RxPrep Drug References: Key Medical Terms & Definitions

package insert

The ________ is the FDA-approved drug information that is part of the drug's official labeling.

true

True or False: Since package inserts contain only information approved by the FDA, they do not include off-label uses or drug costs.

DailyMed, Drugs@FDA

What are 2 locations where package inserts can be found online?

FDA

When drug safety information changes, who publishes a safety communication or alert on their website?

boxed warning

the strictest warnings found in a package insert; alerts prescribers to the risk of death or permanent disability

contraindication

something that causes the risk to outweigh any possible benefit of drug use in a patient; drug cannot be used if this is present

warnings and precautions

part of the package insert that includes serious reactions that can result in death, hospitalization, medical intervention, disability, or teratogenicity

adverse reaction

refers to undesirable, uncomfortable, or dangerous effects from a drug

general drug information resources

________ rely on the package insert for much of their drug monograph content.

Clinical Pharmacology,

Facts and Comparisons,

Lexicomp,

Micromedex

What are 4 commonly used general drug information resources?

drug class comparison,

drug identification,

international drug names,

natural products,

Trissel's IV drug compatibility

Other than the drug monograph, what are 5 other features the commonly used general drug information resources have?

American Hospital Formulary Service

What general drug information resource provides comprehensive monographs that link to supporting evidence and references?

false (can be lag time for both websites and printed versions)

True or False: When drug information is updated, general drug information resources are updated immediately while print versions may experience a lag time.

American Hospital Formulary Service

What general drug information resource is the only resource designated by the U.S. Congress as acceptable for determining reimbursement for off-label uses under Medicare Part D and Medicaid?

Pharmacist's Letter

a monthly newsletter with short summaries on new or updated drug information; comes with online access to helpful practice tools including charts, patient flyers, and continuing education

OTC drug

considered safe and effective for self-diagnosed conditions by the general public, has adequate written directions for self-use, and doesn't require physician supervision

patients

The labeling on OTC drugs is written for (patients/providers).

active ingredients,

dosage instructions,

inactive ingredients,

side effects,

uses,

warnings

The package labeling information for OTC drugs must include what 6 things?

FDA's Center for Drug Evaluation and Research

Who manages the New Drug Application approval process for prescription drugs?

New Drug Application,

OTC Monograph

What are the 2 methods a manufacturer can use to market an OTC product?

New Drug Application

OTC drugs that have gone through the ________ approval process become FDA-approved drugs and can be found on the FDA website through Drugs@FDA as well as other common general drug information resources.

true

True or False: The labeling for OTC drugs doesn't need to be a separate document, but can be the container itself, as long as the required information is present.

American College of Chest Physicians (CHEST)

Who publishes practice guidelines for anticoagulation?

Stroke Prevention in Atrial Fibrillation,

Venous Thromboembolism

What are the 2 anticoagulation guidelines that the American College of Chest Physicians publishes?

American College of Cardiology/American Heart Association (ACC/AHA)

Who publishes practice guidelines for cardiovascular diseases?

Acute Coronary Syndromes,

Atrial Fibrillation,

Heart Failure,

High Cholesterol,

Hypertension

What are the 5 cardiovascular disease guidelines that the American College of Cardiology/American Heart Association publishes?

American Association of Clinical Endocrinologists (AACE),

American Diabetes Association (ADA)

What 2 organizations publishes practice guidelines for diabetes?

Infectious Diseases Society of America (IDSA)

Who publishes practice guidelines for infectious diseases?

US Department of Health and Human Services (HHS)

Who publishes practice guidelines for HIV/AIDS?

Centers for Disease Control (CDC)

Who publishes practice guidelines for sexually transmitted infections?

American Society of Clinical Oncology (ASCO),

National Comprehensive Cancer Network (NCCN)

What 2 organizations publish practice guidelines for oncology?

The American Academy of Pediatrics (AAP)

Who publishes practice guidelines for pediatrics?

The American College of Obstetricians and Gynecologists (ACOG)

Who publishes practice guidelines for pregnancy/women's health?

American Psychiatric Association (APA)

Who publishes practice guidelines for psychiatric conditions?

DSM-5

Where can practice guidelines for psychiatric conditions be found?

Global Initiative for Asthma (GINA),

National Heart Lung and Blood Institute (NHLBI)

What 2 organizations publish practice guidelines for asthma?

Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Who publishes practice guidelines for COPD?

Kidney Disease Improving Global Outcomes (KDIGO)

Who publishes practice guidelines for renal disease?

