Chapter 4 - Pharmacy Law and Ethics

statue

a law, decree, or edict

criminal law

any law dealing with crime or punishment

civil law

any law dealing with the rights of private citizens

plaintiff

the party that initiates a legal actions

defendant

the party against which a legal action is brought

medical malpractice

the negligent treatment of a patient by a healthcare professional

misdemeanor

an offense or infraction less serious than a felony

felony

a serious crime, such as rape or murder

Centers for Medicare and Medicaid Services (CMS)

The agency that regulates the administration of the Medicare, Medicaid, the State Childrens Hospital Insurance Program, the Health Insurance Portability and Accountability Act, and several other heath-related programs

Drug Enforcement Administration (DEA)

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

Food and Drug Administration (FDA)

is responsible for protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food, and cosmetics

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

Evaluates and accredits nearly 15,000 healthcare organizations and programs in the united states

Occupational Safety and Health Administration (OSHA)

establishes protective standards, enforces those standards, and reaches out to employers and employees through technical assistance and consultation programs

State Boards of Pharmacy (SBOP)

Is the state agency that registers and regulates pharmacy facilities, pharmacists, and pharmacy technicians

Adultered

altered and causing an undesirable effect

The Pure and Drug Act of 1906

a law that provided for federal inspection of men products, and forbade manufacture, sale, or transport of adulterer food products or poisonous patient medicines

The Food, Drug, and Cosmetic Act of 1938

a law created to limit interstate commerce in drugs to those that are sat and effective

Legend Drugs

Medications that are not legally available without a prescription from a prescriber (e.g., physician, nurse practitioner, physician assistant; also called prescription drugs).

Over the Counter Drugs

The FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription

The Durham-Humphrey Amendment of 1951

known as the prescription drug amendment required that prescription drugs bear the legend, "caution: Federal law prohibits dispensing without a prescription"

The Kefauver-Harris Amendment of 1962

Known as the drug efficacy amendment. Required drug manufactures to provide proof of effectiveness and safety of their drugs before approval

The Comprehensive Drug Abuse Prevention and Control Act of 1970

Know as the controlled substance act, Regulates the possession of drugs that have a potential for abuse

The Poison Prevention Packaging Act of 1970

Required that the majority of OTC and legend drugs be packaged in child-resistant containers.

The Occupational Safety and Health Act of 1970

ensures that employers provide employees with environmental free from recognized hazards, such as toxic chemicals, loud noises, mechanical dangers, unsanitary conditions

The Drug Listing Act of 1972

The act required that each new drug be assigned a unique and permanent product code called a National Drug Code (NDC)

The Medical Device Amendment Act

the safety and effectiveness of life sustaining and life supporting devices have pre market approval of FDA

The Orphan Drug Act of 1983

Offers federal and financial incentives to commercial and nonprofit organizations to develop and market drugs previously unavailable in the U.S.

The Drug Price Competition and Patent Term Restoration Act of 1984

Also known as Hatch-Waxman Act, This bill streamlined the drug approval process for generic products by requiring submission of only an amended new drug application (ANDA)

The Prescription Drug Marketing Act of 1987

- related to drug samples; protects the American consumer from ineffective drugs, and affects the receipt and dispensing of sample drugs.

The Anabolic Steroid Control Act of 1990

Placed anabolic steroids on Class Schedule III. Anabolic steroids: any drug/hormonal substance chemically and pharmacologically related to testosterone (other than estrogens, progestins, and corticosteroids) that promote muscle growth.

The Omnibus Budget Reconciliation Act of 1990

states that pharmacist are required to offer counsel to all patients who receive new prescriptions. This act is overseen by the Board of Pharmacy

The Dietary Supplement Health and Education Act of 1994

identify the regulation that defined the term "dietary supplement" and established labeling standards

The Health Insurance Portability and Accountability Act of 1996

also known as HIPPA was enacted to ensure patient confidentiality and privacy

The Combat Methamphetamine Epidemic Act of 2005

This act set daily and monthly limits on the OTC sale of ephedrine and psuedoephedrine.(3.6 grams per day and 7.5 grams per month).

Misbranded Drug

a drug that has been misleadingly or fraudulently labeled

Medical Devices

any instrument or apparatus used in the diagnosis, prevention, monitoring, treatment, or allegation of disease

Monograph

a detailed document pertaining to a specific drug

Ethics

a system of principles and duties; often associated with a profession

Medical Ethics

principles and moral values of proper medical care

beneficence

the quality go being kind or charitable

fidelity

faithfulness to obligations and duties

veracity

truthfulness; the quality of conforming with the turth

justice

the principal of moral rightness and equity

autonomy

the condition of quality of being independent

consequentialism

the theory that the value of an action series solely from the value of it consequences

nonconsequentialism

the theory that certain action in and of themselves are wrong

social contract

an understood agreement between individual members of a society

The Ethics of Care

a principle that requires that the decision-maker to more clearly focus on such basic moral skills as kindness, sensitivity, attentiveness, tact, patience, and reliability

Rights-based Ethics

a principle that each individual has certain moral rights as well as legal rights

Principle-based Ethics

the use of moral principles as a basis for defending a chosen path of action in resolving an ethical dilemma

Virtues-Based Ethics

use of virtues, or the idealization of specific morals, establishing right reason in action