Exam 2 Flashcards
(54 cards)
Chemical name
most meaningful to the chemist
Generic name
common name; can be used in any country and by any manufacturer
brand name
trademarked name; name is registered and the use of the name is restricted to the owner of the drug
package inserts
Concise description of the drug, indications and precautions for clinical use, recommendations for dosage, known adverse reactions, contraindications, and other pharmacologic info relating to the drug
nursing journals
articles about drug therapy as it relates to a specific field of interest
nursing journals pupose
obtain professional knowledge of current evidence-based practice changes and they should not be used as a primary source for drug info
Check accuracy of info and validate
example of nursing journal
RN & American Journal of Nursing- provide drug updates and articles that discuss nursing considerations related to drug therapy and drugs
Daily med
electronic database
Sponsored by US National Library of Medicine
Provides a database for new package inserts
is searchable by product name, indications, dosage and admin, warnings, description of drug product, active and inactive ingredients, and how the drug is supplied
AHFS drug info
- Contains monographs about virtually every drug available in the US
- Describes therapeutic use of drug
drug facts and comparisons
- Drug monographs that describe all drugs in a therapeutic class
- Formatted as tables to allow comparison of similar products, brand names, manufacturers, cost indices, and available dosage forms
ASHP’S Handbook on injectable drugs
- Monographs about 360 injectable drugs
- Sections on: available concentrations, compatibility with other drugs, dosage, rate of admin, stability, pH
Handbook of nonprescription drugs: An interactive approach of self-care
- Most comprehensive Info about over-the-counter meds
Martindale: The complete drug reference
- Most comprehensive info about drugs in current use throughout the world
- Contains international names, pharmacologic activity, side effects
- Contains more than 6400 drugs
Natural Medicines Comprehensive Database
- Scientific gold standard
- Info about herbal meds and combo products involving herbal meds
Food, drug, and cosmetic Act of 1938
- Requires new drugs be safe, and pure
- Enforced by FDA
Durham-Humphrey Amendment to the food, Drug and Cosmetic Act
- Gives FDA power to determine which products may be sold with and without prescription
Kefauver-Harris Amendment (1962)
- Requires proof of efficacy and safety for meds released since 1938
- Guidelines for reporting info about adverse reactions, clinical tests, and advertising new drugs
Comprehensive Drug Abuse and Control Act (1970)
- Outlines strict controls in the manufacture, distribution, and prescribing of habit forming drugs
- Establishes drug schedules and programs to prevent addiction
- Established DEA
Dietary Supplemental Health and Education (1994)
- Almost all herbal, vitamins, minerals, amino acids, and chemicals used for health are reclassified as dietary supplements
- Allows label to include info about how these affect the human body
- Label must contain statement that the product has not been evaluated by the FDA for treating, curing, or preventing disease
order of 4 stages of bringing new drugs to market
preclinical research and development
clinical research and development
new drug application review
post marketing surveillance
Preclinical research and development
- goal at this stage is to use laboratory studies to determine whether the experimental drug has therapeutic value and whether the drug appears to be safe in animals
- may require 1-3 years of data collection
Clinical research and development
- Stage where humans are 1st tested
- May last 2-10 years
new drug application review
- sufficient data have been collected to demonstrate that the experimental drug is both safe and effective, the investigator submits an NDA to the FDA to formally request approval to market a new drug for human use.
- Review takes about 24 months
post marketing surveillance
- Manufacturer decides to market med
- consists of an ongoing review of adverse effects of the new drug and periodic inspections of the manufacturing facilities and the resulting products