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Pharmacy Law Test 1
Question | Answer |
---|---|
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. |