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

BACKGROUND William Harvey 1600s Christopher Wren Robert Elman 1930s Safe Fat Emulsion 1960s Wilmore and Dudrick 1968 Circulation Ale,wine and opium IV glucose /electolytres IV protein hydrolysate in men successful PN in child with short bowel syndrome

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.

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

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

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.

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

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

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

First Hurdle CONTACT DETAILS

Second Hurdle HOSPITAL/TRUST CHIEF PHARMACISTS

J EDGAR HOOVER

RESPONSES Backgound Questionaire 96% Neonatal Clinical Questionaire 78% Paediatric Clinical Questionaire 81% Technical Questionaire 82% Rates exceeded those reported in HTA “design and use of questionaires a review of best practice applic to health service surveys

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

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

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

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

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

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?

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

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

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.

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

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

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)

NUTRIENT INTAKE LEVELS Pre-term Neonates Amino Acid Carbohydrate Lipid Median 2.9 15.0 3.0 Range 0.8 - 4.3 9.0 - 18.0 0.0 - 4.0 Wide variation in amounts of macronutrients presribed both at commencement and during standard maintainance table shows standard maintainance figures all measurements in g/kg

TERM NEONATES Term Neonates Amino Acid Carbohydrate Lipid Median 2.7 15.0 3.0 Range 0.94 - 4.0 9.0 - 18.75 0.0 - 4.0 Preterm neonates accumulate signif nutient defecits in early weeks no clear concensus on optimal regimens median protein intake below espghan 3.2-4g/Kg/day carb high may underlie decreased insulin sensitivity in adolescent survivors consensus from prospective registry? all measurements in g/kg

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

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

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

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

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

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

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

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

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

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

OUT OF HOURS ACCESS TO NST 18% ACCESS TO STANDARD BAGS NEONATES 53% CHILDREN 31% ACCESS TO COMPONENTS NEONATES 5% CHILDREN 7%

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

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

DOCUMENTATION Worksheets generated by computer systems ( in house or commercial) 71% photocopied master documents 45% hand written worksheets 14% Validated software with decision support can significantly reduce risks of transcription, calculation,preparation and labelling errors.

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

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

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

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.

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?

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

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

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

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%

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

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