for inpatients with venous thromboembolism
Tyler Tomasek, PharmD; Weslie Donia, PharmD Candidate; Christopher Tuttle, PharmD, BCPS; Abbi Smith, PharmD,
BCPS; Daniel Lewis, PharmD, BCPS.
tomaset@ccf.org
PGY-1
South Pointe Hospital 20000 Harvard Rd., Warrensville Heights, OH 44122
Background: Venous thromboembolism (VTE) is a disease state consisting of deep vein thrombosis and pulmonary
embolism. Historically, the standard of care for acute treatment was continuous intravenous heparin which requires
frequent laboratory monitoring and dose titrations. With the advent of long-acting injectable and novel oral anticoagulants,
patients are now able to be treated on an outpatient basis due to the lack of required monitoring and ease of selfadministration.1 Numerous studies have shown safety and efficacy in treating select patients with VTE on an outpatient
basis.2,3 Several institutions have created successful pharmacy-driven services to improve outpatient transition.4,5 The
South Pointe Hospital pharmacy has developed a discharge evaluation service to identify and assist with the outpatient
transition of VTE patients who are eligible for home anticoagulation. The purpose of this study is to evaluate the impact of
this pharmacist-driven service on the overall length of stay in this patient population. Readmission rates for bleeding and
recurrent VTE, as well as service acceptance, will also be evaluated.
Objectives: (1) To determine if a difference exists in the length of hospital stay between historical and post service
initiation cohorts. (2) To evaluate rates of thirty day readmissions, accepted recommendations, prescriptions filled via
bedside medication delivery service, pharmacist provided patient education, and scheduled post-discharge appointments
post-service initiation compared to historical cohorts.
Methodology: This study was approved by the institutional review board. A retrospective, observational chart review will
be conducted of patients aged 18 years and older diagnosed with VTE at South Pointe Hospital between July 2013 and
March 2014. There will be two phases of the study: a historical cohort of patients hospitalized prior to service initiation,
and a cohort of patients hospitalized since service implementation. Patients will be excluded if their estimated creatinine
clearance calculated with the Cockroft-Gault equation is less than 30 mL per minute, if there is evidence of a thirty day
history of bleeding, if long term injectable anticoagulation therapy is required, if they are therapeutically anticoagulated
upon admission, if there is suspicion of non-adherence, or if there is a history of heparin induced thrombocytopenia. Epic®
MyPractice electronic medical record will be utilized to obtain patient information. Data collected will include: demographic
information, laboratory values, diagnoses, medications, admission and discharge dates, encounters with pharmacy team,
and post-discharge outpatient appointments.
Results and conclusions: To be determined.
References:
1. Kearon C et al. Antithrombotic therapy for VTE disease: antithrombotic therapy and prevention of thrombosis, 9th ed:
ACCP Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e419S–94S.
2. Levine M et al. Comparison of LMWH administered primarily at home with unfractionated heparin in hospital for DVT.
NEJM. 1996. 334;11:677-81.
3. Aujesky D et al. Outpatient vs in-patient treatment for patients with acute PE: international, open-label, randomized,
non-inferiority trial. Lancet. 2011; 378 41-47.
4. Reger MA et al. Outcomes of a Comprehensive, Pharmacist-Managed Injectable Anticoagulation Discharge Program
for the Prophylaxis and Treatment of Venous Thromboembolism. J Pharm Technol. 2011. 27;199-205.
5. Padron M et al. Development of an Anticoagulation Stewardship Program at a Large Tertiary Care Academic Institution.
J Pharm Pract. 2013.
OCCP Fall Meeting 2014
65
Evaluation of Pharmacogenomic Clinical Decision Support on Prescribing Practices
Maya Wai, PharmD; Marc Willner, PharmD; Jeffrey Chalmers, PharmD; David Stowe, RPh; Thomas Daly, MD; Andrea
Pallotta, PharmD, BCPS; Kathryn Teng, MD; J. Kevin Hicks, PharmD, PhD
waim@ccf.org
PGY-2 Drug Information
Cleveland Clinic, 9500 Euclid Ave., Cleveland, OH 44195
Background:
Pharmacogenomics is the study of how an individual’s genetic variants may influence drug response. Integrating
pharmacogenomics into patient care may improve treatment outcomes by identifying those at an increased risk of an
adverse drug reaction or at an increased risk of non-response to pharmacotherapy. Cleveland Clinic’s Personalized
Medication Program (PMP) was established to integrate evidence-based clinical decision support (CDS) tools into the
electronic health record (EHR) to guide pharmacogenomic medical decisions at the point of care. Initially,
pharmacogenomic CDS was developed for two gene-drug pairs, TPMT–thiopurines (e.g., azathioprine, mercaptopurine,
thioguanine) and HLA-B*57:01–abacavir. Patients who have intermediate or low TPMT activity are at an increased risk of
thiopurine-induced myelosuppression, while those who are HLA-B*57:01 positive are at an increased risk for abacavir
hypersensitivity.1,2,3 When a thiopurine or abacavir is ordered, a pharmacogenomic CDS alert fires recommending a
TPMT or HLA-B*57:01 genotype test, respectively. For those with an actionable (abnormal) TPMT or HLA-B*57:01 test
resulted, the CDS tools integrated into the EHR provide pharmacotherapy recommendations. To date, limited evaluations
have been conducted on our pharmacogenomic CDS tools to determine the impact on prescribing practices.
