June 30, 2016
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The utmost care has been taken to ensure the accuracy of information presented in this guide. The guide reflects the information available during its development and is meant to provide initial considerations when preparing the content and design of labels and packages. It is anticipated that new research on various topics addressed in this guide will become available in the future, and revisions may be warranted to integrate such new information.
This document should be read in conjunction with the relevant sections of other applicable Health Canada regulations, guidance documents, and policies.
The guide is divided into three parts:
The appendices contain supplementary information to the guide as follows:
The objective of the Good Label and Package Practices Guide for Prescription Drugs is to provide direction to sponsors, manufacturers and license holders (to be referred to as ‘sponsors’ within this guide) in designing safe and clear labels and packages.
It is essential that all labelling and packaging regulatory requirements be met.
The recommendations provided in this guide will aid sponsors in the organization of (a) information required by the regulations, and (b) other complementary information important to the proper identification, selection, and use of the product. The information is presented to support the design and development of labels and packages that are clear, effective, and minimize the risk of errors causing harm.
The label and package are the first points of interaction between a health product and a healthcare professional or patient. They communicate key information about the safe and proper use of health products, and are important aids in product identification, selection and administration. The ability to perform product identification, selection and administration safely is dependent on the user being able to read and understand the information on the label.
Through the Plain Language Labelling Initiative, new Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use)Footnote1 have been introduced with the intention of improving the safe use of drugs by making drug labels easier to read and understand. These amendments include a requirement for the addition of contact information on the label and the submission of label and package mock-ups. The content presented in this guide will provide information that supports the objectives of the Plain Language Labelling Initiative.
This guide focuses on the inner and outer labels and packages across the following health products for human use:
Any of these may be referred to as a “product” or “health product” in the context of this guide.
This guide is not applicable to whole blood and its components under the Blood RegulationsFootnote2; cells, tissues and organs under the Safety of Human Cells, Tissues and Organs for Transplantation RegulationsFootnote3; consumer health products for self-selection; disinfectant drugs; drug products used in clinical trials; active pharmaceutical ingredients; and drug products for veterinary use.
Aspects of product labelling that are not covered include the naming of health products (refer to Guidance Document for Industry – Review of Drug Brand NamesFootnote6), user-applied labels, product monographs, package inserts (e.g., prescribing information), and Patient Medication Information.
A large volume of information has been published providing direction to optimize the design and content of health product labels and packages to support safe use. This body of knowledge, along with additional research and consultation on the topic, has been reviewed and adapted to produce this guide and is inclusive of the following:
The design of a health product should meet the user’s needs within the environment of use, rather than there being an expectation that the user or the environment of use will change to fit the intended use of the health product.Footnote9 Design the glove to fit the hand, instead of expecting the hand to fit a particular glove.
The environment of use can influence how users interact with a health product, so consideration of the environment should be incorporated into the design and evaluation of health product labels and packages.Footnote9 From a prescription drug perspective, the environment of use can include where the product will be used (e.g., hospitals, long-term care facilities, healthcare professionals’ offices, emergency transport settings), where the product will be stored, types of supporting tools and technologies (e.g., dose organizers and dispensers, medication administration records, bar-coding technology), and lighting level.
It is important that product labels and packages be designed with the user in mind and with consideration of the environment and processes in which the product will be used (stocked, selected, and administered). A recent aggregate analysis of labelling and packaging incidents involving health products offered an overview of some of the issues that users of health products have experienced.Footnote8 The following are some of the potential contributing factors identified in that analysis:
Part 3 of this guide presents information on current good practices in the design and layout of a health product label, the information contained on the label, and the design or choice of package. The topics and principles cover various contributing factors in reported medication incidents and issues identified by environmental scans of sponsors and users.
Although the various topics are presented separately within Part 3, they must be considered together to achieve a balance between standardization and differentiation (e.g., within a sponsor’s product line). Standardization of product labels and choice of packages can reduce errors by reinforcing the pattern recognition on which humans rely when processing information.Footnote10 However, the more label or package characteristics that products have in common (e.g., type style, size and colour of type, size and shape of container or package, layout of information), the more likely that products will look alike. The cumulative effect of individual label and package characteristics can result in look-alike issues that make it difficult for users to distinguish one product from another. The potential for look-alike issues should be considered during the design phase of a product’s labelling and packaging. Similarly, changes to existing product labels and packages should strike a balance to prevent introduction of new look-alike issues. Achieving a balance between standardization and differentiation is particularly important to prevent (or resolve) look-alike issues that involve high-alert medications or a sponsor’s higher-risk products.
In addition to all the topics discussed in the guide, sponsors are strongly encouraged to consider human factors aspects of product selection, use, and handling, as well as user testing with a risk based approach (refer to Appendix 2, “Human Factors Principles and Assessment Methods Relevant to Labelling and Packaging”), in the design of labels and packages.
