Help
Options
Didn't know it?
click below
click below
Knew it?
click below
click below
Don't Know
Remaining cards (0)
Know
retry
shuffle
restart
0:00
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.
Normal Size Small Size show me how
Normal Size Small Size show me how
Arlen Review Ch 3
| Question | Answer |
|---|---|
| Federal agency that enforces regulations concerning drug products | FDA |
| Agency which controls the distribution of drugs that may be easily abused. | Drug Enforcement Administration |
| Law that prohibited adulterated or misbranded food, drinks, and drugs. | Food and Drug Act of 1906 |
| A comprehensive law enacted after the fatal poisoning of 107 people that requires new drugs be shown to be safe before marketing | Food, Drug and Cosmetic Act of 1938 |
| Law that defines legend drugs and requires the labeling "Caution: Federal Law prohibits dispensing without a prescription." | Durham-Humphrey Amendment of 1951 |
| Laws that require drug manufacturers to provide proof of safety and effectiveness before marketing. | Kefauver-Harris Amendments of 1962 |
| Law that requires child-proof packaging on all controlled and most Rx drugs dispensed by pharmacies. | Poison Prevention Packaging Act of 1970 |
| Law that classifies drugs that may be easily abused and restricts their distribution - enforced by the DEA within the Justice Department | Controlled Substances Act of 1970 |
| Law that requires pharmacists to offer counseling to Medicaid patients | OBRA 1990 |
| Law that provides broad and stringent regulations to protect patient privacy | Health Insurance Portability and Accountability Act (HIPAA) of 1996 |
| Inactive substances, not real medications that are used to test the effectiveness of drugs. | placebos |
| A drug patent is in effect for ___ years after its discovery. | 17 |
| Law that extends patents up to 5 years to offset the time an FDA approval can take. | Hatch-Waxman Act of 1984 |
| A drug which has the potential to be abused and appears on one of five schedules. | controlled substance |
| Drug recalls are almost always | voluntary |
| Recall where there is a strong likelihood that there will be serious side effects or fatalities. | class 1 recall |
| Recall where there may be temporary but reversible side effects | class 2 recall |
| Recall where it is not likely that there will be adverse effects | class 3 recall |
| schedule of drugs with a high potential for abuse and no accepted medical use in the US | C-I |
| C-I examples | heroin, various opium derivatives, hallucinogens |
| schedule of drugs with a high potential for abuse leading to physical or psychological dependence | C-II |
| C-II examples | amphetamines, opium, cocaine, methadone, and various opiates |
| schedule of drugs with less potential for abuse than C-II that may lead to moderate or low physical dependence or high psychological dependence. | C-III |
| C-III examples | anabolic steroids, various compounds containing limited narcotic substances such as codeine. |
| schedule of drugs with a low potential for abuse relative to C-III and abuse may lead to low physical or psychological dependence. | C-IV |
| C-IV examples | phenobarbital, chloral hydrate (sedative), methohexital (anesthetic) |
| schedule with a low potential for abuse relative to C-IV, but abuse may lead to limited physical or psychological dependence. | C-V |
| C-V examples | compounds containing limited amounts of narcotic such as codeine. |
| number of refills for C-II | none |
| number of refills for CIII-V | up to five within 6 month period |
| Orange Book published by | FDA |
| first letter of Orange Book code | A - bioequivalent B - not bioequivalent |
| second letter of Orange Book code | additional information on the basis of FDA's evaluation |
| a number all prescribers of controlled substances are assigned | DEA number |
| a court order preventing a specific action | injunction |
| an inactive substance given in place of a medication | placebo |
| an unintended effect of a medication that is negative to a patient's health | adverse effect |
| any drug which requires a prescription and Rx only on the label | legend drug |
| failing to do something you should have done | negligence |
| having to do with the treatment of children | pediatric |
| federal laws that require that a drug and/or its container not be imitative of another drug | "look alike" regulations |
| serving to cure or heal | therapeutic |
| the action taken to remove a drug from the market and return it to the manufacturer | recall |
| the logo which indicates the control schedule of a drug with potential for abuse | controlled substance mark |
| number on the drug label indicating the manufacturer and product information | NDC number |
| The ____ defined what drugs need a prescription | Durham-Humphrey Act of 1951 |
| A need for tighter drug regulations from the thalidomide lesson led to the | Kefauver-Harris Amendment |
| Legend drugs should have the legend ____ on the manufacturer's label. | Rx only |
| in clinical trials, the testing is done on ___ | people |
| The main purpose of phase I clinical trials is | safety |
| the daily sales limit of pseudoephedrine base is | 3.6g per purchaser |
| the NDC is assigned by the | manufacturer |
| DEA form ____ is used to order C-II controlled substances | 222 |
| in each state, pharmacists are licensed by | the state board of pharmacy |
| records for the sales of exempt narcotics must be kept in a | bound record book |
Created by:
anstrickland