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