The background, aims and of these guidelines are expanded in the Clinical Guidelines. Recommendations in the Clinical Guidelines that also apply to consumers are not repeated in the Consumer Guidelines. However, the Consumer Guidelines contain a few important exceptions and additions to the Clinical Guidelines. Medication errors in community settings contribute to patient harm and hospital admissions.[2] [3] [4] Unclear, incomplete or confusing presentation of medicines information can increase the opportunity for consumers to make errors and cause themselves harm. Consumers are increasingly able to access their medicines information on-screen through a number of resources (e.g. the Medicare website, the My Health Record system). Providing clear, standardised medicines information in these formats has the potential to improve patient safety and quality use of medicines. For this reason the Commission has developed the Consumer Guidelines to reflect the of consumers when accessing electronic information about their medicines. 1.1 Consumer needs A recent literature review identified studies on the information that consumers want or need about their medicines.[5] Studies show that consistency of information is critical – consumers want clear instructions from their doctor on exactly how to take their medicines, and for this information to be confirmed by their pharmacist.[6] Knowing when and how to use their medicines is an important need.[7] Consumers also want information on adverse effects, risks, interactions and the condition for which the medicine was prescribed. These issues are outside the scope of these Consumer Guidelines. The Consumers Health Forum of Australia held a consumer workshop in 2010 to discuss best practice for packaging and labelling of medicines.[8] Consumers made a range of recommendations, including the following: Positive statements should be used to avoid ambiguity of the message. Negative directions may be misleading. The active ingredient should be displayed in equal size and prominence as the brand name. Information relating to the quantity of active ingredient per dose or unit must be clearly displayed. 1.2 Best practice for medicines information to consumers Evidence on best practice for provision of medicines information to consumers was summarised by and Roughead.[5] Evidence included research and guidelines on print or electronic media, including Consumer Medicines Information (CMI), medicine labels, medicine lists and electronic health records.
Numbers and of measure Item Recommendation Rationale Identical to Clinical Guidelines? 6.3.1 Use a consistent display format and order Prevent misinterpretation caused by different numerical elements having similar formats and of measure Exception – of information on route differs in information 6.3.2 Use standard approved units of measure, consistently formatted Prevent misreading or misinterpreting units of measure Yes 6.3.3 Use spacing and labels to differentiate display elements Prevent misreading numbers due to close proximity of preceding words Yes 6.3.4 Use a space between numbers and units of measure Prevent misreading numbers due to proximity of trailing units of measure Yes 6.3.5 Do not use trailing Prevent misreading numbers Yes 6.3.6 Display numbers without ambiguity Prevent misreading numbers Yes 6.3.7 Use a to separate groups of three digits for numbers 1,000 and above Prevent misreading very large numbers Yes 6.3.8 Use ‘million’ instead of ‘mega’ Avoid confusion of meaning of ‘m’ or ‘mega’ Yes
This section details the items in the Clinical Guidelines that have been modified in the Consumer Guidelines. Item 6.2.2 Display prescription details in full Recommendation: use full English words in place of symbols The Clinical Guidelines recommend full English words to describe all text elements of a prescription, with the exceptions of ‘%’, decimal points, ‘+’, ‘&’ and ‘/’. Consumers preferred that the ‘/’ symbol be replaced with ‘in’ or descriptors, as appropriate. For example: ‘2 mg/mL’ becomes ‘2 mg in 1 mL’ ’10 mg/hour’ becomes ‘10 mg over 1 hour’. However, consistent information is also important, so where ‘/’ is part of an expression of strength and is used in other presentations of product information, such as the packaging and consumer medicines Information, the ‘/’ should be retained. The ‘/’ symbol is also retained when it is part of a brand name combination (e.g. Coversyl Plus 5 mg/1.25 mg). Recommendation: display time using the 12-hour clock with descriptive words The Clinical Guidelines recommend using the 24-hour clock to display time, with ‘am’ used to show times before midday (e.g. 10:00 am, 19:00). For consumer-facing information, display time using the 12-hour clock, with ‘in the morning’ to show times before midday (e.g. 10:00 in the morning) and ‘in the afternoon’, ‘in the evening’ or ‘at night’ to show times after midday (e.g. 9:00 at night). Midnight should be displayed as ’12:00 midnight’ and midday should be displayed as ’12:00 midday’ (not 12:00 noon). Rationale: improve clarity of information for consumers Consumers may not be familiar with the way the ‘/’ symbol is used by health professionals. Using everyday words such as ‘in’ or ‘over’ improves clarity and prevents misreading or misunderstanding. Consumer testing for these guidelines (see Appendix 1) suggested that ‘am’ or ‘pm’ to indicate time could be misread or missed altogether, and consumers preferred ‘in the morning’, ‘in the evening’, ‘at night’ and similar descriptors.