Health Canada Workshop on Health Product Plain Language Labelling

Summary Report

February 17, 2011

This report was prepared for Health Canada by Ascentum

Table of Contents

1. Introduction

On January 18, 2011, Health Canada's Health Products and Food Branch (HPFB) hosted a stakeholder workshop in Ottawa on the Plain Language Labelling Project. The objectives of the meeting were twofold:

  1. Awareness: Provide stakeholders with an overview of HPFB's Plain Language Labelling Project;
  2. Dialogue: Provide stakeholders with an opportunity to ask questions about and provide general feedback on the Plain Language Labelling Project, and in particular, on how to improve the clarity, readability, and ease of use of the Product Monograph Part III: Consumer Information (for pharmaceuticals and biologics), as well as the Instructions for Use (for medical devices intended for use by consumers).

In addition to sharing their comments during this session, participants were also provided with the opportunity to provide written comments following the session (using a template provided for this purpose).

A total of 23 participants attended the three-hour session, representing a broad cross-section of patient and consumer groups, industry, health literacy groups, and health professional associations. Participation at this initial workshop was by invitation only.

The session began with an overview of the Plain Language Labelling Project by Dr. Nashwa Irfan, Acting Manager of Health Canada's Marketed Health Products Directorate, and was followed by a question and answer session.

Participants were then asked to enter in table discussions to explore and provide feedback on what could be done to improve the clarity, readability, and ease of use of the Product Monograph Part III (PM) and the Instructions for Use (IFU). Key areas of focus included the presentation of information, the content of the PM and IFU, and other suggestions for improvement. Each table was assigned a Health Canada representative as note-taker, who documented the discussion using a worksheet provided for this purpose. During a final plenary, participants were invited to pose their questions and share highlights from their table conversations.

A copy of the session agenda is available in Appendix A, a short background document on the Plain Language Labelling Project is provided in Appendix B, the participant list in Appendix C, and an evaluation summary is available in Appendix D.

2. Key Findings

The following summarizes the key themes that emerged from participants' comments on the Plain Language Labelling Project as recorded in plenary discussions and in their table worksheets, as well as in the written comments received following the session.

2.1 Plain Language Labelling Project Questions and Answers

The introductory presentation was followed by a question and answer session, led by Dr. Nashwa Irfan (Acting Manager, Marketed Health Products Directorate, Health Products and Food Branch). Participants were provided with an opportunity to ask questions of clarification, share general comments and raise concerns or issues.

Participants shared the following general insights or sought to gain a better understanding of the following issues. While they are important issues, they go beyond the scope of the workshop, and will be considered as Health Canada moves forward with the project.

  • Search Engine Optimization (SEO): The existing information on the Health Canada website needs to be optimized on search engines such as Google, to ensure that when Canadians search for information on their health products, Health Canada sites are returned as results. Presently, Health Canada's web pages do not figure prominently in query results when Canadians use search engines to locate health product information.
  • Education: The importance of educating consumers and encouraging doctors to use the information available in the PM and IFU was frequently raised (during the Q and A session, and throughout the workshop).
  • Links with other Health Canada labelling projects/timelines: participants asked about linkages between the current project and other labelling work being undertaken by the Department. They also sought clarifications on the anticipated timelines of the project. Dr. Irfan clarified how the current project fits in with other initiatives, and discussed timelines.
  • Engaging existing patient/consumer groups: Participants noted the importance of engaging existing patient/consumer groups in this project.
  • Tracking impact of changes: Participants asked about existing research on the efficacy of the PM and IFU as they stand today, and recommended that long-term research be built into the current project to assess the impact of any proposed changes.

2.2 Product Monograph - Table Discussions and Plenary

The table discussion time was divided equally between the Product Monograph Part III (PM) and the Instructions for Use (IFU), and hard copy examples of each were provided to participants for reference (Health Canada received permission from the manufacturers of the products used as examples prior to the session). Participants' ideas and comments are synthesized in the sections that follow.

