The complexity and volume of both sterile and non-sterile compounding hasincreased at Sunnybrook in recent years. This is a result of multiple factorsincluding: drug shortages of commercially supplied items, clinical trials requiringspecialized preparations and increased utilization of pain treatment modalitiesincluding epidural and regional pain block cassettes.

The existing compounding software was a Lotus 1,2,3 database that did not havea reliable backup system in place and lacked user-friendliness and key featurescritical to support quality compounding at Sunnybrook.

Customization and Implementation of a Compounding Software Solution

BACKGROUND

OBJECTIVES

SOFTWARE DEVELOPMENT 

CONCLUSIONS & FUTURE STEPS

Perks B1, Bains A, Vidotto S1, DeFigueiredo S1, Cotter N1, Rideout T1, Lye M1, Chow L1, Walker SE1,2. Department of Pharmacy1 Sunnybrook Health Sciences Centre, and Leslie Dan Faculty of Pharmacy2, University of Toronto.

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The objective(s) of this project were to implement a compounding software solutionwhich:1.Secured master formulations from alterations.2.Automatically generated worksheets and labels from the master formulation3.Automatically generated in house lot numbers and Beyond Use Dates based ondate of manufacture and in-built expiry dating4.Checked weights of ingredients used based on integration with the weigh scale5.Verified the ingredients used were correct utilizing barcode scanning technology

The outcomes of the above would serve to reduce workload on the administrativeaspects of compounding and reduce potential sources of errors such as labelling,inaccurate weights, inaccurate ingredient selection, etc.

Despite the significant investment in customizing the labels and barcodeverification feature of the software, the return on investment shows a break-evenat one year and continuous ongoing annual savings thereafter due tosimplification of the administrative steps of compounding.

Given the flexibility of the software chosen (Compounder Lab) which allows bothcustom formulae and label templates to be exported to other users, there issignificant potential for sharing formulae and customizations to other users andsites.

The software solution supports both sterile and non-sterile compounding. Both thebuilt-in safety features (automatic calculations, automated expiry generation,automatic label generation) and the customization of the Pharmaceutical barcodeverification features enhance the safety of our compounded preparations.

Staff are highly engaged and satisfied with the new compounding environmentdue to collaboration and integration at the early stages of the project.

SOFTWARE OPTIONSSoftware options were reviewed including in-house development, outsourced developmentand purchase/customization of commercial software products. A literature search wascompleted, and follow-up with authors of publications surrounding compounding softwarewas undertaken. Constraints for these options in safety/feature set, timelines toimplementation and financial investment were assessed.

for Safe and Efficient Sterile and Non-Sterile Compounding.

After undertaking a root-cause analysis of workload and errors, key issues wereidentified as contributory including: existence of multiple versions of worksheets;ability to edit worksheets by staff (Word Versions); separate system for labellingnot linked to the compounding software; dot-matrix labelling with poor readability;lack of a system to verify weight; lack of a system for ingredient verification prior tocompounding (such as barcodes).

Figure 1.Lotus 1,2,3 Compounding Software with Dot Matrix Printer

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SOFTWARE IMPLEMENTATION AND CUSTOMIZATION

Outsourced Development In-house Development Commercial SoftwareFeature Set Unlimited Limited by development

capabilitiesLimited by version. Potential enhancements with new versions. Customizable?

Liability High High LowerTime to Functional implementation

Long Long Short

Cost High Low – Consider opportunity cost of staff time

Low

Table 1. Software options and for Compounding Software

SPECIFICATIONS DOCUMENTA specifications document was created to outline all “need to have” functionsand “nice to have” features. Key categories included:• General/IT: (DB Backup capability, Different User Roles e.g.. Admin/User, Helpfeature, Expansion/Customizable);• Labeling: (Customizable information, Customizable size and type, numbers,Auxiliary Information, meet Sunnybrook Specifications)• Data Management/Reporting: (Lot traceability)• Workload Measurement/Costing• Core compounding functions: (Scale integration, Barcoding, Automatic LotGeneration, Formula adjustment based on strength changes and batch size,Electronic sign-off, Worksheet generation, Barcode verification of ingredients)• Inventory Management / Workflow Management

SOFTWARE CHOICE and PHASE 1 of IMPLEMENTATIONThe Compounder Lab (Commercial: PK Software www.rxcmpd.com) was chosen as thesoftware which met all the required functionality and had most of the desired additionalfeatures. A summer student (AB) developed a spreadsheet containing all current formulae, andcompleted the inputting of the formulae into the software. All formulae were maintained asinactive until checked by the Pharmacist. In the interest of time, label customization and thebarcode verification feature were not completed during the initial phase.

WORKGROUP DEVELOPMENT and PHASE 2 of IMPLEMENTATIONBefore rolling out the software, a working group consisting of interested Pharmacy Assistantswas convened. The key features missing from Phase 1 were discussed along with animplementation plan. It was decided that additional work be completed to fully utilize the safetyfeatures of the software including the barcode scanning feature. The native barcode scanningin the software required barcode generation and labels affixed to all chemical/medicationsused which was deemed a safety risk and workload prohibitive. To overcome this and allowbarcode scanning verification direct from the original Pharmaceutical barcode, additionalsoftware was purchased (Barcode Studio: www.tec-it.com). Barcodes identical to thePharmaceutical barcode were created in Barcode studio and added to the worksheet of eachformula. In addition to adding this feature, the custom label feature in the Compounder Labwas studied in order to develop this functionality in house. Custom labels can be purchasedfrom PK software, but at roughly $ 225 USD per label, given the number of differentcompounds and labels required, in-house customization allowed for significant cost savingscompared to outsourcing. As many of the Assistants rotated through this function, extensivesoftware skill was built into the department at implementation.

RESULTS & DISCUSSION

Figure 2.Project Goals vs. Constraints

Previous Software (Seconds) New Software (Seconds) % Reduction in TimeSterile Cassette Batch (50 Cassettes) 330 75 77.3

Sterile Tobramycin Eye drop x 1 225 35 84.4Hydrocortisone 1% Cream 1:1 with

Clotrimazole 1% Cream Batch (20 Jars) 210 45 78.6Menthol 0.5% in Hydrocortisone 1%

Cream 100g x 1 235 50 78.7

Table 2. Representative time to complete compounding administrative functions.

One Time Expenditures Annual Expenditures One time Staffing Workload

Compounder Lab $ 5700 CAD $ 1500 CAD

Barcode Studio $ 207 USD

Barcode Verifier $ 1945 USD

Misc. (Printers, Cables, etc.) $ 1000 CAD

Formula Input 0.3 FTE Assistant

Barcode and Label Customization

0.3 FTE Assistant

Formula Verification and Project Management

0.4 FTE Pharmacist

TOTALS ~$ 9,500 CAD ~$ 1,500 CAD 0.6 FTE Assistant0.4 FTE Pharmacist

Table 3. Costs and staff workload to achieve project goals.

STAFF SATISFACTION AND ERROR RATESStaff members utilizing the new compounding software, through informalfeedback, greatly enjoy the new system compared to the old. The reasons givenare “one stop shopping”: automatic system generation of previously manuallyrequired steps and professional documentation and labelling generated by thesoftware. Administrative/manual errors such as wrong year on expiry date,typos, pulling wrong labels files against each formula have been reduced to zero.RETURN ON INVESTMENTBased on compounding volume (approximately 1000 lot numbers generatedmonthly) and differences in administrative time, we estimate 1.5 FTE inTechnician time will be saved annually. Return on Investment (ROI) at 1 year =1%, ROI at 5 years = 405%