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WorksheetsMosby's Federal Requirements
Total questions: 100
Worksheet time: 50mins
Which of the following is a primary consideration for a pharmacy technician according to the American Association of Pharmacy Technicians Code of Ethics?
To ensure the health and safety of the patient and use knowledge and skills to the best of their ability in serving others.
To maximize the profit of the pharmacy.
To follow only the instructions of the pharmacist without question.
To prioritize speed over accuracy in dispensing medications.
According to the code of ethics, what should a pharmacy technician never assist in?
Dispensing, promoting, or distribution of medications or medical devices that are not of good quality or do not meet the standards required by law.
Filing prescriptions.
Counseling patients about general health topics.
Participating in medication reconciliation.
Which of the following is NOT typically a role of pharmacists and pharmacy technicians?
Performing surgery on patients.
Filling prescriptions and verifying instructions from physicians.
Advising patients on potential side effects of medicines.
Participating in medication reconciliation and therapy management.
What is the main difference between ethics and laws as described in the material?
Ethics are embraced by a profession without government involvement, while laws are enacted by the government to achieve a goal.
Ethics are only about personal beliefs, while laws are about professional conduct.
Laws are optional, but ethics are mandatory.
Ethics are enforced by the police, while laws are enforced by pharmacists.
A pharmacy technician is required to respect the confidentiality of a patient’s records. When is it appropriate to disclose this information?
Only with proper authorization.
Whenever a friend asks for it.
If the patient is not present.
If the technician is curious.
Which of the following best describes the role of the state board of pharmacy?
Oversees pharmacy practices, including licensure, registration, and certification requirements for pharmacy technicians.
Manufactures medications for pharmacies.
Sets prices for all medications.
Provides direct patient care in hospitals.
Why is it important for pharmacy technicians to maintain competency in their practice?
To continually enhance their professional knowledge and expertise.
To avoid having to work with pharmacists.
To ensure they can work in any country.
To reduce the number of patients they see.
Which of the following actions would be considered unethical for a pharmacy technician?
Engaging in any activity that will discredit the profession or expose it to fear or favor, illegal or unethical conduct.
Maintaining patient confidentiality.
Supporting the patient’s individuality and dignity.
Assisting the pharmacist in the safe distribution of health services.
Which of the following is a responsibility of a community pharmacy technician?
Assist the pharmacist with filling and labeling prescriptions.
Diagnose patient illnesses.
Prescribe medications to patients.
Counsel patients on medication use.
What is one task that a pharmacy technician cannot perform?
Counsel patients on their medication.
Assist in training new pharmacy technicians.
Screen telephone calls for the pharmacist.
Enter prescription orders into the computer.
Which of the following is a responsibility of an institutional pharmacy technician?
Transport medications and pharmacy equipment to nursing units and clinics.
Write prescriptions for patients.
Perform professional judgment duties such as patient counseling.
Diagnose and treat patient illnesses.
In some states, what expanded responsibility may pharmacy technicians have?
Check the work of other pharmacy technicians.
Prescribe medications.
Diagnose patient conditions.
Counsel patients on medication therapies.
Which of the following best describes a Tech-Check-Tech (TCT) program?
A program where pharmacy technicians check the work of other technicians, often limited to restocking automated dispensing machines and unit-dose batches.
A program where technicians prescribe medications.
A program where technicians provide patient counseling.
A program where technicians diagnose illnesses.
Why are TCT programs generally limited to the institutional setting?
They require advanced education and training and are contingent on ongoing quality assurance tests.
They allow technicians to prescribe medications.
They allow technicians to diagnose illnesses.
They allow technicians to perform surgery.
Which of the following is NOT a responsibility of a community pharmacy technician?
Counseling patients about their medication.
Screening telephone calls for the pharmacist.
Assisting the pharmacist in performing medication reconciliation.
Prepacking bulk medications.
What is one of the tasks institutional pharmacy technicians may perform related to medication dispensing technology?
Deliver unit dose to automated dispensing technology, such as a Pyxis machine.
Prescribe medications for patients.
Counsel patients on medication use.
Diagnose patient illnesses.
Which of the following is a skill/concept (DoK Level 2) task for a pharmacy technician?
Compounding large-volume and small-volume intravenous (IV) mixtures.
Reciting the definition of a pharmacy technician.
Naming the laws that regulate pharmacy practice.