A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug. Manufacturers (or drug sponsors) are required to develop a detailed Product Monograph in accordance with the Health Canada Guidance to Industry: Product Monograph. Health Canada reviews this Product Monograph as part of the drug review process. ("Guidance to Industry: Product Monograph" October 1, 2004)

2.2.1 Product Monograph Part III: Presentation of Information

Participants identified a number of suggestions for how to improve the presentation and layout of information contained in the consumer section of the PM.

  • Language: Some felt the title "Product Monograph" does not explicitly convey to consumers that the document contains valuable information. Some also questioned the accessibility and readability of the language in general, especially for those whose first language is neither English nor French (see more on language/literacy in Section 2.2.2).
  • Flag new/updated information: Some participants suggested a system to flag new safety information in a way that is visually appealing. They felt that new safety information [(e.g.), new side effects not previously mentioned in the PM] should appear first.
  • Order of information: Participants felt that 'Part III' should be moved to the front of the PM to become Part I so that consumers do not get confused with technical information contained in the existing Part I or II. Furthermore, they felt that the order should reflect importance of information, and suggested that the "Before you use product x..." section be placed at the beginning. One suggested that the ordering of content and sections could be determined through consumer feedback.
  • Separate Consumer Product Monograph: Some thought that the consumer information should be separated from the technical/professional information and be made available as a standalone document. It was felt that this would be helpful to consumers, but also to pharmacists at the point of sale.
  • Executive Summary: A one-page executive summary was suggested by some, highlighting the most important information (e.g. indication, contra-indications, side effects, allergies to non-medicinal ingredients, timing between meals and interactions with drug/food/natural health products). Some participants cited a double-sided, one page public information sheet on each drug produced by the European Medicines Agency (EMA) as a good example.
  • Frequently Asked Questions (FAQ) Section/Question and Answer Format: Having a 'frequently asked questions' section was suggested by some as a way to improve the presentation of information. Others suggested conveying all information in the form of questions and answers [(i.e.) questions that a consumer would ask him/herself when starting to use the drug].
  • Table of Contents: An index or table of contents was recommended to improve usability of information and create a 'storyline'.
  • Visual Aspects:
    • Density and length: Participants felt that the document is too long, with too much information to absorb. They felt that a 'happy medium' in length and 'density' needed to be found between the existing PM and the pharmacy-provided fact sheets.
    • Bolding and underlining: Some felt that these needed to be used appropriately to highlight important information, but not both at the same time.
    • Headings: Some participants felt that the white writing on black bars should not be used, as it is difficult for many consumers to read.
    • Font: The font was identified by some as being too small, and requiring more space between characters. Some felt the font needed a standardized size of 9 or 10 points, as recommended in guidance, especially considering the aging Canadian population and their diminishing eye sight.
    • Colour: Some felt that the use of colour would improve readability and visual appeal.
    • Two-column format: The two-column format did not appeal to some participants, who felt it was difficult to read, particularly when section headings appeared at the bottom of one column and the rest of the information continued at the top of the next.
    • Bulleted lists: These could be used to make several terms separated by a comma in one sentence much easier to read, according to participants.
    • Graphics (pictograms and pictures): Others suggested the use of pictograms to illustrate the various vulnerable populations (e.g. pregnant women, elderly, children) and direct their attention to safety information concerning them. They also proposed providing graphics for side effects and warnings, such as a stop sign with an alcoholic beverage. One participant suggested the use of pictures (e.g. smiling people).

