Federal Law

How old must a person be to purchase a controlled substance that is not a prescription medication?

18 years

Which phase of investigational drug clinical studies is usually performed on 20-100 volunteer patients?

Phase 1

Which of the following do HIPAA laws apply to?

All of the above

Which of the following is true concerning patient participation in an investigational drug study?

All of the above

Which professional organization represents pharmacists who serve as patient care providers in hospitals, health systems, ambulatory clinics, and other healthcare settings?

American Society of Health-System Pharmacists (ASHP)

Which recall class applies to a product that will not harm the patient, but should not be sold?

Class 3

Which DEA form is used to report loss or theft of controlled substances?

Form 106

Which DEA form is used for order and record receipt of Schedule II drugs or to return Schedule II drugs to a supplier or "Reverse Distributer" for removal of stock?

Form 222

Which DEA form is used for the destruction of controlled substances?

Form 41

Which of the following is true in regards to HIPAA?

HIPAA protects all forms of information including oral, paper, and electronic

Which three types of Investigational New Drugs do the FDA have?

Investigator, Emergency Use, and Treatment

Which non-governmental agency is responsible for the accreditation of hospital settings?

JCAHO (The Joint Commission on Accreditation of Health Care Organizations)

Which professional organization advances the pharmacy technician profession through education, advocacy, and support?

National Pharmacy Technician Association (NPTA)

Which stage of investigation has the main purpose to establish safety and dosage?

Phase 1

Which phase of investigation establishes effectiveness and side effects?

Phase 2

Which phase of investigational drug clinical studies is usually performed on several hundred volunteers with the disease or condition to establish effectiveness and side effects of a drug?

Phase 2

Which phase of investigation establishes effectiveness and monitors or better defines adverse reactions?

Phase 3

Which phase of investigational drug clinic studies is usually performed on 300 to 3,000 volunteers with the disease or condition to better define adverse reactions?

Phase 3

Which phase of investigation involves the use in patients after FDA approval?

Phase 4

PDMP stands for:

Prescription Drug Monitoring Program

Which of the following is true regarding pseudoephedrine sales?

Products that contain pseudoephedrine must be kept where patients cannot access them without assistance

Which of the following controlled substance schedules contains drugs with no currently accepted medical use?

Schedule I

Prescription records for which controlled substance schedule must be maintained separately from all other records of the registrant?

Schedule II

Prescriptions for which controlled substance schedule CANNOT be refilled?

Schedule II

Prescriptions for which controlled substance schedule may not be refilled more than six times from the date written or refilled more than five times in a six-month period?

Schedule III and IV

Which of the following controlled substance schedules contains drugs with a low potential for abuse and low risk of dependence, such as Xanax?

Schedule IV

Prescriptions for which controlled substance schedule do not have an expiration, nor do they have a limit on refills?

Schedule V

Prescriptions for which controlled substance schedule do not have an expiration, nor do they have a limit on refils?

Schedule V

Which of the following controlled substance schedules has a low potential for abuse and contains medications that are generally used for antidiarrheal, antitussive, and analgesic purposes?

Schedule V

Which agency is responsible for licensing and general professional oversight of pharmacists and pharmacies?

State Board of Pharmacy

Which of the following statements about a controlled substance inventory is true?

There must be an exact count of Schedule II medications

True or False: DEA regulations require a separate ordering of Schedule II substances.

True

True or False: if a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained electronically

True

True or False: if a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained electronically.

True

Which independent, scientific nonprofit organization works to strengthen the global supply chain so that medicines are available when needed and work as expected?

USP (United States Pharmacopeia)

Federal laws require that which of the following information can be documented on a daily basis?

a log of controlled substances dispensed

Which of the following is NOT covered under HIPAA?

a medication invoice for recipient of the pharmacy wholesaler order

Why were the five schedules for controlled substances established?

abuse potential

A DEA number

can be verified on a DEA website if there is any suspicion of fraud

Partial fills of controlled substances is allowed if:

each partial filling is recorded in the same manner as a refilling

How many years does a seller need to maintain each entry in the logbook?

no fewer than 2 years

In which of the following situations do you need the patient's concent?

providing medication records to a hospital emergency room

How must prescriptions for Schedule II medications be filled?

separately from all other prescriptions

Acknowledgement of receipt of the pharmacy's HIPAA privacy practices must be kept on file for

six years

If state, local, and federal pharmacy law differ, which law applies?

state

Susan comes in to ask for a copy of her boyfriend's antibiotic prescription. She tells the pharmacy technician that he is very busy, and she is trying to help him out with an insurance issue. A pharmacy technician should

tell Susan they cannot provide that information without the consent of the patient.

A patient hands a pharmacy technician an empty vial of Methylphenidate, a Schedule II drug, and asks for the Rx to be refilled. What should the technician do?

tell the patient that the medication is not refillable without a new written prescription

Which organization has a code of ethics for pharmacy technicians?

the American Association of Pharmacy Technicians

Which change in the law regulates the retail sales of pseudoephedrine?

the Combat Methamphetamine Act (2005)

Which law implemented regulations on the sale of ephedrine, pseudoephedrine, or phenylpropanolamine?

the Combat Methamphetamine Epidemic Act (2005)

Which law classified drugs based on their potential for abuse?

the Controlled Substances Act (1970)

Which law regulated that dietary supplements are classified as "food" and can be marketed without FDA review?

the Dietary Supplement Health and Education Act (1994)

Which law allowed prescribers to obtain a waiver to prescribe controlled substances to treat opioid addiction?

the Drug Addiction Treatment Act (2000)

Which agency determines the placement of drugs in the controlled substance schedules?

the Drug Enforcement Administration

Which law established national licensure standards for wholesale distributors and third-party logistics providers and requires these entities report licensure and other information to the FDA annually?

the Drug Supply Chain Security Act (2013)

Which change in law made a distinction between prescription and over-the-counter medications?

the Durham-Humphrey Amendment (1951)

Which law gave the FDA authority to remove products from the marketplace if they were found to be ineffective or unsafe?

the Federal Food, Drug, and Cosmetic Act

Which agency requires that a medication comes with a monograph, or detailed information about the medication?

the Food and Drug Administration

Which agency reviews and approves new drug applications?

the Food and Drug Administration

Which law protects the privacy of patient health information?

the Health Insurance Portability and Accountability Act (1996)

Which change in the law required a pharmacist to offer medication counseling?

the Omnibus Budget Reconciliation Act (1990)

Which law improved patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients?

the Patient Safety and Quality Improvement Act (2005)

Which change in the law required child-proof packaging?

the Poison Prevention Packaging Act (1970)

Which law was enacted to address prescription drug-marketing practices that had contributed to the diversion of drugs into a secondary gray market?

the Prescription Drug Marketing Act (1987)

Which law required all foods and drugs to meet a standard of strength and purity?

the Pure Drug and Food Act (1906)

Which agency ensures safe and healthful working conditions?

the U.S. Department of Labor Occupational Safety and Health Organization

According to federal law, controlled substances must be safeguarded by all of the following EXCEPT:

transport records

Records for controlled substances must be maintained for a period of

two years