Drug Resource questions Flashcards

1
Q

Harriet Lane Handbook

A

a pediatric resource which includes pediatric dosing on medications

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2
Q

PI

A

the package insert is the FDA approved drug information that is part of the drugs official labeling. Package inserts DO NOT include off-label uses or drug costs

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3
Q

What are examples of resources to locate PI

A

DailyMed (NLM) —— Online
Drugs@FDA ————Online and Mobile App
The Drug Manufacturers Website —- individual URL address
Attached to the physical product —- Printed resource

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4
Q

What are the Common Content Categories in a drug package insert

A

Prescribing Information
Boxed Warnings
Recent Major Changes
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Info on Drug abuse and Dependence
Over dosage/Toxicity
Pharmacology/MOA
—Additional categories—
description (active and inactive ingredients)
PK and PD
clinical studies
How supplied/storage and handling
Patient counseling information

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5
Q

Dispensing of a drug may require separate patient handouts alerting of the drugs toxicity called _________

A

Medication Guides

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6
Q

When drug safety information changes, the FDA publishes a _________

A

safety communication or alert on their website and an updated PI will reflect the drugs safety

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7
Q

Boxed Warnings: the strictest warnings, alerts prescribers to the _______

A

risk of death or permanent disability

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8
Q

Contraindications: when a patient has a contraindication to a drug, the drug ________

A

CANNOT be used in the patient. The risk will outweigh any possible benefit

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9
Q

Warnings and Precautions: includes serious reactions that can result in ___________

A

death, hospitalization, medical intervention, disability or teratogenicity

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10
Q

Adverse Reactions: refers to ______

A

undetectable, uncomfortable or dangerous effects from a drug

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11
Q

General drug information resources rely on the _____ for much of their drug monograph content

A

Package Insert (PI)

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12
Q

General drug information resources contain: _____

A

-monographs on each drug
-FDA approved information from the PI
-other items depending on the resource like off label indications

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13
Q

Most general drug information resources require a paid subscription, but a few ________ can be accessed by anyone at no cost

A

Drugs.com
Rxlist

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14
Q

which general drug information resources have access to Trissels IV drug compatibility?

A

Lexicomp
Micromedex
Clinical Pharmacology
Facts and Comparisons Eanwsers

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15
Q

(AHFS) American Hospital Formulary Service: provides ______

A

comprehensive monographs that link supporting evidence and references, which makes it a very useful resource for researching a topic in detail.

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16
Q

Pharmacists may need to check _______ to confirm they are retrieving the most current content.

A

multiple sources.
(when drug information is updated, there can be a lag time until the PI and the drug’s monograph include the update)

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17
Q

what 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?

A

American Hospital Formulary Service (AHFS)

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18
Q

which general drug information resources are available as a Mobile App?

A

(AHFS) American Hospital Formulary Service
Clinical Pharmacology
Epocrates/Epocrates +
Lexicomp
Micromedex
Prescribers Digital Reference (mobilePDR)
Drugs.com

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19
Q

which general drug information resources are available as a Drug Information Book?

A

AHFS Dug Information Book
Drug Information Handbook: Book

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20
Q

Which of the Common Drug information resources does NOT provide Drug/Pill Identification?

A

AHFS/AHFS CDI

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21
Q

which common drug information resource provides pricing on drugs utilizing the Red Book?

A

Micromedex

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22
Q

The package labeling information for OTC drugs is in the Drug Facts Panel and must include the : _______

A

Active ingredient
Uses for the product
Specific Warnings, including when the drug should NOT be used and when it is appropriate to consult with a doctor or pharmacist

Side Effects, and substances or activities to avoid
Dosage instructions
Inactive ingredients

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23
Q

NDA

A

New Drug Application

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24
Q

The NDA approval process for prescription drugs is managed through the ________

A

FDA’s Center for Drug Evaluation and Research (CDER)

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25
Q

There are two methods that a manufacturer can use to market an OTC product: _________ and _______

A

New Drug Application (NDA) process &
OTC Monograph process

26
Q

OTC drugs can go through the same drug approval process, or the manufacturer can opt to stick to the standards in the _________

A

OTC monograph, for that therapeutic drug class

27
Q

OTC drugs that have gone through the NDA process become _________

A

FDA-approved drugs

28
Q

The OTC drug labeling can be found on _________

A

FDA website through Drugs@FDA
&
will be listed in common general drug information resources ( Lexicomp, Micromedex)

29
Q

The labeling for OTC drugs DOES NOT need to be a separate document, but can be ______

A

on the container itself, as long as the items specified above are included

30
Q

Which Guidelines should be utilized for Stoke Prevention in Atrial Fibrillation and Venous Thromboembolism?

