Disease-associated maternal and/or fetal risk. Avoid subjective terms (e.g., well-tolerated) since they are non-specific, promotional and/or poorly defined. Certain subsections not applicable to a specific drug product may be deleted. Information should only be presented once, either in narrative or table format. Adverse reactions expected in the infant should be provided and suggested measures to avoid high level exposure to the infant should be presented. It identifies the information to be provided if a package insert is included with a new drug product. The term refers to the label claims for quality and potency. Specify the recommended storage conditions for each dosage form. Presentation: table format. Psychotherapy - Mayo Clinic Information on the solubility of the drug substance in e.g. Cross-referencing to 4 DOSAGE AND ADMINISTRATION may be required when the timing of food consumption with respect to drug administration could avoid or worsen the interaction. However, in cases where the presence of overfill is obvious (e.g., when reconstituting or handling the product), it may be mentioned qualitatively in the relevant section. Health literacy levels in Canada vary significantly among regions and demographically. As with all therapeutic proteins, there is a potential for immunogenicity. In exceptional situations in which optimal ECG data might be lacking, a statement should be included noting this deficiency or describing the best available alternative data. The following or similar statement should be included: A packaged drug product may remain in the distribution chain for some time after manufacture, depending on the expiry date and turnover at the retail level. Guidelines for Medical Record Documentation Consistent, current and complete documentation in the medical record is an essential component of quality patient care. Presentation: table and narrative (see template). Guidance Document: Part C, Division 5 of the Food and Drug Regulations For products that have received an NOC and are marketed, the product monograph must be available in both official languages. For a therapeutic radiopharmaceutical, relating the biologic behaviour of the drug- perhaps an affinity for skeletal tissue- with the desired outcome (e.g., palliation of pain) can be helpful. a qualitative, alphabetical listing of all non-medicinal ingredients. The following boxed statement is to be added at the end of the narrative section. Code of Ethics | College of Massage Therapists of British Columbia When necessary, special instructions should be included for the decontamination and safe disposal of drugs and associated material (e.g., appropriate shielding of radioactive products, use of personal protective equipment (PPE), toilet should be flushed several times after use, etc.). Information to be added to the product monograph by the sponsor is also indicated within square brackets []. If blood or urine gets onto clothing such clothing should be washed separately or stored for 1 to 2 weeks to allow for decay. Further and more detailed information (e.g., pH, particle size) should appear in 13 PHARMACEUTICAL INFORMATION. Summarise the adverse reaction information that would be most useful to the health professional that may affect prescribing decisions or would be useful in observing, monitoring or advising care providers and/or patients. PHI includes health information in any form that contains patient-identifiable information 3. For health care professionals: Cannabis and cannabinoids - Canada.ca For biosimilars, comparative pharmacokinetic/pharmacodynamic (PK/PD) data from the biosimilar program should not be presented in this section. Use active (rather than passive) voice. The sponsor may add a statement similar to the following: This information is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer. Information on dosage and duration of therapy linked to adverse reactions. Empty stomach, 1 hour before or 2 hours after meals; Before meals, usually 15 to 30 minutes before meals; Empty stomach preferably, may be taken with food if gastric upset occurs; With or without food, may be given without regard to meals; a description of the acute and/or long-term signs and symptoms of overdose. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about [Brand name]. When a potential drug class interaction is considered clinically relevant, representative drugs from that class should be added to the drug interactions table. Reasonable and Necessary . Any known incompatibilities should be stated, including incompatibilities between drugs, diluents or infusion fluids, primary packaging, or administration sets, or with any other material with which the drug may come into contact. For biosimilars only, otherwise delete this subheading, as well as 16.1.1 Comparative Non-Clinical Pharmacodynamics and 16.1.2. If the mechanism of action in relation to the therapeutic effects is unknown, this should be stated. This section should describe absolute contraindications, meaning those situations in which the drug should not be used because the risk outweighs any potential therapeutic benefit. For example: [Proper name] is contraindicated with co-administration of [Drug X] as it may result in increased concentrations of [Drug X] due to inhibition of CYP3A, which may lead to QT interval prolongation and torsades de pointes. If there are no serious warnings or precautions, this box is omitted, along with the heading 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. PDF Expectations for Registered Nurses - CRNNL The narrative should incorporate the identities of the compared products. