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74 Cards in this Set
- Front
- Back
Legal responsibility, either criminal or civil; the condition of being bound in law and justice to pay an indebtedness or discharge some obligation
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Liability
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A legally enforceable debt owed for a wrong (crime) committed against SOCIETY
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Criminal Liability
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Conduct forbidden by public law and punishable by the state or other governmental entity by penalty - usually fine or imprisonment or both
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Crime
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A legally enforceable debt owed for a wrong committed against an INDIVIDUAL
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Civil Liability
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A governmental authority, other than a court or legislative body, which affects the rights of private parties through its actions
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Administrative Agency
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Crime for which a sentence is a maximum term of imprisonment for not more than one year
MAXIMUM ONE YEAR IMPRISONMENT |
Misdemeanor
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Crime for which a sentence is a minimum term of imprisonment for more than one year
MINIMUM ONE YEAR IMPRISONMENT |
Felony
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Court order to refrain from doing a particular act declared to be illegal
"Restraining Order" |
Injunction
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Conduct for which criminal liability of a fine or penalty may be imposed, but not imprisonment
FINE/PENALTY, BUT NO PRISON |
Violation
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Court order setting aside of a conviction or record of arrest
SEALING OF THE RECORD |
Expunction of Record
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Intent to commit a substantive crime plus an act
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Attempt
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Combinations of persons for an unlawful purpose
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Conspiracy
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Administrative agency's power to give substance to enabling legislation enacted by legislature
GIVES RULES MADE BY LEGISLATURE THEIR POWER - A general statement labeled a rule or reulation - Having a future effect - Upon a generalized group of individuals (i.e. Pharmacists) PROCEDURES: - Notice - Hearing - Filing and publication |
Rulemaking
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Quasi-judicial power of administrative agency to determine controversies between named parties
- A specific decision labeled an opinion or order - Based on historical facts and having immediate effect - Upon a specific named individual or individuals |
Adjudication
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Rules adopted by administrative agencies to "flesh out" the substantive provisions in the statutes creating the administrative agency
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Legislative Rules
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Rules adopted by AA as a public statement of its policy in enforcing or adjudicating the substantive law enacted by the legislature
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Interpretive Rules
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Type of activity deemed illegal and unlawful WITHOUT any further evidence or proof of damages
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Per se violation
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A civil wrong committed by a BREACH OF LEGAL DUTY imposed by law
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Tort
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Act of another which causes apprehension or fear of an immediate harmful or offensive contact with the person
LOOK LIKE GOING TO HIT |
Assault
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Act intended to cause unpermitted contact with another
HITTING SOMEONE |
Battery
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Restraint within some boundaries or limits defined by a will or power exterior to the person's own will, done without legal justification
WRONGLY HELD AGAINST YOUR OWN WILL |
False Imprisonment
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Conduct exceeding all bounds usually tolerated by decent society, of a nature which is calculated to cause and does cause mental distress
INTENTIONAL ACT THAT CAUSES MENTAL DISTRESS |
Intensional Infliction of Mental Distress
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Any entry of a person or thing upon land in the possession of another; remaining on land of another unlawfully
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Trespass Land
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Intentional interference with PERSONAL PROPERTY of another resulting in damage
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Trespass to Chattel
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Intentional exercise of dominion and control over personal property, so seriously interfering with the right of another to control it that actor will be required to pay full value for it
THEFT, MOVING, HIDING, DISCARDING OF ONE'S PROPERTY |
Conversion
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Communication to a third person, which damages personal or business reputation
FALSE CLAIM (SPOKEN) |
Slander or Defamation
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Defamatory communication, defamatory on its face, more damaging and permanent than slander; actionable without proof of special damages
FALSE CLAIM (WRITTEN) |
Libel
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Conduct falling below the standard of a reasonable and prudent person under the same or similar circumstances
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Negligence
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The breach which, in a natural and continuous sequence, unbroken by and efficient intervening cause, produces the injury, and without which the results would not have occurred.
"event sufficiently related to a legally recognizable injury to be held the cause of that injury" |
Proximate Cause
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Negligence proved by proof (evidence) of defendant's violation of a specific statute.
