implementation of a personnel training and assessment program for the compounding of sterile...
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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
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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
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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
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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.”
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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
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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
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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
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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
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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
%
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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
%
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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
%
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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
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United States Pharmacopeia Chapter <797>
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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
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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.”
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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
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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
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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
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UKCMC Training and Assessment Program
• Didactic Lectures• Instructional Video• Computer based learning modules• Proctored media-fill challenge test and
assessment of aseptic technique
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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
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Instructional audio-video
• Available from ASHP
• Selected sections are viewed and associated workbook chapters are completed
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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
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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/
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Number of participants by group
43
11 30
Pharmacists Technicians Residents
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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
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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
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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/
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Media-Fill Challenge Results
80 (95%)
4 (5%)
Growth No Growth
*Micrococcus and Bacillus spp
*
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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
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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
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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
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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
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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