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NAPLEX 2024 > 5. Drug References > Flashcards

5. Drug References Flashcards

1
Q

Where can you find package inserts for FDA-approved drug info?

A

DailyMed (online)
Drugs@FDA (online/app)
Manufacturer’s website or attached to physical product

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2
Q

What are the labeling requirements for OTC drugs?

A

Active ingredients
Uses
Warnings (including when drug should NOT be used)
Side effects
Dosage instructions
Inactive ingredients

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3
Q

There are 2 ways a manufacturer can use to market an OTC product. What are they?

A

New drug application (NDA) process
OTC monograph process

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4
Q

The NDA approval process for prescription drugs is managed through the FDA’;s ____

A

Center for drug evaluation and research (CDER)

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5
Q

OTC drugs that have gone through the ___ process become FDA-approved drugs

A

NDA approval process

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6
Q

Which organization(s) publishes Stroke Prevention in Afib and VTE guidelines

A

American College of Chest Physicians (CHEST guidelines)

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7
Q

Which organization(s) publishes ACS, AFib, HF, High Cholesterol, HTN guidelines?

A

ACC/AHA

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8
Q

Which organization(s) publishes DM guidelines?

A

American Association of Clinical Endocrinologists (AACE)
American Diabetes Association (ADA)

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9
Q

Which organization(s) publishes Infectious disease guidelines?

A

Infectious disease society of America (IDSA)
HIV/AIDS: US Dept. of Health and Human Services
STIs: CDC

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10
Q

Which organization(s) publishes oncology guidelines?

A

American Society of Clinical Oncology (ASCO)
National Comprehensive Cancer Network (NCCN)

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11
Q

Which organization(s) publishes pediatric guidelines?

A

The American Academy of Pediatrics (AAP)

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12
Q

Which organization(s) publishes pregnancy/women’s health guidelines?

A

The American College of Obstetricians and Gynecologists (ACOG)

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13
Q

Which organization(s) publishes psych guidelines?

A

American Psychiatric Association (APA) Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5)

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14
Q

Which organization(s) publishes asthma guidelines?

A

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

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15
Q

Which organization(s) publishes COPD guidelines?

A

Global Initiative for chronic Obstructive Lung Disease (GOLD)

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16
Q

Which organization(s) publishes renal disease guidelines?

A

Kidney Disease Improving Global Outcomes (KDIGO)

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17
Q

Which organization(s) publishes vaccine guidelines?

A

Advisory Committee on Immunization Practices (ACIP)
CDC

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18
Q

What are some references specifically for adverse reactions?

A

ASHP’s Drug-Induced diseases
FDAble (FDA database, includes MedWatch: FDA’s adverse event reporting system (FAERS), and Vaccine adverse event reporting system (VAERS))

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19
Q

What are some references specifically for compounding and pharmaceutics?

A

Allen’s
ASHP guidelines on Compounding Sterile Preparations
Handbook of Pharmaceutical Excipients
Safety Data Sheets (SDS)
Merck Index: an encyclopedia of chemical, drugs, and biologicals
Remington: The Science and Practice of Pharmacy
Trissel’s Stability of Compounded Formulations
USP 795 (non-sterile), 797 (sterile), 800 (HD), USP-NF (monographs for drug substances, dosage forms, compounded preparations and excipients)

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20
Q

What are some references specifically for drug interactions?

A

Hanstens and Horn’s Drug Interactions Analysis and Management

21
Q

What are some references specifically for drug pricing?

A

Red Book (micromedex)

22
Q

What are some references specifically for drug shortages?

A

ASHP
FDA

23
Q

What are some references specifically for substitutions?

A

FDA Orange book (generic equivalent)
FDA Purple book (biosimilars)

24
Q

What are some references specifically for geriatric info?

A

American Geriatrics Society (AGS) Beers Criteria

25
Q

What are some references specifically for Immunizations?

A

CDC Advisory Committee on Immunization Practices (ACIP) - updates published on morbidity and mortality weekly report (MMWR)
CDC Pink Book
Immunization Action Coalition

26
Q

What are some references specifically for Infectious diseases?

A

IDSA guidelines
Sanford Guide to Antimicrobial Therapy

27
Q

What are some references specifically for HIV?

A

HIVInfo.NIH.gov from the US dept. of health and human services

28
Q

What are some references specifically for Travel medicine?

A

WHO
CDC Yellow book: health info for international travel
CDC Travelers’ Health

29
Q

What are some references specifically for International drug info?

A

Index Nominum: International Drug Directory
Martindale: The Complete Drug Reference
USP Dictionary of US adopted Names (USAN) and International Drug Names

30
Q

What are some references specifically for Investigational drugs?

A

Clinicaltrials.gov

31
Q

What are some references specifically for IV drug compatibility and stability?

A

ASHP’s Handbook on Injectable Drugs
King guide to parenteral admixtures
Trissel’s 2 clinical pharmaceutics database

32
Q

What are some references specifically for Med safety?

A

FDA Medwatch
Institute for Safe Med Practices (ISMP) - report medication errors to ISMP Med Errors Reporting Program (ISMP MERP)
NIOSH - chemo and HD list

33
Q

What are some references specifically for natural products?

A

Natural Medicines Database

34
Q

What are some references specifically for overdosing, poisoning, and toxicity?

A

Lexi-Tox (Lexicomp)
Micomedex
TOXLINE in PubMed

35
Q

What are some references specifically for pediatrics?

A

NeoFax
Lexicomp
Red Book: Report of the Committee on Infectious Disease (AAP)
Harriet Lane Handbook
American Academy of Pediatrics (AAP)

36
Q

What are some references specifically for Pharmacology?

A

Goodman and Gilman’s

37
Q

What are some references specifically for Pregnancy and Lactation?

A

Briggs’ Drugs in Pregnancy and Lactation
CDC
Hale’s medications and mother’s milk
LactMed (NLM)
Micromedex (Reprotox and Reprorisk)

38
Q

What are some references specifically for Regulatory and Business Development?

A

FDA CDER
Pink Sheet

39
Q

What are some references specifically for therapeutics and disease management?

A

DiPiro’s Pharmacotherapy
Handbook of nonprescription drugs
Koda-Kimble’s Applied Therapeutics
The Merck Manual
UpToDate

40
Q

What are some references specifically for veterinary?

A

Plumb’s Veterinary Drug Handbook

41
Q

What is the FDA Orange Book

A

List of approved drugs that can be interchanged with generics based on therapeutic equivalence

42
Q

What is the CDC Pink Book

A

Info on epidemiology and vaccine-preventable diseases

43
Q

What is the Pink Sheet (Pharma Intelligence)

A

News reports on regulatory, legislative, legal, and business developments

44
Q

What is the FDA Purple book

A

List of biological drug products, including biosimilars

45
Q

What is the pharmacy Red Book

A

Drug pricing info

46
Q

What is the red book, pediatrics (AAP)

A

Summaries of pediatric infectious diseases, antimicrobial treatment and vaccinations

47
Q

What is the FDA green book

A

Info on approved animal drug products

48
Q

What is the CDC Yellow Book

A

Info on the health risks of international travel, required vaccines and ppx medications

NAPLEX 2024 (74 decks)

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