Week 1 Pharm - Introduction to Pharmacology and Drug Regulations in Canada PDF

**Introduction to Pharmacology and Drug Regulations in Canada** **Nursing Process** The nursing process is a **research-based organizational framework** for professional nursing practice that ensures the delivery of thorough, individualized, and quality nursing care to patients. It is a **flexible...

**Introduction to Pharmacology and Drug Regulations in Canada** **Nursing Process** The nursing process is a **research-based organizational framework** for professional nursing practice that ensures the delivery of thorough, individualized, and quality nursing care to patients. It is a **flexible, adaptable, and systematic framework** that requires critical thinking and is an ongoing and constantly evolving process. The nursing process has five steps: - **Assessment:** This step involves the systematic collection, review, and analysis of patient data, including medication history, health history, lifestyle factors, and any other relevant information. This includes information about any and all drug use, prescriptions and over-the-counter medications, past or present health history and associated drug regimen, and family history. - **Nursing diagnosis:** This is the second step in the process. - **Planning:** This step includes setting goals and outcome criteria for the patient. - **Implementation:** This step includes putting the plan into action, including patient education. - **Evaluation:** This is the final step, where the nurse evaluates the effectiveness of the care plan and makes any necessary adjustments. The nursing process is important because it ensures **individualized care, promotes patient safety, and guides nurses in making informed decisions about drug administration**. **Canadian Drug Regulations** - **Canadian Food and Drug Act:** Governs foods, drugs, cosmetics, and medical devices. Ensures safety, efficacy, and quality standards. Includes schedules for controlled substances. - **Controlled Drugs and Substances Act (CDSA):** Replaces the Narcotic Control Act. Regulates narcotics and controlled substances. Enforced by the RCMP. Aims to protect public health and safety. - **Natural Health Products Regulations:** Focuses on the safety of natural health products (vitamins, minerals, herbal remedies, etc.). Lower bar for scientific evidence compared to conventional drugs. No false or misleading claims allowed. - **Marihuana for Medical Purposes Regulations:** Replaces the Marihuana Medical Access Program. Regulates medical cannabis. - **Cannabis Act and Cannabis Regulations:** Legalize recreational cannabis use. Address medical cannabis. Health Canada regulates producers of medical cannabis. - **Drug Approval Process:** Stringent process to ensure patient safety and drug efficacy. Involves four clinical phases (preclinical testing and Phases I-IV). **Drug Costs:** High drug expenses are a barrier to access. Affects low-income individuals, those without drug benefits, and people with poor health. Not covered under the Canada ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- **Drug Development in Canada** ------------------------------ **Central Idea:** A rigorous process to ensure patient safety and drug efficacy before market release. **Preclinical Testing** - **Goal:** Assess safety, biological activity, and potential toxicity. - **Methods:** Extensive laboratory and animal studies. **Clinical Trials (Human Testing)** - **Overseen by Health Canada.** - **Four Phases:** - **Phase I** - **Participants:** Small number of healthy volunteers (\