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Improved Parenteral Nutrition Safety

Improved Parenteral Nutrition Safety. Proper Catheter Care Improves Parenteral Nutrition Safety . Potential Sources of Infection. Contaminated Catheter hub Endogenous Skin flora Extrinsic HCW hands. Major sources of IV device-related bloodstream infections (BSI) 1

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Improved Parenteral Nutrition Safety

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  1. Improved ParenteralNutrition Safety

  2. Proper Catheter Care Improves Parenteral Nutrition Safety Potential Sources of Infection • Contaminated • Catheter hub • Endogenous • Skin flora • Extrinsic • HCW hands • 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 Skin organisms Endogenous Skin flora Extrinsic HCW hands Contaminated disinfectant • Contaminated • Infusate • Extrinsic • Fluid • Medication • Intrinsic • Manufacturer Fibrin sheath,thrombus Skin Vein • 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.

  3. 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) Multi-Chamber Bag Premix Offers an Alternative to Compounded PN

  4. Outbreak of Bloodstream Infections (BSI)Associated With Compounded Injections Recent Patient Adverse Events From Compounded Solutions Cited by FDA1,2 • 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.

  5. PN-Related Ordering and Compounding Errors Are Common # Errors per Month Related to PN2 • 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) Survey Respondents (%) Source: 1. Seres, et al. JPEN. 2006; 2. ASPEN Task ForceJPEN. 2004;28:6; 3. ASPEN Task Force JPEN. 2007;31(5):441-448.

  6. Standardized PN Prescribing Reduces Medication Errors Types of All Compounded Drug Preparation Errors (2008) Type of Error (n = 277) % Prescribing error 23 Omission 21 Improper dose/quantity 21 Unauthorized/wrong drug 12 Drug prepared incorrectly 9 Wrong time 6 Extra dose 3 Wrong patient 3 Wrong administration technique 2 Mislabeling 1 Deteriorated product 1 Wrong route 0.36 • 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 Source: USP Patient Safety CAPSLink Report February 2004 and March 2008.

  7. Standardized PN Has Shown Comparable Electrolyte Management vs Customized PN Electrolytes Within Normal Limit (WNL) vs Abnormal (ABN) • 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 p=0.01 PN, % Source:Hayes EM, et al. P&T. 2000;25:78-87.

  8. Multi-Chamber Bag PN May Reduce Number of PN Compounding Errors 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% • 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 Source: Flynn EA, et al. Am J Health-Syst Pharm. 1997;54:904-912.

  9. Multi-Chamber Bag PN Can Effectively Substitute Compounded Formulas Formula Comparison Between TNA and MCB TPN (PTPN) • 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=0.0001 p=NS p<0.001 p=0.0075 p=NS Source: Banchik LH. Nutr Clin Pract. 2005;20:153.

  10. Multi-Chamber Bag PN Formulations Are Widely Used in Europe 90 83% 80% 80 70 60 50 40 30 20 10 0 Switzerland France Belgium Survey Response of PN Multi-Chamber Bag Use for Standard Formulas • 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 44% % MCB Use Source: Maisonneuve N, et al. Nutr. 2004;20:528-535.

  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 801033R-1 02/09

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