PHM 103: ch. 4&5
In most states, pharmacists are usually given certificates of registration, which are granted for...
1 to 3 years.
When controlled substances are stolen or lost, DEA form _____ must be used.
106
The first US act prohibiting the interstate distribution or sale of adulterated or misbranded food and drugs was passed in....
1906
The food, drug, and cosmetic act was passed in....
1938
Inventory records for schedule II drugs must be kept on file for at least _____ years following the date the inventory was taken.
2
Orphan drugs are used to treat diseases affecting fewer than _____ people in the United States.
200,000
Controlled substances that schedule II are ordered by submitting DEA form _____.
222
For destroying controlled substances, DEA form _____ must be used.
41
The total number of dosage units of controlled substances distributed by a pharmacy to another registrant during a 12-month period Should not be exceed...
5 percent of their total amount.
The total number of dosage units of controlled substances distributed to other registrants by a pharmacy may not exceed _____ of all controlled substances dispensed by the pharmacy during a _____-month Period.
5 percent, 12
Before the FDA prevented thalidomide from reaching the US market, it had been tested around the world as....
A tranquilizer A sedative An anti-nauseant during pregnancy
Controlled substances have been categorized according to their potential for _____ and their ____ abilities.
Abuse, addictive
Tampering with or contaminating a product or substance.
Adulteration
Schedule III controlled substances (either drugs or hormonal substances) that are often misused by athletes seeking to enhance their bulk (by increasing muscle mass) and physical prowess.
Anabolic steroids
OBRA-90 requires that manufacturers provide reduced Medicaid costs by rebating the difference between a drug's _____ price and the _____ available price.
Average, lowest
Which of the following drugs is classified on schedule IV?
Benzodiazepines
The five controlled substance schedules were established by which statute?
Comprehensive drug abuse prevention and control act
Which of the following agencies oversees controlled substances and recommends prosecution of individuals who illegally distribute them?
DEA
An alternative, computerized method for the storage and retrieval of prescription refill information for controlled substances on schedules III and IV.
Data processing system
In 1937, the Massengill company introduced elixir sulfanilamide into the market. It contains a solution containing which of the following substances?
Diethylene glycol
The bureau within the United States department of justice that is primarily responsible for enforcing federal laws that concern controlled substances. In addition to investigating the sellers, producers, and smugglers of illicit drugs, the DEA also monitors physician prescribing patterns and pharmacy purchases.
Drug enforcement administration (DEA)
Which of the following laws was passed to establish clear criteria for classifications of legend and OTC drugs?
Durham-Humphrey amendment
The act that restricted the sale of drugs by requiring a prescription was the _____.
Durham-Humphrey amendments of 1951
The CSA requires each DEA registrant to create a complete controlled substances stock record....
Every two years.
A copy of an official document (such as a prescription or medication order) that is transmitted via fax machine.
Facsimile
The drug regulation reform act and its provisions were designed to encourage ______ FDA regulation of the _____ industry.
Fairer, pharmaceutical
Drugs on schedules II, III, and IV must bear which of the following statements?
Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.
Schedule III and IV prescriptions may not be refilled more than....
Five times.
Which act required that pharmaceutical manufacturers file an NDA with the FDA?
Food, drug, and cosmetic act
That intentional use of deceit to deprive another person of his or her money, property, or rights.
Fraud
Deceitful; intending to deceive.
Fraudulent
Schedule I drugs....
Have a high potential for abuse.
Orphan drugs are used for all of the following disorders or conditions, except....
Hepatitis A
The drugs that have the highest potential for abuse but have a currently accepted medical use in the United States are classified on which of the following schedules?
II
Anabolic steroids are classified on which of the following schedules?
III
How and when must significant losses of controlled substances be reported?
Immediately, by phone, to the nearest DEA office
When patients agree to be part of a study that has a new drug they must be thoroughly educated about its possible medical risk. This is referred to as.....
Informed consent.
Drugs used to provide detailed inquiry or systematic examination of their effects.
Investigational
Prescription drug.
Legend drug
In most types of pharmacy practice, controlled substances should be kept in a....
Lock cabinet.
The labeling of a medication in a way that is false or misleading is referred to as....
Misbranding
The FDA uses a special code to maintain a database of drugs; this code is made up of numbers that represent usage, manufacturer, drug product, and type of packaging. This code is known as the _____.
National drug code
Though this is not required, controlled substances are often marked with red ink on any invoice that contains both control and _____ substances.
Non-controlled
The act that required employers to provide safe and healthy working environments was known as _____.
OSHA
Which of the following statements is not true regarding the maintenance of files for scheduled drugs?
One file is used for schedule I and II drugs dispensed.
Drugs used to treat diseases that affect fewer than 200,000 people in the United States.
Orphan drug
Which of the following acts offers federal financial incentives to commercial and nonprofit organizations for the development of drugs?
Orphan drug act
Non-prescription drugs.
Over the counter (OTC) drug
A severe birth defects, also known as "seal limb's", involving the malformation or non-formation of arms and legs; it is caused by the drug thalidomide.
Phocomelia
Which of the following laws requires that most legend drugs be packaged in child-resistant containers?
Poison prevention packaging act
Diphenoxylate Hydrochloride with Atropine Sulfate (Lomotil) is a schedule V preparation that requires a _____.
Prescription
Which of the following acts was designed to protect the public health by requiring that only safe and properly labeled drugs may be introduced into interstate commerce?
Pure food and drug act
The Kefauver- Harris Amendment require that drug products be _____ and _____ as well as _____.
Pure, effective, and safe
The act that regulates solid waste landfills to protect humans, animals, and the environment is known as the _____.
Resource conservation and recovery act
Amphetamines and codeine, and hydrocodone with APAP, are examples of ____.
Schedule III
Causing genetic defects.
Teratogenic
The Harrison narcotics tax act was part of....
The internal revenue code.
Schedule II substances do not have to be labeled according to standard labeling requirements if....
They are unit doses dispensed in a nursing home.
The FDA is a branch of the government department that controls all drugs for legal use. Which one?
US Department of health and human services
Diphenoxylate (with atropine) is listed on which of the following schedules?
V
The drug that was recalled due to thousands of lawsuits related to fatal arrhythmias and heart diseases was called _____.
Vioxx
The organization that accredits healthcare organizations is known as _____.
joint commission
A marking that indicates a controlled substance, and is printed on a drug label, its box, and/or its packaging insert.
"C" symbol
