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115 Cards in this Set
- Front
- Back
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What is the phrase for "let the decision stand"?
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Stare decisis
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Who posited existance of natural justice or natural right?
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Greek philosophers Plato and Aristotle
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Who is credited with developing the tradition of natural justice into natural law? How did they define natural law?
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Stoics
There is an existence of purposeful order in the universe and the means by which a person lives in accordance with this order is the natural law. |
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The concept of natural law was very important in the development of ______________.
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English Common Law
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Which type of law is our legal system derived?
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English common law
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What did Henry II do? How did he go about it?
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in 1154 he established a uniform system of law 'common' to the country.
He incorporated and elevated local customs to the national custom, ending local control and peculiarities, eliminating arbitrary remedies and reinstating the jury system . |
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When was the phrase "stare decisis" first used? What does it refer to?
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in 1154 with Henry II (when he sent his judges into the country to resolve disputes, then their decisions were recorded like a law)
Precedent-based law |
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Other type of law besides the common or case law? what is it based upon?
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Code jurisdictions.
Based upon Roman law |
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The codification of Roman law occurred under______________.
explain what this type of law is based upon? |
Emperor Justinian (the Code of Justinian)
Code law gives judicial precedent much less weight in decision-making, meaning the judge in a given case has more freedom to interpret the text of a statute independently and scholarly literature is given more weight. |
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Give an example of code law.
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the Napoleonic Code upon which Louisiana law is based.
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Define Law.
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Requirements for human behavior, applying to all persons within a jurisdiction, commanding what is right, prohibiting what is wrong, and imposing sanctions for violations.
It is a framework whereby people in a society resolve their disputes in a way that does not involve force and consistently yields results that are satisfactory to most of society |
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Misdemeanor vs. felony
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Misdemeanor (more mild of an offense) Jail time less than or equal to 1 year.
felony (more serious)- jail time at least one year. |
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What is a sanction?
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punishment
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what is constitutional law?
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the supreme law of the USA. Every federal or state law must meet the test of validity (must not conflict with the constitution)
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What is statutory law?
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Laws (statues) enacted by a LEGISLATIVE body (ordinances enacted by a municipal or county council)
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What is an administrative law?
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A law made by an administrative agency. Both the councils and the state legislatures delegate authority to administrative agencies.
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Give an example of an administrative agency.
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State Board of pharmacy
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What factors determine that an administrative rule is valid?
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1. It must be written within the scope of the agency's authority.
2. It must be based upon a statute that gives the agency authority to promulgate the rule 3. It must bear a reasonable relationship to the public health, safety, and welfare 4. administrative rules are subject to review by the legislative body granting authority to the agency. |
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What is "judge-made" law?
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case law
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Judicial decisions establish enforceable legal principles by either explanding ____________ or by ___________.
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Expanding the Common law or interpreting statutes and regulations
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Explain the case of Rite Aid of New Jersey vs. Board of Pharmacy.
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Rite Aid sued the board of pharmacy because all of its five pharmacists were independent pharmacists and rite aid said that chain pharmacies were not fairly represented. They lost, but now most states have laws requiring diversity among the board (usually one chain and one hospital pharmacist)
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What are the two purpsoses of stare decisis?
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1. Establish continuity of decisions
2. Expedite judicial decision-making/ |
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What are the two reasons for which a court may vary from precedent?
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1. If there are factual distinctions between a case before it and previos decision upon which the court relies.
2. A court may vary from a precedent because of changing times or circumstances. |
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In what area can a state regulate?
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A state can regulate in any area it deems necessary within the boundaries of its jurisdiction as long as there is no conflict with a federal law or regulation (if there is a conflict, federal law prevails)
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If a state and federal law regulate the same matter, the more stringent law prevails. what is this called?
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Supremacy clause of the constitution
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Article 1 , section 8 of the constitution grants authority to which governing body to regulate drugs and other articles of commerce pursuant to its power to regulate interstae commerce?
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Congress
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What was the first federal statute to protect US citizens from harmful drugs? What did this law prohibit? What event preceded it?
