Our Documents

The Drug Formulary documents are evidence-informed. Healthcare providers can find drug monographs, regimens, side effect and symptom management information. Patients and their families can learn about cancer drugs, their use and how to manage side effects.

The purpose of drug monographs is to provide information to healthcare professionals on the use and administration of cancer drugs and related supportive therapies. The monographs are designed as general references and are not intended to replace the prescribing information or physician recommendations.

Types of Information Within a Monograph

All monographs have a similar structure. The information they contain is organized into sections as outlined in the following chart.

SECTION	INFORMATION INCLUDED
Drug Name	Generic drug name, as listed in Health Canada’s Drug Product Database Will list the first available trade name Refer to the Health Canada Drug Product Database for other formulations
Mechanism of Action and Pharmacokinetics (How the Drug Works)	Absorption Distribution Metabolism Elimination
Indication and Status	Indications approved or conditionally approved by Health Canada "Other uses" as per Systemic Treatment Quality-Based Procedures (ST-QBP) evidence informed regimens
Adverse Effects	Emetogenic risk Extravasation potential (if applicable) The adverse effects section describes only selected adverse effects and are not intended to provide a complete description of all expected adverse effects, nor the most severe or important ones. Always consult the product monograph for complete descriptions. Some adverse effect terms in the table are used to summarize multiple different events (for example, arterial thromboembolism may refer to transient ischemic attacks (TIAs), cerebrovascular accidents (CVAs), arterial thrombosis or occlusion, ischemic heart disease or myocardial infarction). Severe or life-threatening effects reported from clinical trials or from post-marketing experience may also be included. Some adverse events reported may be related to other drugs given at the same time, or to the cancer itself. Incidences are described (based on product monograph, single-agent adjuvant placebo-controlled randomized clinical trials are used where available, or other pivotal trials) Definitions for onset (immediate, early, delayed or late) Immediate: During the infusion or immediately after the dose Early: On treatment (after first dose; days to weeks) Delayed: cumulative toxicity by dose or time, such as renal or cardiotoxicity Late: Long after treatment ends (e.g. leukemia) Additional description of unusual or severe adverse effects Further information can be obtained from the corresponding symptom management tools or information.
Dosing	The dosing and dose modifications described here relate to single-agent use only. For information on combination use, refer to the related regimen monographs. Dosage with Toxicity section: Health Canada approved dosing or other evidence-informed dosing for toxic effects. Dose modifications for drug induced toxic effects on the liver or kidney are addressed here. Toxicity is graded using The Common Terminology Criteria for Adverse Events (CTCAE) Dose modifications for hepatic and renal impairment: This section refers to dose modifications that may be required due to hepatic or renal impairment, which may impact metabolism/clearance of the drug and thus increase exposure (and potentially increase toxicity). Dosage in elderly, children, ethnicity (if applicable)
Administration Guidelines	How the drug is prepared, administered and stored.
Special Precautions	Considerations for patient selection, e.g., contraindications, warnings/precautions, pregnancy and lactation, and other drug properties.
Interactions	Lists the agent involved, effect, mechanism and management (where available).
Recommended and Suggested Clinical Monitoring	Recommended and suggested clinical monitoring are based on Health Canada recommendations, evidence, common practice, likelihood of toxicity and magnitude of patient risk. Recommended monitoring should be done, while suggested monitoring could be followed. Toxicity is graded using The Common Terminology Criteria for Adverse Events (CTCAE).
Supplementary Public Funding	Sources of public funding in Ontario (e.g. NDFP, EAP)
References	List of materials used to prepare this document (e.g. product monograph, clinical trials)

Additions and Updates to Monographs

A new drug monograph is added after a drug is approved by Health Canada (either conditional or regular approval).

The Drug Formulary Team revises and updates existing monographs on an ongoing basis. Although we strive to ensure that the information is as accurate and up-to-date as possible, you should always refer to the product monograph, and to other resources such as Health Canada's or manufacturers’ websites for the latest drug monograph information as well as health advisories and warnings.

