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Pharmacy Law MidExam
Federal Law Midterm Exam
| Question | Answer |
|---|---|
| Which law requires confidentiality of patient information? | HIPPA |
| 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 counselling for Medicaid patients , 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? | Labelling |
| 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 |
| Match the event with the correct legislation: -Food, Drug, and Cosmetic Act of 1938 -Kefauver Harris Amendment 1962 -Tamper Evident Packaging 1982 -Rx variations in class Durham Humphrey Amendment of 1951 -Sherley Amendment 1912 | Matching in orders: A. Elixir of Sulfanilamide C. Thalidomide E. Tylenol murders B. OTC D. Dr. Johnson's Mild Combination of Treatment for Cancer |
| Who is the current Secretary of The United States Department of Health and Human Services? | Tommy Thompson |
| 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 physician�s office opens in the morning. |
| While you are working in a pharmacy as a pharmacy student, you fill a prescription of antipsychotic 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. |
| Federal Law Quiz 2 | Federal Law Quiz 2 |
| What is the action called that removes a drug from the market and returns it to the manufacturer? | recall |
| Which of the following statements about Clozaril (clozapine) is/are true? | It is a restricted drug, It can cause agranulocytosis, Prescribers must be registered to prescribe it, Pharmacies must be registered to dispense it. |
| Pharmacies may sell and dispense C-5 narcotics without a prescription under the Federal Controlled Substance Act. | True |
| How many testing phases are there in clinical trials? | 3 |
| Which of the following must be recorded in a logbook when a C-5 narcotic is sold without a prescription? :The pharmacists DEA number :The pharmacy's name and address :The NDC number of the sold substance | none of the above |
| Example(s) of protected health information include(s): | patient's age, patient's diagnosis, patient's email address, patient's social security number |
| How many times can a C-II prescription be refilled? | zero |
| Under HIPAA, large fines and sentences are given for | violating confidentiality laws. |
| A prescription is written for Vasotec 5mg tablets. Which of the following products could be substituted using drug product selection? | enalapril 5 mg tablets from Watson bioequivalence rated "A" |
| Pharmacy is one of the least regulated industries. | False |
| The first phase of a clinical trial will focus on which of the following? | Safety of the drug |
| When state and Federal laws are not the same, pharmacies must follow Federal laws. | False |
| In a Class III drug recall, an adverse drug reaction is very likely. | False |
| Protected health information includes | written, spoken, or electronic information; anything that can be used to identify a person; demographic, financial, and medical information; individually identifiable health information. |
| Does BK4593257 comply with the formula by which the DEA usually assigns registration numbers? The prescriber is Dr. Kane. | no |
| What is a clinical trial called when neither the subject nor the researcher know what the subject is receiving? | double blinded |
| What is the name of the post-marketing drug surveillance program administered by the FDA? | Medwatch |
| A Class I recall will likely cause a serious adverse drug reaction or death. | true |
| Which of the following is a typical participant in a clinical drug trial? | an adult |
| A DEA form 222 is required when ordering which of the following medication? | C-II drugs |
| Which of the following statements about Accutane (isotretinoin) is/are true? | All of the above are true. |
| Where might the raw materials come from when a new drug is developed? | a jungle, a rain forest, trees and plants |
| Where would you find a list of FDA approved therapeutic equivalence evaluations? | The Orange Book |
| Under which of the following circumstances can drug product selection take place when a brand name drug is prescribed? | The patient must allow substitution; The prescriber has not designated "Dispense as Written"; The therapeutic equivalent will provide cost savings; An FDA recognized therapeutic equivalent to the prescribed drug must exist |
| According to federal law, how long does a patient have to present a C-II prescription to the pharmacy after a doctor has written it? | no limit |
| Generic medications are given a "B" rating by the FDA when they are deemed therapeutically equivalent to the innovator drug. | false |
| Most drugs that are tested on animals go on to be approved by the FDA | false |
| Pharmacy technicians may sell and dispense C-5 narcotics without a prescription under the Federal Controlled Substance Act. | false |
| How long does the Federal Controlled Substance Act require that purchase records be maintained? | 2 years |
| How soon must a pharmacy receive a written prescription when a prescription is filled under the "Emergency Dispensing" provision of the Controlled Substance Act? | within 7 days |
| Which of the following is an acceptable format for maintaining prescription files according to the CSA? : two separate files; three separate files | all of the above |
| The general rule is that prescriptions may not be phoned into a pharmacy for which of the following medication classes? | C-II |
| Drug recalls are classified as | Class I, Class II, or Class III |
| Why is double blinding used in a clinical trial? | so any potential bias is eliminated |
| How often does the Controlled Substance Act (CSA) require that a physical inventory of controlled substances be taken? | biennially (every 2 years) |
| Regarding the filling of a prescription for a Schedule 5 controlled substance, how many times may the prescription be refilled (assuming refills are authorized by the prescriber)? | The prescription may be filled 5 times or for 6 months (whichever comes first) |
| Which law classifies drugs according to abuse potential and restricts distribution accordingly? | The Controlled Substance Act of 1970 |
| How old must a participant be in order to purchase schedule 5 drugs without a prescription under the Controlled Substance Act (CSA)? | 18 years or older |
| Cocaine, methadone, morphine, and amphetamines are examples of medications in which controlled substance schedule? | C-II |
| Prozac 20mg capsules and Effexor 75mg tablets are examples of which of the following? | Therapeutic Alternatives |
| According to which of the following does the Controlled Substance Act classify medications? | recognized medicinal use, potential for causing psychological and physical dependence, abuse potential |
| If a prescription does not designate refills, how many times may the prescription be refilled? | zero |
| Which of the following prescription label requirements does the Federal Food Drug and Cosmetic Act include? | prescription fill date, prescription serial number, dispenser name and address |
| Prozac 20mg capsules and fluoxetine 20mg capsules are examples of which of the following? | Pharmaceutical Equivalents |
| Which of the following providers are legal prescribers of legend drugs? | Medical Doctors, Veterinarians, and Nurse Practitioners |
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fuekai
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