Exam 1 - Detailed Flashcards
From slides not study guide
What is Pharmaceutical Sciences?
Group of interdisciplinary studies (multiple fields of study) which look at the design, action, delivery and disposition of drugs
What are the 3 disciplines of study in Pharmaceutical Sciences?
Pharmaceutics
Biopharmaceutics
Pharmacokinetics
What does pharmaceutics look into?
The physiochemical properties of drugs and dosage forms (tablet, solution, etc.) as it relates to dosage form design
What does biopharmaceutics look into?
The interrelationship between the physiochemical PROPERTIES of drugs, the dosage forms (tab, solution, etc.), and the route of administration (oral, nasal, etc.) on RATE AND EXTENT of drug absorption into the body
What does pharmacokinetics study?
The movement of drugs within the body (fate after it is released from the dosage form)
Absorption
Distribution
Elimination
What is the purpose of drugs?
To cure or mitigate an abnormality of human physiology (insulin for diabetes)
How do drugs work?
Through interactions with drug targets
What are the 5 common macromolecules that act as drug targets?
Enzymes Ion Channels Membrane Transport Proteins Nuclear Hormone Receptors G-Protein Coupled Receptor (most common)
Where do drugs work for non systemic targets? (3 examples)
Skin
GI tract
Bronchioles
What is the pathway of a drug throughout the body if given orally (by mouth)?
Mouth Stomach/intestines (absorbs) Liver (detoxifies) Right side of heart (non oxygenated blood) Lungs (pick up oxygen) Left side of heart Rest of the body or brain
What is the pathway for IV (intravenous), IM (intramuscular), and SC/SQ (subcutaneous) injections throughout the body?
Site of injection (muscle, under skin, in veins) Blood circulation Right side of heart (non oxygenated) Lungs (pick up oxygen from alveoli) Left side of heart Rest of body or brain (drug target)
What are the main factors of a drugs distribution to its targets in the body?
Anatomical and Physiological factors based on route of administration
Blood flow to various tissues
Protein and tissue binding
Mass Transport (passive or active)
What does LADME mean and what is it in relation to?
The fate of the drug after it is administered
Liberation (release of drug from dosage form)
Absorption (into bloodstream)
Distribution (to various parts of the body)
Metabolism (by enzymes)
Excretion (through the kidneys or other routes)
How do we measure the amount of drug in the body?
Through the concentration of the drug in plasma or urine concentration (usually the urine concentration since it is less invasive)
What is the volume of distribution?
An indicator of how well distributed a drug is in the body
amount of drug in the body/ plasma concentration
What is bioavailability?
The proportion of an administered dose of unchanged drug that reaches systemic circulation
(the amount of drug that the body circulated in relation to the amount of drug given to patient)
What is clearance?
The volume of plasma cleared of drug per unit of time
What is half-life?
The time required for plasma concentration of drug to decrease by 50%
A patient says they feel dizzy and have not eaten that day. What is one QUANTITATIVE measure of effect would you check for?
Blood sugar levels
What route of administration would be given via between the cheek and gums?
Buccal (in anatomy means the cheek)
What route of administration would be given via the eye surface?
Ophthalmic (solution - eye drops)
What route of administration would be given via the mouth when swallowed?
Oral (solution, tablet, capsule)
What route of administration would be given via the nasal cavity?
Intranasal (Flonase spray, solution)
What route of administration would be given via the peritoneal cavity?
Intraperitoneal infusion
What route of administration would be given via the rectum?
Rectally (suppository/cream/ointment)
What route of administration would be given via the striated muscles (thigh, buttocks)?
Intramuscular injection (solution - testosterone)
What route of administration would be given via the subcutaneous fat?
Subcutaneous (under the skin) injection (solution- insulin)
What route of administration would be given via under the tongue?
Sublingual (Disintegrating tablet “ODT” or SL tablets)
What route of administration would be given via the vagina?
Vaginal (suppository/ cream/ ointment)
What route of administration would be given via the veins?
Intravenous injection/infusion (solution)
What route of administration would be given via the epidermal surface?
Topical (creams, ointments)
Transdermal (patches)
What route of administration would be given via the mouth when inhaled?
Pulmonary
usually in a powder form for inhalers
What drug info can you find in the United States Pharmacopeia?
Monographs Dietary Supplements Dosage Forms Compounding Preparations (Mom Diets, Dad Compounds)
What can you find in the National Formulary?
