pharmacy law and ethnic


Terms in this set (...)

constitutional law
The U.S. Constitution outlines the organization of the federal government. All laws passed must conform to the principles and rights set forth in the Constitution. The first 10 amendments to the Constitution are called the Bill of Rights; this is the source of the most fundamental rights, such as freedom of speech and religion, right to a jury trial, and protection against unreasonable searches and seizures.
laws that are passed by federal, state, or local legislatures. they are often assign the power to create regulations, and delegate the responsibility for doing so, to a regulatory agency or a law, decree, or edict.
clarify and explain statutes; must be consistent with the enacted statute and they have the same legal effect and power as the statute
criminal law
any law dealing with crime or punishment. enforced by state agents against specific persons or corporation; designed to protect society as a whole rather than compensate individual victims
civil law
any law dealing with the rights of private citizens
the party that initiates a legal action.
the party against which a legal action is brought.
tort law
a type of civil law that can overlap with criminal law in which a private wrong is committed against an individual or their property
medical malpractice
is a kind of tort law, negligent treatment of a patient by a health care profession
administrative law
to enforce federal laws by administrative agencies except for the Defense Dept. and law enforcement agencies
crimes that are considered less serious than felonies and, depending on state law, are punishable by community service, parole, a fine, or imprisonment for 12 months or less. Infractions, such as traffic violations, are lesser misdemeanors, which are generally punishable by fines only
a serious crime, conviction of which typically results in imprisonment for more than a year. Felonies include murder; rape; aggravated assault; arson; robbery; and the manufacturing, sale, distribution, or possession of illegal drugs, among other crimes
Center for Disease Control and Prevention (CDC)
the federal agency that is charged with protecting public health and safety through the investigation, identification, prevention, and control of diseases. Various institutes and centers are operated under the oversight of the CDC
Centers for Medicare and Medicaid Services (CMS)
the agency that regulates the administration of Medicare, Medicaid, the State Children's Health Insurance Program, the Health Insurance Portability and Accountability Act (HIPAA), the Clinical Laboratory Improvement Amendments, and several other health-related programs.
Drug Enforcement Administration (DEA)
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; they report to the FBI, their offices are nationwide and in 40 foreign countrties
Food Drug Administration (FDA)
responsible for protecting the public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food, and cosmetics and responsible for reviewing and approving new drug applications (NDAs), new generic equivalents, and new therapeutic indications for existing medications.
Joint Commission on Accrediation of Heath Care Organization (JCAHO)
evaluates and accredits nearly 15,000 health care organizations and programs in the United States which includes hospitals, hospice facilities, nursing homes, long-term care facilities, rehabilitation centers, and other health care organizations
Occupational Safety and Health Administration (OSHA)
a division of the U.S. Department of Labor that oversees the administration of the Occupational Safety and Health Act and enforces standards in all 50 states; to ensure the safety and health of U.S. workers by setting and enforcing standards; 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)
the state agency that registers and regulates pharmacy facilities, pharmacists, and pharmacy technicians. Each state has it's own this and is responsible for establishing and maintaining a state pharmacy practice act that regulates the actual practice of pharmacy
state pharmacy law
pertains to the actual practice of pharmacy; license pharmacies and pharmacy professionals; determine standards for pharmacy practice, add restrictions to federal laws
federal pharmacy law
pertains to the manufacturing, marketing, and distribution of pharmaceutical drugs; determines extent to which medical regulations are uniform among the 50 states
Pure Food and Drug Act of 1906
the first federal law; provided for federal inspection of meat products and forbade the manufacture, sale, or transport of adulterated food products or poisonous patent medicines
Pure Food and Drug Act of 1906
What law did not cover this things?
-Cover cosmetics
-Grant the federal government authority to ban unsafe drugs
-Prohibit manufacturers from making false statements about their drugs
-Require labeling to identify the contents of a product
Sherley Amendement of 1912
prohibit labeling medicines with false therapeutic claims intended to defraud consumers
Food, Drug, and Cosmetic Act of 1932
what federal law was prompted by the sulfanilamide disater of 1937?
