5. Drug References Flashcards
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
What are some references specifically for Immunizations?
CDC Advisory Committee on Immunization Practices (ACIP) - updates published on morbidity and mortality weekly report (MMWR)
CDC Pink Book
Immunization Action Coalition
What are some references specifically for Infectious diseases?
IDSA guidelines
Sanford Guide to Antimicrobial Therapy
What are some references specifically for HIV?
HIVInfo.NIH.gov from the US dept. of health and human services
What are some references specifically for Travel medicine?
WHO
CDC Yellow book: health info for international travel
CDC Travelers’ Health
What are some references specifically for International drug info?
Index Nominum: International Drug Directory
Martindale: The Complete Drug Reference
USP Dictionary of US adopted Names (USAN) and International Drug Names
What are some references specifically for Investigational drugs?
Clinicaltrials.gov
What are some references specifically for IV drug compatibility and stability?
ASHP’s Handbook on Injectable Drugs
King guide to parenteral admixtures
Trissel’s 2 clinical pharmaceutics database
What are some references specifically for Med safety?
FDA Medwatch
Institute for Safe Med Practices (ISMP) - report medication errors to ISMP Med Errors Reporting Program (ISMP MERP)
NIOSH - chemo and HD list
What are some references specifically for natural products?
Natural Medicines Database
What are some references specifically for overdosing, poisoning, and toxicity?
Lexi-Tox (Lexicomp)
Micomedex
TOXLINE in PubMed
What are some references specifically for pediatrics?
NeoFax
Lexicomp
Red Book: Report of the Committee on Infectious Disease (AAP)
Harriet Lane Handbook
American Academy of Pediatrics (AAP)
What are some references specifically for Pharmacology?
Goodman and Gilman’s
What are some references specifically for Pregnancy and Lactation?
Briggs’ Drugs in Pregnancy and Lactation
CDC
Hale’s medications and mother’s milk
LactMed (NLM)
Micromedex (Reprotox and Reprorisk)
What are some references specifically for Regulatory and Business Development?
FDA CDER
Pink Sheet
What are some references specifically for therapeutics and disease management?
DiPiro’s Pharmacotherapy
Handbook of nonprescription drugs
Koda-Kimble’s Applied Therapeutics
The Merck Manual
UpToDate
What are some references specifically for veterinary?
Plumb’s Veterinary Drug Handbook
What is the FDA Orange Book
List of approved drugs that can be interchanged with generics based on therapeutic equivalence
What is the CDC Pink Book
Info on epidemiology and vaccine-preventable diseases
What is the Pink Sheet (Pharma Intelligence)
News reports on regulatory, legislative, legal, and business developments
What is the FDA Purple book
List of biological drug products, including biosimilars
What is the pharmacy Red Book
Drug pricing info
What is the red book, pediatrics (AAP)
Summaries of pediatric infectious diseases, antimicrobial treatment and vaccinations
What is the FDA green book
Info on approved animal drug products
What is the CDC Yellow Book
Info on the health risks of international travel, required vaccines and ppx medications
