Implementation of a Personnel Training and Assessment Program

for the Compounding of Sterile Preparations

Philip Trapskin, PharmDPharmacy Practice Management Resident

KSHP 2005 Spring MeetingMay 19th, 2005

Objectives

• Review of the USP 797 standards related to personnel training and assessment

• Describe the personnel training and assessment program at the University of Kentucky Chandler Medical Center

• Discuss practical approaches and provide take home materials for the development and implementation of a training and assessment program at your institution

5-11 Betamethasone

(BM) inj. compounded

5-29 14 pts.

receive BM inj. for back

pain

6-2 Second pt. dies

5-30 First pt.

dies

True Story

5-31 More

BM injs. given

6-6 Autopsy finds fist pt. died of

Serratia meningitis; state

board of pharmacy

notified and pharmacy is

inspected

6-7 Swabs

taken at pharmacy

grow Serratia

6-8 38 pts. treated

with antibiotics; 10 hospitalized;

3 deaths

More Publicity

• 2002 “Painkiller suspected in fourth N.C. meningitis case.”

• 2003 “Enterobacter cloacae bloodstream infections in pediatric patients traced to a hospital pharmacy.”

• 2004 “Stirring Debate: As druggists mix customized brews, FDA raises alarm; ‘Compounders’ often meet special needs, but industry falls in regulatory gap; rare fungus in steroids.”

• 2005 “Safety concerns grow over pharmacy-mixed drugs.”

Why might contamination happen?

• Quality assurance for sterile preparations incurs costs.• Adequate quality assurance requires time and effort …

essential quality assurance functions for sterile preparation may not be performed adequately.

• Not all pharmacists believe in necessity of strict standards… “We have always done it this way”…

• Most pharmacists have not been adequately trained in the theory and practice of sterile product preparation. Training is often on the job and of uncertain adequacy…

Trissel. Am J Health-Syst Pharm 2003;60:432

What level of regulation is necessary?

• Lack of evidence for sterile-product preparation guidelines

• Reports of contamination in the literature lack relevance

• “Are pharmacists unconcerned about their patients’ safety or just not convinced of the need for sweeping changes”

• Education and training… more important than garb…

Kopcha. Am J Health-Syst Pharm 2004;61:1445-46

Where was the profession in 2002?

• National Survey of Quality Assurance Activities for Pharmacy-Compounded Sterile Preparations

• Written questionnaire to pharmacy directors• Survey sample of 600 hospitals in the U.S.• 182 (30.3%) of hospitals returned surveys• Survey designed to measure compliance with

2000 ASHP Technical Assistance Bulletin Compounded Sterile Products (CSP)

Morris et al. Am J Health-Syst Pharm 2003;60:2567-76

Which Guidelines are Used to Develop CSP Policies and Procedures

Morris et al. Am J Health-Syst Pharm 2003;60:2567-76

89.2%

32%

19.7%15.5%

6.1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

ASHP ASPEN CDC FDA USP

Which staff receive CSP training?

Morris et al. Am J Health-Syst Pharm 2003;60:2567-76

50.2

8995.9

0

10

20

30

40

50

60

70

80

90

100

Pharmacists Technicians Nurses

%

What methods are used to train staff in CSP preparation?

Morris et al. Am J Health-Syst Pharm 2003;60:2567-76

96.1

77.8

48.6

0

10

20

30

40

50

60

70

80

90

100

On-the-job training Lectures andVideotapes

Supervised labexercises

%

What areas are covered in training of CSP preparation?

Morris et al. Am J Health-Syst Pharm 2003;60:2567-76

95.687.7

74.1

0

10

20

30

40

50

60

70

80

90

100

IV compounding Labeling andrecordkeeping

Quality assuranceprocedures

%

What methods were used to assess CSP skills?

Morris et al. Am J Health-Syst Pharm 2003;60:2567-76

0102030405060708090

100

Assessment ofskills after

training

Direct observationtechnique

Written tests Media fillvalidation

%

Initial Assessment Follow-up Assessment

United States Pharmacopeia Chapter <797>

Selected Sections of Chapter <797>

• Personnel cleansing and gowning• Responsibilities of compounding personnel• Risk level classification of Compounded

Sterile Products (CSP) and quality assurance• Verification of accuracy and sterilization • Personnel training and assessment• Environmental quality and control• Equipment• Storage and beyond-use dating

Personnel Training and Assessment

“Personnel who prepare CSPs must be

provided with appropriate training from expert

personnel, audio-video instructional sources,

and professional publications in the theoretical

principles and practical skills of aseptic

manipulation before they begin to prepare

CSPs.”