Food, Drug, and Cosmetic Act of 1932 (FDCA)
limited the interstate commerce in drugs to those that are are safe and effective; it established the FDA; it regulated labeling of drugs; regulated who could prescribe legends drug
what is another name for prescription-only
Durham-Humphrey Amendment of 1951 (Prescription Drug Amendment )
required that prescription drugs bear the legend, "Caution: Federal law prohibits dispensing without a prescription."; Later amendments approved a substitute legend that simply reads "Rx only
Federal Hazardous Substance Labeling Act (FHSA) of 1960
it authorized the FDA to regulate hazardous substances, including those that 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 (Drug Efficacy Amendment)
This law focused on drug manufacturers' accountability for the efficacy, or effectiveness, of drugs. advertising of prescription drugs placed under the supervision of the FDA, established procedures for new drug applications
Kefauver-Harris Amendment of 1962 (Drug Efficacy Amendment)
which law was prompted by the thalidomide disaster of 1962
Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substance Act of 1970)
combined all federal laws dealing with narcotics, stimulants, depressants, and abused designer drugs; it estabilished the DEA, establised five classes or schedules, for controlled substance based on potential for abuse
Schedule I (C-I)
a high potential for abuse. They have no currently accepted medical use in the United States, or there is no accepted safety standard for the use of these drugs. Examples: heroin, LSD, and marijuana, meth, crack
Schedule II (C-II)
ave a currently accepted medical use in the United States, but they also have a high potential for abuse, or the abuse of these drugs or other substances may lead to severe dependence. Examples: cocaine, morphine, and Ritalin, methadone, concerta, norco, percoc, oxycodone
Schedule III (C-III)
drugs have less potential for abuse than those in Schedules I and II and have a currently accepted medical use in the United States. Abuse of theses drugs may lead to moderate physical dependence or high psychological dependence. Examples: Vicodin, Lortab, Tylenol #3, and anabolic steroids
Schedule IV (C-IV)
a low potential for abuse and have a currently accepted medical use in the United States, or the abuse of these drugs may lead to limited dependence. Examples: Valium and Librium, ativan, xaniax
Schedule V (C-V)
have a low potential for abuse and have a currently accepted medical use in the United States, or the abuse of these drugs may lead to limited dependence in relation to all other controlled substances. example: Lomotil, lyrica
Drug Enforcement Adiminstration (DEA)
what agency manages drug registration, prescribing, dispensing, refilling, ordering, recording, reporting and inspections?
Poison Prevention Packaging Act of 1970
all legend and controlled drugs, with some exceptions, must be dispensed in a childproof container. For patients such as the older people, who do not wish to have their medications dispensed in such containers, a signed, written request to that effect should be kept on file at the pharmacy. Exceptions include sublingual doses of nitroglycerin, contraceptives, drugs dispensed to inpatients in hospitals, and certain emergency medications.
Occupational safety and Health Act of 1970
ensure worker and workplace safety. The goal was to make sure that employers provide their workers with a place of employment free from recognized hazards to safety and health, such as exposure to toxic chemicals, excessive noise levels, mechanical dangers, heat or cold stress, or unsanitary conditions
Drug Listing Act of 1972
require drug establishments (manufacturers, repackagers, and distributors) to register their products and list all of their commercially marketed drug products with the FDA; it applies to all drug firms manufacturing or processing human drugs, veterinary drugs, and medicated animals feed premixes
national drug code
a unique and permanent product code that every medication has; ( 5-4-2; who's manufactures- what the medication is- container size/qty)
Medical Device Amendment of 1976
required the safety and effectiveness of life-sustaining and life-supporting devices have premarket approval from the FDA.
Orphan Drug Act of 1983
to stimulate the development of drugs for rare diseases (those that affect 200,000 people or fewer); the primary incentives: Seven-year market exclusivity to sponsors of approved orphan products, A tax credit of 50% of the cost of conducting human clinical trials; Federal research grants for clinical testing of new therapies to treat and/or diagnose rare disease
Drug Price Competition and Patent term Restoration act of 1984 (Hatch-Waxman Act)
established the modern system of generic drugs. Manufacturers can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval for generic versions of drugs, for which patent protection is set to expire.
Prescription Drug Marketing Act of 1987
enacted to address certain prescription drug marketing practices that have contributed to the diversion of large quantities of drugs into a secondary "gray" market; the gray market provided a portal through which mislabeled, subpotent, adulterated, expired, and counterfeit drugs were able to enter the nation's drug distribution system.
Anabolic Steroid Control Act of 1980
laced anabolic steroids in Schedule III of the CSA. The CSA defines anabolic steroids as any drug or hormonal substance chemically and pharmacologically related to testosterone (other than estrogens, progestins, and corticosteroids) that promotes muscle growth.
Omnibus Budget reconciliation Act of 1990
focused on federal funding of the Medicare and Medicaid programs; created an increased need for pharmacy technicians; mandated that the pharmacist perform drug utilization reviews (DURs) and offer counseling to patients
Dietary Supplement Health and Education Act of 1994
define dietary supplements and dietary ingredients, establish a framework for assuring safety, outline guidelines for literature displayed where supplements are sold, provide for use of claims and nutritional support statements, require ingredient and nutrition labeling, and grant the FDA the authority to establish GMP regulations.
