Apr 13, 2018 - NIOSH draft protocol using tetraethylurea (TEU, ... NIOSH, instead of 2-phenoxyethanol. ...... Funding: Kenyatta National Hospital funded my.
Volume 24 Number 4(Supplement) June 2018
Contents
Selected abstracts presented at the XVII Symposium of the International Society of Oncology Pharmacy Practitioners, 11–13 April 2018, Shanghai, China
Platform Presentations Plenary
1
Concurrent Session: Research 4
3
Poster Presentations Clinical Science (CS)
7
Process Improvement / Pharmacoeconomics (PR)
10
Trainee (TR)
14
Encore Presentation (EN)
16
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J Oncol Pharm Practice 2018, Vol. 24 4(Supplement) 1–17 ! The Author(s) 2018 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1078155218761020 journals.sagepub.com/home/opp
Abstracts
Platform Presentations Plenary 01 Characterizing the incidence, trajectory and severity of cancer-related fatigue (CRF) in Asian breast cancer patients Yi Long Toh1, Elgenia Wong1, Nigel Lim1, Angie Yeo1, Yan Xiang Gan2, Shwe Maung1,2, Alexandre Chan1,2 1
National University of Singapore, Singapore, Singapore, 2National Cancer Centre Singapore, Singapore, Singapore
Objective / Purpose: To characterize the incidence, trajectory, and severity of cancer-related fatigue (CRF) in early stage breast cancer patients. Study design / Methods: In a prospective, longitudinal cohort study, CRF was assessed using the Multi-Dimensional Fatigue Symptom InventoryShort form (MFSI-SF) and Brief Fatigue Inventory (BFI) across three time points: baseline and prior to chemotherapy (T1), during chemotherapy (T2), and 12 weeks after chemotherapy (T3). CRF status is defined as an increase of 10.8 points from baseline MFSI-SF scores based on predetermined minimal clinically important difference (MCID) range, whereas severity of fatigue was defined as 4 points on the BFI scale based on validated cutoffs. Results / Key findings: A total of 171 patients were analyzed (mean age standard deviation: 51.8 8.8 years; 64.9% received anthracycline-based chemotherapy). The overall incidence of CRF from T1 to T3 was found to be 31.0%, with point prevalence of CRF at T3 (26.3%) almost twice that of T2 (14.0%). Approximately half of the CRF cases (54.1% at T2 and 44.4% at T3) experienced moderate and above in fatigue severity. Findings also showed that patients experienced significant worsening in all fatigue domains (p < 0.01), with greater extent of worsening observed in general, physical, and vigor domains as opposed to the mental and emotional domains.
Conclusion / Recommendations: Approximately onethird of our cohort experienced CRF, during and after chemotherapy, with almost half of CRF cohort reporting moderate and above severity. This warrants future rehabilitation programs to focus efforts toward mitigating fatiguerelated symptoms to improve quality of life in cancer patients. Funding: National University of Singapore (R-148000-166-112—PI: Alex Chan) National Cancer Centre Singapore (NRFCB12131—PI: Alex Chan) National Medical Research Council (NMRC/CIRG/ 1386/2014—PI: Alex Chan)
02 Determining the usefulness of a tele-oncology service to aid in medication adherence, early detection, and management of adverse effects (AEs) to oral anticancer therapies (OAT) Vivianne Shih1, Cindy Chew1, Whee S Ong2, Lita Chew1,3, Jun Tian Wu4, Kevin Yap5, Rebecca Dent6, Mei Kim Ang6, Julian Thumboo7 1
Department of Pharmacy, National Cancer Centre, Singapore, Singapore, 2Division of Clinical Trials & Epidemiological Sciences, National Cancer Centre, Singapore, Singapore, 3Department of Pharmacy, Faculty of Science, National University of Singapore, Singapore, Singapore, 4SingHealth Health Services Research Centre, Singapore, Singapore, 5National Pharmacy Programme Management Office, Ministry of Health, Singapore, Singapore, 6 Department of Medical Oncology, National Cancer Centre, Singapore, Singapore, 7Department of Rheumatology & Immunology, Singapore General Hospital, Singapore, Singapore
Objective / Purpose: Primary objective: To determine the effectiveness of short-messaging service (SMS) reminders in improving OAT adherence. Secondary objectives: To detect and assess the incidence of severe AEs requiring intervention, risk factors for nonadherence, and assess patients’ health-related quality of life (HRQoL).
