Transcript Slide 1

Improved Parenteral
Nutrition Safety
1
Proper Catheter Care Improves
Parenteral Nutrition Safety
• Major sources of IV devicerelated bloodstream infections
(BSI)1
– Colonization of the device
(catheter-related)
– Contamination of the infusate
• Prospective study of 1,098
patients showed 2.7% of CVC
BSI1
– 45% extraluminal, 26%
intraluminal, 29% unknown
• Catheter care effectively reduces
PN-related infections2
• Misunderstood risks should not
deter clinicians from using PN2
Potential Sources of Infection
Contaminated
Catheter hub
Skin organisms
Endogenous
Skin flora
Extrinsic
HCW hands
Contaminated
disinfectant
Endogenous
Skin flora
Extrinsic
HCW hands
Fibrin sheath,
thrombus
Contaminated
Infusate
Skin
Vein
Extrinsic
Fluid
Medication
Intrinsic
Manufacturer
Hematogenous
From distant infection
Source: Safdar N. Intensive Care Med. 2004;30:62-67.
Dimick JB, et al. Am J Crit Care. 2003;12:328-335.
2
Multi-Chamber Bag Premix Offers an
Alternative to Compounded PN
Pharmacy Compounded Bag
• Customized combining, mixing, or
altering of ingredients
• State-regulated
• Follow USP 797 compounding
standards
Multi-Chamber Bag (MCB)
• Products produced by pharmaceutical
companies
• FDA-regulated
• Commercially manufactured
– Follows Good Manufacturing
Practices (GMPs)
• Expiration dating 2 years (in
unopened package)
3
Outbreak of Bloodstream Infections (BSI)
Associated With Compounded Injections
• Multiple outbreaks of infection
caused by contaminated
compounding preparations
• Compounding under heavy
scrutiny
• FDA aware of >200 adverse
events (AE’s) with compounded
products since 19902
– Reported AE’s resulted in
recalls, patient injury, and death
– Consumers should ask doctor if
an FDA approved drug is
available vs compounded
solutions
Recent Patient Adverse Events From
Compounded Solutions Cited by FDA1,2
• March 2006: Warning Letter issued to
compounding firm after 3 patients died of
infections from contaminated solutions
• August 2005: nationwide FDA recall; 2
patients at a D.C. VA hospital were blinded,
others with eyesight damaged from
bacteria contamination of product for
cataract surgery
• March 2005, FDA nationwide alert of
bloodstream infection breakouts from
contaminated magnesium sulfate causing
5 cases of bacterial infection; 1 death
• June 2001, Single site outbreak of 11
patients in 2001 (betamethasone); 3 died2
Source: 1. Civen R. Clinical Infectious Diseases. 2006;43:831-837;
2. www.fda/gov/consumer/updates/compounding053107.html; Sunenshine RH.
Clin Infect Dis. 2007;45(5):527-533.
4
PN-Related Ordering and Compounding
Errors Are Common
• ASPEN survey on PN ordering
and compounding (n = 651)1
# Errors per Month
Related to PN2
– 88% use standardized PN
order forms
– PN electrolytes 71% of errors
• 46% reported AE’s related to PN
– 35% required increase
monitoring, 25% resulted in
harm, 3.3% near death,
1.5% death
• Standardization for PN must be
explored to improve patient
safety, clinical appropriateness3
– Includes commercial PN
products (eg, multi-chamber
bags)
60
Survey Respondents (%)
• Almost 2/3 observed 1-5
errors/month related to PN1
70
60
50
40
30
26
20
10
10
4
0
0
1-5
6-10
>10
Source: 1. Seres, et al. JPEN. 2006; 2. ASPEN Task Force JPEN. 2004;28:6; 3. ASPEN
5
Task Force JPEN. 2007;31(5):441-448.
Standardized PN Prescribing
Reduces Medication Errors
• 2004 MEDMARX report showed
patient harm resulted in 4.4% of
reported PN errors (n = 2,519)
–
–
Compared to 2.5% harm rate for all
MEDMARX error reports
71% errors prescribing, transcribing,
administration
• Medication Error Reporting (MER)
show PN harm rate 18% (vs 14%
overall)
–
Dispensing problems with automated
compounding devices and labeling
• 2008 MEDMARX report shows 60%
of injection compounding errors
(n = 70) involved PN
• Suggestions for improved PN safety
–
–
–
–
–
Standardized order forms
Validate hospital compounding
Policies for outsourcing
Visually inspect bags
Catheter care policy
Types of All Compounded Drug
Preparation Errors (2008)
Type of Error (n = 277)
Prescribing error
Omission
Improper dose/quantity
Unauthorized/wrong drug
Drug prepared incorrectly
Wrong time
Extra dose
Wrong patient
Wrong administration technique
Mislabeling
Deteriorated product
Wrong route
Source: USP Patient Safety CAPSLink Report February 2004 and March 2008.
