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Pharm Ch 5
The Drug Approval Process
| Question | Answer |
|---|---|
| Define pharmacology. | the study of the effects of chemical substances on living tissues |
| What were early drugs derived from? | plants, animals, and minerals |
| What were the most commonly drugs used back in 2700 BC in the Middle East and China? | laxatives and emetics to induce vomiting |
| In 1550 BC Egyptians wrote their empirical observations of drug therapy. What have these writings become known as? | the Ebers Medical Papyrus |
| What were some things that the Egyptians suggested in the Ebers Medical Papyrus? | castor oil for a laxative; opium for pain; moldy bread to be applied to wounds and bruises |
| Who is Galen? | Roman physician and writer considered an authority in medicine and pharmacy; he initiated the common use of prescriptions and used several ingredients to treat a specific illness |
| What did Arabic doctors formulate around 1240 AD? | the first set of drug standards and measurements (grains, drams, minims), known as the apothecary system |
| What breakthrough drugs were introduced in the 18th century? | vaccine for smallpox; digitalis (from foxgrove plant) for strengthening and slowing heartbeat, and vitamin C from citrus fruit |
| What drugs were introduced in the 19th century? | morphine and codeine extracted from opium; atropine, bromides, and iodine; amyl nitrite was used to relieve the pain of angina; and anesthetics ether and nitrous oxide were discovered |
| What drugs were introduced in the 20th century? | aspirin derived from salicylic acid, and phenobarbital, insulin, and the sulfonamides were introduced |
| What drugs were marketed in the 1940s? | antibiotics (penicillin, tetracycline, streptomycin), antihistamines, and cortisone |
| What drugs were marketed in the 1950s? | antipsychotic drugs, antihypertensives, oral contraceptives, and the polio vaccine |
| What is the set of drug standards used in the United States? | United States Pharmacopeia of 1820 |
| What is the United States Pharmacopeia National Formulary (USP-NF)? | the current authoritative source for drug standards; revised every 5 years |
| What standards must drugs meet in order to be included in the USP-NF? | high standards of therapeutic use, client safety, quality, purity, strength, packaging safety, and dosage form |
| What was America's first law to regulate drugs? | Federal Pure Food and Drug Act of 1906, which did not include drug effectiveness and drug safety |
| What governing body did the Food, Drug, and Cosmetic Act of 1938 empower? Why? | Food and Drug Administration to monitor and regulate the manufacture and marketing of drugs |
| List the responsibilities of the FDA. | ensure that all drugs are tested for harmful effects, have labels with accurate information, and enclose with the drug packaging detailed literature that explains adverse effects |
| What does the Durham-Humphrey amendment to the Food, Drug, and Cosmetic Act of 1938 do? | distinguished between drugs that can be sold with or without a prescription and those that should not be refilled without a new prescription. |
| List the drugs that cannot be refilled without a new prescription. | narcotics, hypnotics, or tranquilizers |
| What tragedy resulted in the formation of the Kefauver-Harris amendment (1962) to the Food, Drug, and Cosmetic Act of 1938? | thalidomide tragedy of the 1950s in which pregnant European women who took the sedative-hypnotic thalidomide during the 1st trimester of pregnancy gave birth to infants with extreme limb deformities |
| What legislation increased controls on drug safety and required that adverse reactions and contraindications be included on the label? | Kefauver-Harris Amendment to 1938 Act |
| What was the 1970 Controlled Substance Act (CSA) of the Comprehensive Drug Abuse Prevention and Control Act, Title II, designed to remedy? | the escalating problem of drug abuse |
| List the 4 provisions of the Controlled Substance Act. | (1) promotion of drug education and research into prevention and treatment of drug dependence; (2) strenghtening of enforcement authority; (3) estab. of treatment/rehab facilities; (4) designation of schedules/categories for controlled substances |
| What are controlled substances described in? | five schedules (I through V) |
| Schedule I drugs | not approved for medical use; drugs with high abuse potential |
| Schedule II drugs | high potential for drug abuse; accepted medical use; can lead to strong physical and psychological dependency |
| Schedule III drugs | medically accepted drugs; potential abuse is less than for schedules I and II; may cause dependency |
| Schedule IV drugs | medically accepted drugs; may cause dependence |
| Schedule V drugs | medically accepted drugs; very limited potential for dependence |
| List nursing interventions for controlled substances. | account for all controlled drugs; keep special record for required info; countersign discarded/wasted meds; ensure records and drugs on hand match; keep locked up (narcotic kept under double lock); be certain only authorized persons have access to keys |
| What department of justice was charged with the role of being the nation's sole legal drug enforcement agency. | Drug Enforcement Administration (DEA) in 1983 |
| What reform act shortened the time in which new drugs could be developed and marketed? | Drug Regulation Reform Act (1978) |
