Week 1: Introduction to Pharmacology Flashcards
Identify key Canadian drug regulations that help ensure the safety and efficacy of drugs
If Health Canada authorizes a drug to be marketed in Canada, a Notice of Compliance (NOC) and a Drug Identification Number (DIN) are issued to indicate official approval. The DIN must be displayed on the label of all prescription drugs.
Drug regulations were created to protect the public from drug misuse and to assume continuous evaluation of safety and effectiveness.
Discuss the role of Health Canada in the drug approval process
The mandate for Health Products and Food Branch of Health Canada is “to manage the health-related risks and **benefits **of health products and food by minimizing health-risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food”
Describe the stages of approval for therapeutic and biologic drugs in Canada
A seven-step Approval Process that includes:
Step 1. Initial Drug Research when the drug gets made
Step 2. Pre-clinical trials (i.e., cultured cells, tissues, animals, etc.)
Step 3. Clinical trials: proceed in 4 phases (once application is approved by HC)
i. Safety phase: small group of healthy individuals (testing against the norm)
ii. Effectiveness phase: small group of humans with target disorder
iii. Confirmation phase: larger groups of patients with target disorder
iv. Monitoring phase: after the drug is approved and in the market, more information is gathered
Step 4. Submit NDS (new drug submission) to HC
Step 5. Expert committee review the NDS to determine benefits vs, risks
Step 6. HC reviews information about the drug and passes on details to HCP and consumers
Step 7. HC continues to monitor after release
Explain what characterizes an ideal drug and how drugs are classified
Drugs are classified as either **Traditional Drugs **(produced by pharmaceutical manufacturer), **Biologics **(agents produced by animal cells and micro-organisms - hormones, antibodies, vaccines), and Natural Health Products (supplements).
They may be further classified by their therapeutic classification or pharmacologic classification.
Characteristics of an Ideal Drug:
- Effectively prevents, treats or cures a condition
- Easy to administer
- Produces rapid, predictable response at relatively low doses
- Rapid onset of action
- Duration of action appropriate to reach therapeutic goals
- Rapid elimination of drug
- No adverse effects
- No interactions with food or other drugs
- No contraindications - safe for all clients to take
- Inexpensive and accessible
Connect pharmacotherapy to nursing practice
Pharmacotherapy is an intervention that addresses signs & symptoms - a symptom is what the patient feels, a sign is what you (as the nurse) observe (i.e., foot is red is a sign, pain is a symptom). Drugs are given to address a sign or symptom - sometimes they are also given to prevent disease or improve patient perception of health status (i.e., an anti-depressant)
Nurses must consider many things prior to administering a drug:
- indications for use, mechanism of action, desired effects, adverse effects, interactions, contraindications
- impact of client characteristics on pharmacotherapeutic response
- client rights
- providing appropriate education
Discuss the basic concepts of human growth and development in relation to pharmacotherapy
Growth: progressive increase in body size as an individual ages into adulthood
Development: Functional evolution of physical body and of psychomotor and cognitive abilities
Describe the components of the human integration pyramid model and discuss factors that can affect pharmacotherapeutic outcomes
The Human Integration Pyramid Model categorizes functional environments in which clients exist - categories in the model are interdependent and inter-related and form the basis of a holistic approach to care. The components include:
- Age Corollaries
- Gender Determinants
- Genetic Predisposition
- Community-Environmental Factors
- Cultural and Ethnic Perspectives
- Psychological-Social-Spiritual Dimension
Explain how pharmacogenomics and genetic polymorphisms can impact pharmacotherapy
Pharmacogenomics is a branch of pharmacology concerned with genetic variation in drug responses and considers underlying genetic expression as the reason for why drug therapy is not effective for everyone.
Health Products and Food Branch (HPFB)
Is part of Health Canada and is responsible for ensuring safety & quality of drugs, biologics, and natural health products
The Therapeutic Products Directorate
Oversees medications
Therapeutic Classification
Describes what is being treated by the drug. For example, a drug that treats elevated blood pressure would be classified as an antihypertensive. Clearly states what the drug does clinically.
Pharmacologic Classification
Describes the way the drug works at the molecular, tissues, body system level - it addresses a drug’s mechanism of action. For example, a diuretic treats hypertension by lowering plasma volume.
Prototype Drug
The first form of a drug and is used as a point of comparison for related versions of that drug
Chemical Name
Describes the chemical structure of a drug (i.e., 7-chloro-1,3-dihydro-1-methyl-5-phenyl-1,4-benzodiazepin-2(3H)-one)
Generic Name
Adopted by regulatory agencies to describe active ingredients of a drug (i.e., diazepam)
