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PHAR250 > Module 1 > Flashcards

Module 1 Flashcards

1
Q

Herbal medicine has been used…

A

in every culture, dating to antiquity.

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2
Q

When did chemists isolate pharmacological substances from natural substances?

A

1800’s

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3
Q

Who was the first Canadian apothecary? Where was he born? What city did he immigrate to and in what year?

A

Louis Hebert; Paris; Quebec City, 1617.

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4
Q

Which Indigenous group introduced Louis Hebert to native drug plants?

A

Mi’kmaq First Nations people

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5
Q

Where are drugs synthesized?

A

Laboratories

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6
Q

How long are drugs tested for?

A

Relatively short time

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7
Q

What is the focus of drugs mainly on?

A

Relieving suffering and improving quality of life

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8
Q

What is pharmacology the study of?

A

The study of medicines

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9
Q

What does the pharmacology include?

A

How drugs are administered, where they travel in the body, actual response produced, how the drug is eliminated from the body.

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10
Q

What characteristics does each drug have?

A

Therapeutic applications, interactions, side effects, mechanisms of action

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11
Q

Drugs elicit different responses depending on what individual factors?

A

Age, sex, body mass, health status, genetics

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12
Q

What is pharmacotherapy?

A

The administration of drugs for either: disease prevention; or treatment of suffering

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13
Q

What does pharmacotherapeutics practice?

A

Evidence-based medicine (EBM)

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14
Q

What does evidence-based medicine (EBM) mean?

A

Making decisions according to well designed and conducted research

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15
Q

What is a drug?

A

Chemical agent capable of producing a biological response

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16
Q

What are biologics?

A
  • Medications produced using biological processes in living organisms such as yeast and bacteria
  • Are complex, large molecules derived from living sources and produced through a number of intricate steps
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17
Q

What are some exampled of biologics?

A
  • Hormones (such as insulin)
  • Monoclonal antibodies
  • Natural blood products and components
  • Interferon
  • Vaccines
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18
Q

What are natural health products?

A
  • Vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (e.g. Chinese medicine), probiotics, and other products (amino acids, essential fatty acids, protein supplements)
  • they are likely to have similar actions to modern drugs, but regulated differently
  • Can have clinically significant effects on body, including side effects and drug interactions
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19
Q

What are the advantages of prescription drugs?

A
  • Healthcare provider examines the client and orders a specific drug
  • Amount and frequency of drug is controlled
  • Instructions on use, interactions and side effects of drug are identified and monitored (ideally)
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20
Q

What are the disadvantages of prescription drugs?

A
  • Require a prescription to obtain

- Need for healthcare provider appointment

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21
Q

What are the advantages of Over-The-Counter (OTC) Drugs?

A
  • No healthcare provider appointment required

- Often less expensive than prescription drugs

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22
Q

What are the disadvantages of Over-The-Counter (OTC) Drugs?

A
  • Client may choose wrong drug
  • Client may not know reactions or interactions
  • Ineffective treatment may result in progression of disease
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23
Q

What does the Health Products and Food Branch of the governance structure for drugs include?

A
  • Part of Health Canada
  • Responsible for ensuring health products and food are safe and of high quality
  • Regulates the use of therapeutic products through directorates
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24
Q

What does the Therapeutic Products Directorate branch of the governance structure for drugs include?

A
  • Authorizes marketing of a pharmaceutical drug (both prescription and over-the-counter*) or medical device
  • this might be changing in 2018!

-Products must be sufficiently scientifically proven (through clinical trials) to the Food and Drugs Act and Regulations

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25
Q

What does the Biologics and Genetic Therapies Directorate branch of the governance structure for drugs include?

A
  • Regulates biologic drugs and radiopharmaceuticals
  • Examples of biologics: blood products, vaccines, tissues, organ and gene therapy products
  • Examples of radiopharmaceuticals: radioactive iodine for hyperthyroidism
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26
Q

What does Natural and Non-prescription Health Products Directorate branch of the governance structure for drugs include?

A
  • Regulates the sale and use of natural health products (NHPs)
  • Conduct a review of the safety and appropriate use of each product before it can be authorized for sale
  • Also set up regulations for manufacturing within Canada or importation for sale in Canada
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27
Q

What is phase I during the Prescription Drug Approval Process: New Drugs ?

