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74 Cards in this Set

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Legal responsibility, either criminal or civil; the condition of being bound in law and justice to pay an indebtedness or discharge some obligation
Liability
A legally enforceable debt owed for a wrong (crime) committed against SOCIETY
Criminal Liability
Conduct forbidden by public law and punishable by the state or other governmental entity by penalty - usually fine or imprisonment or both
Crime
A legally enforceable debt owed for a wrong committed against an INDIVIDUAL
Civil Liability
A governmental authority, other than a court or legislative body, which affects the rights of private parties through its actions
Administrative Agency
Crime for which a sentence is a maximum term of imprisonment for not more than one year

MAXIMUM ONE YEAR IMPRISONMENT
Misdemeanor
Crime for which a sentence is a minimum term of imprisonment for more than one year

MINIMUM ONE YEAR IMPRISONMENT
Felony
Court order to refrain from doing a particular act declared to be illegal

"Restraining Order"
Injunction
Conduct for which criminal liability of a fine or penalty may be imposed, but not imprisonment

FINE/PENALTY, BUT NO PRISON
Violation
Court order setting aside of a conviction or record of arrest

SEALING OF THE RECORD
Expunction of Record
Intent to commit a substantive crime plus an act
Attempt
Combinations of persons for an unlawful purpose
Conspiracy
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
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
Rules adopted by administrative agencies to "flesh out" the substantive provisions in the statutes creating the administrative agency
Legislative Rules
Rules adopted by AA as a public statement of its policy in enforcing or adjudicating the substantive law enacted by the legislature
Interpretive Rules
Type of activity deemed illegal and unlawful WITHOUT any further evidence or proof of damages
Per se violation
A civil wrong committed by a BREACH OF LEGAL DUTY imposed by law
Tort
Act of another which causes apprehension or fear of an immediate harmful or offensive contact with the person

LOOK LIKE GOING TO HIT
Assault
Act intended to cause unpermitted contact with another

HITTING SOMEONE
Battery
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
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
Any entry of a person or thing upon land in the possession of another; remaining on land of another unlawfully
Trespass Land
Intentional interference with PERSONAL PROPERTY of another resulting in damage
Trespass to Chattel
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
Communication to a third person, which damages personal or business reputation

FALSE CLAIM (SPOKEN)
Slander or Defamation
Defamatory communication, defamatory on its face, more damaging and permanent than slander; actionable without proof of special damages

FALSE CLAIM (WRITTEN)
Libel
Conduct falling below the standard of a reasonable and prudent person under the same or similar circumstances
Negligence
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
Negligence proved by proof (evidence) of defendant's violation of a specific statute.
Negligence Per Se
Negligence occurring in the practice of professionals
Malpractice
The act of title to goods passing from seller to the buyer for a price
Sale
A promise, either express or implied, that a certain fact is true
Warranty
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
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
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
Enacted to deal with problems caused by abuse of three dangerous drugs: depressants (downers), stimulants (uppers), and hallucinogens
1965 Drug Abuse Control Amendments
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"
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)
Body adapts to the effects of a drug. More is required to obtain same effect.
Tolerance
When tolerance is built, and drug is removed -- body undergoes withdrawal symptoms.
Physical Dependence
socio-pathic consequence of tolerance and physical dependence.

Drug is no longer needed for medical purposes, just for feeling.
Addiction
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
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
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
- 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
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
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
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
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
refers to whether controlled
trials show a treatment effect
Efficacy
refers to whether the
treatment transfers well to real-world populations
Effectiveness
A drug whose container or label bears trademark, trade name or other identifying mark, imprint or device, likeness…

Without legal authorization
Counterfeit Drug
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
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
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
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
Display of written material on the product’s container and on the outside container or wrapper, if any.
Label
All labels and other written, printed, or graphic matter on any container or wrapper or material accompanying the product (package insert, advertising)
Labeling
United States Pharmacopoeia/ National Formulary (USP/NF)

Homeopathic Pharmacopoeia of the United States
Official Compendia
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
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
Pass by Congress and gave authority to FBI, USDA and FDA to investigate product tampering
Federal Anti-Tampering Act 1982
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
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
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)
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)
Established two categories of drugs:
- Prescription/Legend Drugs
- OTC Drugs
Durham-Humphrey Amendment(1951)
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)
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
gave FDA more oversight on medical devices

similar to safety and efficacy issues as drugs.
Medical Device Amendment (1976)
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)
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
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)