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The import drug act of 1848
Prohibited the import of adulterated drugs. Importation of adulterated antimalaria drugs for US troops in Mexico. |
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Which state was the first to regulate adulterated drugs? Who was second?
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Virginia in 1848 and Ohio in 1858.
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When was the FDA created?
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in 1906 with the Pure Food and Drug act (wiley-heyburn act)
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What prompted congress to act and pass the Pure Food and Drug act (wiley-heyburn act)?
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public concern over unsanitary conditions in the food and drug industries, due in part to the publicity surrounding publication of Upton Sinclair's book "the jungle", which detailed unsanitary conditions in the meat-packing industry.
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What did the Pure Food and Drug act (wiley-heyburn act) do?
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Prohibited adulteration and misbranding of drugs (not safety or efficacy)
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Explain United States vs. johnson. Which law did this case clarify?
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Manufacturer made false claims that its product was effcetive against cancer. Court ruled that this was not against the law because the law only prevented false statements as to the drug's identity, strength, quality, and purity- NOT EFFICACY.
Pure Food and Drug act of 1906 (wiley-heyburn act) |
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What did united states vs. johnson prompt congress to do?
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amend the 1906 act to prohibit false and fraudulent efficacy claims (however, this was difficult to prove)
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When did the sulfanilamide tragedy occur? What was the reason for its removal from the market?
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1937
misbranding |
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What prompted congress to pass the FDCA?
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sulfanilamide tragedy of 1937
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What did the FDCA of 1938 do?
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-further clarified adulteration and misbranding
-requires proof of SAFETY -requires pre-market approval with an NDA (exempts "grand-fathered drugs" or those already on the market prior to 1938) - defines a drug |
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Give the definition of a drug
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A. Articles recognized in the USP, the Homeopathic Pharmacopeia, of NF
B, Articles intended for use in the diagnosis, treatment, cure, mitigation, or prevention os disease in man or other animals. C. Articles other than food intended to affect the structure or function of the man or other animals D. Articles intended for use as a component of any articles specified above. (Articles can be chemical or nonchemical entities) |
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why is DMSO not considered a drug?
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Although many people use it topically to relieve arthritic pain, it is not a drug because it is only available as a commercial solvent and it makes no claims of changing the structure or function or relieving pain.
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When is a drug considered adulterated?
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1. If it consists in whole or in part of any filthy, putrid, or decomposed substance.
2. If it has been prepared, packaged, or held under unsanitary conditions (or where is COULD have been contaminated) - If manufactured under conditions that do not fit GMP -if it contains an unsafe color additive - if it is subject to compendia standards and if its strength, quality, or purity differs from those standards (unless the variations are clearly stated on the label) - If it is not subject to compendia standards and its strength, quality or purity differs from those stated on the label. |
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When is a drug misbranded?
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if its labeling is false, misleading, does not contain the name a place of business of the manufacturer, packer or distributor, and an accurate statement of the contents.
(any required information is should be prominently placed on the label in such terms as to render it likely to be read and understood by the ordinary individual) must have: established name quantity of each active ingredient adequate directions for use adequate warnings against unsafe dosage or duration of use. If it purports to be a drug, the name of which is recognized in the compendia, unless it is packaged and labeled as prescribed therein also misbranding if it is an imitation of another drug or if it is dangerous to public health |
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If a product has an unsafe color additive it is
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adulterated
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If a product is expired it is
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adulterated and misbranded
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Explain US vs. Dodovich
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Owner of a company was charged for aadulterating drugs even though he wasn't aware it was going on (employees were doing it)
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Explain US vs Sullivan
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Sullivan sold a bottle of sulfathiazole tablets without proper labeling because he said the 1938 did not apply to his case because his transaction was intrastate commerce and law only covered interstate commerce. He lost, which clarified that the law applies to intrastate commerce as well, and he was charged with misbranding.
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When did we first see OTC vs legend drugs?
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Durham-Humphrey amendment of 1951
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When did we first see: "Federal law prohibits dispensing this drug without a prescription."