2.2.2 Product Monograph Part III: Content

In reflecting on the existing content of the consumer information contained in the PM, participants noted the following:

  • Language/Literacy: This was the most recurring issue across table discussions. Many felt the language of the document needs to be re-evaluated and re-written by trained professionals with skills in design and simple/clear language principles to make it understandable, possibly to a grade eight reading level. They also stressed that the information provided needs to be useful to the 'average Canadian'. For example, the term "dosage form" could be changed to "product appearance". One participant mentioned that the understanding of what is meant by side effects such as 'aggressive behaviour' may differ from person to person, and needs to be explained with examples. One participant suggested referring to the Plain Language Summaries of Cochrane Reviews for examples of effective plain language.
    • Phonetic spelling of drug name: Related to language and literacy is the suggestion by one participant to include the phonetic spelling of the drug name, to aid patients in communicating with their health care providers.
  • Interactions:
    • Food: Participants felt there was missing information around food-drug interactions, particularly with dairy and citrus, and that timing between meals needed to be placed upfront.
    • Alternative medicine: With the increase in use of health supplements and natural health products, participants felt that information on how a drug interacts with these other health products was missing.
    • Other drugs: While interaction with alcohol is mentioned, participants noted that information on interactions with other drugs is absent.
    • Managing length: One participant noted that the serious adverse effects table is growing, and could continue to grow in length, if steps are not taken to include the most serious of effects.
  • Repetition: Some participants found the content to be too repetitive. One way to avoid this, as shared by some, was for Health Canada to give pharmaceutical companies more flexibility in how information is provided. However, some felt that very important warnings needed to be repeated. Others felt that headings could be grouped, in order to combine information.
  • English/French Language Issues: Some mentioned that the French language version of the PM is even longer than the English language version, and that the translation may not always meet expected standards (e.g., quality, precision and accuracy of translation). Others mentioned that there may be language issues for allophones.
  • Non-active ingredients: Participants felt that information on non-active ingredients should be included, in particular, allergens.
  • Clear messaging: Some participants noted that the sample PM advised that pregnant women should not take the drug, but did not mention mothers who are breastfeeding, leading them to suggest the need for clear and precise messaging. Some felt that the PM should move away from warnings that use the word "may, " and rather, convey information in a direct "do this, don't do that" style (e.g. "If you experience the following symptoms, make an appointment with your doctor, but if you experience this other set of symptoms, go to an emergency room").
  • Quality messaging: One participant questioned the utility of having warnings in the PM along the lines of "Tell your doctor about depression before you take this medication", as these sorts of issues should be determined when the physician issues the prescription.
  • Provide rationale: When providing instructions/lists of things that consumers should not do, some participants felt that the rationale should be provided (e.g. the potential outcome/result).
  • Canadian central phone number: Some participants noted the importance of having a central place to call and obtain Canadian-specific (i.e., reflective of what has been approved for sale in Canada) product information.
  • Benefits: Some suggested that the benefits of taking a particular medication should also be included in the PM, as well as possibly including alternative medicines to solve particular ailments (while being mindful not to endorse a particular product/remedy). This information could be mediated for different consumer groups (i.e. for patients with chronic versus acute conditions, for caregivers versus patients themselves), according to some, with the proviso that safety information is not mediated.
  • Expired medication: One participant suggested that information should be included on what to do with expired medication, to ensure safe and proper disposal.
  • Content for specific groups: A few participants suggested creating special content and sections for specific population subsets, for example, parents of children, seniors, women/pregnant women, and those with specific chronic conditions. One participant highlighted the importance of having specific information for children by citing a recent case with TNF Blockers.

Finally, one participant suggested referring to a 2006 technical research paper produced by  Consumer Health Products Canada on Improving Label Comprehension.

2.2.3 Product Monograph Part III: Other Suggestions

Participants shared a number of other suggestions to improve the Product Monograph Part III:

