Drug Resource questions Flashcards
Harriet Lane Handbook
a pediatric resource which includes pediatric dosing on medications
PI
the package insert is the FDA approved drug information that is part of the drugs official labeling. Package inserts DO NOT include off-label uses or drug costs
What are examples of resources to locate PI
DailyMed (NLM) —— Online
Drugs@FDA ————Online and Mobile App
The Drug Manufacturers Website —- individual URL address
Attached to the physical product —- Printed resource
What are the Common Content Categories in a drug package insert
Prescribing Information
Boxed Warnings
Recent Major Changes
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Info on Drug abuse and Dependence
Over dosage/Toxicity
Pharmacology/MOA
—Additional categories—
description (active and inactive ingredients)
PK and PD
clinical studies
How supplied/storage and handling
Patient counseling information
Dispensing of a drug may require separate patient handouts alerting of the drugs toxicity called _________
Medication Guides
When drug safety information changes, the FDA publishes a _________
safety communication or alert on their website and an updated PI will reflect the drugs safety
Boxed Warnings: the strictest warnings, alerts prescribers to the _______
risk of death or permanent disability
Contraindications: when a patient has a contraindication to a drug, the drug ________
CANNOT be used in the patient. The risk will outweigh any possible benefit
Warnings and Precautions: includes serious reactions that can result in ___________
death, hospitalization, medical intervention, disability or teratogenicity
Adverse Reactions: refers to ______
undetectable, uncomfortable or dangerous effects from a drug
General drug information resources rely on the _____ for much of their drug monograph content
Package Insert (PI)
General drug information resources contain: _____
-monographs on each drug
-FDA approved information from the PI
-other items depending on the resource like off label indications
Most general drug information resources require a paid subscription, but a few ________ can be accessed by anyone at no cost
Drugs.com
Rxlist
which general drug information resources have access to Trissels IV drug compatibility?
Lexicomp
Micromedex
Clinical Pharmacology
Facts and Comparisons Eanwsers
(AHFS) American Hospital Formulary Service: provides ______
comprehensive monographs that link supporting evidence and references, which makes it a very useful resource for researching a topic in detail.
Pharmacists may need to check _______ to confirm they are retrieving the most current content.
multiple sources.
(when drug information is updated, there can be a lag time until the PI and the drug’s monograph include the update)
what is the only resource designated by the U.S Congress as acceptable for determining reimbursement for off-label uses under Medicare Part D and Medicaid?
American Hospital Formulary Service (AHFS)
which general drug information resources are available as a Mobile App?
(AHFS) American Hospital Formulary Service
Clinical Pharmacology
Epocrates/Epocrates +
Lexicomp
Micromedex
Prescribers Digital Reference (mobilePDR)
Drugs.com
which general drug information resources are available as a Drug Information Book?
AHFS Dug Information Book
Drug Information Handbook: Book
Which of the Common Drug information resources does NOT provide Drug/Pill Identification?
AHFS/AHFS CDI
which common drug information resource provides pricing on drugs utilizing the Red Book?
Micromedex
The package labeling information for OTC drugs is in the Drug Facts Panel and must include the : _______
Active ingredient
Uses for the product
Specific Warnings, including when the drug should NOT be used and when it is appropriate to consult with a doctor or pharmacist
Side Effects, and substances or activities to avoid
Dosage instructions
Inactive ingredients
NDA
New Drug Application
The NDA approval process for prescription drugs is managed through the ________
FDA’s Center for Drug Evaluation and Research (CDER)