When designing product labels and packages, sponsors are strongly encouraged to undertake a number of steps. The following is an overview of the steps that sponsors can incorporate into existing product development and marketing processes:
Illegibility of printed information is a contributing factor in health product errors.Footnote8, Footnote11 Interactions between or changes to typographic elements on a label (e.g., type style, size, spacing, use of bold or italic, colour, contrast) can affect both legibility and comprehension.Footnote12 Label information must be legible to users in the real-world environments or situations in which products will be used.
The following recommendations do not apply to trademarks, copyrighted text, and logos.
Type Style (Typeface)
TALLman lettering is a method used to assist in the differentiation of look-alike, sound-alike non-proprietary (proper or common) drug names through the application of UPPER CASE lettering to certain syllables or groups of letters within names.Footnote9, Footnote19 TALLman lettering has typically been applied to drug names to bring attention to the points of dissimilarity between confusable names.Footnote19 TALLman lettering may be effective because it draws attention to drug names presented in this format and can act as a warning.Footnote20 Overuse of the technique may reduce its effectiveness as names may no longer appear novelFootnote21
TALLman lettering is only one of many risk mitigation strategies that can be implemented to minimize errors between confusable product names. This technique does not rely on type style, point size, or colour and can be accommodated in electronic systems; for these reasons, it has become a widely accepted method of distinguishing among drug names within healthcare practice settings.Footnote22
The Institute for Safe Medication Practices Canada (ISMP Canada)Footnote23, the Institute for Safe Medication Practices (US)Footnote24, the US Food and Drug Administration (FDA),Footnote9, Footnote24 and various other organizations around the world have supported the application of TALLman lettering for potentially confusable drug names.Footnote22, Footnote25, Footnote26, Footnote27, Footnote28, Footnote29, Footnote30
The Proximity Compatibility Principle specifies that all information relevant to a common task or mental operation should be displayed close together.Footnote31, Footnote32 For example, the name, strength and dosage form are distinct but closely related elements used to identify and administer a health product and would be placed in close proximity on a product label. Conversely, the net quantity in the package is not related to this information or needed to identify and administer the product and would therefore be placed in a separate location. Confusion errors have been reported when the product strength (a numeric value) and the unit or pack size (another numeric value) were placed in close proximity.
Proximity and compatibility can be affected by other label and type attributes, such as colour, type style, and type size and weight. Use of the same colour(s), type style, point size, and markings or graphics can inadvertently link pieces of information (e.g., numeric values) even when there is physical distance between them on the label.
White space is an important aspect of design and requires careful consideration during the design phase. It should be used as liberally as possible to enhance the readability of health product labels.Footnote140, so that healthcare professionals and patients can quickly find the information they need to facilitate safe product useFootnote13
The term “white space” does not necessarily refer to space on a label that appears white. Depending on the background colour, it may be more accurate to use another term, such as “blank space”. Such white space on a health product label or package refers to any space not covered by print, markings, coloured graphics, watermarks, or other elements of the label.
White space surrounding text can create a feeling of openness.Footnote36 It can also help readers to focus on what they are reading.Footnote14 Importantly, it may improve readers’ willingness to read and their ability to find and process the information presented, because it helps to reduce the concentration and mental workload required.Footnote36, Footnote37
Colour on the inner and outer labels of health products must be carefully applied to help, and not hinder, the selection of appropriate products by users. The application of colour is just one of many factors to be taken into account in the design of health product labels and should not be considered in isolation.
People with normal colour vision are able to detect differences between similar colours only when the colours are placed side by side. Without side-by-side comparison, similar colours cannot be easily distinguished, and errors can be made if colour is the only variable used on a health product label. For example, problems may arise if different strengths of the same product are differentiated by using variations of one specific colour.Footnote12
In addition, under less-than-optimal conditions, the ability to discern colours can be further reduced, for example, when print appears on small containers or labels, when viewing time is short (e.g., urgent situations, distractions), when a lower level of lighting is used (e.g., in a patient’s hospital room at nightFootnote38), and when colours of similar products are physically separated (i.e., not viewed together).Footnote39
The effect of colour in label design can be affected by colour-blindness.Footnote5, Footnote25, Footnote38, Footnote43, Footnote44, Footnote45 Certain types of colour-blindness are more common than others. Colour-blind users may have limitations in their perception of specific coloursFootnote35, Footnote38 (e.g., red-green) or may have difficulty in reading text in particular colour combinations or on particular colour backgrounds.Footnote39
Contrast is a fundamental design principle that is used to help the user detect differences in what is seen. Footnote44 It is an important factor for the readability of text, particularly on packages with a coloured background.Footnote1, Footnote9, Footnote10, Footnote16, Footnote33, Footnote35, Footnote41, Footnote42, Footnote43, Footnote45, Footnote46, Footnote47, Footnote48 For example, it has been recommended that text of a dark colour be used on pale backgrounds to ensure sufficient contrast for optimum visibility.Footnote9, Footnote10, Footnote15, Footnote16, Footnote35, Footnote47, Footnote49
Colour Differentiation and Colour-Coding
Colour differentiation is generally used to highlight particular features on a product label or to help distinguish one product from another.Footnote10, Footnote78 However, repeated use of this particular technique can lead to look-alike product labels,Footnote10, Footnote35, Footnote45, Footnote49 which can in turn predispose users to confirmation bias (i.e., users see what they expect to see). Colour differentiation can also reduce the prominence of key information if it is not used skilfully.Footnote15, Footnote45
“Color coding is the systematic application of color to aid in classification and identification. A color-coding system enables users to associate a color with a function.”Footnote10 Colour-coding relates to the use of consistent colours for specific products or product strengths by all manufacturers. For various reasons, many safety experts do not support the use of colour-coding: Footnote9, Footnote10, Footnote16, Footnote35, Footnote41, Footnote50, Footnote51
Colour-coding appears to have some benefits for user-applied labels and in specific practice areas, such as by anesthesiologists in the operating room settingFootnote53, but these benefits are not necessarily applicable to other users or other environments. Users should not be expected to remember and attribute meaning to particular colours, especially given the large number of different product strengths and concentrations, the thousands of drug classes and products, and the limited number of visually distinct colours.