Listing the steps to fill a prescription.
A pharmacy technician is asked to verify that customers received the correct prescription and to check if they have any questions for the pharmacist. What level of depth of knowledge does this task require?
Skill/Concept (DoK Level 2)
Recall and Reproduction (DoK Level 1)
Strategic Thinking (DoK Level 3)
No depth of knowledge required
Which of the following professionals is NOT typically permitted to prescribe medications for humans?
Veterinarians (DVMs; can only prescribe for animals)
Medical doctors (MDs)
Nurse practitioners (NPs)
Physician assistants (PAs)
What was the main purpose of the Pure Food and Drug Act of 1906?
To prohibit the interstate transportation or sale of adulterated and misbranded food or drugs
To require all new drug applications be filed with the FDA
To create the U.S. Food and Drug Administration (FDA)
To regulate prescription drug advertising
Which federal law led to the creation of the U.S. Food and Drug Administration (FDA)?
Food, Drug, and Cosmetic Act of 1938 (FDCA 1938)
Pure Food and Drug Act of 1906
Controlled Substances Act of 1970
Drug Listing Act of 1972
Which of the following is an example of drug adulteration?
A drug prepared, packed, or held under unsanitary conditions
A drug with a misleading label
A drug missing the expiration date
A drug with an incorrect National Drug Code (NDC) number
Which of the following is considered misbranding under federal law?
Labeling that is false or misleading in any particular way
Containing unsafe color additives
Being prepared in unsanitary conditions
Containing poisonous substances
Which of the following is NOT a requirement for manufacturer drug labeling?
Patient’s insurance information
National Drug Code (NDC) number
Statement of ingredients
Expiration date
Why is it important for prescription drugs to include required warning statements on their labels?
To inform users of potential risks and ensure safe usage
To advertise the drug to consumers
To increase the price of the drug
To comply with insurance company policies
Which amendment created two categories of drugs: legend and nonlegend (OTC)?
Durham-Humphrey Amendment of 1951
Kefauver-Harris Amendment of 1962
Poison Prevention Packaging Act of 1970
Occupational Safety and Health Act of 1970
What is the main purpose of the Poison Prevention Packaging Act of 1970?
To require child-resistant packaging for most OTC and legend drugs
To ensure drugs are pure, safe, and effective
To create the Occupational Safety and Health Administration
To separate drugs into legend and nonlegend categories
Which of the following is NOT an example of a medication that does NOT require child-resistant containers?
Betamethasone with no more than 12.6 mg per package
Oral contraceptives in manufacturer’s dispensing package
Mebendazole tablets with more than 600 mg per package
Sublingual nitroglycerin tablets
What does the Occupational Safety and Health Act of 1970 ensure?
A safe and healthful workplace for all employees
That all drugs are pure, safe, and effective
That drugs are packaged in child-resistant containers
That prescription medications require a physician’s supervision
According to the Durham-Humphrey Amendment, which type of medication requires the supervision of a physician?
Legend drugs
OTC drugs
All medications
Investigational drugs
Which amendment requires drug manufacturers to be responsible for good manufacturing process (GMP)?
Kefauver-Harris Amendment of 1962
Durham-Humphrey Amendment of 1951
Poison Prevention Packaging Act of 1970
Occupational Safety and Health Act of 1970
Why are child-resistant containers important according to the Poison Prevention Packaging Act of 1970?
They reduce accidental poisoning in children
They ensure drugs are pure and effective
They allow for easier dispensing of medication
They separate legend and nonlegend drugs
Which of the following is a requirement of the Occupational Safety and Health Act of 1970?
Requires a reporting system for job-related injuries and illness
Requires all drugs to be effective
Requires child-resistant packaging for all drugs
Requires prescription medications to be supervised by a physician
Which of the following is a requirement of the Hazard Communication Standard?
All employees must be informed of the hazards and identities of chemicals to which they are exposed.
Only supervisors need to know about chemical hazards.
Hazard information is only required for non-hazardous chemicals.
Employees are not required to receive any information about chemicals.
What is the main purpose of a Safety Data Sheet (SDS)?
To provide recipes for chemical mixtures
To communicate information on chemical hazards to users
To advertise chemical products
To list employee names
Which section of the SDS provides information about the initial care for someone exposed to a chemical?
