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59 Cards in this Set

  • Front
  • Back
(def)

the study of the effects of chemical substances on living tissue
Pharmacology
Chemical substances classified as drugs can be derived from what 3 sources?
- plants
- animals
- inorganic compounds
What drug is extracted from the foxglove plant?
digoxin (Lanoxin)
Natural conjugated estrogen (Premarin) is derived from what source?
the urine of pregnant mares
What drug can be obtained from the pancreas of pigs?
insulin
Is iron derived from plants, animals or inorganic compounds?
inorganic compounds
What drug type can be produced by the genetic engineering of the DNA of E. Coli?
Insulin
(def)

the application of pharmacology to prevent disease
Pharmacotherapeutics (clinical pharmacology)
In 1906, the "Federal Food and Drug Act" was passed to protect the public by controlling the sale of drugs which were _______, ________, and _______ ________.
altered, dangerous, and falsely labeled
Although the "Federal Food and Drug Act" was the first step taken to make drugs safer, it did little to ensure what?
effectiveness
What original publication was designated as the official publication of drug standards?
"United States Pharmacopeia"
What original publication was designated as the official listing of all drugs available in the US?
"National Formulary"
The "United States Pharmacopeia" and the "National Formulary" are now combined and updated how often?
Every 5 years
What is the purpose of the "Food and Drug Administration Drug Bulletin" that is published quarterly?
to impart new information to health practitioners involved in prescribing or dispensing drugs
How does the term "formulary" apply to Health Insurance companies or Pharmacies?
Health Ins. companies may use a formulary, or list of drugs that they will pay for, as a guideline for payment. Pharmacies may have their own formulary for what drugs they will or will not carry.
What was the purpose for the 1912 "Federal Food and Drug Act - Sherley Amendment"?
to prohibit drug companies from making false claims about their products
What was the purpose of the 1914 Harrison Narcotic Act?
It defined the legal term "narcotic" and regulated the importation, manufacturing, and sale of opium, cocaine, and their derivatives.
What was the purpose of the renaming of the "Federal Food and Drug Act" to the "Federal Food, Drug, and Cosmetic Act" in 1938.
- It mandated pharmaceutical companies to submit an investigational new drug (IND) application to the FDA and conduct toxicity testing in lab animals before marking new drugs (and cosmetics).

- FDA was empowered to approve and recall drugs
What was the purpose of the 1951 "Federal Food, Drug, and Cosmetic Act - Durham-Humphrey Amendment"?
- prescription (legend) and OTC drugs had to be distinguished. Legend drugs had to beard the inscription "Caution - Federal Law prohibits dispensing without a prescription"

- specified that controlled substances could not be refilled without a new prescription

- Restricted the dispensing of drugs to licensed pharmacists
What was the purpose of the 1962 "Federal Food, Drug, and Cosmetic Act - Kefauver-Harris Amendment"?
- required drugs be effective as well as safe
-revisited the issue of drug companies making false claims
- pregnancy safety categories were introduced
What was the purpose of the 1970 "Comprehensive Drug Abuse Prevention and Control Act"?
- categorized addictive drugs into 5 schedules according to abuse potential

- DEA controlled legislation re: controlled substances

- Gov. Programs to prevent and treat drug abuse were established
Which schedule of drugs is considered to be the most addictive?
Schedule 1
What effect did the "Comprehensive Drug Abuse Prevention and Control Act" have on nursing?
Double-lock system
What was the purpose and result of the 1982 "Tamper Proof Packaging Requirement" act?
Purpose - to prevent tampering
Result - OTC drugs had to be packaged in such a way that it was obvious if it had been tampered with
What was the purpose of the 1983 "Orphan Drug Act"?
Offered substantial tax credits to pharmaceutical companies to develop drugs to treat rare diseases or which have a limited market.
What was the purpose of the 1984 "Generic Drug Law"?
enabled pharmaceutical companies to manufacture and market a drug under the generic name and to apply their own trade name once the patent held by the original manufacturer expired.
A generic drug is considered a bioequivalent if the peak serum concentration and the plasma-concentration curve fall within ____ - _____ % of the original brand-name drug.
80-125%
What is the primary reason that generic drugs are less expensive than that of the original manufacturer?
studies do not have to be duplicated
What was the purpose of the 1992 "Drug Relations Act"?
Allowed the review process to be accelerated if the drugs would be used to treat HIV, AIDS, or cancer. (fast-tracked)
What was the purpose of the 2003 "Pediatric Research Equality Act"?
required testing of certain drugs for safety and effectiveness in children
What was the purpose of the 2003 "Medicare Prescription Drug and Modernization Act"?
provides financial assistance to senior citizens to purchase prescription drugs
Who controls drug testing in the US?
Food and Drug Administration
True/False:

Drugs marketed as dietary supplements (vitamins, minerals, and herbs) do not have to be monitored by the FDA.
False- effective 2007 the FDA began monitoring these agents (there is a 3 year phase in for smaller companies)
What is granted by the FDA if the laboratory studies (pre-clinical) studies are satisfactory?
"Investigational New Drug Exemption" which will permit testing on humans
How many phases are clinical trials on humans?
4
During which phase of clinical trials is the drug given to a small # of healthy volunteers?
Phase 1
What group of people are generally excluded from clinical trials?
Women of child-bearing age
During which phase of clinical trials is the drug given to a small number of volunteers who have the disorder that the drug is intended to treat?
phase II
During which phase of clinical trials is the drug given to a large # of patients who have the disorder?
Phase III
During which phase of clinical trials are double-blind studies often uses?
Phase III
At what point can a pharmaceutical company apply to the FDA for a "new drug application" (NDA)?
Phase III
Which phase of clinical trails is referred to as post-marketing surveillance?
Phase IV
What is considered a flaw in the system of reporting adverse drug reactions?
reporting is voluntary
Who do you contact to report adverse drug reactions?
FDA's "Medwatch" program
Approximately how long does the FDA grant a patent to assist a pharmaceutical company in recouping the cost of development?
13-17 years
What are the 3 names drugs are given?
1- chemical
2- generic
3- trade, brand or propriety
Which drug name is related to the chemical structure of the drug?
chemical
Which drug name is assigned to the drug when the pharmaceutical company applies for the approval process?
generic
What drug name is used to facilitate marketing?
trade, brand or propriety
What change to a drug's name is made to indicate some alteration to the drug (ex. SR for sustained release)?
a suffix is added
Drugs are administered according to the "five rights". What are they?
- right patient
- right drug
- right dose
- right route
- right time
Who wrote the code of ethics for nurses which delineates our responsibilities to our profession, our clients and the general public?
American Nurses Association
What is the purpose of the nurse practice act?
to protect the residents of the state by maintaining minimum safe standards for nursing
What test is given to demonstrate that the nurse possesses the expected competencies to practice nursing safely?
NCLEX-RN
To be valid, a medication order must be written by the appropriate licensed professional and contain what information?
- patient's name
- time and date the order is written
- the name of the drug (generic is preferred)
- the dose of the drug
- route the drug is to be administered
- time interval the drug is to be administered
- the signature of the person writing the order
True/False:

Orders written by medical students are not valid unless co-signed by a licensed physician.
True
How long does a practitioner have to cosign verbal orders in an acute care setting?
24 hours
What is the best method a nurse can use to ensure that she/he understands the verbal orders that were given?
repeat them back to the person giving the orders
Who is legally responsible for knowing the purpose, therapeutic effects, and possible adverse effects of drugs administered?
the nurse