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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
Who is responsible for ensuring safety & quality of drugs, biologics, and natural health products?
Health Products and Food Branch (HPFB) of Health Canada
Why are Canadian drug regulations created?
to protect the public from drug misuse and provide a mechanism for quality assurance for safety and efficacy
1st step of Canadian drug approval:
Initial drug research is conducted
2nd step of Canadian drug approval:
Preclinical studies in cultured cells, living tissue, and species of animals are performed
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
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
5th step of Canadian drug approval:
Drug experts (medical and drug scientists) review NDS for benefits and risks
6th step of Canadian drug approval:
Health Canada reviews information and passess it to healthcare providers and consumers
7th step of Canadian drug approval:
Health Canada issues a Notice of Compliance (NOC) and Drug Identification Number (DIN)
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
What is a drug?
chemical agent capable of producing biological responses within the body; given for purpose of producing a therapeutic response
What kind of responses can result from the use of drugs?
Responses could be desirable (therapeutic) or undesirable (adverse)
Define medication
a drug that is considered medically therapeutic
What are the 3 types of drugs?
Traditional drugs - produced by pharmaceutical manufacturers
Biologics - agents produced by animal cells and microorganisms
Hormones, antibodies, vaccines, natural blood products
Natural health products
Natural plant extracts - aloe
Vitamins*,* minerals, herbals
Dietary supplements
What are the 2 classifications of drugs?
Therapeutic and pharmacologic
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
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
easy way to remember the difference between the classifications?
therapeutic - what it treats
pharmacologic - how it works
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
What are the 3 types of nomenclature for drugs?
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
Generic name - adopted by regulatory agencies to describe active ingredient of a drug
diazepam
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
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
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
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
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
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
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
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