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Oncology Pharmacy Practice Journal of Volume 20 Number 3(Supplement) June 2014 Contents Selected Abstracts presented at the XIV Symposium of the International Society of Oncology Pharmacy Practitioners, 2–5 April 2014, Montreal, Quebec, Canada Abstracts Clinical Sciences 3 Practice Research 17 Translational Sciences 26 Encore Presentations 27 Platform Presentations 28 Research Award Presentation 30 Visit http://opp.sagepub.com Free access to tables of contents and abstracts. Site-wide access to the full text for members of subscribing institutions. at TEXAS SOUTHERN UNIVERSITY on December 17, 2014 opp.sagepub.com Downloaded from

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Page 1: Selected Abstracts presented at the XIV Symposium of the International Society of Oncology Pharmacy Practitioners, 2-5 April 2014, Montreal, Quebec, Canada

OncologyPharmacyPractice

Journal of

Volume 20 Number 3(Supplement) June 2014

Contents

Selected Abstracts presented at the XIV Symposium of the International Society of Oncology Pharmacy

Practitioners, 2–5 April 2014, Montreal, Quebec, Canada

Abstracts

Clinical Sciences 3

Practice Research 17

Translational Sciences 26

Encore Presentations 27

Platform Presentations 28

Research Award Presentation 30

Visit http://opp.sagepub.com

Free access to tables of contents and abstracts. Site-wide access to the full text for members of

subscribing institutions.

at TEXAS SOUTHERN UNIVERSITY on December 17, 2014opp.sagepub.comDownloaded from

Page 2: Selected Abstracts presented at the XIV Symposium of the International Society of Oncology Pharmacy Practitioners, 2-5 April 2014, Montreal, Quebec, Canada

OncologyPharmacyPractice

Journal of

Abstracts

Clinical Sciences

1Complementary and alternative medicine use inrural cancer patients in AustraliaAimee Sullivan1, Peter Gilbar1, Colin Curtain2

1Toowoomba Hospital, Australia, 2University of Tasmania, Australia

Objective: Numerous studies have demonstrated thehigh prevalence of complementary and alternativemedicine (CAM) use in metropolitan cancer cohortsbut few have been conducted in regional and remotepopulations. This study aimed to investigate thetrends and regional variations in CAM use bypatients attending a regional cancer-care centre inToowoomba, Australia.

Methods: All English-speaking adult cancer patientsattending the cancer-care centre were invited to par-ticipate. Eligible patients were provided a self-administered questionnaire which was developedbased on a review of published surveys. Ethicsapproval was obtained.

Results: 142 patients completed the questionnaire and68% were currently or had previously used at leastone CAM. CAM users and non-users did not differsignificantly by region, age, gender, time since diag-nosis, income, town size, treatment intent or presenceof metastases. CAM users were more likely to have ahigher level of education. Approximately half ofrespondents used CAM concurrently with conven-tional treatment. The most common reason forCAM use was ‘‘to improve general physical well-being.’’ Family (31%) and friends (29%) were themost common sources of CAM information.Disclosure of CAM use to the General Practitioneror specialist was reported by 46 and 33% of patientsrespectively. The most common reason for non-disclosure was ‘‘doctor never asked.’’

Conclusion: This study supports previous researchthat CAM use is as common in regional andremote areas as metropolitan areas. Non-disclosureof CAM use to health professionals was common.

Future research should investigate strategies toimprove communication between patients andhealth professionals about the use of CAM.

2Incidence of hypersensitivity reactions withintravenous fosaprepitant dimeglumineat an outpatient cancer centreColleen Olson

Saskatoon Cancer Centre, Saskatoon, Canada

Objective: Evaluate the incidence of hypersensitivityreactions in patients receiving intravenous fosaprepi-tant dimeglumine as part of standard-of-care antie-metic regimens as per MASCC guidelines at ourinstitution in comparison to rates reported in clinicaltrials.

Methods: Hypersensitivity reactions in patientsreceiving intravenous fosaprepitant dimegluminefrom 20 November 2012 to 20 November 2013were included. Reactions were identified by nurses,physicians and pharmacists, and chart reviews werecompleted.

Results: During the specified time frame of one year,282 patients were treated with intravenous fosapre-pitant dimeglumine at our centre; with ten patients(3.5%) experiencing reactions. Seven patients (two atcycle 1; four at cycle 2 and one at cycle 3) had acutehypersensitivity reactions that began within minutesof fosaprepitant dimeglumine infusion start time andprior to the administration of any other pre-chemotherapy medications. Reactions included clas-sical hypersensitivity sequalae: shortness of breath,flushing and difficulty breathing. Symptoms comple-tely resolved in all patients following administrationof intravenous diphenhydramine, hydrocortisoneand oxygen. None were re-challenged. Three patientshad reactions that were delayed (days later) and con-sisted of rash; these patients continued to receivefosaprepitant dimeglumine at subsequent cycleswith no intensification of rash. All patient cases iden-tified were reported to Health Canada and themanufacturer.

J Oncol Pharm Practice

2014, Vol. 20 3(Supplement) 3–31

! The Author(s) 2014

Reprints and permissions:

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DOI: 10.1177/1078155214523700

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Conclusion: The occurrence of hypersensitivity reac-tions with intravenous fosaprepitant dimeglumine inthe literature is reported as isolated events (�1%).Our experience has been an incidence of hypersensi-tivity reactions occurring in 3.5% of patients.Vigilance in patient monitoring during infusion andreporting to national adverse reaction databases isrecommended.

3Activity and safety of single agent carfilzomibfor the treatment of relapsed and refractorymultiple myeloma (RRMM): results from4 phase 2 trialsDavid Siegel1, Thomas Martin2, Michael Wang3, Ravi Vij4,Andrzej Jakubowiak5, Sagar Lonial6, Suzanne Trudel7,Vishal Kukreti8, Nizar Bahlis9, Melissa Alsina10,Asher Chanan-Khan11, Francis Buadi12, Frederic Reu13,George Somlo14, A. Keith Stewart15, Edward Stadtmauer16,Beverly Harrison6, Ajay Nooka6, R. Donald Harvey6,Ruben Niesvizky17, Ashraf Badros18, Leanne McCulloch19,Kanya Rajangam20, Robert Orlowski20, Sundar Jagannath3

1John Theurer Cancer Center at Hackensack

University,Hackensack,USA, 2University of California at San

Francisco, San Francisco, CA, USA, 3The University of Texas MD

Anderson Cancer Center, Houston, TXUSA, 4Washington

University School of Medicine, St. Louis, MO, USA, 5University of

Chicago, Chicago, IL, USA, 6Winship Cancer Institute, Emory

University School of Medicine, Atlanta, GA, USA; 7University of

Toronto Princess Margaret Hospital, Toronto, Canada, 8Tom Baker

Cancer Centre, University of Calgary, Calgary, Canada, 9H. Lee

Moffitt Cancer Center, University of South Florida, Tampa, FL, USA,10Mayo Clinic, Jacksonville, FL, USA, 11Mayo Clinic, Rochester,

MN, USA, 12Taussig Cancer Center-Cleveland Clinic, Cleveland,

OH, USA, 13City of Hope National Medical Center, Duarte, SC,

USA, 14Mayo Clinic, Scottsdale, AZ, USA, 15University of

Pennsylvania Abramson Cancer Center, Philadelphia, PA, USA,16Multiple Myeloma Research Consortium, Norwalk, VA, USA,17Weill Cornell Medical College, New York, NY, USA,18Greenebaum Cancer Center, 19University of Maryland,

Baltimore, MS, USA, 20Onyx Pharmaceuticals, Inc., South San

Francisco, CA,USA

Objectives: Carfilzomib, a selective proteasomeinhibitor, is approved in the United States (US) assingle-agent treatment for RRMM patients. This isan efficacy analysis of the pivotal phase 2 study PX-171-003-A1 and a safety analysis of 4 phase 2 studies(PX-171-003-A0, PX-171-003-A1, PX-171-004, PX-171-005), data which supported US approval.

Methods: Single-agent carfilzomib was administeredintravenously over 2–10 minutes at starting and

target doses of 20 and 27 mg/m2 in 28-day cyclesfor all studies except PX-171-005 (15–27 mg/m2).The primary efficacy end point of PX-171-003-A1was overall response rate (ORR). Adverse events(AEs) were graded by Common TerminologyCriteria for Adverse Events v3.0.

Results: Patients in PX-171-003-A1 (N¼ 266) wereheavily pretreated with a median of 5 prior regimens.The ORR was 22.9%, and median overall survivalwas 15.4 months. The safety population (N¼ 526)from the 4 studies had a median of 4 prior therapies.Patients discontinued carfilzomib owing to diseaseprogression (51.0%), AEs (14.8%), or other reasons(12.3%). Dose reductions due to AEs occurred in14.6% of patients. The most common grade �3AEs were thrombocytopenia (23.4%), anemia(22.4%), and lymphopenia (18.1%). New-onset per-ipheral neuropathy occurred infrequently (13.9%overall; 1.3% grade 3).

Conclusions: Single-agent carfilzomib producedrobust responses in heavily pretreated RRMMpatients. The safety profile was acceptable, withfew discontinuations or dose reductions. Efficacyand safety of single-agent carfilzomib in RRMM isbeing compared with low-dose corticosteroidsand optional cyclophosphamide in the randomizedphase 3 FOCUS study (NCT01302392), whichwill facilitate regulatory approval of carfilzomibex-US.

4Implementing CyBorD as first-line therapy fortransplant-eligible multiple myeloma patients: asingle-center preliminary comparisonDominic Duquette, Vincent Laroche

CHU de Quebec, Quebec, Canada

Objective: In 2009, we started to use CyBorD andgradually changed our first-line therapy from Vel-Dex to CyBorD based on published work fromPrincess Margaret Hospital in Toronto. Here, wedescribe the first 11 patients to have receivedCyBorD and compare them to an historical cohortfrom the same institution.

Methods: We conducted a retrospective review ofpatient’s charts and transplant database from2009/10/02 to 2013/04/19. We collected informa-tion on blood labs, cytogenetics, immunofixation,response rates, adverse events and graftcollection.

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Results: All patients (100%) in both cohorts receivedan ASCT (CyBorD, n¼ 11 and Vel-Dex, n¼ 11).The response rates pre ASCT were CR¼ 18%,>VGPR¼ 91% compared to CR¼ 0%, >VGPR¼81.8% in CyBorD and Vel-Dex patients respect-ively. Response rates at 100 days post-ASCT wasCR¼ 60%, >VGPR¼ 100% compared to CR¼36.4%, >VGPR¼ 90.9% in CyBorD and Vel-Dexpatients respectively. Patients in CyBorD had amedian of 1 (1-2) day for graft collection and amedian number of graft cells of 5.01 x 109 (2.06-6.48) compared to 1 (1-2) and 4.46 x 109 (3-6.82)in the Vel-Dex group. The rate of grade 3/4thrombocytopenia was 0 %(n¼ 0) vs 9 %(n¼ 1) inCyborD and Vel-Dex patients respectively.

Conclusion: CyBorD is an effective and safe induc-tion regimen for first-line therapy in ASCT eligiblemultiple myeloma patients. It produces less neur-opathy and has an easier schedule to administer. Itis now our standard protocol.

5The management of skin toxicity duringcetuximab treatment in metastatic colorectalcancerElisa Marletta, Daniela Spadaro, Sandra Guzzardi,Debora Sgarlata

ASP Sisacusa - P.O. Umberto I, Italy, Siracusa, Italy

Objective: The major side effect associated withcetuximab treatment is skin toxicity, including skinrash, dry skin, hair growth disorders, pruritus, andnail changes. Preclinical evidence suggested thattopically-applied vitamin K can reactivate EGFRsignaling in the skin after systemic administrationof EGFR-targeted anti-cancer agents and that theprophylactic use prevents and reduces the skintoxicity.

Methods: At each chemotherapy treatment, allpatients received a cream containing urea and0.1% vitamin K1 and instructions for proper use(twice-daily topical application on face and chest).All patients also receive an educational brochurecontaining general preventive indications: use of sun-screen, avoid products as alcohol-based cosmetics,moisturize skin, avoid tight shoes, and prevent thegrowth of the beard with the regular use of razor,creams emollient pre-shave and after-shave.

Results: Since September 2012, we collected a total of14 patients treated with cetuximab; peak dermal

toxicity is observed around the 3rd week of treat-ment in a percentage 70% (2nd degree / moderaterush). The application of the cream and preventiveindications is associated with gradual reduction oftoxicity (1st degree); the adherence to topical treat-ment is high. No patient was treated with antibioticcreams and for no patient was discontinued therapy.80% of patients report relief from pain and signifi-cant reduction of itching.

Conclusion: Preventive information and applica-tion of the cream have obtained a noticeableimprovement health-related quality of life andoutcomes.

6Role of pharmacist in preventing prescribingerrors of total parenteral nutrition in cancerpatientsGul Ambreen, Farhat Zaheer

Aga Khan University Hospital, Karachi, Pakistan

Objective: Total Parental nutrition is often requiredin cancer patients either as an interim way to managenutritional needs or as the only resort in terminallyill cancer patients. TPN is a high risk product. TheObjective: of this study was to analyze the impact ofpharmacist interventions in minimizing and ensuringsafe prescribing of TPN in terminally ill cancerpatients.

Methods: Pharmacist reviewed 1500 TPN orders pre-scribed during last six months period [April-September, 2013]. Interventions were made forcorrect dose, formulation, addition/deletion of elec-trolytes, dose adjustment and possible interactionsafter reviewing laboratory parameters and patientprofile. All the recommendations by pharmacistwere documented in computerized physician orderentry (CPOE) system as Pharmacist’s interventions.

