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Regulation impact statement: General requirements for labels for medicines

Version 3.0, July 2016

10 August 2016

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What is the problem?

Summary: Medication errors are a significant contributor to healthcare costs in Australia. Many of these errors are associated with consumers or healthcare practitioners having difficulty locating and understanding critical information on medicine labels.

It has been estimated that 2-3 per cent of all hospital admissions in Australia are related to medication errors. As many as 30 per cent of unplanned admissions among patients aged 65 and over are associated with medication problems. Medication errors resulting in hospitalisation cost approximately $1.2 billion annually. Depending on the medicines involved, documented outcomes range from minor to catastrophic.

Consumers and healthcare practitioners have raised concerns about the readability of medicine labels in Australia. As the Australian medicines regulator, TGA regularly receives complaints from consumers who want labels to include more information on medicine ingredients and seek easier identification of critical information, including better legibility and consistent placement on a medicine label.

The current Australian legislation that sets a minimum standard for medicine labels is now more than 16 years old and does not reflect current best practice nor align with standards set internationally by overseas regulators.

Introduction

The design and content of medicine labels can have a significant impact on the quality and safe use of those medicines. For example, a medicine label is usually the first point of interaction between a consumer and a medicine. The selection of a specific medicine, whether by a pharmacist, nurse, doctor or consumer, requires the user to read the label, identify the medicine and (if applicable), prepare to administer the product. Therefore, labels must clearly identify a particular medicine and provide sufficient information to allow people to make safe and informed decisions about its use.

Clear and consistent placement of important information helps to ensure that, from the very point of first interaction, a medicine is selected properly and used safely.

Problems are applicable to prescription and non-prescription medicines

While there are differences in the individual requirements of labels for prescription and non-prescription medicines, many of the issues are common between the two classes.

Prescription medicines are prescribed by a doctor and dispensed by a pharmacist. The consumer receives face-to-face counselling about their medication and Consumer Medicine Information (CMI) documents are available for a patient's on-going reference. These documents provide information on how the medicine works, how and when to take the medicine, potential side effects and interactions. Despite this, errors still occur and may lead to adverse outcomes.

In the case of non-prescription medicines, consumers self-select over-the-counter (OTC) medicines and therefore may not receive any supporting information from a healthcare provider.[18,19] Consumers rely solely on the instructions on the label. This can result in drug misuse, overdose, and abuse leading to hospitalisations, morbidity and even mortality.[20] Whilst non-prescription medicines may be considered to be lower risk than prescription medicines in terms of adverse events, there are still significant risks to consumers due to self-selection.

Therefore, the medicine label serves a crucial function for both prescription and non-prescription medicines.

Consumer dissatisfaction

One of the most common complaints received by the TGA in relation to medicine labelling is that the print on medicine labels is too small to read. This complaint was emphasised in the 1995 International Year of Older Persons Platform for Action, which recommended that manufacturers and pharmacists increase the print size on their labels.[21] Other studies have confirmed that consumers prefer labels printed with larger font size.[22]

Testimonials from consumers and healthcare professionals

'I want the naming and packaging of drugs to be clear and identifiable easily for sick and confused patients.

I want to change how the product is identified.

I even hope for colour coding and large type letters so it is not necessary to use a magnifying glass to read the information on the packet.'

'Why is the generic name of a drug is [sic]not required to be at least as legible as the brand name?... Generic Drug Names are small and, to vision impaired, illegible compared to the colourful brand names.'

Another common complaint is that label information is not easy to understand. The majority of people surveyed in a study commissioned by the Proprietary Medicines of Australia in 1993,[23] indicated that they were happy with the amount of information provided on medicine labels, but needed information that is more easily understood. Although the study has often been criticised for the methodology employed, and only small improvements in label useability were found, it provides evidence that there is increasing demand that labels should be available to assist consumers to make informed choices about the products they purchase.

Testimonials from Consumer and healthcare professionals

'Would it be feasible to suggest to all of the manufacturers to ALWAYS include the pharmaceutical name, after the trade name, on the labelling of the packages? This would make it so much easier for the patient, would save much time and phone calls to the pharmacy, or time with the GP.'

'People with allergies need better access to all ingredients used in creating/manufacturing these medications so that they are not made more ill by medications designed to improve health.'

Current requirements fall short of international best practice

TGO 69 is out of step with current labelling design research and international labelling requirements. Specifically, current Australian labelling requirements do not address issues such as prominence of active ingredient with respect to the trade name, neither in terms of larger text size nor consistent placement. Also, there is no requirement for consistent placement of critical health information to assist consumers self-selecting non-prescription medicines.