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Study design / Methods: Randomized (1:1) controlled trial: Intervention group (IG) received daily SMS reminders, AEs assessed monthly via SMS between day 5 and 7, and contacted for severe AEs (>8/10). Control received standard of care (no SMS reminders/ AEs assessed). Both had adherence rates (via pill count and 4-item Morisky Medication Adherence Scale (MMAS-4)), AEs at pharmacy visits and HRQoL (via Functional Assessment of Cancer Therapy-G, FACT-G) assessed. Nonadherence risk factors were identified via Cox regression. Results / Key findings: Adherence rates of IG (N ¼ 51) were generally higher than control (N ¼ 50) per cycle via MMAS-4 and pill count (pill count nonadherence HR 0.62, 95% CI 0.17–2.19, p ¼ 0.45). Severe AEs (all cycles (C): 3.1%–13.0%) in IG led to 11 calls made. IG reported less severe AEs (p < 0.05 at C3 and C6) at pharmacy visits. Taking >1 tablet per OAT administration was an independent risk factor for nonadherence (HR 5.59, 95% CI 1.44–21.68). IG had higher mean FACT-G total scores than controls at C3 (89.9 versus 82.4, p ¼ 0.02) but was narrowed by C6 (90.9 versus 87.4, p ¼ 0.28). Conclusion / Recommendations: The SMS service was generally effective in aiding with medication adherence and allowed patients to highlight distressing AEs experienced. Appropriate patient selection is essential for this service to add value to patient care.
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Study design / Methods: Ahead of the meeting, a webbased survey was performed to evaluate the agreement of the community members on 50 statements in the following domains: technology and safety, drugs and products, personnel, quality and facilities. The results of the survey were analyzed and presented at the beginning of the meeting as a baseline for discussion. During a two-day meeting, participants discussed in four working groups issues of the four domains in order to develop a set of recommendations on practical aspects of robotic i.v. compounding. In a plenary session participants assessed consensus on the final statements. Results / Key findings: The four working groups prepared in total 92 statements. Six main domains were identified and finally 35 statements were agreed after matching similar and overlapping statements of the different work groups. Conclusion / Recommendations: As an increasing number of cancer centers worldwide are utilizing robotic technology for the preparation of chemotherapy, the international scientific community should develop regulations on safe handling and assess the impact of automation in pharmacy practice. The 35 recommendations are a first contribution toward a better understanding of the role of robotic compounding in pharmacy departments and a guidance for professionals willing to approach this topic.
Funding: SingHealth Foundation Research Grant
03 Robotic I.V. medication compounding: Recommendations from the international community of APOTECAchemo users Irene Kraemer1, Angela Yaniv2, Lita Chew3, Celestino Bufarini4, Demis Paolucci5
04 Implementation of a quality assurance framework for Icon Group oncology pharmacy practice within Australia Russell C Hill, Chris Giles, Ellisha Vas Icon Group Pharmacy Services, Brisbane, QLD, Australia
1
University Medical Center, Mainz, Germany, 2Cleveland Clinic, Cleveland, USA, 3National Cancer Center, Singapore, Singapore, 4 Ancona University Hospital, Ancona, Italy, 5Loccioni Humancare, Angeli di Rosora, Italy
Objective / Purpose: To implement a quality assurance framework for Icon Group oncology pharmacy practice across private and public hospital pharmacies within Australia.
Objective / Purpose: Managing the shift from manual to robotic compounding of i.v. preparations requires awareness regarding how automation affects practice and how to implement robotics successfully into current practice. An international panel of pharmacy professionals, researchers, and technology leaders in i.v. robotics elaborated a general set of principles to broaden the understanding of the fundamental elements of robotic compounding worldwide.
Study design / Methods: A literature review of Australian and international practice standards was undertaken. Two observational audit tools were created (oncology compounding; oncology pharmacy practice). Domains included personnel, occupational health/safety, oncology pharmacist responsibilities, cytotoxic transport/storage, premises/equipment, personal protective equipment, reconstitution, cleaning, and quality control. The oncology pharmacy
Abstracts
practice audit commenced in 2012 and has been repeated annually (five audits, 15 pharmacies); the oncology manufacturing audit commenced in 2013 and has been repeated annually (four audits, nine pharmacies). Results / Key findings: For oncology pharmacy practice mean scores increased from 77 to 96%. Statistically significant (single tail T-test) P < 0.05) improvements were evident for years 1–4. In years 4–5, improvements in quality were less significant (p < 0.10) most likely as quality had improved resulting in reduced variability in scores and difficulty complying with remaining criteria. For oncology manufacturing, mean scores increased from 66 to 90%. In years 1–2 statistically significant improvements were not evident. This is likely the result of pharmacies not understanding requirements resulting in delays in changes to practice. Statistically significant (single tail T-test) P < 0.05 improvements were evident for years 2–4. Conclusion / Recommendations: Introduction of observational audit tools has delivered continual quality improvement. Analysis of the results has indicated where and when difficulties arise in compliance and a higher level of support is required. The program has resulted in statistically significant improvements in oncology pharmacy practice.
