foundations of pharm: quality and safety Flashcards
1
Q
describe pharmacology
A
study of drugs that alter functions of living organisms
2
Q
describe drug therapy
A
- use of drugs to prevent, diagnose, or treat signs, symptoms, and disease processes
- AKA pharmacotherapy
- when prevention or cure is not a reasonable goal, relief of symptoms can greatly improve a pts quality of life
3
Q
describe medications
A
- drugs given for therapeutic purposes
- given for either local or systemic effect
4
Q
describe effects of medications
A
- effects of medications refers to where they work or produce effects
- two categories are local and systemic
5
Q
describe local effects
A
- act mainly at the site of application
- examples include sunscreen lotions, hydrocortisone creams, and local anesthetics
6
Q
describe systemic effects
A
- drugs are taken into the body, and circulated by the bloodstream to sites of action in various body tissues, and are eventually eliminated from the body
- most drugs are given for their systemic effects
- an example would be intravenous antibiotic therapy
7
Q
True or False?
pharmacology is the use of drugs to prevent, diagnose, or treat signs, symptoms, and diseases
A
False
Rationale:
-Pharmacology is the study of drugs that alter functions of living organisms
-Pharmacotherapy (clinical pharmacology) is the use of drugs to prevent, diagnose, or treat signs and symptoms and diseases
8
Q
name some different drug sources
A
- plants
- animals
- minerals
- synthetic compounds
- semisynthetic
9
Q
Altropa belladonna, papavarum somniferum, tobacco, and rautwolfia serpentina are all examples of…
A
plants that can be used for drug sources
10
Q
describe synthetic compounds
A
- manufactured in laboratories
- more standardized in chemical compounds, more consistent in effect, and less likely to produce allergies
11
Q
describe semisynthetic drugs
A
- naturally occurring substances that have been chemically modified
- ex: many antibiotics
12
Q
drugs are classified according to effects on…
A
-specific body systems
-therapeutic uses
-chemical characteristics
13
Q
True or False?
Drugs often overlap classifications
A
True
- example: Morphine*
- specific body systems: central nervous system depressant
- therapeutic uses: potent analgesic
- chemical characteristics: narcotic
14
Q
describe a prototype
A
- individual drugs that represent groups of drug
- often the first drug of a particular group to be developed
- usually the standards against which newer, similar drugs are compared
15
Q
name some examples of prototypes
A
- Morphine - represents opioid analgesics
- Penicillin - represents beta-lactam antibacterial drugs
16
Q
individual drugs may have several different names, but the two that are most commonly used are…
A
the generic (official) name and the brand (trade) name
17
Q
describe a generic drug name
A
- chemical or official name
- independent of the manufacturer
- nonproprietary - not protected by trademark or patent or copyright
- often indicates a drug group (e.g. drugs with generic names ending in “cillin” are penicillins)
18
Q
name an example of a generic drug name
A
acetaminophen / amoxicillin
19
Q
describe a brand (trade) name
A
- designed and patented by the manufacturer
- proprietary - manufactured and sold only by the owner of the patent, formula, brand name, or trademark associated with the product
- examples include Tylenol and Amoxil
20
Q
for NCLEX prep you will need to study which drug names?
A
generic names
21
Q
True or False?