%
23
21
21
12
9
6
3
3
2
1
1
0.36
6
Standardized PN Has Shown Comparable
Electrolyte Management vs Customized
• Prospective study at academic
hospital of 4 standard formulations
PN Electrolytes Within Normal
Limit (WNL) vs Abnormal (ABN)
– Peripheral, central, high stress,
fluid restricted
– Patient acuity not controlled
80
– WNL = % normal
– ABN = % abnormal
• Significantly less electrolyte
abnormalities with the
standardized PN
Source: Hayes EM, et al. P&T. 2000;25:78-87.
67
ABN
60
PN, %
• Laboratory electrolytes
(Na, K, CO2, Mg, PO4, Cl)
WNL
73
70
• Compare metabolic parameters
– Standard 76%
– Customized 24%
p=0.01
50
40
30
33
27
20
Standard Solutions Custom Solutions
(n = 2234)
(n = 1391)
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Multi-Chamber Bag PN May Reduce
Number of PN Compounding Errors
• Compounding errors in 1,679
IV doses at 5 large US acute
care hospitals
– Considered “progressive”
hospitals
– Academic, not-for-profit,
for-profit
• Mean compounding error
rate 9%
• PN compounding errors
highest (26%) of all products
• Ready-to-use products (0.3%
error rate) may reduce PN
errors by decreasing
Type of Errors Observed in
Compounded IV Admixtures
Error Category
Errors
Wrong dose
69%
Wrong base solution
16%
Unauthorized drug
7%
Wrong preparation technique
5%
Omission
3%
– # preparation steps
– Dose calculations
Source: Flynn EA, et al. Am J Health-Syst Pharm. 1997;54:904-912.
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Multi-Chamber Bag PN Can Effectively
Substitute Compounded Formulas
• Retrospective study 100 patients
to assess PN formula substitution
with multi-chamber bag (MCB)
1000
p<0.001
p=0.0075
500
p=NS
86
290 316
86
228 194
Source: Banchik LH. Nutr Clin Pract. 2005;20:153.
Vo
lu
m
e(
m
)
Li
pi
ds
(g
m
)
(g
m
L)
0
)
– Volume ↑ may preclude use in
fluid-restricted patients
1500
Ca
rb
oh
yd
ra
te
– 3 PTPN products met all TNA
formula needs
1665
(g
m
• PTPN can effectively replace
TNA in some patients
1920
1784 1803
Pr
ot
ein
• Formulas matched by nutrition
content and volume
2000
(k
ca
l)
– 20% lipid sol. added
if needed
p=0.0001
p=NS
rie
s
– MCB TPN (PTPN): dextrose+A.A.
2500
Ca
lo
– Total Nutrition Admixture (TNA):
compounded PN
Formula Comparison Between
TNA and MCB TPN (PTPN)
9
Multi-Chamber Bag PN Formulations
Are Widely Used in Europe
• Hospital pharmacy survey
of MCB use in 3 European
countries
Survey Response of PN
Multi-Chamber Bag Use for
Standard Formulas
• Adult PN represented the
main type of prescription
90
• >80% use of MCB in
Switzerland and France
– 3-chamber bag not
available in the US
• Limiting the use of
customized PN formulas to
decrease compounding
error rates
80%
80
70
% MCB Use
– MCB includes 2- and 3chamber bags
83%
60
44%
50
40
30
20
10
0
Switzerland
Source: Maisonneuve N, et al. Nutr. 2004;20:528-535.
France
Belgium
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Improved Parenteral Nutrition Safety
• Proper insertion and care of catheters are essential to
reduce risk of infection
• Multi-chamber bag PN may lower risk of infection related
to contamination compared to compounded solutions
• Standardized multi-chamber bag PN may reduce errors
associated with prescribing and transcription
801033R-1 02/09
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