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1 Improved Parenteral Nutrition Safety. 2 Proper Catheter Care Improves Parenteral Nutrition Safety Major sources of IV device- related bloodstream infections.

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Presentation on theme: "1 Improved Parenteral Nutrition Safety. 2 Proper Catheter Care Improves Parenteral Nutrition Safety Major sources of IV device- related bloodstream infections."— Presentation transcript:

1 1 Improved Parenteral Nutrition Safety

2 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 BSI 1 –45% extraluminal, 26% intraluminal, 29% unknown Catheter care effectively reduces PN-related infections 2 Misunderstood risks should not deter clinicians from using PN 2 Source: Safdar N. Intensive Care Med. 2004;30: Dimick JB, et al. Am J Crit Care. 2003;12: Potential Sources of Infection Skin organisms Endogenous Skin flora Extrinsic HCW hands Contaminated disinfectant Contaminated Catheter hub Endogenous Skin flora Extrinsic HCW hands Contaminated Infusate Extrinsic Fluid Medication Intrinsic Manufacturer Fibrin sheath, thrombus Skin Vein Hematogenous From distant infection

3 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 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 –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: ; 2. Sunenshine RH. Clin Infect Dis. 2007;45(5): 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 died 2 Recent Patient Adverse Events From Compounded Solutions Cited by FDA 1,2

5 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 PN 1 –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 appropriateness 3 –Includes commercial PN products (eg, multi-chamber bags) # Errors per Month Related to PN 2 Source: 1. Seres, et al. JPEN. 2006; 2. ASPEN Task Force JPEN. 2004;28:6; 3. ASPEN Task Force JPEN. 2007;31(5): Survey Respondents (%)

6 6 Standardized PN Prescribing Reduces Medication Errors Source: USP Patient Safety CAPSLink Report February 2004 and March 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 error23 Omission21 Improper dose/quantity21 Unauthorized/wrong drug12 Drug prepared incorrectly9 Wrong time6 Extra dose3 Wrong patient3 Wrong administration technique2 Mislabeling1 Deteriorated product1 Wrong route0.36

7 7 Standardized PN Has Shown Comparable Electrolyte Management vs Customized Source: Hayes EM, et al. P&T. 2000;25: p=0.01 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, CO 2, Mg, PO 4, Cl) –WNL = % normal –ABN = % abnormal Significantly less electrolyte abnormalities with the standardized PN

8 8 Multi-Chamber Bag PN May Reduce Number of PN Compounding Errors Source: Flynn EA, et al. Am J Health-Syst Pharm. 1997;54: %Wrong base solution 7%Unauthorized drug 5%Wrong preparation technique Error Category Errors Wrong dose69% Omission3% 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

9 9 Source: 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 p=NS p<0.001 p= p=0.0001

10 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: Survey Response of PN Multi-Chamber Bag Use for Standard Formulas % MCB Use 44% % 80% SwitzerlandFranceBelgium

11 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 R-1 02/09


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