The “Real” Risks of Aseptic preparation

Tim Sizer, Tim Sizer,

University of LeedsUniversity 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

• Prescription

• Calculation /Dose

• Selection / Picking• Preparation a) Contamination

b) Stability / Degradation

• Distribution & Storage

• Administration

• Effects

JohannesburgJohannesburgDeath 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

Where things have gone wrong -Contamination

Where things have gone wrong -

““Manchester Incident” Manchester Incident” 1994 1994 Death of 2 children Death of 2 children following administration of following administration of contaminated TPN - contaminated TPN -

– FacilitiesFacilities– ContaminationContamination– ValidationValidation– ? Poor technique? Poor technique

ManchesterManchester

Contamination

BloemfonteiBloemfonteinn

• Dirty hands - main reason • Operator Ignorance / poor procedures

Where things have gone wrong -Contamination

2002 Tokyo: • 12 pts infected with Serratia marcescens

from contaminated heparinised-saline drips - 7 died

• Contamination traced to towel in nurses station 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

TokyoTokyo

• 2006  Cremona, Italy• Serratia marcescens outbreak in 24-

bed general surgical ward • “incorrect use of single- &multidose

vials and lack of adherence to hand-hygiene protocols”

Pan A et al Infection Control & Hospital Epidemiology 2006 27 79–82

• 1998: Ireland: “Preparation error led to 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”

Where things have gone wrong -

Poisoning or Overdose

Contamination

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”

Where things have gone wrong - Poisoning or Overdose

Where things have gone wrong - Poisoning or Overdose

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

2005: Las Vegas - “Did This Baby Have to Die?” 3-wk-old baby died of zinc overdose in TPN at Summerlin Hospital:

Where things have gone wrong - Poisoning or Overdose

Baby Alyssa Shinn26 weeks gestation Birth wt: 1 lb 4 oz

• 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• Rx was appropriate, so “how lethal levels

of zinc were present and why no one caught the mistake before it was administered was unclear”

2006: “HOSPITAL'S BLUNDER OVER

SUGAR THAT KILLED TWIN BABY”• “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?)

Where things have gone wrong - Poisoning or Overdose LondonLondon

Jada Pilkington Asanye - in ICU

Inquest Westminster

Coroners Court 26 Apr 2007

What about ward preparation?Aseptic

Preparation

is a RISK

One study of ward-based activity found a massive error rate among doctors (96%) & nurses (83 %) despite formal training & double checking systems

6. O'Hare et al. Errors in administration of intravenous drugs [letter]. BMJ 1995;310:1536-7.

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

Safety First2006

• 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

Recommendations for Trusts

10.Supplying and managing medicines in the trusta. 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 increaseThe Best Medicine January 2007

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

Compounding is expected to increase

Care setting Number

Acute / general hospital 10,920

Ambulance service 37

Community and general dental service 5

Community hospitals/nursing 861

Community pharmacy 33

General practice 100

Learning disabilities service 11

Mental health service 243

Total 12,210

NRLS Incident

Reports

Involving

Injectable

Medicines Sept 2004 – March 2006

Degree of Harm (severity) Number

No Harm 9,654

Low 1,820

Moderate 617

Severe 113

Death 6

Total 12,210

Risks In Prep & Admin Injectable Meds

• 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.

Safety in Doses DoH March 2007

England

• 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

Risks In Prep & Admin Injectable Meds

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.

Fact 4At any given time, 1.4 million people worldwide suffer from infections acquired in hospitals. Hand hygiene is the most essential measure for reducing health care-associated infection and the development of antimicrobial resistance.

10 facts on patient safety

Fact 8The 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 9Industries 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

10 facts on patient safety

Priorities in Ireland

• These are clearly not the same!• 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 in Ireland

• Current focus appears to centre on output of 8 Expert Advisory Groups

Cardiovascular servicesDisabilityMaternity servicesOral Health

ChildrenDiabetesMental HealthOlder People

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