Exam 1 Material Flashcards
Define pharmacology
The study of medicine
Define pharmacotherapeutics
Using medicine to treat disease and alleviate suffering
Define pharmaceutics
The science of preparing and dispensing/sale of drugs
Define drugs/medications
Chemically produced products that elicit an effect
Define biologics
Produced naturally in animal cells, microorganisms, or the body (ex. flu vaccine) Fastest growing group of drugs
Define biosimilar
A biologic that is almost identical to an existing, FDA approved biologic medication (reference product)
Define complementary and alternative medicine (CAM)
Natural plant extracts, herbs, vitamins, minerals, dietary supplements, therapies (massage, acupuncture, PT)
Define therapeutic drug classification
What is the clinical indicator
Define pharmacologic drug classification
How the drug works within the body; its mechanism of action
What are the 3 different types of drug names?
Chemical Generic Trade
What is a chemical drug name?
- Only one chemical name per drug; assigned
- Usually too long and difficult to be practical
What is a generic drug name?
- Only one generic name per drug; assigned
- Commonly used in practice
- Starts with a lowercase letter
What is a trade drug name?
- Brand, proprietary name
- May be several trade names for one drug
- Assigned by manufacturer
- Patient’s may know this better
- First letter will be capitalized
What is bioavailability?
- Physiologic ability of drug to reach target cells and produce an effect
- Factor that can be taken into consideration when comparing generic vs brand drugs
- Small changes can cause changes in bioavailavility
- Some drugs you can’t substitute them without permission (immunosuppressants)
Prescription vs over the counter medications
- Prescriptions
- Patient education
- Stronger dosage
- Drug interactions are noted
- Takes time and money
- More expensive
- OTC
- Cheaper
- Convienent
- Patient education through pharmacologist available
- Treat yourself
- May not be the right drug to treat
- Drug interactions may not be noted
FDA stages of approval for a new medication
- Preclinical investigation (Safety)
- Basic science research, lab tests on cells, animal testing
- Clinical investigation (Efficacy)
- Clinical phase trial
- New drug application (NDA) reviewed (Confirm)
- Phase III trails and animal testing may continue
- Postmarketing studies (Review)
- Continue to observe humans for adverse effects (long term)
What is a schedule I drug?
A drug with the highest abuse potential; little or no therapeutic effects
Examples: heroin, LSD, ecstacy, marijuana
What is a scheudle II drug?
A highly controlled drug
Examples: Dilaudid, fentanyl, methamphetamine, cocaine, Ritalin
What is a scheule III drug?
Medium potential for abuse
Examples: codeine, ketamine, anabolic steroids, testosterone
What is a schedule IV drug?
A drug with little abuse potential
Examples: Xanax, Valium, Versed, Tramadol
What is a schedule V drug?
Has the lowest abuse potential; some available without prescription
Examples: Lomotil, Lyrica, cough syrup with codeine
What is a teratogenic substance?
Something that has the ability to harm a developing fetus or embryo
Why did the FDA implement the Pregnancy and Lactation Labeling Rule (PLLR)?
To better inform providers, pregnant, and lactating women about the risks and benefits of taking medication. The new labeling should help assist health professionals inform patients as well as allow patients to make their own informed and educated decisions for themselves.
How did the pregnancy categories change?
Went from:
- Pregnancy
- Labor and Delivery
- Nursing Mothers
To:
- Pregnancy (includes L&D)
- Lactating women (includes nursing)
- Females and Males of Reproductive Potential