Pharmacotherapeutics For Advanced Practice-Chapter 1

Front 1

How many stages are in the FDA clinical trial process?

Back 1

4

Front 2

What is the first stage of the clinical trial process?

Back 2

Preclinical Trials
Involves testing in animals
Monitoring efficacy, toxic effects, and untoward reactions.

Front 3

When is the application for investigational use of a drug sent to the FDA?

Back 3

After the Preclinical Trials are completed.

Front 4

What does Phase I of clinical trials consist of?

Back 4

The initial evaluation of the drug.
Supervised studies of 20 - 100 healthy people.
Focuses on absorption, distribution, metabolism, and elimination.

Front 5

In what phase of clinical trials are effective administration routes and dosage ranges determined?

Back 5

Phase I

Front 6

What does Phase II of the clinical trial process consist of?

Back 6

Several hundred patients with the disease for which the drug is intended are subjects.
Same testing as Phase I

Front 7

What does Phase III of the clinical trial process consist of?

Back 7

Double-blind research are used for data collection.
Proposed drug is compared to one already proven effective.
Several thousand subjects
Lasts several years.

Front 8

When does Phase III of the clinical trial process begin?

Back 8

When the FDA determines that the drug causes no apparent serious adverse effects and the dosage range is appropriate.

Front 9

What happens at the end of Phase III of the clinical trial process?

Back 9

The FDA evaluates data presented and accepts or rejects the application for the new drug.

Front 10

What does FDA approval of a drug mean?

Back 10

That a drug can be marketed but only by the company seeking approval.

Front 11

What does Phase IV of the clinical trial process consist of?

Back 11

Drug is released initially on a limited basis then later on a more widespread basis.
Everyone taking the drug is monitored for adverse drug reactions.

Front 12

What objectives do the pharmaceutical companies have in late Phase III and IV studies?

Back 12

1. compare drug with other drugs already available.
2. Monitor long-term effectiveness and impact on quality of life.
3. Detemine cost effectiveness in relation to other therapies.

Front 13

What did the FDA's Controlled Substances Act of 1970 establish?

Back 13

A schedule or ranking of drugs that have the potential for abuse or misuse.

Front 14

What are schedule 1 drugs?

Back 14

drugs with a high potential for abuse. Have no therapeutic use. Not available for regular use.
For investigational use only.
Heroin, LSD, Ecstasy

Front 15

What are schedule 2 drugs?

Back 15

Have a valid medical use but a high potential for abuse both psychological and physiologic.
Cannot have refills ordered.
Certain amphetamines, and barbiturates.

Front 16

What are schedule 3 drugs?

Back 16

Have a potential for abuse but lower than schedule 2. Combination of controlled and noncontrolled substances.
Can cause a moderate to low physiologic dependence and a higher psychological dependence.
Refilled up to 5 times q 6 mos.
Narcotics and nonbarbiturate sedatives.

Front 17

What are schedule 4 drugs?

Back 17

Low potential for abuse. Can cause psychological dependency but limited physiologic dependency.
Nonnarcotic analgesics and antianxiety agents.
Ativan

Front 18

What are schedule 5 drugs?

Back 18

least potential for abuse.
Contain a moderate amount of opioids and used mainly as antitussives and antidiarrheals.

Front 19

Who can prescribe scheduled drugs?

Back 19

Only practitioners who are registered and approved by the US Drug Enforcement Agency.

Front 20

What must be written on a prescription for a scheduled substance for the prescription to be valid?

Back 20

DEA number.

Front 21

What happens when a patent on a brand name drug expires?

Back 21

Other drug manufacturers can then produce the same drug formula under its generic name.

Front 22

What values must be obtained for a generic drug to be cleared to be marketed?

Back 22

Values must be whithin 80% to 125% of those obtained for the brand name drug.

Front 23

Do herbal preparations reguire FDA approval as drugs?

Back 23

No legislated standards on purity or quantity of active ingredients are required.

Front 24

What does the Dietary Supplement Health and Education Act of 1994 require?