Concurrent Session: Research 4 05 Evaluation of intravenous preloading magnesium supplementation as a preventive measure of cisplatin-induced nephrotoxicity Marius B Youan Bi1, Eric M Guantai2, Irene Weru3, David Nyamu4, Desire´ A Yapi5, Gise`le K Siransy1 1
Department of Pharmacology, Faculty of Pharmaceutical and Biological Sciences, Felix Houphouet Boigny University of Abidjan, Abidjan, Ivory Coast, 2Department of Pharmacology, University of Nairobi, Nairobi, Kenya, 3Department of Pharmacy Practice and Clinical Pharmacy, University of Nairobi, Nairobi, Kenya, 4Kenyatta National Hospital, Nairobi, Kenya, 5Medicinal Chemistry Department, Faculty of Pharmaceutical and Biological Sciences, Felix Houphouet Boigny University, Abidjan, Ivory Coast
Objective / Purpose: To evaluate the effect of intravenous magnesium preloading supplementation on cisplatin-induced nephrotoxicity(CIN) in cancer patients at Kenyatta National Hospital and Texas Cancer Centre, Kenya.
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Study design / Methods: This is a dual-center, doubleblind, randomized controlled trial that took place from 1 June to 24 October 2015. We enrolled 71 patients diagnosed with cancer and who were to receive cisplatin-based chemotherapy at a single dose 60 mg/m2 or above of cisplatin on day 1. Patients were randomly assigned to receive 8 mEq intravenous magnesium preloading supplementation or not as part of their chemotherapy regimen on the 21-day schedule. The primary outcome measure was incidence of acute kidney injury (AKI) grade 1 (CTCAE 4.03). Results / Key findings: In the Magnesium Preloading group, the incidence of CIN was lower compared to the Non-Magnesium Preloading group (12.12% versus 33.13%, respectively; p ¼ 0.037). Looking at the severity of the AKI, patient in the Magnesium Preloading group showed less increase in SCr that did the Non-Magnesium Preloading group (mean maximum change in serum creatinine (0.10 mg/dl (range 0.090, 1.761) versus 0.19 mg/dl (range 0.147, 1.86); p ¼ 0.006)). Conclusion / Recommendations: These results provide direct evidence and confirm recommendation for magnesium supplementation as a preventive measure of cisplatin-induced nephrotoxicity.
06 Impact of an interactive, visual flowchart-type leaflet for cancer chemotherapy outpatients on telephone counseling hotline Shinya Suzuki1, Hayato Kamata1, Hisanaga Nomura1, Sinya Uozumi1, Takao Fujisawa2, Yuri Ueda2, Tomohiro Enokida2, Susumu Okano2, Masakazu Yamaguchi1, Makoto Tahara2 1
Department of Pharmacy, National Cancer Center Hospital East, Kashiwa, Japan, 2Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan
Objective / Purpose: An interactive, visual flowcharttype leaflet (FCL) was developed to improve adherence to chemotherapy among patients with cancer and help them manage adverse drug reactions (ADR) (Suzuki, ESMO 2012 Congress; 1611P). The present study aimed to determine the feasibility and benefits of using the FCL to counsel outpatients with cancer about chemotherapy via a telephone counseling hotline. Study design / Methods: This retrospective cohort study assessed the effects of using the FCL on the incidence
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of ADR among 121 outpatients (male, n ¼ 96 (79%); median age 61 years; range 28–78 years) undergoing chemotherapy for head and neck cancer. Results / Key findings: Among 96 calls from 53 (44%) patients, 80 were about ADR. The subjects of 63 (79%) of these 80 calls were about items in the FCL, namely fever, nausea/vomiting, skin symptoms, constipation, respiratory symptoms, and stomatitis (n ¼ 35,11, 11, 3, 2, and 1, respectively). Notably, 56 (89%) patients managed their ADR appropriately according to the FCL. These 63 calls about items in the FCL were addressed by observation (n ¼ 42, 66%), emergency hospital presentation (n ¼ 5, 7%), and admission (n ¼ 16, 25%). No serious conditions arose among the 21 patients who presented at or were admitted to a hospital. Sixteen calls to the hotline concerned items that were not in the FCL and were addressed by observation (n ¼ 4, 23%), emergency hospital presentation (n ¼ 8, 47%), and admission (n ¼ 5, 29%). Conclusion / Recommendations: The FCL reduced the incidence of nonadherence and improved the judgment of patients during chemotherapy, resulting in a decrease in serious conditions caused by ADR.
