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Pharmacy Law MidExam

Federal Law Midterm Exam

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
Created by: fuekai



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