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. February 17, 2005. assigned in any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c) (Ref: C.01.001. This subsection should highlight the following: To provide a common understanding when interpreting adverse reaction data from all clinical trials, the following or similar introductory statement should be used: Clinical trials are conducted under very specific conditions. Directions for reconstitution should include the volume and type of diluents to be added and the approximate volume and concentration of the resulting product. A biosimilar relies in part on prior information regarding safety, efficacy and effectiveness that is deemed relevant due to the demonstration of similarity to the reference biologic drug and which influences the amount and type of original data required. It is essential that the user follows the directions carefully and adheres to strict aseptic technique. For example, if the clinical trials only included children from 6-12 years of age, this age range should be indicated. Where applicable, human photosensitivity (photoallergic or phototoxic) reactions should be included. In cases where a drug does not demonstrate reproductive and/or developmental toxicities, or the reproductive potential has not been fully evaluated, this should be stated. Adverse Drug Reaction: a noxious and unintended response to a drug which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function (Ref: C.01.001, Food and Drug Regulations). It is often used when finding an average for numbers presented as percentages. For example, "4.8 Radiation Dosimetry" may be deleted if the product is not a radiopharmaceutical. Tumour findings considered relevant to the safe use of the drug should be briefly described in 7 WARNINGS AND PRECAUTIONS, with a cross-reference to the information provided here. For biosimilars include the following or similar statement for comparative trials: Clinical studies conducted to support similarity between [Biosimilar brand name] and the reference biologic drug included: [text] [Provide a general description of study 1, for example, a randomized comparative bioavailability study performed in healthy volunteers. 4. When there is a boxed statement in any section of Part I or II, a corresponding boxed statement, in plain language, should appear in the relevant section of the Patient Medication Information. When the genotype of the patient or that of an infectious agent will affect the treatment outcome, relevant information should also be included in this section. Include comparative bioavailability studies, as required, for revised formulation and new dosage forms. Flexibility will be exercised in those situations where a smaller font may be necessary due to packaging constraints or printing limitations. In the absence of human data, pertinent animal data should be included (e.g., adverse reactions, concentration detected in the milk plasma ratio) and the following or similar statement should be used: It is unknown if [Brand name] [product] is excreted in human milk. Drug class statements should appear here if the interaction has not yet been documented but would be clinically relevant. The following or similar statements should be included: The contents of this kit are intended for use in the preparation of and are not to be directly administered to the patient. Self-limiting side effects should be described in narrative format. In describing the drug's actions, pharmacology, and toxicology, the proper name (or common name, where there is no proper name) in final dosage form should be used. For biologics, this section should confirm if long-term studies have been done to evaluate immunogenicity. Whether the patient can do something about the effect should be used as the criteria for including side effects in the table. This document is a summary of peer-reviewed literature and international reviews concerning potential therapeutic uses and harmful effects of cannabis and cannabinoids. For anti-infective drugs, a brief description of the action of the drug against microorganisms or enzyme systems involved in replication should be included. It is also intended to be used in place of singular terms such as: healthcare provider, healthcare practitioner, etcetera (etc.). Study results that demonstrate a drug's genotoxic potential should be described. Where different dosage forms are available, if the dosages are not equivalent the conversion value should be stated (e.g., changing from intravenous to oral therapy where a ratio other than 1:1 exists). Include established radiation dose estimates absorbed by organs/tissues of an average adult human after the administration of the recommended amount (activity) of the radiopharmaceutical. For parenteral drugs requiring reconstitution or dilution before use, the relevant information should be presented in a table under subheadings of the recommended routes of administration. potential sequelae/complications which may occur with the drug e.g. In this document, the term plan of care may refer to treatment plan, care plan, care map, service plan, case management, mental health assessment plan, resident