Over the Counter medications are not regulated by law
A
False
Rationale: Over the counter medications are regulated by various drug laws
22
Q
describe prescription drugs
A
- written by a licensed health care provider, such as physician, dentist, or nurse practitioner
- requires a written order
23
Q
describe over the counter (OTC)
A
- drugs available without a prescription
- regulated by various laws
- ease of access of these drugs has the potential to be dangerous
24
Q
describe orphan drugs
A
- drugs that are not financially viable and not adopted by a drug company
- experimental drugs, usually funded by the government, rare
25
**Which law (and its amendments) requires that official drugs meet standards of purity and strength?**
**a.** Durham-Humphrey Amendment
**b.** Comprehensive Drug Abuse Prevention and Control Act
**c.** Food, Drug, and Cosmetic Act of 1938
**d.** Controlled Substances Act
**c. Food, Drug, and Cosmetic Act of 1938**
**Rationale:** The Food, Drug, and Cosmetic Act of 1938 requires that official drugs meet standards of purity and strength as determined by chemical analysis or bioassay
- the Durham-Humphrey Amendment designates which medications mist be prescribed by a health care professional
- the Comprehensive Drug Abuse Prevention and Control Act regulates manufacturing and distribution of controlled substances
- the Controlled Substances Act categorizes controlled substances according to therapeutic usefulness and potential for abuse
26
Describe the Controlled Substances Act (1970)
- Title II of the Comprehensive Drug Abuse Prevention and Controlled Substances Act
- regulates manufacturing and distribution of narcotic, depressants, stimulants, hallucinogens, and anabolic steroids
- developed categories for ranking the abuse potential of various drugs
27
describe the Drug Enforcement Administration (DEA)
- **enforces** Controlled Substance Act
- registers individuals and companies legally empowered to handle controlled substances
- regulates documentation and handling of controlled substances
28
name the 5 categories of controlled substances
- schedule I
- schedule II
- schedule III
- schedule IV
- schedule V
29
define schedule I drugs and give examples
- high potential for abuse
- not currently accepted for medical use in U.S.
- lack of accepted safety for use of the drug under medical supervision
* Examples:* heroin, LSD, methamphetamine (MDMA or ecstasy), peyote, marijuana
30
define schedule II drugs and give examples
- high potential for abuse
- currently accepted medical use in the U.S.
- abuse may lead to severe psychological or physical dependence
* Examples:* hydromorphone, methadone, oxycodone, fentanyl, morphine, opium, codeine, cocaine, amphetamine, methamphetamine
31
define schedule III drugs and give examples
- potential for abuse less than schedule I and II drugs
- currently accepted medical use in the U.S.
- abuse may lead to moderate or low physical dependence or high psychological dependence
* Examples:* Vicodin, tylenol with codeine, ketamine, anabolic steroids (depo-testosterone), mixtures containing small amounts of controlled substances
32
define schedule IV drugs and give examples
- lower potential for abuse less than schedule III drugs
- currently accepted medical use in the U.S.
- abuse may lead to limited physical or psychological dependence relative to schedule III substances
* Examples:* lorazepam, alprazolam, clonazepam, sedative hypnotics, and some prescription appetite suppressants
33
define schedule V drugs and give examples
- low potential for abuse relative to schedule IV substances
- currently accepted medical use in the U.S.
- abuse may lead to limited physical or psychological dependence relative to schedule IV substances
* Examples:* Robitussin AC, antidiarrheal drugs, cough suppressants containing small amounts of codeine
34
what organizations regulates the development and sale of drugs
FDA
35
which laws further regulate and approve prescription and OTC drugs
local
36
which law set standards for toxicity and monitoring labeling
federal food, drug, and cosmetic act of 1938
37
describe FDA pregnancy safety categories
used to have categories. in 2015, due to confusion the FDA no longer uses these categories, but nurses will still see them r/t the complex transition of the new system which includes risk levels
38
describe category A of the FDA pregnancy categories
controlled studies of pregnant women show no risk in first trimester
39
describe category B of the FDA pregnancy categories
animal studies show no risk, or animals show risk unconfirmed in humans
40
describe category C of FDA pregnancy categories
animal studies show risk, caution is advised, benefits may outweigh risks
41
describe category D of the FDA pregnancy categories
evidence of risk to human fetus, benefits may outweigh risks in serious conditions
42
describe category X of the FDA pregnancy categories
risk outweighs benefit
43
medication administration nursing guidelines are dictated by…
QSEN
44
dictates procedure and protocol for safe medication administration
The institutes for safe medication practices (ISMP)
45
what are some sources of drug information
- pharmacology and textbooks
- drug reference books
- journal articles
- internet sites