Objectives:
The primary objectives are to describe the percentage of patients with an actionable TPMT or HLA-B*57:01 result and
evaluate compliance of pharmacogenomic CDS recommendations. The secondary objective is to quantify alert firing and
provider response in order to identify opportunities to improve pharmacogenomics CDS alerts.
Methodology:
The study time frame is a 1-year period post-CDS implementation (July 1, 2013 – June 30, 2014). Any Cleveland Clinic
patient who was prescribed abacavir, mercaptopurine, azathioprine, or thioguanine will be included in this study.
Exclusion criteria are patients from any site where pharmacogenomics CDS was not implemented (e.g., Ashtabula,
Nevada, Toronto) and oncology patients enrolled on treatment protocols that do not include TPMT testing. Patient
characteristics (e.g., age, sex, race, weight), drug order (dose, frequency, prescriber, institute), and resulted TPMT or
HLA-B*57:01 tests will be collected. Additionally, TPMT and HLA-B*57:01 CDS alert firing will be captured. For patients
with an actionable pharmacogenomic test result, a manual chart review will be conducted for indication, compliance with
CDS recommendations, and potential drug interactions. After Institutional Review Board approval, data will be collected,
secured, and analyzed using descriptive statistics.
Results and conclusions:
To be determined
References:
1. Relling, M.V. & Klein, T.E. CPIC: Clinical Pharmacogenetics Implementation Consortium guidelines for thiopurine
methyltransferase genotype and thiopurine dosing. Clin Pharmacol Ther 2011;89:387-91.
2. Booth, R.A., et al. Assessment of Thiopurine S-Methyltransferase Activity in Patients Prescribed Thiopurines: A
Systematic Review. Annals of Internal Medicine 2011;154:814-23.
3. Martin, M.A., et al. Clinical Pharmacogenetics Implementation Consortium guidelines for HLA-B genotype and
abacavir dosing. Clin Pharmacol Ther 2012;91:734-8.
OCCP Fall Meeting 2014
66
Evaluation of a newly implemented pharmacist managed vancomycin dosing service in a community teaching
hospital
Cara Weisenberger, PharmD; Daniel A. Lewis, PharmD, BCPS; Lauren A. Thomas, PharmD; Abbi L. Smith, PharmD,
BCPS
weisenc@ccf.org
PGY-1
South Pointe Hospital 20000 Harvard Avenue, Warrensville Heights, OH 44122
Background: Vancomycin is regularly utilized as treatment for serious gram-positive bacterial infections. Vancomycin
requires patient-specific dosing and monitoring of therapy to ensure efficacy, safety and to prevent the development of
resistance. Vancomycin dosing guidelines from the Infectious Diseases Society of America in 2009 state empiric dosing
should be based on actual body weight, and evidence supports monitoring vancomycin therapy by serum trough
concentrations1. Nationally, there is increasing vancomycin resistance in treating Enterococcus sp., from 60% to 80% of
all E. faecium and from 2% to 6.9% of all E.faecalis infections reported from 2006 and 2007, respectively2. Previous
studies have shown that pharmacist-managed vancomycin dosing and monitoring protocols based on patient-specific
dosing improve optimization of vancomycin therapy3,4. This study will evaluate the pharmacist-managed vancomycin
dosing service at South Pointe Hospital.
Objectives: (1) To determine if a pharmacist-managed vancomycin dosing service will provide more optimal dosing,
based on actual body weight and creatinine clearance, as opposed to non-pharmacist dosed vancomycin. (2) To
determine if a pharmacist-managed vancomycin dosing service will achieve trough concentrations in the therapeutic
range a greater percentage of time compared with non-pharmacist managed vancomycin patients.