  • Drug 'symbol': One participant suggested adding a symbol on all drug products marking the product as a drug.
  • Audience-specific language: Another participant shared that doctors sometimes have difficulty reading the technical PM, and raised the point that language must be adapted for and accessible to each target audience.
  • Improve accessibility:
    • Braille and other languages: One participant questioned whether the PM III is available in Braille or in large print, and whether content is available in languages other than French and English.
    • Adopting new technologies: Some questioned whether new technologies like smartphones, tablet computers (e.g. iPads) and "QR" (Quick Response) codes could be used to access information, especially for younger generations.
    • Create online database of PM's: The creation of an online repository of the consumer sections of the PM was suggested by some, to account for the fact that many consumers throw out the PM. The creation of new databases, and changes to existing databases and Information Technology (IT) systems would need to occur keeping in mind how consumers are accessing the information, and how different audiences use technology (one participant also mentioned that the internet savviness of senior citizens needs to be considered). The paucity of quality information online for some conditions, was highlighted by one participant, referring to a report titled "Surfing for Juvenile Idiopathic Arthritis".
    • Host PM on manufacturer's website: Some suggested that the complete PM should be hosted on the manufacturer's website, as well as the creation of a specific section for consumers containing Part III data. One suggested including Universal Resource Locator (URLs) on the paper version for participants to easily access the digital version.
    • Digital Format: One participant critiqued the current online Portable Document Format (PDF) format as difficult to read and navigate.
  • Pharmacy-provided information:
    • Providing consistent information at point of sale: Some participants were concerned that the information sheets provided by pharmacists differ in content from the PM (and are often based on American data and content), and suggested that consistency should be developed between the two, ensuring that all information is looked at by Health Canada before being distributed to consumers. It was acknowledged that this will be challenging, as pharmacies fall under provincial/territorial jurisdiction. It was also suggested that the information sheet include a link to the manufacturer's website for complete product information.
    • Consider other materials: Participants expressed their appreciation for being able to comment on Part III of the PM, but also pointed out that most consumers do not read the PM. They requested that they be given an opportunity to comment on the pharmacy-distributed information sheets.
  • Engage consumers: Participants asked that different kinds of consumers be invited to assess the readability of Part III as changes are being made, and to include end users of specific drugs (e.g. consulting cancer survivors to provide feedback on cancer-treating drugs).
  • Hospital-prescribed medication: Some participants mentioned that prescriptions supplied by hospitals are rarely accompanied by PMs or other information sheets, and identified the need for a better transfer of information to patients in this context.
  • Pharmacists and new information: Some pointed out the role of pharmacists in sharing PM updates with consumers, especially with those who have chronic conditions and are on medication on a long-term basis.
  • Best practices: Participants encouraged Health Canada to consider best practices around the world as changes to product labelling continue to be considered.
  • Retroactive application: One participant questioned whether an updated PM format would be required for approved drugs currently on the market.
  • Research/evaluate efficacy: There was a desire by some to develop baseline data to test the effectiveness of eventual changes to Part III of the PM. One participant shared that while Part III of the PM is a useful aid for health professionals in counselling their patients, in its entirety it is not an acceptable format for a package insert, and needs to be adequately validated through research. Until validated, the participant asked that over the counter medication be free from the requirement to provide the PM Part III as an insert.
  • Consider added cost: One participant noted that the added expense that the addition of colour, visuals and larger fonts would have on the production and packaging of drugs, and asked that these potential added costs to industry be considered as this project moves forward.

2.3 Instructions for Use - Table Discussions and Plenary

After exploring changes to Part III of the Product Monograph, participants shifted their attention to the Instructions for Use (IFU). Participants' ideas and comments are synthesized in the sections that follow.

Participant feedback was generally positive, but some questioned whether the example used was representative of all IFUs. Some shared their belief that consumers do not have as many concerns about IFUs as with PMs, given that IFUs are likely to be supplemented by instructions on use, via courses, intermediaries such as doctors and other health care providers, and backed up by toll-free hotlines.

Instructions for Use for medical devices is the full information as to the procedures recommended for achieving the optimum performance of the device, and includes cautions, warnings, contraindications, and possible adverse effects.
Medical Devices Regulation)

2.3.1 Instructions for Use: Presentation of Information

Participant feedback on the presentation of information was generally positive.