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
what act enacted to ensure patient confidentiality and privacy. Initially, HIPAA gave patients the right to review their medical records and established the requirement of patient consent for the transfer of medical records and for oral, written, and electronic communications regarding medical records
protect health information
ALl of theses define what: Any information created or received by the pharmacy; Information relating to a patient's health—mental or physical, past, present, or future; Information that may identify a patient
Health Insurance Portability and Accountability Act of 1996 (HIPAA)
this act does regulated electronic health transaction standards, unique identifiers, and security and electronic signature standards; established a mandate for safeguarding the storage, maintenance, and transmission of individual's health information and applied standards for acceptance of electronic signatures
Food and Drug Administration Modernization Act of 1997
resigned to simplify various FDA regulations and procedures; allowed greater ease and speed with which the FDA can approve new drugs and grant access to investigational medications. The required federal legend was also abbreviated to simply "Rx only."
Drug Addiction Treatment Act of 2000
established to permit physicians, who complete a training course and register with the DEA, to prescribe preapproved C-III, C-IV, and C-V medications, as a means of maintenance or detoxification, to individuals with an opioid addiction. Specific restrictions are placed upon the number of patients an approved physician may treat.
Medicare Moderization Act of 2003
ignificant change to Medicare, the government-managed insurance program for seniors. As a result of this act, Medicare beneficiaries were provided with the opportunity to enroll in Medicare Advantage, or Medicare Part D, which is a voluntary prescription drug benefit plan for seniors
what are the four parts of Medicare
A, B, C, D
Medicare Part A
managed by Medicare and provides Medicare benefits and coverage for:
-Inpatient hospital care
-Inpatient stays in most skilled nursing facilities
-Hospice and home health services
Medicare Part B
managed by Medicare and provides Medicare benefits and coverage for:
-Doctor and clinical lab services
-Outpatient and preventive care
-Screenings, surgical fees and supplies
-Physical and occupational therapy
Medicare Part C
combines A and B together and can combine D with A and B
Medicare Part D
Prescription Drug Plan
Combat Methamphetamine Epidemic Act of 2005
this act regulates, among other things, retail OTC sales of ephedrine, pseudoephedrine, and phenylpropanolamine products. Retail provisions of this act include daily sales limits and 30-day purchase limits, placement of product out of direct customer access, sales logbooks, customer identification verification, and employee training
Medicaid Tamper-resistant Prescription Pad Law of 2008
this act required that all written prescriptions for covered outpatient drugs are required to be written on a tamper-resistant prescription pad; the pad must have one of the following: unauthorized copying of a completed or blank prescription form; erasure or modification of information written on the prescription pad by the prescriber; the use of counterfeit prescription form
Affordable Care Act of 2010 (Obamacare)
ensure Americans access to insurance coverage. Americans will have the ability to choose insurance coverage through an open-market insurance exchange, which will pool buying power and give Americans new affordable choices of private insurance plans.
adulterated drug
Characteristics of this type of drug is: Are prepared, packaged, packed, or held under unsanitary conditions;Are manufactured in a way that does not conform to established GMPs; Have a container composed of a poisonous or deleterious substance; Contain an unsafe color additive; Vary from an official compendium standard; Are new, unsafe, animal drugs or animal feeds containing such drugs; Are a Class III device without premarket approval (a banned device); Are OTC drugs that are not packaged in tamper-resistant packaging
altered and causing an undesirable effect
a drug that has been misleadingly or fraudulently labeled
misbranded drug
Characteristics of this type of drug is: have false, misleading, or inadequate labels that either do not contain required information or do contain misleasing information; are not packaged according to the PPPA, are adveritsed without required warning.
Medical device
any instrument or apparatus used in the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
Class I-medical device
what class of medical device has relatively low potential to cause harm
class II- medical devices
what class of medical device to subject to specificity performance standards established by a panel of experts.
class III- medical devices
what class of medical device has life-supporting systems whose failure could cause death or serious injury,
mongraphs (package insert)
a detailed document pertaining to a specific drug
Patient's Bill of Rights
outlines the patients' proper expectations regarding their quality of care, privacy, and individual health care provider's responsibilities. Health care providers and facilities, such as physician offices and hospitals, are obligated to provide all patients with access to a written copy of it
a system of principles and duties; often associated with a profession
medical ehtics
principles and moral values of proper medical care
moral (principle-based) philosphy
an individualized set of values or value system. It is the moral reasoning process that guides you as you decide the rightness or wrongness of conduct
the quality of being kind or charitable
faithfulness to obligations and duites
the principle of moral rightness and equity
the conditions or quality of being independent
the theory that the value of an action derives solely from the value of its consequences
the theory that certain actions, in and of themselves, are wrong.
social contract
an understood agreement between individual members of a society
the ethic of care
principle that requires the decision-maker to more clearly focus on such basic moral skills as kindness, sensitivity, attentiveness, tact, patience, and reliability
rights-based ethics
theory based on an understanding of human rights
principle-based ethics
states that moral principles are general, universal guides to action
virtues-based ethics
the use of virtues, or the idealization of specific morals, establishing right reason in actio
closely related to the system of ethics and sometimes overlaps it, creating confusion and tension about the "right thing to do" in a given situation