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)
Micromedex formats
Online
Mobile App
Prescriber’s Digital Reference
Includes information on drugs, vaccines, and biologics. Includes information like drugs PIs, practical information, where injections can be given, and how long it takes for efffects to be seen.
Prescriber’s Digital Reference formats
Online
Mobile App
PubChem
Includes information on chemical properties, structures, general drug information, and links to additional resources
PubChem formats
Online
Drugs.com
Drug information that is sourced from other products (DI sites)
Drugs.com formats
Online
RXList
Drug information primariy sourced from other products (DI sites and the FDA)
RXList formats
Online
Which drug databases includes Trissels?
Clinical Pharmacology
Facts and Comparisons
Lexi Drugs
Micromedex
Trissels
IV Compatability
True or False: The Pharmacist Letter contains traditional drug monographs
False
How often does the Pharmacist’s Letter get published?
Monthly
What is included in the Pharmacist’s letter online?
New drug approvals
Charts - drug class comparisons, disease-state treatments
Patient Ed summaries and flyers
Continuing Education
Training Materials
True or False: OTC meds require physcian supervision
False
OTC drugs
Considered to be safe and effective for self-diagnosed conditions by the general public
Required to have clear, well written directions
OTC required labeing information
Active Ingredients
Uses
Warnings
Side Effects
Dosage Instructions
Inactive Ingredients
The two methods that can be used for marketing OTC medications
New Drug Applications (NDA)
OTC Monograph
NDAs are submitted to
FDA’s Center for Drug Evaluation and Research (CDER)
OTC monograph
Covers acceptable ingredients, doses, formulations, and labeling. Also includes drug’s safety and efficacy information
PubMed
MEDLINE and free service from NLM
Contains Journal articles
Cocharne library
Provides evidence based information to guide clinical decision making. Contains >7500 systematic reviews
Drugs.com
Free consumer website that contains drug monographs
RxList
Free consumer website that contains drug monographs
Mayo Clinic
Comprehensive Patient information for disease, symptoms, tests, procedures, and drugs
MedlinePlus
Free consumer site that has information on health topics, drugs and supplements, health-related videos, lab tests, and a medical encylopedia
WebMD
Free consumer site that has information covering disease, healthy living, pregnancy, prescriptions, and OTC drug information
FDA for Consumers
Free consumer site that provides information on drugs, food products, medical devices, vaccines, tobacco, and other topics that may fall under the FDA juristriction
MyHealthFinder
Free consumer site from the Department of Health and Human Services that works to encourage a healthy lifestyle through a variety of activities including food and physical activity
SafeMedication
From ASHP. Free consumer site that provides medication tips and tools and a searchable database of patient-focused drug monographs