A

During Phase I, there are 20-100 healthy human volunteers in the study
Dosage is determined
How the drug is absorbed, distributed, metabolized and eliminated (ADME - the pharmacokinetics) is assessed

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28
Q

How long is the pre-clinical study period and what happens during this period when new prescription drugs are being approved?

A

-3- to 5-year period
Begin testing with cells different species of animals
-Provide initial information on potential safety and effectiveness

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29
Q

What happens when a clinical trial application is submitted to Health Canada during the prescription drug approval process for new drugs?

A
  • Detailed information on pre-clinical studies and proposed clinical trials are submitted to Health Canada
  • Committee of experts review information and authorize distribution from clinicians in clinical trial
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30
Q

What is phase II during the Prescription Drug Approval Process: New Drugs ?

A
  • During Phase II there are 100-300 volunteers in the study who have the disease that the drug is intended to treat
  • Dosage is determined
  • Side effects are assessed
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31
Q

What is phase III during the Prescription Drug Approval Process: New Drugs

A
  • During Phase III, there are 1000-3000 volunteers who have the disease that the drug is intended to treat
  • Double-blind study (compare to placebo or conventional treatment)
  • Clinical investigators assess the results
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32
Q

What happens during the New Drug Submission for new drugs during the prescription drug approval process?

A

-Health Canada reviews information about drug product and evaluates the drug’s safety, efficacy and quality

33
Q

Once Health Canada approves of the new drug during the prescription drug approval process, what two permits do they issue for the drug before it is released into the market?

A
  • Issues notice of compliance (NOC)

- Issues drug identification number (DIN)

34
Q

What is meant by “post-marketing” after a new drug is released into the market?

A

-Health professionals report adverse drug reactions

35
Q

What is the process when reporting an adverse drug reaction?

A

Minimum info needed:

  • Patient information – demographics but not name
  • Description of the adverse event
  • Name of the health product – when in doubt, report!
  • Contact information for yourself

-Other helpful info: dates of use of product (start & stop), dates of reaction, lab tests, other health products used

36
Q

What are patents? What happens when the patent ends?

A
  • A period of exclusivity, where that pharmaceutical company only determines the price of the medication
  • Intention of patents is for company to recover high costs of research and development of product (trials)
  • Provides 20 years of patent protection; the actual length of exclusivity is ~ 7-9 years in Canada due to regulatory hurdles
  • Must be registered any time before the New Drug
  • Submission step – each individual drug may be different depending upon legal advice
  • Once that period of exclusivity ends, competing companies (generic companies) market the generic equivalent drug for less money, and consumer savings are considerable
37
Q

What is the approval process for Generics? (prescription and OTC)

A
  • An abbreviated new drug submission
  • Generic companies must prove their product is bioequivalent
  • Bioequivalent = the rate and extent to which the active ingredient is a) absorbed from a drug product, and b) becomes available at the site of drug action to produce its effect

-If they can prove a product is bioequivalent to one that is already on the market, they are granted approval (don’t need to replicate clinical trials)

38
Q

Define “Therapeutic Classification” when naming drugs?

A
  • organizing drugs according to their therapeutic usefulness in treating a particular disease
  • Examples: anti-inflammatories – reduce inflammation; anti-convulsants – reduce seizures; immunosuppressants – suppresses immune system
39
Q

Define “Pharmacological Classification” when naming drugs?

A

-Pharmacological Classification – organizing drugs according to the way a drug works at a molecular level, tissue and body system level

  • Example: calcium channel blocker – blocks calcium channels; α-agonist – stimulates α-receptors; proton pump inhibitor – blocks proton pumps
  • Addresses a drug’s mechanism of action
40
Q

What is a mechanism of action?

A

-HOW a drug produces its effect on the body

Examples:
Does it block a receptor (like a β-blockers)?
Does it inhibit something (like an ACE-inhibitors)?
Does it stimulate a receptor (like an α-agonist)?
What action does it create (like a vasodilator)?

41
Q

What does the “chemical name” of a drug mean?

A
  • a direct description of the chemical structure
  • Gives information about it’s chemical makeup
  • Use is limited – sodium chloride (NaCl), calcium carbonate (CaCO3)
42
Q

What does the “generic name” of a drug mean?

