Drug References General Information - Chapter 5 Flashcards
Package Inserts only contain _________ drug information
FDA approved
True or False: The PI is part of the drug labeling.
True
True or False: The PI contains information regarding off label uses and cost information.
False - ONLY FDA approved indications and nothing on cost
Online resources where you can find PIs
DailyMed
Drugs@FDA
The Manufacturers Website
Where can you find a printed version of the PI?
Attached to the stock bottle/box
Categories on PIs
Prescribing Information
Boxed Warnings
Recent Major Changes
Indications and Uses
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Drug Abuse and Dependence
Overdosage and Toxicology
Pharmacology and MOA
Description
Pharmacokinetics and Pharmacodynamics
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
True or False: all drugs have some degree of risk
True
The _____ must outweigh the _____, when prescribing/recommending a medication
Benefits; Risks
Does the FDA need to communicate when safety information about a drug changes?
Yes - they will publish new safety information and put an alert with the link to the new PI on their website
Boxed Warnings
The strictest of warnings. Issued when there is a risk of death or serious and permanent disabilities
Contrainidications
Issued when a drug cannot be used in a certain population of patients. The risk WILL outweight the benefits
Warnings and Precautions
Risk of serious reactions that could lead to hospitalizations, medication interventions, disability, or teratogenicity
Adverse Reactions
Risk of undesirable, uncomfortable, or dangerous effects. The risk and benefits are patient specific and need to be assessed with each patient and provider.
American Hospital Formulary Service (AHFS)
Collection of drug monographs and medications available in the US
Has real time updates on drug shortages and FDA safety alerts
American Hospital Formulatory Service formats
Online
Book
Mobile App
Clinical Pharmacology
Drug information for RX, OTC, natural products, and investigation drugs
Clinical Pharmacology formats
Online
Mobile App
Epocrates
Drug information and Guideline summaries (free version)
Drug information, guideline summaries, expanded evidence-based disease management which includes some natural products, labs, diagnositic information, and ICD-10 coding information (paid version)
Epocrates formats
Online
Mobile App
Facts and Comparisons
Collection of databases - including drug monographs, comparative drug charts, and other unique resources
Facts and Comparisons formats
Online
Lexi drugs
Drug monographs organized alphabetically, including useful appendices - drug class comparisons, equivalent dosing charts.
Lexi Drugs formats
Book
Online
Mobile App
Micromedex
Multiple clinical databases - includes drug monographs, pricing information (redbook)