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Drug Regulation
Information for Fundamentals of Nursing Test #3
| Term | Definition |
|---|---|
| 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 |
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