By convention, some colours are typically recognized as conveying certain meanings (e.g., red may convey danger, orange may convey a warning, yellow may convey the need for caution).Footnote39 Such conventions are commonly used for signage in dangerous or hazard-prone environments, e.g., for traffic signs or for containers holding hazardous chemicals.Footnote54 Aside from these examples, subjective meanings for colour may also exist in specific populations of users.Footnote55
Use of Colour
The use of certain abbreviations (e.g., OD), symbols (e.g., μ), and dose designations (e.g., 1.0 mg) to convey health product-related information has been identified as an underlying cause of serious, even fatal errors.Footnote63 An abbreviation may have more than one meaning and may therefore be susceptible to misinterpretationFootnote9, particularly if users are unfamiliar with the intended meaning. Practices and terminology may vary among different healthcare professionals and groups (e.g., pharmacists, nurses, physicians), as well as between clinical specialties, or even between patients and healthcare professionals.
Route of Administration
Bilingual labelling may pose challenges for the readability of inner and outer labels because of the possibility of crowding of information. Healthcare professional, patient, and consumer feedback gathered in the development of the guide highlighted the following concerns:
Organization of Information
Expression of Strength or Concentration
Issues can also arise after redesign of a well-known product label. Reasons for a redesign may include standardizing the look of products nationally or internationally,Footnote71 fulfilling marketing purposes, or revising certain aspects of the label to help ensure that errors do not recur. Label redesign requires a balance, such that any existing positive design aspects are maintained for the benefit of users. It has been noted that “while not always feasible, it is important to retest the label designs as they are modified for various purposes, to ensure the changes cause no disruption to the system and user performance”.Footnote72
The safe labelling of health products ensures that all information is readable for the duration of the shelf-life of the product.Footnote40 It has been noted that important information on product labels may be inadvertently removed with handling and use.Footnote74
The principal display panel of a label is the first interface between the user and a health product. It is an important factor in product identification and selection. Health Canada regulations specify information that is required to appear on the principal display panel of a product (Food and Drug Regulations C.01.004).Footnote18
Sponsors are expected to be familiar with the regulatory requirements for their particular product.
In addition to the information required by regulations, eight key elements were identified by the expert advisory panel of healthcare professionals, consumers, and regulators providing input during the development of this guide. These elements assist the user to correctly select a product and use it appropriately. These were noted to be the key pieces of information for inclusion on the principal display panel of health product inner and outer labels (see note below). They align with national and international standards and safety literature, but do not incorporate all of the information required by regulation or guidance for each type of health product. For example, the drug identification number (DIN) is required by regulation, yet is not listed among the eight key elements.
The eight key elements are:
Note: It is vital to consider each specific product, its users, the environment(s) of use, and the regulatory requirements to determine which of the eight key elements may be needed to ensure safe use. (Refer to section 3.5.2, “Small Containers and Small-Volume Containers”.) For example, oral liquid products may be used in environments such as hospitals or even homes where intravenous access may exist. Because it is possible for any liquid product to be injectedFootnote76, or a suppository to be ingested, it is critical to state the intended route of administration (oral for the liquid, rectal or vaginal for the suppository) on the principal display panel of the label on such products.
For very small containers, the inner label may not have the space to include all of the identified key elements. The nature of the product will then suggest which elements are most critical for safe selection and use and should be included on the inner label taking into consideration the regulatory requirements.
Storage instructions are one of the key elements that are not addressed in a separate section of this guide. It may be relevant to include such instructions on the principal display panel if the typical storage requirement for the product is other than room temperature. For example, products that require refrigeration are less typical, and refrigeration instructions for products requiring low storage temperatures should therefore appear on the principal display panel as an alert to users. This is especially important for vaccines that require refrigeration.