Evidence-informed regimen monographs provide information on regimens that are recommended by Cancer Care Ontario’s Systemic Treatment Quality-Based Procedures (ST-QBP) and refer to eligibility criteria for public drug funding, where applicable.

Evidence-informed Regimen Category

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.

Regimen Taxonomy

This taxonomy helps establish standard terms and language for regimens to improve consistency, patient safety, data quality and standardization of practice.

Additions and Updates to Regimens

A new regimen abstract (at minimum) is added once a regimen is approved by the ST-QBP as evidence-informed.

The regimen abstract is an abbreviated version of a Regimen Monograph and contains top level information on usage, dosing, schedule, cycle length and special notes (if available). The maximum number of cycles and indications for use will be indicated where possible. Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be posted on the CCO website for each ST-QBP regimen as they are developed.

The Drug Formulary Team revises and updates existing monographs on an ongoing basis. Although we strive to ensure that the information is as accurate and up-to-date as possible, you should always refer to the product monograph, and to other resources such as Health Canada’s or manufacturers’ websites for the latest drug monograph information, as well as health advisories and warnings.

Supplementary Public Funding Information

Supplementary public funding, if available, is described in section A of the regimen monograph under the heading, “Supplementary Public Funding”. Public funding is for the drug costs of those patients who meet the eligibility criteria for the specific approved drugs. Public funding status is based on publicly available information from the New Drug Funding Program or Ontario Public Drug Programs (i.e., Ontario Drug Benefit Program, Exceptional Access Program) websites.

Pharmacy and Nursing Workload Information

The workload information was determined through discussions with both nursing and pharmacy groups. Each workload value is presented as an average time per visit (in minutes).

Pharmacy workload considers time involved in:

reviewing and verifying order
order entry and/or documentation into pharmacy computer system and/or generating and checking labels
gathering drugs, equipment, and supplies for preparation
hood cleaning
drug reconstitution and preparation
preparation of supportive care drugs
labelling and packaging of the prepared drugs
checking the final product

Nursing workload considers time involved in:

VAD access/IV start and disconnect
preparation time
patient education (in treatment unit)
documentation
toxicity assessment and symptom management
antiemetics, premedications or additional medications
nursing time required for regimen delivery
hydration
observation post-treatment
average reaction
bring-in and turnaround
infection control practices
multitask adjuster

Use of Generic Drug Names in Regimens

Drugs are referred to by their generic names where possible. Trade names and manufacturers are noted where applicable. For ease of use and consistency, we have used some common acronyms for multi-drug regimens, even though an acronym may refer to the trade name of one or more drugs.

e.g., CAF refers to Cyclophosphamide, ADRIAMYCIN® (Doxorubicin), Fluorouracil

In these cases, we list the drug's generic name (instead of the trade name) next to the acronym.

Use of trade names does not constitute endorsement by the Drug Formulary of any particular brand of drug in circumstance where multiple generic equivalents are available.

These documents supplement cancer drug and regimen information and/or provide drug safety and advice to healthcare providers. Some documents are appendices with supplemental info while others are stand-alone recommendations (e.g., antiemetic guidelines).

Drug Therapy Information

Patient Information sheets:

Patients can learn more about specific cancer drugs using our patient information sheets. These provide information about cancer drug therapies, including what they are used for and how to manage side effects.

Info Sheets Support the Doctor’s Advice

The patient information sheets are meant to be used as an extra information source and not in place of advice from doctors and other healthcare providers. They should be provided along with spoken instructions from a healthcare professional. Some of the information in the sheets may not apply specifically to you, since cancer treatments are often very specific to one person.

To contact the Drug Formulary Team, please email drugformulary@cancercare.on.ca.

Disclaimer

The information contained herein is intended to be for informational purposes only. It is not intended to constitute medical advice and should not be relied upon in any such regard. Cancer Care Ontario does not recommend or endorse the use of any drug or treatment method described in any of the documents. Anyone using the information does so at his or her risk. Any use of the information is subject, at all times, to Cancer Care Ontario’s Terms and Conditions.