Surg 126--Chapter 2 Flashcards
International regulation of medications is under the authority of _____.
World Health Organization (WHO)
The WHO acts as the coordinating authority on _____.
international public health, providing technical assistance in the drug field, and promoting research on drug abuse
The WHO’s tasks include _____.
combating disease and promoting the general health of all people
Federal regulation of medications was initially intended to protect consumers from _____.
harmful, impure, untested, and unsafe drugs
The Durham-Humphrey Amendments to the Food, Drug, and Cosmetic Act were passed in _____.
1952
The Durham-Humphrey Amendments to the Food, Drug, and Cosmetic Act required _____.
physician’s order to dispense certain medications and established an over-the-counter (OTC) category of medications
The Controlled Substance Act was passed in _____.
1970
The Controlled Substance Act _____.
- established the DEA
- set tighter controls on drugs capable of being abused
- required stricter security controls for anyone who dispenses, receives, sells, or destroys controlled substances
- set limits on the use of prescriptions: established guidelines for the number of times drugs can be prescribed in a period of time, and set rules on which preparations may be prescribed over the phone to the pharmacy
- required each prescriber register with DEA, and obtain DEA number
- identified drugs that can be abused and that are addicting, classifying them into schedules according to the degree of danger
Pure Food Drug Act was passed in _____.
1906
Pure Food Drug Act _____.
- required all drugs marketed in the U.S to meet minimal standards of uniform strength, purity, and quality
- required that preparations containing morphine be labeled
- established two references of officially approved drugs: the United States Pharmacopeia (USP) and the National Formulary (NF)
Federal Food, Drug, and Cosmetic Act was established in _____.
1938 (amended in 1952 and 1965)
Federal Food, Drug, and Cosmetic Act _____.
- established the FDA
- established specific regulations regarding warning labels on preparations
- stated that both prescriptions and nonprescription drugs must be effective and safe
- stated that all labels must be accurate and include the generic name
- required FDA approval of all new drugs
- designated which drugs could be sold OTC
The DEA was established in _____.
1983
The DEA _____.
- enforces the Controlled Substances Act
2. sets standards for handling controlled substances and has the legal authority to enforce those standards
Institutional policies and procedures for storing and handling controlled substances must _____.
comply with DEA standards and documentation requirements must be strictly followed
When hospitals administer narcotics they must keep careful records of _____.
the amount of medication used, the date, the patient, the person administering the medication, and the person obtaining it
The Occupational Safety and Health Administration’s (OSHA) mission is to _____.
assure the safety and health of American workers by setting and enforcing standards
An example of how OSHA interacts with surg techs is the _____.
Occupational Exposure to Bloodborne Pathogens Standard which went into effect in 2001
Occupational Exposure to Bloodborne Pathogens Standard states that each employer must _____.
have a plane that ensures immediate and confidential post-exposure treatment and follow-up procedures in accordance with current CDC guidelines
The CDC is an agency under _____.
the U.S. Department of Health and Human Services
The CDC serves as the national focus for _____.
developing and applying disease prevention and control
In 1995, the CDC issued a report of a study recommending prophylactic medication treatment ______.
as soon as possible after a needle stick or sharps injury
Post-exposure prophylaxis (PEP) is the use of _____.
antiretroviral drugs as soon as possible after significant occupational exposure to blood or other high risk body fluids that are likely to be infected with HIV
State governments must comply with _____.
federal regulations
State laws known as practice acts govern _____.
the ordering, dispensing, and administration of medications and vary from state to state
Each state controls the limits of delegatory power through the _____.
Medical Licensing Board
Schedule C-I
Heroin, LSD, PCP, marijuana
Schedule C-II
alfentanil, opium, cocaine, codeine, morphine
Schedule C-III
anabolic steroids, products with low amounts of codeine
Schedule C-IV
diazepam, lorazepam, phenobarbital
Schedule C-V
many antitussive and antidiarrheal agents
The Joint Commission _____.
evaluates and accredits approx 16,000 health care organizations and programs in the U.S.
Among the Joint Commissions standards are _____.
National Patient Safety Goals
National Patient Safety Goals are established _____.
annually and address issues such as infection control, Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, and medical errors
The FDA is an agency within _____.
the Department of Health and Human Services
The Center for Drug Evaluation and Research (CDER) regulates _____.
- the pharmaceutical industry, ensuring that basic standards are followed
- regulations include prescription drugs, OTC drugs, biological therapeutics, and generic drugs
- evaluates all new drugs before they are sold
What categories are considered safe to use during pregnancy?
A and B
All new medicines and first tested on _____.
animals
Atleast _____ species of _____ must be used for testing on animals.
two, mammals (both genders must be used)
Pregnancy Category A
no risk to fetus per studies
Pregnancy Category B
No risk in animal studies, well controlled studies in pregnant women not available, assumed little are no risk
Pregnancy Category C
animal studies show risk to fetus, controlled studies in pregnant women not available, risk vs. benefit must be determined
Pregnancy Category D
risk to human fetus has been proved, risk vs. benefit must be determined
Pregnancy Category X
risk to human fetus has been proved, risk outweighs the benefit, drug should be avoided during pregnancy
Pharmacogenetics is the study of _____.
genetic factors in predicting a medication’s action and how it could vary from its intended purpose
The metabolism of a medication can either be enhanced or diminished because of _____.
genetic factors
Pharmacogenomics refers to the _____.
general study of all genes and genetic technology that determine medication behavior
The United States Pharmacopeia and National Formulary (USP-NF) assigns an _____.
official name to the new medication, this is usually the generic name
Pharmaceutical companies have exclusive rights to market medications under its trade name for _____.
20 years
The Federal Pure Food and Drug Act of 1906 established proper _____.
labeling of medications
The manufacturer’s name for a medication is called the _____.
brand, trade, or proprietary name
The brand name is selected by the _____ and used to market the medication.
pharmaceutical manufacturer
The generic name is not _____ by any one company, and is not capitalized.
owned
Information contained on medication is _____.
- brand name
- generic name
- manufacturer’s name
- dosage strength
- form (composition of medication)
- supply dosage
- total volume
- administration route
- label alerts
- expiration date
- lot or control number
- bar code symbols
- National Drug Code (NDC)
- United States Pharmecopeia (USP) and National Formulary (NF ) codes
The USP-NF is the _____.
official medication list recognized by the U.S. government
The USP-NF lists standards for _____.
medication quality, safety, and effectiveness; also contains information on the physical and chemical characteristics