Patient risk and harm

In 2013, the Australian Commission on Safety and Quality in Health Care (ACSQHC) conducted a literature review of medication safety in Australia.[24] The review covered medication safety literature published in Australia between 2008 and August 2003; and literature published internationally between 2002 and 2013.

The review identified that 2-3 per cent of all hospital admissions in Australia are related to medication errors.[25] Further, it has been estimated that as many as 30 per cent of unplanned admissions among patients aged 65 and over are associated with medication problems and that medication errors resulting in hospitalisation cost approximately $1.2 billion annually.[26,27,28] This figure does not account for individuals who do not attend hospital but experience pain and suffering as a result of medication errors.

While there are multiple causes of these medication errors, the ACSQHC suggests that confusion or errors in reading labels could be associated with many accidents, including human error. Medication errors in hospitals, for example, may include prescribing errors, documentation errors, and misinterpretation of labels due to lack of close attention or fatigue. However, with limited data it is not possible to estimate the proportion of the costs attributable solely to labelling issues, beyond the suggestion that it is significant. Depending on the medicines involved, documented outcomes range from minor to catastrophic.[29,30]

There are numerous reports in the literature that labelling issues are both a significant contributor to medicine errors and the source of error themselves.[31,32,33,34] One study reports that confusion with medicine names accounts for 25% of reported medication errors.[35] With the increasing use of generic medicines and subsequently increased patient choice in medicine brands,[36,37] there is increased potential for patients to be confused about their therapy and inadvertently take multiple products with the same active ingredient.[38,39] This is compounded by the fact that the non-proprietary name of a medicine (i.e. the chemical name of the active ingredient e.g. paracetamol) is typically in smaller text and less prominent than the brand name of the product (e.g. Panadol®) on the medicine label. Consumers are often not aware that a different brand of medicine they have been dispensed contains the same active ingredient as the medicine they are currently taking.[40] In many cases, essentially the same products can have dozens of different names, contributing to confusion.[41] The greatest risk associated with this is overdose. While much of the work in this area refers to confusion associated with prescription medicines, awareness of the active ingredient plays an important role in achieving quality use of all classes of medicines and ensuring safety of consumers of all classes of medicines.[42]

Improvements to labelling, such as increased prominence of the active ingredient and standardising its position on the medicine label, has been identified as a factor leading to improved safety and quality use of medicines.[43,44] Consumer groups strongly advocate for greater prominence of the active ingredient on generic medicines to facilitate product identification and reduce the opportunity for error.[45,46] Poor labelling, that makes it difficult for patients to find and understand information, may affect patient safety and the ability of patients to follow instructions regarding the proper use of medicines.[47,48,49] Figures of between 12-20% of consumers experiencing difficulty reading and understanding the medicine labels have also been reported.[50,51] A 1989 review showed that only 54% of 1496 Australian adults were able to correctly identify the dose for a child from a sample medicine label (10% of participants were functionally illiterate).[52] The available data also suggest that improving label useability and consistency of information may assist consumers who have poor or developing literacy skills.

By applying sound design principles to the layout and composition of medicine labels, their usability has been documented to be considerably improved.[53] For example, the use of particular fonts,[54] colour[55] and the layout of information,[56] can be used to produce labels that allow information to be more readily located, identified, and understood. Internationally, literature has confirmed that text with a font size ranging from 9-12 point is optimal for readability of important health information such as the name of the active ingredient[57,58,59] but a larger than 12 point font size has also been suggested, particularly with respect to elderly patients.[60]

Evidence in the literature has also identified that a patient's inability to identify the active ingredients in both prescription and OTC medicines can lead to unintentional adverse effects.[61,62] A 2015 study reported that participants with arthritis who have low health literacy scores do not always recognise paracetamol as an active ingredient when it is present in multi-active products. This places them at risk of potential paracetamol-related adverse events.[63] Further, in a NSW study comprising 849 participants aged 65 years and older, 9% of participants reported problems reading labels while 6% had trouble understanding the label.[64] For the elderly, in particular, lack of adequate information and knowledge about OTC medications can cause drug misuse, overdose, and abuse leading to hospitalisations, morbidity and even mortality.[65]