Results: During study period 1500 TPN were pre-scribed for terminally ill patients and 579 interven-tions were documented, out of which 19 % for renaldose adjustment of amino acids, 18% fat adjust-ments according to LFTs, 17% on volume adjust-ment, 12% on electrolyte/trace elementsadjustments according to serum levels, 12% forwrong calculations, 8% neutralization of TPN, 7%related to caloric requirements, 5% on relevantlaboratory tests required and 2% related to wrongpatient selection. Over all 38 % TPN intervened bypharmacist in study period.

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Conclusions: Pharmacist can play a major role inintercepting and acting on possible prescribingerrors thus ensuring safe, Cost effective and rationalTPN therapy.

7A Phase II single-arm study of aprepitant asanti-emetic prophylaxis in patients receivinginduction chemotherapy for AMLJack Seki, Joseph Brandwein, Karen Yee, Andre Schuh,Vikas Gupta, Mark Minden

University Health Network–Princess Margaret Hospital, Toronto,

Canada

Objective: Patients receiving a 5-HT3 antagonist asanti-emetic prophylaxis during AML inductionchemotherapy continue to experience nauseaand vomiting requiring additional therapy.

Methods: AML patients undergoing induction ther-apy with daunorubicin+cytarabine (3+7) receivedgranisetron or ondansetron prophylaxis on the 3daunorubicin dosing days, along with aprepitant125 mg PO on Day 1 followed by 80 mg PO dailyon Days 2-5. No corticosteroids were used.Additional anti-emetic therapy was given asneeded. Results were compared to a retrospectivecohort of 40 patients who received the same treat-ment, but without aprepitant.

Results: This interim analysis evaluated 27 patientsreceiving aprepitant. By the end of Day 5, 3/27patients (11%) had experienced at least one episodeof vomiting, while by the end of Day 8 four add-itional patients had experienced vomiting, for acumulative incidence of 26%. In comparison, thecumulative incidence of vomiting by the end ofDay 5 in the retrospective cohort was 50% (20/40),and 53% by Day 8. The proportion of patientsexperiencing vomiting was below 8% per day onaprepitant dosing days, but increased to 11% onDay 6. The cumulative incidence of nausea and/orvomiting in the aprepitant group was 52% by theend of Day 5 and 60% at the end of Day 8, com-pared to 78% at both time points in the retrospectivecohort. There were no toxicities attributable toaprepitant.

Conclusion: Aprepitant was highly effective, whencombined with a 5-HT3 antagonist, in preventingvomiting, but less effective in controlling nausea.

8Prophylactic oral minocycline for EGFRi inducedskin rash in patients with non-small cell lungcancerJimmy Cote1, Pierre-Yves Gagnon1, Jean-Francois Tessier2,Benoit Drolet1

1Institut Universitaire de Cardiologie et de Pneumologie de Quebec,

Quebec City, Canada, 2CSSS La Pommeraie, Hopital Brome-

Missisquoi-Perkins, Quebec City, Canada

Objective: The primary endpoint was to evaluate theefficacy of oral minocycline once daily to reduce orprevent epidermal growth factor receptor inhibitor(EGFRi)-induced skin rash at 1 month in non-small cell lung cancer patients. An exploratory end-point was to compare the occurrence of rash at 1month between this study and a previous one con-ducted in the same oncology center.

Methods: Non-small cell lung cancer patients whoinitiated an EGRFi and used minocycline 100 mgonce daily starting the day before for a four toeight weeks treatment were included. Efficacy ofminocycline was evaluated prospectively with a stan-dardized approach by oncology nurses. The data wascollected retrospectively.

Results: Forty-nine patients were screened. Thirtypatients were included according to inclusion cri-teria. Twenty-nine patients used erlotinib and onlyone used gefitinib. Overall, fourteen patients (46.6%)had a rash (all grades included). Four patients(13.3%) had moderate toxicity and none had severetoxicity. The occurrence of rash with once dailyminocycline was comparable with minocyclinetwice daily in the previous study (54.5%).

Conclusion: In this retrospective analysis, minocyc-line at 100 mg once daily decreased the global inci-dence of EGFRi-related rash, including severe rash.The results are consistent with previous data using ahigher daily dose of minocycline. Higher doses don’tseem to increase efficacy of minocycline notably.

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9Cancer in older patients – the polypharmacydomain examinedJude Lees1, Justin Turner2, Nimit Singhal1, Robert Prowse1,Jonathon Hogan-Doran1, Simon Bell3, Sepehr Shakib1

1Royal Adelaide Hospital, Adelaide, Australia, 2University of SA,

Adelaide, Australia, 3Monash University, Adelaide, Australia

Objective: To investigate the prevalence and factorsassociated with polypharmacy in older cancerpatients in an outpatient setting.

Methods: Patients aged �70 years referred to oncol-ogy over 19 months completed a self-administeredscreening questionnaire reviewed during a weeklygeriatric oncology multi-disciplinary team meeting.Comorbidities and prescribed, over the counter andComplementary and Alternative medications wererecorded as well as instrumental activities of dailyliving, performance status, physical function, painscore, weight loss, exhaustion and distress.

Results: Questionnaires including medication datawere returned by 385 patients. Their average age was76.0 years (SD4.8, range 70 to 92) and 59%weremale.The average number of medications was 5.7 (SD 3.7,range zero to 20) with 57% taking �5 medications.Most common were antihypertensives, analgesics,antithrombotics, lipid-lowering agents, acid suppres-sants, and vitamins. Polypharmacy was associatedwith being vulnerable (OR 2.35; 95%CI 1.23-3.86)and frail (OR 4.48; 95%CI 1.90-10.54) compared tobeing fit. When adjusting for age, gender, exhaustion,KPS, IADLs, pain and distress, polypharmacy wasassociated with higher Charlson Comorbidity Indexscores (OR 1.58; 95%CI 1.29-1.94) and poorer phys-ical function (OR 1.13; 95%CI 1.06-1.20).

Conclusions: Future studies should identify whichmedications might be suitable for rationalization.Strategies should be examined for de-prescribing, incollaboration with the patient and their treating team.

10Prevalence of augmented renal clearance inhaematological patients and the impact onvancomycin dosingKaren Vermis, Eva Steel, Johan Vandenbroucke

Ghent University Hospital, Gent, Belgium

Objective: This study investigates the prevalence ofaugmented renal clearance (ARC) in a hematologicalpopulation and evaluates the correlation between

this higher clearance and increased vancomycindosing.

Method: A retrospective study in patients withhaematological malignancies treated with vanco-mycin (continuous infusion: loading 15 mg/kg, main-tenance 30 mg/kg) in a tertiary care hospital.Creatinine clearance was estimated using theCockcroft-Gault formula and was considered as aug-mented when exceeding 120 mL/min. Vancomycindoses were retrieved from the CPOE.

Results: In total 112 vancomycin treatment courses(VTC) (96 patients) were evaluated. Treatment wasempirically in 67 VTC with 72 % of the patientsbeing neutropenic. ARC, with a duration rangingfrom 1 to 100 % within a VTC, was observed in 73VTC with an average renal clearance of 147.0 mL/min versus 79.0 mL/min. Statistical analysis revealeda significant relationship between ARC and age,AML, neutropenia and chemotherapy. Therapeuticvancomycin levels (20 mg/mL) were obtained on day5 (median) with an average vancomycin maintenancedose of 41.7 mg/kg/day when ARC was presentversus 32.7 mg/kg /day on day 3.

Conclusion: Within the study population youngerpatients, patients with AML, neutropenia or chemo-therapy treatment were at risk for ARC, resultingfrequently in sub-therapeutic vancomycin levels,not only on the first days of therapy, but alsoduring. Hence, regular monitoring of the serum con-centration and subsequent dose adjustment is neces-sary. A new dosing schedule with an increasedloading (25 mg/kg) and maintenance dose relatedto the renal clearance (90-130mL/min: 35 mg/kg;>130mL/min: 40 mg/kg) was implemented.

11Palonosetron as a rescue strategy for CINVfollowing failure with standard of careantiemetic regimensKathy Gesy

Saskatchewan Cancer Agency, Saskatoon, Canada

Objective: Improve antiemetic control in patientsreceiving chemotherapy at our cancer centre. Weproposed a serotonin antagonist switching strategy,oral palonosetron for oral ondansetron, be used as arescue strategy for any patient, on any chemotherapyregimen, who failed to achieve control of nauseaand/or vomiting (N/V) following standard of careantiemetic regimens.

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Method: Patients were provided with a PatientSymptom Diary on which they self-reported any epi-sodes of N/V. If a patient failed to achieve control ofN/V (defined as any episode of vomiting or pro-longed nausea), oral palonosetron was substitutedfor oral ondansetron with the next cycle of chemo-therapy. All other antiemetics as used in the previouscycle remained the same. Patients were asked toagain self-report on the diary for outcomes withthe palonosetron substitution.

Results: Fifty one patients were switched to palono-setron from September 2012 – July 2013. Failedregimens included both highly and moderately eme-togenic chemotherapy (HEC and MEC). Of the fiftyone patients who received rescue with palonosetron,44 (86%) self-reported improvement in N/V andcontinued on to further cycles of chemotherapywith the palonosetron and no further changesrequired; 7 (14%) patients continued to experienceN/V with little or no improvement and required fur-ther changes in antiemetic regimens for subsequentchemotherapy cycles.

Conclusions: Our experience demonstrates thatpatients, who experience N/V with ondansetron,could be offered cross-over to palonosetron forfuture chemotherapy cycles with success. Failurewith one oral serotonin antagonist did not necessar-ily lead to a class or route ineffectiveness.

12The oncology pharmacist’s role in smokingcessationKristi Hofer, Anahita Dehmoobed, Horst Wuerfel

CancerCare Manitoba, Winnipeg, Canada

Objective: Smoking cessation is a cost-effective strat-egy in cancer prevention. Additionally, there is evi-dence that patients benefit from quitting smokingeven after a cancer diagnosis. Oncology patientshave unique needs and considerations when quitting.CancerCare Manitoba launched a new smoking ces-sation program to address these issues. Pharmacistsare well resourced to encourage patients to quit, aswell as coaching those who are in the process ofquitting.

Methods: The Quit Smoking Program at CancerCareManitoba is a free program open to patients, staffand their family members. It provides individualcounselling, follow-up and free smoking cessationmedications (including nicotine replacement therapy,

bupropion and varenicline). Counselling, quit plan-ning and follow-up are provided by the multi-disciplinary team. Medications are dispensed atCancerCare Manitoba pharmacy. Pharmacistsassist with choosing appropriate cessation medica-tions, taking into consideration the complex medicalneeds and drug therapy of oncology patients.Pharmacists are involved in medication teachingand follow-up. Follow-up is done through a combin-ation of clinic visits and personal phone calls.

Results: Since the program was initiated in 2012,over 200 participants have accessed the program.The majority of participants have used pharmaco-logical treatments. A positive impact is seen byhigh quit rates> 30% and another 20% of partici-pants reducing tobacco use.

Conclusion: This program has been effective in help-ing patients quit and reduce their tobacco use. Thepersonalized approach, the oncology expertise ofcessation team, the convenient location (in thecancer centre) has provided a unique and effectiveservice to cancer patients. Pharmacists are well pos-itioned to provide cessation counselling and follow-up through involvement in oncology clinics as well isin the dispensary.

13Implementation of an oral cancer therapymonitoring program in a genitourinaryoncology clinicLisa Holle1, Jessica Clement2

1University of Connecticut, School of Pharmacy, Storrs, CT

United States, 2UCONN Health Center, Farmington, CT,

United States

Objective: Oral cancer therapies are now routine intreatment of castrate-resistant prostate and meta-static renal cancer, but require supervision of com-pliance and monitoring for toxicity and druginteractions. The Objective: of this project was tocharacterize the implementation of an oral cancertherapy monitoring program.

Methods: An oral cancer therapy monitoring pro-gram was initiated and staffed by a board certifiedoncology pharmacist, working in collaboration witha medical oncologist. The pharmacist provided oralcancer therapy education, completed medicationtherapy management; monitored for adherence andtoxicity; and recommended treatment of toxicity andrelated supportive care issues. Patient encounters

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included shared clinic visits in collaboration withmedical oncologist visit, clinic visit with pharmacistalone, and telephone or email follow-up betweenvisits.

Results: From December 2012-October 2013, thepharmacist had 68 encounters with prostate(n¼ 64) and renal cancer patients (n¼ 4). Mostwere clinic visit encounters in collaboration withphysician visit or alone (58%); 36% were telephoneencounters, and 17% were recommendations basedon surveillance laboratory results. Compliance andtoxicity was assessed in 63% of encounters; non-adherence was found and addressed in 30%.Cancer therapy education was provided in 30% ofencounters; other medication teaching in 17%.Medication-related problems (MRPs; cancer andother therapies) were identified and addressed in45% of encounters. Other services included provid-ing assistance with coverage for high-cost drugs anddisposal of unused drugs.

Conclusion: A pharmacist-initiated oral cancer ther-apy monitoring program resulted in identificationand resolution of noncompliance and MRPs,demonstrating the benefit of the pharmacist in themultidisciplinary team.

14Explorative study to evaluate neuropathyinduced by oxaliplatin in subjects with colorectalcancer at the CHUSMarie-Pierre Rousseau, Roxanne Dault,Marc-Andre Frenette, Annie Beaudoin, Julie Leblond,Frederic Lemay, Marie-France Beauchesne

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke,

Canada

Objective: To describe the proportion of subjectswith colorectal cancer (CRC) treated with oxalipla-tin who report neuropathies at the CHUS.Secondary Objectives were to describe the meancumulative dose of oxaliplatin, the mean number ofcycles, the mean number of dosage reduction andtreatment interruptions because of neuropathies,and co-morbidities/concomitant medications thatmay influence neuropathic pain.

Methods: Prospective cohort study to characterizethe occurrence of grade 1, 2, 3, or 4 neuropathies,according to the NCI\CTC version 4 criteria.Prospective follow-up was completed every 2 weeksuntil cessation of treatment and at 12 months.