07 Improving medicines safety in oncology care: The role of prospective surveillance by clinical pharmacists to guide changes in clinical practice Himanshu Patel, Parthasarathi Gurumurthy
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Results / Key findings: A total of 1279 ADRs were reported in 1133 patients from a cohort of 1328 patients over three years. Vomiting (23.22%), alopecia (9.53%), diarrhea (8.67%), myelosuppression (7.42%), skin rashes and pigmentation (5.94%) were the common ADRs reported. Inappropriate administration frequency and regimen of antiemetics (22%), lack of/suboptimal supportive care (18%), administration errors (16%), and lack of patient education (14%) were identified as contributing factors for ADRs. In year one we noticed that 81% of ADRs were preventable. Postimplementation of recommendations in years 2 and 3, the proportion of preventable ADRs was minimized by 36 and 47%, respectively. Conclusion / Recommendations: Implementation of an ADR reporting and monitoring system at the study hospital led to identification of many preventable factors contributing to ADRs. Interventions developed by clinical pharmacists in consultation with clinicians helped to prevent and minimize ADRs in subsequent years.
08 Indirect cost of cancer burden among breast cancer survivors After treatment completion in Singapore Chia Jie Tan1, Jia Xin Tio1, Terence Ng2, Kiley Wei Jen Loh2, Alexandre Chan1,2 1
JSS College of Pharmacy, JSS University, Mysore, India
Department of Pharmacy, National University of Singapore, Singapore, Singapore, 2National Cancer Centre, Singapore, Singapore
Objective / Purpose: This study was conducted to detect and monitor adverse drug reactions (ADRs) to anticancer agents and to develop and implement recommendations to minimize ADRs.
Objective / Purpose: This study aims to quantify the indirect cost of cancer burden among breast cancer survivors through assessment of productivity loss in both paid and unpaid work.
Study design / Methods: This study was conducted in a specialty oncology care setting. Clinical pharmacists prospectively followed oncology patients admitted to inpatient wards and an ambulatory care unit for a period of three years. Medical records of the patients were reviewed and patients and their caregivers were interviewed to identify ADR(s). Identified/reported ADRs were discussed with concerned oncologists and nurses, documented electronically and assessed further for their causality, severity, preventability, and CTCAE grading. Based on study findings, recommendations were developed in consultation with clinicians and implemented to minimize ADRs.
Study design / Methods: Using interviewer-administered questionnaires, breast cancer survivors at National Cancer Centre Singapore were surveyed on productivity outcomes related to both paid and unpaid work in the six months preceding recruitment compared to precancer diagnosis. Employment status, time spent on household work, self-reported presenteeism, and time taken off work were captured. Productivity loss was valued by participantreported monthly income. Results / Key findings: A total of 82 survivors were recruited. The median time after treatment was 24 (range 7–108) months. From a societal perspective,
Abstracts
total mean indirect cost burden among breast cancer survivors amounts to US$8246.22 per year. Indirect cost burden was mainly attributed to unemployment. Employment decreased among survivors from 65.9% (n ¼ 54) before diagnosis to 46.3% (n ¼ 38) posttreatment, resulting in a mean productivity loss of US$3870.62 per year. 58.7% (n ¼ 44) of survivors reported spending less time on household work, contributing to a mean loss of US$2746.23 per year. Among survivors employed postdiagnosis, 60.5% (n ¼ 23) perceived decreased work efficiency and 42.1% (n ¼ 16) missed work due to disease surveillance and complications. Both factors were associated with US$1493.88 and US$135.49 productivity loss per year, respectively. Conclusion / Recommendations: Indirect cost burden incurred by breast cancer survivors is substantial and manifests as both reduction in the workforce and productivity loss in both paid and unpaid work. Funding: This work was financed by research grants awarded by National University of Singapore (R148-000-166-112), National Cancer Centre Singapore (NRFCB12131), and National Medical Research Council (NMRC/CIRG/1386/2014)
09 Comparison of closed system transfer devices (CSTDs) for turnaround time and ease of use Zubeir A Nurgat, Myer Lawrence, Ahmed H Al-jedai King Faisal Specialist Hospital & Research Centre, Riyadh, Saudi Arabia
Objective / Purpose: The primary purpose was to compare CSTDs with different mechanical interfaces for suitability for adoption into our daily practice. The secondary purpose was to use the results of this study to support the selection of one CSTD, which would suit both the pharmacy and nursing staff, and enculturation of international recommendations into clinical practice. Study design / Methods: The HDs preparation process was observed and timed continuously from the moment the technician started compounding until the finished product was handed to the designated checker. A self-administered structured questionnaire was used for data collection for EOU of each of the devices from the perspective of pharmacy technicians and nurses. The questionnaire contained an open-ended 10-point Likert scale of eight domains for both nursing and pharmacy technicians.
