Pharmacology
The study of the effects of chemical substances on living tissues.
United States Pharmacopeia National Formulary
The set of drug standards used in the United States. Experts in nursing, pharmaceutics, pharmacology, chemistry, and microbiology all contribute.
The International Pharmacopeia
First published in 1951 by the World Health Organization (WHO), and provides basis for standards in strength and composition of drugs for use throughout the world.
Federal Legislation
Through this, the public is protected from drugs that are impure, toxic, ineffective, or not tested before public sale. The primary purpose of this federal legislation is to ensure safety.
1938: Food,drug,and Cosmetic Act
This empowered a governing body, the FDA, to monitor and regulate the manufacturing and marketing of drugs. It is the FDA's responsibility to ensure that all drugs are tested for harmful effects, have labels with accurate information, and enclose with the
1952:Durham-Humphrey Amendment to the 1938 Act
Amendment which distinguished drugs that can be sold with or without a prescription and those that should not be filled without a new prescription. (i.e. narcotics, hypnotics, tranq.)
1962: Kefauver-Harris Amendment to the 1938 Act
Tightened controls on drug safety as a result of the thalidomide tragedy in the 1950's, pregnant women took this medication during the first trimester resulting in infants born with extreme limb deformities. This act tightened the controls on drug safety,
1970: The Controlled Substances Act
Designed to remedy the escalating problem of drug abuse and included several provisions:
1) the promotion of drug education and research into prevention and treatment of drug dependence; 2) the strengthening of enforcement authority; 3) the establishment
SCHEDULE I (Controlled Substances)
High abuse potential; no accepted medical use in U.S. Examples: heroine and hallucinogens (LSD, and unpresrcibed marijuana)
SCHEDULE II (Controlled Substances)
High potential for addiction and abuse, accepted for medical use in the US, (codeine, cocaine, morphine, opium, and secobarbital) Can lead to strong physical and psycological dependency
SCHEDULE III (Controlled Substances)
Medically accpeted drugs. Potential abuse is less than that for schedules I and II. May cause dependence. Examples are nonnarcotic drugs and codeine preperations.
SCHEDULE IV (Controlled Substances)
Medically accepted drugs. May cause dependence. Examples: phenobarbital,and benzodiazepines
SCHEDULE V (Controlled Substances)
medically accepted drugs. Very limited potential for dependence. Examples: Opioid-controlled substances for diarrhea and cough - like codeine in cough syrups
1978:Drug Regulation Reform Act
This act shortened the time in which new drugs could be developed and marketed.
1992:Drug Relations Act
to increase the approval rate of drugs used to treat AIDS and cancer, the regulations were changed. The Pharmaceutical companies pay a user fee at time of application for new drug
1997:The Food and Drug Administration Modernization Act
5 Revisions: 1.) review and use of new drugs is accelerated 2.) drugs can be tested in children before marketing 3.) clinical trial data are necessary for experimental drug use for serious or life-threatening illnesses 4.) "off-label" drugs must give info
2003:Health Insurance Portability and Accountability act
HIPPA sets the standards for the privacy of individually identifiable information. It gives clients more control over health information including boundaries on the use and release of records.
2003:Pediatric Research Equity Act
FDA requires testing to ensure safety of drug in children. Must not assume children are small adults.
2003:Medicare Prescription Drug Imporvement and Modernization Act
This act provides financial assistance to seniors to purchase needed prescription medications.
Misfeasance
Negligence; giving the wrong drug or drug dose that results in the clients death
Nonfeasance
Omission; omitting a drug dose that results in the client's death
Malfeasance
Giving the correct drug but by the wrong route that results in the client's death
Chemical name
The name that describes the chemical composition and molecular structure of a drug.
Generic name
NONproprietary name of a drug assigned by the government; this name is not owned by any pharmaceutic drug company and it universally accepted. Most drugs are ordered by this name.
Brand name
Proprietary name that is chosen by the drug company and is usually a registered trademark owned by that specific manufacturer.Pharmaceutic companies markey a compound using their given name.
American Hospital Formulary Service (AHFS) Drug Information
This is published yearly by the American Society of Health-System Pharmacists. It is an excellent reference that contains drugs listed according to therapeutic drug classification. The info given for each drug includes chemistry and stability, pharmacokin
Drug Facts and Comparisons (F & C)
contains information on almost all drugs marketed in the United States.
The United States Pharmacopeia-Drug Information (USP-DI)
a three volume set that is available in most hospitals and pharmacies. Monthly supplements are available. Volumes IA and IB provide drug information for the health care provider. Volume II gives drug information for the client.
The Physicians Desk Reference (PDR)
lists several thousand drugs with complete drug information given by pharmaceutic companies
client
The nurse's primary responsibility is to the ___.
front pages of most telephone books
The telephone numbers for PCCs are listed here
nurse
Client education about PCCs is a function of the ____.
International issues
These types of issues are: many drugs can be brought from Canada at a reduced rate compared with those in the United States AND the second issue is that the cost of AIDS drugs is prohibitive for improvished individuals in Africa.