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Pharm. Law Federal
LTC - Pharmacy Law, Federal
| Question | Answer |
|---|---|
| What did the Pure Food and Drug Act of 1906 require? | labelling |
| Why are drugs regulated? | to protect the public |
| What did the Food Drug and Cosmetic Act of 1938 require? | required NDAs and proof of "safety" requirements |
| Which organization is responsible for enforcing the Controlled Substance Act? | The Drug Enforcement Administration |
| 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 |
| All drugs manufactured and sold in the United States must be approved for safety and efficacy by the Food and Drug Administration. True or False | True |
| Which act or amendment was passed in response to "The Jungle" | Pure Food and Drug Act of 1906 |
| Which act or amendment was passed in response to: Elixir of Sulfaniliamide | Food, Drug, and Cosmetic Act of 1938 |
| Which act or amendment was passed in response to: Thalidomide | Kefauver-Harris Amendment 1962 |
| Which act or amendment was passed in response to: Tylenol murders | Tamper-Evident Packaging - 1982 |
| Which act or amendment was passed in response to: OTC - Rx variations in class | Durham-Humphrey Amendment of 1951 |
| Which act or amendment was passed in response to: Dr. Johnson's Mild Combination of Treatment for Cancer | Sherley Amendment 1912 |
| Which legislation is responsible for creating a category of substances called legend drugs? | The Durham-Humphrey Amendment 1951 |
| Which law requires confidentiality of patient information? | HIPAA |
| Which organization is responsible for enforcing the Food Drug and Cosmetic Act? | The Food and Drug Administration |
| The Durham-Humphrey Amendment of 1951 did what? | made the FDA the authority that determines if a drug should be OTC or Rx |
| Laws are generally made in anticipation of problems. True or False | False |
| Who is the current Secretary of The United States Department of Health and Human Services? | Kathleen Sebelius |
| The Poison Prevention Packaging Act of 1970 required what? | required child resistant packaging for hazardous household products |
| Which act extended patent life for up to 5 additional years. | The Waxman-Hatch Act of 1984 |
| What did the Sherley Amendment of 1912 ban? | banned "fraudulent" claims about medications |
| The Omnibus Reconciliation Act of 1990 requires | Counseling for Medicaid patients |
| Which legislaiton 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 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 |
| The Sherley Amendment of 1912 provides protection against | fraudulent claims for therapeutic effects |
| What three things did the Harrison Narcotic Act of 1914 require or ensure? | orderly marketing of narcotics, required doctors and pharmacists to keep certain records, required prescriptions for products exceeding certain limits of narcotics |
| What was the purpose of the Orphan Drug Act of 1983? | encouraged manufacturers to develop drugs for rare diseases |
| The Kefauver-Harris Amendment of 1962 required what? | required proof of "effectiveness" of medications |
| Which do you follow when state and federal laws conflict? | follow the strictest law |
| Which act or amendment established the USP/NF as standards | the Pure Food and Drug Act of 1906 |
| The Omnibus Budget Reconciliation Act of 1990 requires pharmacists to | offer counselling for medicaid patients, perform drug therapy monitoring for medicaid patients |
| Generic medications are given a "B" rating by the FDA when they are deemed therapeutically equivalent to the innovator drug. T or F | False |
| In a Class III drug recall, an adverse drug reaction is very likely. T or F | False |
| Most drugs that are tested on animals go on to be approved by the FDA. T or F | False |
| When state and federal laws are not the same, pharmacies must follow Federal laws. T or F | False |
| A Class I recall will likely cause a serious adverse drug reaction or death. T or F | True |
| Where would you find a list of FDA approved therapeutic equivalence evaluations? | The Orange Book |
| Under which 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. |
| Why is double blinding used in a clinical trial? | so any potential bias is eliminated |
| Who is a typical participant in a clinical drug trial? | an adult |
| Prozac 20mg capsules and fluoxetine 20mg capsules are examples of which of the following? Therapeutic Alternatives, Pharmaceutical Equivalents, Pharmaceutical Alternatives, All of the above, None of the above | Pharmaceutical Equivalents |
| How are drug recalls classified? | Class I, Class II, or Class III |
