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User-applied Labelling of Injectable Medicines, Fluids and Lines1 Staff Training (Name of Presenter) Developed by Medicines and Technology Policy and Programs SA Health 1 Copyright: Australian Commission on Safety and Quality in Health Care User-applied Labelling Recommendations > Developed by the Australian Commission on Safety and Quality in Healthcare 2010*. > Aim for a single, comprehensive national recommendation for clinical practice. > Apply to all public health facilities nationwide. * Updated February 2012 SA Health Labelling for Safety > Labelling of injectable medicines, fluids and delivery devices is a major patient safety issue. > Labelling is often not done or is incomplete, omitting information such as: • name of medicine • medicine dose • patient name • time of preparation. SA SA Health Health Reason for the recommendations Safety in labelling > Errors attributable to labelling have been associated with: • the multi-step process when preparing bolus injection or infusion • absent or inadequate labelling • patient transfer • sterile field - inconsistent practice • 0.9% sodium chloride flush • line misconnections. SA SA Health Health Reason for the recommendations Medicine administration errors Case Report 1 > 10mg morphine was given in error as the clinician thought the syringe contained 0.9% sodium chloride. The unlabelled morphine syringe had a 0.9% sodium chloride ampoule attached (unpublished). SA SA Health Health Reason for the recommendations Medicine administration errors Case Report 2 > A patient was given intravenous (IV) lignocaine with adrenaline solution intended for local anaesthetic infiltration. This syringe had been drawn up and placed in a kidney dish alongside IV morphine and midazolam for procedural sedation (unpublished). SA SA Health Health Labelling Recommendations Development > Draft recommendations developed by NSW Therapeutic Advisory Group Safer Medicines Group. > National consultation and pilot testing, supported by the Australian Commission on Safety and Quality in Health Care, commenced in 2009. SA SA Health Health Labelling Recommendations Development > Recommendations are based on: • international literature/recommendations • Australian Standard AS4940: User-applied identification labels for use on fluid bags, syringes and drug administration lines. • expert opinion • pilot testing • reported medicine administration incidents. SA SA Health Health Labelling Recommendations Consultation > The draft Labelling Recommendations were developed in consultation with: • All state and territory health jurisdictions • All state and territory Safer Medicines Groups • The Council of Australian Therapeutic Advisory Groups • 13 national peak professional bodies.* > Pilot tests conducted in 2009-10 across 12 clinical areas in 8 hospitals (including Mt Gambier Hospital, SA) *National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines August 2010 Appendix 3 SA SA Health Health Labelling Recommendations Aims > provide standardisation for userapplied labelling of injectable medicines > provide minimum requirements for user-applied labelling of injectable medicines > promote safer use of injectable medicines. SA SA Health Health Labelling Recommendations Minimum requirements > medicines or fluid removed from original packaging must be identifiable > all containers (e.g. bags and syringes) containing medicines 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. SA SA Health Health Labelling Recommendations Outline & Scope > what should be labelled > what should be included on the label > where the label should be placed SA SA Health Health Labelling Recommendations Exclusions > injectable medicines and fluids prepared by hospital pharmacy departments or external manufacturers > administration portals > syringe drivers and pumps > enteral, topical or inhalational medicines > preparation and bolus administration of a SINGLE medicine from a SINGLE syringe in one uninterrupted process. SA SA Health Health Labelling for medicine additives SA Health Labelling Recommendations Identifying target tissue/ route of administration > A standard colour system is used to identify the target tissue/intended 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 SA Health Medicines Bag and syringe labels > IntraVENOUS, EPIDURAL, IntraTHECAL, REGIONAL, Subcutaneous and Miscellaneous use > Available in 2 sizes > Use of TALLman lettering All Containers Label content DOB 01/06/1966 > Patient: Given name & family name > Identifier (ID): This is the URN or MRN > DOB: Date of Birth > For each medicine added to the container specify: • generic medicine name • amount • total milligrams, grams, micrograms added to bag or syringe • volume • total volume of fluid in the container – expressed in millilitres (mL). SA Health All Containers Label content DOB 01/06/1966 > Concentration • addition to current labelling process for most facilities • calculation of the amount of medicine in the bag or syringe per mL. > Amount of medication (ie mg) / volume (mL) • ceftriaxone in NaCl bag: 1000mg/500mL = 2mg/mL • morphine in WFI syringe: 10mg/4ml = 2.5mg/mL SA Health All Containers Label content DOB 01/06/1966 > Diluent • complete for all syringes • not necessary if applying to bag with diluent pre-printed > ‘Date’ and ‘Time’ • when the medicine is prepared > ‘Prepared by’ and ‘Checked by’ • to be signed by person responsible SA Health All Containers Label content > If two medications are added, the concentration must be added for both. > All additions should be added on the same label. DOB 01/06/1966 SA Health User-applied labelling of injectable medicines | IV bag Label placement > Place labels on the FRONT of the bag > This ensures the type of base fluid, batch number and expiry date remain visible. SA Health Syringes Label placement > Place