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Chapter 1

Sterile Compounding as a Pharmacy Technician

2012 Paradigm Publishing

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Learning Objectives Gain awareness of the historical roots of pharmacy and sterile

compounding. Define sterile compounding and aseptic technique. Describe the ways in which sterile compounding and aseptic technique

processes may affect patient health and safety. Define the objectives of USP Chapter <797>. Understand the training requirements for pharmacy technicians who

prepare sterile products, and describe the process validation tool used for technique evaluation.

Recognize various quality assurance and end-product testing procedures. Determine appropriate responses to medication safety questions. Demonstrate an awareness of the ethical issues in pharmacy.

2012 Paradigm Publishing

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Topics Learning Objectives Sterile Compounding Aseptic Technique Roles and Responsibilities of IV Technicians The Effect of Aseptic Technique on Patient Health and Safety USP Training and Testing Requirements Process Validation Quality Assurance Medication Safety Monitoring of Medication Errors Ethical Issues in Pharmacy Practice Chapter Summary

2012 Paradigm Publishing

In Slide Show view, click the desired topic to the left to link directly to the related slide. To return to this slide at any point in the presentation, click the Topics button below.

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Sterile Compounding

Sterile compounding involves the dilution, mixing, and injection of various medication products using aseptic technique

2012 Paradigm Publishing

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Aseptic Technique

Aseptic technique is performed by sterile compounding personnel or sterile products personnel

Vital to the compounding process to avoid the introduction of pathogenic organisms or other contaminants into a sterile environment or preparation

2012 Paradigm Publishing

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Aseptic Technique…/2

Failure to follow the protocol of aseptic technique may lead to microbial contamination of the medicationresulting in serious illness or, possibly, death of patient

recipients due to infection It is critical for patient health and safety that you, as

a pharmacy technician, become well-versed in aseptic technique and the procedures for sterile compounding

2012 Paradigm Publishing

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Roles and Responsibilities of IV Technicians

Pharmacy technicians play a major role in preparing compounded sterile preparations (CSPs) in pharmacies

Specialized technicians are largely responsible for preparing injectable medications for patients in hospital and home healthcare settingsoften referred to as sterile compounding technicians,

intravenous (IV) admixture technicians, or simply IV technicians

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Roles and Responsibilities of IV Technicians…/2

Injectable medications may be delivered to the patient via parenteral routes of administrationrefers to the method of medication administration by any

route other than through the alimentary canal including the IV, intramuscular (IM), subcutaneous (Sub-Q), and intrathecal (IT) routes

majority of medications prepared by sterile compounding technicians are administered through an IV

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Roles and Responsibilities of IV Technicians…/3

Parenteral solutions are sterile, injectable solutions that are administered by one of the parenteral routes of administration

CSPs are comprised of small-volume or large-volume parenteral solutions to which a medication or additive has been added

2012 Paradigm Publishing

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Roles and Responsibilities of IV Technicians…/4

Typical Volume for Various Routes of Administration*Intradermal (ID) ≤ 0.1 mLSub-Q ≤ 1 mLIM ≤ 3 mLIT 1 mL–10 mL (larger volumes may be administered via syringe pump or epidural cassette pump)IV Push (IVP) 1 mL–60 mL (volumes ≥ 10 mL are usually administered via syringe pump)IVPB 25 mL–250 mL (infusion rate controlled via tubing’s roll clamp or IV pump)IV > 250 mL (infusion rate controlled via IV pump)

*volumes may vary according to the age or size of the patient and the dosing guidelines

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Roles and Responsibilities of IV Technicians…/5

Small-volume CSPs are those ranging from less than 1 mL to as much as 250 mLsome are administered by intravenous piggyback (IVPB)

Often, a drug is diluted in powder form with a solvent such as sterile water or normal saline (NS)diluted drug is drawn into syringe and injected into sterile

IVPB base solution such as dextrose 5% in water (D5W) or 0.9% sodium chloride (NS)

nurse then injects the final prepared solution

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Roles and Responsibilities of IV Technicians…/6

Large-volume CSPs are 500 mL or greater and are infused parenterally by the IV route of administration

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Roles and Responsibilities of IV Technicians…/7

Prior to the 1980s, most CSPs were prepared at the patient’s bedside by a doctor or nurse

Since then, most CSPs have been prepared in the pharmacy

The use of the laminar airflow workbench (LAFW) has also become commonplace

In 2008, revisions to USP Chapter <797> led to sweeping changes in sterile compounding practices and set forth requirements for training and testing

2012 Paradigm Publishing

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The Effect of Aseptic Technique on Patient Health and Safety

Correct sterile compounding and aseptic technique are essential to patient health and safety

To ensure that these aseptic practices are strictly followed, sterile compounding technicians must undergo frequent and comprehensive evaluations

These safeguards not only prevent medication errors but hold technicians to the highest quality-control standards

2012 Paradigm Publishing

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The Effect of Aseptic Technique on Patient Health and Safety…/2

United States Pharmacopeia (USP) oversees quality control of pharmacy practices by establishing public standards for the preparation and dispensing of prescription and over-the-counter medications

Guidelines set forth by the USP are used by government agenciesdetermine whether or not healthcare institutions receive

government reimbursement for their products

2012 Paradigm Publishing

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Your Turn

2012 Paradigm Publishing

1) The majority of medications prepared by sterile compounding technicians are administered through this route.a. Sub-Qb. ITc. IVd. IM

2) In 2008, revisions to this USP Chapter led to sweeping changes in sterile compounding practices.a. <979>b. <797>c. <676>d. <767>

In Slide Show view, click here to see the answer to Question 1. Then click again to advance to Question 2.