Expression of strength is a key piece of information on a health product label. Unclear expression of strength, or a missing expression of strength, can impede correct selection and use of products. Individual products may be available in multiple strengths, and strength may be expressed in a variety of units; as a result, product strengths can be easily misinterpreted.Footnote10
The following list presents examples of labelling practices that may introduce confusion because of the way in which the strength of a health product is expressed:
Other important issues related to the expression of a product’s strength may increase the possibility of confusion and error. With regard to health products in the form of a salt, potencies and content of the active component can differ significantly among various salt forms. Therefore, there may be inconsistency in how information is presented and how users refer to (or understand) the strength. Users may find it difficult to distinguish between the dose of an active ingredient’s salt form and the dose of the active moiety itself.Footnote80 For example, flupenthixol is available in three salt forms, hydrochloride, acetate, and decanoate. Oral tablets are in the form of the hydrochloride salt. Injectable products are in the form of the acetate salt, where 50 mg provide 42.25 mg of flupenthixol, and the decanoate salt, where 200 mg provide 144.4 mg of flupenthixol. Thus, confusing a dose of 100 mg between the two salts would provide either 72.2 mg or 95.5 mg of the active drug, as well as having a dramatic difference in absorption rates. It is also important to differentiate between two or more formulations of the same active ingredient, especially when the doses differ significantly. Incorrect dosing due to confusion over which formulation was being used (e.g., liposomal vs. conventional amphotericin B) has resulted in serious adverse events, including death.Footnote81
For health products requiring dilution to achieve a final concentration for use, the strength expressed on the label may differ from what is required for the final product. Unclear dilution instructions have caused medication incidents.Footnote82 The following issues have been observed:
Fractional strengths can be more error-prone and confusable, a situation that must be considered when new strengths are added to existing product lines. An example is transdermal fentanyl, which was made available as both 12.5 mcg / h and 125 mcg / h; 10-fold dosing errors have occurred because the decimal point was overlooked.Footnote84 This problem has now been remedied by changing the displayed strength of the 12.5 mcg / h product to read “12 mcg / h”. In cases like this one, the decimal point and matching digits can cause confusion; when the drug involved is a high-alert medication, such as an opioid, the effects could be significant.
Dosage forms that release or deliver an amount of product different from the total amount in the container may need careful consideration. An example is a nicotine inhaler, which contains 10 mg per cartridge but delivers only 4 mg. Such a discrepancy may cause confusion for both the prescriber and the user, because of a mismatch between how the prescribed dose is communicated and how the strength is presented on the label. Furthermore, if the available drug is interpreted as 10 mg of nicotine per cartridge, this could also result in a higher dose and an unnecessary step-up of nicotine therapy when converting from the inhaler to a longer acting transdermal nicotine patch.
Reconstitution and Dilution
Expressions of Strength for Pediatric Products
A critical warning is one that must be highlighted and conveyed to every user before product administration, to facilitate correct product use and to prevent an error that may result in serious harm or death. Critical warnings must hold the attention of users and must create a balance between being explicit yet concise. Footnote54, Footnote92Their goal is to ensure that users notice, read, understand, and comply with the warning message. Footnote93Critical warning statements are often presented framed or boxed in both the product monograph and patient information leaflets, and are commonly shown on the principal display panel of the inner and outer labels.
The design of the label and package should not convey a conflicting message to users. For example, if a topical medication is provided in a vial similar to that used for injectable products, or an inhalation medication is provided in a capsule format, a warning may not be enough to overcome the user’s experience and customary handling and use of similar packages or formats.Footnote94, Footnote95, Footnote96, Footnote97 Additional safeguards that consider human limitations, the ways in which users will interact with the product, and the environment in which this interaction occurs will likely need to be incorporated into the product design to help minimize human error.Footnote98, Footnote99 A warning added to a label may not be sufficient to alert the user to a critical situation.Footnote100 Ideally, the label and package will align and together will convey the product’s intended useFootnote99 (Refer to section 3.5.1, “General Packaging Considerations”).
Critical Warning Statements
Labels, Caps, and Ferrules
Product-Specific Critical Warnings
Ideally, error-prevention strategies such as the use of critical warnings on labels and packaging of a specific product are identified through user testing before they are made available on the market. The following recommendations are based on learning from medication error reporting and analysis from various jurisdictions and organizations. They represent additional improvements identified by regulators, safety organizations and experts, and other stakeholders for inclusion on the main or principal display panels (inner and outer labels) and container, as applicable.
Concentrated injectable medications that must always be diluted before administration
Neuromuscular blocking agents
Vincristine and other vinca alkaloids
Methotrexate for oral administration
Workplace Hazardous Materials Information System (WHMIS)
WHMIS is a “national hazard communication standard”, which specifies the classification of hazardous materials and requirements for the labelling of containers.Footnote117 Some health products may fall under WHMIS regulations and suppliers are required to properly identify and label these products.
Numerous variations exist in how expiry dates are expressed, including differences in the date format, the order of various details, and the grouping of information. These variations may present challenges to users. Incident reviews have shown concerns in two key areas: comprehension and readability.
Issues with Comprehension
Issues with Readability
Concerns have been described about confusion when a lot number has been misinterpreted as the expiry date or confusion caused by the lot number being combined with the expiry date.Footnote10 Users have also reported difficulty reading the lot number on some labels. Readability is hindered when the text is embossed, when there is a lack of contrast between the text and the background, and when the printed text lacks permanence.Footnote10, Footnote35 For some products (e.g., vaccines), the lot number is a component of the process of verification or documentation by users. In such circumstances, a readable lot number is needed to ensure complete documentation of the product’s administration.
