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Pharm Law & Ethics

Acts in Pharm Law in Ethics

Prohibited interstate distribution or sale of adulterated (made impure) and misbranded (improperly labeled) food and drugs Pure Food and Drug Act of 1906
regulated and taxed the distribution, importation, and production of opiates and coca products Harrison Narcotics Tax Act of 1914
Elixir Sulfanilamide was used for: Strep Throat
Food, Drug, and Cosmetic Act of 1938 required: Drug, food, and cosmetic manufacturers to ensure purity, strength, and packaging of products
prohibited dispensing of legend drugs without a prescription: Durham-Humphrey Amendment of 1951
Thalidomide was used as a: tranquilizer
phocomelia is a birth defect that causes: seal limbs
Thalidomide was sold under the name: Kevadon
Act required that drug products (prescription and non-prescription) be effective Kefauver-Harris Amendment of 1963
Main achievement was to divide controlled substances into five schedules Comprehensive Drug Abuse Prevention and Control Act of 1970
This schedule of drugs have the highest potential for abuse Schedule I
This schedule of drugs have the least potential for abuse: Schedule V
created standards for child-resistant packaging Poison Prevention Packaging Act of 1970
Passed to prevent workplace disease and injuries Occupational Safety and Health Act (OSHA) of 1970
Each new drug is assigned a unique and permanent code known as a NDC (national drug code)
Besides an NDC number, this act required all drug manufacturers to list all commercial products with FDA Drug Listing Act of 1972
this amendment subjected medical devices to different levels of control Medical Device Amendment of 1976
Regulates handling of solid wastes and authorizes environmental agencies to handle cleanup of contaminated sites Resource Conservation and Recovery Act of 1976
Designed to increase consumer protection and information, and FDA’s public accountability Drug Regulation Reform Act of 1978 and Provisions
this class of recall has serious potential for injury or death Class 1
This class of recall has the potential of adverse effects even though they are not very likely class 3
This act Covers about 5,000 rare conditions Orphan Drug Act
Created formal generic drug approval process and established abbreviated new drug application (ANDA) approval process Drug Price Competition and Patent Term Restoration Act
Encouraged distribution of authentic, properly labeled, effective prescription drugs Prescription Drug Marketing Act of 1987
Main purpose to reduce Medicaid costs by reducing inappropriate use of drugs by Medicaid recipients Omnibus Budge Reconciliation Act of 1990 (OBRA-90)
Requires pharmacists to review Medicaid patients’ complete drug profiles before filling prescriptions Omnibus Budget Reconciliation Act of 1990
Requires facilities that use medical devices to report if illness, injury, or death occurs because of their use FDA Safe Medical Devices Act of 1990 (SMDA)
Allowed CSA to regulate anabolic steroids, which promote muscle growth and are often used illegally by athletes Anabolic Steroids Control Act of 1990
anabolic steroids belong to this schedule schedule III
Prohibits discrimination against disabled persons Americans with Disabilities Act of 1990
Holds dietary supplements manufacturers responsible for safety of supplements Dietary Supplement Health and Education Act of 1994
Encourages electronic data interchange of private health information Health Insurance Portability and Accountability Act (HIPAA) of 1996
Passed to improve FDA regulation of drugs, biological products, food, and medical devices FDA Modernization Act of 1997
Used subsidies and tax breaks to help patients afford medications they need Medicare Prescription Drug, Improvement, and Modernization Act of 2003
Designed to restrict distribution of isotretinoin because it caused severe birth defects in fetuses of patients who took it during pregnancy Isotretinoin (Accutane®) Safety and Risk Management Act of 2005
Introduced safeguards to make ingredients used in creation of methamphetamine and similar drugs harder to access The Combat Methamphetamine Epidemic Act of 2005
opiates, opium derivatives (e.g., heroin), crystal methamphetamine, hallucinogens, crack cocaine below to schedule: Schedule I
opiates and opioids (narcotics, including methadone, morphine, and oxycodone), stimulants, depressants below to schedule: Schedule II
anabolic steroids, acetaminophen with codeine, butabarbital belong to schedule: Schedule III
long-acting barbiturates, certain hypnotics, minor tranquilizers (including benzodiazepines, phenobarbital, diazepam [Valium®]) below to schedule schedule IV
Physician must physically sign every written prescription for these types of prescription: controlled substance prescription
DEA Form 222 used to order controlled substances in these categories: Schedule I and II
The Max number of different items that may be ordered on form 222 is: 10 different items
The electronic version of form 222 is: e222
Genrally this number of refills are allowed for schedule II No refills
Records for controlled substances must be kept for how many years? 2 years, though some states require 5 years
When controlled substances become out of date this form is used: form 41
When Theft or Loss of Controlled Substances occurs this form is used: form 106
Pharmacy is allowed to use data processing system for storage and retrieval of prescription refill information for these shedules: III and IV controlled substances
beliefs of a person or social group in which they have an emotional investment (either for or against something); "he has very conservatives values" values
is designed to protect society and help it function efficiently by imposing civil or criminal penalties Law
Code of Ethics Professional ethics for Pharmacists are Authored by: American Pharmaceutical Association
key to eliminating medication errors and establishing trusting relationship Counseling patients
is ability or tendency to function independently and make informed decision on health care Autonomy
Involves keeping abreast of new technologies, developments, and latest medical publications Professional Competence
Equitable Treatment refers to: Not discriminating against patients for any reason
Code of Ethics for Pharmacy Technicians is authored by: American Association of Pharmacy Technicians
Technicians must check every drug dispensed, all labeling, and instructions provided by both physician and pharmacist this many times 3 (triple check)
good principles or rules of conduct; more important socially than values Morals
desirable standards or qualities, or rules about right and wrong Values
professional standards or codes of behavior expected by the group or society that the individual belongs to (example professional ethics) Ethics
Most important source of law is: U.S. constitution
guarantees fundamental rights to privacy, freedom of speech, religion, and equal protection Bill of rights
Divisions of Law include: Criminal lawCivil lawAdministrative law
Lesser crimes usually punishable by fines and/or imprisonment of less than 1 year Misdemeanors
Examples of Misdemeanors are traffic violations, thefts under a specified dollar amount, attempted burglary Punishable by much larger fines and imprisonment of more than 1 year or death
Examples of felony: rape, murder, domestic violence, child abuse
Civil wrongs are often punished by: Fines
Civil wrongs are often called: torts
Intentional torts are committed willfully and examples are: assault, battery, false imprisonment, fraud, libel, slander, trespassing, invasion of privacy
These wrongs are committed accidentally Unintentional torts
Malpractice is defined as: professional misconduct or negligence
Top court of the state is known as: State supreme court
Decisions binding on all state and federal courts (top federal court) U.S. Supreme Court
Period of time established by state law during which lawsuit or criminal proceeding may be filed Statute of Limitations
In professional negligence suits, statute of limitations is generally from: 1-6 years
when an individual performs an act that a reasonable and prudent health-care professional would not perform, or when they fail to perform an act that a reasonable and prudent health-care professional would perform Negligence
delivery of care that is below the expected standard Negligence
performance of a totally wrongful and unlawful act (practicing without license) Malfeasance
performance of a lawful act in an illegal or improper manner ( example: not using sterile technique during medical procedure) Misfeasance
failure to act when one should act (not scanning a bar code of a package when should) Nonfeasance
Created by: bismark