A

CHEST guidelines (Guidelines from the American College of Chest Physicians)

31
Q

Which Guidelines should be utilized for Cardiovascular Diseases, including:
Acute Coronary Syndrome
Atrial Fibrillation
Heart Fatigue
High Cholesterol
Hypertension

A

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

32
Q

Which Guidelines should be utilized for Diabetes?

A

AACE = American Association of Clinical endocrinologists
ADA = American Diabetes Association

33
Q

Which Guidelines should be utilized for infectious diseases?

A

IDSA = Infectious Diseases Society of America
HIV/AIDS: US Dept. of Health and Human Services (Clinicalinfo.HIV.gov)
Sexually transmitted infections: Centers for Disease Control (CDC)

34
Q

Which Guidelines should be used for oncology?

A

NCCN = National Comprehensive Cancer Network
ASCO = American Society of Clinical Oncology

35
Q

Which Guidelines should be used for pediatrics?

A

AAP = American Academy of Pediatrics

36
Q

Which Guidelines should be used for pregnancy and women’s health?

A

ACOG = American College of Obstetricians and Gynecologists

37
Q

Which Guidelines should be used to address Psychiatric conditions?

A

APA = American Psychiatric Association
DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, 5th edition

38
Q

Which Guidelines should be used to address Pulmonary conditions?

A

Asthma - (GINA guidelines) Global Initiative for Asthma
&
National Heart, Lung and Blood Institute (NHLBI)

COPD - Global Initiative for Chronic Obstructive Lung Disease (GOLD guidelines)

39
Q

Which guidelines should be used to address renal disease?

A

(KDIGO) = Kidney Disease Improving Global Outcomes

40
Q

Which guidelines should be used to address the administration of immunizations?

A

ACIP = Advisory Committee on Immunization Practices
CDC = Centers for Disease

41
Q

FDAble:

A

FDA searchable database of adverse reactions caused by medicines, vaccines, devices, tobacco products, dietary supplements

42
Q

MedWatch:

A

FDA’s Adverse Event Reporting System (FAERS)

43
Q

VAERS -

A

Vaccine Adverse Event Reporting System

44
Q

MAUDE -

A

Manufacturer and User Facility Device Experience

45
Q

USP 795

A

Non-Sterile Preparations

46
Q

USP 797

A

Sterile Preparations

47
Q

USP 800

A

Hazardous Drugs - Handling in Healthcare setting

48
Q

Specialty Resources for Drug Interactions:

A

Hansten and Horns Drug Interactions Analysis and Management
Facts and Comparisons : Drug Interaction Facts

49
Q

Specialty Resources for Drug Shortages

A

ASHP Current Drug shortages
FDA Drug Shortages

CDC Current Vaccine shortages & Delays
American Hospital Formulary Service Clinical Drug Information (AHFS CDI)

49
Q

Specialty Resources for Drug Pricing

A

Red Book (Micromedex)
Medi-Span Price Rx

49
Q

Specialty Resources for Drug Substitution

A

FDA’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

FDA’s Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilar or Interchangeability Evaluations

50
Q

FDA’s Orange Book:

A

Approved Drug Products with Therapeutic Equivalence Evaluations

51
Q

FDA’s Purple Book:

A

Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilar or Interchangeability Evaluations

52
Q

Yellow Book:

A

Health Information for International Travel

53
Q

CDC Pink Book:

A

Epidemiology and Prevention of Vaccine-Preventable Diseases

54
Q

Specialty Resources for Geriatrics:

A

American Geriatrics Society (AGS) Beers Criteria for Potentially Inappropriate Medication Use in Older Adults

ASHP’s Fundamentals of Geriatric Pharmacotherapy
Geriatric Dosage Handbook (Lexicomp)

55
Q

Specialty Resources for Immunizations (Adults and Pediatrics)

A

CDC Advisory Committee on Immunization Practices (ACIP)
Updates published in the Morbidity and Mortality Weekly Report MMWR

Immunization Action Coalition
CDC Pink Book

Vaccines Blood & Biologics

56
Q

Specialty Resources for Infectious Diseases

A

(IDSA) Infectious Diseases Society of America Practice Guidelines

Sanford Guide to Antimicrobial Therapy

57
Q

Specialty Resources for (HIV) Human Immunodeficiency Virus

A

HIVInfo.NIH.gov from the US Dept. of Health and Human Services

Sanford Guide to HIV/AIDS Therapy

John Hopkins ABX and HIV guides

58
Q

Specialty Resources for Travel Medicine

A

(WHO) World Health Organization
CDC Yellow Book: Health information for International Travel
CDC Travelers’ Health: resources for travelers and healthcare professionals

59
Q

Specialty Resources for International Drug Information

A

Index Nominum: International Drug Directory

Martindale: The Complete Drug Reference

USP Dictionary of United States Adopted Names (USAN) and International Drug Names

Drug Information Handbook with International Trade Names Index (Lexicomp)

European Drug Index

60
Q
A