Paediatric medication errors within hospital settings!
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1 Paediatric medication errors within hospital settings! Tom G. Hansen, MD, PhD, Department of Anaesthesia & Intensive Care Odense University Hospital
2 WHO 2002 Risks in health care system - resolution Patient safety Medical errors Adverse events
3 To Err is human Patient safety defined as freedom from accidental injury due to medical care.. Institute of Medicine. To Err is Human. Building a safer Health System, Washington, National Academy Press: 1999 (
4 The World Health Profession Alliance Definition: An adverse events: harm or injury caused by the management of a patients disease or condition by health care professionals rather than by the underlying disease or condition itself
5 Reason J. Human error. Cambridge: Cambridge University Press 1990 Slips Lapses Mistakes
6 Foundation of research into clinical error and adverse events The California Medical Association s Medical Insurance Feasibility Study 1977 (4.6% of ) The Havard Medical Practice Study 1984 (3.7% of )
7 US Institute of Medicine Report fatal clinical US errors p.a. U$ Billion (US) 6 Billion (UK) AU$ 5 Billion (AUS)
8 Some definitions of error.... Medication error (error in prescribing, dispensing or administering a drug) Adverse drug event (ADE) (injury related to the use of a drug) Prescription error (prescribing decision, or written prescription resulting in an unintentional significant: reduction in probability of treatment being timely or effective, or increase in the risk of harm) Drug administration error (misinterpretation of correct prescription leading to: wrong: drug, dose, rate, formulation, concentration, route, time, patient) Dose error (wrong dose of a drug) Adverse drug reaction (any noxious or unintended response to a drug occurring in doses normally used in humans)
9 How to study medication errors? Retrospective case notes Analysis of malpractice claims Incident reporting systems Disguised observation Prospective drug chart review by pharmacists
10 How common are medication errors? Barker et al. Arch Int Med 2002; 167: % drug administration error (17% dose errors) O Hare et al BMJ 1995; 310: % drug administration error (2% dose errors)
11 How common are ADEs? 6 ADEs per 100 hospital admisssions 5 potential ADEs 1% of medication errors cause ADE Barker et al. Arch Int Med 2002: 162; Bates et al. JAMA 1995: 274: Classen et al JAMA 1991: 266;
12 Causes of error. Person approach System approach
13 An example A fatality occurred when a flow rate of a child s epidural infusion pump for postoperative pain management - was increased to 125 ml/h by a ward nurse who actually wanted to give the child an intravenous fluid bolus dose, despite the pump being correctly labelled and the patient receiving intravenous fluids via a gravity-fed drip set. The person approach would be to blame the nurse. The system approach would highlight the fact, that epidural pumps should have a maximum infusion rate of e.g. 20 ml/h, and that patients with epidural infusions should remain in high dependency areas, where staff are plenty and more experienced.
14 Causes of prescribing error 57% skill-based slips/lapses 39% rule-based mistakes 4% violations Dean et al. Lancet 2002;359:
15 The role of the environment? Day/night shifts? Excessive workload? ICU? Interhospital transfer
16 Transfer of patients. 116/11000 reported incidents 40% equipment 60% management issues 1/3 of incidents showed significant adverse outcome 11% involved drugs 4% failure of infusion devices
17 The role of Staff? Cultural differences? Lack of role models Inexperience and education Lack of technology Nurses vs. Doctors (anaesthetists)? Taxis et al. Quality and Safety in Health Care 2003;12:343-7
18 Latent conditions leading to medication errors Failure to check drugs before administration Lack of communication Inadequate monitoring of treatment or side-effects Lack of standardisation of labels and protocols Equipment (e.g. errors of transference ) Leape et al. JAMA 1995; 274:
19 Patient factors in medication errors ADE Prevention Study Group (few independent predictors with little predictive power) Bates et al Arch Int Med 1999; 159: Other studies: age polypharmacy impaired renal function
