what information is documented in a therapeutic service report?what information is documented in a therapeutic service report?

a basis for decisions regarding patient care, an efficient and effective way information can be authorized and serves as a legal document what is the meaning of the acronym HIPPA? A brief statement about the potential mechanism of the potential interaction should be presented. Serious (e.g., life-threatening) interactions should be included in a brief boxed statement, with a cross-reference to detailed information in 9.4 Drug-Drug Interactions. Use aseptic technique and wear waterproof gloves throughout the entire preparation procedure. It is also intended to serve as a guide for healthcare professionals to easily identify the information needed for counselling patients. Each product monograph will consist of three distinct parts: Contains information required for the safe and appropriate prescribing, dispensing and administering of the drug product. For biosimilars, information should be based on the Canadian Patient Medication Information for the reference biologic drug. When a Recent Major Label Change has been removed, a sponsor may choose to keep it listed until a subsequent submission is filed. This would include interactions suspected based on the pharmacokinetic or pharmacological profile of the drug (e.g., cytochrome P450 interactions, QT interval prolongation potential, genetic polymorphism). The following or similar statements may be included: Comparing the incidences of antibodies between studies or between products may be misleading due to differences in the types, sensitivities and/or specificities of the assays employed. The term geriatric generally pertains to persons over 65 years of age but it is recognized that this may not apply to all products, therefore the Geriatrics subtitle should include the age upon which the geriatric recommendation is based. 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. From the 4 DOSAGE AND ADMINISTRATION section, provide the usual dose, when to take it, how to take it, and other related details. These brackets are to be removed by the sponsor during preparation. The origin of active substance should be defined, including the nature of any cellular systems used for production, including the use of recombinant DNA technology as appropriate (for example, produced in chick-embryo cells) Footnote 2. Serious or significant interactions should be listed in bullet form from the information listed in 9.1 Serious Drug Interactions. In the absence of a Health Canada authorized pediatric indication, this subsection should repeat that the product is not indicated in the pediatric population, and the following statement should be used: Pediatrics (age range): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of [Brand name] in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. Only information relating to clinical studies that directly supports the Health Canada authorized indication(s) should be included in 14 CLINICAL TRIALS. Where there is no proper name, use the common name in final dosage form. ", [Provide a bullet listing of the indications from Part I. A person with normal vision, or those with corrective glasses that restore normal vision, should be able to read the information without straining. for non-inferiority and equivalence studies, the selection of the comparability margin should be clearly justified. Where data is limited, the information may be better presented in narrative format. o Patient Medication Information - Sans Serif type fonts (e.g., Calibri 12 point); Patient Medication Information leaflet - Sans Serif type fonts (such as Arial or Calibri) are recommended, text - 10 point and tables - 9 point. The content of the additional tables should be limited to only those adverse reactions for which there were meaningful differences in rates. The regulatory requirements set out for Class I devices are much less rigorous than those that apply to Class IV. The strength of a medicinal product should be relevant for its identification and use and should be consistent with the quantity stated in the quantitative composition and in the dosage. Tabulated results should include footnotes describing any statistical method used and any applied acceptance criteria (i.e., the "equivalence margin"). The recommended storage period and conditions for each preparation, including after reconstitution, should be stated (include cross-reference to 11 STORAGE, STABILITY AND DISPOSAL). The table should list the proper (or common) name of the drugs, the source of evidence for the interaction (e.g., case study, clinical trial or theoretical), the effect and a clinical comment. This information should be presented in narrative format. ICH Guidance On Nonclinical Safety Studies For The Conduct Of Human Clinical Trials And Marketing Authorization For Pharmaceuticals, M3(R2), June 11, 2009. Brand name (dosage form, strength), submission control number, Product Monograph, Sponsor. MedDRA should be used as the preferred terminology to describe adverse reactions. Recognizing that there are different audiences for this information, for consistency, the Patient Medication Information section should be written as if it will be read by an individual who will use, or be administered