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Pharmacy Law and Ethics

front 1

Constitutional Law

back 1

  • outlines the organization of the federal Government
  • All laws must conform to principles and rights
  • Bill of Rights is the first 10 amendments

Freedom of speech, Chose Religion, Jury trial, Protection aginst unreasonable search and seizures

front 2

statutes

back 2

  • laws passed by Federal, State, or local legistatures
  • asign powere to create regulations and delegate this responsability to a regulatory agent

front 3

Regulations

back 3

  • clarify and explain ststutes
  • must be consistent with enacted ststute
  • same power or authority as a statute

front 4

Legislative Intent

back 4

  • Statutory and regulatory laws are based on legislative intent
  • Legal interpretation can be based on small nuances in language or punctuation.
  • Justices and judges issue opinions and decisions determining legislative intent commonly called “case law.”

front 5

Criminal law

back 5

  • Deals with homicide, illegal drugs, theft, and other antisocial behavior
  • Enforced by state agents against specific persons or corporations
  • Designed to protect society as a whole rather than compensate individual victims
  • Criminal cases are thus titled State v. John Smith or People v. Doe.

front 6

civil Law

back 6

  • Deals with the rights of private citizens in non-criminal matters
  • Plaintiff (injured party) brings charges against defendant (alleged wrongdoer).
  • Parties in a civil case may be individuals, corporations, or the state itself

front 7

tort Law

back 7

  • A type of civil law that can overlap with criminal law
  • When private wrong is committed against an individual or their property
  • Medical malpractice is a kind of tort law - Medical malpractice is the negligent treatment of a patient by a health care professional.
  • Torts can be intentional or unintentional (negligence).

front 8

Administrative Law

back 8

  • Federal government uses administrative agencies to enforce laws (except for Defense Dept. and law enforcement agencies).

Examples of federal agencies

  • Occupational Safety and Health Administration (O S H A)
  • Centers for Medicare and Medicaid Services (C M S)
  • Social Security Administration (S S A)
  • States also operate through administrative agencies.
    • Some state agencies correspond to federal agencies, such as State equal employment opportunity commissions.
    Some state agencies have no federal counterpart, such as State Boards of Pharmacy.
  • –Administrative agencies refine laws with regulations. –Some laws (i.e., A D A) leave little room for interpretation. –Others are more vague, so agencies have room to determine scope and detail of regulations. Once established, regulations have the force of law.

front 9

Violations of the Law

back 9

  • Any violation of the law is a crime, whether criminal, civil, or administrative in nature. –Misdemeanors
    • Crimes that are less serious than felonies
    –Felonies
    • Serious crimes with sentences typically more than a year
    Examples: murder, rape, aggravated assault, arson, robbery, and the manufacturing, sale, distribution, or possession of illegal drugs

front 10

Regulatory Agencies - Centers for Disease Control and Prevention (C D C)

back 10

Centers for Disease Control and Prevention (C D C)

  • –Federal agency –Charged with protecting public health and safety through the investigation, identification, prevention, and control of diseases Various institutes and centers operate under C D C oversight.

front 11

Regulatory Agencies - Centers for Medicare and Medicaid Services (C M S)

back 11

  • Centers for Medicare and Medicaid Services (C M S)

–Regulates administration of

  • Medicare, Medicaid, the State Children’s Health Insurance Program (S C H I P), the Health Insurance Portability and Accountability Act (H I P P A), the Clinical Laboratory Improvement Amendments (C L I A), and several other health-related programs

Conducts inspections to ensure compliance with its guidelines

front 12

Regulatory Agencies - Drug Enforcement Administration (D E A)

back 12

  • Drug Enforcement Administration (D E A)

–Regulates the legal trade in narcotic and dangerous drugs, manages a national narcotics intelligence system, and works with other agencies to prevent illegal drug trafficking

–D E A administrator reports to the director of the F B I.