Back 24

Requires labeling about the effect of herbal products on the body and require the statement that the herbal product has not been reviewed by the FDA and is not intended to be used as a drug.

Front 25

How is the value of herbal therapy measured?

Back 25

By anecdotal reports and not verified by research.

Front 26

What is the role and responsibility of the practitioner in prescribing?

Back 26

To gather data by taking a thorough history and performing a physical examination.
One or more diagnoses are formulated.
Treatment plan established.

Front 27

What is a risk-benefit analysis?

Back 27

evaluating the therapeutic value of a drug versus the risk associated with each drug to be prescribed.

Front 28

What initial questions should be asked when selecting a drug therapy?

Back 28

Is there a need for this drug in treating the presenting problem or disease?
Is this the best drug for the presenting problem or disease?

Front 29

Who regulates the prescribing practices of each practitioner?

Back 29

The state in which the practitioner is practicing.

Front 30

How does each state establish practice parameters?

Back 30

By enacting statutes and rules and regulations.

Front 31

What is a statute?

Back 31

Laws enacted by legislature.

Front 32

What are rules and regulations?

Back 32

Administrative policies determined by regulatory agencies.

Front 33

Who regulates prescriptive authority?

Back 33

State Board of Nursing
Board of Medicine
Board of Pharmacy
depending on the state.

Front 34

What does a collaborative practice entail?

Back 34

Requires a formal agreement with a collaborating physician, ensuring a referral-consultant relationship.

Front 35

What is a supervised practice?

Back 35

Practice overseen or directed by a supervisory physician.

Front 36

What is a delegated practice?

Back 36

Means that prescription writing is a delegated medical act.

Front 37

What was The Prescription Drug Marketing Act of 1988 made for?

Back 37

To protect the American consumer from ineffective drugs.
Also affects the receipt and dispensing of drug samples.

Front 38

How does the PDMA protect the American public?

Back 38

Forbids foreign countries to reimport prescription drugs.
Bans the sale, trade, and purchase of drug samples.
Prohibits resale of prescription drugs purchased by hospitals, health care entities, and charitable organizations.
Requests practitioners ask for drug samples in writing.
Regulates wholesale distributors licensing in states where facilities are located.

Front 39

What are the specific procedures for acquiring drug samples?

Back 39

1. Sample Request Form must be signed.
-requires name, strength, and quantity of the sample.
2. Sample must be recorded on the Record of Receipt of Drug Sample sheet.
3. Sample must be stored away from other drug inventory.
4. Inspect sample monthly for expiration dates, proper labeling, and storage.

Front 40

When distributing sample drugs?

Back 40

Each must be labeled with the patient's name, clear directions for use, and cautions.
To be dispensed free of charge.
Documented in pt chart with dose, quantity, and directions.

Front 41

What is an example of underuse of a drug?

Back 41

Failure to prescribe an inhaled corticosteroid for an asthmatic who uses his albuterol daily.

Front 42

What is an example of overuse of a drug?

Back 42

Prescribing an antibiotic for a cold or prescribing an antihypertensive drug for someone whose blood pressure is elevated because he is taking Sudafed.

Front 43

What is an example of misuse of a drug?

Back 43

Prescribing hydrochlorothiazide to someone who is allergic to sulfa.

Front 44

What is Pharmacokinetics?

Back 44

Refers to movement of drug through the body.

How the body affects the drug.

Front 45

What is involved in Pharmacokinetics?

Back 45

How the drug is:
Administered
Absorbed
Distributed
Eliminated from the body.

Front 46

What is Pharmacodynamics?

Back 46

Refers to how the drug affects the body.

How the drug initiates its therapeutic or toxic effect, both at the cellular level and systematically.

Front 47

Definition of Affinity.

Back 47

The attraction between a drug and a receptor.

Front 48

Definition of Allosteric Site.

Back 48

A binding site for substrates not active in initiating a response.
A substrate that binds to an allosteric site may induce a conformational change in the structure of the active site, rendering it more or less susceptible to response from a substrate.