| What was the purpose of the Drug Relations Act of 1992? | to change regulations to increase the approval rate of drugs used to treat AIDS and cancer; companies must pay user fee at time they file the application for the new drug |
| What act sets the standards for the privacy of individually identifiable health information as of 2003? | Health Insurance and Portability and Accountability Act (HIPPA) |
| What are the implications of HIPPA related to the individual's therapeutic regimen? | limitation on access to informationn from the pharmacy |
| Pediatric Research Equity Act (2003) | FDA is authorized to require testing by drug manufacturers of drugs and biologic products for their safety and effectiveness in children; one must not assume that children are small adults |
| 5 provisions of the Food and Drug Administration Modernization Act of 1997 | see book; pg. 122 |
| 2003: Medicare Prescription Drug Improvement and Modernization Act (MMA) | serves to provide financial assistance to seniors to purchase needed prescription medications |
| Nurse Practice Act | nurses cannot prescribe or administer drugs without a health care provider's order |
| Define misfeasance. | negligence; giving the wrong drug or drug dose that results in the client's death |
| Define Nonfeasance. | omission; omitting a drug dose that results in the client's death |
| Define malfeasance. | giving the correct drug but by the wrong route that results in the client's death |
| In Canada, who controls the manufacture, distribution, and sale of drugs (except narcotics)? | the Canadian Food and Drug Act, amended in 1953 |
| In Canada, who controls the manufacture, distribution, and sale of narcotic drugs? | 1996 Controlled Drugs and Substances Act |
| In Canada, what schedules are drugs assigned to? | Schedule F for all drugs except narcotics; Schedule I to IV for narcotics |
| Nonprescription drugs are administered by the Pharmacy Acts of the respective Canadian provinces which identify the place and conditions of sale. List the 3 categories these drugs are assigned to. | (1) nonprescription drugs sold at any retailer; (2) pharmacy only nonprescription drugs; (3) restricted access nonprescription drugs available from pharmacist only |
| Why are the number of counterfeit and adulterated prescription drugs on the rise? | lack of mandatory reporting of counterfeit incidents and that counterfeiting has features of a "perfect crime." |
| List nursing interventions regarding counterfeit drugs. | be alert to slight variations in packaging or labeling; advise clients to report any diff. in taste/appearance; noting any unexpected side effects; buy drugs from reputable source |
| What should you look for on a pharmacies website to make sure it is reputable? | an approval seal--VIPPS--Verified Internet Pharmacy Practice Site |
| List the 3 names a drug may have. | (1) chemical name; (2) generic name; (3) brand (trade) name |
| chemical name | describes drug's chemical structure |
| generic name | the official or nonproprietary name for the drug; not owned by pharmaceutical company and is universally accepted; most drugs ordered by this name |
| brand (trade) name | also known as proprietary name; chosen by drug company and is usually a registered trademark owned by that specific manufacturer |
| Cons of generic drugs | some may have inert fillers and binders that may result in variations of drug effectiveness |
| Why are generic drugs cheaper? | because manufacturers do not have to do extensive testing; these drugs were clinically tested for safety and efficacy by the pharm company that first formulated the drug |
| When are brand name drugs preferred? | when ordering anticonvulsants for seizures, anticoagulants (e.g., Coumadin), medications for heart failure (e.g., Lanoxin), and aspirin when used in large doses for Rheumatoid arthritis |
| Pregnancy Category A | no risk to fetus; studies have not shown evidence of fetal harm |
| Pregnancy Category B | no risk in animal studies, and well-controlled studies in pregnant women are not available; it is assumed that there is little to no risk in pregnant women |
| Pregnancy Category C | animal studies indicate a risk to fetus; controlled studies on pregnant women are not available; risk versus benefit of the drug must be determined |
| Pregnancy Category D | a risk to human fetus has been proved; risk versus benefit must be determined; could be used in life-threatening situations |
| Pregnancy Category X | a risk to human fetus has been proved; risk outweighs the benefit, and drug should be avoided during pregnancy |
| What is the purpose of Poison Control Centers? | provide information about the drug or toxic chemical compounds and the immediate action that should be taken to prevent injury or death |
| List some common drugs children ingest. | iron tablets, chocolate-covered laxatives, flavored acetominophen, and flavored liquid medicines |
| What is the mortality rate from poisoning in the US? | 28,000 deaths per year, of which 70% are from accidental causes and 30% are from suicides |
| What do nurses do regarding medication according to the ANA Code of Ethics for Nurses? | safeguards client's rights, safety, dignity, and health care |
| List two examples of international issues regarding drugs? | (1) drugs can be bought from Canada at a reduced rate; claims drugs from Canada online are conterfeit; (2) cost of AIDS drugs is prohibitive for impoverished individuals in Africa |
Created by:
thehealthynurse
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