  • Language/literacy: Some participants evaluated the text of the sample IFU as being of grade-eight level, which they found appropriate. Others found that the language used was not plain enough.
  • Layout: Participants were satisfied with the physical size and layout of the document, including the table of contents, troubleshooting section and grouping of information. A few, however, found the document quite lengthy and dense, and thought that important warnings should appear earlier in the document. A few also felt that the information on error codes should be moved up to directly follow the section on how to conduct tests using the device (thus logically linking the two sections).
  • Visual aspects:
    • Diagrams/colour: Participants were satisfied with the diagrams and use of colour. However, they suggested that all diagrams be labelled (e.g. "Fig. 2.1") for ease of reference in the text. Some suggested developing a "traffic light" style scale to represent good and bad values when testing for glycemic control.
    • Font: The font type and size was deemed appropriate by participants. However, it should be noted that the sample IFU provided is likely not representative of what is actually distributed in the market. The IFU comes in the form of a booklet, rather than a PDF format, meaning that the font size is likely smaller in reality.
    • Bold: Some participants felt that there was excessive bolding in the sample IFU.
    • Numbering and bullets: Some felt that these would help to improve the flow of the document.

2.3.2 Instructions for Use: Content

Participants made a few suggestions on changes to content:

  • Intended use: There were some participants who felt that information on the intended use of the device was missing (e.g., "this device assists with the management of x conditions").
  • Safety information: Some felt that safety information was missing. They noted that a statement on safety ought to be made, even in cases where a device has no known safety concerns, including known risks if the device malfunctions.
  • FAQs: Some participants suggested the creation of a frequently asked questions section, allowing consumers to quickly find pertinent information.
  • Canadian measurement values: Participants identified the need for IFU writers to be mindful that the official system of measurement is metric in Canada, rather than relying on the imperial system in the United States.

2.3.3 Instructions for Use: Other Suggestions

Many of the other suggestions for improving the Instructions for Use echo those made for changes to the PM:

  • Two documents: Some recommended having one IFU for consumers, and another for health care professionals.
  • Engage consumers: Participants suggested that Health Canada and manufacturers conduct testing with consumers, during which consumers would perform a "walk through" test to examine the usability and clarity of the IFU.

Parking Lot Items (Beyond the scope of this project):

  • Product design: Some felt that the design of a product (e.g. epipen) must also be considered, making the point that as well laid out as the instructions are, the success and ease of use of a product often comes down to how well it is designed.
  • Other media: Participants suggested making instructional information available in an audio-visual format to supplement the IFUs, as well as posting the IFUs online and linking to these through the Health Canada website. One participant suggested learning from the computer industry (e.g., Apple), which provides a one-page document summarizing the key things to know about a new piece of hardware and a toll-free number for further questions.

3. Conclusion

Health Canada will use the results of this consultation to aid in the decision-making on how best to improve the Product Monograph Part III and the consumer-focused Instructions for Use.

Health Canada considers this information session to be a first step in an ongoing dialogue on changes it is making to the way health products are labelled. Further consultations will occur in the coming months.

3.1 Participant Evaluations

Feedback on the session was overwhelmingly positive. Of the sixteen participants who submitted evaluations on site, 100% strongly or somewhat agreed that the process allowed for an interesting exchange amongst participants, the presenters communicated clearly and effectively, the facilitation made for a productive meeting, the meeting was relevant and a good use of time, and that they were pleased with the meeting and its output.

In their qualitative assessments of the event, participants qualified the table discussions as constructive, interesting and beneficial. They appreciated having a number of different stakeholders around the table. One participant encouraged the participation of provinces and territories, as their Ministries of Health play roles in conveying drug information. Please refer to Appendix D for detailed evaluation results.

Health Canada wishes to thank all participants for their contribution and collaboration.