Front 49

Definition of Bioavailability.

Back 49

The fraction or percentage of a drug that reaches the systemic circulation.

Front 50

Definition of Biotransformation.

Back 50

Metabolism or degradation of a drug from an active form to an inactive form.

Front 51

Definition of Chirality.

Back 51

Special configuration or shape of a drug.

Most drugs exist in two shapes.

Front 52

Definition of Clearance.

Back 52

Removal of a drug from the body.

Front 53

Definition of Downregulation.

Back 53

Decreased availability of drug receptors.

Front 54

Definition of Enantiomer or Isomer.

Back 54

A mirror-image spatial arrangement, or shape, of a drug that suits it for binding with a drug receptor.

Front 55

What is Enterohepatic Recirculation?

Back 55

The process by which a drug excreted in the bile flows into the GI tract, where it is reabsorbed and returned to the general circulation.

Front 56

What is the First-Pass Effect?

Back 56

The phenomenon by which a drug first passes through the liver for degradation before distribution to the tissues.

Front 57

What is Half-life (t1/2)?

Back 57

The time required for half of a total drug amount to be eliminated from the body.

Front 58

What is Hepatic Extraction Ratio?

Back 58

A comparison of the percentage of drug extracted and the percentage of drug remaining active after metabolism in the liver.

Front 59

What is a Prodrug?

Back 59

A drug that is transformed from an inactive parent drug into an active metabolite.

A precursor to the active drug.

Front 60

What is a Receptor?

Back 60

The site of drug action.

Front 61

What is a Second Messenger?

Back 61

A chemical produced intracellularly in response to a receptor signal.

Initiates a change in the intracellular response.

Front 62

What is the Therapeutic Window?

Back 62

The range of drug concentration in the blood between a minimally effective level and a toxic level.

Front 63

What is a Threshold?

Back 63

The level below which a drug exerts little to no therapeutic effect and above which a drug produces a therapeutic effect at the site of action.

Front 64

What is the Volume of distribution (Vd)?

Back 64

The extent of distribution of a drug in the body.

Front 65

Enteral Absorption

Back 65

After the drug is administered by the oral or rectal route.

Front 66

Parenteral absorption

Back 66

Associated with drugs administered intramuscularly, subcutaneously, or topically.

Front 67

What affects the drugs ability to enter the bloodstream?

Back 67

The various administration routes.

The drugs ability to pass through membranes or barriers in the body.

Front 68

What is the bioavailability of a drug administered Intravenously?

Back 68

100% bioavailable.

Front 69

What are the factors that affect absorption?

Back 69

1. Presence or absence of food in the stomach.
2. Blood flow to the area for absorption.
3. Dosage form of the drug.

Front 70

What is the cell membranes phospolipid bilayer most permeable to?

Back 70

Most lipid-soluble compounds.

Hydrophobic

Front 71

What is passive diffusion?

Back 71

Molecules move from one side of a barrier to another without expending energy.

Front 72

How do molecules move during passive diffusion?

Back 72

Molecules move down a concentration gradient.

Move from an area of higher concentration to an area of lower concentration.

Front 73

What does the rate of diffusion depend on?

Back 73

Difference in concentrations.

The relative strength of the barrier.

The distance that the molecules must travel.

Front 74

What does Fick's law of diffusion state?

Back 74

That the greater the distance and the larger the molecule, the slower the diffusion.

Front 75

What is needed to facilitate drug absorption?

Back 75

The solubility of the administered drug must match the cellular constituents of the absorption site.

Front 76

Which form of a drug diffuses more readily through the lipid bilayer?

Back 76

Neutral, non-ionized form.

Front 77

How does a weakly acidic drug become ionized?

Back 77

By traveling through a more alkaline environment such as found in the small intestines.

Front 78

How does a weakly alkaline drug become ionized?

Back 78

By traveling into a more acidic environment such as found in the gastric acid of the stomach.