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Negligence Per Se
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Negligence occurring in the practice of professionals
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Malpractice
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The act of title to goods passing from seller to the buyer for a price
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Sale
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A promise, either express or implied, that a certain fact is true
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Warranty
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A hybrid legal concept combining tort and sale of a product theories to create liability without fault
"It discourages reckless behavior and needless loss by forcing potential defendants to take every possible precaution." |
Strict Liability
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A law for the orderly marketing of opium, morphine, and heroin
Make opioid difficult to obtain and users flocked to physician and hospitals for drugs. |
Harrison Narcotic Act of 1914
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Goal was to eradicate marijuana use
Cultivation or transfer of marijuana was legal. Penalty for unauthorized transfer was $100 per ounce. |
Marijuana Tax Act of 1937
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Enacted to deal with problems caused by abuse of three dangerous drugs: depressants (downers), stimulants (uppers), and hallucinogens
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1965 Drug Abuse Control Amendments
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Establishes a "closed system" for manufacturing, distributing, and dispensing
Drugs subject to abuse are now "scheduled" Medical use of controlled substances regulated primarily by Board of Pharmacy. |
Federal Comprehensive Drug Abuse Prevention & Control Act of 1970
"CONTROLLED SUBSTANCES ACT" |
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Administration of the Controlled Substances Act
Replaced the Bureau of Narcotics and Dangerous Drugs (BNDD) More concerned with criminal activity (DRUG POLICE): - importation - manufacturing - diversion |
Drug Enforcement Agency (DEA)
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Body adapts to the effects of a drug. More is required to obtain same effect.
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Tolerance
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When tolerance is built, and drug is removed -- body undergoes withdrawal symptoms.
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Physical Dependence
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socio-pathic consequence of tolerance and physical dependence.
Drug is no longer needed for medical purposes, just for feeling. |
Addiction
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the dispensing, for a period of time, for a narcotic drug or drugs in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time.
Come off drug slowly |
detoxification treatment
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dispensing for a period in excess of twenty-one days, of a narcotic drug or drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug.
>21 Days IE - Methadone Treament -- allows people to still function in society. Removes need to default to illicit channels. |
maintenance treatment
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Requires a Federal Investigation if:
- theft of CS > $500 in value - death or injury occurs - Interstate of foreign commerce involved in crime Increased penalties for robbing a pharmacy. |
Controlled Sustances Registrant Protection Act of 1984
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- To decrease manufacture of controlled substances
- 20 chemicals and tablet/capsule machines placed under Federal control - Manufacturers must verify legitimacy of their customers - Must maintain records of transactions and report to DEA |
Chemical Diversion and Trafficking Act of 1998
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Placed anabolic steroids into C-III category due to great abuse of drug
Penalties for distribution, possession of steroids Act didn't work well to slow abuse. |
Anabolic Steroids Control Act of 1990
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Regulation of the OTC sale of ephedrine, pseudophedrine, and pheylpropanolamine
Because they are all "precursors chemicals" to illicit METH |
Comprehensive Methamphetamine Control Act of 1996
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Conduct Physical inventory every year in Oregon -- must keep records up to 3 years.
Perpetual inventory of C-II drugs required in institutional drug outlets (hospitals, LTCF) Separate inventory of C-II's required for each outlet USE 222 DEA Order Form |
Record Keeping of C-II for DEA
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1. Prepared in TRIPLICATE
2. One item on each numbered line 3. # of items ordered noted in space provided 4. For each item show: drug name, dosage form, strength, quantity in container, no of containers 5. Name and address of supplier 6. Signature of Purchaser 7. Date 8. Submit copies 1 and 2 to supplier, file copy 3 in pharmacy. |
DEA 222 Order Forms
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refers to whether controlled
trials show a treatment effect |
Efficacy
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refers to whether the
treatment transfers well to real-world populations |
Effectiveness
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A drug whose container or label bears trademark, trade name or other identifying mark, imprint or device, likeness…
Without legal authorization |
Counterfeit Drug
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It is listed in the United States Pharmacopoeia/ National Formulary (USP/NF), or the official Homoeopathic Pharmacopoeia of the United States, or any supplement to them.
