Risk Management in Parenteral Nutrition. J. Boullata

Transcription

1 Risk Management in Parenteral Nutrition J. Boullata

2 Objectives Upon completion of this session, the participant will be able to: Describe safety issues with parenteral nutrition (PN) Present the PN-use process including pharmacist roles Discuss the available safe practice guidelines for PN

3 June 2012 Risk Management in Parenteral Nutrition the U.S. Perspective J. Boullata, PharmD, RPh, BCNSP Professor of Pharmacology & Therapeutics Pharmacy Specialist, Clinical Nutrition Support Services Hospital of the University of Pennsylvania, Philadelphia, PA

4 Hospital of the University of Pennsylvania

5 Outline Risk-Benefit with PN The PN-Use Process Guidelines for Safe Practices Conclusion

6 Risk-Benefit with PN

7 Is Parenteral Nutrition Safe? NO YES

8 Parenteral Nutrition (PN) The most complex drug preparation available

9 Do PN Benefits Outweigh Risks? Risks Benefits

10 Complications of Using PN Mechanical Pneumothorax, hemothorax, air embolus, thrombosis, malposition, catheter occlusion Infectious Product contamination, line-related bacteremia Metabolic Poor glycemic control, hypertriglyceridemia, abnormal electrolytes, abnormal LFTs, metabolic bone disease, GI complications

11 Safe Initiation of Adult PN Requires new (or changed over wire) central access PN ordering guidelines on day #1 (prior to consult): Amino acids: 1 g/kg (~60 g) Glucose: 2-3 g/kg (~ kcal) Fat: g/kg (~ kcal) Regular electrolytes unless contraindicated Standard vitamins and trace elements

12 Complications of Using PN But more than just the PN preparation itself Some current practices in the PN-use process can place patients at some significant risk For example, NOT using standardized PN orders maintaining PN formula safety using dose warning limits in compounding avoiding parenteral misconnections administering other drugs appropriately

13 Complications of Using PN But more than just the PN preparation itself Some current practices in the PN-use process can place patients at some significant risk For example, NOT using standardized PN orders maintaining PN formula safety using dose warning limits in compounding avoiding parenteral misconnections administering other drugs appropriately

14 PN Sterility Compromised (adults) Mix-up of Sodium for Calcium (neonate)

15 Safety Summits American Society for Parenteral & Enteral Nutrition (A.S.P.E.N.) Parenteral nutrition safety summit proceedings: Institute for Safe Medication Practices (ISMP) Sterile preparation compounding safety summit proceedings: mments/default.asp

16 The PN-Use Process

17 PN-Use Process Dietitian, Nutrition Support Team Assess Review patient data Provide nutrition assessment Recommend nutrition care plan (PN) Communicate with prescriber Monitoring Mechanical Metabolic Patient outcome JPEN 2012;36:10S Prescriber Ordering PN Standardized order form Documentation Medical record Transitional care Administer the PN Order verification Access Infusion Infection control Nurse, Patient Caregiver Pharmacist PN Order Review/Verification Dosing appropriateness Stability & Compatibility Compounding Sterile preparation Product testing Dispense PN Labeling Delivery Storage Pharmacy Technician

18 PN-Use Process A Complex Process Benefits from standardization & communication at each node of the process

19 PN-Use Process A Complex Process Benefits from standardization & communication at each node of the process Document Outcomes Deviations from standard of care? PN-related medication errors?

20 PN-Use Process Dietitian, Nutrition Support Team Assess Review patient data Provide nutrition assessment Recommend nutrition care plan (PN) Communicate with prescriber Monitoring Mechanical Metabolic Patient outcome JPEN 2012;36:10S Prescriber Ordering PN Standardized order form Documentation Medical record Transitional care Administer the PN Order verification Access Infusion Infection control Nurse, Patient Caregiver Pharmacist PN Order Review/Verification Dosing appropriateness Stability & Compatibility Compounding Sterile preparation Product testing Dispense PN Labeling Delivery Storage Pharmacy Technician