Appendix A: Session Agenda

Health Canada Stakeholder Consultation on the Plain Language Labelling Project

Ottawa Marriott Hotel
Wellington Salon (3rd floor)
100 Kent Street, Ottawa, Ontario
January 18, 2011

Agenda
Period Session Presenter
1:00 - 1:30 Registration and Coffee
1:30 - 1:45 Welcome and Overview of Agenda Barbara J Sabourin
Senior Executive Director
Therapeutic Products Directorate
1:45 - 2:05 Presentation
Plain Language Labelling Project Overview
Dr. Nashwa Irfan
A/Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate
2:05 - 2:30 Plenary Question and Answer Session
2:30 - 3:00 Small Group Discussion
  • Presentation of information
  • Content
  • Other suggestions for improvement
3:00 - 3:15 Health Break
3:15 - 4:15 Plenary Discussion
  • Presentation of information
  • Content
  • Other suggestions for improvement
4:15 - 4:30 Closing Barbara J Sabourin
Senior Executive Director
Therapeutic Products Directorate

Appendix B: Background Information

Health Canada
Health Products and Food Branch
Discussion Document for Stakeholder Workshop
Plain Language Labelling Project
Ottawa, January 18, 2011

Project overview: Health Canada's Health Products and Food Branch (HPFB) has initiated the plain language labelling project, which specifically aims to improve the clarity, readability, and ease of use of the Part III: Consumer Information section of the Canadian Product Monograph for drugs (such as pharmaceuticals and biologics), as well as the Instructions for Use for medical devices (those intended for use by consumers). Providing Canadians with information in plain, clear, and easy-to-understand language is important for the safe and effective use of therapeutic products. This project represents one aspect of Health Canada's work to improve health product labelling; the Technical Discussions on Regulatory Modernization (January 19 to 21, 2011) will provide the opportunity to consider and discuss the regulatory concepts for health product labelling in general.

A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug. Manufacturers (or drug sponsors) are required to develop a detailed Product Monograph in accordance with the Health Canada Guidance to Industry: Product Monograph. Health Canada reviews this Product Monograph as part of the drug review process.

Instructions for Use for medical devices is the full information as to the procedures recommended for achieving the optimum performance of the device, and includes cautions, warnings, contraindications, and possible adverse effects.

Background: Labels are important tools to assist Canadians in making informed decisions when using health products such as drugs and medical devices. In Canada, the term "label" is broad and is defined in the Food and Drugs Act as including "...any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package." This definition means that "label" includes information such as the package insert, instructions for use, and Product Monograph.

Over the years, Health Canada has led several labelling initiatives related to this project, including:

  • The first guidance document on the development of Canadian Product Monographs was issued in 1976 and underwent major revision in 1989. At the time, the Product Monograph did not have a standard format.
  • In September 2000, multi-stakeholder consultation workshops were held to discuss the newly proposed Product Monograph format and content. In addition to these workshops, Health Canada commissioned a 2001 study to evaluate consumer information needs that guided the development of the Part III: Consumer Information section of the Product Monograph.
  • As a result of these consultations, a revised format of the Canadian Product Monograph was introduced in 2004. The new Product Monograph was divided into the three sections currently in use: Part I: Health Professional Information; Part II: Scientific Information; and Part III: Consumer Information. The intended audience for Parts I and II are health professionals, scientists, and the informed public, while the intended audience for Part III is the patient and/or consumer. The guidance to industry for Part III has not been revised since 2004.

Building on the work done to date, the Health Products and Food Branch has now initiated the plain language labelling project to improve the clarity, readability, and ease of use of the Part III: Consumer Information section of the Canadian Product Monograph for drugs, as well as the Instructions for Use for medical devices (those intended for use by consumers).

Purpose of this document: This document provides information to consumer/patient groups and industry stakeholders about HPFB's plain language labelling project on Part III of the Product Monograph for drugs and the Instructions for Use for medical devices, which provide key information to Canadians and help inform decisions about their health. Associated questions are presented to stakeholders for further examination and discussion during the workshop.

Objective of this workshop: This workshop forms part of the initial consultative phase of the plain language labelling project. HPFB is seeking feedback from stakeholders at the workshop on how to improve the clarity, readability, and ease of use of the Product Monograph Part III: Consumer Information section for drugs, as well as the Instructions for Use for medical devices. Health Canada will use the results of this consultation to aid in the decision-making on how best to improve these product information documents for Canadians. Stakeholders will also have an opportunity to provide written comments to Health Canada following the workshop, as well as in future stakeholder consultations.