Automated identification “is the use of bar codes, radio frequency identification (RFID) and other machine-readable codes to identify, quickly and accurately, an item or process”.Footnote120 Although not a mandatory requirement in Canada, automated identification systems offer opportunities to improve the safety and efficiency of health product use at various stages of the product-use process, including procurement, inventory management, storage, preparation, dispensing, and administration.Footnote121 Automated identification systems can also support product traceability (e.g., during recalls) and verification of the authenticity of health products as they move through the medication-use system.Footnote120
Health product packaging is an important factor in promoting the intended and proper use of a product. The type or format of a container often gives users a cue as to the intended route and method of administration.Footnote8 If a health product container, its format, or its appearance looks similar to that of other products intended to be handled differently, errors may occur, and serious harm may result, as in the following examples.
Outer Packaging or Overwrap
The outer packaging or overwrap is a good medium for displaying important information about the product. It may also provide a reliable way of keeping product components together (e.g., drug, dose delivery device, and patient information leaflet).Footnote74 However, caution must be exercised in using this type of packaging, as overwraps, outer packaging, and shipping cartons can also impede the proper identification and use of a product, as in the following examples:
Health products consisting of multiple items (e.g., a vaccine and its diluent) to be used together can be packaged such that all components are provided in one package; alternatively, the items may be packaged separately. Errors can occur when the labelling or packaging does not support correct use of the separate components by the user, as in the following examples:
Dose Delivery Devices
Health products intended for the pediatric population are often provided as oral liquid formulations for ease of administration.Footnote129 Some of these products are packaged with a measuring or dose delivery device intended to assist with the administration of a specific volume or dose by the patient. This presentation of the oral dose delivery device is intended to give users a way to accurately prepare and administer the dose.Footnote33
Outer Packaging or Overwrap
Dose Delivery Devices
The terms “small container” and “small-volume container” are reserved for containers with obvious restrictions on the amount of information that can appear on the product label or package.Footnote46, Footnote141 This includes special containers that are too small to accommodate a full label.Footnote4
The use of small containers may give rise to errors because of difficulties in reading or understanding labels on the product, as in the following examples:
The pediatric population is inherently at high risk of harm from medication errors.Footnote133 The number of preventable medication errors in this population is three times higher than among adults being treated in hospital.Footnote142 When an error does occur, infants and children are at greater risk of harm or death from an error than are adults.Footnote143 The following labelling and packaging factors can put the pediatric population at increased risk:
Blister packs can be manufactured in a number of configurations, including individual blister cells in a strip that is perforated to allow separation as unit doses or a sheet containing multiple doses to be used as needed or intended for a particular duration of therapy (e.g., 3 days, 2 weeks, 1 month).Footnote9 A blister pack can be removed from its outer package, cut into smaller units, or torn along perforations. Such actions can leave the product information unclear or unavailable, thus jeopardizing safe use of the product. The following concerns have been raised about the design of blister packs:
Health Products Intended for Sequential Use (e.g., Oral Contraceptives)
The use of transdermal medications and the properties unique to this delivery system have led to errors resulting in poor patient outcomes.Footnote147 The following general issues have been reported with the use of transdermal patches:
The recommendations presented here are important for any transdermal format and are especially critical for medications where severe harm could result if the patch is not seen after it is applied or if the patch falls off. Significant safety risks are associated with making patches invisible or too discrete.
Active ingredient: “means a drug that, when used as a raw material in the fabrication of a drug in dosage form, provides its intended effect.” (Food and Drug Regulations, Section C.01A.001Footnote18)
Aggregate analysis: see “Multi-incident analysis”
Brand name (Drug): “means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,
Close proximity: “means, with reference to common name, immediately adjacent to the common name without any intervening printed, written or graphic matter” (Food and Drug Regulations, Section B.01.001Footnote18)
Common name: “means, with reference to a drug, the name in English or French by which the drug is
Confirmation bias: a phenomenon that “leads an individual to ‘see’ information that confirms their expectations, rather than to see information that contradicts expectations.” (Human factors and substitution errors. ISMP Can Saf Bull. 2003;3(5): 1-2.Footnote180)
Critical incident: “an incident resulting in serious harm (loss of life, limb, or vital organ) to the patient, or the significant risk thereof. Incidents are considered critical when there is an evident need for immediate investigation and response. The investigation is designed to identify contributing factors and the response includes actions to reduce the likelihood of recurrence.” (Davies J, et al. Canadian Patient Safety Dictionary. 2003Footnote152)
Critical Warning: A critical warning is one that must be highlighted and conveyed to every user before product administration, to facilitate correct product use and to prevent an error that may result in serious harm or death.