21 INTERDISCIPLINARY NUTRITION CARE Dietitian, Nutrition Support Team Assess Review patient data Provide nutrition assessment Recommend nutrition care plan (PN) Communicate with prescriber Monitoring Mechanical Metabolic Patient outcome JPEN 2012;36:10S PN-Use Process Prescriber Ordering PN Standardized order form Documentation Medical record Transitional care Administer the PN Order verification Access Infusion Infection control Nurse, Patient Caregiver Pharmacist PN Order Review/Verification Dosing appropriateness Stability & Compatibility Compounding Sterile preparation Product testing Dispense PN Labeling Delivery Storage Pharmacy Technician

22 Consults EN/PN Orders Prescribers Nurses 800 consults per month Clinical Nutrition Support Services 22 FTEs 3100 patient interventions per month Home Team Team A Team B Team D Team E Team F Moon Team

23 Prescribing Survey Results (2011) 67% of PN orders are still being handwritten Only 26-35% order nutrients in amount-per-day Order Review A pharmacist is not always dedicated to review PN Very few PN orders seem to require clarification Compounding 64% of organizations use automated compounding devices but only 65% of them make use of alerts (i.e., dose warning limits)

24 Dispensing Survey Results (2011) Half don t keep PN refrigerated/out of light at least 75% of time between compounding and start of infusion Documentation 46% document PN review process on paper Med errors Transcription is required in >80% of organizations Frequency and node involved often not known Limited clinical effectiveness/quality improvement programs for PN

25 Safe Practice Issue 2003 (n=651) 2011 (n=895) Organizational Systems 5 PN admixtures daily 33% 50-82% Outsourcing of PN compounding 15% 21% Exclusive use of premixed PN products % Administer outside PN preparations 43% 25% Order Communication Standardized PN order form 88% 90% CPOE for PN 31% 33% Electronic interface available - - 7% Transcription required % Ordered in amount/day (or amount/kg/day) Macronutrient <19% 21-26% Electrolytes 39% 11-35% Order Review & Clarification Dedicated pharmacist time = 0 FTEs % 10% of orders requiring clarification 61% 69% PN Compounding ACD in use for PN preparations 22% 64% Order transcription to ACD required 84% 82% ACD active dose limits in place % PN admixture kept refrigerated/out of light % Administration Nurse has access to full PN order for review % Policy & procedure for IVFE administration 84% 65% Medication Errors & Documentation Performance improvement process 54% 40% Oversight of PN-use process % Aware of PN-related medication errors % Document PN order review process in MR %

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27 Guidelines for Safe Practices

28 JPEN 2004;28:S39

29 Sections Introduction Ordering Labeling Nutrient Requirements Sterile Compounding Stability & Compatibility Administration JPEN 2004;28:S39

30 Prescriber Ordering PN Standardized order form Standardized PN order process and forms: Reduce prescribing errors Provide prescriber education Improve efficiency & productivity Hosp Pharm 1980;15:511 / Nutr Supp Serv 1981;1:36 / Hosp Pharm 1986;21:648 / Nutrition 1990;6:457 / AJHP 1986;43:594 / Nutrition 1990;6:498 / Militar Med 1993;158:548 / Nutr Clin Pract 1997;12:30

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36 Pharmacist 3 Steps to Review the PN Order 1. Order verification 2. Order review clinical 3. Order review pharmaceutical PN Order Review/Verification Dosing appropriateness Stability & Compatibility Compounding Sterile preparation Product testing Dispense PN Labeling Delivery Storage Pharmacy Technician

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41 [INSERT SCFREEN PRINT OF SCM, DOCUMENTS, CLINICAL NUTRITION NOTE]

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44 Pharmacist Compounding Sterility Medium-risk sterile preparation Pharmacist responsibility Validated Methods Written policies & procedures Manual vs Automated Compounding Device AJHP 2000;57:1150 / AJHP 2000;57:1343 / JPEN 2004;28:S39 / Nutr Clin Pract 2008;23:189 / USP34 <797> / ISMP 2012 PN Order Review/Verification Dosing appropriateness Stability & Compatibility Compounding Sterile preparation Product testing Dispense PN Labeling Delivery Storage Pharmacy Technician

