Transcript Pharmacy Solution Errors in CRRT

CRRT Complications
and Troubleshooting
Objectives
At the end of this presentation, the health care
provider will be able to:
• List the potential errors associated with
pharmacy prepared solutions
• Review actual errors associated with CRRT
solutions that have occurred in different
institutions
• Apply the information to a case study
Potential for Errors in CRRT
• Physician errors when using non standard
orders for dialysate or replacement solutions
• Nursing administration errors in choice of
solutions
• Pharmacy transcription errors in dialysate
orders
• Pharmacy calculation errors in compounding
• Pharmacy product selection errors in
compounding
NEED FOR STANDARD ORDERS
Administration Errors
• Confusion of calcium chloride infusion bags
for sodium bicarbonate replacement solution
bags
• Labeling of calcium chloride infusion bags
with bright fluorescent stickers by pharmacy
• Separation of replacement fluids from
calcium chloride bags in separate bins
Administration Errors
• Nursing mixed concentrated Normocarb
dialysate with normal saline instead of sterile
water
• Pharmacy mixing of Normocarb?
Dialysate Compounding Errors
Foothills Medical Centre, Calgary Health Region
– 83 yo female in CV ICU died suddenly in the
presence of family and physicians
– ICU physician suspected dialysate used for CRRT
– An analysis of dialysate solutions revealed
potassium chloride was used in place of sodium
chloride
– Attributed to another death that occurred one week
prior
Foothills Medical Centre, CHR
• 3 liter bags prepared in batches of 36 bags
• Dialysate concn Na 110 mEq/L, Mg 0.7
mEq/L
• Prepared by 4 pharmacy technicians involved
in setup and documentation, checking of
setup, product transfer, final check
• No empty bottle verification against
worksheet
• No pharmacist check of final product
Foothills Medical Centre, CHR
• At FMC, 34% of the pharmacy staff were
pharmacists
• National averages are 44% pharmacists
• “Tech check tech” delegation endorsed by
CSHP
• Over delegation of pharmacist
responsibilities?
CHR Recommendations
“The feasibility of using commercially prepared
dialysate solutions be explored.”
“When patient care issues necessitate that inhouse manufacturing of complex preparations
be undertaken, process mapping be used to
simplify the processes as much as possible.”
FDA Labeling Changes
Death due to the accidental misadministration of
concentrated KCl Injection led to:
– Changing the official USP name to Potassium
Chloride for Injection Concentrate (emphasis added)
– Labels must now bear a boxed warning
"Concentrate: Must be Diluted Before Use;"
– The cap must be black in color (the use of black caps
is restricted to this drug product only)
– The cap must be imprinted in a contrasting color with
the words, "Must be Diluted."
Different Perspectives
• According to ISMP survey, 91% nurses vs
98% pharmacists consider IV KCL to be a
high alert medication
• 73% nurses vs 94% pharmacists consider
hypertonic sodium chloride inj to be a high
alert medication
Time Requirements
• Pharmacy needs advanced notice to prepare
dialysate, replacement fluids, calcium
chloride, citrate infusions
• Often the same patient requires pressors that
need to be mixed by pharmacy
• Daily rounding and ordering of solutions by
ICU pharmacist to determine need
USP 797
• Immediate Use Exemption from ISO Class 5
(Class 100)
• Three or fewer sterile products may be
prepared in worse than ISO Class 5 air when
there is no direct contact contamination, and
administration begins within 1 hour and is
completed within 12 hours of preparation.
USP 797
• Need for aseptic preparation?
– IHD data on bicarbonate dialysate
• Bacterial growth and endotoxin production
• Sterile versus non sterile dialysate
• IL 1 production
– Interleukin hypothesis
Water and Dialysate Quality
Classification Bacterial
Growth
cfu/mL
AAMI
2000
dialysate
AAMI water
200
Endotoxin
EU/mL
Cytokine
induction
5
+
5
+
Tap water
100
0.25
+
Ultra-pure
0.1
0.03
-
Sterile
10-6
0.03
-
Case Study
• What happened?
• Analysis of the replacement fluid revealed
that the NaHCO3 was never placed in the
solution and the total Na was 105 mEq/L
Case Study
• Root Cause Analysis
– Why was sodium bicarbonate not added to the
solution?
– Are the replacement solutions prepared in batches or
on a patient by patient basis?
– What is the process for pharmacy set-up,
preparation, final check and documentation?
– Are the products and syringes made available for
final check?
– Is the pharmacist involved in checking the final
product?
Extemporaneous Compounded
Solutions
Solution
Na
K
Cl
HCO3
Ca
PO4
Mg
Dextrose
UCSD,
Mehta
117
0-5
121.5
0-40
0
0
1.5
mEq/
L
0.1%
Cleveland
Clinic,
LeBlanc/
Paganini
144
3-4
107
37
3
0
1.4
mg/
dL
N/A
U of
Michigan
135
Per
order
110
25
0
2.35
mg/
dL
1.8
mg/
dL
0
*mEq/L unless otherwise stated
Comparison of Commercial
Dialysate
PO4 Mg
Dextrose
Solution
Na
K
Cl
HCO3 Lactate Ca
RL
130
4
109
0
28
1.5 0
0
0
1.5% PD
132
0
96-102 0
40
1.5 0
0.51.5
83
mmol/L
Normocarb
140
0
106.5
35
0
0
0.75 0
Baxter HF
140
2
117
0
30
1.5 0
0
0.75 55
mmol/L
Solution
Na
K
Cl
HCO3
Lactate
Ca
Mg
Glucose
mg/dL
Prismasate
BK0/3.5
140
0
109.5
32
3
3.5
1
0
Prismasate
BGK2/0
140
2
108
32
3
0
1
110
Prismasate
LGK0/2.5
140
0
109
0
35
2.5
1.5
110
Prismasate
BGK4/2.5
140
4
113
32
3
2.5
1.5
110
Prismasate
B25GK4/0
140
4
120.5
32
3
0
1.5
110
Prismasate
BK2/0
140
2
108
32
3
0
1
0
Recommendations
• Use commercially available products whenever
feasible
• Standard physicians orders for CRRT solutions
• Separate look alike drugs in the pharmacy
• Ensure process for pharmacy prepared
solutions is mapped out
• Ensure pharmacist is the final check!
• Training, training, training!
• Label and separate solutions at the bedside in
appropriate bins