the drug. A product monograph should include appropriate information respecting the name of the drug, its therapeutic or pharmacologic classification, its actions and/or clinical pharmacology, and its indications. A product monograph should be prepared with the following guiding principles as a basis for the information: A product monograph should be prepared in the same software format as the other submission documents. If the volume warrants, the information should be presented in a table using the same format as Clinical Trial Adverse Reactions. Revisions to the product monograph must be in compliance with the Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document, the Post-Notice of Compliance (NOC) Changes - Quality Guidance, and the Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs document. General inquiries may be directed to hc.rpmd-dgpr.sc@canada.ca or hc.brdd.ora.sc@canada.ca. The following statement should be included at the top of the Table of Contents: Following the Table of Contents, for biosimilar biologic drugs (hereafter referred to as biosimilars), include the following statement: [Biosimilar brand name (proper name)] is a biosimilar biologic drug (biosimilar) to [Reference biologic drug brand name]. Introduction. Relevant animal data (e.g., safety pharmacology) should be included only where human studies are lacking or deficient, or where the information is relevant to interpretation of toxicity or mode of action. This information must also appear in the Patient Medication Information. Other items such as those required for administration or quality control, reconstitution, elution etc. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Where applicable, there should be one table for hematologic changes, one for chemistry changes, and one for quantitative data (e.g., electrocardiograms). Teratogenic and nonteratogenic effects on the fetus should be included. It is to comprise laboratory studies and be divided, where appropriate, into in vitro and in vivo subsections. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. 1. Where a pediatric indication has not been authorized by Health Canada, it may still be useful to include the results of pharmacokinetic studies in children that have been submitted to Health Canada, if these results provide useful information for the prescriber. Separate tables may be required for different indications (e.g., oncology and a non-oncology indication) or different formulations (e.g., oral, intravenous) or different drug combinations. should also be included. Identify any safety monitoring procedures that should be implemented before initiating or during therapy to facilitate the safe administration of the drug (e.g., stop drug, adjust dosage, delay additional course) and include steps that should be taken to prevent or mitigate clinically significant adverse reactions identified in 7 WARNINGS AND PRECAUTIONS. It is presented in a language and format that is appropriate for a patient audience, including the general public. Provide detailed and practical information on the recommended dosage. Pictures or graphics can often be misleading as to the use, merit, and character of a drug product and should be avoided. Information on the solubility over the physiological range (e.g. Extent of exposure categories are based on Council for International Organizations of Medical Sciences (CIOMS). Lack of any effect on these parameters should also be stated in the context of the exposures studied. These data should be presented under a separate subheading (e.g., Cardiac Electrophysiology, Electrocardiography). Our file number: 05-104120-52. Clinically significant or serious (e.g., life-threatening) safety hazards when taking the drug should be highlighted in the Serious Warnings and Precautions Box. No specific antidote exists. It establishes the limitations/parameters for all advertising, representations, and promotional or information material distributed or otherwise endorsed by the sponsor. Include important monitoring parameters (e.g., blood pressure), observations, laboratory or other tests required to monitor response to therapy and possible adverse reactions. If the drug is not excreted but eliminated by metabolism (e.g., large proteins), or if it is eliminated by both excretion and metabolism, this should be stated. Graphs should not be used to present adverse reaction information. If abbreviations are used in a table, a legend should be included at the bottom of table. It is also intended to be used in place of singular terms such as: healthcare provider, healthcare practitioner, etcetera (etc.). This section of the product monograph should contain data from the main studies in support of the drug's efficacy and safety and should generally not include other information as this section is not intended to be a comprehensive reference of all studies related to the drug product. The information should be as brief and succinct as the requirements of the guidelines allow. (Ref: ICH - Clinical Safety Data Management: Definitions and Standards For Expedited Reporting E2A). An example of a hospital document is a discharge summary report, 5. Information relating to clinical trial adverse reactions and post-market adverse reactions should be presented separately, in a clear and logical