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Geriatrics > How to Become a Drug > Flashcards

How to Become a Drug Flashcards

1
Q

Who is the FDA?

A

Food and Drug Administration
Housed within the Department of Health and Human Services
Responsible for the review and approval of all new drugs before they can be made available to the public
Responsible for recalling drugs that are unsafe

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2
Q

First and prior to applying for drug approval, the manufacturer must do

A

Preclinical testing which may take 3-6 years
and involves laboratory and animal testing to determine specific biological activity of drug

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3
Q

In vitro testing

A

test tubes

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4
Q

In vivo testing

A

animals

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5
Q

What does in vivo testing involve?

A

Frequency curve
Half-life
Median effective dose
Median toxicity dose
Therapeutic index

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6
Q

What is a frequency curve?

A

Curve- the number of animals who do or don’t respond to the drug

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7
Q

Half-life

A

the time it takes the drug to go from 100% to 50%, the shorter the half-life the more frequently it has to be given

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8
Q

Therapeutic index

A

the higher this number the better, this means there is large difference between the effective and toxic dose

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9
Q

What are the steps in drug testing?

A

In vitro testing
In vivo testing
IND (investigational new drug)

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10
Q

What is IND?

A

Investigational New Drug
Testing on people

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11
Q

What is the new drug approval process?

A
  1. File for IND status
    - show data from in vitro and in vivo testing
  2. Clinical trials
  3. Submit new drug application (NDA)
    - allows physicians to prescribe the new drug
  4. Continuous monitoring of the drug in general population of patients
    - adverse and long term effects
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12
Q

How many phases are there in the clinical trial approval process?

A

3

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13
Q

Phase I of clinical trials

A

Small number (80-100) of healthy volunteer subjects over a 1-2 year period
Purpose: to check how the body handles the drug and confirm safe dosages

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14
Q

Phase II of clinical trials

A

Moderate number (100-300) of actual patients over a 2-3 year period
Purpose: to determine effectiveness and short-term side effects or drug interactions

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15
Q

Phase III of clinical trials

A

Expanded to exceptional populations
Large number (1000-3000) of actual patients over a 3-4 year period
Purpose: to determine effectiveness and short-term side effects or drug interactions of new drug compared to another therapy

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16
Q

Classes of recall

A

Class 1 recall: reasonable potential for health risk to consumer
Class 2 recall: remote potential for health risk to consumer
Class 3 recall: not likely to cause health risk to consumer (usually involves mislabeling of drug)

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17
Q

FDA approval process (quick run down)

A

Lab animals: 3-6 years
Clinical Trials: Can take 4+ years
- Phase I: 20-80 healthy individuals
- Phase II: 1000-300 patients with disease, short term effects
- Phase III: 1000-3000 patients for comparison with other treatment
- FDA Approval
- Phase IV: Post marketing monitoring
> Recalls: lot numbers
> Drug Information Resources: PDR, computer resources
> Drug Information Sheets: prepared to create education for consumers and providers

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18
Q

When are drugs withdrawn or recalled?

A

Adverse effects (usually death)
Incorrect active ingredient
Drug loses effectiveness before expiration date
Contamination

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19
Q

Orphan Drug Act

A

Provides financial assistance and streamlines process of drug development for rare diseases
- impacts les than 200,000 people

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20
Q

Right to Try Law

A

May 22, 2018 signed into law by Donald Trump
Created with the intent of allowing terminally ill patients accessexperimental therapies(drugs, biologics, devices) that have completedPhase Itesting but have not been approved by theFDA.
- False hope
- Hasten death or illness

21
Q

bid

A

twice a day

22
Q

tid

A

three times a day

23
Q

qid

A

four times a day

24
Q

Forms of tablets

A

Solid
Color and shape vary
- Can help the Pharmacist and Pt tell them apart
Scored
Effervescent
Eneric (coated)
Slow release
Caplets
Lozenges (OTC)
Troche: dissolves in a sugary paste when placed in mouth

25
Q

Forms of drugs

A

Tablet
Capsule
Film
Ointment, cream, lotion
Liquid
Powder
Suppository
Transdermal patch
Pellets, seeds, beads, wafers, inserts

26
Q

Capsules

A

One piece gelatin with liquid
2 piece hard gelatin with powdered or granular drugs
- This is what they tampered with in the Tylenol cases
- Most of these are in blister packs or other methods to prevent tampering now.

