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

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

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

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

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

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

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

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)

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: www.fda.gov/cder/ob/default.htm

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

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

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

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

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 www.drugs.com There are others, please refer to textbook

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

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