Guide to DI (Exam 1) Flashcards
Drug Information
Facts or advice on drugs
Drug Information Center
A physical location where pharmacists have the resources to provide drug information
Drug Information Service
A professional service providing drug information
Optimal drug development requires a balance between achieving ________ and eliciting desired ______.
therapeutic concentrations (PK)
therapeutic effects (PD)
Pharmacokinetics (PK)
Body on drug
ADME
Pharmacodynamics (PD)
Drug on body
Drug-receptor interactions
MOA
Dose-response relationship
Drug Development Stages
Pre-clinical
Phase 1
Phase 2
Phase 3
FDA approval
Phase 4
Pre-clinical testing
In vitro/vivo studying on cells and animals
Phase 1
Safety and tolerability of drug in 20-100 healthy humans
Phase 2
Effect of drug in 100-200 patients with target disease
Efficacy and dosing
What percent of drugs will enter phase 3?
25%
Phase 3
Effect of drug in a few thousand patients with target disease
Double-blind design
Applying for FDA Approval
NDA reviewed by FDA and approved/denied
Phase 4
Post-marketing monitoring
MedWatch
Collects reports about unexpected side effects, quality issues, medication errors, and therapeutic failures
Voluntary
FAERS
FDA Adverse Event Reporting System
Information on drug and biologic reports
VAERS
CDC Vaccine Adverse Event Reporting System
Prescribing Information (PI)
Package insert, prescribing information, prescription drug labeling, product label
NO “off-label” indications
Which phase of FDA drug development is most concerned with human pharmacodynamic parameters of the drug?
Phase 1
What is the primary objective of Phase 4 clinical trials in FDA drug development?
Gather additional safety data in real-world setting
Black Box Warning (BBW)
Contraindications
Warnings and Precautions
Adverse Reactions
Drugs with serious safety concerns may require enrollment in _____ to manage.
Risk Evaluation and Mitigation Strategies (REMS)
Risk Evaluation and Mitigation Strategies (REMS)
FDA required safety programs for meds with specific serious adverse effects
Ex. Clozapine REMS
Adverse Drug Event
Harm caused by appropriate OR inappropriate use of drug
includes adverse drug reactions
