Chapter 5. Drug References

Where to find package inserts (PIs)?

DailyMed (NLM) - online

Drugs@FDA - online and app

Who manages the NDA approval process for prescription drugs?

CDER (FDA's center for drug evaluation and research)

What are 4 commonly used comprehensive drug info sources, that compile info from the package insert and other references?

Clinical Pharmacology

Facts and Comparisons

Lexicomp

Micromedex

What reference provides comprehensive monographs that link supporting evidence and references, including for off-label uses?

American Hospital Formulary Service (AHFS)

How do OTC drugs get approved?

NDA with CDER like Rx or mfr can stick to standards in OTC monograph

Where can OTC drug labeling be found?

FDA website through Drugs@FDA

What must an OTC drug have on its label? (does not need to be separate if on container)

active ingredients

uses

warnings/contraindications/when to consult dr

side effects

dosage instructions

inactive ingredients

Anticoagulation guidelines

American College of Chest Physicians - CHEST

stroke prevention in A. Fib

VTE

CV Disease Guidelines

American College of Cardiology (ACC)

American Heart Association (AHA)

ACS

Afib

HF

High cholesterol

HTN

Diabetes guidelines

American Association of Clinical Endocrinologists (AACE)

American Diabetes Association (ADA)

Infectious Disease guidelines

Infectious Diseases Society of America - IDSA

HIV/AIDS: US DHHS

STIs: CDC

Oncology guidelines

American Society of Clinical Oncology (ASCO)

National Comprehensive Cancer Network (NCCN)

Pediatrics guidelines

American Academy of Pediatrics (AAP)

Pregnancy/Women's Health guidelines

The American College of Obstetricians and Gynecologists (ACOG)

Psychiatric Conditions guidelines

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

Pulmonary Condition guidelines

Asthma: Global Initiative for Asthma (GINA)

COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Renal Disease guidelines

Kidney Disease Improving Global Outcomes (KDIGO)

Vaccine guidelines

Advisory Committee on Immunization Practices (ACIP)

Centers for Disease Control (CDC)

What resource by the FDA is a searchable database of adverse rxns caused by meds, vaccines, devices, tobacco, and supplements?

FDAble

(FAERS) FDA Adverse Event Reporting System

MedWatch

Vaccine Adverse Event Reporting System

VAERS

Allen's

The Art, Science, and Technology of Pharmaceutical Compounding

Merck Index Online

database of monographs for chemicals, drugs, and biologicals

Remington

The Science and Practice of Pharmacy (compounding)

USP-NF

monographs for drug substances, dosage forms, compounded preparations and excipients

USP 795

non-sterile preparations

USP 797

sterile preparations

USP 800

Hazardous Drugs - Handling in Healthcare Settings

What resource by Micromedex discusses drug pricing?

RED BOOK

Where can one find information about drug shortages?

FDA

ASHP

FDA Purple Book

Biologic interchangablity book

FDA Orange Book

therapeutic equivalents of a generic to brand based on AB rating

Geriatric guidelines

American Geriatrics Society (AGS) Beers Criteria (inappropriate meds)

Immunization Recommendations

CDC Advisory Committee on Immunization Practices (ACIP)

Where are updates on immunizations/diseases posted?

Morbidity and Mortality Weekly Report (MMWR) from CDC

CDC Pink Book

epidemiology and prevention of vaccine preventable disease

What guide helps wih antibiotic selection for infectious disease?

Sanford Guide to Antimicrobial Therapy

Travel Medicine Guides

WHO (World Health Organization)

CDC Yellow Book (Guide for International Travel)

Travelers' Health

International Drug Information Resources

Index Nominum

Martindale

IV Drug Compatability and Stability Guides

ASHP's Handbook on Injectable Drugs

King Guide

Trissel's

Other than MedWatch, what is a medication safety program?

ISMP Medication Errors Reporting Program (ISMP MERP)

NatMed

a database for natural products/alternative medicine

Pediatric Resources

NeoFax

Lexicomp

Red Book (infectious disease AAP)

Harriet Lane

American Academy of Pediatrics (AAP)

The KIDs List (potentially inappropriate drugs)

Goodman and Gilman's

The Pharmacological Basis of Therapeutics (pharmacology resource)

Pregnancy and Lactation Resources

Briggs'

CDC

Hale's Medications and Mothers' Milk

LactMed (NLM)

Poisoning and Toxicology Resources

Lexi-Tox

Micromedex (Tox and Drug Product Lookup)

Regulatory and Business Development References

FDA CDER

Pink Sheet

Therapeutic and Disease Management References

DiPiro's Pharmacotherapy

Handbook of Nonprescription Drugs

Koda-Kimble's

The Merck Manual

UpToDate

Veterinary Drug Reference

Plumb's

Orange Book (FDA)

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

Pink Book (CDC)

Information on epidemiology and vaccine preventable diseases

Pink Sheet (Pharma Intelligence)

News reports on regulatory, legislative, legal and business developments

Purple Book (FDA)

List of biological drug products, including biosimilars

Red Book, Pharmacy

Drug pricing information

Red Book, Pediatrics (AAP)

Summaries of pediatric infectious diseases, antimicrobial treatment and vaccinations

Yellow Book (CDC)

Information on the health risks of international travel, required vaccines, and prophylaxis medications

Green Book (FDA)

Information on approved animal drug products

Clinical Study Databases that allow using MeSH terms

PubMed (MEDLINE journal articles from NLM)

Cochrane Library (evidence-based info for clinical decision making with systematic reviews) -> supported by government