Front 79

What is active transport?

Back 79

Membrane proteins act as carrier molecules to transport substances across cell membranes.

Front 80

How does a drug get actively transported across a cell membrane by a transport protein?

Back 80

The drug must share molecular similarities with an endogenous substance the transport system normally carries.

Front 81

How is endocytosis used to transport drugs across the cell membrane?

Back 81

The cell forms a vesicle surrounding the drug molecule which invaginates in the cell.

The vesicle is pinched off and the molecule is released into the cytoplasm of the cell.

Front 82

What are the local effects of a drug?

Back 82

Effects are confined to one area of the body.

Front 83

What are the systemic effects of a drug?

Back 83

Occur when the drug is absorbed and delivered to body tissues by way of the circulatory system.

Front 84

What are the aims of sustained release drugs?

Back 84

Administration as infrequently as possible and therefore improve compliance and minimal hour to hour and day to day fluctuations in blood levels.

Front 85

Why is blood flow important to the absorption of a drug?

Back 85

It ensures that the concentration across a gradient is continually in favor of passive diffusion.

As blood flows through an area, it continually removes drug from the area, thereby maintaining a positive concentration gradient.

Front 86

What is the difference between IM injection and SQ injection?

Back 86

Because of minimal vascularization in the sub Q layer compared to the greater vascularity in the muscle, drugs injected Sub q may undergo limited absorption compared to IM.

Front 87

How does GI motility affect drug absorption?

Back 87

High fat meals and solid foods affect GI transit time by delaying gastric emptying, which in turn delays initial drug delivery to intestinal absorption surfaces.
The slower the transit through the GI system the more drug is absorbed.

Front 88

Where does Enteral Absorption take place?

Back 88

Occurs anywhere throughout the GI tract by passive or active transport of the drug through the cells of the GI tract.

Front 89

What is most frequently transported across the cells of the GI tract utilizing Active Transport?

Back 89

Large, usually ionized molecules.

Front 90

What diffuses passively across the cells of the GI tract?

Back 90

Low molecular weight, non-ionized molecules.

Front 91

What does the oral route of administration refer to?

Back 91

Any medication that is taken by mouth.

Front 92

What are common dosage forms administered by mouth?

Back 92

1. Capsules
2. Tablets
3. Caplets
4. Solutions
5. Suspensions
6. Troches
7. Lozenges
8. Powders

Front 93

Where does absorption usually take place after oral administration?

Back 93

The lower GI tract
Small or large intestine.

Front 94

What does absorption depend on when a drug is taken orally?

Back 94

1. Gastric emptying time.
2. Presence of food.
3. Gastric or intestinal pH.

Front 95

Drugs administered orally must be

Back 95

relatively lipid soluble to cross the GI mucosa into the bloodstream.

Front 96

What are some common side effects of drugs administered orally?

Back 96

Nausea
Vomiting
Diarrhea
Mucosal damage

Front 97

What is sublingual administration?

Back 97

Drugs administered under the tongue.

Front 98

What does absorption rely on with drugs administered sublingually?

Back 98

Absorption through the oral mucosa into the vains that drain those vascular beds.

Front 99

What drugs are subject to the first pass effect?

Back 99

Orally administered drugs

Front 100

What is Buccal Administration of drugs?

Back 100

Usually administered between the cheek and gum.
Absorbed through the mucous membranes of the mouth.

Front 101

What is rectal administration of a drug?

Back 101

Drugs administered in the rectum.

Front 102

What drug forms are administered rectally?

Back 102

Suppositories
Enemas

Front 103

Why is the rectal route of administration less effective than other routes of drug administration?

Back 103

Because of the erratic absorption of most agents which is contributed by bowel irritation, early evacuation, and minimal surface area in which to contact and diffuse across.

Front 104

What is the inhalation route of administration?

Back 104

Drugs that are gaseous, or sprayable in small particles are inhaled into the lungs.

Front 105

Why is the inhalation route a more efficient route of drug administration?

