The “Real” Risks of Aseptic preparation

1. The “Real” Risks of Aseptic preparation Tim Sizer, University of Leeds

2. 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

3. Key risk areas for Patients Prescription

4. Key risk areas for Patients • Prescription • Calculation /Dose • Selection / Picking • Preparationa) Contamination b) Stability/Degradation • Distribution & Storage • Administration • Effects

5. Where things have gone wrong- Contamination 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

6. Contamination Where things have gone wrong- Manchester “Manchester Incident” 1994 Death of 2 children following administration of contaminated TPN - • Facilities • Contamination • Validation • ? Poor technique

7. Where things have gone wrong - Contamination Bloemfontein 2002 Tokyo: • 12 pts infected with Serratia marcescens from contaminated heparinised-saline drips - 7 died • Contamination traced to towel in nurses stationTanaka 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 Tokyo • Dirty hands - main reason • Operator Ignorance / poor procedures

8. Where things have gone wrong- Contamination • 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 alInfection 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” Poisoning or Overdose

9. Where things have gone wrong - Poisoning or Overdose 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”

10. 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

11. Where things have gone wrong - Poisoning or Overdose 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 • Rx was appropriate, so “how lethal levels of zinc were present and why no one caught the mistake before it was administered was unclear” Baby Alyssa Shinn 26 weeks gestation Birth wt: 1 lb 4 oz

12. Where things have gone wrong - Poisoning or Overdose London Inquest Westminster Coroners Court 26 Apr 2007 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?) Jada Pilkington Asanye-in ICU

13. Aseptic PreparationisaRISK What about ward preparation? 6. O'Hare et al. Errors in administration of intravenous drugs [letter]. BMJ 1995;310:1536-7. One study of ward-based activity found a massive error rate among doctors (96%) & nurses (83 %) despite formal training & double checking systems

14. 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”

15. Compoundingisexpectedtoincrease State of Healthcare2006 • 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

16. Compoundingisexpectedtoincrease 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

17. Compoundingisexpectedtoincrease Recommendations for Trusts The Best MedicineJanuary 2007 • Supplying and managing medicines in the trust • Trusts - risk assessment of preparation of parenteral medicines in wards, theatres & other clinical areas and agree an action plan to reduce risk. • Trusts - review medicines that they prepared in pharmacy with a view to changing the source to the industry or licensed NHS units, where possible • QC/QA audit reports should be reported to the medicines management committee and high risks should be escalated to the risk management committee

18. Compoundingisexpectedtoincrease 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

19. NRLS Incident Reports Involving Injectable Medicines Sept 2004 – March 2006

20. 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 DosesDoH March 2007 England

21. Risks In Prep & Admin Injectable Meds • 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 thewrong 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

22. Actions for the • Undertake a risk assessment of injectable medicines, procedures and products used • Ensure up-to-date written protocols and procedures for prescribing, preparation and administration • Ensure essential information available at point of use in all near patient areas where injectable medicines are used.

23. Actions for the • 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

24. 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 care-associated infection and the development of antimicrobial resistance.

25. 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

26. 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 2007To err is human, to cover up is unforgivable and to fail to learn is inexcusable.

27. Priorities in Ireland Children Diabetes Mental Health Older People Cardiovascular services Disability Maternity services Oral Health • Current focus appears to centre on output of 8 Expert Advisory Groups 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.”

28. 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