Term
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Definition
| laws that govern wrongdoings against a person or property and generally charges are brought forth by another individual |
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Term
| Controlled Substances Act (CSA) |
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Definition
| 1970 act that was designed to help regulate drug use by creating rules and regulations for record keeping and dispensing, and requiring firms that handle controlled substances to register with the DEA; the act also organized controlled substances into a system of schedules based on the potential for abuse |
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Term
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Definition
| 1972 Act established to establish a list of marketable drugs for the FDA, which would assist in making federal safety laws |
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Term
| Durham-Humphrey Amendment (DHA) |
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Definition
| 1951 amendment that seperated drugs into two categories: legend drugs (prescription drugs) and over-the-counter drugs (OTC); amendment specified that drugs can only be administered through prescriptions (and should contain legends to that effect), but eventually may be chanced to OTC status |
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Term
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Definition
| a system of values, principles, and duties that govern behavior |
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Term
| Food, drug, and cosmetic act (FDCA) |
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Definition
| 1938 act that ensured drugs being delivered were safe, and supported the claimed strength, purity, and quality |
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Term
| Health Insurance Portability and Accountability Act (HIPAA) |
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Definition
| 1996 act that requires health care providers to provide a clear, written explination of how information will be used and disclosed |
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Term
| Kefauver-Harris Amendment (KHA) |
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Definition
| 1962 amendment that became part of the FDCA; the amendment was designed to institute higher safety measures for drugs approved by the FDA by requiring manufacturers to follow Good Manufactering Process (GMC) |
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Term
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Definition
| 1983 act created by the FDA to speed up the approval process for new medications intended to help people with urgent needs |
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Term
| Poison Prevention Packaging Act (PPPA) |
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Definition
| 1970 act created to reduce potential for accidental overdoses |
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Term
| According to HIPAA, confidential inofrmation may only be released under one of the following circumstances: |
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Definition
-under written consent of the patient
-by supoena
-in case of manditory reporting |
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Term
| Which amendment or act is also known as the prescription drug act? |
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Definition
| The Durham-Humphrey Amendment |
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Term
Which of the following is considered confidential information?
a. Directory Information
b. License number
c. Country of origin
d. Marital Status |
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Definition
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Term
| Which organization enforces the Poision Prevention Intervention Act? |
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Definition
| Consumer Product Safety Commission |
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Term
| What is a safe and effective drug? |
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Definition
| A drug approved by the FDA for sale in the US |
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Term
| The KFA of 1962 requires that the drug manufacurers prove to the FDA: |
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Definition
| the effectiveness of their product before marketing them |
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Term
| When completing DEA 222 to obtain Schedule II medication, which requirement must be met? |
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Definition
| Copies 1 and 2 much be forwarded to the wholesaler, with carbon copies intact |
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Term
| Which law ensured that drugs being delivered were safe and fulfilled reported claims? |
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Definition
| Food, Drug, and Cosmetic Act |
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Term
| Which law required pharmisists to counsel patients on new medications? |
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Definition
| Omnibus Budget Reconciliation Act |
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Term
| What is the purpose of the Orphan Drug Act? |
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Definition
| Allows drug companies to bypass lengthy testing to treat persons who have a rare disease |
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Term
| The best time to check for errors when filling a prescription is: |
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Definition
| when checking the origional order against the label, against the stock bottle before filling, and before filling the vial and labeling |
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Term
| Describe "blanket consent" |
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Definition
| The consent outlines many items of routine care and/or information is signed on the first encounter of the healthcare provider |
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Term
| The middle segment of a national drug code represents which of the following product elements? |
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Definition
| product code, stregth, and dosage form |
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Term
| In court law, the intentional altering of records will result in a: |
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Definition
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Term
| The Patient Self-Determination Act, a federal law relating to end-of-life decisions for patients with terminal illnesses, required these two docs under fed. law: |
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Definition
| Durable Power of Attorney and Living Will |
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Term
| Controlled substances for office use can be obtained by a provider through: |
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Definition
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Term
| A controlled substance inventory must be done every: |
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Definition
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Term
| A schedule IV controlled substance may be filled: |
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Definition
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