| Which of the following products could be substituted using drug product selection for Vasotec 5mg tabs? substitutions not allowed, ramipril 2.5mg tabs, enalapril 5 mg tabs rated "A", enalapril 5mg tabs rated "B", enalapril 10mg tabs | enalapril 5 mg tablets rated "A" |
| Which of the following providers are legal prescribers of legend drugs? Medical Doctors; Veterinarians; Nurse Practitioners; Coice 1 and Choice 2 only; Doctor, Vet, and Nurse Practitioner. | Medical Doctors, Veterinarians, and Nurse Practitioner |
| What is the action called that removes a drug from the market and returns it to the manufacturer? | recall |
| What is a clinical trial called when neither the subject nor the researcher know what the subject is receiving? | double blinded |
| Prozac 20mg capsules and Effexor 75mg tablets are examples of which of the following? Pharmaceutical Equivalents, Pharmaceutical Alternatives, Therapeutic Alternatives, All of the above, None of the above | Therapeutic Alternatives |
| What will the first phase of a clinical trial focus on ? | Safety of the drug |
| 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) |
| 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 |
| Where might the raw materials come from when a new drug is developed? | a jungle, a rain forest, trees and plants |
| How many testing phases are there in clinical trials? | 3 |
| Which law classifies drugs according to abuse potential and restricts distribution accordingly? | The Controlled Substance Act of 1970 |
| Cocaine, methadone, morphine, and amphetamines are examples of medications in which controlled substance schedule? | C-II |
| If a prescription does not designate refills, how many times may the prescription be refilled according to the Federal Food Drug and Cosmetic Act? | zero |
| Which is an acceptable format for maintaining prescription files according to the CSA? 2 files(c-IIs)(non-cs, with C-IIIs, C-IVs, C-Vs with red C); 2 files(non-cs)(C-IIs, with C-IIIs, C-IVs, C-Vs with red C); 3 files(non-cs)(C-IIIs,C-IVs, C-Vs)(C-IIs) | All of the above: 2 files (c-IIs)(non-cs, with C-IIIs, C-IVs, C-Vs with red C); 2 files (non-cs)(C-IIs, with C-IIIs, C-IVs, C-Vs with red C); 3 files (non-cs)(C-IIIs,C-IVs, C-Vs)(C-IIs) |
| Does BK4593257 comply with the formula by which the DEA usually assigns registration numbers? The prescriber is Dr. Kane. | no |
| According to which criteria does the Controlled Substance Act classify medications? | recognized medicinal use, potential for causing psychological and physical dependence, abuse potential |
| Which of the following must be recorded in a logbook when a C-5 narcotic is sold without a prescription? pharmacists DEA number, pharmacy's name and address, NDC number of the sold substance, all of the above, none of the above. | none of the above |
| 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 |
| The general rule is that prescriptions may not be phoned into a pharmacy for which medication classes? | C-II |
| How many times can a C-II prescription be refilled? | zero |
| What prescription label requirements does the Federal Food Drug and Cosmetic Act include? | prescription fill date, prescription serial number, dispenser name and address |
| What is the name of the post-marketing drug surveillance program administered by the FDA? | Medwatch |
| A DEA form 222 is required when ordering which medication? | C-II drugs |
| How often does the Controlled Substance Act (CSA) require that a physical inventory of controlled substances be taken? | biennially (every 2 years) |
| 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 |
| Pharmacy technicians may sell and dispense C-5 narcotics without a prescription under the Federal Controlled Substance Act. T or F | False |
| Pharmacy is one of the least regulated industries. T or F | False |
| Under HIPAA, large fines and sentences are given for what? | violating confidentiality laws |
| Which of the following does protected health information include? written, spoken, or electronic information; anything that can be used to identify a person; demographic, financial, and medical information; individually identifiable health information | written, spoken, or electronic information; anything that can be used to identify a person; demographic, financial, and medical information; individually identifiable health information |
| Example(s) of protected health infromation include(s) which of the following? patient's age, patient's diagnosis, patient's email address, patient's social security number | All of the above: patient's age, patient's diagnosis, patient's email address, patient's social security number |
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