Section 1: Identification
Section 4: First aid measures
Section 7: Handling and storage
Section 10: Stability and reactivity
Section 2 of the SDS is primarily concerned with which of the following?
Fire-fighting measures
Hazards identification
Physical and chemical properties
Toxicological factors
Why is it important for workers to be familiar with the format and contents of SDSs?
So they can ignore safety procedures
To ensure they can quickly find and understand hazard information in an emergency
To memorize chemical formulas
To create new chemicals
A chemical spill occurs in a laboratory. According to the SDS, which section should be consulted for recommendations on the appropriate response?
Section 6: Accidental release measures
Section 3: Composition/information on ingredients
Section 9: Physical and chemical properties
Section 11: Toxicological factors
A worker needs to know the safe storage conditions for a chemical. Which section of the SDS should they refer to?
Section 7: Handling and storage
Section 5: Fire-fighting measures
Section 8: Exposure controls and personal protection
Section 10: Stability and reactivity
Suppose a new chemical is introduced in the workplace. What steps should an institution take to comply with the Hazard Communication Standard?
Ignore the new chemical
Write a hazard communication program and obtain an SDS from the manufacturer, importer, or distributor
Only inform the management about the chemical
Store the chemical without any documentation
What is the main purpose of the Orphan Drug Act of 1983?
To provide orphan status to drugs and biologics for rare diseases affecting fewer than 200,000 people in the U.S.
To regulate the pricing of all prescription drugs
To ensure all drugs are tested on children
To ban the use of biologics in drug therapy
Which of the following is NOT one of the three essential components of the Omnibus Budget Reconciliation Act (OBRA) of 1990 drug use review programs?
Prospective drug use review
Retrospective drug use review
Educational programs
Drug manufacturing regulations
According to OBRA '90, what must a pharmacist discuss with a patient during counseling? (Select the best answer)
The name and description of the medication
The cost of the medication
The manufacturer’s stock price
The history of the pharmacy
Which act provides the general guidelines for hazardous waste management in the United States?
Resource Conservation and Recovery Act (RCRA)
Orphan Drug Act
Omnibus Budget Reconciliation Act (OBRA)
Health Insurance Portability and Accountability Act (HIPAA)
Which of the following is a requirement of the Health Insurance Portability and Accountability Act (HIPAA) of 1996?
Protecting patient information confidentiality
Mandating all drugs be generic
Banning the use of biologics
Requiring all pharmacies to be open 24 hours
Which of the following is a characteristic of hazardous waste as defined by the RCRA?
Ignitability
Solubility
Edibility
Biodegradability
A pharmacist is reviewing a patient’s drug therapy for potential duplication and drug-disease contraindications before filling a prescription. Which OBRA '90 component is being applied?
Prospective drug use review
Retrospective drug use review
Educational programming
Hazardous waste management
Why must pharmacies arrange for the disposal of their hazardous waste through an outside vendor under RCRA regulations?
To adhere to regulations and protect human health and the environment
To increase pharmacy profits
To reduce medication costs
To comply with HIPAA
Which of the following is NOT a topic that may be discussed during patient counseling under OBRA '90?
The medication’s expected onset of action
The medication’s relationship to laboratory tests
The pharmacist’s salary
Instructions for 24-hour access to a pharmacist
What is the main goal of the educational programming component of a state’s drug use review program under OBRA '90?
To improve prescribing and dispensing practices
To increase drug prices
To promote pharmaceutical advertising
To reduce pharmacy staff
Which of the following is covered by the HIPAA Privacy Rule?
Patient's health information
Hospital construction codes
Medical equipment manufacturing
Insurance premium rates
According to the HIPAA privacy rule, what must covered entities do to protect patient privacy?
Have a set of privacy practices appropriate for their health care services
Only allow doctors to access patient records
Destroy all patient records after one year
Share patient information with insurance companies without consent
Which of the following is considered Protected Health Information (PHI) under HIPAA?
Patient's address and date of birth
Hospital cafeteria menu
Number of hospital beds
List of hospital staff schedules
What is a required security measure under the HIPAA security rule?
Encryption of electronic health information
Posting patient information on public websites
Allowing unrestricted access to medical records
Disabling all computer passwords
Which act provides a voluntary prescription drug benefit to Medicare beneficiaries?
