Chapter 1

What is a black box warning?

Indicates a very serious life-threatening problem Probability of a drug acquiring a new black box warning or being withdrawn from the market within 25 years of being released is 20%

What is fast tracking?

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

Describe the structure of biosimilar products.

complex with potential structure variations

Describe the immunogenicity (promotes immune response; potential for allergy) of biosimilar products.

higher potential

---- uses water, light, and heat

physiotherapy

---- identifies stressors and methods used to reduce them.

psychotherapy

Describe the new drug application (NDA) review stage.

range is 2 months to 7 years average time is 17 months

Before manufacturers, prescribers, and dispensers carry controlled substances - what should they do?

register with the DEA requirements must be met to dispense scheduled medications

Which schedule of controlled substance is being described below? 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

schedule II

It currently takes an average of 8 to 15 years and more than ---- in research and development costs to bring a single new drug to market.

$2 billion

What is the brand or trademark name?

(proprietary name) is the name assigned to the drug by its manufacturer to distinguish the drug for advertisement and sale registered by manufacturer; capitalized

What are the 2 official sources for American drug standards?

1. The United States Pharmacopeia (USP) / National Formulary (NF) 2. USP Dictionary of United States Adopted Names (USAN) and International Drug Names

What is biological therapy?

A new class of drugs Has transformed treatment of patients with disorders that attack the body's own organs, tissues, and cells.

What are orphan drugs?

Medicines developed for rare disorders

What is the chemical name?

Most meaningful to the chemist Chemist understands the exact chemical constitution of the drug and the exact placement of its atoms or molecular groupings

Describe the Orphan Drug Act (1983).

Promotes development of products that demonstrate promise for diagnosis or treatment of rare diseases or conditions

Of the 2 official sources for American drug standards, which one contains more than 10,000 drug names?

United States Adopted Names (USAN)

What is parallel tracking?

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

What is the official name?

listed by the FDA

List the abuse potential, medical use, and an example for the following schedule of drugs. Schedule IV

low abuse potential some medical use diazepam

List the abuse potential, medical use, and an example for the following schedule of drugs. Schedule V

low abuse potential prescription not needed (OTC) robitussin

What is the effectiveness of drug legislation in regard to controlled substances?

enforcing laws regarding the proper distribution and use of drugs is dependent on many organizations working together to ensure understanding of reasons for drug legislation

How are controlled substances handled in hospitals?

inventory and dispersion control records are kept

Describe the postmarking surveillance stage.

involves adverse reaction reporting, surveys/ sampling testing, and inspecting ongoing review of adverse effects of new drugs black box warning

Describe the clinical research and development stage.

involves testing on humans and 3 phases may require 2 to 10 years average is 5 years

What are therapeutic methods of pharmacology?

therapeutic methods are approaches to treating illnesses therapeutic methods are often used in combination with one another you don't always have to give a patient a medication to make them feel better

Describe manufacturing of biosimilar products.

unique bank of living cells unlikely to achieve identical copy

What is an illegal or recreational drug?

used for non therapeutic purposes and is obtained illegally

Describe the preclinical research and development stage.

utilizes discovery and animal testing range is 1 to 3 years average time is 18 months

What is a prescription?

requires an order by a health professional licensed to prescribe drugs

Describe the Federal Food, Drug, and Cosmetic Act (1938, 1951, 1962).

requires the FDA to determine the safety of the drugs before marketing and to ensure that certain labeling specifications and standards in advertising are met in the marketing of products

Which schedule of controlled substance is being described below? 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

schedule I

Which schedule of controlled substance is being described below? 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

schedule III

Which schedule of controlled substance is being described below? 1. Low potential for abuse compared with drugs in Schedule III 2. Currently accepted for medical use in the United States Abuse potential that may lead to limited physical or psychological dependence compared with drugs in Schedule III

schedule IV

Which schedule of controlled substance is being described below? 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

schedule V

Describe the Controlled Substances Act (1970).

defined five classifications or schedules of controlled

What are the 4 common electronic databases?

1. Cumulative Index of Nursing and Allied Health (CINAHL) 2. Lexicomp 3. ePocrates 4. DailyMed

What are the 3 broad drug classifications?

1. body system classification (eg., cardiovascular or gastrointestinal) 2. therapeutic use or clinical indications (eg., antacids or antibiotics) 3. physiologic or chemical action (eg., anticholinergics or calcium channel blockers)

What are 4 examples of therapeutic methods?

1. diet therapy 2. drug therapy 3. physiotherapy 4. psychotherapy

Pharmakon is Greek for ---- and logosis Greek for ----: The origin of pharmacology.

1. drugs 2. science

What are the 3 resources for prescription and nonprescription drug information?

1. package inserts 2. nursing journals 3. electronic databases

Rules and regulations evolved by the FDA divide new drug development into four stages. List them.

1. preclinical research and development 2. clinical research and development 3. new drug application (NDA) review 4. postmarketing surveillance

National Organization for Rare Disorders estimates that ---- rare health conditions exist in about 20 million Americans.

6,000

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

A Schedule I drugs have the highest potential for abuse. They are not currently accepted for medical use in the United States.

Which name(s) of a drug should the nurse use when teaching a patient about a new prescription? a)Trade b)Generic and trade c)Generic and chemical d)Official

B

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

C 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)

C 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

D 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.

---- are large, complex proteins manufactured in a living system

biologic agents

What is a biosimilar product?

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

Describe the complexity of biosimilar products.

difficult to fully characterize

What is the general name?

formularies use them; not capitalized the proper name is the nonproprietary (generic) name which is used to identify an official drug typically the common name of the drug

List the abuse potential, medical use, and an example for the following schedule of drugs. Schedule I

high abuse potential no medical use heroin

List the abuse potential, medical use, and an example for the following schedule of drugs. Schedule II

high abuse potential some medical use pentobarbital or lortab

List the abuse potential, medical use, and an example for the following schedule of drugs. Schedule III

high abuse potential some medical use codeine

Describe the size of biosimilar products.

large

Describe the approval requirements for biosimilar products.

large clinical trials in patients

Describe the stability of biosimilar products.

more sensitive to storage and handling conditions

Describe the possession of controlled substances by individuals.

nurses may not have controlled substances in their possession

What is a nonprescription?

over-the-counter (OTC) drugs sold without a prescription

---- deals with the study of drugs and their actions or effects

pharmacology