27
Q

Film

A

Looks like tape
Dissolves under tongue, absorbs into mucal membrane
Works super fast

28
Q

Ointment, cream, lotion

A

Most are local or topical
Stays at dermal or epidermal layer
Ointment - thick
Cream - a little less thick
Lotion - thin

29
Q

Liquid

A

Solutions: the drug in liquid form, the drug is concentrated equally in the liquid base
- Injections (come in ampules or vials)
- Elixirs: have alcohol
- Syrups: thicker (soothing effect) no alcohol
- Tictures: liquid but not taken by mouth! Iodine
- Sprays: usually nose or mouth
- Foams/Mousse-Rogaine-RID
Suspension: the drug is suspendend in the
After a while it settles

30
Q

Powders

A

2 types
- Crushed: has to be reconstituted in water before it can be injected or taken orally
-Topical: antifungal for skin Tinactin

31
Q

Suppository

A

Vaginal or rectal

32
Q

Transdermal patch

A

Designed to release a drug that penetrate the skin, systemic

33
Q

Pellets, Seeds, Beads, Wafers, Inserts

A

Long term slow release
- Cancer
- Contraception devices

34
Q

Topical route

A

Applied to skin, eye, ears, vagina
Usually localized effect
Eye drops, yeast infections, birth control(spermicide), fungus

35
Q

Transdermal route

A

Applied to the skin but the effect is systemic
Hormones, Nicoderm, birth control
- Often a patch

36
Q

Oral route

A

Most commonly used
Absorbed from the stomach or intestines into blood stream
- PO or p.o vs NPO
Problems
- People who can’t swallow
- Vomiting or unconscious
- Stomach acid or liver
- Some foods or no foods

37
Q

Sublingual and buccal routes

A

Cross between oral and topical
- Not a lot of drugs
- Small dosages
Under tongue or cheek
Not swallowed-dissolves
Fast acting
- Nitroglycerin (Nitrostat)

38
Q

Intranasal and inhalation route

A

Intranasal-Typically locally acting for allergies, can be systemic
- Absorbed by the mucal surfaces-surpasses the liver
Inhalation-absorbed through the alveoli
- Usually respiration related, asthma, COPD

39
Q

Nasogastric route

A

Any oral medication can be given this way
Food

40
Q

Gastronomy or jejunostomy tube

A

Feeding tube

41
Q

Intravesical route

A

Through urethra
Bladder infections and chemo

42
Q

Rectal route

A

Pts who are unable to take oral meds
Systemic absorption-not as predictable
Suppositories for constipation

43
Q

How do we measure drugs?

A

Typically using metric system
Milligrams and micrograms
If less than 1, it is written as a decimal, never a fraction
0.5 ml of Tylenol

44
Q

When do we use inches when measuring drugs?

A

for ointment

45
Q

When do we use drops when measuring drugs?

A

eye and ear liquids

46
Q

When do we use percentages when measuring drugs?

A

Percentage-how much of the product is drug (10% solution) or Ratio-1:10000 (1 part drug to 10000 parts solutions)

47
Q

When do we use household measurements when measuring drugs?

A

Unofficial (varies) teaspoon (4-7 ML)

48
Q

How to dispose of drugs

A

Pharmacies often dispose
Police Departments
DO NOT FLUSH OR PUT DOWN SINK
Dissolve in water and put in something inedible substance (dirt, coffee grounds, kitty litter) and throw away
Scratch out personal information

Geriatrics (20 decks)

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