Medicare prescription drug improvement and modernization act of 2003
Anabolic steroid control act of 2004
HIPAA security rule
Biologics price competition and innovation act of 2009
What was a major change introduced by the Anabolic Steroid Control Act of 2004?
Redefined anabolic steroids and changed administrative scheduling actions
Allowed over-the-counter sale of anabolic steroids
Removed all restrictions on anabolic steroid use
Required all medications to be labeled in Spanish
Why are standard code sets important in HIPAA electronic health care transactions?
They provide uniform codes for diseases, procedures, and medications
They allow hospitals to set their own codes
They are only used for billing purposes
They are optional for health care providers
Which of the following is a security policy example required by HIPAA?
Informing employees about protecting electronically stored information
Allowing employees to share passwords
Posting patient data on social media
Disabling all security software
How did the Medicare prescription drug improvement and modernization act of 2003 impact senior citizens?
Added preventive medical benefits
Removed all prescription drug coverage
Increased out-of-pocket costs for drugs
Eliminated Medicare Part B
What is the purpose of appointing a privacy official under the HIPAA privacy rule?
To ensure privacy practices are adopted and followed
To manage hospital finances
To schedule patient appointments
To oversee cafeteria operations
Which of the following is a goal of the Drug Supply Chain Security Act (DSCSA)?
To increase the price of prescription drugs
To allow verification of the authenticity of the drug product identifier down to the package level
To ban the use of all biological products
To eliminate the need for drug recalls
Which act created an abbreviated pathway for approval of biological products demonstrated to be biosimilar to or interchangeable with an FDA-licensed reference biological product?
Drug Supply Chain Security Act
Safe Water Drinking Act
Biologics Price Competition and Innovation (BPCI) Act of 2009
National Institute for Occupational Safety and Health Act
According to the DSCSA, what must manufacturers and repackagers be required to put on certain prescription drug packages?
Expiration date
Unique product identifier, such as a bar code
Manufacturer's address
Patient's name
Which of the following is NOT a criterion for identifying a drug as hazardous?
Carcinogenicity
Genotoxicity
High solubility in water
Teratogenicity or developmental toxicity
Which of the following is classified as a hazardous drug according to the National Institute for Occupational Safety and Health (NIOSH)?
Acetaminophen
Estradiol
Ibuprofen
Amoxicillin
A pharmacy wants to return expired and discontinued drugs to the manufacturer. Which type of distributor is permitted to process these returns?
Primary distributor
Reverse distributor
Wholesale distributor
Third-party logistics provider
Which of the following is an example of an antineoplastic hazardous drug?
Tamoxifen
Acetaminophen
Amoxicillin
Ibuprofen
Why are third-party logistics providers required to obtain a state or federal license under the DSCSA?
To manufacture new drugs
To provide storage and logistical operations related to drug distribution
To prescribe medications
To conduct clinical trials
Which of the following is required before pharmacy personnel handle hazardous drugs?
Training in the receipt, storage, compounding, dispensing, and disposal of hazardous drugs
Certification in first aid
Training in customer service
Certification in nutrition
How often must competency training for handling hazardous drugs be completed?
Every 6 months
Every 12 months
Every 2 years
Every 5 years
Which of the following is NOT a component of training for handling hazardous drugs?
Providing a list of HDs and their risks
Reviewing SOP regarding handling of HDs
Training in financial management
Spill management
What is the primary purpose of containment primary engineering controls (C-PEC)?
To increase drug potency
To minimize exposure to hazardous drugs through control of airborne contaminants
To improve drug flavor
To reduce drug cost
Which of the following must be available in the room where C-PEC is stored?
A television
A sink and eye wash station for emergency rinsing and washing
A refrigerator for snacks
A treadmill
When must personal protective equipment (PPE) be worn when handling hazardous drugs?
Only when transporting drugs
Only during spill control
When receiving, storing, transporting, compounding, deactivation/decontamination, and spill control
Only when compounding drugs
Why must access to areas where hazardous drugs are handled be restricted?
To prevent theft
To restrict access to authorized personnel only and ensure safety
To save energy
To reduce paperwork
Which of the following is a requirement for the storage of hazardous drugs?
Storage must be located away from employee break areas, patients, and visitors
Storage must be in the pharmacy manager’s office
Storage must be in the patient waiting area
Storage must be in the hospital cafeteria
What is the correct procedure for disposing of hazardous drug-related waste according to the OSHA Technical Manual?