The language used on a label can also be a significant factor in medicine safety and quality use of medicines.[66] Poor recognition or understanding of medication labelling or failure to recognise the consequences of exceeding a maximum recommended dosage may lead to unintentional overdoses. In a 2011 qualitative study, it was found that consumers had poor recognition of products containing paracetamol, e.g. only 31% of subjects knew acetaminophen (paracetamol) was in Tylenol®.[67]

The NSW Poisons Information Centre (NSW PIC) is the largest Poisons Information Centre in Australia and provides a 24-hour service to manage suspected and known poisonings and an after-hours drug information service. Some research has recently been conducted by Australian PICs on medication errors and adverse events, based on calls received by the centre.[68] In 2013, NSW PIC confirmed that it had received 13, 542 calls relating to medication errors (12% in or referred to hospital and 3% at or referred to GPs) and 11,696 requests for drug information. NSW PIC has also confirmed that many of these calls originate from confusion in the packaging and labelling of products, particularly consumer product misidentification and errors reading the dosage. Paracetamol is the most common product involved in calls to the centre, with 7243 calls received in 2013. It should be noted that these figures only account for a proportion of the true picture in Australia as NSW PIC is one of four PICs.

Consumers also report having trouble identifying the active ingredient in compound medicines such as cold and flu preparations. As these preparations could contain paracetamol or aspirin, negative health consequences are possible for some people if accidently (or purposely) taken in quantities above those recommended. Given the ease of access and high volumes associated with over the counter medicine use, the risks are high.[69] Improved active ingredient prominence would assist consumers to identify which medicines contain the same ingredients and help prevent unintentional overdose.

Clear dosage instructions are also critical for the safe use of self-selected medicines. A 2009 study investigated factors associated with caregivers' understanding of the importance of age of the child in determining the dosage of paediatric cough and cold medication. It was found that language and graphics used for dosage instructions on a medicine label can lead to incorrect interpretation of the appropriate dose.[70]

International experience has also identified labelling of medicines as a potential safety risk. For example, a Health Canada report recently estimated that the annual cost of medication error to their health care system is $1.8 billion[71], with labelling being a contributing factor. Further, poorly designed prescription medicine labels are reported to account for, or contribute to, approximately one-third of medication errors investigated by the United States of America's Pharmacopeial Convention (the body that sets standards for medicines in the United States).[72]

International practices

A number of comparable overseas regulators have, during the time of the Australian review of medicine labelling, updated their equivalent standards. Updates have been made to keep pace with developments such as an increasingly ageing population (who are likely to be on several prescription medicines simultaneously and suffer from failing eyesight); increasing demands from consumers for information about the medicines they take; emerging safety issues and the emergence of new types of more complex medicines.

A key part of these updates relate to promotion of active ingredient prominence and a hierarchy of information on medicine labels. Changes have been implemented in both new legislation and also guidance materials.

Other significant technological advances are also being implemented in a number of overseas jurisdictions. This includes mandating the inclusion of electronic data on medicine labels to discourage the introduction and distribution of counterfeit drugs.

The International Medication Safety Network

The International Medication Safety Network (IMSN), of which Australia is a member, is an international network of established safe medication practice centres. These operate medication error reporting programs and produce guidance to minimise preventable harms from medicine use in practice.[73] It is recognised that safe design in healthcare products and systems is a key for reducing some preventable deaths and harm. The IMSN has identified that unclear, ambiguous or incomplete label information, similarities in packaging and labelling appearance and sound-alike and look-alike medicine names can lead to confusion contributing to these preventable deaths.

In October 2013, the IMSN published a position statement along with some key elements of guidance for the labelling and packaging of medicines. These highlighted the need to clearly and prominently present the following information on the outer packaging[74]:

  • Proprietary name of medicine (brand)
  • International non-proprietary (generic) names of active pharmaceutical substances (with emphasis on the generic name/active ingredients)
  • Dose strength/concentration
  • Method(s) of administration
  • Dosing instructions
  • Specific warnings

The IMSN also identified the use of use larger fonts for better readability.

The position statement recommends that, in all countries, regulations be strengthened for medicine naming, labelling and packaging to:

  1. require better design and field testing of medicines naming, labelling and packaging before release for use
  2. incorporate human factors theory
  3. promote safer use in practice.[75]

European Union

While the European Union does not mandate the font size of the active ingredient it does legislate that the active ingredient must be prominently displayed, as well as mandating a hierarchy for the order of information on the medicine label.[76] Further information on prominence is provided in guidelines, including an active ingredient font size of not less than 7 point text size.[77]

United States

In 1999, the US FDA introduced a standardised format and content requirements for the labelling of over-the-counter (OTC) medicines.[78] This was intended to assist consumers in reading and understanding OTC medicine labelling so that these products are used safely and effectively.