Advisory Committee on Immunization Practices (ACIP),

Centers for Disease Control (CDC)

What 2 organizations publish practice guidelines for vaccines?

ASHP's Drug-Induced Diseases,

FDAble

What are 2 places where adverse reaction information can be found?

FAERS,

MedWatch,

VAERS

What are 3 places on FDAble where adverse reaction information can be found/reported?

Allen's,

ASHP Guidelines,

Handbook of Pharmaceutical Excipients,

Merck Index,

Remington,

Safety Data Sheets,

Trissel's,

USP

(ALLENS HANDBOOK REMains SAFE while MERChant ASH TRIeS to USurP him)

What are 8 places where compounding and pharmaceutics information can be found?

795, 797, 800, NF

What are 4 USP sections where compounding and pharmaceutics information can be found?

795

(797 = sterile, 800 = hazardous)

select the correct chapter of UPS compounding compendium that includes standards for Non-sterile compounding

a. 795

b. 800

c. 797

d. 825

e. 785

Hansten and Horn

(DI HH)

What is a place where drug interaction information can be found?

Red Book

What is a place where drug pricing information can be found?

ASHP,

FDA

What are 2 places where drug shortage information can be found?

Orange Book, Purple Book

What are 2 places where drug substitution information can be found?

American Geriatrics Society Beers Criteria

What is a place where geriatrics information can be found?

Advisory Committee on Immunization Practices (ACIP),

Immunization Action Coalition (immunize.org),

Pink Book

What are 3 places where immunization information (adult and pediatric) can be found?

Morbidity and Mortality Weekly Report

Where are CDC Advisory Committee on Immunization Practices' updates published?

Infectious Diseases Society of America (IDSA),

Sanford Guide

What are 2 places where infectious disease information can be found?

HIVInfo.

NIH.gov

What is a place where HIV information can be found?

Traveler's Health,

World Health Organization (WHO),

Yellow Book

What are 3 places where travel medicine information can be found?

CDC

Who publishes the Yellow Book and Traveler's Health,

the CDC or WHO?

Index Nominum,

Martindale,

USP Dictionary

What are 3 places where international drug information can be found?

clinicaltrials.gov

What is a place where investigational drug information can be found?

ASHP's Handbook on Injectable Drugs,

King Guide,

Trissel's

What are 3 places where IV drug compatibility and stability information can be found?

Institute for Safe Medication Practices,

MedWatch,

NIOSH

What are 3 places where medication safety information can be found?

Medication Errors Reporting Program

Where do you report medication errors to ISMP?

Natural Medicines Database

What is a place where natural product/alternative medicine information can be found?

Lexi-Tox,

Micromedex,

TOXLINE

What are 3 places where overdoses, poisoning, and toxicology information can be found?

American Academy of Pediatrics,

Harriet Lane Handbook,

Lexicomp,

NeoFax,

Red Book (also AHFS)

What are 5 places where pediatric information can be found?

Goodman and Gilman's

What is a place where pharmacology information can be found?

Briggs', CDC, Hale's, LactMed, Micromedex

(Brigg Hales is a Micro-manager at the CDC because she is pregnant and Lactating)

What are 5 places where pregnancy and lactation information can be found?

Center for Drug Evaluation and Research,

Pink Sheet

What are 2 places where regulatory and business development information can be found?

DiPiro's,

Handbook of Nonprescription Drugs,

Koda-Kimble's,

Merck Manual,

UpToDate

What are 5 places where therapeutics and disease management information can be found?

Plumb's

What is a place where veterinary information can be found?

Orange Book

resource that's used to determine if a generic substitution of a branded product is acceptable based on an AB rating

AB rating

used to indicate therapeutic equivalence of a generic substitution to a brand name product

b

Which of the following is a list of approved drugs that can be interchanged with generics based on therapeutic equivalence?

a) Green Book

b) Orange Book

c) Pink Book

d) Pink Sheet

e) Purple Book

f) Red Book, Pediatrics

g) Red Book, Pharmacy

h) Yellow Book

c

Which of the following has information on epidemiology and vaccine-preventable diseases?

a) Green Book

b) Orange Book

c) Pink Book

d) Pink Sheet

e) Purple Book

f) Red Book, Pediatrics

g) Red Book, Pharmacy

h) Yellow Book

d

Which of the following has news reports on regulatory, legislative, legal, and business developments?

a) Green Book

b) Orange Book

c) Pink Book

d) Pink Sheet

e) Purple Book

f) Red Book, Pediatrics

g) Red Book, Pharmacy

h) Yellow Book

e

Which of the following is a list of biological drug products, including biosimilars?

