Sterile Products and Aseptic Techniques for the Pharmacy

The Seven Rights • • Right patient Right medication Right dose Right route of

Quality Assurance Functions • • • Written policies & procedures Documentation Personnel training System

Quality Improvement • Ensures that integrity is not lost due to – Lack of

Quality Improvement (cont’d) • Process includes – Monitoring trends – Conducting audits – Identifying

Guidelines FDA • Publishes Good Manufacturing Practices (GMP) • GMP covers compounding sterile products

Guidelines (cont’d) FDA (cont’d) • Regulations make standards consistent with requirements Sterile Products and

Guidelines (cont’d) The Joint Commission • Publishes standards on – Pharmaceuticals – Facilities that

Guidelines (cont’d) • Performs stringent inspections at timed intervals • Offers accreditation for health

Guidelines (cont’d) CDC • Focus: preventing spread of disease/infection • Same focus as goal

Guidelines (cont’d) ASHP • Publishes Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products •

Guidelines (cont’d) USP • Published USP Chapter 797 – First enforceable national standards for

ASHP Guidelines on QA for CSPs: Risk Level 1 • Products that are –

ASHP Guidelines on QA for CSPs: Risk Level 2 • Products that are –

ASHP Guidelines on QA for CSPs: Risk Level 3 • Products that are –

USP 797: Low-Risk Level CSPs • Any CSP that is prepared – Using proper

USP 797: Low-Risk Level CSPs (cont’d) • Any CSP that is prepared (cont’d) –

USP 797: Medium-Risk Level CSPs • Any CSP that is prepared (cont’d) – As

USP 797: Medium-Risk Level CSPs (cont’d) • Any CSP that is prepared (cont’d) –

USP 797: High-Risk Level CSPs • Any CSP that is prepared (cont’d) – By

USP 797: High-Risk Level CSPs (cont'd) • Any CSP that is prepared (cont’d) –

USP 797: Environmental Sampling Testing • Should occur – Upon commissioning of new facilities

USP 797: Environmental Sampling Testing (cont’d) • Should occur (cont’d) – In response to

USP 797: Cleaning & Disinfecting of Compounding Area • Primary engineering control must be

USP 797: Cleaning & Disinfecting of Compounding Area (cont’d) • Counters, work surfaces, floors

USP 797: Other Guidelines • Policies & procedures – Needed in every pharmacy –

USP 797: Other Guidelines (cont’d) • Personnel, education, & evaluation – Personnel must constantly

USP 797: Other Guidelines (cont’d) • Storage & handling inside & outside pharmacy –

USP 797: Other Guidelines (cont’d) • Facilities & equipment – All compounding areas are

USP 797: Other Guidelines (cont’d) • Aseptic technique, product preparation, & garb – Manufacturing

USP 797: Other Guidelines (cont’d) • Process validation – Documenting/proving that process will consistently

Documentation and Labeling • All products dispensed must be labeled • Every piece of

Documentation and Labeling (cont’d) • Required product info for each product (cont’d) – Ingredients,

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Sterile Products and Aseptic Techniques for the Pharmacy Technician CHAPTER 9 Quality Control and Assurance Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

The Seven Rights • • Right patient Right medication Right dose Right route of administration Right time Right technique Right documentation Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Quality Assurance Functions • • • Written policies & procedures Documentation Personnel training System checks & process validation Daily assessment of all operations Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Quality Improvement • Ensures that integrity is not lost due to – Lack of training – Equipment failure – Outdated facilities – Other noncompliance issues Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Quality Improvement (cont’d) • Process includes – Monitoring trends – Conducting audits – Identifying & analyzing problems – Taking corrective measures – Conducting testing – Suggesting change Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Guidelines FDA • Publishes Good Manufacturing Practices (GMP) • GMP covers compounding sterile products • Other guidelines: manufacture of sterile products • Guidelines include quality system regulations Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Guidelines (cont’d) FDA (cont’d) • Regulations make standards consistent with requirements Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Guidelines (cont’d) • Performs stringent inspections at timed intervals • Offers accreditation for health care organizations • Offers support to help comply with accreditation Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Guidelines (cont’d) CDC • Focus: preventing spread of disease/infection • Same focus as goal of aseptic compounding • Provides info for hospital environment controls Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

Guidelines (cont’d) USP • Published USP Chapter 797 – 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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 than 1 hr – By improperly gowned personnel Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

USP 797: Other Guidelines • Policies & procedures – Needed in every pharmacy – Address updating, accessibility to personnel, accuracy, SOP, monitoring – All personnel must know policies & procedures Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.

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 Sterile Products and Aseptic Techniques for the Pharmacy Technician, Second Edition Mike Johnston Copyright © 2011 by Pearson Education, Inc. All rights reserved.