Results: Fifty-three patients were included and com-pleted 12 months of follow-up. Subjects had a meanage of 63.6, and 22 (41.5%) were females. Fifty-one(96.2%) were prescribed the ‘‘Folfox’’ and 2 (3.5%)‘‘The Xelox’’ regimen. Eight (15.1%) had chronicpain, 1 (1.9%) rheumatoid arthritis, and 6 (11.3%)diabetes. The proportions of subjects who reportedhaving grade 1-2 and grade 3-4 neuropathies were of40 (75.5%), and 10 (18.9%), respectively. The meancumulative dose of oxaliplatin and the mean numberof cycles received was of 688.5 mg/m2 and 8.3 inpatients who had grade 1-2 neuropathies and 664.0mg/m2 and 8.3 for grade 3-4 neuropathies.Treatment was interrupted in 10 cases because ofneuropathies and the dose of oxaliplatin was reduced17 times because of neuropathies. Twenty-four sub-jects received a medication that could have influ-enced neuropathic pain during follow-up.

Conclusions: A significant number of subjects onoxaliplatin have neuropathies which influences thetreatment of CRC.

15Artocarpin induces apoptosis in A549 non-smallcell lung carcinoma via MAPK signaling pathway/p53/NF-iB dependent pathwaysMing Horng Tsai

Chang Gung Memorial Hospital, Houston, United States

Objective: Artocarpin, a prenylated flavonoid iso-lated from a medicinal herb Artocarpus communishas been shown to induce apoptosis in variouscancer cells and suppress growth of human cancerxenografts in vivo. We aimed to examine the roleof mitogen-activated protein kinases (MAPKs) inhuman non-small cell lung carcinoma (NSCLC)apoptosis induced by Artocarpin.

Methods: We detected the effects of Artocarpin onNSCLC A549 cell line. A cell proliferation assay wasused for measuring cell number. Apoptosis assay fordetecting apoptosis and necrosis, and immunoblot-ting for protein detection were used, respectively.

Results: Artocarpin induced rapid generation ofintracellular ROS and significantly inhibitedgrowth of the A549 cells. Western blotting analysisalso demonstrated that Artocarpin increased pro-tein level of ERK, Akt and p38 and activated cyto-chrome c release from mitochondria depended onROS generation. Inhibition of ERK, AKT and p38through using pharmacologic inhibitor, significantly

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abolished apoptosis induced by Artocarpin.Moreover, treatment with antioxidants effectivelydiminished induced hydrogen peroxides productionand p53 activation. These observations imply thatArtocarpin mediated hydrogen peroxide formationacts as an initiator of MAPK signaling pathways,leading to p53 activation and apoptosis in A549cells. In addition, Artocarpin cause more efficientactivation of NF-kB transcriptional activity and sub-sequent p65 nuclear translocation. Furthermore, theROS generation is required for Artocarpin inducedapoptosis in NSCLC A549 with the cleavage of poly(ADP-ribose) polymerase (PARP).

Conclusion: These results suggest that ROS acts asa mediator in Artocarpin induced apoptosis viaMAPK signaling pathway/p53/NF-kB dependentpathways.

16Developing competency through webinar toestablish oncology pharmacy services at the AgaKhan Hospital, Dar-es-Salaam, TanzaniaNadia Ayoub, Abdul Latif Sheikh, Salwa Ahsan,Farhat Zaheer

Aga Khan University Hospital, Karachi, Pakistan

Objective: Implementing new services in a hospitalis a big challenge for any organization. Our aimwas to train the Tanzania colleagues through dis-tance learning so that they can develop an excellentoncology pharmacy services at Dar-us-SalamHospital.

Methods: The oncology Pharmacy team experts ofAga Khan University Hospital Pakistan developeda training program for a multidisciplinary team ofpharmacist, pharmacy technician, biomedical staff,nursing and doctor. The training program was com-prised of 6 modules, each approximately an hourlong. The sessions were delivered through webinarsby our specialized Oncology pharmacist. The train-ing sessions were followed by quizzes for trainingevaluation. These modules were exclusive reflectionof ISOPP & USP standards. Our topics of discussionincluded overview of oncology pharmacy, facilitiesfor sterile cytotoxic clean room and personnel pro-tective equipment, verification of chemotherapy pre-scription, safe handling of hazardous drugs, cleaningand spill management. One extra video basedWebEx meeting was conducted for CPOE demon-stration. Comfort level of staff was assessed throughPost evaluation form.

Results: 12-15 Multidisciplinary staff participated inwebinar meetings. These sessions helped buildproper infrastructure of oncology pharmacy at theTanzania Hospital. Participants scored above 90%in the quizzes indicating significant understanding ofthe subject and improvement of their knowledge.

Conclusion: Our experience shows Webinarmeetings is an effective method/way for the develop-ment of new setup in an organization. Distancelearning is a good opportunity for professionaldevelopment of staff. Future effort is to providehands on training for fully establishment of oncologysetup.

17Validation of chemotherapy regimen by clinicaloncology pharmacist and its impact on directpatient careNadia Ayoub, Saira Abro, Muneeba Akram, Latif Sheikh,Salwa Ahsan

Aga Khan University Hospital, Karachi, Pakistan

Objective: Our primary aim is to analyze the role aclinical pharmacist plays in preventing errors inchemotherapy regimen. This study explored the clin-ical interventions made by pharmacists in dispensingof chemotherapy doses, and evaluated pharmacist’scontribution to patient care.

Method: The documented data of interventions inCPOE was collected from January 01, 2013 tillSeptember 30, 2013. The prescriptions were thenanalyzed and each intervention was grouped intoeither ‘‘Highly Significant’’ or ‘‘Significant’’ on thebasis of their clinical importance. Highly Significantinterventions included wrong route, wrong dose,wrong frequency and duration of chemotherapy.On the other hand less significant interventionswere comprised of wrong infusion rate, wrong dilu-ents, inappropriate supportive care and druginteractions.

Results: During the study period 231 clinical phar-macy interventions were made. Out of the 231 inter-ventions 147(63.6%) were recorded as ‘‘Highlysignificant’’ and 84 were (36.3%) ‘‘Significant’’.

Conclusion: Clinical interventions made by pharma-cists had a significant impact on patient care.Clinical oncology pharmacist plays a vital role inreducing medication error and any life threateningconsequences. The integration of pharmacist’s

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technical and clinical roles into dispensing of chemo-therapy doses is required for providing high-qualitycancer services and optimum patient care.

18Role of pharmacy staff in reducing chances oflost to follow up and improving adherence henceachieving chemotherapeutic goals in KenyaPaul Wasike

Kenya

Objective: A good fraction of cancer patients in aresource limited setting get lost to follow up. A retro-spective single institution cohort study was done toanalyze their reason for lost to follow up and definethe role of the pharmacy staff in reducing thechances of lost to and achieving compliance andadherence.

Methods: This was a retrospective study using med-ical records that were in the clinic. Eligible patientswere those who had been classified as lost to followup. 200 patients were traced through cell phone anda questionnaire was used to analyze their main rea-sons for lost to follow to up. The patients were seenin the clinic between the years 2010-2013.

Results: Number of patients Reflected percentageReason for lost to follow up 65 (32.5%)Chemotherapy side effects 52 (26%) Switched toalternative medication 28 (14%) Died 20 10% Dueto palliative chemotherapy 20 (10%) Misinformedon prognosis 15 (7.5%) Due to cost

Conclusion: All the patients who had been brandedlost to follow up had at one time or another receivedchemotherapy which was probably prescribed by adoctor and dispensed by the pharmacy staff so thepharmacy staff apart from dispensing needs toundertake the following responsibilities. The phar-macy staff is usually the last contact before thepatient heads home and as such they can do morein prevention of lost to follow up. Interventions suchas patient education, cell phone follow, and routineadherence monitoring can be initiated to minimizethe lost to follow up cases. Ensure that the chemo-therapy consent form is signed and that the patientunderstands it fully.

19Novel immunotherapeutics and concurrent CYPsubstrate use in advanced cancerR. Donald Harvey

Winship Cancer Institute of Emory University, Avondale Estates,

GA, United States

Objective: Novel anticancer agents that enhanceimmune function (e.g., ipilimumab, PD-1 pathwayactivators) may also impair CYP-mediated drugclearance through increasing cytokines such as IL-6following T cell activation. We investigated theprevalence of CYP substrate use and detectableadverse events (AEs) in a population of patients inthe clinic and on early phase trials.

Methods: Reports were generated of ipilimumab,PD-1, and/or PD-L1 antagonists given alone or incombination. Patient records were reviewed fordemographics; response; immunotherapy agent anddose; AEs of immunotherapy; and concurrent CYPsubstrates before, during, and after treatment forrelevant laboratory values and recorded subjectiveAEs potentially attributable to the CYP substrate.Patients were included in the analysis if they receivedmore than one infusion of immunotherapy.

Results: Nineteen patients received 20 courses oftherapy, with 3 excluded due to limited immunother-apy. The overall response rate was 15%, with onepatient discontinued due to toxicity (2 doses) andone lost to follow-up. AEs due to immunotherapyor concurrent CYP substrates were rarely seen/docu-mented. One patient developed gr 2 diarrhea fromipilimumab, another developed lab-only hypophysi-tis. The total number of concurrent CYP substratesin the population was 41, with a median of 2 (0-4)per patient. The majority 16/41 (39%) were cardio-vascular, with centrally acting agents (e.g., anti-depressants, anxiolytics) accounting for 12/41(29%). One patient on warfarin required a reductionfrom 42.5 mg/wk (INR 1.3) to 25 mg/wk (INR 3.1)on ipilimumab.

Conclusion: CYP substrate use is common in patientsreceiving novel immunotherapeutics. AEs potentiallydue to decreased clearance of CYP substrates wasrare in this series, however, documentation of sub-jective AEs and vital signs was lower than expected.Additional investigation in a larger cohort ofpatients receiving single and combination agents iswarranted.

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20BC Cancer Agency education program foroncology pharmacistsRhonda Kalyn, Lynne Nakashima

BC Cancer Agency, Kelowna, Canada

Objective: To develop an online, self-directed educa-tion curriculum that integrates the unique perspec-tive of oncology practice in British Columbia toequip pharmacists with broad oncology knowledgeto confidently provide care to cancer patients. Thisprogram addresses the unmet needs identified in a2009 Canadian Oncology Pharmacy EducationalNeeds Survey.

Methods: The BCCA Clinical Oncology ResourceEducators in Pharmacy (CORE-Rx) Team overseesthe following components of the program curricu-lum design and implementation: � Scope, curriculumtopics, and method of delivery � Module develop-ment, including writing, editing, expert review, andpilot testing � Program delivery � Biannual review ofcurriculum based on learners’ feedback CORE-Rxappointed two representatives to assume programcoordination and editorial responsibilities. Eachlearning module is developed by a BCCA pharma-cist, and reviewed by two experts and one educationexpert. Completed modules are pilot tested by asmall group of pharmacists prior to full implemen-tation on the BCCA website.

Results: A curriculum consisting of approximately 50modules is planned to be developed and imple-mented between January 2012 and July 2016. Theprogram also incorporates the Oncology Basics edu-cation module developed by CAPhO. The curricu-lum is divided into two levels: Level 1 – coreclinical practice for pharmacists new to oncology;Level 2 – advanced clinical practice for experiencedoncology pharmacists. Seven modules in the Level1 curriculum have been successfully implementedto date.

Conclusion: The BCCA Pharmacist EducationProgram curriculum is being developed to meet theunmet educational needs identified by oncologypharmacists in British Columbia.

21Pharmacist-led monitoring program for patientson sunitinib for metastatic renal-cell carcinoma:A Canadian experienceScott Edwards

Dr. H. Bliss Murphy Cancer Clinic, St. John’s, Canada

Objective: Sunitinib is a standard of care for first-linetreatment of metastatic clear cell renal cell carcinoma(mRCC). With the rapid rise in the use of Sunitiniband other oral cancer agents, we instituted a phar-macist-led monitoring program in the ambulatorycare setting to prospectively document, monitor,and manage toxicities in our province. We reportthe results of this program with regards to thesafety and efficacy in patients on Sunitinib formRCC.

Methods: The pharmacist-led monitoring program inNewfoundland and Labrador consisted of patientassessments in clinic with the oncology team com-bined with a call back program on day 14 of eachtreatment cycle. A chart review of consecutivepatients who were prospectively monitored by thisprogram was conducted for the first six cycles oftherapy. A standardized data collection spreadsheetwas used to obtain the following information:number of dose reductions, therapy delays, therapydiscontinuation and time to treatment failure (TTF);occurrence and severity (NCI CTCAE V4.0) ofnausea, vomiting, palmar-plantar erythrodysesthesia(PPE), mucositis, diarrhea, hypertension, hypothy-roidism, and thrombocytopenia.

Results: Fifty six patients are included in the studycohort. Nausea, diarrhea and PPE were the mostcommon toxicities reported over a six-cycle period.Antihypertensive therapy and thyroid hormone sup-plementation was required for fifteen and twopatients, respectively. There were a total of 39 dosereductions in this patient population and 45 patientsdiscontinued therapy with a TTF of 9.72 months.

Conclusions: Pharmacist-Led monitoring of oralcancer therapies is a practical and feasible methodof monitoring patients on Sunitinib for mRCC. Thepharmacy team was able to document toxicities andoffer management suggestions such as anti-hypertensives, anti-nauseants, anti-diarrheals andtherapy for PPE and mucositis management. Thesuccess has led to its implementation with otheragents a (abstract submission truncated because itexceeded the word limit).

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22Survey of pharmacists’ involvement in cancertreatment and rates of improper regimens incancer core hospitals and general hospitalsShinya Suzuki1, Hiroomi Sakurai2, Kenji Kawasumi1,Keishiro Izumi3, Shinichiro Saito1, Kazushi Endo4

1National Cancer Center Hospital East, Kashiwa, Japan, 2Keio

University Hospital, Kashiwa, Japan, 3National Center for Global

Health and Medicine Center Hospital, Kashiwa, Japan, 4Meiji

Pharmaceutical University, Kashiwa, Japan

Objective: The role of pharmacists in clinical oncol-ogy has grown every year. However, pharmacists’involvement in cancer care has not been revealedon a nationwide scale yet.

