Pharm. chapter 1

Generic name

common name

Brand name

trademark

Fast tracking

Used to expedite drug development and approval for life-threatening illnesses

Drugs

chemical substances that have an effect on living organisms

Chemical name

most meaningful to the chemist

Drug Legislation

provides a legal basis for drug treatments and protects the consumer from false claims made by the drug manufacturer.

Illegal drugs

recreational drugs, are drugs or chemical substances used for nontherapeutic purposes

7. During which stage of the process of new drug development does testing on humans start? 1. The preclinical research and development stage 2. The postmarketing surveillance stage 3. The postclinical research and development stage 4. The clinical research and development stage

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1. A patient has received a prescription from his primary care provider for the drug metoprolol (Lopressor). He asks the nurse why there are two names for the same drug. The nurse responds with which statements(s)? (Select all that apply.) 1. "One of the names is the brand name of the drug, and the other is the generic name." 2. "When drugs are discovered, all drugs are given a detailed chemical name and a simple generic name. If the company that discovered the drug brings it to the marketplace for sale, the manufacturer will give it a distinctive brand name. 3. "Lopressor is the generic name, and metoprolol is the brand name." 4. "The two names are used to determine whether the drug is a Schedule III or a Schedule IV drug." 5. "Generally, the generic form of the drug is less expensive."

1,2,

Schedule 1 drugs

1. Very high potential for abuse 2. Not currently accepted for medical use in the United States 3. Lack of accepted safety for use under medical supervision Examples: lysergic acid diethylamide (LSD), peyote, heroin, hashish

Orphan drugs

Medicines developed for rare disorders •Examples of rare diseases include cystic fibrosis, Hansen's disease (leprosy), sickle cell anemia, infant botulism.

Parallel tracking

Used for patients with life-threatening illnesses who cannot participate in controlled trials, when there is no other alternative

FYI

Rules and regulations evolved by FDA divide into four stages ØPreclinical research and development: Average time is 18 months ØClinical research and development: May require 2 to 10 years; average is 5 years ØNew Drug Application (NDA) review: Average time is 17 months ØPostmarketing surveillance

Nonprescription drugs

over-the-counter (OTC) drugs, are sold without a prescription in a pharmacy or in the health section of department or grocery stores.

Phase 2

involve a smaller population of patients who have the condition that the drug is designed to treat

Biosimilar

is a biologic product that is close in structure and function to an existing approved biologic product, known as a reference product

Pharmacology

the study of drugs and their interactions with living systems

electronic databases

ØCumulative Index of Nursing and Allied Health (CINAHL) ØLexicomp ØePocrates ØDailyMed

Sources for prescription and nonprescription drugs

ØPackage inserts ØNursing journals ØElectronic databases

Examples of therapeutic methods

• Drug therapy: Treatment with drugs • Diet therapy: Treatment with diet (e.g., a low-salt diet for patients with cardiovascular disease) • Physiotherapy: Treatment with natural physical forces (e.g., water, light, heat) • Psychological therapy: The identification of stressors and methods that can be used to reduce or eliminate stress

Which drug schedule indicates drugs with the highest risk for abuse? a)Schedule I b)Schedule II c)Schedule III d)Schedule IV e)Schedule V

•Answer: a •Rationale: Schedule I drugs have the highest potential for abuse. They are not currently accepted for medical use in the United States.

How many years on average does it take for a drug to be brought to market from the time of its conception? a)2 to 3 b)4 to 7 c)8 to 15 d)12 to 18

•Answer: c •Rationale: It takes 8 to 15 years and can cost up to $2 billion to get a drug to market. This amount of time and money is necessary to adequately test the drug for safety before releasing it to the general population.

Which entity is responsible for monitoring drug safety in the United States? a)Drug Enforcement Agency (DEA) b)Department of Justice (DOJ) c)U.S. Food and Drug Administration (FDA) d)World Health Organization (WHO)

•Answer: c •Rationale: The FDA is responsible for overseeing drug and cosmetic manufacture and promotion to determine their safety before allowing them to be released to the public.

Which source of information is best for the nurse to obtain drug information? a) Physicians' Desk Reference (PDR) b) Nursing journals c) United States Pharmacopeia (USP) and National Formulary (NF) d) Electronic databases

•Answer: d •Rationale: All can be sources of drug information, but keeping information current is extremely important. Reliable electronic databases can provide the most up-to-date information to health care providers, unlike printed resources that are published only periodically.

Therapies

diseases that cause illness may be treated in different ways.