label so graduations on the syringe scale remain visible > Apply parallel to the long axis of the syringe barrel, top edge flush with scale > ‘Flag’ for small syringes SA Health Medicines IV flushes > Label any fluid drawn up in a syringe for use as an IV flush (e.g. 0.9% sodium chloride) unless preparation and bolus administration is one uninterrupted process SA Health All Containers Discarding content > Recommendations address the risk of administering an unidentified fluid. > Discard: • any unlabelled container holding a solution • any container, where there is doubt over content • any medicine remaining in the container at the end of a procedure. SA Health Medicine Burettes DOB > Use ‘peel-off’ labels reserved for use on burettes ONLY. > Place label so that text is upright and ensure that the burette graduations are not obscured. > Burette labels must be removed once the medicine has been administered to the patient. SA Health Labelling for administration lines SA Health Lines and catheters Route of administration Available for intraVENOUS, CENTRAL VENOUS, EPIDURAL, intraTHECAL, REGIONAL, subcutaneous and intra-ARTERIAL and miscellaneous. SA Health Lines and catheters Route of administration > Labelling administration lines and catheters • label all lines to identify route • add date and time the line change is due • identify catheters where there is a risk of wrong route administration, e.g. where the patient entry portal is distant from the administration site. > Labelling invasive monitoring lines • identify all lines, including those not primarily intended for medicine administration. 12/07/2013 14:00 SA Health Lines Active ingredient > Identify the active ingredient within administration lines dedicated for continuous infusions. > Pre-printed line labels are also permitted.* > Lines for other infusions (e.g. intermittent) may be labelled for medicine content.** *See pre-printed medicine line labels for continuous infusions section of this presentation ** Always ensure the label is removed on completion of infusion SA Health Lines and catheters Label Placement > Route label • Use colour coded route label • Label near the injection port on the patient side SA Health Lines and catheters Label Placement > Medicine label • Use generic medicine label. • Label close to patient entry portal adjacent to route label. SA Health Peri-operative environments SA Health Pre-printed medication labels > The National anaesthetic guidelines AS/NZS 4375 for pre-printed medication labelling of syringes is recognised by the Labelling Recommendations. > Pre-printed labels have specific colour coding associated with drug class. > Only appropriate for use in environments where the patient is recognised as identified (within Theatre, in an Ambulance or retrieval emergency). SA Health Peri-operative environments > Labelling of syringes containing drugs used during anaesthesia to comply with AS/NZS 4375. > Labelling of bags, syringes, lines, catheters and invasive monitoring lines in all areas of the perioperative environment, other than drugs in syringes used during anaesthesia, are to comply with the Labelling Recommendations. > Use abbreviated container label in operating room where patient identity is established and there are other means of recording labelling and preparation signatories. SA Health Pre-printed Medicine Line Labels – Dedicated Continuous Infusions SA Health Dedicated Continuous Infusions > Dedicated continuous infusions may be labelled with a pre-printed line label. > Concentration is not required. > Colour-coding on pre-printed labels should follow the anaesthetic standard (AS/NZS 4375) EXCEPT • High risk medicines that fall in the ‘miscellaneous’ category should be printed red on white SA Health Pre-printed Medicine Line Labels – Syringe labels in interventional cardiac catheter and radiology laboratories SA Health Syringe labels in interventional cardiac catheter and radiology laboratories > Syringe labels in interventional cardiac catheter and radiology laboratories may be labelled with a pre-printed line label. > Concentration is not required. > Colour-coding on pre-printed labels should follow the anaesthetic standard (AS/NZS 4375) EXCEPT > > > > > antiplatelet agents/anticoagulants to be labelled with teal green (PMS 3255) heparin to be teal green with a black border protamine to be teal green with a black diagonal stripe border heparinised saline to have a teal green border (PMS 3255) contrast to have a brown border (PMS 471) SA Health Syringe labels in interventional cardiac catheter and radiology laboratories > Examples of the cardiac and radiology syringe labels can be found at: http://www.safetyandquality.gov.au/our-work/medication-safety/safer-naming-labelling-andpackaging-of-medicines/user-applied-labelling/ SA Health Labelling for Safety e-learning SA Health Labelling for Safety: e-learning > SA Health has developed an e-learning tool – Labelling for Safety > The course is intended for clinical staff involved in direct patient care • in particular, for staff involved in the preparation and administration of injectable medicines in a clinical or ward area. > Access the course at: http://digitalmedia.sahealth.sa.gov.au SA Health SA Label - For Enteral Use Only SA Health SA Label – For Enteral Use Only > South Australia has developed a label for enteral feeding lines. > Label aligns with the Australian Standard including colour and size. DOB DOB Enteral Bag Label Enteral Syringe Label Enteral Line Label SA Health Our Implementation SA Health Implementation Our plan for implementation > Include details here of: • Implementation date • How you will be running education • If you did the implementation survey give some of the results about focus areas… • Plan for withdrawing old labels • People to contact on site for questions SA Health SA Health Posters SA Health Questions? SA Health