Drug Definitions, Standards, and Information Sources
USP Dictionary of USAN and International Drug Names
contains more than 10,000 drug names
Non prescription
Over-the-counter (OTC) drugs sold without a prescription
Phase 3
Provides additional information about proper dosing and safety
Food and Drugs Act (1927), Food and Drug Regulations (1953, 1954, 1979)
protect the public in Canada through the Therapeutic Products Directorate
Electronic Databases
-Cumulative Index of Nursing and Allied Health (CINAHL) -Lexi-Comp -ePocrates -DailyMed -http://dailymed.nlm.nig.gov
Controlled Substances Act (1970)
-Defined five classifications or schedules of controlled substances •Schedule I •Schedule II •Schedule III •Schedule IV •Schedule V
Official source for American drug standards
-The United States Pharmacopeia (USP)/National Formulary (NF) -USP Dictionary of USAN and International Drug Names
Psychotherapy
identifies stressors and methods used to reduce them
Controlled Drugs and Substances Act (1997)
establishes requirements for the control and sale of narcotics and substances of abuse in Canada
Black Box warning
indicates a very serious life-threatening problem
Diet Therapy
treatment with diet (e.g., a low-salt diet for patients with cardiovascular disease)
Physiotherapy
treatment with natural sources such as water, light, and heat
Illegal or recreational drugs
used for nontherapeutic purposes; obtained illegally
Parallel-tracking
used for patients with life-threatening illnesses who cannot participate in controlled trials and there is no other alternative
Fast-tracking
used to expedite drug development and approval for life-threatening illnesses
Drug Classification
•Body system classification (cardiovascular, gastrointestinal, etc.) •Therapeutic use or clinical indications (antacids, antibiotics, etc.) •Physiologic or chemical action (anticholinergics, calcium channel blockers, etc.)
Sources of Drug Information (Canada)
•Compendium of Pharmaceuticals and Specialties (CPS) •Patient Self-Care: Helping Patients Make Therapeutic Choices •Compendium of Self-Care Products (CSCP) •Therapeutic Choices
Legislative Acts
•Food and Drugs Act (1927), Food and Drug Regulations (1953, 1954, 1979)—protect the public in Canada through the Therapeutic Products Directorate •Schedule F—drugs that require a prescription and are not under the controlled drugs schedule •Controlled Drugs and Substances Act (1997)—establishes requirements for the control and sale of narcotics and substances of abuse in Canada
Scheduled II Drugs
•High Potential for abuse •Accepted for medical use in the United States •Abuse potential that may lead to severe psychological or physical dependence. •Requires new prescription; no refills.
Scheduled III Drugs
•High potential for abuse but less so than drugs in Schedules I and II. •Accepted for medical use in the United States. •Abuse potential that may lead to moderate or low physical dependence or high psychological dependence. •Prescription outdates in 6 months; no more than five refills in that 6 months.
Schedule V Drugs
•Low potential for abuse compared with drugs in Schedule IV. •Accepted for medical use in the United States. •Prescription not needed. •Abuse potential of limited physical or psychological dependence liability compared with drugs in Schedule IV; because abuse potential is low, a prescription may not be required. •Prescription outdates in 6 months, no more than 5 refills in that 6 months.
Schedule IV Drugs
•Low potential for abuse compared with drugs in the Schedule III. •Accepted for medical use in the United States. •Abuse potential that may lead to limited physical or psychological dependence compared with drugs in Schedule III. •Prescription outdates in 6 months; no more than five refills in that 6 months.
Controlled Substances
•Manufacturers, prescribers, and dispensers must register with the DEA -Requirements must be met to dispense scheduled medications •Controlled substances in hospitals -Inventory and dispersion control records All individuals involved with controlled substances have responsibilities to ensure patient safety.
Canadian Drug Names
•Official drug name -Any drug described specifically in the Food and Drug Regulations; there are some dissimilarities in brand names between Canada and the U.S. •Proper name -Nonproprietary or generic name used to describe an official drug in Canada
Post marketing Surveillance Stage
•Ongoing review of adverse effects of new drugs •Black Box warning -Indicates a very serious life-threatening problem
Developing and marketing new drugs
•Preclinical research phase •Phase 1: Determines the drug's pharmaceutical properties •Phase 2: Studies various dosages •Phase 3: Provides additional information about proper dosing and safety
Scheduled I Drugs
•Very high potential for abuse. •Not currently accepted for medical use in the United states. •Lack of accepted safety for use under medical supervision. Examples: lysergic acid diethylamide (LSD), peyote, heroin, hashish
Pharmacology
•deals with the study of drugs and their actions or effects •Greek in origin, meaning drugs and science •Pharmakon is Greek for drugs and logos is Greek for science: the origin of pharmacology.
Generic Name
►Important to know because formularies use them. ►Not capitalized.
Official Name
►Listed by FDA.
Possession of controlled substances by individuals
►Nurses may not have controlled substances in their possession. ►Effectiveness of drug legislation.
Brand or trademark
►Registered by manufacturer. ►Capitalized.
Chemical Name
The name that describes the chemical composition and molecular structure of a drug.
Schedule F
drugs that require a prescription and are not under the controlled drugs schedule
Prescription
require an order by a health professional licensed to prescribe drugs
Federal Food, Drug, and Cosmetic Act (1938, 1952, 1962)
requires the FDA to determine the safety of drugs before marketing and to ensure that certain labeling specifications and standards in advertising are met in the marketing of products
The United States Pharmacopeia (USP)/National Formulary (NF)
sets standards of purity for drugs and lab tests used to determine purity
Sources for prescription and nonprescription drugs
-Package inserts -Nursing journals
Phase 2
Studies various dosages
Drug Therapy
Treatment with drugs
Which drug schedule indicates drugs with the highest risk for abuse? A. Schedule I B. Schedule II C. Schedule III D. Schedule IV E. Schedule V
Answer: A. Rationale: Schedule I drugs have the highest potential for abuse. They are not currently accepted for medical use in the United States.
•Which name(s) of a drug should the nurse use when teaching a patient with a new prescription? a) Trade b) Generic and trade c) Generic and chemical d) Official
Answer: B Rationale: Drug prescriptions may be filled with a trade-name drug or a generic equivalent. If the nurse teaches only one name, it may lead to confusion for the patient when he or she receives a drug with a different name.
•How many years on average does it take for a drug to be brought to market from the time of its conception? a) 2 to 3 b) 4 to 7 c) 8 to 15 d) 12 to 18
Answer: C Rationale: It takes 8 to 15 years and can cost up to $1 billion to get a drug to market. This amount of time and money is necessary to adequately test the drug for safety before releasing it to the general population.
Which entity is responsible for monitoring drug safety in the United States? A. Drug Enforcement Agency (DEA) B. Department of Justice (DOJ) C. U.S. Food and Drug Administration (FDA) D. World Health Organization (WHO)
Answer: C Rationale: The FDA is responsible for overseeing drug and cosmetic manufacture and promotion to determine their safety before allowing them to be released to the public.
•Which source of information is best for the nurse to obtain drug information? a) Physicians' Desk Reference (PDR) b) Nursing journals c) United States Pharmacopeia (USP) and National Formulary (NF) d) Electronic databases
Answer: D Rationale: All can be sources of drug information, but keeping information current is extremely important. Reliable electronic databases can provide the most up-to-date information to health care providers, unlike printed resources that are published only periodically.
Phase 1
Determines the drug's pharmaceutical properties
Therapeutic Methods
approaches used to treat diseases; combination often used, such drugs, diet, P.T. etc.