Everything not found in the USP
You receive a prescription for In versaPro Base Cream (a non-sterile compound), what USP chapter would you look into for information of this kind of compounding?
USP Chapter 795
What can you find in USP Chapter 797?
Sterile Preparations for compounding
If you wanted to find information about the handling and disposing of Warfarin (a hazardous drug), what USP chapter would you look in?
USP Chapter 800
What can you find in USP 1160?
Pharmaceutical Calculations
What can you find in USP 1163?
Quality Assurance for Compounding
What are the compendial standards (a bunch of info important to protecting public health) found in USP and NF?
Strength
Purity
Quality
Packaging and Labeling
What are 3 other pharmacopeias other than the USP and NF?
HPUS (homeopathic pharmacopeia of the us)
IP (pharmacopeia internationalis)
EP (European Pharmacopeia)
What did the Food and Drug Act of 1906 require?
Compliance of drugs marketed between states to comply with standards for strength, purity, and quality.
What amendment prohibited false claims of drug uses?
Sherley Amendment of 1912
What act created the FDA in response to deaths in patients using an antibiotic that contained antifreeze?
Federal Food, Drug, and Cosmetics act of 1938
What Amendment created Rx Only and refill status?
Durham-Humphrey Amendment of 1951
What Act made companies submit a New Drug Application (NDA)?
Federal Food, Drug and Cosmetics Act of 1938
What amendment allowed the FDA to inspect manufacturing sites and practice guidelines?
Kefauver-Harris Amendments of 1962
in response to the birth defects from Thalidomide which was given to pregnant women to get rid of morning sickness
What did the Comprehensive Drug Abuse Prevention and Control Act of 1970 do?
Create scheduling of drugs
Created the DEA
A patient comes in to pick up her prescription for Alprazolam 2mg. You ask to see her ID and she is asking why you need to see her ID. What would you tell her?
Alprazolam (Xanax) is a federally controlled substance and we would need to confirm her Identity for pick up.
(it is a schedule 4 drug)
If a drug has no medical use (according to federal law) and a high potential for abuse, what schedule would it be in?
Schedule I
LSD, weed, heroin, ecstasy
What schedule is cocaine classified as?
Schedule II
has a medical use - local anesthetic - but is highly abused
What schedule is testosterone in?
Schedule III
accepted for medical use and still abused but less abused than CII and CI
What Act created NDC codes?
1972 Drug Listing Act
What do the first 5 numbers of the NDC code represent?
The manufacturer
What do the second 4 numbers of the NDC represent?
Drug
What do the last 2 numbers of the NDC code represent?
package size
A patient gets diagnosed with a rare disease that only 100,000 people have, but luckily there is a new FDA approved drug for their disease. Without which act would this have probably not been possible?
The Orphan Drug Act of 1983
If a manufacturing company’s patent for a drug was about to end and they wanted to release a generic form of their medication, what application would they need to complete?
Abbreviated New Drug Application (ANDA)
What act allowed approval for cheaper generic equivalents of brand name drugs?
Drug Price Competition and Patent Term Restoration Act of 1984
Your company wants to speed up the drug approval process and essentially bribes the FDA to hurry up and it works. What act does your company have to thank for the FDA’s speed?
1992 Prescription Drug User Fee Act
You are now a pharmacist. The only medical health care provider that gives out free medical knowledge to patients. What act can patients thank for our free advice?
The omnibus budget reconciliation act of 1990
What actS require that OTC (over the counter) supplements must contain the disclaimer “This product is not intended to diagnose, treat, cure, or prevent any disease”.
Dietary Supplement Health and Education Act of 1994
Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006
What did the biologics price competition and innovation act of 2009 do?
Shortened or accelerated approval pathway for biologic drugs that have demonstrated to be highly similar to or interchangeable with FDA licensed biological products.
What act created Obamacare?
Patient Protection and Affordable Care Act of 2010
If a drug has a black box around the label, what can you tell about this drug?
It has serious adverse reactions
TF:80% of the active ingredients used in the manufacture of drug products are made in the US?
False
80% are imported from other countries
A drug is recalled for causing serious adverse health consequences and some deaths. What Class of recalls does this fall into?
Class I
A drug is recalled because of faulty packaging. What class of recalls does this fall into?
Class III (no serious adverse health consequences)
A drug is recalled due to a bacterial contamination in a batch that was sent out which may cause symptoms for 3-5 days. What class of recalls would this fall into.
Class II (temporary health consequences)