Dispose of in regular trash bins
Use properly labeled, sealed, and covered disposal containers handled by trained personnel
Flush down the sink
Burn in open air
A pharmacy is planning to store both sterile and nonsterile hazardous drugs. According to the guidelines, what is the best practice for storage?
Store them together
Store them in the same container as nonhazardous drugs
Store them in the patient waiting area
Store them in a dedicated refrigerator in a negative-pressure area (for refrigerated antineoplastic HDs)
Which of the following is a potential route of exposure to hazardous drugs for pharmacy personnel during compounding?
Crushing tablets or opening capsules
Counting tablets from bulk containers
Moving HDs within a health care setting
Spill generation and management
What is the first step personnel should take if exposed to hazardous drugs?
Immediately remove the gloves or gown
Obtain medical attention
Flood the affected eye at an eyewash station
Document exposure in the employee’s medical record
Which item is NOT typically included in a hazardous drug spill kit?
A stethoscope
Absorbent, plastic-backed sheets or spill pads
Disposable toweling
Puncture-resistant container for glass fragments
What should be done with nonhazardous pharmaceutical materials?
Discarded in a regular trash container
Disposed of using sharps containers
Flushed down the sink
Incinerated immediately
Why is it important to post signs to limit access to a spill area during hazardous drug cleanup?
To prevent unprotected personnel from entering and being exposed
To notify housekeeping to clean the area
To indicate the area is under construction
To mark the location for future reference
During hazardous drug spill cleanup, why should cleanup proceed from areas of lesser to greater contamination?
To minimize the spread of contamination
To save time during cleanup
To use fewer cleaning materials
To avoid using protective equipment
What is the appropriate action for handling glass and used needles?
Dispose of using sharps containers
Place in regular trash
Flush down the toilet
Burn in an open area
Which of the following is considered a type of waste according to the Occupational Safety and Health Act?
Solid waste
Hazardous material
Infectious waste
All of the above
What characteristic defines a hazardous waste as ignitable?
It has a flash point less than 60°C
It has a pH less than 2 or greater than 12.5
It is liable to explode when in contact with water
It contains a regulated substance above the limit
Which of the following is an example of a P-list waste?
Warfarin >0.3%
Mitomycin
Chloral hydrate
Cyclophosphamide
Which of the following is NOT a characteristic of hazardous waste?
Ignitability
Corrosivity
Solubility
Reactivity
What is required for every facility that dispenses controlled substances?
It must be registered with the DEA
It must use only P-list waste
It must dispose of all waste in regular trash
It must renew registration every year
Which of the following best describes U-list waste?
A chemical substance that is the commercially pure grade or technical grade
A waste that is always liquid
A waste that is always solid
A waste that is only found in hospitals
Why should hazardous drug-related wastes be disposed of according to EPA, state, and local regulations?
To ensure proper recycling
To prevent environmental contamination and comply with legal requirements
To save money for the pharmacy
To reduce the amount of regular trash
Which of the following is a correct procedure for handling hazardous waste in a pharmacy?
Use thick, leak-proof plastic bags labeled as “Hazardous Drug-related wastes”
Dispose of all waste in the same container
Label all waste as “Non-hazardous”
Store hazardous waste in open containers
How often must a pharmacy renew its DEA registration for dispensing controlled substances?
Every 3 years
Every year
Every 5 years
Every 10 years
Which of the following is an example of a U-list waste?
Mitomycin
Warfarin >0.3%
Phentermine
Nicotine
Which of the following statements best describes Schedule I medications according to DEA schedules?
They have accepted medical use in the United States and a low potential for abuse.
They have no accepted medical use in the United States and possess an extremely high potential for abuse.
They are available over the counter and have minimal side effects.
They are only prescribed for severe pain and have moderate potential for abuse.
Which of the following is an example of a Schedule I narcotic?
Acetaminophen
Heroin
Ibuprofen
Codeine
Which drug is NOT classified as a Schedule I narcotic?
Marijuana (cannabis)
Methaqualone
Lysergic acid diethylamide (LSD)
Acetaminophen
Why are Schedule I drugs considered to have a high potential for abuse?
They are commonly prescribed for medical use.
They have no accepted medical use and can lead to severe psychological or physical dependence.
They are available in pharmacies without a prescription.
They are used to treat minor illnesses.