Back 105

The lungs provide a large surface area for diffusion to take place.

Medication administered by this route bypasses the first-pass effect.

Front 106

What are disadvantages of inhalation administration of medications?

Back 106

Alveolar space irritation
Need for good coordination during self administration

Front 107

What is Intravenous (IV) administration?

Back 107

Drugs administered directly into a vein.

Front 108

Advantages of IV administration.

Back 108

Rapid access to the circulatory system with a known quantity of drug. Bypasses first-pass effect
Gold standard in regard to bioavailability.

Front 109

Disadvantages of IV administration.

Back 109

Repeated bolus doses can produce large fluctuation in peak and trough.

Front 110

When is intra-arterial administration of a drug usually done?

Back 110

When injection into a specific tissue is indicated.

Anticancer treatment for a specific tumor.

Front 111

What is Subcutaneous administration?

Back 111

Drug injected directly beneath the skin.

Front 112

What are absorption issues with Subcutaneous administration?

Back 112

Produces a slower, more prolonged release of medication into the blood stream.

Drug must diffuse through layers of fat and muscle to encounter sufficient blood vessels for entry into systemic circulation.

Front 113

How much liquid can safely be administered with a subcutaneous adminstration?

Back 113

2 to 3 mL

Front 114

What are possible problems associated with Subcutaneous administration?

Back 114

Dermal irritation and Necrosis.

Front 115

What is Intramuscular administration?

Back 115

injection of medication directly into the highly vascularized skeletal muscle.

Front 116

What are drawback to IM administration of drugs?

Back 116

Local pain and muscle soreness.

Front 117

What is the major factor when considering a site for IM injection?

Back 117

Blood flow to the area determines the rate of absorption.

Front 118

What is Topical Administration of drugs?

Back 118

Applying drugs to the site of action, primarily the skin.

Front 119

What are some topically administered drugs?

Back 119

Ointments
Creams
Drops
Gels.

Front 120

What are ointments?

Back 120

Occlusive, prevents water absorption or evaporation therefore having a hydrating effect typically produces greater local effects than creams.

Front 121

What is a cream?

Back 121

Water soluble and can be washed away from the skin more easily.

Front 122

What is a gel?

Back 122

The most water-soluble topical dosage form.

Allows medication to be spread more easily over a large area.

Front 123

What is Transdermal administration?

Back 123

The systemic delivery of medication through the skin.

Continuously delivers medication to achieve a constant blood level.

Front 124

What factors do drug distribution depend on?

Back 124

Blood flow to an area
Lipid or water solubility
Protein binding

Front 125

What must be available for an absorbed drug to distribute from the blood to the site of action?

Back 125

Adequate blood flow to the area.

Front 126

Where do lipid-soluble drugs readly distribute?

Back 126

Into the fatty tissues.

Front 127

Where do Water-soluble drugs readily distribute?

Back 127

Into the highly vascularized spaces of the skeletal muscle.

Front 128

What does the extent of drug binding to carrier proteins depend on?

Back 128

The affinity of the drug for the carrier protein.

The concentrations of both the drug and the proteins.

Front 129

Acidic drugs commonly bind to what?

Back 129

Albumin

Front 130

Alkaline drugs commonly bind to what?

Back 130

Alpha1-acid glycoprotein or lipoproteins.

Front 131

After absorption into the blood and lymph a drug may ciculate throughout the body bound to________.

Back 131

Carrier proteins such as albumin or
Unbound (free drug)

Front 132

What is the only way a drug can exert a pharmacologic effect?

Back 132

Unbound or free

Front 133

When does a drug become inactive in the blood stream?

Back 133

When it is bound to a protein.

Because it cannot leave the blood stream to exert its therapeutic action.

Front 134

When can a bound drug be realeased from a protein to become active?

Back 134

Once free drug is eliminated from the body through metabolism or excretion.

Front 135

What patient-specific factors can change the percentage of free drug in the blood stream?

Back 135

Nutritional status
Renal function
Levels of circulating protein or albumin.