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Durham-Humphrey Amendment of 1951
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When did it become law that doctors had to authorize refills?
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Durham-Humphrey Amendment of 1951
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If a prescriber dispenses a medication directly to a patient, does it have to say "Caution: federal law...."
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Yes, per Durham-Humphrey Amendment of 1951
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Prior to the Durham-Humphrey Amendment of 1951, which drugs required a presscription?
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controlled substances, per Harrison Narcotic Act of 1912.
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What prompted the congress to pass the Kefauver-Harris Amendment of 1962?
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Thalidomide tragedy
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Was thalidomide on the market in the US?
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No. The tragedy occured in Europe. It was brought into clinical trials here under the trade name Kevadon, but Dr. Frances Kelsey demanded more data about safety before approving it.
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What did the Kefauver-Harris Amendment of 1962 do?
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-Required both safety and EFFICACY of all drugs between 1938-1962.
-required a positive approval by the FDA prior to marketing (instead of marketing until FDA said not approved) -Transferred RX advertising from the FTC to the FDA -Established GMP -required informed consent of research subjects |
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Which act requried drug safety? Which required efficacy?
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FDCA of 1938;
Kefauver-Harris Amendment of 1962 |
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Which act required the FDA to approve generic drugs shown to be bioequivalent to a previously approved drug with the submission of an ANDA?
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The Drug Price Competition and Patent Restoration Act of 1984 (Waxman-Hatch Act)
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What is an ANDA?
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abbreviate new drug application (for bioequivalent generic approval)
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Which act provides innvovater drug firms 5 yeard pf patent restoration or at least 5 years of exclusive marketing once their drug has been approved?
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The Drug Price Competition and Patent Restoration Act of 1984 (Waxman-Hatch Act)
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Which act streamlined the generic approval process while giving patent extensions?
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The Drug Price Competition and Patent Restoration Act of 1984 (Waxman-Hatch Act)
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When did congress switch "Cautions: federal...." to "Rx Only"?
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FDAMA (FDA Modernization Act of 1997)
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Which act made it illegal for a pharmacy to possess drug samples?
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Drug Diversion Act of 1987
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What act required states to license drug wholesalers of Rx drugs?
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Drug Diversion Act of 1987
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Which law bans reimportation of Rx drugs except by the manufacturer, or for emergency use?
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Drug Diversion Act of 1987
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Which act bans the sale, trade, or purchase of srug samples?
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Drug Diversion Act of 1987
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Which act bans the resale of Rx drugs purchased by hospitals except under certain conditions?
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Drug Diversion Act of 1987
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Which act bans the trafficking or counterfeiting of drug coupons?
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Drug Diversion Act of 1987
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What act required premarket approval of devices?
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The Medical Devise Amendments Act of 1976
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What didThe Medical Devise Amendments Act of 1976 do?
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Gave FDA the authority to:
-classify devices according to function -require premarket approval -regulate performance standards -ensure manufacturers are in conformance with GMP -record and report requirements |
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When was the second act dealing with medical devices? What did it entail?
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Safe Medical Devices Act of 1990.
Granted the FDA additional authority related to post- marketing requirements. Also, expedited the premarket approval process. |
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Explain the NDA process.
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1. After pre-clinical animal trials, IND (investigational new drug) application is submitted to the FDA for approval.
2. Provided the IND is approved, clinical testing on humans may begin. 3. clincal trials phases 1-3. 4. All of the data collected in the clinical testing is incorporated into the NDA and submitted to the FDA for approval prior to marketing. 5. once approved, phase 4 (post-marketing) continues. |
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Phase one clinical trial:
Number of subjects? Healthy or diseased? What is studied? |
Small number of patients (20-100)
Healthy volunteers Determines safety, toxicity, PK (ADME) |
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Phase 2 clinical trial;
Number of subjects? Health or diseased? What are thiey testing here? |
100-200 patients
Patients have the disease Mostly evaluating efficacy (PK studies continue) |
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Phase 3 clinical trial :
Number of subjects? Health or diseased? What are thiey testing here? |
600-1000 patients
patients with disease. safety and efficacy of the drug (mainly to see if the drug has a potential value outweighing its possible hazards) |
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What are the three classes of drug recall? Which is most severe?
