PHARMA: Chapter 1

_______ refers to the frequency, size, and number of doses; it is a major determinant of drug actions and responses, both therapeutic and adverse. a. Dosage b. Route c. Mode

a. Dosage

The ________ formalized a policy that women and minorities be included in human subject research studies funded by the ______ and that women and minorities be included in clinical drug trials. a. National Institutes of Health (NIH) Revitalization Act b. Food, Drug, and Cosmetic Act of 1963 c. DEA

a. National Institutes of Health (NIH) Revitalization Act

What phase is described below? Pre-FDA status Investigational New Drug (IND) Status Drug testing occurs in animals and small groups of humans. a. Phase 0 b. Phase 1-4

a. Phase 0

________ are more standardized in their chemical characteristics, more consistent in their effects, and less likely to produce allergic reactions. a. Synthetic drugs b. Semisynthetic drugs

a. Synthetic drugs

The _______ is charged with enforcing the law described by amendments such as the Durham-Humphrey Amendment. a. U.S. Food and Drug Administration (FDA) b. Drug Enforcement Administration (DEA) c. Federal Trade Commission

a. U.S. Food and Drug Administration (FDA)

Biotechnology Each hybrid molecule produces a genetically identical molecule, called a a. clone b. seed c. xanthus

a. clone

Sunscreen and local anesthetics are examples of a. drugs with local effects b. drugs with systemic effects c. drugs with intermediate effects

a. drugs with local effects

The names of many drug groups are based on _________ instead of therapeutic uses such as adrenergics and benzodiazepines. a. ability to cure a disease b. color and size c. chemical characteristics

c. chemical characteristics

_______ are drugs categorized according to therapeutic usefulness and potential for abuse a. addictive medication b. opioids c. controlled substances

c. controlled substances

The goal of most pharmacoeconomic research is to identify drug therapy regimens that provide the a. lowest cost only b. most benefits only c. desired benefits at the lowest cost

c. desired benefits at the lowest cost

The generic name often indicates the ______ (e.g., drugs with generic names ending in "cillin" are penicillins). a. clone b. prototype c. drug group

c. drug group

Pharmaeconomics includes the cost of all of the following EXCEPT a. purchasing b. dispensing c. gas used to visit laboratory d. storage

c. gas used to visit laboratory

An ideal drug has all of the following properties EXCEPT: a. reversible action b. predictability c. high cost d. ease of administration

c. high cost

All of the following are included in the 10 rights of medication administration EXCEPT: a. right documentation b. right patient education c. right evaluation d. right to search information e. right to refuse the medication

d. right to search information

Amoxicillin is an example of a ______.

generic name

Sulfanilamide

had contained antifreeze, 100 died

Beers List

identifies drugs with a high likelihood of causing adverse effects in older adults

Trade names are capitalized and generic names are

lowercase

Drugs given for therapeutic purposes are also called

medications.

What is the branch of pharmacology that uses drugs to treat, prevent, and diagnose disease?

pharmacotherapeutics

The therapeutic goal of drug therapy is to:

provide maximum benefit with minimum harm.

Pharmacogenomics is the ________.

study of how one's genetic inheritance affects the body's response to drugs.

abstinence syndrome

the physical effects that result from depriving an addict of the drug to which he or she is habituated.

Pharmacology

the study of drugs (chemicals) that alter functions of living organisms.

Pharmacotherapy

the use of drugs to prevent, diagnose, or treat signs, symptoms, and diseases.

BLACK BOX WARNINGS (BBWs)

warnings about serious adverse effects

What are the (3) most important factors of a drug?

1. effectiveness 2. safety 3. selectivity

Drugs are classified according to what (3) factors?

1. effects on particular body systems 2. therapeutic uses 3. chemical characteristics

The (2) most commonly used names for individual drugs are their _________.

1. generic (official) name 2. brand (trade) name

What established the five schedules that classify controlled substances?

1970 Comprehensive Drug Abuse Prevention and Control Act; Controlled Substance Act

Drug development can take __________ years.

6-12 years

For which patient will the nurse need to consult the Beers Criteria prior to administering medications?

An elderly patient who has been prescribed new medications for pain control

True or False Generic drugs are required to be therapeutically equivalent to trade-named drugs.

True, generic drugs are required to be therapeutically equivalent to trade-named drugs.

True or False Many antibiotics are semisynthetic drugs.

True, many antibiotics are semisynthetic drugs.

True or False. Some prototypes are replaced over time by newer, more commonly used drugs.

True, some prototypes are replaced over time by newer, more commonly used drugs.

1906 Pure Food and Drug Act

Unethical and unsanitary practices; public pressure Created the FDA who is entrusted with testing all foods and drugs destined for human consumption

The client tells the nurse about a new drug being tested to treat the disease he or she was diagnosed with and asks the nurse whether the doctor can prescribe a medication still in the preclinical phase of testing. What is the nurse's best response?