Questions and options: The following questions are presented for consideration from the perspectives of the various stakeholder groups, and will form the basis for the discussion at the workshop on January 18, 2011. These questions are specific to the scope of the project: Part III of the Product Monograph for drugs and the Instructions for Use for medical devices.

Presentation of information:

  • Order: Could Part III of the Product Monograph for drugs and the Instructions for Use for medical devices be structured differently in order to help improve usability? For example:
    • Moving the Part III: Consumer Information section to the front of the Product Monograph so that it's the first section
  • Visual presentation: What changes to the document layout would improve ease of use? For example:
    • Using large illustrations
    • Adding boxed warnings
    • Using larger text
    • Adding colour
    • Adding more white space
    • Adding symbols to Instructions for Use for medical devices

Content:

  • Clarity: What suggestions would you make for improving the clarity of Part III of the Product Monograph and the Instructions for Use for medical devices? For example:
    • Using plainer language, avoiding terminology that would be used by professionals (refer to Appendix A for examples of technical terms and their plain language equivalents)
    • Using shorter sentences and paragraphs
    • Including more precise information, such as expressing the frequency of side effects with numbers (such as "affects 1 user in 10") instead of terms (such as "very common")
  • Effectiveness and ease of use: Is there enough information and detail provided in these product information documents? Is the information written in a way that is understandable by intended users? What suggestions would you make for improving the effectiveness and ease of use of these product information documents? For example:
    • Adding a table of contents
    • Aiming to shorten the overall length of the documents, where appropriate or possible
    • Stating headings as questions that patients might ask themselves, as is done in other countries

Further questions for discussion:

  • In the existing Part III of the Product Monograph for drugs and Instructions for Use for medical devices, what types of product information do you find to be most useful and relevant for consumers and patients?
  • Is there any information missing from these documents that you would like to see added?
  • Is there a need for changes to address the unique needs of specific patient groups, such as seniors? If so, what suggestions would you make?
  • Do you have any further suggestions or concerns regarding Part III of the Product Monograph for drugs or Instructions for Use for medical devices?

Appendix A
Examples of Technical Terms and their Plain Language Equivalents

The following is a list of some technical terms used by health professionals that laypersons may have difficulty understanding, and suggested equivalent terms in plainer language.

Examples of Technical Terms and their Plain Language Equivalents
Technical Term Suggested Plain Language Equivalent
Adverse reaction Side effect
Angina pectoris Chest pain
Arrhythmia Irregular heart beat
Arthralgia Joint pain
Cerebrovascular accident Stroke
Diplopia Double vision
Dyspepsia Indigestion
Edema Swelling
Epistaxis Nosebleed
Hypo/hypertension Low/high blood pressure
Myalgia Muscle pain
Myocardial infarction Heart attack
Paraesthesia of extremities Tingling or numbness in the hands or feet
Peripheral oedema Swelling of the ankles, feet, or fingers
Pyrexia Fever
Renal pain Kidney pain
Tachycardia Faster heart beat
Tinnitus Ringing in the ears

