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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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Medication errors and the role of labelling

It has been estimated that the rate of medication related hospital admissions in Australia is around 2-3%, with as many as 30% of unplanned geriatric admissions being associated with an adverse medicines event. Approximately 50% of these admissions are considered potentially avoidable (Runciman et al, 2003; Roughead & Semple, 2009). In addition to hospitalisations related to adverse medicine events, there are thought to be over 400,000 general practitioner visits annually in Australia for addressing medication errors (Safety and Quality Council, 2002; Runciman et al, 2003).

It is difficult to more precisely determine the actual rate of adverse drug events, particularly those associated with labelling errors (Winterstein et al, 2002) as many may go unreported due to lack of severity or due to embarrassment of making an error with self-medication (Evans et al, 2006). Data collection is complicated as there are multiple ways of reporting adverse drug events and there is not a single central repository or analysis of adverse drug events that are reported in Australia (Safety and Quality Council, 2002; Runciman et al, 2003).

Taking these data limitations into account, it has been reported in the literature that medication misadventure resulting in hospitalisation in Australia is estimated to cost $660 million annually (Roughead & Semple, 2009). A number of factors have been identified as contributing to the medication errors which occur in either a hospital or acute care setting or in the community or home setting (Weingart et al, 2000; Safety and Quality Council, 2002; Taylor et al, 2009a, Taylor et al, 2009b).

Factors contributing to medication errors include:

  • environmental (distractions, lighting, level of activity) and personnel factors (not taking enough care, failure to confirm, fatigue, communication failure)(Weingart et al, 2000; Pharmaceutical Defence Limited, 2008);
  • a lack of co-ordination between health care professionals in the care setting (Lu and Roughead, 2011);
  • process or system failures between prescribing, transcribing/verifying, dispensing and administration (Senders, 1993; Leape et al, 1995; Safety and Quality Council, 2002).

Labelling and packaging issues either contributed to these errors or were the source of error in some instances (Cohen, 1995; Jensen et al, 2004; Hellier et al, 2006; Gernerin et al, 2007). Unsafe pharmaceutical packaging, nonexistent warning systems, look-alike labelling and poorly conceived drug nomenclature have been identified as major contributing factors to medication errors (Cohen, 1995).

The comprehensive review by Hellier et al (2006) of evidence-based research in related areas such as food and chemical labelling and more general warnings research considered design characteristics such as font size, colour, signal words and language and the effect of these on performance variables including compliance, understandability and discriminability; and discussed the relevance of these factors to medicine labels. The authors concluded that signal words, colour, format and wording are the design variables that have the most consistent effect on user outcomes. The outcomes that were likely to be most relevant to reducing medication errors were those that relate to product noticeability and discriminability and those that relate to compliance.

Jensen et al (2004) developed evidence-based recommendations for the minimisation of errors in intravenous drug administration. Specific recommendations regarding labelling and packaging included standardisation of font, size, colour and information included on the labels of ampoules and the avoidance of similar packaging and presentation of drugs.

Labelling and packaging, may adversely affect patient safety and adherence to instructions by increasing the difficulty of finding and comprehending information (de Somer and Trofimov, 2011; Shrank et al, 2007a). In the US, poorly designed prescription drug labels are reported to account for approximately 1/3 of errors investigated by the US Pharmacopoeia, and is due, at least in part from confusion caused by the label (Shrank et al, 2007b). Furthermore, the observation that many patients receive no information from a health care provider except the instructions on the label highlights the importance of the medication label (Holt et al, 1992, Shrank et al, 2007b).

Shrank et al (2007a) conducted a systematic review of the published literature to evaluate the evidence regarding optimal content and format of prescription labels that might improve readability, understanding and medication use. The evidence about label format supported the use of larger fonts, lists, headers and white space, using simple language and logical organisation to improve readability and comprehension.

References

Chermak TE & Lambert BL, Descriptive analysis of primary package labels from commercially available prescription solid oral dosage form drugs. J Am Pharm Assoc, 2009;49:399-406.

Cohen MR, Drug product characteristics that foster drug-use system-errors. Am J Health-Sys Pharm, 1995;52:395-399.

De Somer E & Trofimov I, Medicine Partnership of Australia – Packaging and labelling of pharmaceuticals and consumer safety - A survey of the literature, 2011.

Evans SM, Berry JG, Smith BJ et al, Attitudes and barriers to incident reporting: a collaborative hospital study. Qual Saf Health Care 2006;15:39-43.

Gernerin P, Perneger T, Chopard P et al, Drug Selection errors in relation to medication labels: a simulation study. Anaesthesia, 2007;62:1090-1094.

Hellier E, Edworthy J, Derbyshire N & Costello A, Considering the impact of medicine label design characteristics on patient safety. Ergonomics, 2006;49:617-630.

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

Jensen LS, Metty AF, Webster CS et al, Evidence-based strategies for preventing drug administration errors during anaesthesia. Anaesthesia, 2004;59:493-504.

Leape LL, Bates DW, Cullen DJ et al, System analysis of adverse drug events. JAMA 1995;274:35-43.

CY & Roughead E, Determinants of patient-reported medication errors: a comparison among seven countries. Int J Clin Pract, 2011;65:733-740.

Defence Limited Annual Report 2008.

E & Semple S, Medication safety in acute care in Australia: where are we now? Part 1: a review of the extent and causes of medication problems 2002-2008. Australia and New Zealand Health Policy 2009; 6:18.

Runciman WB, Roughead EE, Semple SJ & Adams RJ, Adverse drug events and medication errors in Australia. International Journal for Quality in Health Care, 2003; 15 (supp 1):i49-i59.

Safety and Quality Council, Second National Report on Patient Safety: Improving Medication Safety. July 2002.

Senders JW, Theory and analysis of typical errors in a medical setting. Hospital Pharmacy, 1993;28:505-508.

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, 2007a;41:783-801.

Shrank WH, Agnew-Blais J, Choudhry NK et al, The variability and quality of medication container labels. Arch Intern Med, 2007b;167:1760-1765.

Taylor D, Robinson J, MacLeod D et al, Therapeutic errors among children in the community setting: nature, causes and outcomes. Journal of Paediatrics and Child Health 2009;45:304-309.

Taylor D, Robinson J, MacLeod D et al, Therapeutic errors involving adults in the community setting: nature, causes and outcomes. Australian and New Zealand Journal of Public Health, 2009;33:388-394.

Weingart SN, Wilson R, Gibberd RW & Harrison B, Epidemiology of medical error. BMJ 2000;320:774-7.

Winterstein AG, Sauer BS, Hepler CD & Poole C, Preventable drug-related hospital admissions, Ann Pharmacother, 2002;36:1238-1248.

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