1. Keynote address: The recent DH neonatal and paediatric TPN project
James Wallace, Lead Pharmacist for Women and Children, Yorkhill, Glasgow

3. BACKGROUND William Harvey 1600s Christopher Wren Robert Elman 1930s
Safe Fat Emulsion s
Wilmore and Dudrick
Circulation Ale,wine and opium IV glucose /electolytres IV protein hydrolysate in men successful PN in child with short bowel syndrome

5. RISKS INFECTION METABOLIC IMBALANCE LIVER DISEASE
COMPLICATIONS of CANNULATION
Phlebitis
Thrombosis
Malposition
Blockage
Intestinal failure associated liver disease
Complex therapy prescribing/ compounding errors are addition risk.

6. AIMS of PROJECT Scoping exercise to :-
Examine current practice across UK
Governance
Role of Guidelines
workload
compounding process
Administration and monitoring

7. AIMS (2) Provide data for expert groups
Make recommendations to minimise risk
Potential for rationalisation

8. SCOPING INSTRUMENT Electronic web based questionaire Advantages
Easier data analysis
Better response rate
Disadvantage
Cost
External specialist supplier
Exec group agreed how to take forward Supported appointment project manager and cost of web based questionaire.

9. LITERATURE SEARCH Centre for Paediatric Pharmacy reasearch
Systematic Review to compare individulised and standarised PN
Only 5 relevant studies
Initially 237 references found , 206 not related, of remaining 31 only 5 relevant

10. CONCLUSIONS STANDARDISED SOLUTIONS Improve early nutrient supplies
may be appropriate for large proportion of clinically stable patients
no significant clinical & biochemical differences in infants given them compared to individualised solutions
BUT

11. No conclusions on adequacy of nutrition provided
Conflicting reports on cost effectiveness.

12. First Hurdle
CONTACT DETAILS

13. Second Hurdle
HOSPITAL/TRUST CHIEF PHARMACISTS

14. J EDGAR HOOVER

15. RESPONSES Backgound Questionaire 96%
Neonatal Clinical Questionaire 78%
Paediatric Clinical Questionaire 81%
Technical Questionaire %
Rates exceeded those reported in HTA “design and use of questionaires a review of best practice applic to health service surveys

16. DATA ANALYSIS
Raw and summary data to project exec/team Issues identified for reference groups Analysis of data/expert opinion Recommendations to help reduce risk Report to PCPG and Health depts

17. Project Team
Paediatric Chief Pharmacists Project executive group Trust chief pharmacists Paediatric Gastroenterologist National Pharmaceutical QA Committee Technical services Pharmacists Pharmacy Practice and Research

18. CLINICAL REFERENCE GROUP
Paediatric Gastroenterologist
Project team
Neonatologist
Specialist Clinical pharmacist
NPSA
RCPCH
FNPP
National Nurse Nutrition group
Dietitian

19. TECHNICAL REFERENCE GROUP
Paediatric Chief Pharmacists Group
Project team
NPPG
National Pharmaceutical QA committee
Hospital Pharmacists Group
Aseptic Services Group
NHS Pharmacy Production Committee

20. BACKGROUND QUESTIONAIRE
61% compounded PN or made additions to purchased bags for their hospital 27% purchased PN and supplied unchanged 12% only compounded for other hospitals
211 HOSPITALS

21. CAPACITY PLANS 61% HAD FORMALLY AGREED PLAN
92% of them stated pharmacy staff were aware of plan
50% included risk assessment
At what level should plan be agreed?

22. CLINICAL QUESTIONAIRE
Nutritional Support Teams
Initiation and prescribing of PN
Interface with Pharmacy
Clinical guidelines
Nutrient intake levels
Standard PN Solutions

23. CLINICAL QUESTIONAIRE (2)
Route of Delivery
Safety checks and Biochemical monitoring
Out of hours provision

24. NUTRITIONAL SUPPORT TEAMS
Only 25% of hospitals treating newborn and children had access to childrens nutritional support team
Importance of NSTs frequently emphasised in the literature. Composition will vary. Access to multidisciplinary expert knowledge vital.

25. PRESCRIBING Decision to initiate Defining content Writing on chart
Initiation senior medical decision if define content should be able to prescribe on chart.

26. GUIDELINES
21% agreed clinical guidelines for neonatal PN 46% agreed clinical guidelines for children’s PN

27. European Society of Clinical Nutrition and Metabolism
GUIDELINES (2)
European Society for Paediatric Gastroenterology, Hepatology and Nutrition
(ESPGHAN)
Comprehensive GL for newborn and older children available over internet review of ten years literature by paeds,pharms and nurses
Other reference sources available. Much based on fairly low level evidence. Need robust trials.
European Society of Clinical Nutrition and Metabolism
(ESPEN)

28. NUTRIENT INTAKE LEVELS
Pre-term Neonates
Amino Acid
Carbohydrate
Lipid
Median
2.9
15.0
3.0
Range
Wide variation in amounts of macronutrients presribed both at commencement and during standard maintainance table shows standard maintainance figures
all measurements in g/kg

29. TERM NEONATES Term Neonates Amino Acid Carbohydrate Lipid Median 2.7
15.0
3.0
Range
Preterm neonates accumulate signif nutient defecits in early weeks no clear concensus on optimal regimens median protein intake below espghan g/Kg/day carb high may underlie decreased insulin sensitivity in adolescent survivors consensus from prospective registry?
all measurements in g/kg

30. STANDARD SOLUTIONS
Standardised PN feasible? for neonates 84% for children 78% Standardised PN used for neonates 71% for children 44%
Barrier lack of resource

31. ADVANTAGES LOWER RISK OF ERROR AVAILABLE OUT OF HOURS
IMROVED PHARMACEUTICAL
QUALITY ASSURANCE
INCREASED CAPACITY
LESS ADDITIONS. Started earlier potential QA better.

