Constitutional Law

• 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

statutes

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

Regulations

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

Legislative Intent

• 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.”

Criminal law

• 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.

civil Law

• 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

tort Law

• 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).

Administrative Law

• 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.

Violations of the Law

• 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

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

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.

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

• 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

Regulatory Agencies - Drug Enforcement Administration (D E A)

• 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.

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

–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

The Joint Commission

• 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

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

–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

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

–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.

State Pharmacy Law

• 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

Federal Pharmacy Law

• 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.

Pure Food and Drug Act of 1906

–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

Shirley Amendment of 1912

–Shirley Amendment of 1912

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

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

• 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

Durham-Humphrey Amendment of 1951

• 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”.

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

• 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.

Kefauver-Harris Amendment of 1962

• 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

Comprehensive Drug Abuse Prevention and Control Act of 1970

• 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

D E A manages drug

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

Inspections

schedule 1 Drugs

Heroin, LSD, Marijuana

Schedule 2 Drugs

Cocaine, Lortab, morphine, Norco, Ritalin

schedule 3 Drugs

Tylenol #3, anabolic steroids

schedule 4 Drugs

Valium, Librium

schedule 5 Drugs

Lomotil