D E A has offices nationwide and in 40 foreign countries.

front 13

Regulatory Agencies - Food and Drug Administration (F D A)

back 13

–Responsible for:

  • Protecting public health by ensuring safety, efficacy, and security of drugs, biological products, medical devices, food, and cosmetics

Reviews and approves new drug applications, new generic equivalents, and new therapeutic indications for existing medications

front 14

The Joint Commission

back 14

  • Evaluates and accredits nearly 15,000 U.S. health care organizations and programs
  • Establishes/enforces standards for improving quality and safety of care provided by health-care organizations
  • Evaluates and accredits hospitals, hospice facilities, nursing homes, long-term care facilities, rehabilitation centers, and other health care organizations

front 15

Regulatory Agencies - Occupational Safety and Health Administration (O S H A)

back 15

–Division of U.S. Dept. of Labor

–Oversees administration of the Occupational Safety and Health Act and enforces standards in all 50 states

–Ensures the safety and health of America’s workers by setting and enforcing standards

front 16

Regulatory Agencies - State Boards of Pharmacy (S B O P)

back 16

–Stage agencies that register and regulate pharmacy facilities, pharmacists, and pharmacy technicians

–Each state has own S B O P, responsible for establishing and maintaining a state pharmacy practice act that regulates the actual practice of pharmacy.

front 17

State Pharmacy Law

back 17

  • Generally pertains to actual practice
  • License pharmacies and pharmacy professionals
  • Determine standards for pharmacy practice
  • Add restrictions to federal laws, such as food and drug laws

front 18

Federal Pharmacy Law

back 18

  • Generally pertains to manufacturing, marketing, and distribution of pharmaceuticals
  • Determines extent to which medical regulations are uniform among the 50 states
  • If federal and state pharmacy-related laws conflict, the more stringent law is applied.

front 19

Pure Food and Drug Act of 1906

back 19

–Pure Food and Drug Act of 1906

  • Provided for federal inspection of meat products
  • Forbade manufacture, sale, or transport of adulterated food products or poisonous patent medicines
  • Did not:

–Cover cosmetics

–Provide the authority to ban unsafe drugs

–Prohibit false statements about drugs

–Require labeling to identify product contents

front 20

Shirley Amendment of 1912

back 20

–Shirley Amendment of 1912

  • Prohibited labeling medicines with false therapeutic claims intended to defraud consumers

front 21

Food, Drug, and Cosmetic Act of 1938 (F D C A)

back 21

  • Prompted by the sulfanilamide disaster of 1937
  • Limited interstate commerce in drugs to those that are safe and effective
  • Established Food and Drug Administration (F D A)
  • Regulated labeling of drugs
  • Regulated who could prescribe legend (prescription-only) drugs

front 22

Durham-Humphrey Amendment of 1951

back 22

  • Also known as the Prescription Drug Amendment
  • Required prescription drugs to bear the legend, “Caution: Federal law prohibits dispensing without a prescription”
  • Later amendments approved a substitute legend that reads “Rx only”.

front 23

Federal Hazardous Substance Labeling Act (F H S A) of 1960

back 23

  • Authorized F D A to regulate hazardous substances including those which are toxic, corrosive, irritants, strong sensitizers, flammable or pressure-generating
  • Specifically, this act required hazardous substances to bear labels cautioning consumers of the potential hazards.

front 24

Kefauver-Harris Amendment of 1962

back 24

  • Also known as the Drug Efficacy Amendment
  • Focused drug manufacturers’ accountability for efficacy of drugs

–Established good manufacturing practices (G M P s)

–Prior to marketing, manufacturers required to supply proof of a new drug’s effectiveness and safety

–Advertising of Rx drugs under F D A supervision

Established procedures for N D A s and investigational drugs

front 25

Comprehensive Drug Abuse Prevention and Control Act of 1970

back 25

  • Also called Controlled Substances Act of 1970
  • Combined all federal laws dealing with narcotics, stimulants, depressants, and abused designer drugs
  • Established the D E A
  • Established five classes, or schedules, for controlled substances based on potential for abuse

front 26

D E A manages drug

back 26

  • Registration
  • Prescribing
  • Dispensing
  • Refilling
  • Ordering
  • Record keeping
  • Reporting

Inspections

front 27

schedule 1 Drugs

back 27

Heroin, LSD, Marijuana

front 28

Schedule 2 Drugs

back 28

Cocaine, Lortab, morphine, Norco, Ritalin

front 29

schedule 3 Drugs

back 29

Tylenol #3, anabolic steroids

front 30

schedule 4 Drugs

back 30

Valium, Librium

front 31

schedule 5 Drugs

back 31

Lomotil