National User-applied Labelling of Medicines in the Perioperative Setting

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Diana Shipp, Senior Project Officer, Australian Commission on Safety and Quality in Health Care delivered this presentation at the 2013 Operating Theatre Management conference in Sydney/Australia. The event offers attendees insights into the latest programs and practices being implemented across the country & key strategies and methods to help improve your skills and knowledge as a Theatre Manager. For more information, please visit www.healthcareconferences.com.au.

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National User-applied Labelling of Medicines in the Perioperative Setting

  1. 1. Labelling of medicines and fluids on the perioperative sterile field 1 National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines Implementation in the perioperative setting August 2013
  2. 2. Labelling of medicines and fluids on the perioperative sterile field 2 Labelling Recommendations  Identification of injectable medicines and fluids is a major patient safety issue  A standardisation to identify injectable medicines and fluids removed from their original packaging  Set of minimum requirements  Excludes anaesthetic drugs given by syringe during anaesthesia  Mandated in Australia Nov 2010 and part of National Safety and Quality Health Standards (NSQHS)
  3. 3. Labelling of medicines and fluids on the perioperative sterile field 3 Labelling Recommendations Medicine administration consistent with ‘7 rights’ (wicks RW and Wanzer L, AORN Journal 2011) Right patient Right medicine Right dose Right route Right time Right indication Right record
  4. 4. Medication errors Unintentional use of a wrong plan or failure to carry out a planned action as intended Trying to do right but getting it wrong Trying harder may or may not be successful Processes and systems intrinsically improve safety Well-labelled syringes are more likely to have been prepared correctly than poorly labelled or unlabelled syringes Labelling of medicines and fluids on the perioperative sterile field 4
  5. 5. Labelling of medicines and fluids on the perioperative sterile field 5 Labelling Recommendations Minimum requirements All medicines and fluids removed from original packaging must be identifiable All containers (e.g. bags and syringes) must be labelled on leaving the hands of the person preparing the medicine Prepare and label one medicine at a time Discard medicines or fluids in unlabelled containers
  6. 6. Perioperative setting - Case reports A 69 year old woman died when she was injected with an antiseptic skin preparation fluid instead of contrast media A patient died when glutaraldehyde was confused with spinal fluid and injected intrathecally During angiography, a patient suffered a grand mal seizure after receiving lignocaine instead of contrast media A seven year old boy died following elective surgery when mistakenly injected with adrenaline (1 in 1000) instead of lignocaine 1% and adrenaline 1 in 100,000, i.e. 100x the intended dose of adrenaline
  7. 7. Perioperative setting  Closed environment – a single patient with established identity (cf. Open environment – more than one patient in the same area)  Multidisciplinary team – each member interacts with medication use process in different ways and at different times  Patient transfer through multiple clinical areas and personnel routinely perform multiple handoffs  Medications are transferred into a container system appropriate for delivery to sterile field  Mixing, diluting multiple medications or solutions on the sterile field is often time sensitive Labelling of medicines and fluids on the perioperative sterile field 7
  8. 8. Safer use of injectable medicines in perioperative setting Performance Improvement Study – ‘scrub persons are likely to label medications and syringes more often and more accurately when pre-printed labels are provided’ (Jennings et al, AORN Journal 2007) Provide pre-printed, sterile labels Standardisation of user-applied labelling with minimum requirements Purchase medicines in pre-filled, sterile, labelled syringes Use commercially available applicators or swabs Labelling of medicines and fluids on the perioperative sterile field 8
  9. 9. Labelling of medicines and fluids on the perioperative sterile field 9 Open environment Bag and syringe labels
  10. 10. Labelling of medicines and fluids on the perioperative sterile field 10 Open environment Bag and syringe labels  
  11. 11. Labelling of medicines and fluids on the perioperative sterile field 11 Lines and catheters: Route of administration