manner and be included in a table where possible. Words or phrases that lack a commonly understood meaning (e.g., imprecise quantitative terms), are not easily defined, are vague, misleading, or promotional in tone should be avoided (e.g., unique, novel, convenient, potent). Adverse reactions that are reported under different terms in the database, but that represent the same phenomenon (e.g., sedation, somnolence, drowsiness) or disease pathophysiology in more than one body system (e.g., congestive heart failure, nocturnal dyspnea, angina, pedal edema) should be grouped together as a single adverse reaction to avoid diluting or obscuring the true effect. Structural formula, including relative and absolute stereochemistry; Relevant physicochemical properties, for example, physical description, solubility over the physiological pH range (pH 1-8), polymorphic form. Psychotherapy is an approach for treating mental health issues by talking with a psychologist, psychiatrist or another mental health provider. It should not be a summary of the safety database. how subjects were assigned to treatment groups (e.g., randomized). Avoid duplication of information. The table should define the magnitude of change from normal values that was considered clinically relevant, and the number of patients and percentage of the population that met the criteria. If you have any side effects not listed here, tell your healthcare professional. 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. Where applicable, a statement should be included to indicate that the drug product is authorized for use as an adjunct to other forms of management of the condition (e.g., lifestyle modification with osteoporosis). The following may interact with [Brand name]: Include information to ensure patients are aware of any medications, foods (e.g., citrus, dairy), beverages (e.g., alcohol) or natural health products known to interact with this medication. As in the use of any other radioactive material, care should be taken to minimize radiation exposure to patients consistent with proper patient management, and to minimize radiation exposure to occupational workers. Consider the following or similar statement as required: [Brand name] will be given to you by a healthcare professional in a healthcare setting. Only those indications authorized by Health Canada can be listed. 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.). The product monograph serves the following purposes: Information in the product monograph is organized in a manner appropriate for the intended audience. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organizations. Subsection C.08.002(2) of the. The following or similar statement should be included after the serious side effects table: If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional. 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. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. When any part of the product monograph is revised, the revision date should be reflected as the "Date of Revision" on the title page, and as "Last Revised" date in Patient Medication Information. Studies briefly described here may include photosafety, immunotoxicity, abuse liability, combination drug toxicity, etc. Despite these measures, such products can still potentially transmit disease. Different strengths containing different ingredients should be listed on a separate line. Before authorizing a drug for sale in Canada, we verify that it meets the safety, efficacy and quality requirements of the Food and Drugs Act and its Regulations. 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. Include any effects that may impair performance of a task requiring attention, including driving and operating machinery, along with the following or similar statement: Exercise caution when driving or operating a vehicle or potentially dangerous machinery. The Serious Warnings and Precautions Box is to be located immediately following 2 CONTRAINDICATIONS. For drugs where the patient is not an active participant (e.g, inhaled anaesthetics or other drugs, such as radiopharmaceuticals, that are administered under special conditions), the language may be adjusted. Information related to clinically significant or life-threatening product class-related adverse reactions should also be included, if applicable, with a cross-reference to 8 ADVERSE REACTIONS. Part I: Health Professional Information It identifies the information that should be provided to the patient respecting the use of that product [that is (i.e., Patient Medication Information]. 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. Provide information to the patient, or care provider, on how to prepare, reconstitute or administer the drug or operate a device (e.g., metered dose inhaler). For biologics, this subsection should describe the method of manufacture. Health Canada will advise the sponsor if the submission is judged to be incomplete in complying with the requirements of Section C.08.002 or C.08.003 of the Food and Drug Regulations. a qualitative, alphabetical listing of all non-medicinal ingredients. Notice of Compliance: a notice issued under section C.08.004 of the Food and Drug Regulations. 