7.5 Compounding Workflow: SOPs, Workflow Software, Production Queues & Labeling

7.5 Compounding Workflow: SOPs, Workflow Software, Production Queues & Labeling

A sterile compounding area is a small production line. Most errors in it, such as the wrong drug, a wrong concentration, a missed dose, an expired BUD or a mislabeled bag, come from workflow design rather than from aseptic technique. The BCSCP outline (task 1B3) names SOPs, workflow software and production queues as tools for controlling that process.

The end-to-end workflow

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Each stage has its own controls:

USP <797> requirements that shape workflow

• SOPs (Section 17): Facilities must write SOPs for the compounding process and support activities, stating which categories of CSPs they prepare. Personnel must be trained to spot problems, deviations, failures and errors and to report them to the designated person (see 10.5).
• Records (Section 11): Every Category 1, 2 and 3 CSP has a compounding record. An MFR is required for nonsterile ingredients or for more than one patient.
• Release (Section 12): Visual inspection happens before release. A CSP not dispensed on the day it is made is inspected again just before it is released.
• Labeling (Section 13): Labeling procedures must prevent labeling errors and CSP mix-ups.

Production queues and batch scheduling

Queues set priorities. Common tiers are STAT and first doses, then timed doses in the next delivery window, then scheduled batches such as next-day PN or cassettes. Workflow software displays each queue and flags items that are late.

Batching is efficient but has to respect three limits:

1. The BUD clock. A batch must be made late enough that the BUD still covers administration. For example, a Category 1 CSP made at 08:00 expires at 20:00 at room temperature, so it cannot cover a 22:00 infusion.
2. Stability. The labeling or literature may set a shorter limit than the USP table (see 5.2).
3. Sterility testing. Batches of CSPs that require sterility testing are capped at 250 units. Testing then sets both the batch sample size and the timing of release.

One preparation at a time

ISMP's guidelines for safe preparation of compounded sterile preparations advise that only the components for one CSP, or one batch, be in the PEC at a time. Separate label sets and clear staging trays per order prevent mix-ups between patients. Hazardous and non-hazardous work flows are separated physically as well as in the schedule.

Workflow software (IVWMS/DEWS)

IV workflow management systems, also called dose-edge or workflow systems, typically:

• manage queues and priorities, and show turnaround times;
• scan barcodes on every component and block wrong-product additions;
• verify volumes by weight (gravimetrics) and capture images for remote pharmacist checks;
• calculate BUDs from the product's rules;
• build an electronic compounding record with lot numbers and expiration dates. USP <797> accepts electronic records from ACDs or workflow systems if they are retrievable and complete;
• interface with the EHR and with PN or ACD compounding software.

The software also creates data for quality management, such as caught errors, near misses and wasted doses.

USP <797> label requirements (Section 13)

On the immediate container label (minimum):

1. Assigned internal identification number (for example a barcode, prescription, order or lot number)
2. Active ingredient(s) and their amounts, activities or concentrations
3. Storage conditions, if other than controlled room temperature
4. BUD
5. Dosage form
6. Total amount or volume, if not obvious from the container
7. A single-dose statement, if it is a single-dose container (when space permits)
8. A multiple-dose statement, if it is a multiple-dose container

In the labeling, as applicable: the route of administration, special handling instructions, warning statements, and the compounding facility's name and contact information if the CSP is sent outside the facility or health system. USP also says the labeling should indicate that the preparation is compounded.

Measuring the process

Useful workflow metrics include order-to-dispense turnaround (especially for first doses), the percentage of CSPs verified with technology, errors caught per 1,000 doses, doses wasted from expired BUDs, and batch yield. Review them with the environmental and personnel data in the quality program (see 10.6).