Quality Control and Assurance 9 Quality Control and Assurance

The Seven Rights Right patient Right medication Right dose Right route of administration Right time Right technique Right documentation

Quality Assurance Functions Written policies & procedures Documentation Personnel training System checks & process validation Daily assessment of all operations

Quality Improvement Ensures that integrity is not lost due to Lack of training Equipment failure Outdated facilities Other noncompliance issues

Quality Improvement (cont’d) Process includes Monitoring trends Conducting audits Identifying & analyzing problems Taking corrective measures Conducting testing Suggesting change

Guidelines FDA Publishes Good Manufacturing Practices (GMP) GMP covers compounding sterile products Other guidelines: manufacture of sterile products Guidelines include quality system regulations

Guidelines (cont’d) FDA (cont’d) Regulations make standards consistent with requirements

Guidelines (cont’d) The Joint Commission Publishes standards on Pharmaceuticals Facilities that manufacture, store, & deliver them Constantly revises standards to Improve compliance Keep up with drugs & their manufacturing processes

Guidelines (cont’d) Performs stringent inspections at timed intervals Offers accreditation for health care organizations Offers support to help comply with accreditation

Guidelines (cont’d) CDC Focus: preventing spread of disease/infection Same focus as goal of aseptic compounding Provides info for hospital environment controls

Guidelines (cont’d) ASHP Publishes Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products This document Outlines considerations that are subjected to quality testing & assurance Addresses all areas impacted by quality assurance

Guidelines (cont’d) USP Published USP Chapter 797 Miscellaneous First enforceable national standards for sterile compounding Adopted by state boards, JCAHO, FDA Miscellaneous Other local, state, & national agencies Find out what rules apply in your state

ASHP Guidelines on QA for CSPs: Risk Level 1 Products that are Stored at room temperature Completely administered within 28 hrs of prep Unpreserved Sterile Prepared for administration to >1 patient Prepared by closed-system aseptic transfer

ASHP Guidelines on QA for CSPs: Risk Level 2 Products that are Administered beyond 28 hrs after prep Stored at room temperature Batch-prepared without preservatives Intended for use by >1 patient Compounded by complex, numerous manipulations using closed-system aseptic transfer

ASHP Guidelines on QA for CSPs: Risk Level 3 Products that are Compounded from nonsterile Ingredients/components Containers Equipment Prepared by combining multiple ingredients Sterile or nonsterile Using open-system transfer before terminal sterilization

USP 797: Low-Risk Level CSPs Any CSP that is prepared Using proper aseptic technique In an ISO Class 5 or better environment Using only sterile ingredients & supplies With 3 or less commercially available products/packages With 2 or less entries into any one sterile IV bag or vial

USP 797: Low-Risk Level CSPs (cont’d) Any CSP that is prepared (cont’d) Limited to Opening ampules Transferring liquids in syringes to sterile containers Penetrating disinfected vial stoppers At least 48 hrs storage @ room temp 14 days or less refrigerated 45 days or less frozen

USP 797: Medium-Risk Level CSPs Any CSP that is prepared (cont’d) As more than 1 individual or small doses administered to: Multiple patients One patient on multiple occasions By complex manipulations Of long durations That involve processes other than single-volume transfer

USP 797: Medium-Risk Level CSPs (cont’d) Any CSP that is prepared (cont’d) 30 hrs or less storage @ room temp 9 days or less refrigerated 45 days or less frozen

USP 797: High-Risk Level CSPs Any CSP that is prepared (cont’d) By compounding using nonsterile ingredients Using sterile contents of commercially manufactured products Without antimicrobial preservatives Exposed to less than ISO Class 5 environment for more than1 hr By improperly gowned personnel

USP 797: High-Risk Level CSPs (cont'd) Any CSP that is prepared (cont’d) With nonsterile water-containing products that are stored for more than 6 hrs 24 hrs storage or less @ room temperature 3 days or less refrigerated 45 days or less frozen

USP 797: Environmental Sampling Testing Should occur Upon commissioning of new facilities & equipment After any servicing of facilities & equipment As part of periodic recertification of facilities/equipment In response to Issues with compounded sterile products Observed improper technique of personnel

USP 797: Environmental Sampling Testing (cont’d) Should occur (cont’d) In response to Issues with compounded sterile products Observed improper technique of personnel If a CSP is a potential source of patient-related infection

USP 797: Cleaning & Disinfecting of Compounding Area Primary engineering control must be cleaned At beginning of each shift Before each batch At least every 30 min after previous disinfection During continuous compounding activities After spills When suspected contamination occurs

USP 797: Cleaning & Disinfecting of Compounding Area (cont’d) Counters, work surfaces, floors must be cleaned Daily when no aseptic compounding is occurring Walls, ceilings, storage shelving must be cleaned monthly

USP 797: Other Guidelines Policies & procedures Needed in every pharmacy Address updating, accessibility to personnel, accuracy, SOP, monitoring All personnel must know policies & procedures

USP 797: Other Guidelines (cont’d) Personnel, education, & evaluation Personnel must constantly Update skills Continue education Must have process of evaluating personnel’s Skills (assessment) Knowledge

USP 797: Other Guidelines (cont’d) Storage & handling inside & outside pharmacy How drugs are packaged, prepared, delivered Need for refrigeration Risk of contamination if stored/handled improperly

USP 797: Other Guidelines (cont’d) Facilities & equipment All compounding areas are held to high standards All equipment & supplies must be Installed properly Used properly Maintained Monitored

USP 797: Other Guidelines (cont’d) Aseptic technique, product preparation, & garb Manufacturing processes Require constant evaluation & improvement Have many checkpoints Focus on prevention of microbial contamination

USP 797: Other Guidelines (cont’d) Process validation Documenting/proving that process will consistently produce product meeting specifications End-product evaluation Pharmacist’s “final check” Inspections with periodic sampling/testing of batches manufactured under same conditions

Documentation and Labeling All products dispensed must be labeled Every piece of equipment must have records SOPs illustrate how a product is made/processed Required patient info for each product Patient diagnosis, IV regimen, dosages, BSA, lab values

Documentation and Labeling (cont’d) Required product info for each product (cont’d) Ingredients, prep/process, labeling, warnings, storage/handling, expiration date, batch/lot ID numbers