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ESPEN Congress Leipzig 2013
Pharmaceutical Session
Pharmaceutical risk management strategies for parenteral nutrition
J. Eastwood (UK)
Pharmaceutical risk management strategies for parenteral nutrition
Jackie Eastwood
Pharmacy Manager, St Mark’s Hospital
Chair, British Pharmaceutical Nutrition Group
Evening Standard 27 April 2007
Hospital blunder
over sugar that
killed twin baby
Baby Jada
Very premature twin – transferred to Chelsea and Westminster Hospital
PN made by an Automix compounder
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
Baby Jada
The solution was administered to Jada on 26 April 2006 at 11.00 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.
Baby Jada
Mix-up of
Sodium for Calcium
(neonate)
PN Sterility
Compromised
(adults)
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%
What has almost happened?
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
Why is this important?
Sacks et al, Pharmacotherapy 2009;5:966-74
Safety Summits
American Society for Parenteral & Enteral Nutrition (A.S.P.E.N.)
Parenteral nutrition safety summit proceedings: http://pen.sagepub.com/content/36/2_suppl.toc
Institute for Safe Medication Practices (ISMP)
Sterile preparation compounding safety summit proceedings: http://www.ismp.org/Tools/guidelines/IVSummit/comments/default.asp
Nurse,
Patient Caregiver
PN-Use Process
Administer the PN •Order verification
•Access
•Infusion
•Infection control
Prescriber
Ordering PN •Standardized
order form
Dietitian, Nutrition Support Team
Assess •Review patient data
•Provide nutrition assessment
•Recommend nutrition care
plan (PN)
•Communicate with prescriber
Pharmacist
Pharmacy Technician
Dispense PN •Labeling
•Delivery
•Storage
PN Order
Review/Verification
•Dosing appropriateness
•Stability &
Compatibility
Compounding •Sterile preparation
•Product testing Documentation •Medical record
•Transitional care
Monitoring •Mechanical
•Metabolic
•Patient outcome
JPEN 2012;36:10S
INTERDISCIPLINARY
NUTRITION CARE
Nurse,
Patient Caregiver
PN-Use Process
Administer the PN •Order verification
•Access
•Infusion
•Infection control
Prescriber
Ordering PN •Standardized
order form
Dietitian, Nutrition Support Team
Assess •Review patient data
•Provide nutrition assessment
•Recommend nutrition care
plan (PN)
•Communicate with prescriber
Pharmacist
Pharmacy Technician
Dispense PN •Labeling
•Delivery
•Storage
PN Order
Review/Verification
•Dosing appropriateness
•Stability &
Compatibility
Compounding •Sterile preparation
•Product testing Documentation •Medical record
•Transitional care
Monitoring •Mechanical
•Metabolic
•Patient outcome
JPEN 2012;36:10S
Purchasing Prescribing
Compounding Administration and monitoring
Safe Parenteral Nutrition
Prescribing
Prescribing of parenteral nutrition
Ensuring competency of the PN prescriber?
Medical & non-medical prescribers
Standardised prescription form
Use of standard formulations
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”
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”
Competency of the PN prescriber
BAPEN’s document: The MDT must contain: doctor nutrition nurse specialist dietitian pharmacist
NCEPOD – 47% of PN had no initial nutrition team involvement
MDT involved in complex nutrition support and PN
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
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%
Changing from a tailored to a standardised formula reduced the error rate from 9.3% to 0%
How to reduce prescribing risks
Brown et al, Am J Perinatology, 2007
Petros et Shank Hosp Pharm, 1986
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
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
Multi-Chamber Parenteral Nutrition Bags (MCB)
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
Purchasing
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
Bulk PN components
Jan 2003 - Dec 2007
- 13 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
What can go wrong
• Are they licensed for the product they are preparing for you? Licensed units
• Are the facilities up to required standards?
• Have the facilities been audited by QA?
Appropriate facilities
• Is there a responsible pharmacist?
• Do the personnel have appropriate training?
Appropriate personnel
• Do QA processes fulfil national and international requirements?
• Is there a contingency plan?
Quality assurance processes
Compounded Parenteral Nutrition
Compounding
Potential for Error
• Translates prescription to a formulation Worksheet &
label production
• Storage & easy identification needed Selection of Ingredients
• Correct volumes of the correct solutions mixed in a sterile environment
Manufacture of PN formulation
• All aspects of the compounding assessed & formulation checked against the prescription Final Check
• Correct storage of completed bag Storage
National Aseptic Error Reporting Scheme
JPEN 2004;28:S39
Pharmacist
Pharmacy Technician
Dispense PN •Labeling
•Delivery
•Storage
PN Order
Review/Verification •Dosing appropriateness
•Stability & Compatibility
Compounding •Sterile preparation
•Product testing
3 Steps to Review the PN Order
1. Order verification
2. Order review – clinical
3. Order review – pharmaceutical
• Compounding
– Sterility
– Medium-risk sterile preparation
– Pharmacist responsibility
– Validated Methods
– Written policies & procedures
– Manual vs Automated
Compounding Device
Pharmacist
Pharmacy Technician
Dispense PN •Labeling
•Delivery
•Storage
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
Pharmacist
Pharmacy Technician
Dispense PN •Labeling
•Delivery
•Storage
PN Order
Review/Verification •Dosing appropriateness
•Stability & Compatibility
Compounding •Sterile preparation
•Product testing
• Labelling
– Should match elements of the order
– All active ingredients included
– Beyond-use date provided
• Storage
– Refrigerate and keep out of light
JPEN 2004;28:S39 / USP34 <797> / ISMP 2012
What about Home Parenteral Nutrition?
Medication errors: 3.8%
Service errors: 3%
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
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
Standardisation
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?
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
Summary