2 Scope of the Labelling Standard The purpose of the Labelling Standard is to improve patient safety. labelling of injectable medicines and fluids by the user at the point of delivery should help to reduce the risk of medicine administration errors. 2.1 Inclusions The Labelling Standard sets out the requirements for user-applied labelling of: containers for injectable medicines and fluids (bags, bottles and syringes) in which the medicine can no longer be identified by its original packaging conduits (administration lines, invasive monitoring lines, catheters and burettes) that are used to deliver injectable medicines and fluids non-injectable fluids that can no longer be identified by their original packaging, including topical solutions, and oral and inhalational liquids. The Labelling Standard identifies: what should be labelled what should be included on the label where the label should be placed where the Labelling Standard applies. Figure 1 shows examples of injectable medicines, containers and conduits that require labelling. Figure 1 Examples of containers and conduits for injectable medicines that require labelling The Labelling Standard applies to: all health services where injectable medicines and fluids are administered. These include, but are not limited to, hospitals (including day procedure units), primary care services (such as ambulance services) and community health services (such as immunisation clinics) all clinical areas where injectable medicines and fluids are administered all injectable medicines and fluids prepared in the ward or clinical area, including perioperative injectable medicines, defined as any sterile medicine intended for administration by bolus injection, perfusion or infusion by the following routes: intravenous, intramuscular, intrathecal, intra-arterial, subcutaneous, intradermal, intraventricular, epidural, intravesicular, intravitreal, intrapleural and intra-ocular (46). This list is not exhaustive, and other routes of injection should also be considered in the context of the applied applied
Benzodiazepine antagonists Orange with white diagonal stripes RGB: 255.102.0 CMYK: 0.60.40.0 PMS: 151 Flumazenil Muscle relaxants Fluorescent red or warm red. Exception: suxamethonium (red name reversed out of a bar on the upper half of the label) RGB: 253.121.86 or 245.64.41 CMYK: 0.52.65.1 or 0.75.90.0 PMS: 811 pancuronium, vecuronium Relaxant reversal agents Fluorescent/ warm red with white diagonal stripes RGB: 253.121.86 or 245.64.41 CMYK: 0.52.65.1 or 0.75.90.0 PMS: 811 Neostigmine, pyridostigmine Opioids Blue RGB: 133.199.227 CMYK: 37.11.0.11 PMS: 297 Morphine, fentanyl, pethidine Opioid antagonists Blue with white diagonal stripes RGB: 133.199.227 CMYK: 37.11.0.11 PMS: 297 Naloxone
Vasopressors Violet. Exception: adrenaline (violet name reversed out of a black bar on the upper half of the label) RGB: 222.191.217 CMYK: 0.12.2.13 PMS: 256 Adrenaline, metaraminol, noradrenaline Hypotensive agents Violet with white diagonal stripes RGB: 222.191.217 CMYK: 0.12.2.13 PMS: 256 Sodium nitroprusside, glyceryl trinitrate, phentolamine, hydralazine Local anaesthetics Grey RGB: 194.184.171 CMYK: 0.4.9.24 PMS: 401 Procaine, lignocaine, bupivacaine, ropivacaine Anticholinergic agents Green RGB: 163.217.99 CMYK: 21.0.46.15 PMS: 367 Atropine, glycopyrrolate Antiemetics Salmon RGB: 237.194.130 CMYK: 0.17.42.7 PMS: 156 Droperidol, Anticoagulant/ antiplatelet agentsc Teal green RGB: 34.211.197 CMYK: 64.0.32.0 PMS: 3255 Abciximab, bivalirubin, eptifabatide, tirofiban, urokinase de
Intrathecal Pantone Yellow with 70% stipple Solid black 70 mm × 25 mm Intravenous Blue PMS 2985 with 70% stipple Black/blue hatched 70 mm × 25 mm Epidural Pantone Yellow with 70% stipple hatched 70 mm × 25 mm Central venous White Black/blue PMS 2985 hatched 70 mm × 25 mm Regional White Yellow hatched 70 mm × 25 mm Subcutaneous Beige PMS 723 with 70% stipple Black/beige hatched 70 mm × 25 mm Intra-arterial Red PMS 1787 with 70% stipple Black/red hatched 70 mm × 25 mm Miscellaneous Pink PMS 806U with 70% stipple Black/pink hatched 70 mm × 25 mm Dialysis Blue PMS 2985 with 70% stipple Black/blue hatched 60 mm × 50 mm (‘peel-off’)* PMS = Pantone Matching System Lines and catheters: non-injectable medicines and fluids – route label Route Example Background Border Size Enteral PMS 361 with 70% stipple Black/green hatched 70 mm × 25 mm PMS = Pantone Matching System Lines and catheters: medicine labels Medicine Example Background Border
Preprinted Consistent with ISO 26825:2008 and extension to ISO 26825:2008 (see Section 3.3.2) Consistent with ISO and extension to ISO 26825:2008 (see Section 3.3.2) To be determined by health facility Generic Nil 70 mm × 25 mm a Label stock used in evaluation was unplasticised PVC tape (see Section 5.2.2).
Background colour to be except for neural route, which is to be yellow Background is coloured (70% of primary colour) A coloured background was introduced to increase the visibility of labels applied to fluid bags in clinical settings. This was applied to both labels (small and large). To allow for readability of label content, 70% of the primary colour was chosen. A combination of coloured (70% of primary colour) and white backgrounds was to line labels to assist differentiating between similar routes (e.g. intravenous and central venous) Background colour to be except for neural route, which is to be yellow Yellow background retained for intrathecal and epidural routes. Regional background colour is white The white background was to the regional route to differentiate between the two other neural routes – epidural and intrathecal Border pattern to be of squares of alternating and coloured squares Alternating black and coloured square borders have been retained in all cases with the exception of the intrathecal route Using the same border and background for intrathecal and epidural routes was judged to be a source of high-risk error and patient harm, due to similar label design. A solid black border has been introduced to assist in differentiating between intrathecal and epidural Border to be at 4 mm in width Border at least 3 mm in width The border width was reduced to maximise space for label content Border to occupy at least 3 sides of the label Border occupies 2 sides of the label The border was applied to the lateral to retain the border feature and to maximise space available for label content AS 4940 = Australian Standard AS 4940:2002 User-applied identification labels for use on fluid bags, syringes and drug administration lines (67, 68)
Anticoagulant/ antiplatelet agents Teal green (PMS 3255; CMYK 64.0.32.0; RGB 34.211.197) abciximab, bivalirubin, eptifabatide, tirofiban, urokinase Heparin Teal green (PMS 3255; CMYK 64.0.32.0; RGB 34.211.197) with solid black border (1–2 mm) Protamine Teal green (PMS 3255; CMYK 64.0.32.0; RGB 34.211.197) with black diagonal-stripe border (1–2 mm) Heparinised saline White with teal green (PMS 3255; CMYK 64.0.32.0; RGB 34.211.197) border Contrast media White with brown (PMS 471; CMYK 20.70.100.7; RGB 188. 97.36) border