Transcript Essential Elements of Study Design

Implementation of a Personnel
Training and Assessment Program
for the Compounding of Sterile
Preparations
Philip Trapskin, PharmD
Pharmacy Practice Management Resident
KSHP 2005 Spring Meeting
May 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
True Story
5-11
Betamethasone
(BM) inj.
compounded
6-7
Swabs
taken at
pharmacy
grow
Serratia
5-31
More
BM injs.
given
5-29
14 pts.
receive BM
inj. for back
pain
5-30
First pt.
dies
6-2
Second
pt. dies
6-6
Autopsy finds
fist pt. died of
Serratia
meningitis; state
board of
pharmacy
notified and
pharmacy is
inspected
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
100%
90%
89.2%
80%
70%
60%
50%
40%
32%
30%
19.7%
20%
15.5%
10%
6.1%
0%
ASHP
ASPEN
CDC
FDA
USP
Morris et al. Am J Health-Syst Pharm 2003;60:2567-76
Which staff receive CSP training?
100
90
80
95.9
89
70
60
% 50
40
30
50.2
20
10
0
Pharmacists
Technicians
Nurses
Morris et al. Am J Health-Syst Pharm 2003;60:2567-76
What methods are used to train staff
in CSP preparation?
100
90
80
70
60
% 50
40
30
20
10
0
96.1
77.8
48.6
On-the-job training
Lectures and
Videotapes
Supervised lab
exercises
Morris et al. Am J Health-Syst Pharm 2003;60:2567-76
What areas are covered in training
of CSP preparation?
100
90
80
70
60
% 50
40
30
20
10
0
95.6
87.7
74.1
IV compounding
Labeling and
recordkeeping
Quality assurance
procedures
Morris et al. Am J Health-Syst Pharm 2003;60:2567-76
What methods were used to assess CSP
skills?
100
90
80
70
60
% 50
40
30
20
10
0
Assessment of
skills after
training
Direct observation
technique
Initial Assessment
Written tests
Media fill
validation
Follow-up Assessment
Morris et al. Am J Health-Syst Pharm 2003;60:2567-76
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 mediafill challenge testing initially and:
– Annually for personnel preparing low and mediumrisk 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 reevaluation 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 ongoing 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
30
11
43
Pharmacists
Technicians
Residents
Cumulative CBL Module Assessment Scores
Mean percentage of correct answerss
100
P<0.05
P<0.001
90
80
70
60
50
40
30
20
10
0
Pre-Aseptic
Post-Aseptic
Pre-USP797
Post-USP797
Math Assessment
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
Growth
No Growth
4 (5%)*
80 (95%)
*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 lowrisk-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