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 following boxed statement is to be added at the end of the narrative section. This information is not available for this drug product. The recommended diluent for each proposed route of administration should also be included under each subheading. Where there is absence of information, clearly state that no data exist. Immunogenicity or allergenicity should be given special consideration if applicable. services promote the documented therapeutic goals. Presentation: table and narrative (see template). Italics and underlining should be avoided. Presentation: narrative. Perioperative: refers to the time before, during or after surgery. Subsequent Entry Product: a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients. Pediatrics (age range): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of [Brand name] in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. Health Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission. Use in combination with other drugs (e.g., in same intravenous solution) should also be described. Include effects on sexual desire, erection, orgasm and ejaculation. Applicants and authorized representatives do not have a right to access the medical information of other family members except to the extent that such information is strictly required for the purpose of ensuring procedural fairness and for the purpose of the decision-making process. There is also the possibility that unknown infectious agents may be present in such products. If research supports a particular approach, citations are provided. (Ref: C.01.001. Overview. Whether comparator data would be included or not in this subsection of the product monograph, should be based on consultation with Health Canada. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Include a brief description of physical characteristics including physical half-life, principle radiation emission data and physical decay chart (in tabular format). Whether the patient can do something about the effect should be used as the criteria for including side effects in the table. The Pharmaceutical Drugs Directorate (formerly the Therapeutic Products Directorate (TPD)) is Canada's regulator of prescription pharmaceutical drugs for human use. The product monograph is not intended to serve as a repository of all information currently available on a drug. Where information is substantially different for each indication (e.g., diagnosis versus treatment/therapy), route of administration or formulation of the product, a separate Patient Medication Information section is required for each. Headings and Subheadings: bold type face should be used. the scheduling symbol (e.g., Pr, N, T/C), as applicable. If contraindicated in pregnancy, this should be included here and cross-referenced to 2 CONTRAINDICATIONS. Information for the Serious Warnings and Precautions Box may be drawn from any section of the product monograph and will be determined in consultation with Health Canada. 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. Sites and pathways of metabolism (e.g., p-glycoprotein, cytochrome P450) and extent of first-pass metabolism, metabolites and their activity, dose dependent changes in metabolism, effect of the drug, including active metabolites, on metabolic pathways (e.g., inhibition or induction of p-glycoprotein, cytochrome P450). [1][2][3] The Subjective, Objective, Assessment and Plan (SOAP) note is an acronym representing a widely used method of documentation for healthcare providers. In the cases where a drug product requires reconstitution or further preparation prior to being administered to a subject, the sponsor is responsible for demonstrating that the drug used at the clinical trial site meets all of the requirements of section C.05.011. Provide a bullet listing of the authorized indications from Part I. Comparative Toxicology. health insurance portability and accountability act Biologic drug: a drug listed in Schedule D to the Food and Drugs Act. 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. For Parts I and II, the first use of the brand name should be followed by the proper name (or common name, where there is no proper name) in final dosage form, in parentheses. For a radiopharmaceutical drug, it is also important to note that the patient will receive a radiation dose. The Health Professional Information portion of the product monograph may also be made available as a package insert. For subsequent revisions to any part of the product monograph, the date of initial authorization is kept and is followed by the "Date of Revision" which is the date of the most recently authorized product monograph; and, Drug XY 600 mg/300 mg film-coated tablets, Drug XYZ 600 mg X, 200 mg Y and 150 mg Z (as 153.2 mg Z sodium), Drug IV 2 g iv (as iv sodium)/per vial [or] 2 g/mL after reconstitution, Drug Nasal Spray 0.1 mL (10 mcg) drug per spray [or] per compression/actuation, Micrograms should be spelled out in full, or abbreviated as "mcg" only, 50 mg A (as citrate) or A citrate equivalent to 50 mg A, Each patch contains 750 micrograms of estradiol in a patch size of 10 x 10 cm, releasing 25 micrograms of estradiol per 24 hours, 7 Warnings and Precautions, 7.1.1 Pregnant Women 12/2019, 7 Warnings and Precautions, 7.1.3 Pediatrics 09/2018, 3 Serious Warnings and Precautions Box, Lactic Acidosis [Removed] 04/2019.