Canadian Pharmacists Association
Canadian Pharmacists Association

Editorial Policy

About Monographs

General
CPS (CPS: Drug Information/CPS: Full Access) contains information on proprietary and nonproprietary products intended for human use. Product monographs are listed by brand names. The brand names are the registered trademarks of the companies whose names, in full or abbreviated form, immediately follow the trademark.

CPS is not comprehensive of all drug products available in Canada. The editorial staff at CPhA format monographs that have been submitted by the manufacturer for inclusion in CPS. The inclusion of a manufacturer’s product monograph in CPS does not imply that the editors or the CPhA Editorial Advisory Committee accept, endorse or recommend these preparations as being clinically superior to similar products of any other manufacturer.

Great care has been taken to ensure the accuracy and completeness of the information contained in CPS. However, the editors and publisher are not responsible for errors or any consequences arising from the use of the information published herein.

Users are advised that the information provided in CPS is not exhaustive. Other sources may contain additional necessary information on safe use of drug products.

Product Monographs
CPS contains product monographs prepared by pharmaceutical manufacturers and approved by the Therapeutic Products Directorate (TPD), Health Canada. Natural Health Products have been approved by the Natural and Non-prescription Health Products Directorate, Health Canada, and bear the NHP logo . Also included are Health Canada–approved medical devices that are available for use in Canada and bear the medical device logo . Product information as published in CPS is a direct equivalent of the prescribing information contained in Part I of the Health Canada–approved monograph. References to Part II (Scientific Information) have been omitted since this section is not published in CPS. A disclaimer appears in the monograph if the product contains both marketed and nonmarketed product information. The disclaimer specifies which products are marketed in Canada at time of publication. Monographs appear in varying formats, reflecting changes to Health Canada’s standard monograph template that periodically occur. Editorial changes are limited to those required for consistency of style, clarity and presentation.

Product monographs approved by TPD, Health Canada, for products containing the same therapeutic ingredient(s) may differ in their indications, contraindications, warnings, precautions, adverse reactions, dosing regimens and constituents. Users are encouraged to consult the specific product monograph to ensure accurate information.

Product monographs contain listings of nonmedicinal ingredients. A statement may appear in the Supplied or Dosage Forms, Strengths, Composition and Packaging sections indicating the presence or absence of a specific nonmedicinal ingredient in the product. Lack of inclusion of an ingredient in these sections is not conclusive evidence that it is not currently contained in the product. Users are urged to consult the product monograph of the specific product. See also Packaging section, Clin-Info topics and Ingredients of Concern in Pharmaceuticals for further discussion on this topic. Contacting the manufacturer is recommended to ensure direct confirmation of the most current ingredient information.

Some monographs contain boxed text indicating that the product has been approved under the Notice of Compliance with Conditions (NOC/c) policy of Health Canada. NOC/c is a form of market approval granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Products approved under this policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical need in Canada or have demonstrated a significant improvement in the benefit/risk profile over existing therapies. Health Canada has provided access to these products on the condition that sponsors carry out additional clinical trials to verify the anticipated benefit within an approved time frame.

These product monographs contain boxed text at the beginning of each major section clearly stating the nature of the market authorization. Sections for which NOC/c status holds particular significance are identified by the symbol NOC/c.

CPhA requests that manufacturers submit the most recent version of the product monograph for publication in CPS.

Patient Medication Information
Patient Medication Information monographs (Part III of the Health Canada–approved monograph) is provided for health-care professionals to use in keeping their patients informed and are intended to be used separately as information for the patient. They contain information, in lay language, that is required by the patient for safe and effective use of the drug. Health-care professionals may wish to supplement the advice given within these sections on an individual basis, as necessary.

Although CPhA maintains copyright on this information, we grant permission to print and distribute individual files for the purpose of providing information to patients.

CPhA Monographs
CPhA monographs bearing the CPhA logo are developed by CPhA editorial staff. CPhA monographs are an important source of prescribing information that may not otherwise appear in CPS. They are based on the best available evidence and reviewed by expert physicians and pharmacists. Readers should be aware that the text may contain information different from that found in Health Canada–approved product monographs. The phrase "Uses Without Health Canada Approval" refers to indications not approved by Health Canada. The phrase "Use or Purpose" replaces "Indications" for natural health products, as defined by Health Canada’s Licensed Natural Health Product Database.

Health Canada Advisories
Health Canada provides timely information on issues that concern the health of Canadians and posts Advisories, Warnings and Recalls (Advisories). CPhA assigns these links to Advisories in CPS. Advisories posted in CPS are provided for convenience only; CPhA does not warrant their accuracy or completeness nor does it warrant that all Advisories are posted in CPS. CPS is not a comprehensive, up-to-date source of Advisories, and the prescribing or dispensing professional should check with Health Canada to determine whether a particular medication is the subject of an Advisory. In the case of drug interaction Advisories, CPhA does not post the Advisory on the pages of all medications implicated by an Advisory, but only to the pages of medications that Health Canada makes the subject of the Advisory. CPhA retains the Advisories in CPS for a period of 4 years.