Black box warnings

safety concerns that are identified after a drug is approved for marketing

Phase 1

studies determine an experimental drug's pharmacologic properties, such as its pharmacokinetics, metabolism, safe dosage range, potential for toxicity at a certain dosage, and safe routes of administration. usually require 20 to 100 subjects who are treated for 4 to 6 weeks.

6. The nurse knows which of these factors are the differences between prescription and nonprescription drugs? (Select all that apply.) 1. Nonprescription drugs are available over-the-counter. 2. Prescription drugs are those drugs that may be prescribed by dentists, pharmacists, nurse practitioners, and physicians. 3. Recreational drugs are available by prescription only. 4. Over-the-counter drugs are available at a pharmacy or health section of grocery stores. 5. Prescription drugs have been approved for use by the FDA.

1,2,3,4,5

4. Which electronic database(s) provide(s) drug information for healthcare providers? (Select all that apply.) 1. Lexicomp 2. CINAHL 3. Medline 4. DailyMed 5. Health on the Net

1,3,4

Schedule 2 drugs

1. High potential for abuse 2. Currently accepted for medical use in the United States 3. Abuse potential that may lead to severe psychological or physical dependence 4. Requires new prescription; no refills Examples: amphetamines, morphine, hydrocodone/acetaminophen (Vicodin), hydrocodone/acetaminophen (Lortab), hydrocodone/acetaminophen (Norco), methadone, oxycodone/aspirin (Percodan), methylphenidate (Ritalin), amphetamine/dextroamphetamine (Adderall)

Schedule 3 drugs

1. High potential for abuse but less so than drugs in Schedules I and II 2. Currently accepted for medical use in the United States 3. Abuse potential that may lead to moderate or low physical dependence or high psychological dependence 4. Prescription outdates in 6 months; no more than five refills in that 6 months Examples: aspirin/codeine (Empirin with codeine), aspirin/butalbital/caffeine (Fiorinal), acetaminophen/codeine (Tylenol with codeine)

Schedule 4 drugs

1. Low potential for abuse compared with drugs in Schedule III 2. Currently accepted for medical use in the United States 3. Abuse potential that may lead to limited physical or psychological dependence compared with drugs in Schedule III 4. Prescription outdates in 6 months; no more than five refills in that 6 months Examples: phenobarbital, chlordiazepoxide, diazepam, flurazepam, temazepam

Schedule 5 drugs

1. Low potential for abuse compared with drugs in Schedule IV 2. Currently accepted for medical use in the United States 3. Abuse potential of limited physical or psychological dependence liability compared with drugs in Schedule IV; because abuse potential is low, a prescription may not be required 4. Prescription outdates in 6 months, no more than five refills in that 6 months Example: atropine/diphenoxylate (Lomotil, Virtussin AC)

5. A patient asked the nurse for an example of an appropriate source for drug information on the Internet. What would be an appropriate response by the nurse? 1. "The Internet is not an appropriate place to look up any drug information; you need to ask your physician or pharmacist." 2. "There are several reliable sites for drug information that are from official sources, for example, DailyMed." 3. "The Internet is reliable for any drug information that you search for." 4. "The only acceptable drug information sources are the package inserts."

2

2. Antacids, antibiotics, antihypertensives, diuretics, and laxatives are examples of drugs that are classified by which method? 1. Nonprescription status 2. Body system 3. Chemical action 4. Clinical indication

4

3. The nurse giving a drug to a patient for the effect it will have on the cardiovascular system understands that which method is used to classify the drug? 1. Therapeutic use 2. Physiologic action 3. Clinical indication 4. Body system

4

FYI

Drugs that are listed in Schedule I are not available for other than highly controlled research purposes. Drugs in Schedule II are available by prescription only in limited quantities, usually no more than a 30-day supply. The prescription cannot be refilled; a new prescription must be issued for continued use. Drugs categorized as Schedule III, IV, or V may be ordered by prescription with a maximum supply of 30 days of medicine. The prescription may be refilled up to five times but outdates at 6 months, at which time a new prescription is required if the medicine is to be continued. Prescription medicines that are not classified as controlled substances may be refilled for up to 1 year, if approved by the prescriber. Most state laws mandate that a prescription outdates in 1 year.

Therapeutic drugs (medicines)

are those drugs that are used for the prevention or treatment of diseases

Prescription drugs

require an order by a health professional who is licensed to prescribe drugs, such as a physician, a nurse practitioner, a physician assistant, a pharmacist, or a dentist.

Phase 3

larger patient populations are used to ensure the statistical significance of the results.

Orphan drugs

manufacturers have been unable to recover the costs of the research on account of the very limited use of the final product