A 2007 US study evaluated the effectiveness of the 1999 FDA-mandated standardised format for the labelling of OTC medicines (called 'Drug Facts') by comparing three labelling formats amongst consumers.[79] The three formats comprised previously FDA-compliant labels, new labels (min 6 point text size) and simulated labels (similar information as the new label but a 10 point text size). The study report noted that the new OTC drug labels, with the standardised 'Drug Facts' format and a minimum 6 point font size, may not be easy for some consumers to use and understand, although they are an improvement over old unstandardised labels. The study found that consumers' product knowledge was significantly improved with the simulated label. It was concluded that manufacturers should look beyond the mandatory minimum FDA font size of 6 points and develop strategies to further improve comprehension of information on OTC medication labels.

Canada

In April 2014, Health Canada launched its Plain Language Labelling Initiative.[80] This initiative aims to improve the safe use of medicines by making medicine labels and packaging information easier to read and understand. The intention is that this will be achieved through updating both Regulations and guidance. Changes that improve labelling include:

  • greater active ingredient prominence
  • standardised medicine information presentation
  • dispensing label space
  • harmonisation of labelling plans with other jurisdictions where possible

Broader medicine label requirements

In addition to information needed by health practitioners and consumers for quality use of medicines, labelling requirements are being expanded to address additional international concerns and the availability of new technology.

It is estimated that counterfeit prescription drugs have a market worth $75 billion a year worldwide.[81] In an attempt to discourage the introduction and distribution of counterfeit drugs, Europe and the US have implemented legislation to mandate serialisation - that is, to require that every product holds a unique serial number. In short, serialisation measures aim to provide visibility and full traceability within the supply chain, so that a product's lifecycle can potentially be traced from production right through to patient use.

The European Union has recently published delegated regulations detailing rules concerning serialisation and verification features. From February 2019, these features must appear on the packaging of medicines. The Commission Delegated Regulation (EU) 2016/161 under the Falsified Medicines Directive (Directive 2011/62/EU) requires a unique identifier and an anti-tampering device to allow the verification of the authenticity of medicinal products.

In the US, the Drug Supply Chain Security Act commences in a staggered fashion from 2017. This legislation outlines critical steps to build an electronic system to identify and trace prescription drugs as they are distributed throughout the US. The legislation mandates unique serialisation numbers and bar codes to be used on these products.

Although the two serialisation models in the US ('transaction model') and Europe ('authentication model') are distinctly different,[82] the enactment of these laws is both jurisdictions is a major step in providing clear requirements and guidance to combat counterfeits.

Concluding remarks

We can see that internationally, overseas regulators are one step in front of Australia in regard to labelling of medicines.

In response to the recent reviews and consultations, it is proposed that Australian requirements are updated to (generally) mirror requirements from the FDA (health information back panel) and MHRA (active moiety front panel), thereby improving international harmonisation. Both regulators' updated labelling requirements are well-accepted although there are no conclusive studies that confirm that their adoption has resulted in lower rates of medication errors overseas. This is largely due to the complexity of isolating labelling from other contributing factors, for example, prescribing errors, documentation errors or fatigue.

In the absence of explicit evidence; by implementing new labelling requirements, we expect to see increased legibility of medication information, increased consumer satisfaction and potentially improved patient outcomes. Following the proposed 4 year transition period we will see the majority of medicine labels in the Australian marketplace presenting information in a consistent manner. This standardisation will, over time, increase consumer awareness and knowledge, allowing consumers to be comprehensively informed and engaged in all phases of health treatment. Where applicable, this increased awareness will also facilitate open and collaborative discussions between patients and their treating physician.


