Transcript YOUR NAME

The “Real” Risks of Aseptic
preparation
Tim Sizer,
University of Leeds
Infusion - associated septicaemia
can be life-threatening
So can other mistakes made in the
aseptic preparation of medicines
Deaths or harm continue to be reported
from contaminated or wrongly made
• infusions,
• cytotoxic syringes,
• parenteral nutrition mixtures
• eye preparations
In most cases, the problems resulted
from the error or ignorance of the
professionals involved
Key risk areas for Patients
Prescription
Key risk areas for Patients
•
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Prescription
Calculation /Dose
Selection / Picking
Preparation a) Contamination
b) Stability/Degradation
• Distribution & Storage
• Administration
• Effects
Contamination Where things have gone wrong -
Johannesburg
Death of Babies due to
Serratia contamination
• 1990: 15 babies died at two
Johannesburg hospitals after being given
contaminated TPN
• The bags were made in an isolator by a
commercial company (Sabax)
• ‘Components “sterilised” with gas/vapour
• “Good” procedures used
• Operator Ignorance
• Poor procedures
Contamination Where things have gone wrong -
Manchester
“Manchester Incident”
1994 Death of 2 children
following administration of
contaminated TPN –
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Facilities
Contamination
Validation
? Poor technique
Contamination Where things have gone wrong -
2002 Tokyo:
• 12 pts infected with Serratia marcescens
from contaminated heparinised-saline
drips - 7 died
• Contamination traced to towel
in nurses station
Tokyo
Tanaka T et al Jpn. J. Infect. Dis. 2004 57 189-192
2004: “Drip of death kills babies”
• 6 premature babies died
• Enterobacter cloacae bacteria in 3 PN
bags and one infusion set
• “Good” facilities and procedures
• Dirty hands - main reason
• Operator Ignorance / poor procedures
Bloemfontein
Contamination Where things have gone wrong -
• 2006 Cremona, Italy
• Serratia marcescens outbreak in 24bed general surgical ward
• “incorrect use of single- &multidose
vials and lack of adherence to handhygiene protocols”
Pan A et al Infection Control & Hospital Epidemiology 2006 27 79–82
Poisoning or • 1998: Ireland: “Preparation error led to
Overdose
fatal injection
• IV antibiotics intended for 69yr-old pt
mixed with potassium chloride
• €170,000 awarded to family
• “phials of potassium chloride were
not stored safely or securely”
Poisoning or
Overdose
Where things have gone wrong -
2003: USA
- Record payout $3.75m
“Child gets lethal dose of nutritional solution”
• Surgery 6 yr-old with suspect appendicitis
• PIC line : Dietician Rx “adult” TPN
• Pharmacist asks why adult TPN : dietician
obtained a new order for “pediatric” TPN.
• Pharmacist entered order into
computerised TPN Admixture System
“Paed PN” made with adult content and
given – repeatedly
“checks and balances system in place at
the institution failed to prevent the lethal
bag of nutrition from being administered”
Poisoning or
Overdose
Where things have gone wrong -
2005: USA - ISMP report
Institute for Safe Medication Practices
• 25 wk-gestation neonate:
• hypotension & RDS » ventilator + PN
+ arterial line fluids
• After 18hrs Na+ >190 mmol/L (normal: 136-146)
• Clinical pharmacist discovers 250mL
glass bottle conc. NaCl (23.4%) used
instead of 250mL bag of sterile water
Later error analysis found conc. NaCl
(23.4%) kept on the same shelving as
other IV solutions
Pack and label very similar to other products
Poisoning or
Overdose
Where things have gone wrong -
2005: Las Vegas
- “Did This Baby Have to Die?”
3-wk-old baby died of zinc overdose in
TPN at Summerlin Hospital:
• 8 Nov: New PN bag sent by pharmacist
• Nurses began the drip about 10pm
• 9 Nov: 6:30am pharmacist sent a memo to
the nurses notifying them of a possible error
in the prescription
• Dr asked "Send new TPN stat"
• But IV not changed until 1 pm
Baby Alyssa Shinn
26 weeks gestation
Birth wt: 1 lb 4 oz
• Rx was appropriate, so “how lethal levels
of zinc were present and why no one
caught the mistake before it was
administered was unclear”
Poisoning or
Overdose
Where things have gone wrong -
London
2006:
Inquest
“HOSPITAL'S BLUNDER OVER
Westminster
SUGAR THAT KILLED TWIN BABY”
Coroners Court
26 Apr 2007
• “40% glucose instead of 4% after the
wrong number was entered into a
mixing machine”
• “A system of checks in the pharmacy
unit at the hospital in South London,
failed to spot the error”
• “Jada died a day after the blunder - the
third day of her short life” - of heart
failure and brain damage
• “Solicitor said the hospital failed to act
after a similar error in 2005”
(similar cases Birmingham in 2004, Leeds 200?)
Jada Pilkington Asanye - in ICU
Aseptic
Preparation
is a RISK
6. O'Hare et al. Errors
in administration of
intravenous drugs
[letter]. BMJ
1995;310:1536-7.
What about ward preparation?
