Nursing Process and Canadian Drug Regulations

Nursing Process

• The nursing process is a systematic framework for providing quality patient care.
• It's a research-based, individualized process.
• Five steps include: assessment, nursing diagnosis, planning, implementation, and evaluation.
• Assessment involves gathering patient data, including medication history, health history, lifestyle factors and relevant information.
• Nursing diagnosis identifies the patient's health problems.
• Planning sets goals and criteria for patient care.
• Implementation involves carrying out the care plan, including patient education.
• Evaluation assesses the effectiveness of the care plan and makes necessary adjustments.

Canadian Drug Regulations

• Canadian Food and Drug Act governs foods, drugs, cosmetics, and medical devices.
• It ensures safety, efficacy, and quality standards.
• Schedules exist for controlled substances.
• Controlled Drugs and Substances Act (CDSA) controls regulated narcotics and substances.
• Replaced the Narcotic Control Act and is enforced by the RCMP.
• Natural Health Products Regulations regulate natural health products (like vitamins, minerals and herbal remedies), focusing on safety and preventing false claims.
• There is a lower bar for scientific evidence compared to conventional drugs.
• Marihuana for Medical Purposes Regulations regulate medical cannabis.
• Cannabis Act and Cannabis Regulations legalize recreational cannabis use and regulates medical cannabis. Health Canada regulates producers of medical cannabis.

Drug Approval Process

• A rigorous process that includes preclinical testing and four clinical phases (I-IV).
• Preclinical testing assesses drug safety, biological activity and potential toxicity using laboratory and animal studies.
• Clinical trials (I-IV phases) oversee drug development and safety testing in human subjects and are overseen by Health Canada.
• Phase I studies involve a small number of healthy participants to assess safety and determine optimal dosage.
• Phase II tests the drug in a larger group of patients with the target disease, and focuses on assessing safety and efficacy and pinpointing side effects.
• Phase III studies test the drug in a larger population to confirm efficacy and compare it to existing treatments, monitoring long-term side effects.
• Phase IV post-marketing studies ongoing, after market release, collecting long-term safety and efficacy data and exploring new uses.

Herbal Products in Canada

• Natural health products (NHPs), including herbal remedies, are popular but require caution due to potential risks and limited safety data.
• Widespread use of NHPs exists.
• Vitamins are the most common NHP.
• NHPs are often perceived as natural and harmless, however, this is not always the case.
• Natural Health Products Regulations (2003) focus on safety and prevent false claims.
• Lower bar of scientific evidence compared to conventional drugs.
• Labeling restrictions: Cannot claim to cure diseases.
• Potential risks like allergic reactions, toxicity, drug interactions and adverse effects exist.
• Examples of risks include toxicity, cardiovascular risks or heavy metals.
• Recommendations include consulting healthcare providers and reporting adverse effects to the NHP Canada's Vigilance program.
• The takeaway: "Natural" does not always equal "safe." Informed decision-making is important.

Properties of an Ideal Drug

• Ideal drugs possess effectiveness, safety, minimal drug interactions, low cost
• Drug characteristics aim to maximize effectiveness, safety and patient-centered care.
• These characteristics include selectivity (precise targeting), reversible action (effects subside predictably) and predictability (consistent and predictable response)
• Additional considerations include low cost, minimal drug interactions, and ease of administration.

Additional Considerations (Ideal Drug Properties)

• Importance of selectivity and minimizing unintended effects.
• Reversing action and ensuring short-term, reversible effects.
• Predictability to enable informed and consistent outcomes.
• Additional drug properties include minimal cost (affordable), minimal or no drug interactions and ease of administration for patient compliance. This also factors into ensuring treatment success.