assessment forms, or other terms organizations use. Include information that does not fall under the subheadings listed below. The following or similar statement should be included for all drugs: Read this carefully before you start taking [Brand name] and each time you get a refill. When a Recent Major Label Change has been removed, a sponsor may choose to keep it listed until a subsequent submission is filed. All clinically relevant drug-drug interactions (including those only supported by animal or in vitro studies) should be presented. the proper or common name of the drug product(s) in final dosage form. Studies briefly described here may include photosafety, immunotoxicity, abuse liability, combination drug toxicity, etc. For radiopharmaceuticals, the following or similar statement should be used: [product] will be given to you by a healthcare professional who is experienced in the use of radiopharmaceuticals. Include clinically significant information about all effects that may pose a hazard to the patient, as well as precautions to be exercised by the health professional, care provider, or by the patient to promote safe and effective use of the drug. It is beyond the scope of the product monograph to provide information on the disease targeted by the authorized indications. ], "For the following indication(s) [Brand name] has been approved without conditions. An accompanying statement should explain that warnings applicable to adults are also relevant to pediatric use. The record should minimally indicate the plan or direction that the therapy is intended to take and should log the client's initial and subsequent consent (s) as necessary. For biosimilars, include toxicology information that appears in the reference biologic drug product monograph. A group of Pts for which a particular physician is providing care Hospital practice A group of medical practitioners who have clinical privileges in a specific area of medicine, surgery, obstetrics, pediatrics, or other. Suggested standard statements are provided for sponsors to use in the preparation of the product monograph. It establishes the limitations/parameters for all advertising, representations, and promotional or information material distributed or otherwise endorsed by the sponsor. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. Comparative Toxicology. This subsection should include details concerning the methods of administration, particularly for parenteral products or for other unique formulations such as inhalation devices, implants, and transdermal formulations. All 5 associated templates, Formatting and administrative changes throughout guidance document, Instruction added related to Notifiable Change submissions
This information is not available for this drug product. Common Adverse Drug Reaction: an adverse drug reaction with a frequency of 1/100 and <1/10 (1% and <10%). The potential for serious adverse reactions or tumourgenicity should be clearly stated. In cases where this may not be easily understood or predictable, a statement may be added to help the patient understand what course of action they should take. If a statement does not fit a particular product, the sponsor may amend it. The product monograph should also include: contraindications, dosage and administration, symptoms and treatment of overdosage, dosage forms, warnings, precautions, adverse reactions, drug interactions, effects on laboratory tests, storage and stability, special handling instructions, pharmaceutical information, information on clinical trials, microbiology, toxicology, and information for the patient. It also is known as talk therapy, counseling, psychosocial therapy or, simply, therapy. See the Glossary section for more detailed definitions. Jared's notes are tools that can benefit his work and any other clinician involved in the client's care. Findings considered relevant to the safe use of the drug should be briefly described in 7 WARNINGS AND PRECAUTIONS, with a cross-reference to the information provided here. For example, individuals who for genetic reasons, are either "fast" or "slow" metabolizers. The frequency of monitoring before, during and after therapy should be included. In addition the Patient Medication Information may also be provided as part of the package insert for a drug product. Biosimilar data should be presented in Part II: Scientific Information, 14 CLINICAL TRIALS. This information should be presented in narrative format. Instructions that may be useful in preparing the product monograph are contained within square brackets [] in the Microsoft Wordtemplate. