Frequently Asked Questions - Plain Language Revisions to the Product Monograph, Patient Medication Information (formerly Consumer Information)
1. What is plain language?
Plain language is a clear writing style designed to be easy to read and understand by the intended audience. It includes how information is set out on the page, using white space, fonts that are easy to read, and the 'active' instead of 'passive' voice for instructions.
For the Patient Medication Information section of the Product Monograph (PM), the targeted reading level is between Grades 6 and 8.
2. What is the connection between the new Patient Medication Information section and work on the broader Plain Language Labelling initiative?
Revisions to the Patient Medication Information section [that is (i.e.) Part III of the PM] are an example of the non-regulatory work that Health Canada is undertaking to improve Canadians' understanding of health information and to decrease medication errors. Proposed regulatory changes target the labels affixed to a variety of health products and complement the proposed changes to the Patient Medication Information.
3. Why are changes to the Patient Medication Information important?
The goal of the changes is to make drug product information clear, concise and easier to understand for Canadians. When information about drug products is unclear or confusing, there are often negative health impacts such as medication errors. Improved labelling is an important step in decreasing the number of negative health events caused by drug products.
4. What are the changes exactly?
Information for Canadians is being changed in two ways: the way the information is presented will become more streamlined and easier to read, and the language used to give the information will be simpler and more direct. Distracting elements like headers, underlining and complex type will be changed in favour of simple sentences and bulleted lists. Technical words and jargon will be replaced by common words and active phrases.
For example, revised documents will feature:
- a more descriptive title;
- shorter sentences and bulleted lists;
- some information in Question and Answer format;
- sans serif fonts to increase legibility; and
- vocabulary targeted at Grades 6-8 reading level.
5. What products does this apply to?
The new format applies to biologics and radiopharmaceuticals as well as to prescription pharmaceutical products which are being submitted for approval. The new format is being introduced in a phased approach to give industry more time to adjust to the new requirements. More details are outlined below.
6. When should the new template be used?
To provide industry with sufficient time to transition to the new format there will be a phased implementation:
Phase I: June 1, 2014 - November 30, 2015 - All New Active Substance New Drug Submissions (NAS-NDS) and Abbreviated New Drug Submissions (ANDS) and Supplements to Abbreviated New Drug Submissions (SANDS) where the innovator Product Monograph is in the 2014 Patient Medication Information format, are the only submissions required to adopt the 2014 Patient Medication Information format.
Phase I will last 18 months, ending November 30, 2015, at which time the Department will have performed an assessment of the work to confirm the direction of Phase II.
Phase II: December 1, 2015 - May 31, 2017 - The requirement to file with the new format will apply to all New Drug Submissions (NDS).
The requirement to file in the 2014 Patient Medication Information format will continue to apply to all ANDS and SANDS where the innovator PM is in the 2014 format during Phase II.
Please note that under certain circumstances, the 2014 format could be applied to drugs which may otherwise be outside of the scope described for the phased implementation. In these cases Health Canada will notify the sponsor.
7. What if my product is not included in the scope of either Phase? Can I submit my PM in the new format anyway?
The implementation plan is designed to give industry the time to update their documents and to facilitate performance targets for review of the new format in an organised and efficient manner. Each phase will be assessed to consider whether the requirements should be expanded to other submission types.
8. How do I know if my wording is suitable?
The target reading level is Grades 6 to 8 and there are tests and resources available online and in libraries which evaluate text information. The Flesch-Kincaid, Fry Graph Readability Formula and SMOG (Simple Measure of Gobbledygook) are a few health literacy tools which sponsors can use to test their revised information.
9. Are there any tools or references on plain language writing?
The Canadian Public Health Association website is a good source of information on health literacy, including plain language writing, and includes links to reference documents such as Good Medicine for Seniors: Guidelines for Plain Language and Good Design in Prescription Medication.
10. What if my PM is not in the 3 part format?
Only products within the scope indicated in the implementation notice, are affected by the revisions to the Patient Medication Information section, at this time.
11. What if my product is currently on the market?
Products which are currently available in the Canadian marketplace are not included in the revisions to Patient Medication Information at this time. Please note that under certain circumstances, the 2014 format could be applied to drugs which may otherwise be outside of the scope described for the phased implementation. This may include products that are currently available in the Canadian marketplace.
12. What if I am in the submission queue on the implementation date?
Products which are under review but do not have a decision at the implementation date are exempt from the revisions to the Patient Medication Information section.
13. Does the 2014 format apply to administrative submissions?
PMs filed with administrative submissions should match the format of the referenced PM.
14. Why has the rest of the PM not been changed?
The remaining sections of the Guidance to Industry: Product Monograph (Part I: Health Professional Information and Part II: Scientific Information) will be revised in the near future. A broad consultation will take place prior to implementing any changes. Although the audience for these sections is health professionals, plain language revisions are still appropriate but may be applied differently from those intended for the general public.
15. Where can I get more information about the Product Monograph?
Questions regarding the guidance document should be directed to:
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locater 3102C5
Questions regarding submissions should be directed to the Office of Submissions and Intellectual Property via email at OSIP-BPPI@hc-sc.gc.ca.
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