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Results / Key findings: Compounding of HDs using PhasealÕ (n ¼ 46), ChemoLockTM (n ¼ 45), and EquashieldÕ II (n ¼ 45), respectively, against the historical control (n ¼ 86) was statistically significant (p < 0.001). No statistically significant difference among the different CSTDs for preparations of HDs was observed in our study (p ¼ 0.1). Ease of Use, among the pharmacy, no difference in the preference for ChemoLockTM over EquashieldÕ II scoring a median of 10. Nursing staff had a slight preference for ChemoLockTM over EquashieldÕ II a median of 9.2 and 9, respectively. Conclusion / Recommendations: With experienced staff, compounding of HDs with CSTDs can be as fast as or even faster than with the traditional needle and syringe method. The ChemoLockTM device was found to be most appropriate for implementation due to low consistent preparation times and ‘‘Click-to-lock’’ closing mechanism gave the nursing staff confidence in the secure connection. Funding: The samples of the CSTDs were provided to us by local sales representative marketing the CSTDs in the country, with no obligation to purchase after our evaluations. In addition, they were informed of the purpose of our evaluations and gave written permission to evaluate their product. They had no role whatsoever in conducting the research or writing the manuscript.
10 Containment performance assessment of closed system drug transfer devices (CSTDs) using the NIOSH draft protocol and TEU as surrogate Alan S Wilkinson1, Michael C Allwood1, Colin P Morris1, Andrew Wallace1, Rebecca Finnis1, Donata Stonkute1, Ewelina Kaminska1, Maja Szramowska1, Joseph Miller1, Ian Pengelly2 1
Biopharma Stability Testing Laboratory Ltd, Nottingham, UK, 2The Health and Safety Laboratory, Buxton, UK
Objective / Purpose: Develop and validate the 2016 NIOSH draft protocol using tetraethylurea (TEU, 2.5% v/v in water), a challenge agent proposed by the NIOSH, instead of 2-phenoxyethanol. Validate quantification with an LOQ below 1 ppb using Automated Thermal Desorption (ATD) Gas ChromatographyMass Spectrometry (GC-MS) detection. Test containment performance of four different CSTDs. Study design / Methods: PhaSeal (Becton Dickinson), Equashield, Vial shield with spinning spiros (ICU
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Medical), and Tevadaptor (Teva Medical) were tested in this study. Blank and test samples were collected using dual GilAir pumps/ Tenax TA tubes pre-loaded with 100ng internal standard. Air sampling was performed for 30 min at 100 mL/min. Tenax tubes were analyzed using a calibrated ATDGC-MS (HSL, UK). An open ‘‘needle and syringe system’’ was used for a positive control. Five replicate tests were performed. Results / Key findings: Limit of detection (LOD) and lower limit of quantitation (LLOQ) for TEU were 0.30 and 0.7 ppb, respectively. Syringe and needle (positive control) released 13.6 0.04 ppb (task 1) and 55.5 1.31 ppb (task 2). Ten-microliter TEU produced a system response of 22 0.7 ppb. Blanks (n ¼ 74) gave 0.16 0.07 ppb. PhaSeal, Equashield,
Journal of Oncology Pharmacy Practice 24 4(Supplement)
and Tevadaptor released