Methodology: Prior to commencement, this study was submitted to the Institutional Review Board for approval. Epic My
Practice will be utilized to identify inpatients admitted to any unit who are 18 years or older and prescribed intravenous
vancomycin for at least 48 hours. Patients will be excluded if they were on IV vancomycin therapy prior to admission, on
hemodialysis or received surgical prophylaxis doses. The following patient data will be collected: age, gender, height,
actual body weight, serum creatinine, BUN, vancomycin doses, administration times, trough goals, trough concentrations
and timing, number of troughs, suspected infection source, suspected diagnosis, and concomitant nephrotoxic
medications. Optimal initial dose is defined as ≥13.5mg/kg, with an interval determined by calculated creatinine clearance
using Cockroft-Gault, per protocol. Target therapeutic range is determined by indication for vancomycin use, and is
provided in institutional dosing guidelines. Data will be collected until vancomycin is discontinued or the patient is
discharged.
Results and conclusions: To be determined.
References:
1. Rybak MJ, Lomaestro BM, Rotschafer JC, et al. Therapeutic monitoring of vancomycin in adults summary of
consensus recommendations from the American Society of Health-System Pharmacists, the Infectious Diseases
Society of America, and the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2009;29(11):1275-9.
2. Hidron AI, Edwards JR, Patel J, et al. NHSN annual update: antimicrobial-resistant pathogens associated with
healthcare-associated infections: annual summary of data reported to the National Healthcare Safety Network at
the Centers for Disease Control and Prevention, 2006-2007. Infect Control Hosp Epidemiol. 2008;29(11):9961011.
3. Devabhakthuni S, Gonzales JP, Tata AL, et al. Evaluation of Vancomycin Dosing and Monitoring in Adult
Medicine Patients. Hosp Pharm. 2012; 47(6):451-459.
4. Bond CA, Raehl CL. Clinical and economic outcomes of pharmacist-managed aminoglycoside or vancomycin
therapy. Am J Health Syst Pharm. 2005;62(15):1596-605.
OCCP Fall Meeting 2014
67
Antimicrobial Treatment and Mortality Risk for Carbapenem-Resistant Klebsiella pneumoniae pneumonia
Sarah Welch, PharmD; Elizabeth Neuner, PharmD, BCPS (AQ-ID); Simon Lam, PharmD, BCPS; Seth Bauer, PharmD,
BCPS; Eric Cober, MD; David van Duin, MD, PhD; Stephanie Bass, PharmD, BCPS
Resident’s email address: welchs@ccf.org
Research Site: Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH, 44195
Background: Klebsiella pneumoniae carbapenemase (KPC)-producing bacteria are a group of emerging highly drugresistant gram-negative bacilli causing infections with reported mortality rates of 47% to 66%. 1 There are little data
investigating treatment outcomes in patients infected with KPC pneumonia. In vitro data have demonstrated that
combination therapy with tigecycline and colistin produces synergistic effects on bacterial killing, and studies investigating
KPC bloodstream infections suggest better outcomes when two or more drugs with activity against the isolate (i.e.
tigecycline and colistin) are used, especially regimens also including a carbapenem.2,3 Although there is evidence that
these agents may work for bloodstream infections, there is concern of their efficacy in treating pneumonia. Tigecycline
has been shown to have excellent in vitro activity, however, it may not achieve adequate concentrations in the epithelial
lining cells of the lung.4 Similarly, the distribution of colistin, a polymixin antibiotic, into the pleural cavity and lung
parenchyma is poor. Failure with colistin as monotherapy for the treatment of multi-drug resistant nosocomial pneumonia
has been reported.5 Clinical outcomes in a real-world setting are needed to establish optimal therapeutic regimens.
Objective: To identify factors associated with mortality of carbapenem-resistant Klebsiella pneumoniae pneumonia
Methodology: A non-interventional, retrospective case-control study will be conducted to evaluate factors associated with
mortality of carbapenem-resistant Klebsiella pneumoniae pneumonia. The primary objective is to describe the influence of
combination antimicrobial therapy on mortality at 30-days. Secondary objectives include describing the influence of
baseline characteristics, definitive tigecycline-based therapy and colistin-based therapy, and other treatment factors on
mortality. Other treatment factors to be evaluated include empiric regimen, duration of definitive therapy, and time to
appropriate antibiotics. Adult patients admitted to the hospital with a positive respiratory culture with carbapenem-resistant
Klebsiella pneumoniae and evidence of pneumonia will be included. Data describing patient demographics, baseline
characteristics, organism susceptibility and MIC, organism strain and genotype, daily antibiotic use, duration of therapy,
and 30-day mortality will be collected. Nominal data will be analyzed using the Chi-Square or Fisher’s exact test and
continuous data will be analyzed using the Student’s t-Test or the Mann-Whitney U-Test. A multivariate logistic regression
will be used to assess for independent predictors of 30-day mortality.
