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Thursday, March 26, 2020

PTCB - Chapter 12 - Information - Definitions

Primary Literature
- original reports of clinical trials, research, and case studies; use for the most up to date information

Secondary Literature
- general reference works based upon primary literature sources; use to find primary literature

Tertiary Literature
- condensed works based on primary literature (e.g. textbooks); use to find background information or a summary of information

Abstracting Services
- services that summarize information from various primary sources for quick reference

Health Insurance Portability and Accountability Act (HIPAA)
- a federal law created to protect the privacy of patient health records

Off label indication
- a use of a medication for an indication not approved by the FDA

Orange Book
- the common name for the FDA's Approved Drug Products with Therapeutic Equivalence

Common References
1) AHFS Drug Information (www.ahfsdruginformation.com)
----- use AHFS when investigating off label medication indications (ie. an indication not approved by the FDA)
2) Martindale, The Complete Drug Reference
----- use Martindale to research foreign drugs
3) The Merck Index (www.merckmanuals.com)
----- use The Merck Index when information on chemical attributes of drug is needed
4) Physicians' Desk Reference (PDR) (www.pdr.net)
----- the information is similar to pharmaceutical manufacturers' drug package inserts since manufacturers prepare the essential drug information found in the PDR
5) Drug Facts and Comparison (DFC) (www.factsandcomparisons.com)
----- it is used to compare medications in the same therapeutic class
6) American Drug Index
----- use this reference to find trade and generic names
7) Handbook on Injectable Drugs (www.ashp.org)
----- it includes information on preparation, storage, administration, compatibility and stability of injectable drugs
8) King's Guide to Parenteral Admixtures (www.kingguide.com)
----- this reference provides information on injectable drug compatibility and stability, updated quarterly
9) Red Book: Pharmacy's Fundamental Reference (www.redbook.com)
----- it provides the latest pricing information, including nationally recognized AWP's and suggested retail prices for OTC products
10) Orange Book (www.accessdata.fda.gov/scripts/cder/ob/default.cfm)
----- Orange Book is the common name for the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations. Use the Orange Book to determine the therapeutic equivalence of a brand and generic drug
11) Purple Book
----- biosimilar products of Biotech products

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