The Drug Approval Process Flashcards
What phase is this:
Who? NORMAL Volunteers SPECIAL POPULATION ( renal and hepatic Impairment
Why? SAFETY, Biological Effects, metabolism kinetics, DRUG INTERACTIONS
By whom? CLINICAL PHARMACOLOGIST
Phase 1
What phase is this:
Who? SELECTED PATIENTS
Why? THERAPEUTIC efficacy, dose range, kinetics, metabolism
By whom? Clinical PHARMACOLOGIST and clinical INVESTIGATORS
Phase 2
What phase is this:
Who? LARGE sample of SELECTED populations
Why? safety and efficacy
By whom? Clinical INVESTIGATORS
Phase 3
What phase is this:
Who? Patients given drug for THERAPY
Why? ADVERSE reactions, patterns of drug utilization, ADDITIONAL indications DISCOVERED
By whom? All PHYSICIANS
Phase 4
In this phase of clinical trials, the MAJORITY of the RISKS ASSOCIATED with the NEW DRUG therapy are identified.
Phase IV
prohibited the sale of misbranded or adulterated food and drugs
Pure Food and Drug Acts
require that drug products, both prescription and non prescription, must be pure, effective and safe
Federal Food, Drug, and Cosmetics Act of 1938
allows FDA to set good manufacturing practices and mandated regular inspections of production facilities. transferred to FDA control of prescription drug advertising
Kefauver-Harris Amendment
• United States Pharmacopeia National Formulary (USP-NF)
• The International Pharmacopeia (1951)
• (met high standards for therapeutic use, patient safety, quality, purity, strength, packaging safety, and dosage form)
Drug standards
What year?
Food, Drug, and Cosmetic Act
1938
What year?
Durham-Humphrey Amendment to the 1938 Act (established two classes of drugs: Re legend and OTC)
1952
What year?
Food and Drug Administration Amendments Act mandate post marketing safety studies
2007
What year?
Family Smoking Prevention and Tobacco Control Act regulate cigarettes by various measures
2009
Patient Protection and Affordable Care Act quality, affordable health care
2010
Negligence (GIVING the WRONG drug or drug dose that RESALMS in the patient’s death)
Misfeasance
Omission (OMITTING a drug dose that results in the patient’s death)
Nonfeasance
Giving CORRECT drug via WRONG ROUTE
Malfeasance
The nurse identifies the act that provides for the PRIVACY of patient health information is the —
Health Insurance Portability and Accountability Act.
If a nurse administers the wrong medication to a patient and the patient is harmed, the offense is termed
Misfeasance
The nurse identifies the primary purpose of federal legislation in drug standards as —
Ensuring Public Safety
Which situation regarding controlled substances requires the supervising RN to intervene?
A. The staff keeps a separate controlled-substances record for all required information.
B. Controlled substances are locked away from patients, and all staff members have keys for necessary access.
C. Opioids are kept under double lock to limit access to them.
D. All discarded or wasted controlled substances are countersigned.
D.
A nurse administers the correct drug, but by the wrong route, and it results in the patient’s death. The legal term for this offense is —
Malfeasance
A nurse is to administer a dose of furosemide (Lasix). The nurse is aware that Lasix is the — for the drug.
Brand name
