Pharmacology Chapter 1

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. 8-15 D. 12 to 18 C. 8-15 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

Illegal or recreational drugs

Used for non-therapeutic purposes; obtained illegally

What are some examples of rare diseases?

cystic fibrosis, Hansen's disease (leprosy), sickle cell anemia, and infant botulism

A bio similar is known as a:

reference product

Brand or trademark:

registered by manufacturer; capitalized

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 ANS: 4. The clinical research and development stage

5. 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. Chemical action 4. Body system ANS: 4. Body System

Biologic therapy

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

Drug classifications are

Body system (cardiovascular, gastrointestinal) therapeutic use or clinical indications (antacids. antibiotics) physiologic or chemical action (anticholinergics, calcium channel blockers)

Schedule I

High abuse potential and no medical use (heroin)

Schedule III

High abuse potential; some medical use (codeine)

Schedule II

High abuse potential; some medical use (pentobarbital)

Controlled substances in hospitals:

Inventory and dissension control records

Schedule V

Low abuse potential; prescription not needed (Robitussin)

Schedule IV

Low abuse potential; some medical use (diazepam)

Chemical Name

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

Possession of controlled substances by individuals:

Nurses may not have controlled substances in their possession

Nonprescription

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

Sources for prescription and nonprescription drugs

Package inserts Nursing journals Electronic databases

Official source for American drug standards

The United States Pharmacopeia (USP/National Formulary (NF) USP DICTIONARY of USAN and International Drug Names

USAN stands for

United States Adopted Names

USP-NF stands for

United States Pharmacopeia/National Formulary

Controlled Substances Act of 1970

a federal statute that regulates the manufacture and distribution of the drugs that are capable of causing dependency.

Orphan Drug Act of 1983

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

Schedules of Controlled Substances

Schedule I, Schedule II, Schedule III, Schedule IV, Schedule V

Official name:

listed by FDA

Psychotherapy

indefinites stressors and methods used to reduce them

Pharmakon

is Greek for drugs

Logos

is Greek for science: The origin of pharmacology.

Orphan drugs

the medicines that are developed for rare health conditions

Paraelle tracking:

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

Fast tracking:

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

Physiotherapy

uses water, light and heat

Prescription

requires an order by a health professional licensed to prescribe drugs

black box warning

Indicates a very serious life-threatening problem

1. A patient has received from his primary care provider for the drug metoprolol (Lopressor). He asks the nurse why there are two names for the same drug. The nurses responds with which statement? (Select all that apply)

1. "One of the names is the brand name of the drug, the other is the generic name, and the last is the chemical 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 market place for sale, the manufacturer will give it a distinctive brand name." 5. "Generally, the generic form of the drug is less expensive." ANS: 1, 2, 5

4. A patient asked the nurse what would be an example of an appropriate source for drug information on the Internet. The nurse responds:

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. "There internet is reliable for any drug information that you search for." 4. "The only acceptable drug information sources are the package inserts." ANS: 2. "There are several reliable sites for drug information that are from official sources, for example, DailyMed."

6. A nurse was teaching a patient from Canada the names of her medications and reviewed the differences between Canadian names. Which statement indicates the patient understands the instructions?

1. "The proper name of the medication is the same as the brand name in Canada." 2. "The proper name of the medication is the same as the generic name in Canada." 3. "The chemical name is the one used the most when buying medications in Canada." 4. "The chemical names and the brand names are the only names used in Canada." ANS: 2. "The proper name of the medication is the same as the generic name in Canada."

3. Which electronic database(s) provide(s) drug information for healthcare providers? (Select all that apply.)

1. Lexi-Comp 2. CINAHL 3. Medline 4. DailyMed 5. Health on the Net ANS: 1, 3, 4 Lexi-Comp is a particularly strong database for healthcare providers because the American Hospital Formulary Service is available through its portal. Medline, provided by the U.S. National Library of Medicine, is a searchable database at no cost. DailyMed, developed in collaboration with several federal agencies, is available to healthcare providers and the public and provides high-quality information about marketed drugs. CINAHL (Cumulative Index to Nursing and Allied Health Literature) is available in many college libraries and gives nurses access to a wealth of information from sources published in the United States and other countries. Most of the drug information sources listed in Table 1-1 are also available via electronic retrieval from libraries. Other databases for practitioners available by subscription include UpToDate and ePocrates (see Online Resources at the end of the text chapter). Health on the Net is not a drug information database source.

2. Antacids, antibiotics, antihypertensives, diuretics and laxatives are examples of drugs that are categorized by which factor?

1. Nonprescription status 2. Body system 3. Chemical action 4. Clinical indication ANS: 4 Clinical indication

8. The nurse knows that the difference between prescription and nonprescription drugs involves: (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. ANS: 1, 2, 4, 5

The probability of a drug acquiring a new black box warning or being withdrawn from the market within 25 years of being released is ____

20%

National Organization for Rare Disorders estimates that ______ rare health conditions exist in about __ million Americans

6000 and 20

It currently takes an average of ___ to ___ years and more than 2 billion in research and development costs to bring a single new drug to market.

8 to 15 years

Biosimilar

A biologic product highly similar to reference product; Should have same mechanism, route, form & strength as reference product; No clinical meaningful difference between safety, purity & potency; Are not exchangable

Drug classification

A method of grouping drugs; may be based on structure or therapeutic use.

Which entity is responsible for monitoring drug safety in the US?

A. Drug Enforcement Agency (DEA) B. Department of Justice (DOJ) C. U.S. Food and Drug Administration (FDA) D. World Heath Organization (WHO) C. U.S. Food and Drug Administration (FDA) 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 informaton?

A. Physicians Desk Reference (PDR) B. Nursing Journals C. United States Pharmacopeia (USP) and National Formulary D. Electronic databases D. Electronic databases - 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.

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

Which name(s) of a drug should the nurse use when teaching a patient with a new prescription? A. Trade B. Generic and trade C. Generic and chemical D. Official

B. Generic and trade If the nurse only teaches one name, it may lead to confusion for the patient when he or she receives a drug with a different name

Preclinical Research and Development

Average time is 18 months

Electronic databases

Cumulative Index of Nursing and Allied Health (CINAHL) Lexicomp ePocrates DailyMed

Manufactures, prescribers, and dispensers must register with the:

DEA: Requirements must be met to dispense scheduled medications

Effectiveness of drug legislation:

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

Postmarketing surveillance

Evaluation of a new drug after it has been approved and used in large numbers of patients.

Biologic agents

are large, complex proteins manufactured in a living system

New Drug Application (NDA) review:

average time is 17 months

Therapeutic methods are approaches to treating illnesses:

diet therapy drug therapy physiotherapy psychotherapy

Pharmacology deals with the study of

drugs and their actions or effects

Generic name:

legal noncommercial name for a drug formularies use them not capitalized common name

Clinical Research and Development

may require 2 to 10 years; average is 5 years

All individuals involved with controlled substances have responsibilities to ensure:

patient safety