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

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Page 1: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

ESPEN Congress Leipzig 2013

Pharmaceutical Session

Pharmaceutical risk management strategies for parenteral nutrition

J. Eastwood (UK)

Page 2: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Pharmaceutical risk management strategies for parenteral nutrition

Jackie Eastwood

Pharmacy Manager, St Mark’s Hospital

Chair, British Pharmaceutical Nutrition Group

Page 3: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Evening Standard 27 April 2007

Hospital blunder

over sugar that

killed twin baby

Page 4: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Baby Jada

Very premature twin – transferred to Chelsea and Westminster Hospital

PN made by an Automix compounder

Page 5: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 6: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 7: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Mix-up of

Sodium for Calcium

(neonate)

PN Sterility

Compromised

(adults)

Page 8: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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?

Page 9: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 10: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 11: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 12: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 13: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Purchasing Prescribing

Compounding Administration and monitoring

Safe Parenteral Nutrition

Page 14: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Prescribing

Page 15: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Prescribing of parenteral nutrition

Ensuring competency of the PN prescriber?

Medical & non-medical prescribers

Standardised prescription form

Use of standard formulations

Page 16: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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”

Page 17: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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”

Page 18: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 19: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 20: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 21: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 22: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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)

Page 23: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 24: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Purchasing

Page 25: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 26: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 27: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

What can go wrong

Page 28: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

• 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

Page 29: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Compounding

Page 30: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 31: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

National Aseptic Error Reporting Scheme

Page 32: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use
Page 33: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use
Page 34: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

JPEN 2004;28:S39

Page 35: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 36: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

• 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

Page 37: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 38: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

What about Home Parenteral Nutrition?

Medication errors: 3.8%

Service errors: 3%

Page 39: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 40: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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

Page 41: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

Standardisation

Page 42: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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?

Page 43: Pharmaceutical Session Pharmaceutical risk … · Pharmaceutical risk management strategies for parenteral nutrition J. Eastwood ... 27.9% prescribing error rate ... –Beyond-use

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