Appendix C: List of Participants

Invited Participants

  1. Tonino Antonetti - Roche Diagnostics (MEDEC)
  2. Louise Binder - Canadian Treatment Action Council
  3. Deb Byrnes - Canadian Literacy and Learning Network
  4. James Chauvin - Canadian Public Health Association
  5. Ray Chepesiuk - Pharmaceutical Advertising Advisory Board
  6. Bruce Cran - Consumers' Association of Canada
  7. François Decary-Gilardeau - Option consommateurs
  8. Loretta Del Bosco - Abbott Laboratories, Limited
  9. Rocelyn DelCarmen - AstraZeneca (BIOTEC)
  10. Sylvia Hyland - Institute for Safe Medication Practices Canada
  11. Effy Koukoulas - Pfizer Inc. (BIOTEC)
  12. Kathy Kovacs Burns - Best Medicines Coalition
  13. Maria Perotta - Novartis Pharmaceuticals Canada Inc.
  14. Linda Sohet - The Centre for Literacy
  15. Jill Skinner - Canadian Medical Association
  16. Klaus Stitz - Canada's Medical Devices Technology Companies (MEDEC)
  17. Kathy Vesterfelt - National Association of Pharmacy Regulatory Authorities
  18. Lousie Welbanks - Canadian Pharmacists Association
  19. Robert White - Consumer Health Products of Canada
  20. Linda Wilhelm - Canadian Arthritis Patient Alliance
  21. Durhane Wong-Reiger - Consumer Advocare Networks
  22. Dawn Culp - Canadian Generic Pharmaceutical Association
  23. Jo-Anne Soltesz - Canadian Generic Pharmaceutical Association

    Health Canada Secretariat Participants

  24. Barbara Sabourin (Chair) - Senior Executive Director, Therapeutic Products Directorate, HPFBFootnote 1
  25. Dr. Nashwa Irfan - A/Manager, Marketed Health Products Directorate, HPFB
  26. Mary Raphael - Associate/Director, Marketed Health Products Directorate, HPFB
  27. Isabelle Rousse - Scientific Evaluator, Marketed Health Products Directorate, HPFB
  28. Isabel Renart-McGowan - Manager, Therapeutic Products Directorate, HPFB
  29. Michelle Crozier - Policy Analyst, Therapeutic Products Directorate, HPFB
  30. Yen Luc - Regulatory Information Officer, Therapeutic Products Directorate, HPFB
  31. Marion Haas - Manager, Office of Paediatrics Initiatives, HPFB
  32. Holly Hutchings - Senior Analyst, Office of Legislative and Regulatory Modernization, HPFB
  33. Dhurata Ikonomi - Manager, Office of Consumer and Public Involvement, HPFB
  34. Ryan Benson - Senior Public Involvement Officer, Office of Consumer and Public Involvement, HPFB

Facilitation Team

Facilitator: Manon Abud, Ascentum, Inc.
Note-Taker: Stephan Telka, Ascentum, Inc.

Appendix D: Participant Evaluations

Participant Evaluations
Strongly Disagree Somewhat Disagree Undecided Somewhat Agree Strongly Agree No Answer
A. The process allowed for an interesting exchange between participants, where people were able to express their views and ideas. 1 15
B. The presenters effectively communicated relevant information and ideas. 1 15
C. The facilitation helped make for a productive meeting. 2 14
D. This meeting was relevant to my work and a good use of my time. 5 11
E. Overall I am pleased with the meeting and its output. 3 13

Number of Completed evaluations: 16

What are some of the features of the meeting that you particularly liked?

  • Great work! Good ideas and opportunities
  • Sample documents to use for feedback
  • Good range of participants.
  • Small groups
  • Health Canada person helps provide context and takes notes
  • Table gathering for effective interaction
  • Very interactive, good ideas. Will wait to see a new consumer/patient portion of the product monograph
  • Interaction among stakeholders
  • Multi-stakeholder
  • Examples used, rather than theoretical discussions
  • Good to meet new people
  • The different interactions, ideas that we exchanged to listen to the different issues coming from the different consumer groups as well as industry.
  • The discussions
  • New area for me - Very constructive and interesting

What are some aspects that you think could be improved?

  • Examples from jurisdictions
    • More options
  • Provinces could have been invited. Ministries of Health, including Quebec. Have a role in education on drug information.
  • Did we really need translation, was anybody using it? It should be suggested that prior to other meeting to verify with the people attending if it is needed.

Additional Comments:

  • Appreciate Health Canada continuing to consult on these important issues. Want to make sure we are on the leading edge, including use of technology. And not just doing what is already being done.
  • Very good consultation!
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