Question | Answer |
The Food and Drug Administration (FDA) has authority to | regulate the manufacture and sale of drugs |
The Health Care Financing Administration (HCFA) has authority over | Medicare and Medicaid programs |
Accreditation by the Joint Commission | All of the above (is voluntary under law;is required by many insurance carriers; involves a rigorous inspection process) |
The purpose of the Pure Food and Drug Act of 1906 was to | prohibit interstate transportation of adulterated drugs |
The Food, Drug, and Cosmetic (FDC) Act of 1938 | created the Food and Drug Administration (FDA); required submission of a new drug application (NDA) for new drugs |
Adulterated drugs are those | All of the above (prepared with unsafe color additives; in containers made from poisonous substances; packed under unsanitary conditions) |
Misbranded drugs may include those that are labeled with | misleading information |
Toxicological studies are conducted on ___, whereas clinical trials are conducted on ___. | animals; humans |
Through the Food, Drug, and Cosmetic Act of 1938, the FDA had the authority to | require that drug be useful for its stated purpose; conduct manufacturing plant inspections |
The Durham-Humphrey Amendment of 1951 provided for the | All the above (refilling of prescriptions; dispensing of drugs over the counter; taking of herbal prescriptions) |
Legend drugs are also known as __ drugs. | prescription |
The amendment that required that drugs be effective as well as safe was the | Kefauver-Harris Amendment |
To combat ad control drug abuse, the ___ Act was passes | Controlled Substances |
The Drug Enforcement Administration (DEA) was created to | enforce and prevent the abuse of controlled substances |
A Schedule II drug | All of the above (has potential for severe psychological and physical dependence; cannot be refilled; cannot be prescribed by phone except in an emergency) |
Which of the following schedules of drugs must be prescribed in writing except in case of an emergency? | Schedule II |
A Schedule V drug | may be sold without a prescription in some states; has the lowest abuse potential |
The ___ Act requires over-the-counter and legend drugs be packaged in child-resistant containers | Poison Prevention Packaging |
Under the Drug Listing Act of 1972, each new drug is assigned a unique and permanent product identifier called the | national drug code (NDC) |
An orphan drug is one | that is intended for use in a few patients with a rare disease |
Exceptions to the requirement for child-resistant containers include | inhalation aerosols; multiple vitamin with iron |
What is a true statement regarding generic drugs | They can be marketed by any manufacturer once the original patent expires and they are usually less expensive than name brands |
The creation of both generic and innovative new drugs is encouraged by the ___ Act | Drug Price Competition and Patent-Term Restoration |
The Prescription Drug Marketing Act of 1987 prohibits | re-importation of drugs into the U.S by anyone except the manufacturer |
Under the Anabolic Steroid Act, prescriptions for testosterone can be refilled | up to five times or for up to 6 months from the date written |
The __ Act requires that pharmacists review the patient's profile and offer counsel to the patient. | Omnibus Budget Reconciliation |
Under OBRA-90, the pharmacist is required to offer to counsel patients regarding the | methods of self-monitoring |
The Omnibus Budget Reconciliation Act requires the manufactures to provide | rebates to Medicaid for the difference between wholesale and average billed prices |
Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers of dietary supplements are not required to prove ____ to the FDA | All of the above (safety; effectiveness; standardization) |
After the Food and Drug Administration removes a dietary supplement from the market, | it must prove that the supplement is unsafe |
Under the Health Insurance Portability and Accountability Act (HIPAA) | health insurance can be moved between employers without restrictions |
One of the the main purposes of the Health Insurance Portability and Accountability Act (HIPAA) is to | safeguard patient confidentiality |
Under Medicare Part D | Medicare beneficiaries pay an extra premium for prescription benefits |
The sale of products containing ___ has been restricted to avoid illegal manufacture of methamphetamine | pseudoephedrine |
When advertising a drug to the public, the manufacturer must disclose | side effects |
Which of the following is regulated by the FDA | content of advertising; labeling of OTC medications; approval of new drugs (ALL OF THE ABOVE) |
OSHA's place in pharmacy is to | protect employees from unnecessary hazardous drug exposures |
Who can prescribe controlled substances | dentist |
The ___ represents all fifty of the state boards of pharmacy | National Association of Board of Pharmacy (NABP) |
A pharmacist may have his or her pharmacy license revoked by a | state board of pharmacy |
Prescriptions for nonscheduled drugs are usually refillable for up to | one year from the date written |
Prescriptions for Schedule III, IV, V drugs are usually refillable for up to | 6 months from date written |
The role of the pharmacy technician is | defined from state to state |
The pharmacy technician may typically | prepare medication labels |
In the preparation of a compound prescription, what activity must be performed by a pharmacist | calculating weights |
Torts are wrongs committed against | another citizen |
Standard of care is defined as the | level of care expected from healthcare providers |
Contributory negligence occurs when | two or more causes are a factor in the negligence and personal injury |
The term that applies to the pharmacy technician's acting as an agent of the pharmacist is | respondeat superior |
What is a true statement regarding the Pharmacy Technician Certified Board. | It develops and administers pharmacy technician certification programs |