A
  • the unique name given to a chemical structure that somewhat describes it’s structure
  • Remains the same across languages (few exceptions)
43
Q

What does the “brand/trade name” of a drug mean?

A

-the marketed name given to a drug, usually short and easy to remember
-Sometimes can sound-alike; differences between countries
Champix® vs. Chantix®; Losec® vs. Lasix®

44
Q

Which type of nomenclature is the safest to use in practice? (Chemical, generic, or brand/trade name?)

A
  • It is safest practice to use generic names when referring to a medication
  • Reduces errors
  • Encourages efficient communication between disciplines and across borders
45
Q

What are generic companies?

A
  • When patents expire, any company can then manufacture that drug and charge less money for it (we call these generic companies)
  • A generic company must prove bioequivalence before their product can be sold
  • A generic company cannot change the active ingredient
  • It can change non-medicinal ingredients such as fillers and excipients (lactose, colours)
  • The medicinal ingredients must be identical, but the non-medicinal ingredients may be different
46
Q

What are “controlled substances”?

A

Any drug in whose manufacture, possession, or use is regulated by the government

47
Q

True or False: can provinces change the scheduling of any drug identified as a narcotic or controlled substance?

A

False.

48
Q

What is drug scheduling? What level of government controls it?

A
  • Control the import, production, export, distribution, and possession of narcotics and controlled substances
  • Govern manufacturers, pharmacies, hospitals and healthcare professionals – require proper security, detailed inventory records
  • Federal government
49
Q

What is Schedule I?

A

Drugs only available by prescription.

50
Q

What is Schedule II?

A

Drugs available without a prescription, but must be kept behind pharmacy counter. (to ensure pharmacist interaction)

51
Q

What is Schedule III?

A

Drugs available without a prescription, but must only be sold in a pharmacy. (to access guarantee to pharmacist)

52
Q

What is meant by Unscheduled?

A

Drugs available anywhere.

53
Q

What are pharmacokinetics?

A

The study of how a drug moves in the body.

54
Q

What are the 4 components of pharmacokinetics?

A

4 components:

  • Absorption
  • Distribution
  • Metabolism
  • Elimination / Excretion
55
Q

What is a nurse’s role when it comes to pharmacokinetics?

A

-The care that a nurse provides directly affects the pharmacokinetics of a medicine
Example: Covering a patient in a warm blanket reduces stress hormone levels and increases blood flow directly influencing a drug’s movement within the body
-It is also important to know what to expect from a drug response in order to recognize problems
-We use this information to our benefit when trying to solve problems

56
Q

What is passive diffusion?

A

– moving from an area of high concentration to an area of lower concentration; does not require energy
-Small, non-ionized, lipid soluble drugs can pass through a membrane using passive diffusion

57
Q

What is active transport?

A

– moving against the concentration gradient; requires energy (ATP – adenosine triphosphate)
-Large, ionized, non-lipid soluble molecules use carrier proteins or send a messenger within a cell via a receptor

58
Q

What does the passage of a drug through a plasma membrane depend on?

A
  • Size of drug molecule
  • Ionization of a drug molecule
  • Lipid solubility of a drug molecule

**Small, non-ionized, lipid-soluble drugs can pass through a membrane using passive diffusion

59
Q

Define absorption.

A
  • Absorption is the process of moving a drug from the site of administration to the bloodstream
    ex) Oral, injection, topical, sublingual, buccal, inhalation
  • A large factor in determining a drug’s onset of action (the time it takes for a drug to become effective)
  • Fast absorption = Fast onset (IV)
  • Slow absorption = Slow onset (IM)
60
Q

What are the variables that influence absorption?

A
  • Route of administration
  • Drug formulation
  • Drug dosage
  • Gastrointestinal (GI) tract environment
  • Blood flow to absorption site
  • Drug ionization
  • Drug interactions
  • Surface area
61
Q

Define Enteral Route for route of administration of drugs

A 
-delivered to the gastrointestinal (GI) tract
Includes oral (PO), buccal, sublingual (SL), nasogastric (NG) tubes (and sometimes rectal)
-Oral and NG – susceptible to gastric acid, enzymes, first pass effect, ability to swallow 
-Buccal (cheek), sublingual (under tongue) – absorbed through mucosa of oral cavity – avoids acid, enzymes and first pass effect
62
Q

Define Topical Route for route of administration of drugs.

