Fundamentals 1

Tuesday, September 20, 2022 2:36 PM

Learning Objectives for Fundamental Principles Lecture

1. List the attributes of the “perfect drug”.

"TRAIIN MEE"

Treats, prevents, or cures a patient's condition

Rapid, predictable
Adverse effects (None, baby~)
Infrequent
Inexpensive
Non-interactive w/ other meds
Mouth (PO): convenient/easy to take
Eliminate quickly
Effective

VERY FEW DRUGS, IF ANY, ARE PERFECT.

2. Differentiate between the chemical, generic and trade name.

Chemical name: Named after the drug's chemical structure; this is almost never used to identify a drug because it's a pain in the ass to remember.

Generic name: A name given to it by the FDA, this is a non-proprietary name that is always given to a specific drug compound. Often has patterns to it. A
drug will NEVER have more than one generic name.

Trade name: Also known as the proprietary name, this is the brand name of a drug. Drugs can have multiple of these because there's a lot of drug
companies.

Example: N-acetyl-p-aminophenol is the chemical name, acetaminophen is the generic name, and Tylenol is one of the trade names.

3. Define indications and contraindications as they refer to medications.

Indications: Why someone is going to be taking the thing.

Contraindications: Why someone BETTER NOT BE TAKING the thing. The thing can cause them some serious harm!

4. Describe the most common types of abbreviation and dosing errors.

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5. What are the sources of drugs. Give examples for each source.

Plants: aspirin (it comes from willow trees), opium (comes from opium poppies)
Animals: Premarin (estrogen source from pregnant mares), insulin (used to come from beef and pork animals after slaughter), pepsin (comes from the
stomach of a cow), fish oil (comes from little fish like anchovies and sardines), antitoxin sera (we stab an animal with diphtheria or tetanus, take the
antibodies from their blood)
Microbes: Penicillin from Penicillium molds, Dextran from lactobacillus family
Minerals: you can use ferrous sulfate for anemia, magnesium sulfate for constipation, and selenium in dandruff shampoo (Thanks Head n Shoulders)
Synthetic: we make this in a lab - think things like aspirin, antihistamines, anesthetics, and fentanyl.
Semi-Synthetic: We take something and then mess with it to make it better to take. So think penicillin being turned into ampicillin.
Biosynthetic: Hepatitis B vaccine (yeast) , recombinant insulin (bacteria). Basically, we make it in a lab like this:

6. Differentiate between primary, secondary and tertiary references.

Primary: Most recent info, data from clinical studies

Secondary: Databases used to search for primary sources
Tertiary: summarizes, evaluates, or interprets primary sources

7. Given a source, properly identify it as primary, secondary or tertiary.

If you have to interpret it or if it's from a study/medical journal, it's primary.

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If you have to interpret it or if it's from a study/medical journal, it's primary.

If it's a data base, it's secondary.

If it's anything of the above, it's tertiary.

8. Provisions of the Pure Food and Drug Act of 1906, Food Drug and Cosmetic Act of 1938, the
Durham-Humphrey Amendment of 1952, the Kefauver-Harris Amendment of 1962, the
Drug Price Competition and Patent Term Restoration Act of 1984 and the Controlled
Substances Act of 1970.

Before 1906: No laws at all.

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Pure Food and Drug Act of 1906: You have to list 1 of 11 dangerous drugs if it's in there, there can be no false claims on the packages, the United States
Pharmacopoeia and the National Formulary can set standards and purity strength. BUT this only applied to drugs sold between states or internationally
so it was basically useless even though it was passed in order to protect the public from adulterated or mislabeled drugs and food.

Food Drug and Cosmetic Act of 1938: drug manufacturers have to test for harmful effects AND drug labels need to be accurate and complete.

Durham-Humphrey Amendment of 1952: specified how prescription drugs can be ordered and dispensed.

Kefauver-Harris Amendment of 1962: All drugs now need proof of safety and efficacy before they can be approved for sale. Generics of drugs originally
sold between 1938 and 1962 can now be sold.

Drug Price Competition and Patent Term Restoration Act of 1984: generic drugs now need an abbreviated new drug application, companies get 5 years of

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Drug Price Competition and Patent Term Restoration Act of 1984: generic drugs now need an abbreviated new drug application, companies get 5 years of
market exclusivity (AKA they're the only ones allowed to sell it) for pioneer drugs which can be extended for developments, and there can now be generics
of drugs made after 1962.

Controlled Substances Act of 1970: Controlled substances are now sorted into classes by abuse potential AND prescriptions need to be sent electronically to
the DPS.

9. List the requirements for approval of an NDA and an ANDA.

NDA Requirements:

These need to be safe to take, effective for whatever they're treating, you have to know what side effects it has, and what the dose is. There's a lot of testing
involved.

ANDA Requirements:

They have to have pharmaceutical equivalence and bioequivalence to the original drug. They've got a much more revised process, which is why it's called
the "abbreviated" new drug application.

10. Definitions for pharmaceutical equivalence and bioequivalence.

Pharmaceutical equivalence: a generic will have the same active ingredients as the original drug, same dosage form, same strength, and the same route (so
you can't have the original drug be a pill and the generic be an IV drug, it'd technically be a different drug). BUT it can be a different shape, scored
differently, and have different excipients.

Bioequivalence: the rate and extent of absorption is within 80 to 125% of the pioneer drug (most drugs within 5% because who wants a shittier version of
the drug?) so it's basically the same or close enough.

11. The differences between Phase 1, Phase 2, Phase 3 and Phase 4 studies in the FDA approval and review process.

Phase Requirements
New Drug Made None
Phase 1 Initial pharmacologic eval, you test on a small
amount of regular people to make sure it's
okay
Phase 2 You start testing on a small group of actual
sick people to see if it treats their disease
Phase 3 You test on a bunch of people to figure out
dosages and side effects AKA how much is it
okay to give someone.
Phase 4 Submit New Drug application for FDA

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Phase 3 You test on a bunch of people to figure out
dosages and side effects AKA how much is it
okay to give someone.
Phase 4 Submit New Drug application for FDA
approval

12. Definition of Schedule I, Schedule II, Schedule III, Schedule IV, Schedule V controlled substances

Phase High abuse Accepted Dependence Refills? Example

potential Medical Use
Schedule Yes No, research only Severe dependence NO Heroin, Mescaline, Marijuana, Peyote,
I LSD, Ecstasy
Schedule Yes Accepted medical Severe dependence No refills, need WRITTEN Oxycodone, Cocaine, Morphine,
II use official prescription Pentobarbital, Meperidine, Amphetamine
Schedule Less abuse Accepted medical Low/moderate physical 6 months of refills, can have Acetaminophen with codeine,
III potential than I & use dependence, high oral or written prescription Buprenorphine (Suboxone®), Anabolic
II psychological steroids, Ketamine
dependence
Schedule Less abuse Accepted medical Limited dependence Written/oral prescription, 6 Phenobarbital, Diazepam (Valium®),
IV potential than III use months refills Carisoprodol (Soma®)
Schedule Less abuse Accepted medical Limited dependence May not need a prescription Codeine (in limited quantities)
V potential than IV use at all

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