IMPLEMENTATION OF CAMERA TECHNOLOGY: Meeting Traceability Standards for Compounded Sterile Products

BACKGROUND ODETTE CANCER CENTRE IMPLEMENTATION

DESIGN

BENEFITS

Charbonneau LF, Tin LY, Chen‐Paz S, Rotman L, Mascioli MDepartment of Pharmacy, Sunnybrook Odette Cancer Centre

2nd and 6th largest comprehensive cancer centre in Canada and North America, respectively 250,000 visits per year, 125,000 courses of radiation, 3,000 major cancer surgeries 20,000 new patient consults 20 medical oncologists and 5 gynecologic oncologists 25,000 chemotherapy treatments given; Average 80 patients/day in chemo clinic

~45,000 injectable doses made annually Program supports 6 regulated pharmacy technicians , 3 clinical pharmacists and 1 admin pharmacist

RESULTS

PROJECT BACKGROUND Ontario College of Pharmacists Accreditation:

“The Pharmacy ensures a system of auditability and traceability to the patient for each bulk or patient‐specific compounded sterile product (CSP).”

Manual capture of lot # and expiry dates estimated at 3 minutes per patient order = 0.6 FTE Technologies considered: ChemoCato®, Phocus Rx®, Automated compounding Experience at another regional cancer centre and in-house staff expertise Grifols (vendor) and local distributor (Healthmark) Financial opportunity through revenues from retail pharmacy

Site visit Southlake Regional Cancer Centre March 9, 2016; Odette equipment purchased March 2016 Working group established May 2016: pharmacy manager, quality improvement and subject matter expert

pharmacists, senior and aseptic technique trainer technicians, summer student Weekly meetings to describe workflow, transition to biweekly with vendor teleconferences Detailed current state workflow; multiple scenarios prepared for future state workflow Vendor teleconferences initiated August 24, 2016; Hospital IT liaison established Installation date set for early November: Staff communication Infrastructure upgrades: additional data drops and electrical outlets in sterile preparation room

Staff communication – general meetings; workflow options Staff orientation: by lead group for workflow, by vendor for technology

Vendor on-site deployment over 3 weeks with local distributor support Hardware & IT connectivity; staff training and go-live; clinical support

Staffing complement enhanced to minimize effect on patient wait times End-of-day huddles workflow redesign of approval phases 80% of doses prepared captured using new technology Down time procedures developed

Celebratory lunch for staff at end of week 2 Technical issues: headsets, black/blank images, scanner operation Metrics captured

Approved by nursing; ready in pharmacy

Web based: allows remote access Traceability: CSP log for individual patients (NAPRA* 6.3) Dose tracking: 2nd source of info. when CPOE down Electronic – paper storage eliminated

Compounding status dashboard – real time Less access to clean room required to perform verification

(NAPRA 6.6.6.1) Facilitates tech-check-tech procedure Checkpoints customizable: 4 checking stages: Dilution,

Drug, Final, Visual Check Part vials remain in ISO Class 7 room

Increased productivity during break times Accurate reflection of pharmacy workload Quality Assessment for technician training Report generation

Web based: dependent on reliability of hospital network

Visual check for particulate matter required Small camera field: difficult for large preps or those

with multiple components Limits ability for batching

Scanning labels to input preparation information 30% error rate; CPOE interface would

eliminate scanning One way communication: checker mixer Increased movement in/out of sterile field to operate

touchscreen

Future enhancement of hardware will include foot pedals

Significant cost: $25K per camera Installation: $13K Server & License for 8 clients: $34K

Taking a photo of the drug drawn up in syringe(s)

Screen view for checking pharmacist/tech: drug volume drawn up prior to injection into infusion bag

Scanned CPOE label

Phocus Rx record

LIMITATIONS

*National Association of Pharmacy Regulatory Authorities

FUTURE PLANS Expand to clinical trial preparations (~20% of workload) Designate registered technician to checking role; free up pharmacist Improved KPI reports Future CPOE systems must have capability for HL-7 interface with PhocusRx