Drug: “includes any substance or mixture of substances manufactured, sold or represented for use in
Drug in dosage form: “means a drug in a form in which it is ready for use by the consumer without requiring any further manufacturing.” (Food and Drug Regulations, Subsection C.01.005(3)Footnote18)
Expiration date or Expiry date: “means the earlier of
Font: “A complete set of characters in one design, size, and style. In traditional metal type, a font meant a particular size and style; in digital typography a font can output multiple sizes and even altered styles of a typeface design.” (Carter R, et al. Typographic design: Form and communication, fifth edition. 2012Footnote12)
High-alert medications: “drugs that bear a heightened risk of causing significant patient harm when used in error.” (Institute for Safe Medication Practices. c2015.Footnote153)
Human factors engineering: “the discipline concerned with understanding how humans interact with the world around them. It draws upon applied research in many areas, such as biomechanics, kinesiology, physiology, and cognitive science, to define the parameters and restraints that influence human performance. This knowledge can be used to design systems so that they are compatible with human characteristics. Conversely, if systems are not compatible with human characteristics, performance can be adversely affected.” (Institute for Safe Medication Practices Canada. Failure mode and effects analysis (FMEA): A framework for proactively identifying risk in healthcare. Version 1. 2006Footnote151)
Immediate container: “means the receptacle that is in direct contact with a drug” (Food and Drug Regulations, Section C.01.001Footnote18)
Inner label: “means the label on or affixed to an immediate container of a food or drug” (Food and Drug Regulations, Section A.01.010Footnote18)
Key Elements: For the purposes of this guide, eight elements were identified by the expert advisory panel as being the key pieces of information for inclusion on the principal display panel of a health product label. These elements assist the user to correctly select a product and use it appropriately. They are intended to complement international regulatory recommendations and align with national and international standards and safety literature. They do not incorporate all of the elements required by regulation or guidance for various types of health products. For example, the drug identification number (DIN) is required by regulation, but is not listed among the eight key elements.
Key Information: For the purposes of this guide, key information includes the key elements (refer to section 3.4.1, “Key Elements on the Principal Display Panel” for further information) and label information required by regulations.
Label: “includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package” (Food and Drugs Act, Section 2Footnote5)
Legibility: Ease of identifying each letter or character; affects the readability of words and sentences.
Lot number: “means any combination of letters, figures, or both, by which any food or drug can be traced in manufacture and identified in distribution” (Food and Drug Regulations, Section A.01.010Footnote18)
Main panel: see “Principal display panel”
Manufacturer or distributor: “means a person, including an association or partnership, who under their own name, or under a trade-, design or word mark, trade name or other name, word or mark controlled by them, sells a food or drug” (Food and Drug Regulations, Section A.01.010Footnote18)
Medication error: see “Medication incident”
Medication incident: “Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Medication incidents may be related to professional practice, drug products, procedures, and systems, and include prescribing, order communication, product labelling/packaging/nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use.” (Institute for Safe Medication Practices Canada. Definitions of terms.Footnote154).
Microgram: one-millionth of a gram, 1 x 10-6 gram.
Mock-up: In the context of medication labelling and packaging, a full-colour, actual-size copy of the labels and a colour representation (e.g., photograph) of the packages intended to be used for the sale of the drug, including all presentation and design elements, proposed graphics, fonts, colours, and text (with a place holder for expiry date, DIN, and lot number).
Multi-incident analysis: “a method for reviewing several incidents at once instead of one by one, by grouping them in themes (in terms of composition or origin) … This method of analysis can generate valuable organizational and/or system-wide learning that cannot be obtained through the other methods.” (Canadian Incident Analysis Framework. 2012Footnote155)
Non-proprietary name: describes the drug substance. International Non-proprietary Names are unique, universally applicable, and globally accepted names. A non-proprietary name is the proper name of an ingredient (or the common name if the ingredient has no proper name). (Food and Drug Regulations, Section C.01.001Footnote18)
Outer label (Drug): “means the label on or affixed to the outside of a package of a food or drug” (Food and Drug Regulations, Section A.01.010Footnote18)
Package: “includes anything in which any food, drug, cosmetic or device is wholly or partly contained, placed or packed” (Food and Drugs Act, Section 2Footnote5)
Parenteral use: “means administration of a drug by means of a hypodermic syringe, needle or other instrument through or into the skin or mucous membrane” (Food and Drug Regulations, Section C.01.001Footnote18)
Plain Language: “is a clear writing style designed to be easy to read and understood by the intended audience. It includes how information is organized and displayed within a space, such as the use of white space, fonts, ‘active’ instead of ‘passive’ voice of instructions, design elements and color. (Guidance Document: Questions and Answers: Plain Language Labelling RegulationsFootnote156)
Point: “A measure of size used principally in typesetting … It is most often used to indicate the size of type or amount of leading added between lines.” (Carter R, et al. Typographic design: Form and communication, fifth edition. 2012Footnote12)
Point size: “the approximate distance from the top of an uppercase letter to the bottom of a lowercase letter with a descender (for example, the bottom of a ‘j’).” (Singer JP, et al. Manufacturer's guide to developing consumer product instructions. 2003Footnote157)
Principal display panel (also referred to as “main panel”): “means
Proper name (Drug): “means, with reference to a drug, the name in English or French
Proprietary name: see “Brand name”
Readability: “Readability refers to how easy a piece of writing is to read and understand.” (Plain Language Commission. Readability ReportsFootnote159)
Root cause analysis: “an analytic tool that can be used to perform a comprehensive, system-based review of critical incidents. It includes the identification of the root and contributory factors, determination of risk reduction strategies, and development of action plans along with measurement strategies to evaluate the effectiveness of the plans.” (Canadian Patient Safety Institute. Canadian Root Cause Analysis Framework. 2006Footnote160)
Security package: “means a package having a security feature that provides reasonable assurance to consumers that the package has not been opened prior to purchase.” (Food and Drug Regulations, section A.01.010Footnote18)
Substitution error: an error where the wrong product is selected instead of the intended product.
