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adverse effects = an unintended side effect of a medication that is negative or in some way injurious to a patient's health. civil law = laws pertaining to wrongs to an individual Combat Methamphetamine Epidemic Act (CMEA) = federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine compliance = doing what is required
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contracts = legal agreements that have duties associated with them controlled substance mark = the mark (CII-CV) that indicates the control category of a drug with a potential for abuse controlled substances = 5 groups of drugs identified by the 1970 Controlled Substances Act (CSA) as having the potential for abuse and who distribution is therefore strictly controlled by five control schedules set fourth in the CSA criminal law = laws pertaining to a wrong to society
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dual marketing = status of medication like plan B that are classified as both prescription and OTC drugs ethics = a branch of philosophy that helps determine what should be done in a principled sense exempt narcotics = medications with habit-forming ingredients that can be dispensed without a prescription by a pharmacist to persons at least 18 years of age Health Information Technology for Economic and Clinical Health Act (HITECH) = a federal act that strengthens HIPAA and promotes electronic prescribing and electronic medical records
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Because of fatal poisoning from liquid sulfanilamide, the _______ required new drugs to be shown to be safe before marketing
Because of fatal poisoning from liquid sulfanilamide, the _______ required new drugs to be shown to be safe before marketing
Pharmacists were required to offer counseling to Medicaid patients by the
Pharmacists were required to offer counseling to Medicaid patients by the
Drugs that require prescriptions are _________ drugs
Drugs that require prescriptions are _________ drugs
Both domestic and imported drugs require approval by (a/the) __________ before they can be marketed in the US.
Both domestic and imported drugs require approval by (a/the) __________ before they can be marketed in the US.
The main purpose of phase 2 clinical trials is
The main purpose of phase 2 clinical trials is
After a patent has expired for a medication, other manufacturers may copy the drug and release it under the _______ name.
After a patent has expired for a medication, other manufacturers may copy the drug and release it under the _______ name.
Drugs that do not require a prescription are ______ drugs
Drugs that do not require a prescription are ______ drugs
The Combat Methamphetamine Epidemic Act requires that OTC cold allergy medications containing which of the following drugs be kept behind the counter?
The Combat Methamphetamine Epidemic Act requires that OTC cold allergy medications containing which of the following drugs be kept behind the counter?
Purchasers of exempt narcotics must be at least ____ years of age.
Purchasers of exempt narcotics must be at least ____ years of age.
The second set of digits in the NDC represents the
The second set of digits in the NDC represents the
The FDA reporting system for adverse effects that occur from use of approved drugs is called
The FDA reporting system for adverse effects that occur from use of approved drugs is called
____________ drug recalls are issued by manufacturers when there is a strong likelihood that the product will cause serious adverse effects or death
____________ drug recalls are issued by manufacturers when there is a strong likelihood that the product will cause serious adverse effects or death
Amphetamines, opium, cocaine, and methadone are in the DEA schedule _____ because they have accepted medical use, but have a high potential for abuse and may lead to physical or psychological dependence.
Amphetamines, opium, cocaine, and methadone are in the DEA schedule _____ because they have accepted medical use, but have a high potential for abuse and may lead to physical or psychological dependence.
The form for ordering Schedule II controlled substances is DEA Form
The form for ordering Schedule II controlled substances is DEA Form
The error that led to Emily's Law involved
The error that led to Emily's Law involved
Which FDA recall classification is the most serious?
Which FDA recall classification is the most serious?
What law should be followed when federal and state laws don't agree?
What law should be followed when federal and state laws don't agree?
Which USP chapter sets the legal standard for non-sterile compound preparations.
Which USP chapter sets the legal standard for non-sterile compound preparations.
What does the first set of numbers in the national drug code indicate?
What does the first set of numbers in the national drug code indicate?
According to the Poison Prevention Packaging Act, who can request containers that are not child-proofed?
According to the Poison Prevention Packaging Act, who can request containers that are not child-proofed?
Which drug has a REMS?
Which drug has a REMS?
Which is not an example of protected health information (PHI)?
Which is not an example of protected health information (PHI)?
Which phase of clinical trials involves healthy patients without the disease or condition?
Which phase of clinical trials involves healthy patients without the disease or condition?
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Childproof packaging was required by the Drug Enforcement Administration
Childproof packaging was required by the Drug Enforcement Administration
The CMEA sets daily and monthly restrictions on the sale of pseudoephedrine
The CMEA sets daily and monthly restrictions on the sale of pseudoephedrine
Only about 25% of drugs tested on humans are approved for use by the FDA
Only about 25% of drugs tested on humans are approved for use by the FDA
OTC medications do not require a prescription but sometimes prescriptions are written for them
OTC medications do not require a prescription but sometimes prescriptions are written for them
The prescriber's name must appear on the label of a dispensed prescription container
The prescriber's name must appear on the label of a dispensed prescription container
A class III recall is most likely to cause harm or death
A class III recall is most likely to cause harm or death
HITECH effectively amends HIPAA
HITECH effectively amends HIPAA
Schedule III, IV, and V drugs may be stored openly on shelves in retail and hospital settings
Schedule III, IV, and V drugs may be stored openly on shelves in retail and hospital settings
All controlled schedule substances must be ordered using a DEA controlled substance order form
All controlled schedule substances must be ordered using a DEA controlled substance order form
Justice means fairness and equality should be applied when providing care to all patients
Justice means fairness and equality should be applied when providing care to all patients
The ______ defined what drugs require a prescription
The ______ defined what drugs require a prescription
Legend drugs should have the legend _______ on the manufacturer's label
Legend drugs should have the legend _______ on the manufacturer's label
A need for tighter drug regulations from the thalidomide lesson led to the
A need for tighter drug regulations from the thalidomide lesson led to the
In clinical trials, the testing is done
In clinical trials, the testing is done
The main purpose of phase II clinical trials is
The main purpose of phase II clinical trials is
The monthly sales limit of the pseudoephedrine base is
The monthly sales limit of the pseudoephedrine base is
The National Drug Code (NDC) is assigned by the
The National Drug Code (NDC) is assigned by the
Legal agreements that have duties associated with them
Legal agreements that have duties associated with them
A branch of philosophy that helps determine what should be done in a principled sense
A branch of philosophy that helps determine what should be done in a principled sense
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