1. Package Inserts
As mention before, the drug package insert is part of the labeling of the drug product
It is required by the FDCA of 1938
See lesson 3 Pharmacy Law

2. Drug Facts and Comparisons
Publisher: Wolter Kluwer
Availability: print medium, CD ROM, electronic media
Contents:
Information on more than 20,000 legend drugs
Information on more than 5,000 OTC drugs
Presented in table format in comparison of drugs in each class
Drug monograph, or package inserts are divided into 14 areas by type of therapy drug is used in. i.e.. Endocrine and metabolic agents for diabetes drugs

3. Physician’s Desk Reference (PDR)
Publisher: PDR Network
Availability: print medium, CD ROM, electronic media
Basically the package inserts of the common use legend drugs
Indexes drugs by
Manufacturer
Product (trade name)
Product category (beta blockers)
Generic

4. American Hospital Formulary Service Drug Information
Publisher: ASHP, American Society of Health System Pharmacists
Availability: print medium, CD ROM, electronic media and mobile application editions
Basically the package inserts of the common use legend drugs with the some information mandated by FDCA 1938
Basically contains every drug marketed in the USA

5. Martindale: Complete Drug Reference
Publisher: Pharmaceutical Press
Availability: print medium, CD ROM
Contains the most commonly used drugs marketed throughout the world
Indexes include drug names, investigational drugs, veterinary agents, herbal supplements, vitamins, vaccines, etc.
Indexed in 13 major European languages

6. United States Pharmacopeia- National Formulary
Publisher: USP/NF committee
Availability: print medium, CD ROM, electronic
Contains a standard for 4,500 + drug monographs that manufacturer use to produce their products
Covers topics on drug quality, purity, excipients, etc.
Cover standards for dietary supplements
230 different chapters that set standards on drug quality and preparation
USP 797 on parenteral drug preparation

7. Trissel’s Handbook on Injectable Drugs
Publisher: Lawrence A. Trissel
Availability: print medium, CD ROM, electronic, mobile application
Drug monographs for common parenteral drugs and solutions
Lists route of administration for all drugs in index (i.e. intravenous, intramuscular, etc.)
Contains tables with compatibility data on drugs mixed with each other or mixed in different type of diluents

8. Therapeutic Equivalence
Therapeutic Equivalence (TE) is the state where two drugs have both pharmaceutic equivalence (PE) and bioequivalence (BE)
Pharmaceutic Equivalence (PE) is the state where both drugs are the same chemical and dosage form
Enalapril Maleate 10 mg tablet made by two different manufacturers
Bioequivalence (BE) is the state where both drugs have the same rate and extent of absorption from the site of administration.
Enalapril from the above example by both companies have shown to be absorbed from the GI tract to about 50% over the course of 60 minutes
If a drug manufacturer can prove both PE and BE to the FDA their version of the drug is considered to be TE to the brand drug
All States define an acceptable generic substitution as one where the drugs are therapeutic equivalent (TE)

9. Approved Drug Products with Therapeutic Equivalence Evaluations
Publisher: FDA
Availability: print medium, electronic
Drug monographs for all approved drugs in the US
Also known as the “orange book”
Orange Book publishes ratings data on drug therapeutic equivalence(TE) between drugs
For drugs to be consider therapeutically equivalent to each other, they must have a TE rating of A
Drugs that have B ratings are not therapeutically equivalent and substitution between them is not permitted
Pharmacists are to determine substitutability
revised yearly with month updates
Can be accessed at:

10. RED BOOK Publisher: Medical Economics
Availability: CD ROM editions updated quarterly
Drug monographs for all 200,000 + drugs
Contains much the same info as the “orange book”
Information on AWP pricing
MAC information
Suggestions on retail pricing

11. Brigg’s: Drugs in Pregnancy and Lactation
Publisher: Wolter Kluwers
Availability: Print, CD ROM editions
Contains information on drugs and their implication in pregnancy and lactation

12. Pregnancy Categories
Drugs are classified into 5 classes based on their safe uses in pregnancy
Category A: Studies in pregnant women shows no risk (of birth defects)
Drugs in this case are the safest to use in pregnancy
Category B: Animal studies show no risk
Drugs in this case are still safe to use
Category C: Animal studies show some risk but benefits may outweigh the risk
Category D: Some human risk has been shown or adverse fetal complication are known
ACE inhibitors
Statin Drugs
Tetracycline drugs
Category X: Known teratogen
Thalidomide
Isotretinoin

13. Drug Information Handbooks
Publisher: LexiComp
Availability: Print Edition, electronic version
Drug monographs for all thousands of drugs
Arranged in alphabetical orders
Provide specific handbooks
Geriatric
Pediatric and Neonatal versions

14. Electronic Online Reference
Micromedex
Useful online indexes for doctors and pharmacists
Product databases useful for pharmacists
DRUGDEX- drug monographs
DRUG REAX- drug interactions with drugs, herbals and food
INDENTIDEX- drug identification database using imprint code.
Another free resource for this is
There are others, please refer to textbook

15. Electronic Online Reference
Medline
US National Library of Medicine (NLM)
Medline is a database of journal links to over 5000 journals in the medical and healthcare fields
Journals in over 30 different languages
PubMed.gov is a search engine (free) that is linked to this database

16. Electronic Online Reference
MEDMARX
Adverse drug events database
Subscription based
Over 400 institutions are members
Reports adverse drug events and “near misses”
Meant as a means to track and analysis adverse drug events