2023 RxPrep Ch. 5 Drug References

The Prescribing Information ONLY includes the FDA-approved drug information (True/False)

true

Where can package inserts be located?

- DailyMed

- Drugs@FDA

- Manufacturer website

- Attached to the product

What are Boxed warnings?

- Strictest safety warning

- Risk of death or permanent disability

What are contraindications?

Factors that prohibit the use of certain drugs because the risk outweighs the benefit

What are warnings & precautions?

Serious reactions that may result in death, hospitalization, medical intervention, disability, or teratogenicity

What are adverse reactions?

Undesirable, uncomfortable, or dangerous effects from a drug

The Drug Facts Panel on OTC drugs must include what information?

- Active ingredients

- Indications

- Warnings

- Side effects

- Dosage instructions

- Inactive ingredients

What process must a drug go through to be marketed?

NDA (New Drug Approval) - Rx or OTC products go through this process monitored by the FDA

OTC Monograph - for OTC products only, produce the relevant information needed for a drug of that particular therapeutic drug class

USP 795

Non-sterile Preparations

USP 797

Sterile Preparations

USP 800

Hazardous Drugs

Red Book

Drug pricing

Orange Book

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

Purple Book

List of biological drug products, including biosimilars

Pink Book

Epidemiology and Prevention of Vaccine-Preventable Diseases

Yellow Book

Health information for International travel

Green Book

Animal drug products

General Drug Information Resources

- AHFS (American Hospital Formulary Service)

- Clinical Pharmacology

- Drug Information Portal

- Epocrates

- Facts & Comparisons

- Lexicomp

- Micromedex

- Prescriber's Digital Reference

- Drugs.com

- RxList

What set of guidelines would be used for anticoagulation?

CHEST

What set of guidelines would be used for CV disease?

ACC/AHA

What set of guidelines would be used for Diabetes?

ADA, AACE

What set of guidelines would be used for ID?

IDSA

What set of guidelines would be used for Oncology?

NCCN, ASCO

What set of guidelines would be used for Pediatrics?

AAP

What set of guidelines would be used for Pregnancy/Women's health?

ACOG

What set of guidelines would be used for Psychiatric conditions?

APA --> DSM-5

What set of guidelines would be used for Asthma?

GINA

What set of guidelines would be used for COPD?

GOLD

What set of guidelines would be used for Vaccines?

ACIP, CDC

References for Adverse effects

- FDAble (FAERS, VAERS, etc.)

References for Compounding

- Allen's - Pharmaceutical Compounding

- ASHP guidelines

- Safety Data Sheets

- Merck Index

- Remington

- Trissels

- USP 795/797/800

References for Drug Interactions

- Hansten & Horn's

References for Drug Pricing

Red Book

References for Drug shortages

- ASHP

- FDA

References for Drug substitution

- Orange book (generics)

- Purple book (biosimilars)

References for Geriatrics

Beers Criteria

References for Infectious disease

- IDSA

- Sanford guide

References for Travel medicine

- WHO

- CDC

- Yellow book

- Traveler's health

References for International drug information

- Index nominum

- Martindale

References for Investigational drugs

Clinicaltrials.gov

References for IV drug compatibility and stability

- ASHP Handbook on injectable drugs

- King guide

- Trissels

References for Medication safety

- MedWatch

- ISMP (institute for safe medical practices)

- NIOSH List (hazardous drugs)

References for Natural products and alternative medicine

- NatMed

References for Overdose, Poisoning, Toxicology

- Lexi-Tox

- Micromedex

References for Pediatrics

- Neofax

- Lexicomp

- Red Book

- Harriet Lane

- AAP (American Academy of Pediatrics)

- The KIDs List

References for Pharmacology

- Goodman & Gilman

References for Pregnancy & Lactation

- Briggs' Drugs in Pregnancy & Lactation

- CDC: Medications during Pregnancy/Breastfeeding

- Hale's Medications and Mothers' Milk

- LactMed

References for Regulatory and business development

- FDA CDER

- Pink Sheet

References for Therapeutics & Disease management

- DiPiro

- Koda-kimble

- Merck manual

- UpToDate

- Handbook of nonprescription drugs

References for Veterinary medicine

Plumb's Veterinary Handbook