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Pharmacy Law Test 1

QuestionAnswer
Which law requires confidentiality of patient information? HIPAA
Which legislation was prompted by the poisoning death of 107 children by the solvent mixed with the anti-infective sulfanilamide? The Food Drug and Cosmetic Act of 1938
Which legislation is responsible for creating a category of substances called legend drugs? The Durham-Humphrey Amendment 1951
Which legislation was also known as the "drug efficacy" amendment and required that manufacturers prove efficacy for a drug's intended use? The Kefauver-Harris Amendment 1962
Which organization is responsible for enforcing the Controlled Substance Act? The Drug Enforcement Administration
Which legislation was significant because it was the first time that drugs were recognized as requiring a unique set of laws and regulation? The Pure Food and Drug Act of 1906
All new drugs manufactured and sold in the United States must be approved for safety and efficacy by the Food and Drug Administration.Clarification: "new drugs" does not mean herbals or dietary supplements True
The Sherley Amendment of 1912 attempted to provide protection against? Fraudulent claims for therapeutic effects
The Omnibus Budget Reconciliation Act of 1990 requires pharmacists to? Offer counseling for medicaid patients and perform drug therapy monitoring for medicaid patients
Which organization is responsible for enforcing the Food Drug and Cosmetic Act? The Food and Drug Administration
Laws are generally made in anticipation of problems. False
Which do you follow when state and federal laws conflict? Follow the strictest law
Why are drugs regulated? To protect the public
What did the Pure Food and Drug Act of 1906 require? Labeling
The Omnibus Reconciliation Act of 1990 requires? Counseling for Medicaid patients
The Waxman-Hatch Act of 1984: Extended patent life for up to 5 additional years
The Orphan Drug Act of 1983: Encouraged manufacturers to develop drugs for rare diseases
The Poison Prevention Packaging Act of 1970: Required child resistant packaging for hazardous household products
The Kefauver-Harris Amendment of 1962: Required proof of "effectiveness" of medications
The Durham-Humphrey Amendment of 1951: Made the FDA the authority that determines if a drug should be OTC or Rx
The Food Drug and Cosmetic Act of 1938: Required NDAs and proof of "safety" requirements
The Harrison Narcotic Act of 1914: Ensured orderly marketing of narcotics, required doctors and pharmacists to keep certain records, required prescriptions for products exceeding certain limits of narcotics
The Sherley Amendment of 1912: Banned "fraudulent" claims about medications
Which act or amendment established the USP/NF as standards: The Pure Food and Drug Act of 1906
A. Food, Drug, and Cosmetic Act of 1938 B. Kefauver = Harris Amendment 1962 C. Tamper = Evident Packaging = 1982 D. Rx variations in class = Durham = Humphrey Amendment of 1951 E. Sherley Amendment 1912 D=OTC A=Elixir of Sulfaniliamide C=Tylenol murders B=Thalidomide E=Dr. Johnson's Mild Combination of Treatment for Cancer
Who is the current Secretary of The United States Department of Health and Human Services? Kathleen Sebelius
You filled a prescription bottle and the pharmacist finds an error on the label. What should you do? Remove the old label and toss it in the trash that will get shredded, then put a label with the proper instructions on the bottle.
It is 6:00 p.m.. Some medical information needs to be faxed to a physician's office. The physician's office closed at 5:00 p.m.. What should you do? Leave a note for the morning pharmacy technician to fax it after the physicians office opens in the morning.
While you are working in a pharmacy as a pharmacy student, you fill a prescription of anti psychotic medications for one of the local high school teachers. Which of the following is appropriate? You should recognize that a chemical imbalance is being appropriately treated or that they may be taking the medication for some condition you wouldn't imagine.
While you are working in a pharmacy as a pharmacy student, you fill an anti-seizure prescription for a friend. You know she does not have epilepsy. This is confusing to you. Which of the following is a true statement? You can ask the pharmacist, the pharmacy technicians, your instructor, but not your friend.
Created by: beautyyyme