  12. 12. Labelling of medicines and fluids on the perioperative sterile field 12 Continuous infusion lines: Medicine ● Identify the medicine in lines dedicated continuous infusion lines ● Pre-printed line labels evaluated in ICUs ● Labels ‘fit for purpose’ and larger than anaesthetic labels
  13. 13. Labelling of medicines and fluids on the perioperative sterile field 13 Identifying target tissue/route of administration Standard colours assist identification of target tissue/route of administration Target tissue Route of administration Colour Intra-arterial Intra-arterial Red Intravenous Intravenous Blue Neural tissue Epidural / Intrathecal / Regional Yellow Subcutaneous tissue Subcutaneous Beige Miscellaneous Any other route not specified above Pink
  14. 14. Labelling of medicines and fluids on the perioperative sterile field 14 Discarding Content For all containers (bags, syringes, hollowware) discard Any unlabelled container holding a fluid Any container, where there is doubt over content Any medicine remaining in a container at the end of a procedure
  15. 15. Labelling of medicines and fluids on the perioperative sterile field 15 Closed environment-Perioperative Setting 2 Labelling standardisations ISO 2685:2008 (AS/NZS 4375:1996) for medicines in syringes used during anaesthesia. • Colour coded for drug class User-applied Labelling of Injectable Medicines, Fluids and Lines for all other situations in the perioperative environment • Colour-coded for target tissue
  16. 16. Labelling of medicines and fluids on the perioperative sterile field 16 User-applied labelling of drugs in syringes in anaesthesia ISO26825:2008 (AS/NZS4375:1996)
  17. 17. Labelling of medicines and fluids on the perioperative sterile field 17 User-applied labelling of drugs in syringes in anaesthesia ISO26825:2008 (AS/NZS4375:1996)
  18. 18. Labelling of medicines and fluids on the perioperative sterile field 18 Perioperative sterile field  On the operating room sterile field use sterile abbreviated container labels  Or use sterile pre-printed labels with advantages  No sterile marker  Ready supply  Less time to select and apply  Use full container labels and check all remaining lines are labelled when the patient moves into the open practice environment, e.g. PACU.
  19. 19. Labelling of medicines and fluids on the perioperative sterile field 19 Examples of pre-printed labels (Calvary Wakefield Hospital)
  20. 20. Poster reproduced with kind permission of Princess Alexandra Hospital, Woolloongabba, Queensland Irrigations Skin Preparations Heparin Local Infiltration without Adrenaline Local Infiltration with Adrenaline Specialty specific
  21. 21. Labelling of medicines and fluids on the perioperative sterile field 21
  22. 22. Labelling of medicines and fluids on the perioperative sterile field 22 Example of pre-printed labels for cardiac catheter laboratories
  23. 23. Labelling of medicines and fluids on the perioperative sterile field 23 Contrast media  Black text on white background with a brown (PMS 471) border for contrast media.  Labelling is not required where contrast is decanted directly into a high speed pump reserved solely for the purpose of contrast injection.  Use the term ‘contrast’. Specifying contrast material by brand or generic name(s) is unlikely to confer a benefit in the closed practice environment of the operating room and may be misleading.  Royal Australian and New Zealand College of Radiologists (RANZCR) reviewing contrast labelling black border Protamine White with black stripe border Miscellaneous drugs White
  24. 24. Labelling of medicines and fluids on the perioperative sterile field 24 Labelling on the perioperative sterile field Medication errors are associated with medicines and fluids incorrectly identified or unidentified Labelling medicines and fluids removed from original packaging provides a process for identification Availability of sterile packed labels on the perioperative sterile field assists this process Providing a generic abbreviated label requiring population with a sterile marker is a barrier to labelling (may be only option) Pre-printed sterile labels have advantages
  25. 25. Labelling on the perioperative sterile field Maintain label integrity with exposure to fluids and frequent handling Maintain label adhesion throughout procedure. Label removal from reusable containers, e.g. stainless steel Minimise packaging to minimise waste and facilitate handling Sterile pens fit for purpose. Some have tendency to run Label availability at point of use (Stock, storage, obsolete) Labelling of medicines and fluids on the perioperative sterile field 25
