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P100 Chapter 2

Study Guide

QuestionAnswer
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
Created by: bejaranohill09