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Class 1 is most severe
Class 2 medium Class 3 least severe |
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Explain a class 1 recall.
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Reasonable possibility exists that use of or exposure to the drug or device will cause adverse side effects.
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Explain a class 2 recall.
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Use or exposure may cause temporary or medically reversible adverse effecrs on health or where the probability of serious adverse effects is remote.
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Explain a class 1 recall.
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Use or exposure is not likely to cause serious adverse health consequences.
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What did the Poison prevention act of 1970 do?
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-Protects children from accidental poisoning from household substances.
-Defines household substance - States that products in the Act must be dispensed or sold in child-resistant packaging (exception can be made if the prescriber ot patient requests non-compliant packaging and it is in writing. Also, manufacturers of OTC products are presmitted to market one sixe that is not child-resistant provided it is clearly marked "for sale to households without children.") -Rx containers may only be used once. |
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What did OBRA 90 require?
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Requires drug manufactureres to provide drugs to medicaid patients at their "best price" (the lowest price they sell to any customer)
- Requires DUR for Medicaid patients to improve outcomes. - Requires pharmacists to counsel Medicaid patients and to maintain records of the counseling |
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Explain Action on smoking Health vs. Harris. What was the verdict?
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in 1980 a public health organization sued the FDA to have cigarettes classed as drugs since they contain nicotine.
Court decided the drug definition applies only to brands of cigarettes for which a supplier makes a therapeutic claim. |
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Explain FDA vs Brown and Williamson tobacco group
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In 1990s FDA changed its position on cigarettes, making nicotine a drug and the cigarette a drug delivery device. Brown and Williamson sued and won, since congress intended to exclude tobacco from the FDA's jurisdiction.
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What prompted congress to pass the Family Smoking Prevention and Tobacco Act of 2009?
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FDA v Brown and williamson tobacco corp
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What did the Family Smoking Prevention and Tobacco Act of 2009 do?
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Gave FDA authority to:
-regulate contents of cigarettes -require disclosure of product contents -Prohibit certain additives. -require more effective warnings -strictly control or prohibit marketing and sales campaigns, especially those directed at children |
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Explain National nutritional foods association vs. Matthews. what was this an example of?
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The FDA wanted to classify vitamin A and vitamin D in high doses as drugs, but they lost on the basis of lack of nutritional value and potential toxicity
an example that although courts interpret the term "drug" broadly, the FDA does not always prevail |
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Does part C of the drug definition exclude all substances normally defined as foods, regardless of their intended use? Give an example.
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No.
Nutrilab vs. Schweiker (the manufacturer of a weight-reduction product known as a starch blocker derived from the kidney beans maintained it was a food. The court disagreed) |
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A food that supplies a special dietary need is called ______________
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Special dietary foods
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Infant formula, artificial sweeteners and caloric supplements are considered ______________ foods.
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Special dietary foods
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a food that is formulated for oral use undera physician's supervision and intended for specific dietary management of a disease or condition is called a ___________.
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Medical food
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Food formulated without the amino acid phenylalanine would be considered a ______________ food.
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medical food
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Foods that have been fortified with a dietary supplement such as calcium or ginseng is called ___________ foods
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Functional foods
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Foods that provide some health or medical benefit, such as prevention or treatment of disease are called ___________.
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Nutraceuticals
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Confusion over health claims for foods and what would be permitted prompted congress to enact what act?
What did this act do? |
Nutritional Labeling and education Act of 1990.
Allows food labeling to contain a health or disease-prevention claim if the FDA has promulgated a rule approving the claim and establishing the conditions under which a claim may be used. |
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True or false.
