CHEMOTHERAPY DISPENSING

Transcription

1 CHEMOTHERAPY DISPENSING AUTOMATION: THE TAIWANESE EXPERIENCE 1 Sarah Lo MS, BCOP Oncology Pharmacy, Department of Pharmacy National Taiwan University Hospital Taipei, Taiwan.

2 2 BACKGROUND National Taiwan University Hospital: tertiary medical center, over 2,500 beds in total. Chemotherapy dispensing unit delivers >300 doses/day Increasing work load and stringent safety requirements prompted a search for automation devices. Evaluation began in Decrease occupational hazard, increase dosing accuracy Relieve pharmacists of dispensing work Save cost on protective equipment

3 3 CYTOCARE First automated processor specialized for chemotherapy dispensing in a sterile environment. Meets ISO Class 5 clean room standard. Manufactured by Health Robotics (Bolzano, Italy)

4 4 CYTOCARE 1. Multi-axis robotic arm 2. Loading carousel 3. Computer area 4. Air treatment unit 5. Waste bin (automatic seal)

5 5 Robotic arm Vial stand Syringe holder Scale Shaker

6 6 CYTOCARE Management software (Cytoplan) Barcode label printer Error rate of dose <2.5% (<0.5% for a 20 ml dose according to manufacturer s data)

7 7 INSTALLATION AND INITIATION Dispensing room refurbished to make room for Cytocare and associated equipment Installation of robot began in late 2009 Installation, programming, staff education and testing took around 6 months

8 8 INSTALLATION AND INITIATION Workflow analysis: for work days. Selecting drugs Vials only Solutions: Fluorouracil, etoposide, carboplatin, methotrexate Lyophilized powders: cyclophosphamide, epirubicin Establishing drug profiles Photographic identification Vial measurements Specific gravity of drug solutions

9 9 INSTALLATION AND INITIATION Syringes: programmed 3 sizes Needles: non-coring vented needle On-site engineer: trained at Bolzano site Order entry: by operating pharmacist, into Cytoplan Definition of failure: Self-detected difference of >5% between product and prescribed dose Alerts operating pharmacist

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12 12 PERFORMANCE First 2 months Data from May 4 th to July 9 th, 2010 (first 10 weeks of formal operation) Operated on 47 days (94% of working days) Total doses: 1028, increased as pharmacists become more familiar with robot. Maximum doses in a single day: 47 doses.

13 13 WH Chen, el al. J Formos Med Assoc 2013; 112:

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15 15 REASONS FOR FAILURE Air failure: Air drawn into syringe, resulting in doses with errors of over 5% (79.7% of all failed doses) Syringe quality More vials used per dose the worse. Other failures: Loading failure (Manual): failure to load syringe/needle properly. Decreases with practice Clamp failure (mechanical)

16 16 PERFORMANCE The year after installation (2011) doses per work day Success rate 96.4% (Range %) Mechanical failure, especially clamp positioning, is major reason for failure.

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19 19 LATER YEARS Stable through Best at 80 syringes/day Clamp positioning failures put operation on hold in late 2014, fixed in 2015 Breaking of clamp in Sep 2015, operation suspended until new clamp installed in 2017.

20 DAILY AVERAGE Daily Average Doses Hardware failure: clamp break on Sep 30 th, Clamp positioning issues, repair and reprogramming

21 Robot repaired in May. Reprogramming and testing starting May 3 rd 2017 Staff training: Staff had rotated since late 2015, few pharmacists have extensive operating experience. Formal operation restarted May 16 th 2017.

22 Clamp fixed May 2017 Doses Complete Failed Total May-17 Jun-17 Jul-17 Aug-17 Sep-17

23 Daily Average Doses May-17 Jun-17 Jul-17 Aug-17 Sep-17

24 FLUOROURACIL 94% DOXORUBICIN 0% CYCLOPHOSPHAMIDE 6% GEMCITABINE 0% PACLITAXEL 0%

25 25 DISCUSSION Limitations of consumables: Final containers: narrow- neck polypropylene bottles used in NTUH not compatible syringes only Syringes: 3-60 ml, may program 3 types; needs to be reprogrammed and tested if we change brands. Limitations on drug selection: Limited by vial size, width and length of vial neck, etc. Loading limitations: only 9 positions for each of syringes and vials on carousel (max. 9 orders per batch) Failure rate higher if multiple vials are needed for a single syringe.

26 26 LIMITATIONS Speed: max syringes per day Pharmacists: estimated 20 doses per hour not including dilution by manual compounding Lack of impact on manpower: 1 Pharmacy personnel needed for Order entry Printing labels and labeling Loading and loading machine Trouble shooting Waste management Above work estimated 6 person-hours (Chen et al, 2013)

27 27 LIMITATIONS Frequent dysfunctions: Very sensitive, smallest of problems may halt its process; every syringe and needle must be placed in a certain exact direction Any air drawn into syringe may cause a dose to fail Clamp positioning settings sensitive and prone to failure Residuals and waste Cost: vented needles and waste bins have to be purchased exclusively.

28 RELATED STUDIES 28 Seger AC, et al (2012): 124-bed inpatient cancer center (Dana-Farber), Before vs. after Cytocare Decreased staff safety events Improved dose accuracy Decreased cost by 56% on ancillary materials (protective equipment etc) Mean drug preparation time: increased by 47%. Labor cost, rates of severe medication error unchanged. Encountered mechanical failures that resulted in wasted medications

29 29 Seger AC, el al. J Oncol Pract 2012; 8:

30 30 Seger AC, el al. J Oncol Pract 2012; 8:

31 31 RELATED STUDIES Nurgat Z, et al (2015) Higher failure rates Encountered clamp failures and robot down time (* in chart) Nurgat Z, el al. Am J Health Sys Pharm 2015; 72:

32 32 Sessink PJM, et al. (2015) University Hospital Saint-Luc (Brussels, Belgium) doses/day Workplace contamination study Wipe testing Study drug: cyclophosphamide Simulated spill test on last study day Result: contamination mostly confined inside Cytocare. RELATED STUDIES

33 33 Simulated spill Sessink PJM, el al. J Oncol Pharm Practice 2015; 21:118-27

34 FUTURE PLANS Automation of chemotherapy is indeed safer: Less staff exposure/staff events, less contamination Better dose accuracy Workflow analysis Automation is definitely slower than manual compounding How to incorporate with best efficiency 2 may be better than 1? 1 pharmacist or technician needed to take care of Cytocare 1 person may be able to take care of 2 robots 34

35 FUTURE PLANS Lessons from Cytocare: Choice of consumables and equipment: take automation systems into consideration (syringes, final containers, needles) Choice of drugs and vial sizes: less vials per dose the better. Consider pharmacy bulk packages, vial size allowing. (NHI?) IT support: interface needed between hospital information system and operating system (Cytoplan) Entering orders by hand is too laborious and error-prone. Importance of maintenance engineers and local representatives 35

36 36 THANK YOU!