Chapter 5- Drug References Flashcards
Package Inserts
Include the FDA approved drug information that is part of the drugs official labeling.
Prescribing information, boxed warning, recent major changes, indications and usage, dosage and administration, dosage forms and strengths, contraindications, warnings/precautions, AE, drug interactions, use in specific populations, drug abuse/dependence, overdosage/toxicology, pharmacology/MOA
Package inserts locations
DailyMed- online
Drugs@FDA- online and app
The drug manufacturers website
Attached to physical product
What happens when drug safety information changes?
The FDA publishes a safety communication or alert on their website and an updated PI will reflect the changes
Boxed Warnings
Strictest warnings.
Alerts the prescribers to the risk of death or permanent disability
Contraindications
When a patient has a contraindication, the drug cannot be used.
The risk will outweigh the benefit.
Warnings/precautions
Includes serious reactions that can lead to death, hospitalization, medical intervention, disability, or teratogenicity.
May or may not change prescribing decision.
The American Hospital Formulary Service (AHFS) Clinical Drug Information
Provides comprehensive monographs that link to supporting evidence and references. The off label drug section is well researched with linked references.
Collection of drug monographs for medications available in the US.
Clinical Pharmacology
Online and mobile app
Monographs for Rx, OTC, natural products, and investigational products
Drug Information Portal
Online
Free from NLM
Epocrates/Epocrates+
Online and mobile app
Free with registration
Drug information plus guideline summaries
Facts and Comparisons
Online
Collection of databases; includes drug monographs, comparative drug charts, and other unique resources
Lexicomp
Book, online, and app
Drug monographs and multiple clinical databases
Micromedex
Online and mobile app
Multiple clinical databases
Prescribers digital reference
Online and mobile app
Free with registration
Includes information on drugs, vaccines, and biologics
Detail is more than the drugs PI and contains more practical information
Drugs.com
Online and mobile app
Free
Drug info is primarily sourced from other products
RxList
Online
Free
RxList
Online
Free
Drug info is primarily sourced from other products
Which references include off-label uses?
All except mobilePDR
Which references include IV Drug Compatibility?
AHFS, Clinical Pharmacology, Facts and Comparisons, Lexicomp, Micromedex
Which references include drug/pill identification?
All except AHFS
Which references include natural products?
All except AHFS and mobilePDR
Which references include drug class comparisons?
All except AHFS
Which references include pricing?
Clinical pharmacology, Drugs.com, Epocrates, Lexicomp, Micromedex
Which references include international drug names?
All except epocrates and mobilePDR
Pharmacists Letter
Does not contain traditional drug monographs, but is a valuable resource that provides evidence-based drug information.
Subscribers receive a monthly newsletter with short summaries of new or updated drug information and have online access to helpful practical tools
-Charts, patient flyers, CR, training material
Labeling requirements for OTC drugs
Written for patients who may not have medical training.
Package labeling is typically in the Drug Facts panel
-active ingredients, including amount in dosage unit and purpose
-Uses
-Warnings
-AE
-Dosage instructions
-Inactive ingredients
OTC drug approval
2 methods-
NDA and OTC monograph process
Anticoagulation guideline
CHEST guidelines
-Stroke Prevention in AFib
-VTE
CV disease guidelines
ACC/AHA Guidelines:
-Acute coronary syndromes
-Afib
-HF
-High cholesterol
-HTN
Diabetes guidelines
ADA, AACE
Infectious disease guidelines
IDSA
HIV/AIDS: US dept of Health and Human Services
STD: CDC
Oncology guidelines
ASCO, NCCN
Pediatrics guidelines
AAP
Pregnancy/Womens health guidelins
ACOG
Psychiatric conditions guidelines
APA DSM5
Pulmonary conditions guidelines
Asthma- GINA and NHLBI
COPD- GOLD
Renal disease guidelines
KDIGO
Vaccine guidelines
ACIP, CDC
Specialty references for AE
ASHPs Drug Induced diseases
FDAble: FDA searchable database
MedWatch (FAERS)
VAERS
Manufacturer and user facility device experience (MAUDE)
Safety reporting portal
Meylers side effects of drugs
Compounding and pharmaceutics specialty references
Allen’s
ASHP Guidelines
SDS
Merck Index
Remington
Trissels
USP Compounding compendia
USP 795
Non sterile drugs
USP 797
Sterile preparations
USP 800
Hazardous drugs
USP-NF
Monographs for drug substances, dosage forms, compounded preparations, and excipients
Drug interactions specialty resources
Hansten and Horns
Drug Interaction Facts: Facts and Comparisons
Drug Pricing Resources
Red Book (Micromedex)
Med-Span Price Rx
Drug Shortages references
ASHP Current drug shortages, FDA drug shortages, CDC vaccine shortages, AHFS CDI
Drug substitution references
FDAs Orange Book- approved drug products with therapeutic equivalent evaluations
FDAs Purple Book- List of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluation
Geriatrics drug references
Beers criteria
Immunization references
CDCs Pink Book- epidemiology and prevention of vaccine preventable diseases
Immunization action coalition
CDC ACIP
ID resources
IDSA and Sanford guide
HIV Resources
HIV.info.NIH.gov
Travel Medicine resources
CDC
WHO
CDC Yellow book- international travel
CDC Travelers Health
International drug information
Index Nominum
Martindale
USP Dictionary of USAN and international drug names
Lexicomp
European drug index
IV Drug compatibility and stability resources
ASHPs handbook on injectible drugs
King Guide
Trissels
Natural Products resources
Natural Medicines
Dietary Supplements Label Database
USP Dietary Supplements Compendium
Overdoses, Poisoning, and toxicology resources
Lexi-Tox
Micromedex Toxicology Management
TOXLINE in Pubmed
Pediatrics resources
NeoFax (micromedex)
Lexicomp
Red Book- report on infectious diseases
The Harriet Lane handbook
AAP
Pharmacology resources
Goodmans and Gilmans
Pregnancy and Lactation Resources
Briggs
CDC
Hales medication and mothers milk
LactMed (NLM)
Micromedex
MothertoBaby
Regulatory and Business development Resources
FDA CDER
Pink Sheet
Therapeutics and Disease Management Resources
DiPiros
Handbook of Nonprescription Drugs
Koda-Kimbles
The Merck Manual
UptoDate
CDC
Veterinary references
Plumbs
Orange Book (FDA)
List of approved drugs that can be interchanged with generics based on therapeutic equivalence
Pink Book (CDC)
Information on epidemiology and vaccine preventable diseases
Pink Sheet (Pharma Intelligence)
News reports on regulatory, legislative, legal, and business developments
Purple Book (FDA)
List of biological drug products, including biosimilars
Red Book, Pharmacy
Drug Pricing Information
Red Book, Pediatrics (AAO)
Summaries of pediatric infectious diseases, antimicrobial treatment, and vaccinations
Yellow Book (CDC)
Information on the health risks of international travel, required vaccines, and prophylaxis medications
Green Book (FDA)
Information on approved animal drug products