Exception For consumer presentation, use ‘in’, ‘over’ or other descriptors instead of ‘/’. (Retain ‘/’ when this is consistent with other presentations of product information) n/a Exception For consumer presentation, out ‘morning’, ‘evening’ and other descriptors instead of using either the 24-hour clock, or ‘am’ and ‘pm’ n/a Addition For consumer presentation, use everyday words and avoid technical terms n/a Addition For consumer presentation, expand instructions to improve clarity n/a n/a = not applicable Numbers and of measure – see 6.3 for details Item Description Source 6.3.1 Recommendation Use a consistent display format and order CUI Rationale Prevent misinterpretation caused by different numerical elements having similar formats and units of measure n/a Exception For consumer presentation, order of information on route differs n/a 6.3.2 Recommendation Use standard approved of measure, consistently formatted NPSA, ACSQHC Rationale Prevent misreading or misinterpreting units of measure n/a 6.3.3 Recommendation Use spacing and labels to differentiate display elements ISMP Rationale Prevent misreading numbers due to proximity of preceding words n/a 6.3.4 Recommendation Use a between numbers and units of measure ISMP, AMT
11 Frequency qualifier at 10:00 am Optional n/a 12 Indication – Optional Mandatory for medicines prescribed ‘when required’ 13 Additional instructions – Optional n/a 14 Duration of treatment for full course for 10 days Optional n/a 15 – N/A Mandatory for pack-based prescribing 16 Supply – N/A Mandatory for prescribing n/a = not applicable Two active ingredients product Description Example Status Notes 1a 1st active ingredient perindopril arginine Mandatory In bold 2a Strength of 1st active ingredient 10 mg Mandatory for pack-based prescribing Described as quantity, non-breaking space and a unit of measure. Optional for dose-based prescribing 1b 2nd active ingredient amLODIPIne Mandatory In bold 2b Strength of 2nd active ingredient 10 mg Mandatory for pack-based prescribing As for first active ingredient 3 Brand name – Optional Mandatory for dispense according to display requirements in Section 6.1.3 4 Form tablet Optional n/a
11 Frequency qualifier when required Optional n/a 12 Indication for pain relief Optional Mandatory for medicines prescribed ‘when required’ 13 Additional instructions do not exceed 4 in 24 hours Optional The calculation of a maximum daily dose of paracetamol is outside of the scope of this document 14 Duration of treatment for full course – Optional n/a 15 SUPPLY Mandatory Mandatory for pack-based prescribing 16 Supply 100 mL Mandatory Mandatory for pack-based prescribing n/a = not applicable Product with four or more active ingredients For example, the fixed-dose combination medicine Stribild, which contains: Tenofovir disoproxil fumarate 300 mg Emtricitabine 200 mg Elvitegravir 150 mg Cobicistat 150 mg. Display the name alone for all fixed-dose formulations with four or more ingredients (see Section 6.1.3). However, the active ingredients should be easily accessible (for example, fully displayed on ‘hover over’, with each active ingredient displayed on a separate line). Description Example Status Notes 1 Active ingredient – Mandatory n/a 2 Strength – Optional n/a 3 Brand name Stribild Mandatory case 4 Form tablet Optional n/a 5 Route oral Mandatory n/a 6 Site – Optional n/a
If doses should be taken with food, specify ‘with food’. If doses should be taken with meals, specify ‘with meals’. Use of verbs Verbs should be used in instructions (for example, ‘2 tablets’ becomes ‘Take 2 tablets’, ‘Sparingly’ becomes ‘Apply sparingly’). Alerts and warnings Alerts or warnings should be included (for example, ‘Do not take more than 8 tablets in 24 hours’). Consumer testing indicated that maximum daily doses can be a source of confusion, especially for liquids. The minimum recommendation is to the number of tablets or volume of liquid (for example, ‘Do not take more than 8 tablets in 24 hours’, ‘Do not take more than 40 mL in 24 hours’). However, for liquids, doses may also be specified in brackets to aid consumers, if necessary (for example, ‘Do not take more than 40 mL (4 doses) in 24 hours’). Order of information These guidelines recommend presenting information in a consistent order. This is true for both clinical and consumer-facing medicines information. However, the order of information is different in consumer-facing medicines information – the route of administration should be moved to become part of the dosing instructions to improve readability. For example: Clinical information systems: ‘paracetamol 500 mg – tablet – oral – DOSE 2 tablets every 6 hours’ Consumer-facing medicines information: ‘paracetamol 500 mg – tablets – DOSE Take 2 tablets by mouth every 6 hours’. Rationale – avoid misinterpretation of instructions Consumers want clear and consistent instructions about how to take their medicines. For most consumers, the most important information is instructions on when and how to take their medicine.