The FDA requires premarket approval of dietary supplements. |
false
Dietary Supplemental Health and Education Act of 1994 |
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true or false
The FDA is responsible for determining if a dietary supplement is safe and its claims substantiated by adequate evidence. |
false (that is the manufacturer's responsibility)
Dietary Supplemental Health and Education Act of 1994 |
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When was the category of dietary supplements created?
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Dietary Supplemental Health and Education Act of 1994
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True or false
The FDA regulates dietary supplements as food additives. |
false
Dietary Supplemental Health and Education Act of 1994 |
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Define dietary supplements
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Products intended for ingestion and intended to supplement the diet, containing one or more of the following:
- vitamin -mineral -herb or other botanical -amino acid -dietary substance for use by humans to supplement the diet by increasing the total dietary intake a concentrate, metabolite, constituent, extract or combination of the previuos |
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What are the four nutritional support statements that dietary supplement manufacturers are allowed to say without fear that the FDA will consider their products "drugs"?
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-Deficiency (as long as it discloses prevalence)
-Role in structure or function -Mechanism -Well-being from consumption |
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When were devices first differentiated from drugs?
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Medical Device Act of 1976
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the display of written, printed or graphic material upon the immediate container of any article
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label
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all labels and other written, printed or graphic matter on any article, its containers, or wrappers or accompanying the artciel
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labeling
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explain US vs Guardian Chemical company
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Guardian sold a product for the purpose of cleaning dairy equipment and discovered it will also effective in treating kidney and bladder stones. the company distributed brochures to the medical profession promoting the product (Renacidin)
FDA ruled that due to the claims, Renacidin was a drug and the bottles and brochures were mislabeled. |
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true or false
rx drug labeling is directed to the patient. |
false
to the practitioner |
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In 2000, the FDA reorganized the critical information in package inserts so that health care professional can find it more quickly by adding what three things?
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1. A highlights section that summarizes the important information about the drug
2. A patient counseling section 3. Prominent black box warnings for about 450 drugs |
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in what year ddi the FDA begin reviewing OTC drugs marketed between 1938 and 1962?
How did they go about it? |
1972
on the basis of therapeutic category/class. |
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When reviewing OTC products, the FDA publishes a final monograph that places an ingredient in one of three categories. what are the categories?
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Category 1- safe, effective, and not misbranded
Category 2- API are not generally recognized as safe or effective, or they are misbranded Category 3- data are insufficient |
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true or false
if the FDA places an OTC drug in a category 3, it is okay for it to stay on the market until it is proved unsafe. |
true
cutler vs. kennedy |
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What pandemic made the FDA alow investigational drsug to be used for treatment? What are the conditions?
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AIDS
to treat patients with serious of imemdiately life-threatening disease for which no satisfactory alternative therapy is available. |
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true or false
it okay for the MedWatch toll free number to be on a separate piece of paper that accompanies the prescription |
true
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The Durham-Humphrey amendment categorizes prescription drugs are those that are...
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unsafe for use except under the supervision of a practitioner because of the toxicity, method of use, or the collateral measures necessary to use the drug
subject to the NDA approval process |
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What two things must the FDA prove in order to switch an OTC drug to rx only status?
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1. That the toxicity and method of use require practitioner supervision and
2. That the collateral measures necessary to use the drug require supervision. |
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Under which circumstances can the FDA switch drugs from Rx only status to OTC status?
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1. When a manufacturer requests the switch by submitting a SNDA (supplemental NDA)
2. If the FDA amends an OTC monograph 3. If a manufacturer petitions the FDA. |
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When was Plan B approved? When was it switched to OTC status?
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1999
SNDA was submitted in 2003, and in 2006 it was approved for OTC status for 18+ yoa. in 2009 (Tummino v. Torti) it became available to 17+ yoa. |
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when is a patient package inserts required?
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For oral contraceptives, estrogen-containing products.
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What is a med guide? How many drugs require it?
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It followed the tread of the PPI
Meant for consumer. 180 |
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What is the official name of the information leaflets that accompany each prescription?
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CMI (consumer medication information)
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What policy regulates the practice of extremporaneous compounding?
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Compliance Policy Guide in 2002.
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