Chapter 5: Learning Drug References Flashcards
What is a pediatric resource for drug dosing
The Harriet Lane Handbook
Name for the FDA-approved drug information that is part of the drug’s official labeling
Package insert
Where can you find package inserts online
DailyMed
Drugs@FDA
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 drug’s safety-related labeling changes
Who provides comprehensive monographs that link to supporting evidence and references of drugs
The American Hospital Formulary Service (AHFS) Clinical Drug Information
Subscribers to Pharmacist’s Letter receive ______
- monthly newsletter with summaries on new or updated drug info
- charts
- patient fliers
- continuing education (CE)
What must the Drug Facts Panel include for OTC items
- active ingredients
- Uses
- Warnings
- Side effects
- Dosage instructions
- Inactive ingredients
The NDA approval process for prescription drugs is managed through who
the FDA’s center for Drug Evaluation & Research (CDER)
OTC drugs can go through the same approval process as Rx drugs or manufacturers can opt to stick to the standards in the
OTC monograph for that therapeutic drug class
OTC drugs that go through the NDA approval process become
FDA-approved drugs
The OTC labeling can be found on the FDA website through Drugs@FDA and will be listed in common general drug info resources like Lexicomp & Micromedex
Guideline for Stroke prevention in AFib & VTE
Guidelines from the American College of Chest Physicians (aka CHEST guidelines)
Guideline for ACS, AFib, HF, high cholesterol, HTN
Guidelines from the American College of Cardiology/American Heart Association (ACC/AHA)
Guidelines for Diabetes
American Association of Clinical Endocrinologists (AACE) & American Diabetes Association (ADA)
Guidelines for Infectious Diseases
Infectious Diseases Society of America (IDSA)
HIV/AIDS US Dept of Health & Human Services (AIDSinfo)
STIs: CDC
Guidelines for Oncology
American Society of Clinical Oncology (ASCO) & National Comprehensive Cancer Network (NCCN)
Guideline for Pediatrics
The American Academy of Pediatrics (AAP)
Guideline for Pregnancy/Women’s Health
The American College of Obstetricians & Gynecologists (ACOG)
Guidelines for Psych Conditions
American Psychiatric Association (APA)
Diagnostic & Statistical Manual of Mental disorders, 5th edition (DSM-5)
Pulmonary Guidelines
Asthma: Global Initiative for Asthma (GINA)
COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD)
Renal disease guideline
Kidney Disease Improving Global Outcomes (KDIGO)
Vaccine guidelines
Advisory committee on Immunization Practices (ACIP) & CDC
Specialty references for adverse reactions
ASHP’s Drug-Induced Diseases
FDAble - MedWatch: FDA safety information and adverse event reporting system (FAERS) & Vaccine adverse event reporting systems (VAERS)