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Labelling and packaging practices: A summary of some of the evidence

Version 1.0, January 2013

21 January 2013

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Over-the-counter medicines

Label formats and lettering

Research has found that consumers prefer to have medicine information presented under headings and in a list format with 'white space' on the packaging clearly differentiating the information (Wogalte & Vigilante, 2003). The most important information is generally regarded as being: active ingredient and what the drug is used for, how to take (dosing instructions), and outcomes and hazards associated with the drug. The remaining information on the packet could cover inactive ingredients, storage instructions, manufacturer information and the bar code (Vigilante and Wogalter, 1997; Morrow et al, 1998; Shrank et al, 2007).

Information presented in standardised schemas has also been found to be better recalled by consumer groups, as it allows consumers to rapidly find information they require and compare products (Vigilante and Wogalter, 1997; Morrow et al, 1998, Shrank et al, 2007).

A systematic review of randomised controlled trials, observational studies and of label format found that the use of larger fonts, lists, headers and white space, simple language and logical organisation may all improve readability and comprehension of prescription medicine labels (Shrank et al, 2007). These authors noted that when optimizing label format, use of lists, headers and white space enhance readability and the content should be organised in a schema that patients use to understand medication information. Wogalter & Vigilante (2003) found that line spacing (white space) made simulated over-the counter medicine labels easier to read and paragraph style separation between sections of text helped consumers differentiate the different parts of the label.

In a study of prescription medicine labels, which could also be applied to OTC medicine labels, Sundar et al (2012) argued that proper and informative labelling is a promising and important tool in the prevention of adverse drug events. In particular they found that understanding consumers' attentive behaviour, which is attracting the consumer’s attention, is crucial for developing effective medicine labels. There is a need for consistency in format and content and labels need to effectively attract attention to ensure information is more effectively conveyed (Lalor, 2011; Sundar et al, 2012). As previously discussed, the often limited interaction between consumers and healthcare professionals when purchasing non-prescription and prescription products further highlights the importance of the label (Holt et al, 1992; Shrank et al, 2007). The study by Holt (1992) raised serious concerns regarding the assumptions associated with dosage instructions. The variety of responses to commonly used dosage instructions indicated that the instructions may not be as simple and clear as authorities consider them to be. Holt suggested that the assumptions regarding common label language be re-examined since the availability of non-prescription products is, in part, based on the assumption that label instructions are sufficiently clear that intervention by health professionals is unnecessary.

Watanabe (1994) has suggested that lettering on OTC medicine labels should be at least 1.2 mm in vertical height (or 20/40 Reduced Snellen visual acuity level) and should have no more than 40 characters per inch (approx 16 characters per cm). Along with the importance of letter height, horizontal compression had a significant effect on readability and should be a major consideration in defining readability (Watanabe, 1994). Shrank et al noted that there are limitations regarding space for increased font size, however this should not be used as justification for not using the largest possible font size (Shrank et al, 2007).

A study by Murty et al (2007) evaluated the effectiveness of the 1999 FDA-mandated standardised format called “Drug Facts” for the labelling of over-the-counter-medicines, and compared three labelling formats, the old, new and simulated. They found that consumers preferred the label format with a larger font size over those currently available. In addition, it was noted that the new OTC drug labels may not be easy for some consumers to use and understand, although they are an improvement over old unstandardised labels. It was concluded that manufacturers should look beyond the mandatory minimum font size (FDA 6 point) and develop strategies to improve comprehension of information on OTC medication labels (Murty et al 2007).

Label language

In addition to the physical presentation of information on a label, the language used to convey that information was also a significant factor in medicines safety and quality use of medicine (King et al, 2011). Poor understanding of medication labelling or failure to recognise the consequences if exceeding a maximum recommended dosage may lead to unintentional overdoses. (King et al, 2011). In a study of paracetamol by these authors, it was found that consumers had poor recognition of which products contained paracetamol.

Brand name confusion

Consumer confusion has also been reported regarding similar branded names of OTC products. It takes a degree of awareness for the consumer to realise that similar branded products may contain different medicines or different combinations of medicines. Some products may have slightly different names reflected by use of suffixes but the brand name may confuse patients as it does not reflect the active ingredient in the product. This confusion may lead to accidental poisoning (Aronson, 1994; Alambo, 2010).

Paediatric and elderly patients

A study by Lokker et al (2009) investigated factors associated with the understanding by caregivers of the importance of age of the child and dosing instructions on labels for paediatric OTC cough and cold medication. It was found that label language and graphics can lead to inappropriate interpretation of the appropriate dose (Lokker et al, 2009).

There are also issues with the readability of OTC labels for the elderly population. As OTC labels are the primary source of information for consumers, older people need medication information in large font and easy-to-understand language so that they can use the medications independently. Lack of adequate information and knowledge about OTC medications can cause drug misuse, overdose, and abuse leading to hospitalisations, morbidity and even mortality (Pawasker and Sansgiry, 2006).

A survey conducted by Holt et al (1992) found that despite US FDA requirements that OTC labelling be written in sufficiently simple language, dosage instructions were often misinterpreted, further highlighting the need for clear, simple and tested instructions. A similar situation exists in Australia, with statements such as "take two tablets twice a day" correctly interpreted by 71% of consumers with adequate literacy and by as few as 33% with literacy problems (Lalor, 2011).

References

Alambo, D, Mistaken identity: some OTCs look alike but are very different. Consumer Health Information Corporation 2010.

Aronson, JK, What's in a brand name? BMJ, 1994;308:1140.

Holt GA, Dorcheus L, Hall EL, et al, Patient Interpretation of Label Instructions. American Pharmacy, 1993;NS32:58-62.

King JP, Davis TC, Bailey SC et al, Developing consumer-centered, non-prescription drug labelling, a study in acetaminophen. Am J Prev Med, 2011;40:593-598.

Lokker N, Sanders L, Perrin EM, et al, Parental Misinterpretation of Over-the-Counter Cough and Cold Medication Labels. Pediatrics, 2009;123:1464-1471.

Morrow DG, Leirer VO, Andrassy JM, Hier CM and Menard WE, The influence of list format and category headers on age differences in understanding medication instructions. Experimental Ageing Research, 1998;24:231-256.

Murty S & Sansgiry S, Consumer comprehension of OTC Medication Labels and the scope for improvement in font size. J Pharm Technol, 2007; 23:207-213.

Pawaskar MD & Sansgiry SS, Over-the-counter medication labels: problems and needs of the elderly population. JAGS, 2006;54:1955-1956.

Shrank W, Avorn J, Rolon C & Shekelle P, Effect of content and format of prescription drug labels on readability, understanding and medication use: a systematic review. Ann Pharmacother, 2007;41:783-801.

Sundar RP, Becker MW, Bello NM & Bix L, Quantifying age-related differences in information processing behaviours when viewing prescription drug labels. PLoS ONE, 2012;7:e38819.

Vigilante WJ & Wogalter MS, The preferred order of over-the-counter (OTC) pharmaceutical label components. Drug Information Journal, 1997;31:973-988.

Watanabe RK, The ability of the geriatric population to read labels on over-the-counter medication containers. J Am Optom Assoc, 1994;65:32-37.

Wogalter MS & Vigilante WJ, Effects of label format on knowledge acquisition and perceived readability by younger and older adults. Ergonomics, 2003;46:327-344.

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