Footnotes

  1. Holt, G, Dorcheus, L, Hall, E, et al., 1993, 'Patient Interpretation of Label Instructions', American Pharmacy, 1993; vol. 32, no. 3, pp. 58-62.
  2. Shrank W, Agnew-Blais, J, Choudhry, K et al., 2007, 'The variability and quality of medication container labels'. Archives of Internal Medicine, vol. 167, no. 16, 1760-1765.
  3. Pawaskar, M & Sansgiry, S 2006, 'Over-the-counter medication labels: problems and needs of the elderly population', Journal of the American Geriatrics Society, vol. 54, no. 12, pp. 1955-1956.
  4. Therapeutic Goods Administration, Review of the Labelling Requirements for Medicines: Consumer focused labeling - a way forward? (pdf,166kb) (March 2002).
  5. Vigilante, W.J. & Wogalter M.S., Over-the-counter (OTC) drug labeling: format preferences. In: Proceedings of the Human Factors and Ergonomics Society 43rd Annual Meeting. Human Factors Society, Santa Monica, CA, pp. 103-107.
  6. Russell G & and Antill J (1992), 'Making medicine labels work' 1992, Macquarie University (unreported).
  7. Australian Commission on Safety and Quality in Health Care, Sydney 2013, Literature Review: Medication Safety in Australia.
  8. Ibid p8.
  9. Ibid p25.
  10. Australian Institute of Health and Welfare. Australian hospital statistics 2011–12. Health services series no. 50. Cat. no. HSE 134. Canberra, 2013.
  11. Runciman, W, Roughead, E, Semple, S & Adams, R 2003, 'Adverse drug events and medication errors in Australia', International Journal for Quality in Health Care, vol. 15, supplement 1, pp. 49-59.
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  20. Department of Health, Department of Health and Ageing-Medicines Australia joint monitoring report on Trends in and drivers of Pharmaceutical Benefits Scheme expenditure, p 33.
  21. Carney, S, Gazarian, M, Denholm, J et al., 2011, 'What's in a name? Brand name confusion and generic medicines'. Medical Journal of Australia, vol. 195, no 11, pp. 650-651.
  22. McLachlan AJ. (2010), 'Generic medicines literacy - minimising the potential for patient confusion.' Medical Journal of Australia, vol 192, no 7; pp. 368-9.
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  24. Australian Broadcasting Cooperation, Rise of generic drugs increases fears of overdose, 7 December 2011.
  25. Lalor, D 2011, 'Medicines Labelling'. Australian Prescriber, vol. 34, pp. 136-138.
  26. Consumer Health Forum 2009, Equal prominence of active ingredient and proprietary names on labels for prescription medicines (pdf,43kb), Consumer Health Forum of Australia.
  27. Lalor, D 2011, 'Medicines Labelling'. Australian Prescriber, vol. 34, pp. 136-138.
  28. Consumer Health Forum 2009, Equal prominence of active ingredient and proprietary names on labels for prescription medicines (pdf,43kb), Consumer Health Forum of Australia, May 2013.
  29. Consumers' Health Forum, Achieving Best Practice in the Packaging and Labelling of Medicines: Report from National Consumer Workshop (pdf,527kb), January 2011.
  30. ibid.
  31. Shrank, W, Avorn, J, Rolon, C, & Shekelle, P2007, 'Effect of content and format of prescription drug labels on readability, understanding and medication use: a systematic review', Ann Pharmacother, vol. 41, no. 5, pp. 783-801.
  32. O'Hare F, Jeganathan VSE, Rokahr CG, Rogers SL, Crowston JG (2009), 'Readability of prescription labels and medication recall in a population of tertiary referral glaucoma patients,' Clinical and Experimental Ophthalmology vol, 37, no.9, pp. 849-54.
  33. Sweet G, Wilson S. The 3D label project. Dandenong: Dandenong District Division of General Practice, 2006.
  34. O'Hare F, Jeganathan VSE, Rokahr CG, Rogers SL, Crowston JG (2009), 'Readability of prescription labels and medication recall in a population of tertiary referral glaucoma patients', Clinical and Experimental Ophthalmology, vol 37, no.9, pp. 849-54.
  35. Wickert R., 1992, 'No single measure: summary report' (1992). Australian Journal of Education, v.36, no.1, p.105-107.
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  37. Shrank, W, Avorn, J, Rolon, C, & Shekelle, P2007, 'Effect of content and format of prescription drug labels on readability, understanding and medication use: a systematic review', Ann Pharmacother, vol. 41, no. 5, pp. 783-801.
  38. Hellier E, Tucker M, Kenny N, Rowntree A and Edworthy J 2010, 'Merits of using color and shape differentiation to improve the speed and accuracy of drug strength identification on over-the-counter medicines by laypeople', Journal of Patient Safety, vol. 6, pp. 158-64.