You Selected: "Drugs in the preclinical phase of testing are only tested on animals and so would not be available to you."

The nurse is caring for a patient who admits to having taken anabolic steroids to enhance his cycling ability. What schedule medication was this patient abusing?

You Selected: Schedule III

A drug has been approved by the Food and Drug Administration. What study phase would occur next?

You Selected: phase IV study

After teaching a group of nursing students about drug classes and categories, the instructor determines that the teaching was successful when the students identify legend drugs as referred to as which medication?

You Selected: prescription drugs

The care provider has prescribed intravenous hydromorphone for a client using a client-controlled analgesia (PCA) pump. The nurse is aware that this drug has a high abuse potential. Under what category would hydromorphone be classified?

You Selected: schedule II

1938 Food, Drug, and Cosmetic Act

This act made the food and Drug Act more comprehensive to include cosmetics. Requires that a new drug has to be proven safe under FDA guidelines before marketing

In the United States, the _______ assigns the generic name. a. chemists b. United States Adopted Names Council c. pharmaceutical companies

b. United States Adopted Names Council

The ________ is designated and patented by the manufacturer. a. generic name b. brand name

b. brand name

Advil and Benadryl are examples of a. drugs with local effects b. drugs with systemic effects c. drugs with intermediate effects

b. drugs with systemic effects

People and companies legally empowered to handle controlled substances must do all of the following EXCEPT a. register with the DEA b. get a patent c. keep accurate records of all transactions d. provide for secure storage

b. get a patent

Because no drug is _____ all healthcare members are responsible. a. imperfect b. ideal c. perfect

b. ideal

Cloning makes it possible to identify the DNA sequence in a gene and to produce the protein product encoded by a gene, such as _____. a. asprin b. insulin c. heme

b. insulin

An individual drug that represents groups of drugs is called a a. clone b. prototype c. xanthus

b. prototype

All of the following are included in the 10 rights of medication administration EXCEPT: a. right drug b. right location c. right dose d. right patient

b. right location

Antidepressants and antihypertensives are examples of terms used to describe a drug's _____. a. effects on particular body systems b. therapeutic uses c. chemical characteristics

b. therapeutic uses

Drugs with systemic effects act a. mainly at the site of application b. through the bloodstream to the sites of action

b. through the bloodstream to the sites of action

An ideal drug has all of the following properties EXCEPT: a. freedom from drug interactions b. unpredictability c. low cost d. chemical stability

b. unpredictability

What process is described below? 1. manipulate DNA and RNA 2. recombine genes into hybrid molecules that can be inserted into living organisms 3. hybrid molecules are repeatedly reproduced a. meiosis b. mitosis c. biotechnology

c. biotechnology

Schedule II

Drugs that are used medically and have high abuse potentials: - opioid analgesics (e.g., codeine, oxycodone) - CNS stimulants (e.g., cocaine, methamphetamine) - barbiturate sedative-hypnotics (e.g., pentobarbital).

Schedule I

Drugs that have no accepted medical use, have lack of accepted safety, and have high abuse potentials (e.g. heroin, LSD)

Schedule IV

Drugs with an accepted medical use in the United States but with some potential for abuse: - benzodiazepines (e.g., diazepam, lorazepam), - other sedative-hypnotics (e.g., phenobarbital, chloral hydrate) - some prescription appetite suppressants (e.g., phentermine).

Schedule III

Drugs with less potential for abuse than those in Schedules I and II, but abuse of which may lead to psychological or physical dependence: - androgens and anabolic steroids - some depressants (e.g., ketamine, pentobarbital) - some CNS stimulants (e.g., methylphenidate) - mixtures containing small amounts of controlled substances

True or False Many drugs fit into one group because of their specific effects on the human body.

False, many drugs fit into multiple groups because of their wide-ranging effects.

True or False The company/organization tests the drugs.

False, the company/organization does not test the drugs.

Schedule V

Products containing moderate amounts of controlled substances. They may be dispensed by the pharmacist without a physician's prescription with restrictions Included are cough suppressants containing small amounts of codeine and antidiarrheal drugs, such as diphenoxylate and atropine (Lomotil).