Methods: The subjects were 388 cancer medicinecooperation base hospitals (core hospitals) and 984randomly selected general hospitals. The question-naire was conducted for the regimen regarding 13different regimens that treat 5 different majorforms of cancer (breast, colorectal, gastric, liver,and lung cancer) in Japan.

Results: The recovery rate was 70% (274/388) at thecore hospitals and 43% (428/984) at the generalhospitals. The core hospitals had more oncologistsand pharmacists who had professional qualifica-tions. Percentage of facilities that checked chemo-therapy regimens in inpatient and in outpatientinfusion by pharmacists were 98% (270/274) and99% (272/274) at the core hospitals and 99%(425/428) and 98% (420/428) at the general hos-pitals, respectively. Percentage of facilities thatpharmacists checked oral chemotherapy regimensin prescriptions in hospitals or out of hospitalswas 55% (153/274) and 10% (30/274) at the corehospitals and 67% (286/428) and 17% (74/428) atthe general hospitals, respectively. Of the 13 differ-ent regimens, the cases of using improper doses orintervals of drug administration were 40% at thecore hospitals and 52% at the general hospitals.The median number of cases was 1 (range 0-15)in the core hospitals and 1 (range 0-22) in the gen-eral hospitals.

Conclusions: The results revealed that pharmacists’interventions to check chemotherapy regimens andrates of improper regimens were not significantly dif-ferent between the core hospitals and the generalhospitals. However, there was only 50% regimencheck rate in oral chemotherapy, and the rate waslower in outpatient chemotherapy (10%) in bothhospitals.

23Assessment of the feasibility of a pharmacy-ledanemia monitoring program for gastric cancerpatients in an ambulatory settingSoha Ahrari, Mark Pasetka, Karthi Chandrakumaran,Alyssa Truong, Noreen Jamal, Angie Giotis, Carlo De Angelis

Sunnybrook Health Sciences Centre, Toronto, Canada

Objective: Anemia is undertreated in the cancerpopulation and is associated with a worse prognosis.The primary objective of this study was to assess thefeasibility of a pharmacy-led anemia monitoring pro-gram (PLAMP) in the outpatient oncology setting.

Methods: This was a prospective observational studyconducted in a large ambulatory cancer centre fromFebruary to November 2013. Gastric cancer patientsreceiving active treatment were identified andapproached by the PLAMP. Pre-specified laboratorytests were ordered upon enrollment and approximatelyevery 4-6weeks during treatment.Additionally, patientscompleted two validated questionnaires regularly whileenrolled. Patient laboratory results were regularlyreviewed by a clinical pharmacist and, when required,interventions were recommended.

Results: Seventy five percent (25/33) of all patientsapproached consented to take part in PLAMP overa six month period. The clinical pharmacist spent amean of 3.7 minutes per patient per week reviewingpatient results. Recommendations made by thePLAMP were accepted by patients 82.4% (14/17) ofthe time, and by physicians 100% (14/14) of the time.All laboratory test requests made by the pharmacyteam were accepted by oncologists at this institution.

Conclusion: The minimal amount of evaluation timeby a clinical pharmacist and the high degree of inter-vention acceptance by oncologists and patients sug-gests a PLAMP is a feasible initiative. Further resultsare pending.

24Combination cabazitaxel plus filgrastim intreating patients with metastatic castration-resistant prostate cancerStanislav Synek

Hospital of St. Anne, Brno, Czech Republic

Objective: Semisynthetic taxane cabazitaxel isapproved chemotherapy agent for the second-linetreatment of metastatic castration resistant prostatecancer for patients who previously treated with a

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docetaxel-containing regimen. Common adverseevents with cabazitaxel include neutropenia (includingfebrile neutropenia), diarrhea, fatigue, and asthenia.Administration of filgrastim is beneficial for patientswith chemotherapy-induced febrile neutropenia.

Methods: A retrospective study of patients receivingcabazitaxel for metastatic castration resistant pros-tate cancer between March 2011 and November 2013at St. Anne hospital in Brno. Patient data wereaccessed through the hospital’s computer program(NIS HOSP). Filgrastim was administered subcuta-neously in a dose of 5 mcg/kg/day, 24, 48 and 72hours after administration of cabazitaxel.

Results: A total of 28 patients with a mean age of64.3 year (range: 56-84 year) and progressivemCRPC were included. Cabazitaxel at a dosage of25 mg/m2 intravenously every 3 week combined with10 mg of oral prednisone a day. Patients received amedian of 6 cabazitaxel cycles. Grade 3 or more neu-tropenia was common, occurring in 68.5% ofpatients. Neutropenic fever was reported in 0% ofthe patients. Grade 3/4 gastrointestinal toxicity(diarrhea) was identified in 7.5% of the patients.

Conclusion: Our analysis suggests that prophylaxiswith filgrastim may considerably reduce the inci-dence of febrile neutropenia in mCRPC patientstreated with cabazitaxel.

25Effectiveness of pharmaceutical care in reducingadverse eventsSulamta Miranda1, Betzabe Rubio1, Marcela Berrios2

1Universidad de Chile, Santiago, Chile, 2Hospital Barros Luco

Trudeau

Objective: To determine the effectiveness of pharma-ceutical care plan in addition to the usual manage-ment of patients undergoing chemotherapy, theaverage adverse events.

Methods: During August 2012 to April 2013 con-trolled sequential study in which two groups ofpatients, a control group receiving usual care pro-vided by the oncology team Barros Luco TrudeauHospital and involved group joined the enlisted wasperformed usual care received pharmaceutical careservice.

Results: Each group had 20 patients presented thecontrol group versus 120 146 adverse events in the

intervention group. Of which in the control group,127 were related to drugs versus 116 in the interven-tion group. The main category of problem related todrugs in both groups was security. The effectivenessof pharmaceutical care for decreased adverse eventsresulted in an OR of 3.07 (p¼ 0.265) and decrease ofDRPs in an OR of 1.82 (p¼ 0.821).

Conclusion: Pharmaceutical care allows the reductionof adverse events in cancer patients undergoingchemotherapy, however to define statistical powerrequires a larger ample size.

26Integration of a Clinical Support PharmacyTechnician into a Pediatric Hematology/Oncology/Transplant ClinicTara Leslie, Jennifer Jupp, Martha Nystrom

Alberta Children’s Hospital, Calgary, Canada

Objective: To describe and quantify the key activitiesperformed by a newly deployed Clinical SupportPharmacy Technician in a pediatric hematology,oncology, transplant clinic.

Methods: Alberta, Canada is implementing regula-tion for pharmacy technicians. With this change,there is an opportunity to expand the role of the tech-nician. A pilot project, involving the deployment of aClinical Support Pharmacy Technician (CSPT) to anambulatory pediatric hematology, oncology, trans-plant (HOT) clinic, was initiated. The CSPT wasmade consistently available and was provided withappropriate training including skills to accuratelyobtain thorough medication histories. A list of keyactivities was created encompassing those describedin the literature as well as tasks that are currentlybeing performed by other CSPTs within the province.The HOT clinic CSPT recorded the number of timeseach key activity was performed for four months.

Results: Over the data collection period, obtainingBest Possible Medication Histories (661), providingfollow up phone calls (53), coordinating with otherpharmacy providers to ensure seamless care (53), andreferring drug information questions to the pharma-cist (47) were the most commonly performed activ-ities. The development of standard adherence aidsand managing drug access issues were also notablecontributions.

Conclusion: The integration of a CSPT into an out-patient pediatric HOT clinic resulted in the provision

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of several services including consistent acquisition ofcomprehensive patient medication histories. Thedeployment of the CSPT may allow clinical pharma-cists more time for direct patient care and expandedclinical practice activities.

27Clinical pharmacy activities in apediatric hematopoietic stem celltransplantation unitTiene Bauters, Victoria Bordon, Johan Vandenbroucke,Catharina Dhooge, Yves Benoit, Genevieve Laureys

Ghent University Hospital, Ghent, Belgium

Objective: The number of pediatric hematopoieticstem cell transplantations (HSCT) has increasedover the last ten years. Advances in optimization oftransplantation techniques and supportive care prac-tices have improved long-term survival. Due to thecomplexity of drug therapy, pharmacists can have anadded-value in optimizing pharmacotherapy. As therole of the pharmacist in pediatric HSCT has notbeen extensively studied, this study aims to analyzepharmacist’s interventions in a pediatric HSCTsetting.

Methods: Retrospective analysis of interventionsperformed by a clinical pharmacist on all pedi-atric patients with hematopoietic stem celltransplantation.

Results: During 115 non-consecutive days, 294drug-related problems were observed in 35 patients.In the pre-transplant period (day -10 till day -1) 50interventions (17.1%) were performed and 244(82.9%) were observed in post-transplant period(day 0 till day+100). They included drug-druginteractions (50.4%), check of conditioning regi-mens (11.9%), therapeutic drug monitoring(10.6%), improper drug administration (7.8%),sub-therapeutic dosages (5.4%), adverse drugevents (5.1%), clarification of prescriptions(2.7%), untreated indications (2.7%), provision ofspecific products (2.0%) and determination of drugsused without indication or with non-conformity tohospital guidelines (1.4%). Drugs involved (n¼ 480)were classified according to the AnatomicalTherapeutical Chemical classification and mainlyincluded anti-infectives for systemic use (41.9%),antineoplastic and immunomodulating agents(22.5%), drugs for the alimentary tract and metab-olism (14.4%), central nervous system (6.0%) andsystemic hormonal preparations (5.8%).

Conclusion: Given the complexity of drug regi-mens in pediatric HSCT, the pharmacotherapyof transplanted patients’ needs to be followed clo-sely, especially in the post-transplant period. Apharmacist on the ward can contribute to achievethis goal.

28Use of rasburicase in prevention and treatmentof tumor lysis syndrome in childrenTiene Bauters, Veerle Mondelaers, Yves Benoit,Barbara De Moerloose, Johan Vandenbroucke

Ghent University Hospital, Ghent, Belgium

Objective: Tumor lysis syndrome (TLS) is an onco-logic emergency caused by massive tumor cell lysiswith release of large amounts of potassium, phos-phate and nucleic acids into the systemic circulation.High concentrations of uric acid and phosphatepotentiate the risk of acute kidney injury. Thecornerstone of TLS prevention is aggressive intra-venous hydration, use of allopurinol or administra-tion of rasburicase.

Methods: To evaluate the use of rasburicase in pre-vention and treatment of TLS in children (February2009-December 2012) by performing a Drug UseEvaluation.

Results: Thirty-three patients were administered ras-buricase. Diagnoses included acute lymphoblasticleukemia (42.5%), acute myeloid leukemia (21.2%),Burkett lymphoma (18.2%) and germ-cell tumors(6.1%). Seventeen patients (51.5%) received rasburi-case on my, from which 16 (94.1%) in prophylaxisand 1 patient (5.9%) as therapeutic treatment. Theother 16 patients (48.5%) received allopurinol andrasburicase, from which 3 (18.8%) in treatment dueto immediate onset of TLS. From the other 13patients, 6 developed TLS despite prophylactic treat-ment. Rasburicase was effective in decreasing the uricacid concentration in 84.8% of all patients within 24hours. Alkalization was performed in 14 out of 33patients (42.4%), 6 patients (18.2%) were not alkali-nized. For the 13 remaining patients (39.4%) dataconcerning alkalization were not available.

Conclusion: Rasburicase was proven to be effective inprevention and treatment of TLS. As alkalization wasstill performed in a substantial percentage of patientswith allopurinol and/or rasburicase, the hospitalguideline will be updated as alkalization is no longerrecommended as the standard of care in literature.

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29Novel secondary prevention strategy for acisplatin hypersensitivity reaction-case reportToni Bailie1, Stephanie Lynch2, Ronald Burkes1

1Mount Sinai Hospital, Toronto, Canada, 2University of Toronto,

Toronto, Canada

Objective: To describe a case of an atypical cisplatinhypersensitivity reaction and subsequent secondarymanagement strategy.

Methods: An extensive literature search usingPubMed, Medline, Cochrane and Google Scholardatabases was undertaken to determine the best evi-dence-based strategy.

Results: Cisplatin hypersensitivity reactions occur in5-20% of patients, typically within minutes ofinfusion and most commonly between the fourthand eighth cycle. Our patient’s reaction—lightheadedness, disorientation, diaphoresis andanxiety– developed at the end of the first one hourinfusion as part of the ECX protocol for gastriccancer. The literature reveals three main strategiesfor secondary prevention: premedication and pro-longation of infusion time, rapid desensitization orsubstitution with a different platinum containing saltfollowing a negative skin test. The evidence suggestspremedication and prolongation of infusion time isassociated with a 55% failure rate. Rapid desensi-tization protocols have been efficacious but areimpractical due to time and resource requirements.More success has been reported when switching tooxaliplatin versus carboplatin. Thus we opted for acombination strategy. On cycle 2, we switched to theXELOX protocol, pre-medicated our patient withhydrocortisone 100mg IV and diphenhydramine50mg IV and administered a prolonged graduated4 hour oxaliplatin infusion. This was tolerated well.We omitted an oxaliplatin skin test. Subsequentcycles were given over 3 hours with the same pre-medication with no further reactions.

Conclusion: In patients presenting with a first expos-ure hypersensitivity reaction to cisplatin, switchingto oxaliplatin, in combination with premedicationand prolongation of infusion time may prevent sub-sequent reactions.

30Tociluzumab for the treatment of an unusualcase of multicentric Castleman’s diseaseVicki Wilmott, Kim Cartwrigth

Wollongong Hospital, Wollongong, Australia

Objective: Castleman’s disease is a lymph prolifera-tive disorder usually associated with either humanimmunodeficiency virus (HIV) or human herpesvirus 8 (HHV-8). We report a case of MulticentricCastleman’s disease that presented in the absence ofeither HIV or HHV-8 who is being treated withtociluzumab.