Le Système international d’unités (The International system of units, also known as the “SI”): “consists of a set of base units, prefixes and derived units...:
The SI is not static but evolves to match the world's increasingly demanding requirements for measurement.” (Bureau International des Poids et Mesures. The International System of Units (SI), 8th edition. 2006.Footnote65)
TALLman lettering: the application of upper case lettering to certain syllables or groups of letters within look-alike, sound-alike names as a method to assist in their differentiation.Footnote22 This technique should be specifically applied to non-proprietary (proper or common) drug names. In order to demonstrate the concept of using capital letters within a word, “TALLman” is used in this guide.
Trade dress: “any material quality of a product’s packaging or physical appearance that serves a branding function”.Footnote161 This includes “the manner in which a company packages, wraps, labels, a drug or biologic product including the use of colour schemes, sizes, designs, shapes, and placements of words or graphics on a container label and/or carton labeling”.Footnote9
Type size: is commonly measured in points. See “Point” and “Point size”.
User: group or individual who will use a health product in the sponsor’s original container with its original label. Users can be identified through product use mapping and can include a sponsor’s internal staff as well as users across the supply chain, including the point of administration of a health product.
White Space: “the ‘negative’ area surrounding a letterform” (Carter R, et al. Typographic design: Form and communication, fifth edition. 2012Footnote12). Such white space on a product label or package refers to any space not covered by print, markings, coloured graphics, watermarks, or other elements of the label
Human Factors: An Overview
Human factors engineering is a discipline concerned with understanding human characteristics and how humans interact with the world around them.Footnote154 These characteristics and interactions can be referred to as “human factors”. The discipline draws upon applied research in many areas (e.g., cognitive science, physiology, kinesiology, biomechanics) to define the things that influence human performance. This knowledge can then be used to design processes, systems, or objects that humans use or interact with so that performance is enhanced and errors are minimized.
It is important that product labels and packages be designed with the user in mind and with consideration of the environment and processes in which the product will be used (stocked, selected, and administered). Users are not designers, and designers are not users.Footnote162 Although it is the designers who are primarily responsible for the design process, consideration should be given to involving users in all aspects of product design from the outset. In particular, designers must go beyond simply asking users what they may need or want.
Label and package designs may also benefit from ongoing review, also known as iterative designFootnote163 Making stepwise changes to a label or package design and tracking the rationale for each design change can help to optimize the design process. Part of the process can include asking the following questions. Is the information on the label grouped in a manner that will be understood by the user? What information is most prominent? What does the container tell the user about how the product is to be used? Does the product’s appearance and how the information is presented infer the appropriate meaning to the user?
The following subsections present sample questions that can be used to define users and environments of use.
Most products will have multiple types of users with different visual acuity, underlying diseases or conditions, and the number of health products already being used. Each category of user will have different requirements. To optimize safety, label and package design features may need to accommodate these differing requirements. Ideally, testing should involve novice users (people with little to no experience or knowledge of the product), occasional users (people with limited previous experience, who may not recall details of previous use), transfer users (people whose previous experience involves only similar health products, not the product in question), and expert users (people with extensive experience and knowledge of the product under consideration).Footnote164
Environments of Use
Health products may be used in hospitals, long-term care facilities, healthcare professionals’ offices, dialysis centres, other free-standing care centres, retail pharmacies, dispensaries, specialty pharmacies, emergency transport settings, and the patient’s home. Although all interactions with health product labels and packages will ideally occur in optimal environments, health products are often used and stored in poorly lit rooms with multiple high stress variables contributing to the complexity of choosing and using a product.
Any form of assessment, whether internal or external, requires a good understanding of who the users are, how the product will be used, the environments in which it will be used, and how users will interact with various aspects of the product, such as the container, the inner and outer labels, the packaging itself, and dosing devices.
What Is User Testing?
User testing refers to a broad set of methods for assessing usability, identifying problems experienced by users, and developing solutions to eliminate or reduce the consequences of these problems. User testing simulates or mimics the circumstances of product use to provide a realistic view of how the label and package function within the intended environments. User testing is not quality assurance testing, nor is it market research. User testing is performed under controlled conditions to determine whether people can accomplish specific goals with the product or system of interest.
How Can User Testing Help?
User testing can help to determine whether the intended users can safely and effectively perform the critical tasks involved in selecting and using the health product or whether they will make errors, have difficulty, or be unable to use the product at all. This is especially important for high-alert products.