Results and Conclusions: To be determined
1. Arnold, R.S., et al., Emergence of Klebsiella pneumoniae carbapenemase-producing bacteria. South Med J,
2011. 104(1): p. 40-5.
2. Pournaras, S., et al., Activity of tigecycline alone and in combination with colistin and meropenem against
Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae strains by time-kill assay. Int J
Antimicrob Agents, 2011. 37(3): p. 244-7.
3. Tumbarello, M., et al., Predictors of mortality in bloodstream infections caused by Klebsiella pneumoniae
carbapenemase-producing K. pneumoniae: importance of combination therapy. Clin Infect Dis, 2012. 55(7): p.
943-50.
4. Freire, A.T., et al., Comparison of tigecycline with imipenem/cilastatin for the treatment of hospital-acquired
pneumonia. Diagn Microbiol Infect Dis, 2010. 68(2): p. 140-51.
5. Levin, A.S., et al., Intravenous colistin as therapy for nosocomial infections caused by multidrug-resistant
Pseudomonas aeruginosa and Acinetobacter baumannii. Clin Infect Dis, 1999. 28(5): p. 1008-11.
OCCP Fall Meeting 2014
68
Safety and efficacy of levetiracetam for the prevention of early posttraumatic seizures in patients with traumatic
brain injury
Benjamin Witt, PharmD; Martin Ohlinger, PharmD, BCPS, FCCM
Benjamin.Witt@UToledo.edu
PGY-1
University of Toledo Medical Center 3000 Arlington Ave, Toledo, OH 43614
Background: Traumatic brain injuries (TBIs) may have severe complications, including seizures. Current guidelines
recommend early antiseizure prophylaxis with either phenytoin or valproate to decrease the incidence of seizure within
seven days of injury in the patients with higher risk for posttraumatic seizures. In patients without these risk factors,
antiseizure prophylaxis may also be withheld. These medications are associated with toxic effects and necessitate
therapeutic drug monitoring. Levetiracetam, on the other hand, is associated with less toxic effects and does not require
therapeutic drug monitoring. However, there is conflicting evidence to support the efficacy of levetiracetam in the setting of
TBI.1,2,3 This study will evaluate the safety and efficacy of levetiracetam for the prevention of early posttraumatic seizures
in patients with TBI.
Objectives: (1) To determine if the use of levetiracetam in patients with TBI will decrease the rates of posttraumatic
seizure, as compared to phenytoin, valproic acid, and no treatment. (2) To determine if the use of levetiracetam in patients
with TBI will shorten hospital length of stay and lessen adverse effects. (3) To examine the relationship between time to
initiation of antiseizure therapy and rates of seizure.
Methodology: This study will be a retrospective chart review and will be submitted to the Institutional Review Board for
approval. Patients with an admitting diagnosis of TBI will be identified using ICD-9 codes. The rates of seizure within
seven days of trauma will be compared between patients who receive prophylaxis with levetiracetam and those who
receive phenytoin, valproic acid, or no prophylactic therapy. Patients will also be evaluated for any adverse effects, length
of hospital stay, and for possible association between time to initiation of antiseizure therapy and rates of seizure. The
following data will be collected: patient age, gender, ethnicity, height, weight, length of stay, name and dose of seizure
medication if given, medication route, time to initiation of antiseizure therapy, presence or absence of a past medical
history of seizures, the presence or absence of certain known risk factors for posttraumatic seizures (Glasgow Coma
Scale score, presence of cortical contusion, presence of depressed skull fracture, presence of subdural hematoma,
presence of epidural hematoma, presence of intracerebral hematoma, penetrating head wound or seizure within 24 hours
of brain injury) and presence or absence of early posttraumatic seizures (seizures occurring within 7 days of trauma).
Patients will be stratified based on the severity of TBI.
Results and conclusions: To be determined.
References:
1. Inaba K et al. A prospective multicenter comparison of levetiracetam versus phenytoin for early posttraumatic
seizure prophylaxis. J Trauma Acute Care Surg. 2013 Mar;74(3):766-71.