Method: A 75 year old woman with a 12 month his-tory of pyrexia of unknown origin presented withassociated lethargy, weight loss, anemia and elevatedinflammatory markers. Excisional lymph nodebiopsy and muscle biopsy suggested a diagnosis ofCastleman’s disease. The patient failed treatmentwith high dose steroids and rituximab. As the patientwas discovered to have a significantly raised level ofinterleukin 6 (IL-6), treatment with tociluzumab, ahumanized monoclonal antibody that inhibits theactivity of IL-6, was commenced in April 2013.Tociluzumab was dosed at 8mg/kg every 2 weeksinitially for 4 doses. Dosing was then changed toevery 3 weeks for one dose. Due to a markedresponse to tociluzumab, treatment was changed toevery 4 weeks. However due to declining condition inthe 4th week dosing was changed back to every 3weeks.

Results: A dramatic clinical and biochemicalimprovement was observed. Her peripheral edemaresolved, her appetite improved and she gainedweight, and she became independent in her activitiesof daily living with her ECOG status improving from4 to 1.

Conclusion: This patient with MulticentricCastleman’s disease has gained significant benefitfrom treatment with tociluzumab. In the absence ofHIV or HHV-8, raised IL-6 levels should be used todirect therapeutic options.

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31Incidence of neutropenia (N) in Asian metastaticbreast cancer (MBC) patients treated witheribulin (E) in a routine clinical settingVivianne Shih1, Alexandre Chan2, Rebecca Dent1,Raymond Ng3

1National Cancer Centre, Singapore, Singapore, 2National

University of Singapore, Singapore, Singapore, 3Medical Oncology,

Singapore, Singapore

Objective: To define the incidence of Grade 3/4 neu-tropenia (G3/4 N), dose modification and complica-tions arising post cycle 1 (C1).

Methods: A retrospective review of Asian MBCpatients who received E between Apr 2011 to Oct2013. Descriptive statistics and Chi-square testswere used to evaluate the association of dosemodification with demographics and clinicalcharacteristics.

Results: Seventy patients were evaluated. Mean agewas 54.5 +/� 7.1 years and 77.1% Chinese. Seventypercent were hormone-receptor positive, 21.4%HER2-positive and 18.6% were triple negative.Sites of metastases were bone (54.3%), liver(52.9%) and lung (51.4%). Mean number of priorchemo- and hormonal therapies received were 5.2+/� 2.0 and 2.1 +/� 1.8 respectively. C1 D8 wasomitted in 31.4%, of which 77.3% had G3/4 N.Patients who received >/¼ 4 lines of hormonal ther-apy were more likely to have D8 omitted (OR 3.46;95% CI 1.11 – 10.81). Amongst 45.7% who receivedattenuated doses, 28.1% received prophylactic G-CSF and 21.9% developed G3/4 N. G-CSF did notprevent omission of D8 E (p¼ 0.035). At the end oftreatment, 17 (24.3%) were hospitalized, with 4 forFN and 1 for neutropenic sepsis. Majority (11patients, 15.7%) occurred in C1, of which 5 receivedfull-dose E and 9 received G-CSF. There was oneneutropenic death.

Conclusion: This is the first Asian study that demon-strates the tolerability of E in a routine clinical set-ting. Despite dose attenuation, 21.9% experiencedD8 omission mainly for G3/4 N. This suggestshigher than anticipated rates of N and cliniciansneed to be aware when starting E in heavily pre-treated patients.

Practice Research

32The quality of life amongst the differentpharmacological treatments of women withbreast cancer in tertiary care hospital in IndiaAnantha Naik Nagappa1, Daisy Augustine1, Udupa N1,Vadiraj BM2, Rajesh Balakrishnan3

1Manipal University Manipal College of Pharmaceutical Sciences,

Manipal Udupi District, India, 2Kasturba Medical College, Manipal,

India, 3Michigan University, Ann Arbor, MI, USA

Objective: To compare the humanistic outcomesamongst the different pharmacological treatments(ACT, FAC & FC) of women with breast cancer.

Methods: Women with breast cancer receiving treat-ments and /or follow ups were the subjects con-sidered for inclusion in the study. The sample sizewas 303. A purposive sampling technique was usedto collect required information. The data wasobtained by using a background pro forma, includ-ing demographic details, disease characteristics andtreatment variables. The questionnaire used for mea-suring the humanistic outcomes comprised ofEORTC QLQ C 30 and its breast specific moduleQLQ BR 23.The validity of the developed proforma was established by experts and the reliabilitywas established by Cronbach‘s alpha for EORTCQLQC 30 and QLQ BR 23. (1¼ 0.76).

Results: The present study carried out for comparingthe humanistic outcomes after three commonly usedchemotherapy regimens found that unwanted effectsin different forms and degrees were very commonwith cytotoxic drugs. Fatigue, systemic therapy sideeffects, diarrhea and sleep loss was maximum inFAC regimen, and least in ACT regimen. Eventhough there are slight differences in the symptomsscores among the 3, one way ANOVA revealed stat-istically insignificant P values except for constipationand upset by hair loss (P¼ 0.03and 0.022 respect-ively). Post hoc analysis for multiple comparisonsby Tukey test showed that there were differencesbetween the groups except with respect to pain, con-stipation and hair loss (D¼ 0.154, 0.048 and 0.98respectively).

Conclusion: Quality of life assessment in practice is avaluable message to patients. QOL assessment offersa patient-centered approach to study the variousfactors that affect patient centered outcomes ofthe individual or population. ACT: Adriamycin,

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Cyclophosphamide & Taxol FAC: 5 Fluorouracil,Adriamycin & Cyclophosphamide AC: Adriamycin& Cyclophosphamide.

33Pharmacist Involvement within treatmentfunding model development to supportquality careAnnie Cheung, Vicky Simanovski, Sherrie Hertz,William K. Evans, Carlin Lalonde, Huma Tariq, Irene Blais,Leonard Kaizer

Cancer Care Ontario, Toronto, Canada

Objective: In alignment with Ontario Ministry ofHealth and Long-Term Care’s (MOHLTC) directionfor Health System Funding Reform (HSFR) andCancer Care Ontario’s (CCO) Corporate Strategy,CCO is currently undertaking an initiative todevelop and implement a new patient-based fundingmodel for systemic treatment. The new fundingmodel aims to improve quality of care by aligningfunding with evidence-informed (EI) practice, pro-moting equitable access to patient care services andreducing inequities in funding allocations. Itaddresses funding needs to support complexity ofcare differences within the phases of systemictreatment.

Methods: This funding model was developed by aWorking Group which involves clinical and admin-istrative representatives, including pharmacists.Disease Site Group (DSG) experts defined the listof EI regimens. A Pharmacy subgroup identified amethodology and time for pharmacy resource inten-sity (RI) associated with parenteral treatment regi-mens. Work to incorporate pharmacy best practiceand workload related to oral chemotherapy andfollow-up is in progress.

Results: Future funding for systemic treatment willbe provided for service bundles, including bundlesfor consultation, treatment and follow-up.Treatment bundles include multiple price points toaddress cost variations of EI regimens. PharmacyRIs were used along with other activity-related infor-mation for costing and regimen banding analysis.

Conclusion: Multidisciplinary working groups ensurethat funding model development is clinically relevantand fiscally responsible. Pharmacy engagement iscritical to the successful development of the newfunding model and associated evidence-informeddefinitions.

34Aseptic processing validation of the IVcompounding robot in a hospital pharmacyCelestino Bufarini1, Andrea Marinozzi1, Sabrina Guglielmi1,Demis Paolucci2, Valeria Rosini2

1AO Ospedali Riuniti Ancona, Ancona, Italy, 2Loccioni Human Care,

Moie di Maiolati, Italy

Objective: When a health care product is intended tobe sterile and cannot be terminally sterilized, asepticprocessing provides an alternative. This is the case ofthe IV chemotherapy compounding. Media Fill pro-cess simulation is a standard method to assess andvalidate the aseptic technique of the pharmaceuticalmanufacturing, using microbial growth mediainstead of drug. The Objective: of this study was tovalidate the aseptic process of the automatized IVcompounding that represents, on average, 90% ofthe daily chemotherapy production of theUniversity Hospital of Ancona.

Methods: The ISO 13408-1 standards was applied tothe robotic production with APOTECAchemo. Themanufacturing simulation covered every single stepof the aseptic process, including ‘‘worst case’’ condi-tions such as multi-dose vials, simulation of down-time, syringe reuse. Tryptic Soy Broth was selectedbecause it supports the growth of a wide range ofmicroorganisms, the common aerobes and the facul-tative anaerobes. At the end of the test, all sampleswere incubated 7 days at 22.5�C to check the growthof psychrophilic microorganisms and, afterwards, 7days at 32.5�C to verify the growth of mesophilicmicroorganisms.

Results: Three production batches of 35 preparationseach were performed. A total of 105 bags were com-pounded and incubated, along with the partiallyused vials. No products were discarded or notincluded in the study. None of the incubated prod-ucts have showed microbial contamination after14 days.

Conclusion: According to the acceptance criteriadefined by ISO 13408-1, the aseptic processing ofthe automated drug compounding were successfullyvalidated.

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35Incorporation of national oncology drugrecommendations into the provincial oncologydrug review process – The Manitoba experienceDanica Wasney, Venetia Bourrier

CancerCare Manitoba, Winnipeg, Canada

Objective: With the launch of the pan-CanadianOncology Drug Review in Canada in 2011, nation-ally created recommendations and related clinical/economic reports are publicly available for use at aprovincial level. Assessment of these national recom-mendations, including steps for implementation, isstill required at a provincial level. This presents thetools developed within Manitoba to incorporatepCODR recommendations into our provincialreview process.

Methods: Our provincial committee’s process mapwas amended to incorporate the pCODR review pro-cess. A communication strategy was developedbetween our provincial oncology drug review com-mittee and local Disease Site Groups. A templatePowerPoint presentation was created for DiseaseSite Groups to use when presenting pCODR recom-mendations to our provincial committee. Three fur-ther steps were taken to support the provincialreview process: 1) Creation of a guidance documentfor local Disease Site Groups, including informationrequirements for presentations. 2) Formation of anew working group regarding companion testingfor applicable targeted therapies. 3) Creation of adatabase to track the timing of pCODR recommen-dations in relation to provincial review and subse-quent provincial funding.

Results: With development of improved tools andcommunication, the role of Disease Site Groups inthe evaluation, assessment, and implementation ofpCODR recommendations in Manitoba has beenstandardized. Assessment of time lines betweenpCODR recommendations and provincial review/funding in Manitoba will be facilitated with thenew database.

Conclusions: Ongoing evaluation of current tools andprocesses will be required to ensure timely review ofpCODR recommendations and potential funding ofnew oncology drugs/indications in Manitoba.

36Determinants of intravenous chemotherapypharmacy processing timeFlay Charbonneau1, Ben de Mendonca2, Tiffany Leung1,Carlo De Angelis1

1Sunnybrook Odette Cancer Centre, Toronto, Canada, 2Provincial

Health Services Authority, Vancouver, Canada

Objective: We set out to identify factors which sig-nificantly affect the pharmacy processing time forintravenous chemotherapy.

Methods: Six months of data extracted from apatient scheduling and communication programused at our centre was used identify and determinethe time to complete various steps in the chemother-apy preparation process. Evaluation of chemother-apy ‘‘specific’’ determinants of turnaround timeincluded type of chemotherapy (clinical trial versusnot), number of agents in the regimen, reconstitutionrequired versus not, and final product type (syringe,mini-bag, large volume bag). External factors (notcontrolled by Pharmacy) such as blood work turn-around time, number of patients in the queue, needfor order clarification, patient arrival time and orderin on time were also evaluated.

Results: The median overall pharmacy turnaroundtime is approximately 1 hour. The median time toactually prepare the chemotherapy (processing time)is 45 minutes. The greatest variation exists in theamount of pharmacy preparation lead time.Approval is given with less than 1 hour remainingto the patient’s appointment 70% of the time. As thenumber of appointments entering the processingqueue increases, processing time increases.However, the spread between the median and 80thpercentile is not constant and at about 6-8 orders inthe queue, the range increases significantly. Thereappears to be no single chemotherapy specificfactor which significantly impacts processing time.External factors significantly impact on the overallpharmacy turnaround time. Data analysis isongoing.

Conclusions: Chemotherapy preparation time is lessvariable than the overall pharmacy turnaround time.The ability to prepare chemotherapy in a specifiedperiod of time can be significantly impacted by fac-tors external to pharmacy.

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37Oral oncology safe use and handling: Results ofthe first pan-Canadian survey of provincialcancer agencies and programsHeather Logan1, Scott Livingstone2, Dr. Max Coppes3,Ric Abbott4, Dr. Jehan Siddiqui4

1Canadian Association of Provincial Cancer Agencies, Toronto,

Canada, 2Saskatchewan Cancer Agency, Regina, Canada, 3BC

Cancer Agency, Vancouver, Canada, 4Dr. H. Bliss Murphy Cancer

Centre, St. John’s, Canada

Objective: Oral chemotherapy offers numerousadvantages over intravenous administration, how-ever, published evidence suggests that concernabout the safe use and handling of these agents iswidespread. Many oral chemotherapy prescriptionsare dispensed by a community pharmacy rather thanby a specialized cancer centre which may amplifythese concerns given the limited exposure communitypharmacists have to oral chemotherapeutic agents intheir practice. This study – the first of its kind everconducted across provincial cancer agencies inCanada - explored the current practices regardingthe safe use and handling of selected oral anti-cancer agents.

Methods: A similar survey from the US was adaptedto reflect the delivery of cancer care in Canada anddistributed to a single cancer program in every prov-ince. In total, the survey included 45 questions across6 sections. It explored current end-to-end processes,policies and practice.