Orphan Drug Act of 1983

Provided incentives for the development of orphan drugs for treatment of rare diseases

5 Drug Standards

Purity Bioavailability Potency Efficacy (effectiveness) Safety and toxicity (ncidence and severity of adverse reactions)

1970 Comprehensive Drug Abuse Prevention and Control Act; Controlled Substance Act

Regulates: Manufacture Distribution Dispensing of drugs with a potential for abuse

The _______ is related to the chemical or official name and is independent of the manufacturer. a. generic name b. brand name

a. generic name

When a drug is switched from prescription to OTC status, profit for drug companies increase and costs to consumers increase because a. health insurance companies do not cover most OTC drugs b. you don't need a prescription c. it is a more expensive route

a. health insurance companies do not cover most OTC drugs

Most drugs are manufactured from a. laboratories b. plants, animals, and minerals c. fungi

a. laboratories

Drugs with local effects act a. mainly at the site of application b. through the bloodstream to the sites of action

a. mainly at the site of application

All of the following are included in the 10 rights of medication administration EXCEPT: a. right room b. right route c. right time d. right reason

a. right room

A patent protects a new drug for _______. During this time, other drug companies cannot manufacture and market the drug until the patent expires. a. several years b. 1-3 years c. 10-15 years

a. several years

Accelerated programs a. shortens the normal approval process/drug development b. prolongs the normal approval process/drug development

a. shortens the normal approval process/drug development

Examples of orphan drugs _____________ which are used to treat leprosy symptoms and AIDS a. thalidomide (Thalomid) and zidovudine (Aztec) b. benzodiazepines and amoxicillin c. morphine and penicillin

a. thalidomide (Thalomid) and zidovudine (Aztec)

The ________ enforces the Controlled Substances Act. a. U.S. Food and Drug Administration (FDA) b. Drug Enforcement Administration (DEA) c. Federal Trade Commission

b. Drug Enforcement Administration (DEA)

The ________ designates drugs that must be prescribed by a licensed physician or nurse practitioner and dispensed by a pharmacist. a. Drug Enforcement Administration (DEA) b. Durham-Humphrey Amendment c. Food, Drug, and Cosmetic Act of 1938

b. Durham-Humphrey Amendment

What phase is described below? 4-6 week trial with 20-100 "normal" patients To determine safe dosages, routes of administration, absorption, metabolism, excretion, and toxicity. a. Phase 0 b. Phase 1 c. Phase 2 d. Phase 3

b. Phase 1

Prescriptions for ______ cannot be refilled; a new prescription is required. a. Schedule I drugs b. Schedule II drugs c. Schedule X drugs

b. Schedule II drugs

______ are naturally occurring substances that have been chemically modified. a. Synthetic drugs b. Semisynthetic drugs

b. Semisynthetic drugs

Generic equivalents can be substituted for trade-named drugs unless the prescriber writes ________ on the prescription. a. "be advised" b."replace with equivalent" c. "do not substitute"

c. "do not substitute"

The _______ regulates the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, and anabolic steroids and requires the pharmaceutical industry to maintain physical security and strict record keeping for these drugs and substances. a. Food, Drug, and Cosmetic Act of 1938 b. Durham-Humphrey Amendment c. Controlled Substances Act

c. Controlled Substances Act

The _________ and its amendments regulate the manufacture, distribution, advertising, and labeling of drugs. a. Drug Enforcement Administration (DEA) b. United States Adopted Names Council c. Food, Drug, and Cosmetic Act of 1938

c. Food, Drug, and Cosmetic Act of 1938

What phase is described below? Has subjects with the disease or symptom for which the drug is being studied, and responses are compared with those of healthy subjects. a. Phase 0 b. Phase 1 c. Phase 2 d. Phase 3

c. Phase 2

All of the following are good sources of drug information EXCEPT a. American Hospital Formulary Service b. Drug Facts and Comparisons c. Physicians' Desk Reference (PDR) d. Lippincott Nursing Drug Guide

c. Physicians' Desk Reference (PDR)

The DEA assigns prescribers a ______ which they must include on all prescriptions they write for a controlled substance. a. symbol b. letter c. number

c. number

Morphine is the ________ of the opioid analgesics. Penicillin is the _________ of the beta-lactam antibacterial drugs. a. clone, clone b. xanthus, gum c. prototype, prototype

c. prototype, prototype

Most drugs are given for their ______. a. local effects b. long-term effects c. systemic effects

c. systemic effects

Prototypes are ______. a. substandard, first drug of a specific drug class to be developed b. an old-fashioned way of making drugs c. the standard, first drug of a specific drug class to be developed

c. the standard, first drug of a drug class to be developed

Pharmaeconomics includes the cost of all of the following EXCEPT a. administration (staff/supplies) b. laboratory and tests for pt responses c. therapy sessions d. losses from expiration

c. therapy sessions

Pharamacoeconomics involves the ________.

cost of drug therapy

What phase is described below? Large sampling The drug is given to different populations and different dosages and by using the drug in combination with other drugs. a. Phase 0 b. Phase 1 c. Phase 2 d. Phase 3

d. Phase 3

What phase is described below? Post-marketing Surveillance Drug release for general use a. Phase 1 b. Phase 2 c. Phase 3 d. Phase 4

d. Phase 4