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Drug Regulation

Information for Fundamentals of Nursing Test #3

TermDefinition
Which law required to list the presence of 11 drugs that were dangerous or potentially addictive? Federal Food & Drug Act of 1906
The act that prevented the use of fraudulent therapeutic claims is __________. Sherley Amendment of 1912
(True/False) The food, drug, and cosmetic act of 1938 requires that drug labels must be accurate and complete. True
Prescription drugs must bear the legend "federal law prohibits dispensing without prescription" comes from what law? Durham-Humphrey Amendment of 1952
The amendment that states all old drugs had to be tested as well as any new ones is know as __________. Harris-Kefauver Amendment of 1962
(True/False) The Controlled Substance Act of 1970 categorized controlled substances on the basis of their potential for abuse. True
Which act shortened the drug investigation process to release drugs sooner to the public? Drug Regulation Reform Act of 1978
The Orphan Drug Act of 1983 allowed drug companies to take tax deductions for about 3/4 of the cost to manufacture of drugs with ___________. Rare Diseases
(True/False) The food and drug administration modernization act of 1997 gives a 6 month notice to drug companies who plan to stop making a drug. True
The most serious type of warning label by the FDA is know as the ___________. "Black box" warning
Who is responsible for every medication they administer? Nurse
When does product liability exist? -If a product is defective or not fit for its reasonable foreseeable uses -The defect arose before the product left the control of the manufacturer -The defect caused some person harm
Who is collectively responsible for accounting for the inventory and management of the flow and distribution of controlled substances? Drug suppliers, hospitals, physicians, pharmacists, and nurses
(True/False) The law was designed to prevent & provide increased research into substance abuse and dependence and to provide treatment and rehabilitation is know as the Controlled Substance Act of 1970. True
Which act established "Narcotic" as a legal term and regulated the importance, manufacture, sale, and use of narcotics? Harrison Narcotic Act of 1914
What is known as the chemical or biological technique by which the strength and purity of a drug are measured? Assay
What is performed by determining the amount of precipitation required to produce a defined effect on a suitable lab animal under certain conditions? Bioassay
(True/False) 300,000 out of the 400,000 drugs in the US and Canada are OTC True
According to the study conducted by the FDA advisory panel, how many drugs were found to be safe & effective for labeled use? 1/3
How would a prescriber note a drug substitution if it's not wanted? -dispense as written -brand unnecessary -medically necessary
(True/False) Nursing practice is not only regulated by drug standards and legislation but also by individual state nurse practice acts. True
The code that explains the rights of human participants in medical research is _____________. Nuremberg Code
What does a written consent include in drug research? -explanation of the nature -procedures -drugs/devices involved -potential benefits, risks, and discomforts -alternative treatments -compensation
Which phase of drug testing is used by a greater number of clients for a longer period of time with additional effects? 4
(True/False) Some limitations of drug testing include pregnant women, people with multiple disease states, children, and older adults. True
What are the goals of human testing for drug development? -determine clinical effectiveness -determine drug safety -establish tolerated dose/range
The steps of animal testing for drug development include: -toxicity (acute, subacute, and chronic) -therapeutic index -modes of absorption, distribution, metabolism, and excretion
Which phase of human testing has a small number of human volunteers & used to determine pharmacokinetics? Phase 1
What occurs during phase 2 of human testing of drug development? -limited controlled evaluation -in selected individuals with targeted disease -closely monitored for side effects
(True/False) Extended clinical evaluation & the drugs is tests in various centers across the US are part of phase 3 in human testing. True
What are some basic guidelines for professional nursing practice? -knowing the limitations of nursing practice in the community -maintaining a rel. w/ fam & clie -knowing the limitations of ones own skills -informing involved personnel of and documenting thoroughly and carefully all happenings related to client care
How can a nurse take precautions against malpractice? Observing the 6 rights of med admin
What does a nurse do if he/she believes a medical order is an error? -validate w/ the pharmacist or other authoritative resource -report the conflicting facts to the prescriber in a factual & no blaming manner
(True/False) No one can relieve a nurse of responsibility for the nurses action. True; for a nurse to carry out an order that the nurse knows to be incorrect constitutes negligence.
How should the med order be written? -correct -legible -complete -clearly understandable
(True/False) The drug must be deemed appropriate for that specific client. True
What are the 3 legal requirements before med admin? -med order must be valid -prescriber & the nurse must be licensed -nurse must know the purpose, actions, effects, and major adverse effects & teaching required
Some examples of the expanded roles of nurses regarding other areas of drug therapy include: Nurse Practitioner & Prescription writing
What is a function of state nurse practice acts? Protect the public from unskilled, undereducated, or unlicensed nurses and to delineate clearly the scope of nursing as a health care profession.
What refers the effect of a patient's age, gender, size, body composition with associated changes in how an individual absorbs or metabolizes specific drugs? Drug polymorphism
How is culture important to holistic nursing? Affect the patient's health, health beliefs, and health care practices.
The US health care system advocates a what type of treatment? "One size fits all."
(True/False) It is the nurses responsibility to assist the client in the decision making process by ensuring the client is informed of the risks and benefits of therapy and can make a knowledgeable decision. True
Some nurses responsibilities to clients include: -promote health -prevent illness -restore health -alleviate suffering
(True/False) The most powerful fundamental force of the actual implementation of right and proper nursing practice is the nurses own concept of ethical & moral correctness and responsibility. True