  26. 26. Labelling of medicines and fluids on the perioperative sterile field 26 Calvary Wakefield Hospital Labelling Trial  Pre-printed labels with medicine name and concentration  Abbreviated container label where pre-printed unavailable  Colour coding to follow ISO26825:2008 A) Miscellaneous medicines in ISO26825:2008 to remain black on white B) Heparin and protamine borders C) Combination products with 2 medicines, e.g. local anaesthetic/adrenaline – use a single label  Labels must be intact for duration of procedure  Label must adhere for duration of procedure  Label may be removed at the end of the procedure for reusable hollowware containers
  27. 27. Labelling of medicines and fluids on the perioperative sterile field 27 Perioperative sterile field label procurement ● Steam sterilisation unsuitable for paper dyes ● Small scale - ethylene oxide (CWH) ● Large scale - gamma irradiation ideal for paper products, consider ● Packaging composition ● Radiation levels ● Test sterilisation ● Label manufacturers and suppliers of customised procedure packs with labels Paper stock and glue must be fit for purpose
  28. 28. Labelling of medicines and fluids on the perioperative sterile field 28 Reusable vs. disposable containers  Stainless steel and other reusable containers still used in preference to disposable containers in a high proportion of health facilities in Australia  Labels must be removed from stainless steel/reusable hollowware for reuse  Labelling Recommendations specify ‘peel off’ labels for container labels on the perioperative sterile field  Apply label at the time the container is filled. Pre-labelling disposable containers with medicine name is a source of medication error.
  29. 29. Reusable vs. disposable containers St Vincent’s Hospital evaluation 1 SVH Darlinghurst evaluated sterile labels and adherence to reusable containers used in the perioperative area  Tested labels from 3 suppliers after exposure to 3 fluids  Labels from 2 manufacturers could be removed either with or without application of alcohol wipes and/or eucalyptus oil. Note limitations:  only 3 fluids were tested and labels appeared to perform differently with exposure to different fluids  fluids were tested by adding a 'wipe' of fluid not by making the label very wet Labelling of medicines and fluids on the perioperative sterile field 29 Stirling Fildes Baypac Defries Industries Sodium chloride ContrastWater
  30. 30. Reusable vs. disposable containers St Vincent’s Hospital evaluation 2  SVH tested labels from 5 suppliers after exposure to 3 fluids including the CWH trial labels  Labels from 2 manufacturers could be swiftly removed  One label could be removed entirely provided this was done slowly  2 sets of labels left too much residue to be viable for disposable containers Labelling of medicines and fluids on the perioperative sterile field 30 Stirling Fildes (CWH) Mayo Big Green Surgical (E-Z Peel) Big Green Surgical (Permenant) Mermed Sodium chloride ContrastWater
  31. 31. Labelling of medicines and fluids on the perioperative sterile field 31 Feedback and support www.safetyandquality.gov.au Frequently Asked Questions Common issues addressed with reference to Labelling Recommendations, explanatory notes, implementation guide or the pilot test experience Issues Register Issues not addressed by Labelling Recommendations and referred to the Labelling Recommendations Reference Group (LRRG) 3rd edition
  32. 32. Labelling of medicines and fluids on the perioperative sterile field 32 Labelling Recommendations Reference Group (LRRG) includes representatives from Australian and New Zealand College of Anaesthetists (ANZCA) Australian College of Operating Room Nurses (ACORN) Australian Nursing Federation (ANF) College of Emergency Nursing (CENA) Australian an New Zealand Intensive Care Society (ANZICS) Australian College of Critical Care Nurses (ACCCN) The Cardiac Society of Australian and New Zealand (CSANZ) Australian Commission on Safety and Quality in Health Care State and Territory jurisdictions
  33. 33. Acknowledgements Australian Commission on Safety and Quality in Health Care acknowledges contribution from health services and label manufacturers involved in Pilot testing labels Evaluation on perioperative sterile field Adherence to containers on perioperative sterile field Evaluation in intensive care setting Evaluation in cardiology and radiology Feedback to inform Issues Register and other health services

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