User testing can be used to discover more specific information about users’ experiences with a product and can help to identify problems beyond the general principles outlined in this guide.
When Should User Testing Be Considered?
Although not mandatory, sponsors are encouraged to consider user testing in label and package design in the following situations:
User testing carries certain costs, however these up-front investments are often much lower than the economic costs of correcting poorly designed packages and labels that increase the risk of serious harm after the products have been released on the market. Well-designed packages and labels improve user satisfaction and can ultimately cost less for a wide variety of reasons.
User Testing Methods
Information and links are provided below to a number of methodologies that may be used to assess labels and packages. With higher levels of risk, additional and more rigorous testing methods are typically recommended. Development of product-use process maps are an integral component of these methodologies.
Failure Mode and Effects Analysis (FMEA) is a type of proactive risk assessment that can be used to systematically evaluate product-related hazards and points of risk within the broader system where a product will be used (users, environments). It represents a way to identify and prioritize these risks, identify strategies to mitigate or address problems or potential errors (e.g., to reduce the probability of occurrence of the error, to reduce the severity of consequences of an error, or to increase the likelihood that the error will be noticed), and evaluate the mitigation strategies.
Comprehension testing assesses user understanding of the communication elements of a label based on language, layout and graphics.Footnote170 It should ideally be applied to all key messages on product labels.Footnote74 Comprehension testing involves having an interviewer show the health product or a mock-up to participants and asking them to state the meaning of the label’s content (e.g., abbreviation). The interviewer then asks additional questions to assess any discrepancies between intended and interpreted meanings and to identify potential solutions to these discrepancies.
Cognitive walkthrough involves guiding a small number of users through a process or task, often early in the design process, to examine mental activities and challenges experienced.Footnote171, Footnote172 It can be used as part of an FMEA and can be applied in any setting.Footnote151 Cognitive walkthrough can be used to assess health products that have a narrow therapeutic index, those that are contraindicated in specific populations, and to assess critical warning messages.
Users walk through the assigned tasks, “thinking out loud” as they do so, to allow the investigator to gain a detailed understanding of users’ expectations and challenges. Potential design solutions identified through the cognitive walkthrough should then be applied to improve the design of health product labels and packages.
An accurate understanding of the situation, achieved by involving users in their own environments (either real life or “high-fidelity simulations”), will enhance the value and benefit of findings of the cognitive walkthrough.
Usability evaluation (also called simulated-use testing or user testing) is a systematic way of collecting data from representative participants in realistic situations. It involves having users perform specific tasks as part of a scenario while data are collected to identify potential errors or challenges. Similar to the scenarios for a cognitive walkthrough, the scenarios for usability evaluation provide context. A set of tasks is then assigned to be performed by participants. Scenarios are developed on the basis of user consultation, the product-use process map, and direct observation.
User testing can include cognitive walkthroughs with enactment of scenarios that replicate as closely as possible the real product-use process, or components of that process. Verbal protocol analysis can be used, whereby participants are instructed to think aloud during the scenarios and vocalize all thoughts and difficulties encountered.Footnote174 Information collected can include user feedback (e.g., satisfaction surveys, interviews), task analysis (e.g., number of steps in the process), and task performance measures (e.g., training time, completion time, number of steps that cause confusion, number and nature of errors made by users).
Information recall tasks can be performed to assess how label design affects a participant’s memory of information presented on the label. Experiments involving memory tasks can be used to assess labels and packages of products with a risk of severe harm or death if administered in error or given by the wrong route, as can occur with high-alert medications.
Experiment: Selection Tasks
Health product selection tasks can be used to assess or compare performance as affected by label or package design. This method has been used to compare existing labels against redesigned drug labelsFootnote178, to assess the comprehension of common abbreviationsFootnote179, and to determine whether inclusion of an additional sponsor logo will affect drug selection.Footnote72
Product-use process maps outline where and how a product will be used, according to its indications and who will potentially come into contact with it. They are intended to provide a complete and accurate understanding of how the product will be used, the environments of use, and how users will interact with it (e.g., with the container closure, container label, packaging and package labels, dose delivery devices) to identify and make decisions about using the product.
Product-use process maps can be helpful when human factors-based user testing is planned, as such maps will help in identifying the scope of use and the primary users.
An example of a product-use process map is presented below. Selection and administration are the key points in the process where users interact with products (specifically with the label and the package). In the example below, these points of interaction are presented in red italic text.
Sample Medication-Use Process Map for an Intravenous Antineoplastic Drug
Note: Information presented in red italicized text highlights the processes involved in selection and administration—key points in the process where users interact with products.
Expert advisory panel members:
This guide was prepared with the collaboration of ISMP Canada. A special thank-you is extended by Health Canada and ISMP Canada to other members of the expert advisory panel for their direction, input, and support for the guide:
Sincere appreciation is also extended to the following individuals, who provided expert input and advice in development of the guide (in alphabetical order):
Where possible and applicable, references have been sourced from publicly available Internet sites.
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