Understanding USP : A Practical Approach for Pharmacy Technicians Barbara Limburg Mancini, Pharm.D., BCNSP University of Chicago Medical Center Pharmacy Sterile Preparations & Quality Systems Manager

South Suburban College, South Holland IL Instructor for Pharmacy Technician PHT103: Sterile Products

Conflict of Interest Statement

I have no conflicts to disclose for this session.

Learning Objectives • Explain the difference between single and multidose containers • List the risk levels in your pharmacy & give example of each • Describe differences in hazardous from non-hazardous compounding • Recognize QC & environmental monitoring requirements for your workplace

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Organization and Content • • • •

Polling of audience Baseline knowledge of objectives Introduction to USP Highlight requirements with high interest or concern to pharmacy technicians • Post-test

Glossary of terms & definitions • CSP : Compounded Sterile Preparation • USP: United States Pharmacopeia • Beyond Use Date (BUD) vs. Expiration Date (Exp.) • Risk Levels • Stability • Sterility

Background on USP • Applies where ever CSPs are prepared & stored • First effective : January 1, 2004 • Revisions in effect : June 1, 2008 • Compliance is ongoing • Regulatory impact

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Contents of USP Glossary of terms *

Responsibilities

Risk Levels *

Staff & Patient Training

Immediate Use

Containers

Special preparations

Accuracy & Sterility

Suggested SOP’s

Quality Control *

ACDs

Releases & Checks

Storage & BUDs *

Maintaining Sterility

Abbreviations/Acronyms Appendices * 1

Adapted from The United States Pharmacopeial Convention General Chapter 2007.

Single vs. Multiple Dose Containers • Single Dose do not contain preservatives • Multiple Dose have preservatives • Common preservatives – Benzyl alcohol, Parabens

• Why important to pharmacy techs ?

Single vs. Multiple Dose Containers USP says: • Single dose : 5 hours in ISO 5 Air • Multiple dose : 28 days unless specified by manufacturer What to do if your Policy & Procedure says: • Throw away single dose vial • Put in the refrigerator • Keep for 30 days or date on the vial

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Single vs. Multiple Dose Containers Examples of Single Dose containers: Prefilled syringe Single dose vial Ampul Examples of Multiple Dose containers: Insulin vial Pharmacy Bulk Package

USP Risk Levels • Different from ASHP defined Risk Levels • Basis for Risk Levels is Sterility and Contamination Probability • Why are Risk Levels important for Pharmacy Technicians

USP Risk Levels • • • •

Low Risk Medium Risk High Risk Low Risk with 12 hour BUD

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Low Risk • • • • •

Prepared in ISO Class 5 environment Simple transfers of sterile products Less than or equal to 3 containers No more than 2 entries into a container Media Fill testing annually

Low Risk In the absence of sterility testing • Room temperature BUD: 48 hours • Refrigerated temperature BUD: 14 days • Frozen temperature BUD: 45 days

Low Risk Examples • D5LR 1000 ml with Multivitamins • D5W 1000 ml with 2 amps Sodium Bicarb • NS 250 ml with Norepinephrine 8mg

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Medium Risk • Prepared in ISO Class 5 environment • More complex compounding than low risk • Batch or bulk compounding using sterile products • Media fill testing annually

Medium Risk In the absence of sterility testing • Room temperature BUD: 36 hours • Refrigerated temperature BUD: 9 days • Frozen temperature BUD: 45 days

Medium Risk Examples • Batch compounding of Heparin syringes • Admixtures with more than 3 containers • Preparing 5 doses of 1 gram from Pharmacy Bulk Package • Parenteral nutrition solutions • D5W 1000 ml with 3 amps Sodium bicarb

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High Risk • • • • •

Compounding in air less than ISO Class 5 Use of non-sterile starting materials Personnel improperly garbed & gloved Exposed to air quality < ISO 5 for 1Hr Requires testing of preparation before release • Semi-annual media fill testing

Low Risk with 12 hour or less BUD Same as Low risk except: – ISO Class 5 air in non-controlled Buffer Zone – LAFW or BSC not placed in segregated ISO 7 – Sinks should not be adjacent to PEC – No non-hazardous or radiopharmaceuticals

Immediate Use Risk • CSP Administration begins within 1 hour Ambulances, Emergency Department, Operating Rooms, Clinics, Physician Offices, ICUs, “Codes” • Air not controlled at ISO 5 • Not more than 3 containers • Not more than 2 entries into container

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Compounding Sterile Preparations: Hazardous & Non-Hazardous • • • • •

Garb : Chemoprotective Closed system transfer devices in BSC Negative pressure monitored daily Annual documentation of training Staff confirm knowledge of reproductive risks

Compounding Sterile Preparations: Hazardous & Non-Hazardous Recommended – 100% exhaust of PEC – Surface wipe samples every 6 months

Quality Control & Environmental Monitoring • • • •

Certification of PEC and clean rooms Air Pressure differential monitoring Viable & Non-Viable Air Sampling Surface Cleaning and Disinfecting Sampling & Assessment

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Quality Control & Environmental Monitoring Staff competency assessment for: Garbing Media Fill Validation Gloved Fingertip Sampling Cleaning and Disinfecting

Summary • is an enhancement to pharmacy practice • is providing a means of standardizing practice • an opportunity for improved performance

Post Test Question #1 I can reuse a single dose vial if I keep it in the hood for 8 hours?

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Post Test Question # 2 You prepare 10 doses of 1 gram antibiotic from Pharmacy Bulk Vial. The manufacturer says the stability is 30 days. If doses are stored in the refrigerator, what is the BUD ? a. b. c. d.

24 hours 14 days since it is Low Risk 9 days since it is Medium Risk 2 days since it is High Risk

Post Test Question # 3 I have to wear a mask only when compounding hazardous medications.

References United States Pharmacopeial Convention Pharmaceutical Compounding-Sterile Preparations USP-31 NF-26. 2007 The ASHP Discussion Guide on USP http://www.ashp.org/s_ashp/docs/files/DiscGuide797-2008.pdf

Any Questions? [email protected]

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