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USP

USP Pharmacists’ Pharmacopeia is an official publication whose guidelines are a mainstay for both pharmacists and pharmacy techniciansoffers valuable information

on nearly every aspect of pharmacy practice

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USP…/2

The most relevant part to sterile compounding and aseptic technique is the chapter titled “Chapter <797> Pharmaceutical Compounding – Sterile Preparations”includes importance of beyond-use dating (BUD)also identifies four specific risk levels for CSPs: low-risk

level, medium-risk level, high-risk level, and immediate use designates the types of preparations that may be

compounded and the special training and testing required for sterile compounding personnel

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USP…/3

USP produced a supplemental guidebook for sterile compounding personnel titled USP <797> Guidebook to Pharmaceutical Compounding – Sterile Preparationscommonly referred to as the

USP <797> Guidebook

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Training and Testing Requirements

Most states now require that pharmacy technicians pass a national certification examPharmacy Technician Certification Exam (PTCE) is offered

by the Pharmacy Technician Certification Board (PTCB) and accepted by all of the U.S. Boards of Pharmacy

Exam for the Certification of Pharmacy Technicians (ExCPT) is offered by the Institute for the Certification of Pharmacy Technicians (ICPT), is currently accepted by only a portion of the State Boards of Pharmacy

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Training and Testing Requirements…/2

Some agencies develop guidelines for trainingAccreditation Council on Pharmacy Education (ACPE)American Society of Health-Systems Pharmacists (ASHP)American Pharmacists Association (APhA)Board of Pharmacy for each individual state

Many refer to USP Chapter <797> as a guideline for developing policies

Another tool widely used is the ASHP’s Model Curriculum for Pharmacy Technician Training

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Training and Testing Requirements…/3

It is considered best practice that all personnel complete an ACPE-accredited training program in sterile product preparation and aseptic technique

Sterile compounding technicians should either be experienced and knowledgeable pharmacy technicians who have good backgrounds in math and science, or students who have graduated from well-designed pharmacy technician schools or training programs

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Training and Testing Requirements…/4

Students should receive a minimum of forty hours of hands-on training

Employees should receive a minimum of forty hours of practical on-the-job training and must pass intensive process validation evaluations and quality assurance testing

USP Chapter <797> requires annual recertification

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Process Validation

During process validation, instructors observe, critique, and grade students’ technique on specialized process validation checklistssterile garbing and glovinghorizontal laminar airflow hood cleaningvial preparationampule preparationlarge-volume parenteral preparation

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Process Validation…/2

Once you become a sterile compounding technician, the process validation checklists continue to serve you as a valuable tool—a study aid to help you prepare for your initial and annual competency tests

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Quality Assurance

Sterile compounding personnel must also undergo various quality assurance proceduresnegative-growth fingertip testproperly clean and disinfect a hoodaseptic technique testing kitend-product testing

All personnel who prepare sterile products should successfully complete process validation and an aseptic technique testing kit at least once a year

2012 Paradigm Publishing

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Quality Assurance…/2

The media-fill kit is one of the most commonly used aseptic technique testing kits

If the person being tested has a break in technique, the aseptic technique testing kit will indicate that error in technique

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Medication Safety

Any breach of established guidelines could lead to a medication error

Verify the five patient “rights” of correct drug administration: right patient, right drug, right dose, right route, and right time

Medication errors typically involve incorrect drugs (“right drug” errors) or errors in pharmacy calculations (“right dose” errors)

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Monitoring of Medication Errors

Several organizations track medication errorsThe Institute for Safe Medication Practice (ISMP) is a

nonprofit organization that educates the healthcare community and consumers about safe medication practices

MedWatch, a voluntary program of the Food and Drug Administration (FDA), supports healthcare workers in the reporting of medication errors and adverse drug effects (ADEs)

The Joint Commission has several programs designed to decrease medication errors and improve patient safety

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Monitoring of Medication Errors…/2

Every pharmacy has its own policies and procedures in place to reduce medication errors and encourage error reportingexamine the system that allowed the error to occur, rather

than placing blame on the individual responsible for the error

Once processes have been put in place to reduce the chance of error, individuals are then held responsible for adhering to those improved processes

2012 Paradigm Publishing

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Ethical Issues in Pharmacy Practice

Each state’s Board of Pharmacy provides legal guidelines and oversight for pharmacy-practicemost states have regulations defining mandatory error

reporting procedures The American Association of Pharmacy Technicians

(AAPT) has published the Code of Ethics for Pharmacy Techniciansserves as a standard for technicians faced with ethical and

legal decisions

2012 Paradigm Publishing

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Ethical Issues in Pharmacy Practice…/2

Many pharmacy technician training programs develop a code of ethics for pharmacy techniciansfrequently part of a training program’s student handbook

and is sometimes recited by students during the program’s graduation ceremony

outlines and defines the ethical responsibilities of the pharmacy technician, often including guidelines that promote patient health and safety and encourage honest and dependable actions by the pharmacy technician

2012 Paradigm Publishing

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Your Turn

2012 Paradigm Publishing

3) How many patient “rights” of correct drug administration are there?a. 5b. 6c. 7d. 8

4) This association has published the Code of Ethics for Pharmacy Technicians.a. APTTb. APPTc. APATd. AAPT

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