PAT 201 - WEEK 1 with correct answers 100%

PAT 201 - WEEK 1 with correct answers 100% What does effective use of drugs by a health care team depend on? - Correct Answer Being able to apply knowledge related to: - Anatomy & Physiology - Pathophysiology - Chemistry - Microbiology - CJ - Nursing Process Canadian Drug Regulations - Correct Answer Created to protect public from drug misuse and provide mechanism for quality assurance for safety & efficacy Health Products and Food Branches (HPFB) - Correct Answer HPFB of Health Canada is responsible for ensuring safety and quality of drugs, biologics, and natural health products What is the standard set by? - Correct Answer Food and Drug Act and Regulations How many steps are there for approval of drugs marketed in Canada? - Correct Answer 8 steps STEP 1 - Correct Answer Initial drug research is conducted STEP 2 - Correct Answer Preclinical studies in cultured cells, living tissue, and species of animals are performed STEP 3 - Correct Answer A Clinical Trial Application (CTA) is submitted to Health Canada, followed by extensive clinical trials which are done in 4 phases 4 Phases of Clinical Trials - Correct Answer Phase 1: Safety phase; a small group of healthy humans Phase 2: Effectiveness phase; small group of humans with the target disorder Phase 3: Confirmation phase; larger groups of clients with the target disorder Phase 4: Monitoring phase; after drug is approved and in the market, more info is gathered on use, benefits, and risks STEP 4 - Correct Answer The pharmaceutical company completes a New Drug Submission (NDS) to Health Canada which details important safety and efficacy info (production, packaging requirements, reactions, side effects) STEP 5 - Correct Answer A committee of drug experts including medical and drug scientists reviews the NDS to identify potential drug benefits and risks STEP 6 - Correct Answer Health Canada reviews info about the drug and passes on essential details to HCPs and consumers STEP 7 - Correct Answer Health Canada issues a Notice of Compliance (NOC) and Drug Identification Number (DIN) which are both required for manufacturer to market the drug STEP 8 - Correct Answer Health Canada monitors efficacy of drug and any safety concern following its marketing. This is done by regular inspection, notices, newsletters, and feedback from consumers and HCPs. Traditional Drugs - Correct Answer Produced by pharmaceutical manufacturers Biologics - Correct Answer - Agents produced by animal cells and microorganisms - Hormones, antibodies, vaccines Natural Health Products - Correct Answer - Natural plant extracts - Vitamins and minerals - Dietary supplements Pharmacologic Classification - Correct Answer - Way drug works at molecular, tissue, body system level - Addresses drug's mechanism of action (how a drug produces its effect in the body) i.e., diuretic treats hypertension by lowering plasma volume Most drugs have _______________ classifications? - Correct Answer Most drugs have MULTIPLE classifications and are a MIX of therapeutic and pharmacological classifications Prototype Drug - Correct Answer 1st form of a drug - Representative drug from a class that is used as a point of comparison for related versions of that drug