a) Green Book

b) Orange Book

c) Pink Book

d) Pink Sheet

e) Purple Book

f) Red Book, Pediatrics

g) Red Book, Pharmacy

h) Yellow Book

g

Which of the following contains drug pricing information?

a) Green Book

b) Orange Book

c) Pink Book

d) Pink Sheet

e) Purple Book

f) Red Book, Pediatrics

g) Red Book, Pharmacy

h) Yellow Book

f

Which of the following has summaries of pediatric infectious diseases, antimicrobial treatment, and vaccinations?

a) Green Book

b) Orange Book

c) Pink Book

d) Pink Sheet

e) Purple Book

f) Red Book, Pediatrics

g) Red Book, Pharmacy

h) Yellow Book

h

Which of the following has information on the health risks of international travel, required vaccines, and prophylaxis medications?

a) Green Book

b) Orange Book

c) Pink Book

d) Pink Sheet

e) Purple Book

f) Red Book, Pediatrics

g) Red Book, Pharmacy

h) Yellow Book

a

Which of the following has information on approved animal drug products?

a) Green Book

b) Orange Book

c) Pink Book

d) Pink Sheet

e) Purple Book

f) Red Book, Pediatrics

g) Red Book, Pharmacy

h) Yellow Book

c

Which of the following is the organization that publishes the Orange Book?

a) American Academy of Pediatrics

b) CDC

c) FDA

d) Pharma Intelligence

b

Which of the following is the organization that publishes the Pink Book?

a) American Academy of Pediatrics

b) CDC

c) FDA

d) Pharma Intelligence

d

Which of the following is the organization that publishes the Pink Sheet?

a) American Academy of Pediatrics

b) CDC

c) FDA

d) Pharma Intelligence

c

Which of the following is the organization that publishes the Purple Book?

a) American Academy of Pediatrics

b) CDC

c) FDA

d) Pharma Intelligence

a

Which of the following is the organization that publishes the Red Book, Pediatrics?

a) American Academy of Pediatrics

b) CDC

c) FDA

d) Pharma Intelligence

b

Which of the following is the organization that publishes the Yellow Book?

a) American Academy of Pediatrics

b) CDC

c) FDA

d) Pharma Intelligence

c

Which of the following is the organization that publishes the Green Book?

a) American Academy of Pediatrics

b) CDC

c) FDA

d) Pharma Intelligence

Medical Subject Headings

used in searches to group articles with the same content

Cochrane Library, PubMed

What are 2 common databases used to locate clinical study data and research summaries?

PubMed

(Cochrane Library/PubMed) accesses MEDLINE and is a free service available from the National Library of Medicine.

MEDLINE

database that has journal articles in medicine, nursing, dentistry, veterinary medicine, life sciences, and more

Cochrane Library

(Cochrane Library/PubMed) provides evidence-based information to guide clinical decision making and is supported by government funds and donations, with no cost for users.

a

Which of the following is a consumer resource that has a symptom checker and provides information on infectious diseases, immunizations, and travelers' health?

a) CDC

b) drugs.com

c) Mayo Clinic

d) MedlinePlus

e) RxList

f) WebMD

b, e

Which of the following are consumer resources that provide drug monographs and other information? (select all that apply)

a) CDC

b) drugs.com

c) Mayo Clinic

d) MedlinePlus

e) RxList

f) WebMD

c

Which of the following is a consumer resource that provides comprehensive patient information for diseases, symptoms, tests and procedures, and drugs and supplements?

a) CDC

b) drugs.com

c) Mayo Clinic

d) MedlinePlus

e) RxList

f) WebMD

d

Which of the following is a consumer resource that has sections on health topics, drugs and supplements, health-related videos, lab tests, and a medical encyclopedia with images?

a) CDC

b) drugs.com

c) Mayo Clinic

d) MedlinePlus

e) RxList

f) WebMD

f

Which of the following is a consumer resource that covers diseases, healthy living, pregnancy, and prescription and OTC drug information and has a pill identifier and interaction checker?

a) CDC

b) drugs.com

c) Mayo Clinic

d) MedlinePlus

e) RxList

f) WebMD

FDA

What resource could you use to find boxed warning on a drug

a. NIOSH

b. SDS

c. FDA webstie

d. ToxLine

e. PubMed

drugs@fda

clincial pharmacology

drugs.com

lexicomp

a student is research off-label uses of a drug. this info is best located in which of the following resources (select all that apply)

a. drugs@fda

b. clinical pharmacology

c. drugs.com

d. kings guide

e. lexicomp