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective. Issued also in French under title: Rapport annuel du rendement des prsentations de drogue. For radiopharmaceutical use during pregnancy, the following or similar statement should be included: Ideally, examinations using radiopharmaceuticals, especially those elective in nature of women of childbearing capability, should be performed during the first ten days following the onset of menses, or after ensuring the woman is not pregnant. The statement may be modified to provide the most appropriate advice according to current standards of care for this drug product: If you think you, or a person you are caring for, have taken too much [Brand name], contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. Proper Name: with reference to a drug, the name in English or French: Rare Adverse Drug Reaction: an adverse drug reaction with a frequency of 1/10,000 and <1/1,000 (0.01% and <0.1%) (Ref: CIOMS convention). For more information visit, Non-prescription Drug Action Plan. Pediatrics (age range): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. Include information related to Pregnancy Registries. To avoid duplication they do not need to be repeated in the text. Effects on mechanistically important biomarkers should be included. Additional information may be found in Health Canada's Guidance Document: Labelling of Pharmaceutical Drugs for Human Use. The Medical Devices Regulations specify different requirements for products that pose different risks, ranging from lowest (i.e., Class I) to highest risk (i.e., Class IV). Refrain from any involvement, direct or indirect, in fraudulent billing activities. [1][2][3] The Subjective, Objective, Assessment and Plan (SOAP) note is an acronym representing a widely used method of documentation for healthcare providers. Interactions with herbal products have not been established. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Briefly list safety issues to consider when developing a dosage regimen in an individual patient (e.g., renal or hepatic disease, age, concomitant therapy, genetic polymorphism, titration, changing from intravenous to oral therapy, lab values prior to infusion, rule out pregnancy prior to administration, pre-medication is required, duration of effect, imaging time post-injection). The Patient Medication Information section is a plain language translation of information contained in Parts I and II of the product monograph. frequency exceeds that of placebo or control; time relationship and evidence of de-challenge or re-challenge; consistency with pharmacology of the drug; serious events including those rarely seen and that occur generally in association with drug therapy. ), hospital] or method of administration (e.g., by a third party). Illustrations that help demonstrate the proper use of a self-administered product (e.g, inhaler, injectable products) are encouraged. For example, subjects or patients deficient in a specific enzyme may experience a different rate or severity of adverse reactions. Photoallergic: a delayed immunologic type of photosensitivity involving a chemical substance to which the individual has become previously sensitized and radiant energy (Ref: Dorlands). All serious side effects should be included in the table. Drug submission performance annual report. For example: When a new indication is authorized with the filing of an SNDS or SANDS, new information is often added to other sections of the PM, such as Dosage and Administration, Adverse Reactions, and Clinical Trials in addition to the Indications section. For biosimilars, Part I should be completed by importing information from the reference biologic drug's product monograph pertaining to indications to be authorized for the biosimilar. For each study described, and where applicable, the species, route of administration, dosage regimen (e.g., dose levels, frequency of administration, duration of dosing, formulation), relevant findings, the No Observed (Adverse) Effect Level and/or Lowest Observed (Adverse) Effect Level, and calculated margins of exposure should be provided. Plan for therapy The plan for therapy will depend on particular circumstances including the therapeutic approach or model used. As with other radiopharmaceuticals which distribute intracellularly, there may be increased risk of chromosome damage from Auger electrons if nuclear uptake occurs. A draft copy of the proposed or revised product monograph should be included in the master volume when a New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Abbreviated New Drug Submission (ANDS) or Supplement to an Abbreviated New Drug Submission (SANDS) is filed for either a prescription or nonprescription drug. (Ref: ICH - Clinical Safety Data Management: Definitions and Standards For Expedited Reporting E2A). Potential interactions should be presented in the Overview subsection. Additional style instructions are provided within the Patient Medication Information. A biosimilar is authorized based on its similarity to a reference biologic drug that was already authorized for sale. Include pharmacokinetic information that is relevant to special populations [e.g., pediatrics, geriatrics, sex, pregnancy and breast-feeding (placental transfer and secretion into milk), genetic polymorphism, ethnic origin] and certain conditions (e.g., hepatic insufficiency, renal insufficiency, obesity). This subsection applies specifically to vaccines and should describe the duration of effect of the recommended dose (e.g., duration of detectable levels of antibodies and/or conferred immunity status). The product monograph serves as a standard against which all promotional material, or advertising distributed or endorsed by the sponsor about the drug can be compared. Information on drug resistance and cross-resistance should be included. 2. Within each group the effects should be listed alphabetically. [Include cross-reference to relevant sections.]. Notice of Compliance: a notice issued under section C.08.004 of the Food and Drug Regulations. The Patient Medication Information section should not be promotional in tone or content.
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