32. DISADVANTAGES LACK OF FLEXIBILTY INCOMPLETE ( vitamins/trace elements)
No definative data to suggest individualised better than standarised .will always be need for scratch bags for unstable,fuid restricted etc scottish data all agreed on formulations (14000 bags used in 2008) work with industry

33. ROUTE OF DELIVERY Peripheral for short term PN but
glucose concentration restricted (12.5%)
extravasation risk
phlebitis
Both periferal and central venous catheters used.

34. central venous delivery most reliable for long term PN
catheter related blood stream infections
atrial perforation in premature neonates
Pollicy for administration
concentrations for peripheral or central use.
what is central access in new born
clear labelling
Complications of PN reduced by involvement of NST plus training

35. LABEL CHECKS
9% reported nurses did not routinely check dates for infusion
16% did not check rates of infusion
42% did not check ingredients against prescription

36. LABEL CHECKS (2) Name and ID no of patient Route of administration
Date for infusion
Rate of infusion
Expiry date
Appearance of solution/bag
Checks need to be practical ,defined in pollicy

37. MONITORING Routine clinical and biochemical monitoring crucial
No universally agreed protocol
Abnormal test results need to be acted upon
Difficult to interpret or very specialist tests to be avoided or used in long term patients only.
Daily assessment of requirements versus actual intake received.
Some reported no daily blood glucose or electrolytes checked

38. VITAMINS AQUEOUS OR LIPID PHASE?
POLLICY FOR ADMINISTRATION IF NORMAL ROUTE UNAVAILABLE
ONLY 36% NEONATAL AND 55% PAEDIATRIC UNITS HAD POLLICY FOR ALTERNATIVE ROUTE

39. ADDITIONS NO ADDITIONS AT WARD LEVEL?
14% NEONATAL UNITS AND 3% PAEDIATRIC UNITS STILL MAKE ADDITIONS AT WARD LEVEL

40. OUT OF HOURS ACCESS TO NST 18% ACCESS TO STANDARD BAGS NEONATES 53%
CHILDREN %
ACCESS TO COMPONENTS
NEONATES %
CHILDREN %

41. TECHNICAL QUESTIONAIRE
Process and quality Control
Methods of Compounding
Process Controls
Workload
Stability Data
Workforce Planning
QA of Purchased Products
Giving Sets and Filters
Error reporting

42. Process and Quality Control
27 Hospitals compounded under MHRA Licence
85 under Section 10 exemption
12 used a combination of the two
5 reported significant differences in QA and process controls depending on which applied
Scale may vary but underlying principle is same QA systems should apply

43. DOCUMENTATION Worksheets generated by
computer systems ( in house or commercial) 71%
photocopied master documents %
hand written worksheets %
Validated software with decision support can significantly reduce risks of transcription, calculation,preparation and labelling errors.

44. COMPOUNDING MANUAL SYSTEM USING SYRINGES GRAVITY FILLING
VACUUM FILLING
AUTOMATED COMPOUNDERS
88% intended to use automation in the future
AUTOMATION INTRODUCED TO REDUCE RSI , ERRORS AND INCREASE CAPACITY

46. PROCESSES AND PROCESS CONTROLS
Set up ingredients on compounder in same order
as worksheet.
Sharing of ingredients/accurate reconciliation
65% routinely use more than one strength of glucose
62% routinely stock more than one strength or salt of the same electrolyte

48. PROCESSES AND PROCESS CONTROLS (2)
Range of pre-process and final product tests variable
Nearly 30% of hospitals did not formally accredit staff to undertake checks and final release.
64% do not weigh finished PN bag as part of final product testing.
Majority do little or no end product testing

49. WORKLOAD
Wide variation in workload From less than 200 bags /year to more than 2000 bags/year for each of a number of categories of patients Range of licensed standardised PN solutions to meet needs of children of all ages required.
Large amount of detail collected.

50. STABILITY DATA 97% from Industry 20% obtained data from within NHS
6% generated in house data
Should the NHS recognise this as a source of risk?

51. WORKFORCE PLANNING 61% intended to continue in-house compounding
30% considering outsourcing some or all
66% planned to introduce a standardised approach

52. Workforce planning (2)
Strategy driven by: Staff shortages 80% Need to prioritise resources in technical services 73% Increasing demand 60% Risk assessment 36% need to upgrade premises 31% adverse inspection 25%
Clear that aseptic services are under pressure across the UK

53. PURCHASED PN SOLUTIONS
47% purchase from NHS QA approved supplier
36% had service level agreement
9% monitored performance against it
11% had QA approval before release

54. GIVING SETS AND FILTERS
NEONATES
34% Attach giving set and filter in pharmacy
CHILDREN
17% attach giving set and filter in pharmacy
Validation for resistance to leaks
24% 9%

55. ERROR REPORTING 9% had systems in place for internal error reporting
74% reported PN related errors and near misses on
National Aseptic Error Reporting System

56. THANKS Sue Conner project manager
Antje Neubert paediatric medicines research centre
Nicholas Jackson Acuity Computing Enterprise Technology Ltd
John Puntis Chair clinical reference group
Alastair Gibson Chair technical reference group
Steve Tomlin NPPG
Tim Root Hospital Pharmacists group
Judith Cope Great Ormond Street Hospital
Keith Ridge PCPG all the many other s contributed