question
Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Amendment)
answer
- extends patent life for all drugs
- allows generic drug companies to rely on findings of an innovators drugs with patent extensions
- allows generic drug companies to rely on findings of an innovators drugs with patent extensions
question
Pure Food and Drug Act
answer
require all foods and drugs to meet certain standard of strength and purity
question
Food Drug and Cosmetic Act
answer
- misbranding/adulteration of drugs is illegal
- requires companies to provide package inserts
- habit forming drugs must be labeled
- medical devices must be proven effective
- prescription labeling
- requires companies to provide package inserts
- habit forming drugs must be labeled
- medical devices must be proven effective
- prescription labeling
question
American Association for Pharmacy Technicians
answer
set forth code of ethics detailing responsibilities of pharmacy technicians
question
HIPAA (Health Insurance Portability and Accountability Act)
answer
- provides limitations on who can access, distribute, and receive patient health info
- medical professionals cannot discuss or disclose PHI (protected health info) to general public
- medical professionals cannot discuss or disclose PHI (protected health info) to general public
question
Food and Drug Administration Act
answer
established FDA as an agency of the Department of Health and Human Services
Any adverse reactions must be reported to FDA
Any adverse reactions must be reported to FDA
question
Kefauver-Harris Amendment
answer
This requires drug manufacturers to provide proof of safety and efficacy
thalidomide tragedy in Europe
thalidomide tragedy in Europe
question
Federal Trade Commission
answer
handles drug advertisement
question
Anabolic Steroid Control Act
answer
Placed all hormones that promote muscle growth or are similar to testosterone under the Controlled Substance Act (into Schedule III)
question
Medicare Modernization Act
answer
subsidize the cost of prescription drugs
question
Durham-Humphrey Amendment
answer
- Defined two specific kinds of medications
- Legend drugs ( Prescriptions
- Over the counter Drugs
- allows over the phone prescriptions
- Legend drugs ( Prescriptions
- Over the counter Drugs
- allows over the phone prescriptions
question
CMEA (Combat Methamphetamine Epidemic Act)
answer
Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine, ephedrine, and phenylpropanolamine products
limits purchases of pseudophedrine to 3.6g a day and no more than 9g in 30 days
limits purchases of pseudophedrine to 3.6g a day and no more than 9g in 30 days
question
Drug Supply Chain Security Act
answer
"Track and trace"
set up electronic, interoperable system to track prescription drugs
set up electronic, interoperable system to track prescription drugs
question
Joint Commission
answer
responsible for the accreditation of institutional settings
question
Federal Food and Drug Act
answer
Forbids the manufacture or sale of adulterated or fraudulently labeled foods and drugs
question
Controlled Substance Act
answer
- formed DEA
controlled substances placed into schedules (I-V) based on abuse potential from highest (I) to lowest (V)
controlled substances placed into schedules (I-V) based on abuse potential from highest (I) to lowest (V)
question
Harrison Narcotic Act
answer
limits transportation of opium marijuana synthetic agents and derivatives
prescription required to purchase opium
prescription required to purchase opium
question
Drug Listing Act
answer
requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.
question
Omnibus Budget Reconciliation Act (OBRA)
answer
requires pharmacist to counsel patients; and the technicians to offer counseling to patients free of charge
question
Orphan Drug Act
answer
This act gives incentives to companies to create drugs for rare diseases
question
Federal Hazardous Substances Act
answer
all hazardous materials must be handled with care and disposed of in a specifically marked container
question
Prescription Drug Marketing Act
answer
- allows for "free" samples to be given to hospitals
- keeps companies from forming monopolies
- keeps companies from forming monopolies
question
Poision Prevention Packaging Act
answer
required childproof packaging on most prescription drugs
emergency drugs like nitroglycerin are exempt
80% of children under 5 cannot open packaging
emergency drugs like nitroglycerin are exempt
80% of children under 5 cannot open packaging
question
OSHA (Occupational Safety and Health Administration)
answer
promotes safety in the workplace
question
American Disabilities Act
answer
help for handicap
question
Health Information Technology for Economic and Clinical Health Act (HITECH)
answer
promotes use of health information technology; addresses concerns of privacy and security of electronic transmission of health info
- strengthened enforcement of HIPAA rules
- strengthened enforcement of HIPAA rules
question
Patient Protection and Affordable Care Act (Obama Care)
answer
reformed the health insurance industry and healthcare
question
American Recovery and Reinvestment Act
answer
required to move from paper to electronic records (EMARS)
question
Resource Conservation and Recovery Act
answer
tracks hazardous waste (chemotherapy drugs, cytotoxic, antineoplastic) from beginning to removal
question
Freedom of Choice Act
answer
allows patient to choose ANY pharmacy they choose
question
Center for Medicare Services
answer
regulates Medicare (Federal run) and Medicaid (Federal and State run)
question
Pharmacy and Therapeutics Committee
answer
develops formularies
question
Insitute for Safe Medication Practices (ISMP)
answer
- implements error prone abbreviations lost
- high alert list
- oversees Medmarx and MERP (track errors in hospitals)
- high alert list
- oversees Medmarx and MERP (track errors in hospitals)
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