How to Become a Drug Flashcards
Who is the FDA?
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
First and prior to applying for drug approval, the manufacturer must do
Preclinical testing which may take 3-6 years
and involves laboratory and animal testing to determine specific biological activity of drug
In vitro testing
test tubes
In vivo testing
animals
What does in vivo testing involve?
Frequency curve
Half-life
Median effective dose
Median toxicity dose
Therapeutic index
What is a frequency curve?
Curve- the number of animals who do or don’t respond to the drug
Half-life
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
Therapeutic index
the higher this number the better, this means there is large difference between the effective and toxic dose
What are the steps in drug testing?
In vitro testing
In vivo testing
IND (investigational new drug)
What is IND?
Investigational New Drug
Testing on people
What is the new drug approval process?
- File for IND status
- show data from in vitro and in vivo testing - Clinical trials
- Submit new drug application (NDA)
- allows physicians to prescribe the new drug - Continuous monitoring of the drug in general population of patients
- adverse and long term effects
How many phases are there in the clinical trial approval process?
3
Phase I of clinical trials
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
Phase II of clinical trials
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
Phase III of clinical trials
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
Classes of recall
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)
FDA approval process (quick run down)
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
When are drugs withdrawn or recalled?
Adverse effects (usually death)
Incorrect active ingredient
Drug loses effectiveness before expiration date
Contamination
Orphan Drug Act
Provides financial assistance and streamlines process of drug development for rare diseases
- impacts les than 200,000 people
Right to Try Law
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
bid
twice a day
tid
three times a day
qid
four times a day
Forms of tablets
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
Forms of drugs
Tablet
Capsule
Film
Ointment, cream, lotion
Liquid
Powder
Suppository
Transdermal patch
Pellets, seeds, beads, wafers, inserts
Capsules
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.
Film
Looks like tape
Dissolves under tongue, absorbs into mucal membrane
Works super fast
Ointment, cream, lotion
Most are local or topical
Stays at dermal or epidermal layer
Ointment - thick
Cream - a little less thick
Lotion - thin
Liquid
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
Powders
2 types
- Crushed: has to be reconstituted in water before it can be injected or taken orally
-Topical: antifungal for skin Tinactin
Suppository
Vaginal or rectal
Transdermal patch
Designed to release a drug that penetrate the skin, systemic
Pellets, Seeds, Beads, Wafers, Inserts
Long term slow release
- Cancer
- Contraception devices
Topical route
Applied to skin, eye, ears, vagina
Usually localized effect
Eye drops, yeast infections, birth control(spermicide), fungus
Transdermal route
Applied to the skin but the effect is systemic
Hormones, Nicoderm, birth control
- Often a patch
Oral route
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
Sublingual and buccal routes
Cross between oral and topical
- Not a lot of drugs
- Small dosages
Under tongue or cheek
Not swallowed-dissolves
Fast acting
- Nitroglycerin (Nitrostat)
Intranasal and inhalation route
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
Nasogastric route
Any oral medication can be given this way
Food
Gastronomy or jejunostomy tube
Feeding tube
Intravesical route
Through urethra
Bladder infections and chemo
Rectal route
Pts who are unable to take oral meds
Systemic absorption-not as predictable
Suppositories for constipation
How do we measure drugs?
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
When do we use inches when measuring drugs?
for ointment
When do we use drops when measuring drugs?
eye and ear liquids
When do we use percentages when measuring drugs?
Percentage-how much of the product is drug (10% solution) or Ratio-1:10000 (1 part drug to 10000 parts solutions)
When do we use household measurements when measuring drugs?
Unofficial (varies) teaspoon (4-7 ML)
How to dispose of drugs
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
