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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) 7 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. 8 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 10 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 11