  39. Garnerin P, Perneger T, Chopard P, Ares, M, Baalbaki R, Bonnabry P, et al. 2007, Drug selection errors in relation to labels: a simulation study, Anaesthesia, vol. 62, pp.1090-4.
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  42. Hellier, E, Edworthy, J, Derbyshire, N, & Costello, A 2006, 'Considering the impact of medicine label design characteristics on patient safety', Ergonomics, vol. 49, no. 5-6, pp. 617-630.
  43. Shrank, W, Avorn, J, Rolon, C, & Shekelle (2007) 'Effect of content and format of prescription drug labels on readability, understanding and medication use: a systematic review', Ann Pharmacother, vol. 41, no. 5, pp. 783-801.
  44. Kripalani, S, Henderson, L et al. 2006, 'Predictors of medication self-management skill in a low-literacy population', Journal of General Internal Medicine, vol. 21, no. 8, pp. 852-6.
  45. Wolf, M, King, J, et al. 2012, 'Risk of unintentional overdose with non-prescription acetaminophen products', Journal of General Internal Medicine, vol. 27, no 12, pp 1587-93.
  46. Ellis, J, Mullan, J, Weston, K et al., 2015, 'Prescription and over-the-counter pain medication in arthritis: awareness of active ingredients and attitudes to medication borrowing and sharing'. Journal of Pharmacy Practice and Research, vol. 45, no. 1, pp 10-17.
  47. Pit SW, Byles JE, Cockburn J (2008), 'Prevalence of self-reported risk factors for medication misadventure among older people in general practice.' Journal of Evaluation in Clinical Practice, vol. 14, no. 2, pp 203-8.
  48. Pawaskar, M & Sansgiry, S 2006, 'Over-the-counter medication labels: problems and needs of the elderly population', Journal of the American Geriatrics Society, vol. 54, no. 12, pp. 1955-1956.
  49. King, J, Davis, T, Bailey, S et al., 2011, 'Developing consumer-centered, non-prescription drug labelling, a study in acetaminophen'. American Journal of Preventative Medicine, vol. 40, no. 6, pp. 593-598.
  50. ibid.
  51. Therapeutic Goods Administration, Submissions received: medicine labelling (2015) (pdf,57kb), NSW Poison Information Centre.
  52. Wolf M, King, J et al., 2012, 'Risk of unintentional overdose with non-prescription acetaminophen products', Journal of General Internal Medicine, vol. 27, no. 12. pp. 1587–93.
  53. Lokker, N, Sanders, L, Perrin, E, et al., 2009, 'Parental Misinterpretation of Over-the-Counter Cough and Cold Medication Labels'. Pediatrics, vol. 123, no. 6, pp. 1464-1471.
  54. Health Canada 2012, Cost-Benefit Analysis: Regulations Amending the Food and Drug Regulations - Good Manufacturing Practices for Active Ingredients Amendments to the Food and Drug Regulations (Labelling, Packaging and Brand Names)
  55. Holt, G, Dorcheus, L, Hall, E, et al., 1993, 'Patient Interpretation of Label Instructions', American Pharmacy, 1993; vol. 32, no. 3, pp. 58-62.
  56. International Medication Safety Network
  57. International Medication Safety Network 2013, Position Statement: Making Medicines Naming, Labeling and Packaging Safer (pdf,225kb)
  58. International Medication Safety Network 2013, Position Statement: Making Medicines Naming, Labeling and Packaging Safer (pdf,225kb), page 2.
  59. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use, Article 59.
  60. European Commission, Guideline on the readability of the labelling and package leaflet of medicinal products for human use (pdf,118kb), Revision 1, 12 January 2009, page 12.
  61. Department of Health and Human Services, Food and Drug Administration, Federal Register of March 17, 1999 (64 FR 13254).
  62. Murty, S, & Sansgiry, S 2007, 'Consumer comprehension of OTC Medication Labels and the scope for improvement in font size', Journal of Pharmacy Technology, vol. 23, no 4, pp. 207-213.
  63. Health Canada 2014, Notice - Final Release: Plain Language Revisions to Part III: Patient Medication Information and Associated Templates of the Guidance Document - Product Monograph.
  64. Pharmaceutical Manufacturing, Serialisization and the Drug Quality and Security Act, January 2015.
  65. Information from Pharmaceutical Manufacturing, Serialisization and the Drug Quality and Security Act, January 2015, Under the U.S. "pedigree" model, products are serialized, aggregated and authenticated when a change of custody occurs. Data is shared between trading partners along the supply chain. In Europe, the "authentication model" relies on item-level serialization, registration of product in a national or regional database, and then authentication at the point of dispensation.

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