It is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. It is intended to affect the structure or any function of the body. It is a component of any article specified above. |
Drug
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instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory
Intended to diagnose or treat diseases |
Medical Device
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i.e.., St. John’s Wort to treat depression
Sometimes called “Nutraceuticals” if neither food or drug Often lacking evidence of efficacy |
Natural products--Health Foods
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both prohibit disease prevention claims of dietary supplements
regulates allowable claims: nutrient deficiency, how it affects the body, mech. of action etc. |
Nutrition Labeling and Education Act of 1990
Dietary Supplement & Health Education Act of 1994 |
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Display of written material on the product’s container and on the outside container or wrapper, if any.
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Label
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All labels and other written, printed, or graphic matter on any container or wrapper or material accompanying the product (package insert, advertising)
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Labeling
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United States Pharmacopoeia/ National Formulary (USP/NF)
Homeopathic Pharmacopoeia of the United States |
Official Compendia
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FDA can remove adulterated or misbranded products from the market via a recall
Usually a manufacturer informs the FDA of a problem and initiates a voluntary recall |
Product Recalls
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If it consists in whole or in part of any filthy, putrid or decomposed substance
If it has been prepared, packed or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health If the strength differs, or quality or purity fall below label standards Most provisions apply to manufacturers A pharmacy is considered a manufacturer if it repackages or compounds for resale |
Adulterated Drugs
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Pass by Congress and gave authority to FBI, USDA and FDA to investigate product tampering
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Federal Anti-Tampering Act 1982
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If the label is false or misleading
Label must contain name/place of business Accurate statement of contents If required information is not displayed as required Label must warn of habit forming drugs |
Misbranded Drugs
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Revises current regulations to require that prescribing information of new and recently approved products includes:
- Highlights of the prescribing information - Table of contents - Full prescribing information Reorders currently required information and makes minor changes in its content Establishes minimum graphical requirements |
Labeling Requirements - 2006
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Inspired by widespread sales of ineffective or unsafe "remedies"
No provision to test drug prior to sale, action taken only after harm has occurred GOAL: Protect Public from adulterated and misbranded drugs |
Pure Food and Drug Act (1906)
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Current Law of the Land, as amended.
DRUGS NEED TO BE PROVEN TO BE SAFE. "Adequate directions for use" required on labels. Established definition of "drug". |
Food Drug and Cosmetic Act (FDCA) (1938)
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Established two categories of drugs:
- Prescription/Legend Drugs - OTC Drugs |
Durham-Humphrey Amendment(1951)
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Proof of SAFETY and EFFICACY now required for a drug
Led to DESI - Drug Evaluation Study Implementation Established Good Manufacturing Practices (GMP) Strengthened clinical trial safeguards/adverse actions reporting. |
Kefauver-Harris Amendment (1962)
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Review of Pre-1962 Drugs and placement into categories
- Effective - Less than effective: - Probably effective - Possibly effective - Ineffective Manufacturers had to revise package labeling based on findings |
DESI Review of Pre-1962 Drugs
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gave FDA more oversight on medical devices
similar to safety and efficacy issues as drugs. |
Medical Device Amendment (1976)
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Provided pharmaceutical manufacturers tax and licensing incentives for researching and manufacturing drugs for rare diseases.
Because Orphan drugs have littler commerical value so manufacturer's make no, or lose money on them. |
Orphan Drug Act (1983)
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Streamlined the approval process of generic drugs to get them to market quicker so that drug is more readily available.
In place because manufacturers of brand name drugs are getting more creative @ delaying generics. BUSH administration limited drug manufacturers to only one automatic 30-month patent extension in 2002. |
Waxman-Hatch Amendment (1984)
aka Drug Price Competition and Patent-Term Restoration Act |
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established sales restrictions and record-keeping requirements for Rx drug samples
Prohibits hospitals and non-profit orgs from reselling Rx items to businesses. REQUIRES STATE LICENSURE OF DRUG WHOLESALERS |
Prescription Drug Marketing Act (1987)
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