A

– delivered to skin or mucous membranes
-Includes skin, eyes, ears, inhalation, vagina, (and sometimes rectum)
-Usually used for direct application (antibiotic for skin infection, inhalation for asthma)
-Generally slower absorption, less presence of drug in blood
-We use these characteristics to our advantage, to prolong duration of action (nitroglycerin patches) or to minimize side effects (inhaled corticosteroid)
IF the area is compromised (abrasion, open sore - we see higher absorption toxicity)

63
Q

What is the Parenteral Route for route of administration of drugs?

A

– anything other than enteral or topical

  • Includes intravenous (IV), intramuscular (IM), subcutaneous (SC), intradermal, intraperitoneal (IP), intra-arterial, intra-osseous (bone), intrathecal (spinal canal), intraocular
  • Avoids gastric enzymes, acidity, and first pass effect
  • SC, intradermal – limited by small volume
  • IM – larger volumes, faster absorption but often use depot injections
  • IV – fastest onset and most dangerous (adverse effects, cannot reverse)
64
Q

What is drug formulation?

A
  • Is the drug a tablet, capsule, liquid, aerosol, disintegrating tablet?
  • Liquid formulations dissolve faster and absorb faster than solid formulations (liquid > solid)
  • Tablets or capsules can be “enteric-coated” – coated to withstand acid of stomach, and not dissolve until in small intestine
  • Extended Release – designed to dissolve slowly, to lengthen duration of action (XR, SR, XL, CR)
65
Q

What types of drugs are designed to dissolve in mouth with no water?

A

Oral disintegrating tablets (ODT)

66
Q

What type of injections are formulated in an oily, viscous base to promote slow and continuous absorption from muscle?

A

IM depot injections

67
Q

What absorbs faster: higher or lower doses/concentrations?

A

-Higher doses or concentrations absorb faster and provide a faster response than lower doses or concentrations
Example: diltiazem is given as 100mg tablet, which is 50% absorbed through GI tract
50% of 100mg = 50mg
50% of 300mg = 150mg

68
Q

GI Tract Environment: where does most absorption occur?

A

-small intestine – depends on gastric motility, pH level

69
Q

Differentiate between slower and faster motility when a drug is in the GI Tract Environment.

A
  • Slower motility may leave drug more susceptible to enzymes in stomach
  • Faster motility may reduce absorption by speeding drug along before absorption occurs
70
Q

True or False: do fatty foods slow drug absorption?

A

True

71
Q

True or False: Acidic drugs need acidic environment to absorb;
Basic drugs need basic environment to absorb

A

True

72
Q

True or False: drugs absorb faster from areas of the body where blood flow is LOW?

A

False. Drugs are absorbed faster from areas of the body where blood flow is high.

  • Muscles, buccal cavity, vagina, rectum
  • Ice packs>vasoconstriction>slower absorption
  • Heat>vasodilation>faster absorption
73
Q

Differentiate between ionized and non-ionized

A
  • Ionized = a positive or negative charge
  • Non-ionized = no charge
  • Depends on pH of environment
  • *Remember how drugs pass through plasma membranes**
  • Acidic drugs need an acidic environment because they are non-ionized
  • Basic drugs need a basic environment because they are non-ionized
74
Q

Are acidic drugs ionized?

A

No, they are non-ionized, therefore they need an acidic environment.

75
Q

Are basic drugs ionized?

A

No, they are non-ionized, therefore they need a basic environment.

76
Q

What happens during drug-drug interactions?

A
  • Drug-drug interaction = tetracycline capsule + calcium carbonate (CaCO3) delays absorption (bind to make a molecule too large to pass through plasma membrane)
  • Not all drug interactions occur at the receptor level
77
Q

What happens during drug-food interactions?

A

-Drug-food interaction = high fat meal + carbamazepine = higher rate of absorption

78
Q

True or False: Smaller surface area = faster absorption

A

False. Larger surface area = faster absorption

-Examples: skin, villi and microvilli of small intestine, lung

PHAR250 (1 decks)

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