How to Harm Children with Medicines – a guide for pharmacists *

1. How to Harm Children with Medicines – a guide for pharmacists* James Wallace – Yorkhill Hospital Glasgow Peter Mulholland – Southern General Hospital Glasgow *With apologies to Professor Imti Choonara

2. Learning outcomes • Definitions & identification of medication errors • Extent & nature of medication errors in children • Strategies to avoid errors

3. Definition A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer

4. In the UK • The UK Department of Health in 2000 recognised that a weakness of the NHS is in preventing serious incidents in which patients are harmed or experience poor outcomes of care.

5. NPSA 2007. Safety in doses: improving the use of medicines in the NHS. • National Reporting and Learning System - 60,000 incidents reported in 18 months • Children ≤ 4years involved in 10% incidents where age stated

6. NPSA 2007. Safety in doses: improving the use if medicines in the NHS Recurring themes • Problems with injectable medicines • Gentamicin – NPSA alert issued Feb 2010 • Children being treated in non-paediatric areas • Errors in dose calculation • 10 fold errors • Vaccines

14. Most common error type • Dosing errors 28% • Route of administration 18% • MAR transcription & documentation 14% • Wrong date 9.9% • Frequency 9.4%

15. Classification of errors • Wrong dose administered • Dose omitted • Additional dose given • Wrong drug given • Wrong infusion rate • Dispensing / labelling error • Wrong I/V concentration • Wrong patient • Wrong route • Other

16. How do errors occur? • Medication errors are almost never caused by the failure of a single element or the fault of a single practitioner • Usually the result of the combined effects of ‘latent’ errors in the system combined with ‘active failures by individuals

17. Psychological state Interruptions Lack of information Calculation errors -Electronic calculators Corporate livery Confirmation bias Tiredness/stress Noise Temperature Workload/staffing levels / Rotas Why do individuals make errors ?

19. Unreasonable to expect absolute perfection or error free performance from any person • Systems need to be in place to minimise the risk of medication errors by providing opportunities for checks, good communication, and a stress free environment • In any post error evaluation process - any system deficiencies should be identified and corrected before placing all responsibility on human error

21. Why are children at greater risk of medication errors?& What can WE do about it? • Drug doses calculated individually • Based on age, weight, surface area • More calculations • Weights change rapidly (esp neonates) • 10-fold errors • Inadequate information • Incorrect use of dose information resources

22. Why are children at greater risk of medication errors?& What can WE do about it? • Lack of suitable dosage forms and concentrations • Need for complex calculations & dilutions by medics/nurses/pharmacy

23. Medication errors with the potential to cause harm are eight times more likely to occur in neonatal intensive care units (NICUs) compared with hospital patient care areas for adults. Kaushal R, Bates DW, Landrigan C et al. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001; 285:2114–20.

24. Medication errors in children more likely with unlicensed medicines 13% of errors caused moderate harm and 60% of these involved unlicensed and off label drugs. Medication errors causing moderate harm were significantly more likely to be associated with unlicensed and off label drugs than licensed drugs Reference: Arch Dis Child, published early online 4 December 2010

25. Children can’t always tell us • if we’re about to make a mistake • if they suffer adverse effects • Children have less internal reserves with which to ‘buffer’ the effects of errors

33. Reporting system Review of errors Identification of system weaknesses Change of policies / procedures / training / availability of information Feedback to staff Non disciplinary Confidential telephone line Strategy for error reduction

34. What has been done? • Ward-based clinical pharmacist 95% • Computerised physician order entry with decision support 68% • e.g. drug-allergy; drug-dose; drug-drug interaction checks • Computerised medication administration record 18% Kaushal R et al. Medication errors and adverse drug events in pediatric inpatients. JAMA 2001;285:2114-20

35. Interventions • Increased input from clinical pharmacists • Prospective review of 10778 medication orders in two children’s hospitals • Analysed 10 error prevention strategies • 3 interventions had the greatest potential impact • clinical pharmacists might have prevented 81.3% • computerised prescribing might have prevented 72.7% • improved communication between staff might have prevented 47.7% • In combination 98.5% could potentially have been prevented. Fortescue et al, Pediatrics. 2003;111:722-9

36. Simpson et al (Arch Dis Child 2004) Glasgow • Pharmacist led education programme • Errors fell from 24/1000 to 5/1000 • Change in staff increased rate to 12/1000 • Still lower than before intervention

37. Ways to avoid? • Education for prescribers (& testing?) • Rules regarding zeroes/decimal points • Ready access to paediatric drug dosing texts • Avoid calculations by use of standard doses/dose charts etc • Provide drug monographs of high risk drugs • Individualised emergency drug dose chart

38. Other ways to avoid? • Check weight is appropriate for age • Ensure dose is not > adult dose • Do not accept poor/ambiguous prescriptions • Accurate patient history taking • involve families • maintain patient profiles for regular patients

39. Other ways to avoid? • Avoiding interruptions • tabards • quiet room • medication nurse/technician • Double checking • Root-cause analysis of all major errors

40. Handwritten drug name Verbal drug name Dose overlap Presentation Directions & frequency Purchasing for safety Assess all new products before introducing: • Indication • Alphabetical location • Packaging & labelling • Information

41. Storage for safety Numerous commercially available parenteral medications indicated for neonates were being stored on shelves in the central pharmacy adjacent to similar-sounding and similar-appearing medications for adults. • Resolution Neonatal medications were segregated into a “neonates only” portion of clearly marked shelving. Purchasing personnel created this new segregated shelving space and allocated purchased medications to this space when deliveries arrived from the distributor

43. Summary • Acknowledge the problem • Quantify it’s extent and causes • Cease finger pointing • Analyse all errors via quality assurance • Evaluate proposed solutions

44. Summary of learning points • Establishment of a medication error review scheme is essential • A ‘no blame’ system of reporting should be established • Suitable paediatric reference sources should be readily available • Users should be aware of problems relating to unlicensed or off label drug use • Patients / carers should have suitable information

45. Any system that helps prevent medical mistakes, by helping doctors come forward without the fear of being blamed, would hold real benefits for the NHSMichael Wilks, chairman of the British Medical Association's Medico-Legal Committee