For Past Advisories, Warnings and Recalls, please consult https://recalls-rappels.canada.ca/en.

About Therapeutic Content

Content in CPS pertaining to clinical treatment of health conditions is written with input from expert health professionals and is based on the best available evidence. CPhA employs a rigorous peer review process to ensure the information is accurate and unbiased. Content is extensively reviewed and validated by CPhA's Clinical and Scientific Editors and by at least 2 reviewers (physicians, pharmacists and other health-care professionals) who are recognized experts in their relevant clinical area.

CPhA asks authors and reviewers to disclose any potential conflicts of interest. CPhA does not accept funding from pharmaceutical manufacturers for any content that it develops.

Clin-Info
Clin-Info provides quick-reference clinical information and practice tools for health-care practitioners. This information is not intended to present a comprehensive review; the reader is therefore encouraged to seek additional and confirmatory information.

Description and Limitations of Information
While based on the best available evidence, CPS also contains selected information representing the opinions and experience of individual authors, particularly if evidence is limited. The authors, editors and publisher have made every attempt to ensure the accuracy of the information at the time of printing. Readers should be aware that the text may contain information, statements and drug dosages that differ from those approved by Health Canada. Readers are advised that the information presented in this text is not intended to be all-inclusive. Consequently, health-care practitioners are encouraged to seek additional and confirmatory information to meet their practice requirements and standards as well as the information needs of the patient.

Erratum Policy

In spite of the rigorous review process, should a major error occur, it will be corrected immediately in CPS and posted at www.pharmacists.ca/errata.

Commitment to Diversity

CPhA recognizes that available evidence is often based on study populations that may not be representative of the entire Canadian population. Data used often excludes Black, Indigenous and People of Colour (BIPOC), the 2SLGBTQI+ community and other misrepresented/underrepresented/vulnerable groups. CPhA is committed to improving the information provided in CPS to better include all populations and to identify areas where the applicability of the data is limited. New information and topics are developed and added as needed to address systemic biases in the health-care system and medical literature.
CPhA is committed to adapting the language used in therapeutic content to be more inclusive of all people. Where this is not possible due to limitations of the available evidence, a disclaimer has been applied to the content. Users are referred to CPhA’s Language Policy for Inclusion for more details.

CPhA Language Policy for Inclusion
CPhA understands that words matter and can help or harm patients. CPhA’s Diversity and Inclusion Working Group makes editorial changes to content in the areas of both race and gender to ensure bias is either eliminated or to clearly state where it is not possible to due to inherent bias in the medical literature. CPhA strives to drive change in the areas of diversity and inclusion in the profession and within the health-care field.

Race
CPhA openly embraces the multitude of identities that make up Canadian society and understands that race and identity are social constructs. This has led to changes in content to move away from race-based medicine (characterizing race as an essential, biological variable) and toward race-conscious medicine (being aware of differences and questioning factors that may be involved). Rather than stating discrepancies in race as a medical fact, CPhA’s clinical editors question whether the discrepancy may stem from other factors like systemic racism. Language has been removed that might imply hierarchy, like non-White, and terms such as racialized, underrepresented and marginalized have replaced outdated terms such as minorities.

CPhA continues to question the need for outdated race-based algorithms and calculators. Such corrections may lead to poorer outcomes and have the potential to harm through delayed diagnosis.

CPhA works with authors to remove implicit bias and race-based claims that can’t be substantiated. As much as possible, content in CPS states when racial disparities are social/structural in nature or may be genetic/biological. Descriptive identifiers are used only if evidence exists that is relevant to screening, testing, decision-making and/or treatment.

CPhA ensures that descriptions of conditions reflect presentation in all skin tones and has secured images that represent a variety of patients. CPhA recognizes that images in CPS do not represent all skin tones and continues to work to secure a wider collection of images to better represent the population of Canada. Outdated language related to colour, such as red man syndrome (now vancomycin flushing syndrome) and erythema (now inflammation), have been removed from CPS.

Gender & Sexual Orientation

CPhA strives to provide guidance for health-care professionals on the appropriate care of all individuals. Through working with and learning from external consultants knowledgeable in their respective fields, CPhA’s clinical editors have updated terms in CPS that imply binaries, heterosexuality and monogamy and have revised terminology to avoid generalizations and avoid implicit bias.

CPhA recognizes that because of the diversity in our population, gender labels must be eliminated. Instead, terms that focus on roles, such as gestational parent or nonbirthing parent, are used. CPS uses patient-first language, putting patients first without making assumptions about gender––pregnant patients, people who need abortions.

CPhA understands that clinical studies within health care don’t represent or include all people. For this reason, disclaimers have been added to many chapters in CPS where, for accuracy, wording remains consistent with that of the original studies, and readers are pointed toward external resources to learn more about diverse patient populations.

About the Canadian Pharmacists Association

The Canadian Pharmacists Association (CPhA) is the voice for Canadian pharmacists.

Read more about CPhA’s mission, vision and strategic plan: www.pharmacists.ca/about-cpha.

CPS is Canada’s primary source of prescription and nonprescription drug and therapeutic information for pharmacists, physicians, nurses and other health-care practitioners.