Results: Forty-five responses were received. Morethan half have standard operating procedures inplace for oral chemotherapy prescribing (70%), dis-pensing (60%), adherence monitoring follow-up(60%), and prescription verification. With theexception of two provinces, the majority use handwritten prescriptions (median 44%), followed bypre-printed orders (median 5.5%) and computerizedorder entry (median 1.5%), with significant vari-ation between provinces. Less than ¼ report thatthe recommended elements of an oral chemother-apy prescription are provided. Fifty percent ofrespondents report a serious adverse event relatedto oral drug therapy in the past 12 months, and60% report at least one serious close call in 24months. Awareness of leading, published recom-mendations regarding oral chemotherapy safe hand-ling and administration was low.

Conclusion: Standards used to ensure the safe use ofintravenous chemotherapy are not as commonlyused for oral chemotherapy.

38Change in the procedure for the supply ofmedicines at a time of economic recession: A 3.5year experience in a Greek anticancer hospitalIoanna Saratsiotou

Saint Savvas Anticancer Hospital, Athens, Greece

Objective: Our Objective: is to demonstrate that thechange in the procedure governing the supply ofmedicines will result in pharmaceutical expenditurereduction, without any change in the medicinal treat-ment of patients during a period of financial crisis.

Methods: Until May 2010, we were ordering medi-cines at the prices defined in the drug pricelistdetermined by the ministry of Commerce. In thesecond half of 2010 we decided to request financialoffers. The date of submission for the financialoffers was posted at the hospital website. Offerswere accepted every month at the beginning, everythree months later and every six months thereafterand up to date. After each assessment by theCommittee for Medicinal Products, we exclusivelypurchased the product of the lowest price. We arecomparing the annual pharmaceutical expenditureas a result of the new procedure. Paclitaxel,Carboplatin, represent two examples for medicinalproducts and the percent discount on the list priceis presented.

Results: The total reduction between 2009-2013 was52.8% and ranged from 15.27% (2009-2010) to30.59% (2010-2011). For the medicines that are inhigh demand and face highly competitive market,the percent reduction was much higher. The priceof Paclitaxel 100 mg was reduced by 96.24% andthe price of carboplatin 150 mg was reduced by65.69%.

Conclusion: In a period of financial crisis, theimplementation of this procedure resulted in dra-matic reduction in the pharmaceutical expenditure,essentially maintaining unchanged the medicinalcare provided to the patients treated in theHospital.

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39Validation of the cleaning and disinfectionprocedure in robotic aseptic preparation ofcytotoxic injection solutionsIrene Kraemer

University Medical Center, Mainz, Germany

Objective: The Objective: of this study was to vali-date the cleaning and disinfection procedures of therobotic system APOTECAchemoTM by media pre-parations and supplemental microbiological environ-mental control.

Methods: The aseptic preparation of cytotoxic injec-tion solutions was simulated by using double concen-trated tryptic soy broth, water for injection and 50mL plastic syringes as primary packaging. In total500 units were prepared on 8 working days, incu-bated at 22�C for 4 weeks and visually inspectedfor turbidity. Growth promotion tests were per-formed with S. epidermidis. Settles plates were usedfor passive air monitoring and contact plates for sur-face monitoring and fingerprints. The robot wassanitized according to the current standard operatingprocedure on day 1 and 7 prior to media prepara-tion. On the other working days only 6 critical com-ponents were sanitized after media runs. At eachworking day UV irradiation was operated for 4hours after finishing work.

Results: None of the 500 media fill products showedturbidity after the incubation period Growth promo-tion tests with S.epidermidis were positive. Therecommended limits of (abstract submission trun-cated because it exceeded the word limit).

40Ifosfamide-induced encephalopathy: Aretrospective review of incidence over 5 yearsJanelle Penno, Senthil Lingaratnam, Sue Kirsa

Peter MacCallum Cancer Centre

Objective: To determine the incidence of Ifosfamideinduced encephalopathy (IIE) over 5 years. Toreview each case to determine if known risk factorswere present prior to administration of Ifosfamide.

Methods: IIE cases were identified from dispensingrecords of methylene blue (MB) between 1 January2006 and 31 August 2012. MB is recommended forall patients with suspicion of Grade 3 or 4 IIE at thiscentre, in addition to other supportive measures.Patients who received MB for diagnostic objectives

were excluded. Uniform data was collected includingpatient demographics, chemotherapy regimen,timing of IIE onset, clinical features of IIE, presenceof risk-factors, and outcome of MB treatment.

Results: 331 patients were treated with ifosfamideover the 5 year period. Seven patients received MBfor IIE, accounting for an overall incidence rate of2.11% (95% CI 0.93 – 4.14). Four patients had adiagnosis of lymphoma (3.31% (95% CI 1.06-7.78)) and three patients of sarcoma (1.69% (95%CI 0.43-4.52). Six patients had risk factors presentprior to ifosfamide administration, five of which hadhypoalbuminaemia. IIE occurred during the firstcycle in the majority (71%) of patients. Four patientsrecovered after the episode of IIE, of which only onewas successfully re-challenged.

Conclusions: This review adds to the limited evidencesurrounding incidence of and risk factors for devel-oping IIE. Further study into clinical and theoreticalrisk factors is needed to guide clinicians regardingmonitoring prior to ifosfamide to prevent this rarebut serious adverse event.

41Oral Chemotherapy: Bridging Gaps IdentifiedFrom an Environmental ScanKathy Vu, Sherrie Hertz, Leonard Kaizer, Vicky Simanovski,Monika Krzyzanowska, Noor Ahmad

Cancer Care Ontario, Toronto, Canada

Objective: The safe delivery of oral chemotherapy isof great interest due to the potential for errors alongthe continuum from clinic to home. Cancer CareOntario (CCO) conducted an environmental scanof the 14 Regional Cancer Programs to furtherunderstand the current state, including gaps andchallenges, in oral chemotherapy with a plan to usethe results to inform quality improvement initiatives.

Method: A pre-circulated survey was completedthrough a series of semi-structured interviews withparticipants from regional cancer centres inOntario between July and August 2012.Participants included medical oncologists, pharma-cists and nurses. Questions encompassed areas ofconcern related to oral chemotherapy identifiedfrom the literature.

Results: A total of 13 interviews were conducted with43 participants during the study period. The inter-views identified three key areas of focus for quality

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improvement: prescribing, dispensing in the commu-nity and patient education. This led to initiation of38 individual regional and/or provincial qualityimprovement projects focusing on the followingthemes: 1. Standardization and development ofpatient education tools; 2. Computerized PhysicianOrder Entry systems and pre-printed orders for safeprescribing; 3. Implementing and/or evaluating acall-back program for patient adherence; 4.Development of tools for monitoring and facilitatingadherence; and 5. Safe dispensing in communitypharmacies.

Conclusion: An environmental scan focusing on thegaps that exist in the prescribing and dispensing pro-cesses, patient education and adherence resulted in abetter understanding of challenges related to oral che-motherapy and subsequently helped to shape the pro-vincial quality agenda on oral chemotherapy.

42Near infrared spectroscopy to reducemedication errors with limited exposure ofhealthcare workersLaetitia Le1, Eric Caudron1, Luc Eveleigh2,Arlette Baillet-Guffroy1

1Paris Sud University, European Georges Pompidou Hospital (AP-

HP), Chatenay-Malabry, France, 2AgroParisTech, INRA, Massy,

France

Objective: Medication errors during preparation canlead to side drug events. Regarding their toxicity,cytotoxic drugs are particularly at risk. By identifica-tion and quantification, analytical control can ensurecorrect molecule and concentration before adminis-tration. The aim of this study was to assess thefeasibility of a non-invasive and non-destructiveanalytical method to control two of the most usedcytotoxic drugs. It contributes to improve the safetyfor the patient with administration of conformpreparation and for healthcare worker by limitedpreparation handling.

Method: Near-infrared spectroscopy (NIRS) wasused to analyze gemcitabine (GEM) and 5-fluorour-acil (5FU) by direct measurement through standardglass vials at therapeutic concentrations. Because ofcomplex spectral data, chemo metric approach wasapplied to predictive cytotoxic concentration.

Results: Two calibration models were developed for5FU and GEM using partial least-squares regressionwith determination coefficient (R2) higher than

0.9992, low prediction error (RMSECV: 0.483 and0.139 mg/ml respectively) and ratio prediction devia-tion (RPD: 36 and 125 respectively) signing a goodcapacity of the method to predict the concentrationfrom 7 to 50 mg/ml and 2 to 40 mg/ml respectively inless time than 1 minute.

Conclusion: This study is an example of the potenti-ality of NIRS, currently used in industry, to controldrugs preparation before administration and withoutdelaying it. It was applied on cytotoxic drugs but canextend to other drugs extemporary prepared at hos-pital by pharmacy but also nurses and thus, secureadministration by reducing medication errors withlimited exposure of healthcare workers.

43Improving the safety of oral systemic therapy:An exploratory human factors projectLarry Broadfield

Cancer Care Nova Scotia, Halifax, Canada

Objective: To identify and prioritize safety issues inthe processes used for prescribing, verifying, educat-ing patients, dispensing, and follow up monitoring oforal systemic therapy (ST) used for cancer treatmentin the Canadian province of Nova Scotia. To deter-mine the root causes of the identified issues and tomake recommendations to address these root causes.To advise the development and implementation ofprovincial policy on oral ST drugs towards improvedsafety and efficiencies. Study

Design: This is a human factors ethnographic study,observing the daily practices of a representativesample of oncologists, oncology nurses, oncologypharmacists and community pharmacists involvedin the process steps for the delivery of oral STdrugs. Formal and informal incident reports werereviewed to characterize identified risks to patients.Identified issues Quantitative and qualitative obser-vations were subjected to healthcare failure modeand effects analysis (HFMEA) to prioritize interven-tions for risks associated with current practice pat-terns. Recommendations to address the highestpriority risks are designed for integration into pro-vincial policy continuing development andimplementation.

Results: The provincial policy development group isincorporating the risk-reduction recommendations,and will be moving towards implementation acrossthe province.

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Conclusion: A human factors approach providesstrong Objective: support to provincial policy devel-opment and implementation on the safety of oralST drugs.

44Evaluating factors associated with lifeexpectancy less than 3 months among elderlypatients receiving palliative chemotherapyLita Chew, Zhi Yao Chan, Si En Hui Phebe

National University of Singapore, Singapore, Singapore

Objective:Abetter understanding of risk factors asso-ciated with limited life expectancy (LE) is crucial toachieve optimal treatment decisionmaking for elderlypatients with advanced cancers. Our Objective: was toestablish factors associated with limited life expec-tancy old receiving palliative chemotherapy.

Methods: Bivariate analysis was utilized to identifyand verify risk factors associated with limited lifeexpectancy of metastatic sites and patient’s func-tional status (ECOG Performance Status).

Results: Among 766 patients (median age 71 [range65-93], 50.5% female) with stage IV cancers (lung30.8%, colorectal 23.9%, breast 11.9%), 13.3%died within 3 months of initiation of palliative che-motherapy. In bivariate analysis, patients with lim-ited life expectancy 3�ULN and poorer ECOGPerformance status (p that having more metastaticsites was not a significant risk factor that will predis-pose patients to having limited life expectancy.

Conclusion: Predispose elderly patients to limited lifeexpectancy realize these risk factors to make betterdecisions when it comes to initiating palliativechemotherapy on elderly patients with incurablecancers.

45Patient safety first by compounding one drug ata timeMari Culotta-Mascioli

Odette Cancer Centre, Maple, Canada

Objective: The presence of multiple drugs when com-pounding in a Biological Safety Cabinet (BSC) isthought to be a risk factor for medication errors. A‘‘one drug in the BSC’’ process was created with theintent to decrease errors, but maintain both patientwait times and staff complement.

Method: The compounding room was staffedwith three pharmacy technicians (two compoundersand one checking technician). For the trial thefunction and flow of the checking technician wasaltered to allow control of all items entering andexiting the BSC; additionally checking of medicationand supplies at different points in the process andlabelling of the final product were also included.The process was repeated for each separatemedication.

Results: The incidence of an incorrect medication orIV base solution entering the BSC were less likelysince drugs were double checked at the point ofentry. There was also a decreased risk of usingthe wrong drug or base since only one drug was inthe BSC at any given time. We also realized that theprocess was manageable with the current staffingcomplement and that patient wait times for treat-ment did not increase.

Conclusion: Implementing a ‘‘one drug in the BSC’’process and utilizing a technician to doublecheck several steps in the compounding processappears to reduce the incidence of errors while notnegatively impacting patient wait times or staffingcomplement.

46Integration of a clinical pharmacist in amultidisciplinary team for renal cell carcinomapatients treated with oral chemotherapy:impact on adherence and financial aspectsNele Clottens

Ghent University Hospital, Ghent, Belgium

Objective: Oral chemotherapy offers several benefits.Continuous and adequate dosing is essential to guar-antee therapeutic outcomes. However when usingoral cytotoxics, patients are now fully responsiblefor daily intake of their antitumor drug. Adherenceof metastatic renal cell carcinoma (mRCC) patientstreated with oral chemotherapy will be evaluatedbefore and after establishment of a multidisciplinaryteam including a pharmacist. Financial consequenceswill be investigated.

Methods: The medication refill adherence methodwas used to evaluate adherence of mRCC patientsretrospectively (41 months¼ period 1) and prospec-tively (17 months¼ period 2). During the secondperiod patients were assisted by the multidisciplinaryteam, including a clinical pharmacist.

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Results: Thirty-two mRCC patients were treated withoral chemotherapy (period 1), from which 7 out of 32patients (22%) were non-adherent. Adherenceranged from 63% to 94%. The overall cost of che-motherapy treatment for 32 patients was 1.425.322euro. An unnecessary (i.e. more than needed for ther-apy) amount of tablets were dispensed correspondingwith 89.676 euro (6.3%). In period 2, only 1 out of 24mRCC patients (4%) was non-adherent. The overallcost of chemotherapy treatment of 24 mRCC patientswas 432.690 euro. Medication dispensing was super-vised by the clinical pharmacist, yet only 1 box ofpazopanib was dispensed unnecessary, correspond-ing with 2.523 euro (0.58%).