Personnel Training and Assessment

• Compounding personnel shall perform didactic review, and pass written and media-fill challenge testing initially and: – Annually for personnel preparing low and medium-

risk level products

– Semi-annually for personnel preparing high-risk level products

• Media-fill tests must simulate the most challenging and stressful compounding products and conditions

Personnel Training and Assessment

• Media-fill challenge – Sterile bacterial culture medium transferred via a

variety of aseptic manipulations– Products are monitored for microbial growth indicated

by visual turbidity for 14 days

• Failure to successfully complete all components of the assessment requires re-instruction and re-evaluation before personnel are permitted to compound sterile products

Steps for Implementation

• Create training and assessment curriculum for your institution

• Obtain necessary references and materials• Create a system to document and track

personnel training status• Identify personnel that require training and

assessment• Train and assess personnel as part of an on-

going quality assurance process

UKCMC Training and Assessment Program

• Didactic Lectures• Instructional Video• Computer based learning modules• Proctored media-fill challenge test and

assessment of aseptic technique

Didactic Lectures

• Instructors– Pharmacist– Technician Supervisor

• Review of theoretical principles of aseptic technique and sterile compounding

• Review of practical skills of aseptic technique with hands-on simulations of common aseptic manipulations

• Provided over 3 separate 1-hour sessions

Instructional audio-video

• Available from ASHP

• Selected sections are viewed and associated workbook chapters are completed

Computer Based Learning Modules

• Administered via NetLearning® Software (Knoxville, TN)

• Personnel can access PowerPoint slide lectures via the internet

• Content created by UKCMC staff• Pre and post-test capabilities allow for the

assessment of learners and documentation via an electronic transcript

Computer Based Learning Modules

• USP <797> CBL curriculum includes:– Aseptic manipulations

• Review of definitions and theoretical principals and practical skills of aseptic manipulations

– Pharmacy Calculations• Review of definitions, common abbreviations and common

math calculations

– USP chapter <797> standards• Review of background for creation and overview of the

standards

– CBL slides are available at the UK Pharmacy Services Website www.hosp.uky.edu/pharmacy/

Number of participants by group

43

11 30

Pharmacists Technicians Residents

Cumulative CBL Module Assessment Scores

0

10

20

30

40

50

60

70

80

90

100M

ean

per

cen

tag

e o

f co

rrec

t an

swer

ss

Pre-Aseptic Post-Aseptic Pre-USP797 Post-USP797 Math Assessment

P<0.05 P<0.001

Media-Fill Challenge Test

• Proctored by one of two pharmacists• Assessment checklist developed to

standardize assessment• Simulated products included:

– Ampule to minibag– Vial to minibag– Vial to minibag via mini-spike– Syringe dilution

• Total number of manipulations >25

Media-Fill Challenge Test

• Soybean-Casein Digest Medium– Aerobic bacteria and fungi– Incubate at room temperature for 14 days

• Vendors– QI Medical http://www.qimedical.com/– Valiteq http://www.valiteq.com/

Media-Fill Challenge Results

80 (95%)

4 (5%)

Growth No Growth

*Micrococcus and Bacillus spp

*

Limitations

• Relatively small sample size for media-fill challenge tests

• Testing conditions for practical exam may bias (underestimate) true contamination rate– Attention bias or Hawthorne effect– Testing was scheduled not by surprise

Low-Risk-Level Contamination Rate

• Use of medium-fill simulation to simulate low-risk-level compounding– 1035 1-ml TB syringes filled with 0.9ml of medium– Performed by 2 CPhT in ISO 5 conditions

• No bacterial growth was detected in any of the 1035 syringes

• Contamination rate concluded to be <0.1%

Trissel. Am J Health-Syst Pharm 2003;60:1853-55

Medium-Risk-Level Contamination Rate

• Use of medium-fill simulation to simulate medium-risk-level compounding– Reconstitution of dry growth medium– Withdrawals from vials ampuls with syringes,

needles, a dispensing pin, and a filter straw– Transfers of the growth medium into an empty

plastic bag

• Of 539 evaluations over 2 years, 28 (5.2%) yielded microbial growth

Trissel. Am J Health-Syst Pharm 2005;62:800-03

Conclusions

• Training and assessment program successfully developed and implemented to meet USP standards

• CBLs able to teach key concepts and document understanding

• Lack of standard practice in aseptic manipulation techniques observed during assessments

• Media-fill growth rate for medium risk level preparations consistent with other reports in the literature

• Contamination rate of 5% would be unacceptable if extrapolated to all CSPs

Summary

• Focus on the basics• Training and assessment of aseptic

manipulations should be ongoing• Don’t reinvent the wheel• A good program does not need to break the

bank