1

Improved ParenteralNutrition Safety

2

Proper Catheter Care Improves Parenteral Nutrition Safety

• Major sources of IV device-related 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

Source: Safdar N. Intensive Care Med. 2004;30:62-67. Dimick JB, et al. Am J Crit Care. 2003;12:328-335.

Potential Sources of Infection

Skin organismsEndogenous Skin floraExtrinsic HCW hands Contaminated disinfectant

ContaminatedCatheter hub

Endogenous Skin floraExtrinsic HCW hands

ContaminatedInfusate

Extrinsic Fluid MedicationIntrinsic Manufacturer

Fibrin sheath,thrombus Skin

Vein

HematogenousFrom distant infection

3

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)

4

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

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.

• 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

Recent Patient Adverse Events From Compounded Solutions Cited by FDA1,2

5

PN-Related Ordering and Compounding Errors Are Common

• ASPEN survey on PN ordering and compounding (n = 651)1

– 88% use standardized PN order forms

• Almost 2/3 observed 1-5 errors/month related to PN1

– 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)

26

60

104

0

10

20

30

40

50

60

70

0 1-5 6-10 >10

# Errors per Month Related to PN2

Source: 1. Seres, et al. JPEN. 2006; 2. ASPEN Task Force JPEN. 2004;28:6; 3. ASPEN Task Force JPEN. 2007;31(5):441-448.

Sur

vey

Res

pond

ents

(%

)

6

Standardized PN Prescribing Reduces Medication Errors

Source: USP Patient Safety CAPSLink Report February 2004 and March 2008.

• 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 23Omission 21Improper dose/quantity 21Unauthorized/wrong drug 12Drug prepared incorrectly 9Wrong time 6Extra dose 3Wrong patient 3Wrong administration technique 2Mislabeling 1Deteriorated product 1Wrong route 0.36

7

Standardized PN Has Shown Comparable Electrolyte Management vs Customized

Source: Hayes EM, et al. P&T. 2000;25:78-87.

p=0.01

67

2733

73

20

30

40

50

60

70

80

Standard Solutions(n = 2234)

Custom Solutions(n = 1391)

WNL

ABN

PN Electrolytes Within Normal Limit (WNL) vs Abnormal (ABN)

PN

, %

• Prospective study at academic hospital of 4 standard formulations – Peripheral, central, high stress,

fluid restricted

– Patient acuity not controlled

• Compare metabolic parameters– Standard 76%

– Customized 24%

• Laboratory electrolytes (Na, K, CO2, Mg, PO4, Cl)

– WNL = % normal

– ABN = % abnormal

• Significantly less electrolyte abnormalities with the standardized PN

8

Multi-Chamber Bag PN May Reduce Number of PN Compounding Errors

Source: Flynn EA, et al. Am J Health-Syst Pharm. 1997;54:904-912.

16%Wrong base solution

7%Unauthorized drug

5%Wrong preparation technique

Error CategoryError Category ErrorsErrors

Wrong dose 69%

Omission 3%

Type of Errors Observed in Compounded IV Admixtures

• 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– # preparation steps

– Dose calculations

9Source: Banchik LH. Nutr Clin Pract. 2005;20:153.

Formula Comparison Between TNA and MCB TPN (PTPN)

Multi-Chamber Bag PN Can Effectively Substitute Compounded Formulas

• Retrospective study 100 patients to assess PN formula substitution with multi-chamber bag (MCB)

– Total Nutrition Admixture (TNA): compounded PN

– MCB TPN (PTPN): dextrose+A.A.

– 20% lipid sol. added if needed

• Formulas matched by nutrition content and volume

• PTPN can effectively replace TNA in some patients

– 3 PTPN products met all TNA formula needs

– Volume ↑ may preclude use in fluid-restricted patients

1784

86

290 228

16651803

86

316194

1920

0

500

1000

1500

2000

2500

p=NS

p=NS

p<0.001p=0.0075

p=0.0001

10

Multi-Chamber Bag PN Formulations Are Widely Used in Europe

• Hospital pharmacy survey of MCB use in 3 European countries

• Adult PN represented the main type of prescription

• >80% use of MCB in Switzerland and France

– MCB includes 2- and 3-chamber bags

– 3-chamber bag not available in the US

• Limiting the use of customized PN formulas to decrease compounding error rates

Source: Maisonneuve N, et al. Nutr. 2004;20:528-535.

Survey Response of PN Multi-Chamber Bag Use for

Standard Formulas

% M

CB

Use

44%

0

10

20

30

40

50

60

70

80

90 83%80%

Switzerland France Belgium

11

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

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