5. Drug References Flashcards
(48 cards)
Where can you find package inserts for FDA-approved drug info?
DailyMed (online)
Drugs@FDA (online/app)
Manufacturer’s website or attached to physical product
What are the labeling requirements for OTC drugs?
Active ingredients
Uses
Warnings (including when drug should NOT be used)
Side effects
Dosage instructions
Inactive ingredients
There are 2 ways a manufacturer can use to market an OTC product. What are they?
New drug application (NDA) process
OTC monograph process
The NDA approval process for prescription drugs is managed through the FDA’;s ____
Center for drug evaluation and research (CDER)
OTC drugs that have gone through the ___ process become FDA-approved drugs
NDA approval process
Which organization(s) publishes Stroke Prevention in Afib and VTE guidelines
American College of Chest Physicians (CHEST guidelines)
Which organization(s) publishes ACS, AFib, HF, High Cholesterol, HTN guidelines?
ACC/AHA
Which organization(s) publishes DM guidelines?
American Association of Clinical Endocrinologists (AACE)
American Diabetes Association (ADA)
Which organization(s) publishes Infectious disease guidelines?
Infectious disease society of America (IDSA)
HIV/AIDS: US Dept. of Health and Human Services
STIs: CDC
Which organization(s) publishes oncology guidelines?
American Society of Clinical Oncology (ASCO)
National Comprehensive Cancer Network (NCCN)
Which organization(s) publishes pediatric guidelines?
The American Academy of Pediatrics (AAP)
Which organization(s) publishes pregnancy/women’s health guidelines?
The American College of Obstetricians and Gynecologists (ACOG)
Which organization(s) publishes psych guidelines?
American Psychiatric Association (APA) Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5)
Which organization(s) publishes asthma guidelines?
Global Initiative for Asthma (GINA) and National, Heart, Lung, and Blood Institute (NHLBI)
Which organization(s) publishes COPD guidelines?
Global Initiative for chronic Obstructive Lung Disease (GOLD)
Which organization(s) publishes renal disease guidelines?
Kidney Disease Improving Global Outcomes (KDIGO)
Which organization(s) publishes vaccine guidelines?
Advisory Committee on Immunization Practices (ACIP)
CDC
What are some references specifically for adverse reactions?
ASHP’s Drug-Induced diseases
FDAble (FDA database, includes MedWatch: FDA’s adverse event reporting system (FAERS), and Vaccine adverse event reporting system (VAERS))
What are some references specifically for compounding and pharmaceutics?
Allen’s
ASHP guidelines on Compounding Sterile Preparations
Handbook of Pharmaceutical Excipients
Safety Data Sheets (SDS)
Merck Index: an encyclopedia of chemical, drugs, and biologicals
Remington: The Science and Practice of Pharmacy
Trissel’s Stability of Compounded Formulations
USP 795 (non-sterile), 797 (sterile), 800 (HD), USP-NF (monographs for drug substances, dosage forms, compounded preparations and excipients)
What are some references specifically for drug interactions?
Hanstens and Horn’s Drug Interactions Analysis and Management
What are some references specifically for drug pricing?
Red Book (micromedex)
What are some references specifically for drug shortages?
ASHP
FDA
What are some references specifically for substitutions?
FDA Orange book (generic equivalent)
FDA Purple book (biosimilars)
What are some references specifically for geriatric info?
American Geriatrics Society (AGS) Beers Criteria