2. Jones KE et al. Levetiracetam versus phenytoin for seizure prophylaxis in severe traumatic brain injury.
Neurosurg Focus. 2008 Oct;25(4):E3.
3. Torbic H et al. Use of antiepileptics for seizure prophylaxis after traumatic brain injury. Am J Health Syst Pharm.
2013 May 1;70(9):759-66.
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Implementation of a cardiac patient medication transition pilot program: a prospective study of pharmacy
services for patients with congestive heart failure and acute myocardial infarction
Idris Yakubu, PharmD; Rachel. E. Rarus, PharmD; Sean O.P. McKee, PharmD; Julie A. Murphy, PharmD, FASHP,
FCCP, BCPS; Michelle N. Schroeder, PharmD, BCACP; Steven J. Martin, PharmD, BCPS, FCCP, FCCM.
Idris.yakubu@utoledo.edu
PGY1 Pharmacy Practice Resident
The University of Toledo Medical Center, 3000 Arlington Avenue, Mail Stop 1013, Toledo, OH 43614
Background: Pharmacists play an integral role in reducing 30-day readmission rates for patients with heart failure (HF)
exacerbation or acute myocardial infarction (AMI) by promoting adherence to evidence-based medication regimens.
Several published studies have demonstrated that a high level transitional care program decreases readmission rates for
HF and AMI patients. It has been shown that the hospitals with the readmission rate in the lowest quartile had modestly
higher scores for discharge and transitional care domain.1 There is also a modest correlation between lower 30-day
readmission rates and a complete discharge and transition care process. 2 A study conducted by Szkiladz et. al. showed
that after speaking with a pharmacy student or pharmacy resident at discharge, most patients agreed to have a better
understanding about their medications and medication reactions. 3 Using pharmacy students and residents to provide
discharge medication education to patients reduced medication errors and also provided significant cost avoidance
without any impact on pharmacy staffing.3 This study evaluates the effectiveness of a multidisciplinary transitional care
program on HF and AMI 30-day readmission rates and patients’ quality of life.
Objectives: The primary objective is to determine the change in 30-day readmission rates for patients with HF or AMI
after implementation of the “high-touch” standard of care. Secondary objectives include: 1) change in 72-hour emergency
department visit rates, 2) change in 30-day mortality rate, 3) change in scores on the Minnesota Living with Heart Failure
Questionnaire (MLHFQ) or Myocardial Infarction Dimensional Assessment Scale (MIDAS) Questionnaire, 4) adherence to
HF or AMI medications, and 5) compliance with follow-up MTM and cardiologist appointments.
Methodology: This prospective pilot study was approved by the University of Toledo (UT) Institutional Review Board and
funded through a grant from the Cardinal Health Foundation (2013 E3 Grant Program). The program focuses on a
multidisciplinary collaboration involving nurses, dieticians, physicians and trained pharmacy personnel. Patients admitted
to the University of Toledo Medical Center with HF exacerbation, Non-ST-elevation MI or ST-elevation MI from August 1,
2013 to December 31, 2014 are eligible for this study. On the second day of admission, patients are educated on the
signs and symptoms of HF or AMI, the importance of a healthy diet, and post-discharge HF or AMI medications. On the
day of discharge, all concepts are reinforced, and the MLHFQ or MIDAS questionnaire is administered. Follow-up
telephone calls are made by a pharmacist 4 to 7 days or 48 to 72 hours post-discharge for HF and MI patients,
respectively, to ensure understanding and compliance with medication regimens. A follow-up appointment with an MTM
pharmacist is scheduled within two weeks of discharge which includes a comprehensive medication review, HF or AMI
medication education, and administration of the MLHFQ or MIDAS questionnaire. Patients will also be contacted by a
dietician within three weeks of discharge.
Results and conclusions: To be determined
References:
1. Kociol RD, Peterson ED, Hammill BG, Flynn KE, Heidenreich PA, Piña IL, et. al. National survey of hospital strategies
to reduce heart failure readmissions: findings from the Get With the Guidelines-Heart Failure registry. Circ Heart Fail.
2012 Nov;5(6):680-7.
2. Clark A, Nadash P. The effectiveness of a nurse-let transitional care model for patients with congestive heart failure.
Home Healthc Nurse. 2004 Mar;22(3):160-2.
3. Szkiladz A, Carey K, Ackerbauer K, Heelon M, Friderici J, Kopcza K. Impact of Pharmacy Student and Resident-Led
Discharge Counseling on Heart Failure Patients. J Pharm Pract. 2013 Jun 24.
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