DRUG INFO RESOURCES Flashcards
Info about med
• Includes:
- dosing
- drug interactions
- side effectsPACKAGE INSERTS
WHO REQUIRES PACKAGE INSERT?
FDA
Boxed warnings Indications & Use Dosage & Administration Dosage form & strength Contraindications Warning & Precautions Adverse Reactions Drug Interactions Any Recent Major Changes to prescribing information
HIGHLIGHT SECTION
WHAT IS THE PURPOSE OF THE HIGHLIGHTED SECTION?
help you find important info quickly
WHAT IS AN EASY REFERENCE TO HELP YOU FIND WHERE DETAILED OR SPECIFIC PRESCRIBING INFO IS LOCATED ON A PACKAGE INSERT?
Table of Contents Sections
ARE OFF LABEL INDICATIONS ON THE PACKAG INSERT?
No
explains what diseases or conditions that drug is approved to treat by FDA
Indications & Use
provide specific dosing for different diseases states, particular age groups
Dosage & Administration
- what form the med comes in, whether it’s a tab, cap, syrup, injectable solution or another form
- description of what the med looks like
Dosage form & strength
- when drug should NOT be used
- warnings about allergic reactions, caution against using the med w/ interacting drug, using the drug in certain disease state
=can lead to very serious side effects or death
- warnings about allergic reactions, caution against using the med w/ interacting drug, using the drug in certain disease state
Contraindications
list activates or situations that requires causation while taking the med
- about the possible side effects or certain pt populations - certain conditions or age can affect the way med is metabolized or eliminated by the body - notes regarding lab tests that can be affected by the drug
Warning & Precautions
all side effects reported from using drug during its testing phases
- charts grouped together by affected body system - report showing how many people experienced specific side effects - include side effects that were reported AFTER the drug hit the market, refer to "Postmarketing Experience"
Adverse Reactions
side effects that were reported AFTER the drug hit the market
POSTMARKETING EXPERIENCE
guide whether the interacting med must be avoided altogether or if using a different dose minimizes the interaction
Drug Interactions
list safety concerns when using the drug in certain patients
- Risk from using the med during labor and delivery, while breast feeding, in kids and elderly - Pregnancy Categories- based on the risks of harm to the developing fetus
Use in Specific Population
LETTER A PREGNANCY CATEGORIES IS THE SAFEST . (TRUE OR FALSE)
True
WHAT LETTER IN PREGNANCY CATEGORIES IS THE RISKIEST?
X
WHICH SECTION IN THE PACKAGE INSERT HAS THE LIST OF MED’S SCHEDULE CLASSIFCATION?
Drug Abuse and Dependence Section
illegal drugs
ex: heroin - highest potential for abuse and dependence
Schedule I
(controlled substances)
ex: Morphine, Oxycontin, Norco - highest stringent requirements in the pharmacy - high potential for abuse and phaysical dependence or addiction
Schedule II
controlled substances)
ex: Tylenol #3, Suboxone - low abuse and addiction potential
Schedule III
(controlled substances)
ex: Xanax, Ambien, Valium - lower potential for abuse and addiction
Schedule IV
(controlled substances)
ex: Robitussin AC, Lomotil - lowest potential for abuse and addiction - limited amounts of the controlled substance in each dose
Schedule V
Highest stringent requirements in the pharmacy
Schedule II drugs
Lowest potential for abuse and addiction
Schedule V
Highest potential for abuse and dependence
Schedule I
list the signs, symptoms, and treatment options of an overdose situation
Overdose Section
gives the chemical name and a structure formula of the drug
- list of active/inactive ingredients such as fillers, colors, and flavorings
- important in case pt is allergic to inactive ingredients, such as food coloring, dyes, or lactose
Product Description Section
- described how the drug works, aka mechanism of action
- explains how the drug is absorbed, metabolized, and eliminated by the body
- explanation of the various studies performed using the drug in different disease states, age groups, races, genders
- mostly used by pharmacist and prescribers
Clinical Pharmacology Section
- list any cancer risk from using the med
Nonclinical Toxicology Section
info on drug’s clinical studies showing how well the drug works as its approved indications
- mostly used by pharmacist and prescribers
Clinical Studies Section
- lists all med’s dosage form, such as tabs, IV forms, liquids, creams
- each form is described by color, shape, and markings for easy identification
- provides any special storage and handling instructions for the drugs, such as “store at room temperature” or “protect from light”
How Supplied/Storage and Handling
- highlights most important counseling points
- used by pharmacists and prescriber as a tool to ensure the patient understands how to take their med
Patient Counseling Information Section
all of the wording must be approved by FDA
- takes a significant amount of time for the package insert to reflect this an update in information about a product
Biggest limitations
The Approved Products w/ Therapeutic Equivalence Evaluations
Orange Book
- Created and maintained by FDA
- Standard that many states uses to guide substitution w/ generic meds
- Tells us which generic are equivalent to which brand-name drugs
- Standard that many states uses to guide substitution w/ generic meds
Orange Book
TE
Therapeutic Equivalence
TE CODE
ratings to show if substitution is allowed, has 2 letters - A or B
TE CODE: A (first letter)
Demonstrated therapeutic equivalence
TE CODE: B (first letter)
not therapeutic equivalent
TE CODE: A (second letter)
A=oral dosage form
TE CODE: N (second letter)
N=aerosolization
TE CODE: P (second letter)
P=parenteral or injectable product
TE CODE: T (second letter)
T=topical
MOST COMMON TE CODE
AB rated
- Identical active ingredients
- Identical strength
- Identical dosage form
- Absorb and release identically in the body
- Have same safety profile and clinical effect
Therapeutic equivalence
compilation of package inserts used to look up drug info
Prescriber’s Digital Reference (PDR)
defines the standards for medications
US Pharmacopedia-National Formulary (USP-NF)
provide info about parenteral meds, such as IV, intramuscular, subcutaneous meds
Handbook on Injectable Drugs (Trissel’s)
provide up-to-date info on dietary supplements, vitamins, menials, and other natural remedies
Natural Medicines
gives healthcare professionals and pts the opportunity to alert researchers and FDA about any adverse effects of supplements, vitamins, etc
Natural Medicine Watch
Morphine, Oxycontin, Norco
Schedule II
Tylenol #3, Suboxone
Schedule III
Xanax, Ambien, Valium
Schedule IV
Robitussin AC, Lomotil
Schedule V