Conclusion: A higher adherence and a minimum ofunnecessary medication dispensing, i.e. 89.676 euro(6.3%) versus 2.523 euro (0.58%) was achieved inperiod 2. This highlights the need for a tighter patientfollow-up which can be attained by implementing amultidisciplinary team with a clinical pharmacist.

47Logarithmic Dose Banding: an opportunity forbatch productionNele Clottens, Johan Vandenbroucke

Ghent University Hospital, Ghent, Belgium

Objective: Chemotherapy doses are normally calcu-lated according to patient’s body surface area orpatient’s weight. This involves individual preparationwhich can be a cause of major delay in the chemother-apy treatment. Dose banding offers an opportunity toovercome this issue and offers pharmacy capacity plan-ning. In the current investigation, logarithmic dosebanding was extrapolated on chemotherapy drugs sui-table for batch production in the Ghent UniversityHospital. The banded doses of 4 molecules were inves-tigated as qualification for stock production.

Methods: Four criteria were used to investigate thesuitability of a drug for batch production: physicaland chemical stability, cost and annual consumption(retrospective analysis of chemotherapy preparationin the hospital, period 2012-2013). Concept of loga-rithmic dose banding according to Geoff Hall (1) willbe applied on chemotherapy drugs.

Results: Twenty-two chemotherapy drugs weredefined as suitable for batch production. Of these22 chemotherapeutics a total of 16.224 infusionswere prepared whereof 5.873 different doses wereprescribed in 1 year. After implementing dose

banding on these 22 molecules only 350 differentdoses would have remained, this corresponds witha reduction of 94% of doses. The prescribed dosesof 5-fluorouracil, cyclophosphamide, cetuximab andrituximab were respectively reduced from 1.091, 539,200, 253 to 30, 29, 10, 8 banded doses whereof 21, 4,7 and 8 were suitable for stock production.

Conclusion: Dose banding offers advantages astimely provision of chemotherapy infusions and pos-sibility to manage the workload. Approval of theprescribers for dose banding is necessary. This willbe the next step for further exploration before imple-menting the concept.

48Cost of treatment sequences in metastaticcolorectal cancer (mCRC): A Canadianretrospective chart review comparingoxaliplatin- to irinotecan based first line therapyPetr Kavan1, Aline Mamo1, Gerald Batist1, Sean Hopkins2,Jean Maroun2

1Jewish General Hospital, Montreal, Canada, 2The Ottawa

Hospital Cancer Centre, Ottawa, Canada

Objective: To compare mCRC drug treatment costsfrom first- to third-line for patients starting on afirst-line oxaliplatin-based (1L OX-B) versus irinote-can-based (1L IR-B) treatment.

Methods: In this retrospective cohort study, we col-lected first- and second-line therapy data from 334mCRC patients treated between January 2010 andDecember 2011 (Ottawa Hospital Cancer Centre,1L IR-B, n¼ 244; Jewish General Hospital, 1LOX-B, n¼ 90). Number of cycles per regimen andpercentage use with bevacizumab were recordedand served as real-world inputs to a costing model.Assumptions were made for missing data.

Results: Ottawa patients received a mean of 15 cyclesof 1L IR-B; 85% with bevacizumab. At the JewishGeneral Hospital, 60% of patients receivedmFOLFOX6 (mean: 10 cycles), 69% with bevacizu-mab (mean: 10 cycles); 40% received XELOX (mean:7 cycles), 78% with bevacizumab (mean: 5 cycles).Due to still immature second-line data, it was assumed60% of patients received 8 cycles of second-line ther-apy and 30% received a third-line therapy with cetux-imab+ irinotecan (60%) or capecitabine (40%).Inputting these values in the model yielded costs of$36,214 when starting on IR-B therapy compared to$30,589 when starting on OX-B therapy.

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Conclusion: These results indicate that when startingwith 1L OX-B, costs may be overestimated when oneconsiders actual number of cycles and use with bev-acizumab. Even at 85% use of bevacizumab in theOX-B arm, costs were of $32,780. Considering simi-lar mCRC drug costs regardless of first-line therapychoice, focus should be on determining the therapythat best meets each patient’s needs.

49Development and implementation of embeddedchecklists into chemotherapy preparationworksheetsRoxanne Dobish, Carole Chambers, Jonas Shultz

Alberta Health Services, Spruce Grove, Canada

Objective: Embed checklists into fully revised che-motherapy preparation worksheets to standardizethe checking processes followed by provincial imple-mentation of the worksheets across all oncologypharmacy sites.

Methods: An environmental scan of best practices inthe preparation of chemotherapy was conducted anda gap analysis was performed against current localpractices. Front line pharmacy staff working with aHuman Factors specialist created chemotherapy drugpreparation worksheets with embedded checklists.Critical stop check points were identified and clearrole definitions were established. Concepts such asindependent double checks, unbiased checking, andmental estimation were incorporated into the check-ing processes. Simulation based tests of the newwork-sheets were conducted with staff at two sites. Somescenarios incorporated errors (i.e., wrong drug placedin a bin) to assess if the worksheets assisted in catchingerrors. Error data as well as process deviation, usabil-ity issues, and user feedback were used to furtherrevise the worksheets prior to implementation.

Results: Implementation was initiated at the twomajor cancer centre pharmacies. Staff training, on-site champions, and phased implementation were keysuccess factors. Lessons learned are being utilized asimplementation proceeds across the additional 19sites in the province. To date, 12/21 sites have fullyimplemented the worksheets and several others arein various stages of implementation.

Conclusion: Chemotherapy drug preparation work-sheets with embedded checklists have created a stan-dardized system for checking across the oncologypharmacies in Alberta. Next steps include

completing implementation at the remaining sitesas well as creating worksheets for all clinical trialand special access program drugs.

50A Robotic System in support of the HospitalPharmacist in management of MetastaticColorectal Cancer TherapiesSilvia Massacese, Eugenio Ciacco, Esther Liberatore,Serena Corridoni

Hospital San Salvatore L’Aquila, L’Aquila, Italy

Objective: Hospital Pharmacy of L’Aquila hasacquired on June 2012 a Robotic System,APOTECAchemo (AC), which optimizes the man-agement of drug residues and isolates the activitiesat risk for the operator, avoiding any possible exter-nal contamination. The study intends to analyze theperformance of therapies with Bevacizumab andCetuximab prescribed from Oncology Division topatients with metastatic colorectal cancer (first andsecond line) comparing two periods, January-September 2011 (pre-centralization) and 2013 (post-centralization), with and without robot.

Methods: It has been calculated for each patient fullcost savings resulting from the use of drug residuesduring the second period. In the first period has setup for Bevacizumab 122 preparations for 19 patientsand for Cetuximab 202 preparations for 16 patients.In the second period has set up for Bevacizumab 205preparations for 23 patients and for Cetuximab 194preparations for 15 patients. For each preparationprocessed in AC was evaluated Error AveragePercentage (E %) and Standard Deviation (DS).

Results: The average error was for Bevacizumab -0.36% (DS¼ 1.2) and for Cetuximab �1.12%(DS¼ 0.6). The cost of a mean dose ofBevacizumab in 2011 was E1.344 and in 2013 wasE1.186. The cost of a mean dose of Cetuximab in2011 was E990 and in 2013 was E905. In the secondperiod, using material that would previously havebeen discarded, we have a considerable saving,which corresponds approximately to E32.000(Bevacizumab) and E16.400 (Cetuximab).

Conclusion: With centralization of therapies we havefully achieved objectives safety of sterile and accu-rate preparation and optimization of economicresources.

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51The impact of utilizing intravenous roboticdispensing in oncology pharmacyZubeir Nurgat, Dima Faris, Maher Momenah, Arris Vibar,Mohamed Ashour, Sakra Balhareth, Ahmed Al-Jedai

King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi

Arabia

Objective: The Objective: of this study were to com-pare and contrast productivity of intravenousrobotic dispensing with manual process for com-pounding cytotoxic medication; to explore the chal-lenges for successful implementation; to evaluate theefficiency of the robot in preventing medicationerrors and how best to incorporate the robot intoour daily operational workflow.

Method: Computer generated data from our HealthInformation System (HIS) and robot software dataover a 3- year period were utilized. We looked atpercentage ‘‘pass’’ or ‘‘fail’’ (+/�5%) of chemother-apy prepared to analyze the efficiency of the robot.We also investigated the number of days robot wasoperational vs. not operational and the reasonsbehind. We also assessed the staffing requirementsto run the robot.

Results: With more experienced gained for usingrobot, our efficiency had risen from 77.04% in2011 to 84.63% in 2012. The number of chemother-apy doses reconstituted in the robot rose from 3.84%in 2010 to 10.94% in 2011 and 14% in 2012 of thetotal number. The percentage ‘‘pass’’ chemotherapydoses also increased. The robot was operation 61%of the available working days in 2012 compared to39% of the available working days in 2011. Thedowntime of the robot was due to a variety of factorssuch as problems with external exhaust fan, pro-blems with robot hand gripper, lack of availabilityof cytotoxic medications, lack of specific gravity dataand lack of WTE staff to run robot.

Conclusion: With intensive training and experiencegained of utilizing robot it improved our safety,accuracy and efficiency of chemotherapy dispensed.The introduction of the robot had limited positiveimpact on preparation of patient-specific chemother-apy doses especially in out-patient settings.However, we envisage better utilization of therobot in batch preparation of cytotoxic with suffi-cient stability and in inpatient setting. Potentialdown time of this delicate machine’s should betaken into consideration

Translational Sciences

52To evaluate effectiveness of more diluted IVgemcitabine solution on infusion relatedpain score and patient comfort level duringchemotherapyNadia Ayoub, Latif Sheikh, Salwa Ahsan, Farhat Zaheer

Aga Khan University Hospital, Karachi, Pakistan

Objective: In Aga Khan University Hospital lots ofpatients get gemcitabine. It was observed by pharma-cist that common complain encountered by patient ispain at injection site which was reported in almost85% patients. Primary aim was to reduce injectionsite pain improving patient safety. Secondly toensure termination of infusion within 30 min tolimit prolonged infusion related toxicity.

Methods: Oncology pharmacist did extensive literaturereview which showed gemcitabine can be diluted inrange of 0.1-10 mg/ml. Previously our pharmacydiluted gemcitabine in range of 9-10 mg/ml NS 0.9%(arm 1). We analyzed 105 patients to determine theimpact of variable concentration on pain level. In firstphase pharmacist increased dilution and prepared gem-citabine in rangeof 6-7mg/ml (arm2) for 2months thenit was gradually increased to 3-4mg/ml (arm 3) for nexttwomonths.Data regarding injection sitepaincollectedfor each arm and impact on pain scale is analyzed.

Results: Pre implementation data revealed averagepain score of 8.2 in arm 1. While in arm 2 it was4.5 which was further decreased in third arm i.e.(abstract submission truncated because it exceededthe word limit)

53EGFR mutations in Lung Adenocarcinoma andcorrelation with p63 and TTF1immunohistochemical expression in GreekpopulationSavvas Papadopoulos1, Marianna Mitratza1,Chrysanthi Bili1, Athanasios Krasas1, Ioanna Saratsiotou2,Elizabeth Kyrkou2, Lina Florentin1, Kosmas Iliadis1,Paraskevas Kosmidis1

1Hygeia Hospital, Marousi, GREECE, 2Saint Savvas Anticancer

Hospital, Athens, Greece

Objective: Detection of EGFR mutations is impor-tant for personalized therapy with TKIs in NSCLC.

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The aim of this study was to determine the fre-quency and spectrum of EGFR mutations in anunselected group of Greek NSCLC patients, tocompare the results with published data and corre-late them with TTF1 and p63 immunohistochemicalexpression.

Methods: A total of 181 cases of lung adenocarci-noma diagnosed from Jan 2012 to Jun 2013 wereexamined. FFPE tissue was analyses with the auto-mated 3100-Avant ABI sequencer for the detectionof EGFR gene mutations in exons 18, 19, 20 and 21and FFPE tissue sections were examined immuno-histochemically with the BenchMark ULTRA(Ventana) using antibodies against p63 and TTF1.

Results: 26 of 181 patients (14.4%) harbored 16 dif-ferent EGFR mutations. The percentage was higherin women (23/77; 29.8% vs 3/104; 2.9% in men).Exon 19 E746-A750 deletion was the most frequentmutation (8/26; 30.8%), followed by the L858R(exon 21) and G719A (exon 18) point mutationsand the L747-A750>P (exon 19) complex deletion(3/26; 11.5% each). E709A and T790M point muta-tions were found in 2 patients each and the remain-ing 10 mutations in 1 patient each. ICH testing ofEGFR mutated tumors identified 20/25 (80%),TTF1+/p63- cases and 5/25 (20%) TTF1+/p63+cases (one case lost).

Conclusions: The most prevalent EGFR mutation inlung adenocarcinoma in the Greek population wasexon 19 E746-A750 deletion, in accordance to pub-lished data, with a greater frequency in women. Thegreat majority of EGFR mutated lung adenocarci-nomas are TTF1+/p63-.

Encore Presentations

54

Managing chemotherapy drug shortages inOntario

Annie Cheung, Sherrie Hertz, Leonard Kaizer, Lyndee Yeung,Lisa Milgram, Scott Gavura, Ram Iyer,Monika Krzyzanowska

Cancer Care Ontario, Toronto, Canada

55

Implementation of a medicationreimbursement specialist (MRS) role tofacilitate medication access for outpatientoncology patients – an interim evaluation

Karen Chuk, Yvonne Ta, Vivian Choy, Esther Fung, Anna Lee

University Health Network, Toronto, Canada

56

What doses should our chemotherapy robotprepare?

