PAT201 Week 1

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What is pharmacology?

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1

What is pharmacology?

the study of medicines; effective use of drugs by a health care team depends on being able to apply knowledge related to:

  • Anatomy & physiology

  • Pathophysiology

  • Chemistry

  • Microbiology

  • Clinical judgment

  • Nursing process

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2

Who is responsible for ensuring safety & quality of drugs, biologics, and natural health products?

Health Products and Food Branch (HPFB) of Health Canada

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3

Why are Canadian drug regulations created?

to protect the public from drug misuse and provide a mechanism for quality assurance for safety and efficacy

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4

1st step of Canadian drug approval:

Initial drug research is conducted

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5

2nd step of Canadian drug approval:

Preclinical studies in cultured cells, living tissue, and species of animals are performed

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6

3rd step of Canadian drug approval:

A clinical trial application (CTA) is submitted to Health Canada, followed by extensive clinical trials

  • Phase I (the safety phase): small group of healthy humans

  • Phase II (the effectiveness phase): small group of humans with the target disorder

  • Phase III (the confirmation phase): larger groups of patients with the target disorder

  • Phase IV (the monitoring phase): after the drug is approved and in the market, more information gathered on use, benefits, and risks

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4th step of Canadian drug approval:

The pharmaceutical company completes a New Drug Submission (NDS) to Health Canada

  • Safety and efficacy information, testing data, how the drug is produced/packaged, expected therapeutic benefits, adverse reactions

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5th step of Canadian drug approval:

Drug experts (medical and drug scientists) review NDS for benefits and risks

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9

6th step of Canadian drug approval:

Health Canada reviews information and passess it to healthcare providers and consumers

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10

7th step of Canadian drug approval:

Health Canada issues a Notice of Compliance (NOC) and Drug Identification Number (DIN)

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11

8th step of Canadian drug approval:

Health Canada monitors the efficacy of the drug and safety concerns after being marketed

  • Regular inspection, notices, newsletters, feedback from consumers and healthcare providers

  • Post-market evaluation

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12

What is a drug?

chemical agent capable of producing biological responses within the body; given for purpose of producing a therapeutic response

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13

What kind of responses can result from the use of drugs?

Responses could be desirable (therapeutic) or undesirable (adverse)

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14

Define medication

a drug that is considered medically therapeutic

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15

What are the 3 types of drugs?

  1. Traditional drugs - produced by pharmaceutical manufacturers

  2. Biologics - agents produced by animal cells and microorganisms

  • Hormones, antibodies, vaccines, natural blood products

  1. Natural health products

  • Natural plant extracts - aloe

  • Vitamins*,* minerals, herbals

  • Dietary supplements

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16

What are the 2 classifications of drugs?

Therapeutic and pharmacologic

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17

What is therapeutic classification of drugs?

describes what is being treated by the drug

  • Elevated blood pressure → antihypertensive drug class

  • Clearly states what drug does clinically

  • Therapeutic usefulness

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18

What is pharmacologic classification of drugs?

the way the drug works at a molecular, tissue, body system level

  • Addresses drug’s mechanism of action

  • How a drug produces its effect in the body

    • A diuretic treats hypertension by lowering plasma volume

There are often many different but related versions of a drug

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19

easy way to remember the difference between the classifications?

therapeutic - what it treats

pharmacologic - how it works

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20

What is a prototype drug?

1st form of drug; representative drug from a class that is used as a point of comparison for related versions of that drug; well-understood drug

  • Can allow nurses to extend knowledge to other similar drugs within that class with similar actions, effects, and adverse effects

    • Point of reference

  • -coxib: celecoxib, parecoxib

  • -parin: heparin, dalteparin

  • -semide: furosemide, azosemide

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21

What are the 3 types of nomenclature for drugs?

  1. Chemical name - describes chemical structure of a drug

  • diazepam/valium: 7-chloro-1,3-dihydro-1-methyl-5-phenyl-1,4-benzodiazepine-2(3H)-one

  1. Generic name - adopted by regulatory agencies to describe active ingredient of a drug

  • diazepam

  1. Trade (proprietary/owndership or brand) name - used by company that produces a drug

  • Valium

  • Happens because drug patents last 20 years (other companies cannot manufacture the same drug for that amount of time) which gives a dominant company “ownership” over the drug they sell

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22

Some characteristics of an ideal drug?

  • Effectively prevents, treats, or cures condition of client

  • Easy to administer

  • Produces rapid, predictable response at relatively low doses

  • Rapid onset of action

  • Duration of action appropriate to reaching 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

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23

What are some of the different drug schedules?

  • Schedule I: available only by prescription and provided by a pharmacist; includes:

    • All prescription drugs

    • Drugs with less potential for abuse: Schedule F

    • Controlled drugs: Schedule G

    • Narcotic drugs

  • Schedule II: available only from a pharmacist; must be retained in an area with no public access

  • Schedule III: available via open access in a pharmacy or pharmacy area (over the counter)

  • Unscheduled: can be sold in any store without professional supervision

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24

What is pharmacotherapy?

  • The application of drugs to prevent disease and ease suffering

  • Client experiences decreased s&s, more satisfaction of health status, and prevention of disease after pharmacological intervention

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25

What are some things that the nurse should consider prior to administering drugs?

  • Indication for use, mechanism of action, desired effects, adverse effects, interventions, contraindications

  • Impact of client characteristics on pharmacotherapeutic response

  • Client rights

  • Providing appropriate education

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26

What is the human integration pyramid model?

*refer to notes for image

  • Categorizes functional environments in which clients exist

  • Categories in model are interdependent and inter-related

    • Form basis of holistic approach to care

  • Emphasizes the importance of holistic pharmacotherapy

  • See the entire person aside from pharmaceuticals

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27

What is pharmacogenomics?

  • branch of pharmacology; studies role of genetic variation in drug responses

  • Considers underlying genetic expression as reason for why drug therapy not effective for everyone

  • Genetic differences discovered in drug-metabolizing enzymes (P450) have been discovered

    • Opens door to individualized drug therapy

    • Ultimate goal is to improve safety, efficacy of drug therapy through use of genetically guided treatment

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28

Explain an example of the consequences of genetic poly morphisms

  • Patient A has normal gene encoding for drug-metabolizing enzyme

  • Patient B has genetic polymorphism for drug-metabolizng enzyme

    • Drug not metabolized and remains free in the plasma to produce enhanced effect or toxictiy

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