20 US Pharmacopoeia hospitals released medication incidents reports, including 14 deaths (3.5%) Children (2 deaths) 5.6% were ADE Reports w/ temporary harm: adults (0.4%) and children (0.9%) Reports leading to deaths: adults (0.02%) and children (0.1%)
21 Steps in the medication process for paediatric medication safety incident reports Prescribing 8.6% Dispensing 22.6% Administration 51.7% Documentation 15.5% Monitoring 1.5%
22 Types of paediatric medication incident reports (US Pharmacopoeia 2002) Wrong dose/quantity 29% Omission 24% Wrong time 15% Unauthorised dose 11% Extra dose 7% Wrong drug preparation 6% Prescribing error 5% Wrong patient 3% Wrong administration 2% Wrong dosage form 2% Wrong route 1%
23 Types of Paediatric Medication Incidents reported Odense University Hospital in the UK (Cousins DH et al Paed Perinat Drug Ther 2002) Type of error No % Fatalities % Wrong dose Wrong drug Wrong route Incorrect container Incorrect rate of administration Omitted in error Wrong strength Wrong patient Duplicate dose Expired drug Incorrect label Miscellaneous Total
24 Drugs or drug groups involved in medication errors in children Odense University Hospital Type of error Drug/drug group involved Wrong dose Wrong formulation Adrenaline Asparaginase Benzylpenicillin BCG vaccine Diamorphine Digoxin IV fluids Magnesium sulphate Methylphenidate Morphine Phenytoin Sedatives Sodium nitroprusside tacrolismus penicillin Wrong route Vincristine Nystatin oral suspension Wrong strength Chloroform water double strength Magnesium sulphate
25 Why are children high risk population? Different and changing PK (and PD?) Dosing based on age, mg/kg, mg/bsa and clinical condition Lack of pharmacological studies in children Lack of medicinal products with dosage forms and concentration appropriate for neonates, infants and children
26 The Washington Post April 20, 2001 Overdose Kills Girl at Children's Hospital A 9-month old girl died last week after a misplaced decimal point caused a Children s Hospital nurse to administer a massive overdose of morphine, illustrating a problem that plagues hospitals nationwide. Children s Hospital officials said that, instead of two 0.5 milligram doses of morphine, a narcotic prescribed to control postoperative pain, the child was given two doses of 5 milligrams each--10 time amount the surgeon intended. The doses were given two hours apart Aril 11 as the girl recovered from successful surgery that day. By Avram Goldstein Washington Post Staff Writer
27 So What s the Big Deal? 1 in 10 medication errors result from: Incorrect names Confusing expressions of dosage forms Misunderstood abbreviations, symbols and acronyms Misinterpreting decimal point placement Result: Catastrophic Consequences!! JAMA 1997 Jan;277(4):312-17
28 Problem-Prone Abbreviations Signs Greek Letters Latin Terms Ambiguity
29 Dangerous Abbreviations: Bad Handwriting U or u for Unit Frequently used with dangerous or High Alert medications: Insulin and Heparin Read as a zero (0) or a (4), causing a 10 fold overdose or greater (4U misread as 40 or 44 units.) Unit has no acceptable abbreviation USE UNIT ALWAYS!!
30 Do not use U for Units Order for 8 units could be mistaken for 80 Odense University Hospital
31 Dangerous Abbreviations: Greek Letters µg for Microgram Mistaken for mg when handwritten Can result in a 10-fold overdose Use mcg or write out micrograms (preferred)
32 Decimals and Zeros Always include leading zeros to draw attention to the decimal Here 0.2mcg may be misread as 2mcg also avoid the use of decimal points
33 Decimals and Zeros The zero here is especially dangerous as lines in the order mask the decimal. 2mg becomes 20mg.
34 Avoid Elemental symbols This order for magnesium could have easily been read as morphine
35 What is being done about medication errors?.an organisation with a memory..changes to a systems of work...reconsider all processes and actions afresh.
36 Technology and defence against error Barcode systems Prescribing using Computerised Physician Order Entry (CPOE)
37 Conclusions Keep it simple Education List hazardous drugs that can kill Reliable audits, detection and reporting systems (fair and non-punitive) System failures not individual failures Hospital committee to deal with major medication errors Use of new technology (electronic prescribing system, and computer system to calculate doses)
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