One study of ward-based activity found a massive
error rate among doctors (96%) & nurses (83 %)
despite formal training & double checking systems
The big current issue:
Error and Risk Management
• 65% of injectable doses given in UK
hosp’s are prepared outside pharmacy
Gandy R, Cummins I, Beaumont I, Lee MG; “Aseptic Preparation of
Pharmaceutical Products” Br.J.Health Service Management 1998
• Concern over suitability of Ward and
Clinic Environments for IV preparation:
– Microbiological
– Personnel
– Medication Errors / Error Rates
• Increasing demands on pharmacy
“The potential for an error to occur exists in every step of the
process, from the doctor writing the prescription, through
compounding, to administration of the drug to the patient”
Compounding is expected to increase
State of Healthcare
2006
• A more consistent approach to safety is
required
• One fifth of 8000 complaints are safety
related
• Lack of reliable information e.g. number
of avoidable deaths
• Trusts still reactive
• Culture of blame
• Not enough reporting
Compounding is expected to increase
Safety First
2006
• Patient safety not given the same priority
as reducing waiting times and achieving
financial balance
• Little evidence that data collected
through NRLS leading to learning
• Environment does not motivate and
inspire to make safety a priority
National Reporting
& Learning System
Compounding is expected to increase
The Best Medicine
January 2007
Recommendations
for Trusts
10. Supplying and managing medicines
in the trust
a. Trusts - risk assessment of preparation of
parenteral medicines in wards, theatres
& other clinical areas and agree an
action plan to reduce risk.
b. Trusts - review medicines that they
prepared in pharmacy with a view to
changing the source to the industry or
licensed NHS units, where possible
c. QC/QA audit reports should be reported
to the medicines management committee
and high risks should be escalated to the
risk management committee
Compounding is expected to increase
NPSA Alerts
• Mandatory guidance on how to address
specific risk areas
• Issued in response to areas of concern
• Guidance on implementation
• External pressures to address safety
issues
• Part of Department of Health NHS
performance monitoring
NRLS Incident
Reports
Involving
Injectable
Medicines
Care setting
Acute / general hospital
Ambulance service
Community and general dental service
Community hospitals/nursing
Community pharmacy
Sept 2004 –
March 2006
General practice
Learning disabilities service
Mental health service
Total
Degree of Harm (severity)
Number
10,920
37
5
861
33
100
11
243
12,210
Number
No Harm
9,654
Low
1,820
Moderate
617
Severe
113
Death
Total
6
12,210
Risks In Prep & Admin Injectable Meds
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Safety in Doses
DoH March 2007
England
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Lack of essential information which may not
be included in the manufacturer’s pack or
from common ref sources.
Incomplete and ambiguous prescriptions
e.g. don’t include full details of the diluent, final
volume, final concentration or intended rate of
administration
Injectable medicine presentations that may
require complex calculation, dilution and
handling procedures before the medicine
can be administered
Selection of the wrong drug or diluent.
Risks In Prep & Admin Injectable Meds
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Drug use (or diluent / infusion) after expiry
Calculation errors during prescription,
preparation, administration of the drug
> wrong dose, wrong concn or wrong rate
Incompatibility of diluent, infusion, other
medicines and administration devices.
Administration to the wrong patient.
Administration by the wrong route.
Unsafe handling or poor aseptic technique
> contamination
Hlth & safety risks to operator / environment
Variable levels of knowledge, training &
competence
Actions for the
1. Undertake a risk assessment of injectable
medicines, procedures and products used
2. Ensure up-to-date written protocols and
procedures for prescribing, preparation and
administration
3. Ensure essential information available at
point of use in all near patient areas where
injectable medicines are used.
Actions for the
4. Implement purchasing for safety
procurement policies
> obtain products that are safer
5. Implement training programmes to ensure
staff are competent to prescribe and use
injectable medicines safely.
6. Produce an injectable medicines report
each year.
> communicated to Clinical Governance and
Drugs and Therapeutics Committees
• Estimates show that in developed
countries as many as one in 10 patients is
harmed while receiving hospital care.
• In October 2004, WHO launched the World
Alliance for Patient Safety in response to a
World Health Assembly Resolution (2002)
urging WHO and Member States to pay the
closest possible attention to the problem of
patient safety.
10 facts on patient safety
Fact 4
At any given time, 1.4 million people worldwide suffer
from infections acquired in hospitals. Hand hygiene is
the most essential measure for reducing health careassociated infection and the development of
antimicrobial resistance.
10 facts on patient safety
Fact 8
The economic benefits of improving patient safety are
compelling. Studies show that additional
hospitalization, litigation costs, infections acquired in
hospitals, lost income, disability and medical
expenses have cost some countries between US$ 6
billion and US$ 29 billion a year
Fact 9
Industries with a perceived higher risk such as
aviation and nuclear plants have a much better safety
record than health care. There is a one in 1 000 000
chance of a traveller being harmed while in an aircraft.
In comparison, there is a one in 300 chance of a
patient being harmed during health care
Priorities • These are clearly not the same!
in Ireland • HSE is only 2½ years old:
Established in Jan 2005 under the Health Act 2004
• Transformation Programme 2007-2010
– 13 programmes listed (so far)
– some of which could be used to
benefit developments in
pharmaceutical aseptic services
HIQA since May 2007
“Independent Authority set up to help drive
continuous improvement in Ireland's health
and social care services”
Central to work of HIQA is safety of patients
& users of health & social care services
Patient Safety Conference Croke Park 6 Sept 2007
To err is human, to cover up is unforgivable and to fail to
learn is inexcusable.
Priorities • Current focus appears to centre on
output of 8 Expert Advisory Groups
in Ireland
Children
Diabetes
Mental Health
Older People
Cardiovascular services
Disability
Maternity services
Oral Health
Some roles of EAG’s could be very influential:
“... bring international perspective to health
transformation programme”
“Ensure that the highest international standards
of care and best practice are integral….”
“… driving integration across the HSE's three
service delivery units - ……. and also in
promoting national consistency.”
Conclusion
Aseptic Compounding of Medicines requires
careful attention to a multitude of steps and
actions
Failure at any one stage may result in harm
We must learn from mistakes
Error reporting and analysis are vital
All those involved must be adequately
trained
Pharmacy is the safest place for this task