45 Pharmacist Labeling Should match elements of the order All active ingredients included Beyond-use date provided PN Order Review/Verification Dosing appropriateness Stability & Compatibility Compounding Sterile preparation Product testing Storage Refrigerate and keep out of light JPEN 2004;28:S39 / USP34 <797> / ISMP 2012 Dispense PN Labeling Delivery Storage Pharmacy Technician

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47 Match Label to the Order All critical elements Integrity of PN and Equipment Administration set, filter, pump Line Care Prevent complications Administer the PN Order verification Access Infusion Infection control Nurse, Patient Caregiver

48 Documents to Come A.S.P.E.N. Clinical Guidelines Editorial Board Evaluate data evidence-based guidelines to support safe PN-use process A.S.P.E.N. Task Force Common questions best practices for PN safety JPEN 2009;33:255 / JPEN 2012;36:77 / JPEN 2012;36:62S

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51 Conclusion

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53 Conclusions PN is a high-alert medication The PN-use process is complex It benefits from better standardization and communication at each step to improve safety The available safe practice guidelines for PN should be applied more widely in practice Pharmacists can support other health care providers with their critical roles in the PNprocess

54 Outline Risk-Benefit with PN The PN-Use Process Guidelines for Safe Practices Conclusion

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57 References American Society for Health-System Pharmacists. ASHP guidance on the safe use of automated compounding devices for the preparation of parenteral nutrition admixtures. Am J Health-Syst Pharm. 2000;57: Boitano M, Bojak S, McCloskey S, McCaul DS, McDonough M. Improving the safety and effectiveness of parenteral nutrition: results of a quality improvement collaboration. Nutr Clin Pract. 2010;25: Boullata JI. Overview of the parenteral nutrition use process. JPEN J Parenter Enteral Nutr. 2012;36(Suppl):10S-13S. Boullata JI, Guenter P, Kochevar M, Mirtallo JM. A parenteral nutrition use survey with gap analysis. JPEN J Parenter Enteral Nutr. (in review). Cohen MR. Safe practices for compounding of parenteral nutrition. JPEN J Parenter Enteral Nutr. 2012;36(Suppl 2):14S-19S. Compher CW, Boullata JI, Braunschweig CL, et al. Clinical guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients, JPEN J Parenter Enteral Nutr 2009;33: Druyan ME, Compher C, Boullata JI, et al. and the A.S.P.E.N. Board of Directors. Clinical guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients: applying the GRADE system to development of A.S.P.E.N. clinical guidelines. JPEN J Parenter Enteral Nutr 2012;36: Institute for Safe Medication Practices. Sterile preparation compounding safety summit proceedings, Accessed May 2012.

58 References Institute for Safe Medication Practices. TPN-related deaths call for FDA Guidance and Pharmacy Board oversight of USP Chapter <797>. 7 April Accessed May Mirtallo J, Canada T, Johnson D, et al. Safe practices for parenteral nutrition. JPEN J Parenter Enteral Nutr. 2004;28:S39-S70. Mirtallo JM. Drug-nutrient interactions in patients receiving parenteral nutrition. In: Boullata JI, Armenti VT (eds). Handbook of Drug-Nutrient Interactions. 2nd edition. New York, NY: Humana Press; 2010: National Advisory Group on Standards and Practice Guidelines for Parenteral Nutrition. Safe practices for parenteral nutrition formulations. JPEN J Parenter Enteral Nutr. 1998;22: O Neal BC, Schneider PJ, Pedersen CA, Mirtallo JM. Compliance with safe practices for preparing parenteral nutrition formulations. Am J Health-Syst Pharm. 2002;59: Sacks GS, Rough S, Kudsk KA. Frequency and severity of harm of medication errors related to the parenteral nutrition process in a large university teaching hospital. Pharmacotherapy. 2009;29: Seres D, Sacks GS, Pedersen CA, et al. Parenteral nutrition safe practices: results of the 2003 American Society for Parenteral and Enteral Nutrition survey. JPEN J Parenter Enteral Nutr. 2006;30: United States Pharmacopeia. USP general information chapter <797>: pharmaceutical compounding sterile preparations. U.S. Pharmacopeia/National Formulary, edition 35/30. Rockville, MD: United States Pharmacopeia Convention, Inc., 2012.

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