Pharmaceutical risk management strategies for parenteral nutrition. J. Eastwood (UK)

Transcription

1 ESPEN Congress Leipzig 2013 Pharmaceutical Session Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood (UK)

2 Pharmaceutical risk management strategies for parenteral nutrition Jackie Eastwood Pharmacy Manager, St Mark s Hospital Chair, British Pharmaceutical Nutrition Group

3 Evening Standard 27 April 2007 Hospital blunder over sugar that killed twin baby

4 Baby Jada Very premature twin transferred to Chelsea and Westminster Hospital PN made by an Automix compounder

5 Baby Jada Prescription 27.4 ml vaminolact, 24.2 ml glucose & 111 ml water Compounding issues Ports on Automix in a different order than printed on the worksheet Glucose had to be added manually Solution prepared 27.4 ml vaminolact and 111 ml glucose Double checked by the supervisor but error not detected

6 Baby Jada The solution was administered to Jada on 26 April 2006 at pm. It was a massive glucose overdose. The baby died on the following day. The coroner at the inquest found that a number of factors contributed to her death, one of which was hyperglycemia caused by the glucose overdose.

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

8 What has almost happened? Catastrophic Neonatal TPN Dextrose 50% instead of 20% used Sodium Chloride 30% instead of 0.9% Major Neonatal TPN Sodium Chloride 30% instead of Calcium Chloride 14.7% Sodium Chloride 30% instead of Magnesium Sulphate 20%

9 Why is this important? Parenteral nutrition is the most complex intravenous therapy that we give In 2009, Sacks et al looked at 4730 PN prescriptions and recorded the errors 1% prescribing process 39% during transcription 24% during preparation 35% during administration Sacks et al, Pharmacotherapy 2009;5:966-74

10 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: ents/default.asp

11 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

12 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

13 Purchasing Prescribing Safe Parenteral Nutrition Compounding Administration and monitoring

14 Prescribing

15 Prescribing of parenteral nutrition Ensuring competency of the PN prescriber? Medical & non-medical prescribers Standardised prescription form Use of standard formulations

16 Competency of the PN prescriber PN is a high risk product & complications are not always recognised PN prescribing is often left to the most junior medical staff who has little or no knowledge Basic nutrition is only recently part of medical undergraduate training (UK) Should not be I just did what the told me to do

17 Competency of the PN prescriber NICE guidance all trusts should have a multidisciplinary team nutritional requirements should be assessed by healthcare professionals with the relevant skills and training in the prescription of nutritional support

18 Competency of the PN prescriber BAPEN s document: The MDT must contain: doctor nutrition nurse specialist dietitian pharmacist MDT involved in complex nutrition support and PN NCEPOD 47% of PN had no initial nutrition team involvement

19 Non-medical prescribers In England, nurse & pharmacist prescribers can now prescribe PN Can prescribe licensed & unlicensed products within their field of expertise Needs to be signed off by a clinical tutor Allows trained & experienced staff to make decisions & take responsibility

20 How to reduce prescribing risks Audit of 204 NNU PN prescriptions 27.9% prescribing error rate Paediatric residents made more errors than neonatal nurse practitioners (39% vs 16%) Introduced standardised computer PN worksheet Errors reduced to 11.7% Brown et al, Am J Perinatology, 2007 Changing from a tailored to a standardised formula reduced the error rate from 9.3% to 0% Petros et Shank Hosp Pharm, 1986

21 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

22 Multi-Chamber Parenteral Nutrition Bags (MCB) Licensed parenteral nutrition formulas Remain within licence as long as additions are made according to the SPC Stability has been extensively tested Wide number of formulas now available Limits the prescribing range

23 Multi-chamber bags 43% of initial PN given were MCBs 13% MCB with micronutrients 22% MCB with micronutrients & tailored additions 22% were tailored to patients requirements NCEPOD Report, 2010

24 Purchasing

25 PN Components MHRA state that where possible licensed medications must be purchased over unlicensed medications Most PN components are licensed Some additions are not available in a licensed form

26 Bulk PN components Jan Dec errors reported - Incorrect choice of ingredients when compounding PN Consider the presentation What is the ingredient packed in? Can you easily identify each ingredient? Where has it come from? UK National Aseptics Error reporting scheme

27 What can go wrong

28 Compounded Parenteral Nutrition Licensed units Are they licensed for the product they are preparing for you? Appropriate facilities Appropriate personnel Quality assurance processes Are the facilities up to required standards? Have the facilities been audited by QA? Is there a responsible pharmacist? Do the personnel have appropriate training? Do QA processes fulfil national and international requirements? Is there a contingency plan?

29 Compounding

30 Potential for Error Worksheet & label production Selection of Ingredients Manufacture of PN formulation Final Check Translates prescription to a formulation Storage & easy identification needed Correct volumes of the correct solutions mixed in a sterile environment All aspects of the compounding assessed & formulation checked against the prescription Storage Correct storage of completed bag

31 National Aseptic Error Reporting Scheme

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34 JPEN 2004;28:S39

35 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

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

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

38 What about Home Parenteral Nutrition? Medication errors: 3.8% Service errors: 3%

39 2012 National HPN Tender Aim: Consistency in contracting arrangements with Homecare providers Hackett review recommendations implemented QUALITY to be improved across the board Procurement options explored Compounding and delivery of HPN Nursing services Working party included clinicians, nurses, pharmacists, procurement specialists and commissioners

40 Specification Quality and safety were included in the following sections: How HPN should be prescribed Assessment of stability matrices How and where the HPN is compounded Delivery and cold chain Equipment and ancillaries Nursing

41 Standardisation

42 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?

43 Summary PN errors can be fatal Every step should be scrutinised for potential error Experienced members of the MDT should be prescribing When purchasing risks should be considered PN compounding is the highest risk activity within pharmacy Standards for homecare also need to be considered