Jeanne Chu, Roy Lee, Rita Kwong, Tamara Rumsey

Princess Margaret Cancer Centre, Toronto, Canada

57

Using guideline adaptation to updateantiemetic recommendations in Ontario

Kathy Vu

Cancer Care Ontario, Toronto, Canada

58

Multidisciplinary approach to safeadministration of intra-cerebrospinal fluidchemotherapy (ICC) and error prevention

Michel Bidros1, Lisa Holle2, Jessie Riemer1,Susan Tannenbaum1, Jessica Clement1

1UCONN Health Center, Farmington, CT, United States, 2UCONN

School of Pharmacy, Storrs, CT USA

59

Use of pharmacist integration in oncology clinicsto identify and resolve moderate to major drug-drug interactions

Jack Seki, Matthew Hughsam, Monika Krzyzanowska,Pamela Ng, Vishal Kukreti

University Health Network–Princess Margaret Hospital, Toronto,

Canada

60

Administration of intravenous vincristine:Survey of ISOPP members

Peter Gilbar1, Carole Chambers2, Maria Larizza3

1Toowoomba Health Services, Toowoomba, Australia, 2Alberta

Health Services, Calgary, Canada, 3Alfred Health, Melbourne,

Australia

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61

Incidence of febrile neutropenia in early breastcancer after adjuvant chemotherapy withdocetaxel and cyclophosphamide

Peter Gilbar1, Ian McPherson1, Natacha Sorour1,Jasotha Sanmugarajah2, Alessandra Francesconi3,Elizabeth McCaffrey4

1Toowoomba Health Services, Toowoomba, Australia, 2Gold Coast

University Hospital, Southport, Australia, 3Nambour Hospital,

Nambour, Australia, 4Princess Alexandra Hospital, Woolloongabba,

Australia

62

Pain severity and impairment of activitybetween pegfilgrastim (P) and fixed-dosefilgrastim (F) in women with early-stagebreast cancer receiving chemotherapy

Tiffany Marr-Del Monte, Jessica Kano, Joy Florendo,Mova Leung, Brian Higgins, Robert Myers, Jenny Kim,Glenn Jones

Trillium Health Partners - Peel Regional Cancer Centre,

Mississauga, Canada

63

DeMIStifying pharmacy workload measurement

Venetia Bourrier

CancerCare Manitoba, Winnipeg, Canada

64

Integration of a Clinical Pharmacist into aPediatric Hematology/Oncology/TransplantClinic

Jennifer Jupp, Kim Hugel, Tara Leslie

Alberta Children’s Hospital, Calgary, Canada

65

Oncology Competence Pharmacy – A Germanapproach to improve quality inoncology pharmacy

Klaus Meier1, Kristina Ohlinger2, Sven-Ole Nissen2,Eva-Maria Ohlinger2

1Deutsche Gesellschaft fur Onkologische Pharmazie, Hamburg,

Germany, 2MEDAC, Wedel, Germany

66

Medication incident reduction at IllawarraCancer Care Centre

Vicki Wilmott

Wollongong Hospital, Wollongong, Australia

Platform Presentations

Selected as best abstracts for oral presentation atISOPP XIV

67Description of the hematological toxicity ofdifferent regimens using bortezomib in multiplemyeloma (CyborD, Vel-Dex and VMP)Dominic Duquette, Vincent Laroche

CHU de Quebec, Quebec, Canada

Objective: The use of bortezomib has evolved sincethe APEX study published in 2005. It remains, how-ever, the only study providing a detailed account ofthe changes in hematological parameters in responseto bortezomib-based chemotherapy. The APEX trialenrolled multiple myeloma patients in relapse. Infirst-line transplant eligible multiple myelomapatients, we use bortezomib twice weekly with low-dose dexamethasone (VelDex) or bortezomib onceweekly with dexamethasone and cyclophosphamide(CyBorD). For patients non-eligible to transplant,we use bortezomib once or twice weekly with melpha-lan and prednisone (VMP). The goal of this study is todescribe changes in platelet counts during these threetypes of bortezomib-based induction therapies.

Methods: We conducted a retrospective chart reviewto examine the complete blood count (CBC) resultsduring treatment with VelDex, CyBorD or VMP.Neutrophil count, hemoglobin and platelet countwere measured before every bortezomib infusion.

Results: 31 patients were included in this review(VelDex¼ 11, CyBorD¼ 11, VMP¼ 9) Results areshowed in the following graphs. The use of twiceweekly bortezomib is associated with a more pro-nounced drop in platelets. CyborD once weekly isassociated with less severe drop in platelets.

Conclusion: These findings show that once weeklybortezomib is associated with less severe thrombocy-topenia. This suggests that the blood monitoringcould be less frequent than at each dose of bortezo-mib. A biweekly monitoring of blood counts couldreduce significantly blood tests and waiting time forpatients.

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68Pharmacy toolkits for oral systemic therapyagents: Just-in-time information for thepracticing pharmacistLarry Broadfield1, Philip Shaheen2

1Cancer Care Nova Scotia, Halifax, Canada, 2Cape Breton District

Health Authority, Sydney, Canada

Objective: To develop ‘just-in-time’ tools for oncol-ogy and community pharmacists when dispensingoral systemic therapy (ST) agents, teaching cancerpatients or performing follow up management ofcancer patients receiving oral ST agents.

Methods: The use of oral ST agents is a complicatedprocess in Nova Scotia. Orders are written in hos-pital-based cancer clinics, but dispensed fromcommunity pharmacies throughout the province.Communication between hospital and communityhealth care professionals is sub-optimal and commu-nity practitioners are unfamiliar with these newdrugs. A web-based toolkit was designed to supportthe practical information needs of practitioners inboth practice sites. The toolkit comprises succinctinstructions to the pharmacist while dispensingeach prescription, consistent with the provincialpolicy on oral ST agents. Other information is pro-vided on common adverse effects and drug-druginteractions. A suggested schedule for follow-upmonitoring, with focus points at each encounter, isprovided. For more details, a supplemental AdverseDrug Effects Management Guide, specific to eachagent, is also available on the website. A genericfollow-up tool is also available, with questionprompts to identify and manage adherenceproblems.

Results: The toolkit was reviewed by representativestakeholders and modified in response to feedback.The toolkits are now available on a public websiteand the address is cross-referenced on standard ordersets for these drugs.

Conclusion: Simple, publically-accessible toolkits,designed to support pharmacists managing prescrip-tions and patients on oral ST agents, are available foruse just-in-time as pharmacists are facing orders forunfamiliar drugs, or interacting with cancer patients.

69Integrating pharmacogenetic information intoelectronic prescriber order entry using clinicaldecision supportBarry Goldspiel, Willy A. Flegel, Gary Dipatrizio,Tristan Sissung, Sharon D. Adams, Scott R. Penzak,Leslie G. Biescker, Thomas A. Fleisher, Jharana (Tina) Patel,David Herion, William D. Figg, Juan J.L. Lertora,Jon W. McKeeby

NIH Clinical Center, Bethesda, MD, United States

Objective: To develop the organizational and techni-cal framework to integrate pharmacogenetic (PG)information into electronic prescriber order entryusing clinical decision support (CDS).

Methods: A multidepartment team was establishedto define the institutional processes to evaluate andapprove using PG information for clinical care. Theteam first developed CDS algorithms for abacavir,carbamazepine, and allopurinol because our institu-tion performs the associated PG HLA tests onsite ina CLIA-certified lab and knowledge about apatient’s genotype can predict and possibly preventsevere hypersensitivity reactions. The team thenworked with our informatics department to developa universal framework to translate the genotypeinformation into a CDS message displayed to theprescriber at the time of order entry. Based on thetest results, the CDS determines if the prescriber canplace the order, place it but require an overridereason, or be blocked from placing the order.

Results: Since implementation, 420 medicationorders have been placed for 170 patients by 125 dif-ferent prescribers. Prescribers have adapted to usingthe CDS and have ordered PG testing as a directresult of the implementation. Providing an overridereason was common (70%) primarily becausepatients had been receiving the drug without reactionprior to implementation of the CDS program.

Conclusion: Successful incorporation of PG CDSrequired a coordinated, interdisciplinary effort toensure smooth activation and a positive effect onpatient care. The framework has been establishedfor expanding the implementation to any drug, forexample, 6-mercaptopurine, where PG informationmight improve medication outcomes.

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70Development and validation of a patient-reported diarrhea assessment questionnaire inpatients with cancer treatment-related diarrheaMichelle Lui, Soha Ahrari, Jacques Raphael, Angie Giotis,Mark Pasetka, Sunil Verma, Scott Walker, Carlo De Angelis

Sunnybrook Health Sciences Centre, Toronto, Canada

Objective: Cancer treatment-related diarrhea(CTRD) is poorly defined and inadequately assessedin clinical practice. To address the absence of a stan-dardized and validated tool to assess and monitorCTRD, we aimed to develop and validate theSystemic Treatment-Induced Diarrhea AssessmentTool (STIDAT).

Methods: This study consisted of two phases. In thedevelopment phase, clinicians designed a preliminarySTIDAT based on stool form, stool frequency,onset/duration, diarrhea-associated symptoms, self-treatment strategies, healthcare resources, diarrhea-associated complications and impact on quality oflife. Using feedback from interviews conductedwith patients with current or recently resolvedCTRD, the STIDAT was revised to better reflecttheir experience. Subsequently, the validation phaseinvolves weekly assessments of 125 patients startinghigh-risk CTRD regimens using the final version ofSTIDAT, Common Terminology Criteria forAdverse Effects (CTCAE), and EORTC QLQ-C30in their first cycles. The STIDAT will be comparedwith daily diarrhea diaries to determine internalreliability and with CTCAE and EORTC QLQ-C30 for criterion validity. Multiple regression andfactor analyses will be employed to revise theSTIDAT and determine its scoring system.

Results: In the development phase, patients unani-mously defined diarrhea as watery stool. They alsohighlighted the importance of capturing a range ofstool forms over time, including those associatedwith constipation. Patients emphasized the impor-tance of documenting CTRD’s impacts on qualityof life. Validation phase results/analyses are pending.

Conclusion: Stool form is integral to patients’ defini-tion of CTRD. Ideally, CTRD assessment tools mustinclude comprehensive evaluation of stool form andimpact on quality of life.

Research Award Presentation

Recipients of the 2012 ISOPP Research Awards

71The effect of race on the CYP3A mediatedmetabolism of vincristine in pediatric patientswith acute lymphoblastic leukemiaRosalyn P. Sims

Children’s Hospital of Michigan, Detroit, Michigan USA

Objective: The Objective: of this study was to com-pare racial background and CYP3A distribution inpediatric acute lymphoblastic leukemia patients as itrelates to vincristine related neurotoxicity.

Methods: Patients with B-precursor acute lympho-blastic leukemia treated at Children’s Hospital ofMichigan were eligible to participate in this study.Determination of the CYP3A variant for eachpatient was done using Qiagen DNA Blood MiniKit and PCR amplification. Patients were monitoredduring their leukemia treatment course for vincris-tine related neurotoxicity.

Results: Fifty-four patients were enrolled. Twenty-nine Caucasian patients (81%) and 13 African-American patients (77%) experienced neurotoxicity.CYP3A genotyping was done for 52 patients. TwoAfrican-American and 2 Caucasian patients werehomozygous A/A for the CYP3A5*3 polymorphism.Three of these patients (75%) experienced grade 2neuropathy. Two Caucasian and 1 African-American patient were heterozygous A/G. Two ofthese patients (66.7%) experienced grade 2 or 3neuropathy.

Thirty-five patients (67.3%) were homozygous forthe mutant inactive G/G allele for CYP3A5*3,eight African-American, and 27 Caucasian patients.Of these, 6 of the African-American patients (75%)experienced neuropathy and 22 of the Caucasianpatients (81.5%).

Conclusion: The CYP3A5*3 genotype causes very lowexpression of the CYP3A5 protein, hence, decreasedvincristine metabolism. In this study, patients whoexpressed CYP3A5*3 had an increased incidence ofvincristine related neurotoxicity. Overall, a greaterpercentage of Caucasian patients experienced neuro-toxicity. A larger sample size and more detailed geneanalysis are needed for future studies.

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72Evaluation of the Stability of Ifosfamide andMesna in Elastomeric Pumps: Bench to BedsideDahlia Salman, Julian Swinden, Jean-Marie R. Peron,Stephen Barton, Shereen Nabhani-Gebara

School Pharmacy and Chemistry; Kingston University London, UK

Objective: Continuous infusion of Ifosfamide andMesna (IfosM) for 14 days is a common ambulatorychemotherapy treatment used for metastatic softtissue sarcoma. However, no previous studies haveinvestigated the stability and degradation productsof IfosM for more than 7 days, so the therapy isadministered as two consecutive 7-day infusions.The aim of this research is to evaluate the stabilityof IfosM in elastomeric pumps over a 14-day period.The effect of reconstituting Ifosfamide with Mesnainstead of water for injection is also investigated; thisreduces the total volume of infusion.

Methods: Elastomeric pumps were filled with IfosMand incubated at 8�C, 25�C and 37�C for 21 days.

Solutions of Ifosfamide, 80 mg/ml in water and 100mg/ml in Mesna, were also prepared and incubatedat 25�C for 10 days. Samples were taken periodicallyand analyzed by LC-MS/MS, 1D proton NMR andassessed for physical stability by microscopicanalysis.

Results: LC-MS/MS indicated that Ifosfamide con-centration decreased over 21 days by less than 1% at8�C, by 8% at 25�C in light and 4% at 25�C in darkconditions. At 37�C, concentration decreased by12% over 14 days. Ifosfamide was found to be lessstable when reconstituted with Mesna instead ofwater. NMR results suggested that the main degrad-ation product was 3-[(2-hydroxyethyl) amino] pro-pylhydrogen (2-chloroethyl) phosphoramidate.

Conclusion: the results of this study indicate thatIfosM is not sufficiently stable at 37�C to permit acontinuous 14 day infusion. Stability studies areimportant to answer and resolve practice basedchallenges.

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