DRUG INFO RESOURCES

Question 1

Info about med
• Includes: 
	 - dosing
	 - drug interactions
         - side effects

Answer 1

PACKAGE INSERTS

Question 2

WHO REQUIRES PACKAGE INSERT?

Answer 2

FDA

Question 3

Boxed warnings
Indications & Use
Dosage & Administration
Dosage form & strength
Contraindications 
Warning & Precautions
Adverse Reactions
Drug Interactions
Any Recent Major Changes to prescribing information

Answer 3

HIGHLIGHT SECTION

Question 4

WHAT IS THE PURPOSE OF THE HIGHLIGHTED SECTION?

Answer 4

help you find important info quickly

Question 5

WHAT IS AN EASY REFERENCE TO HELP YOU FIND WHERE DETAILED OR SPECIFIC PRESCRIBING INFO IS LOCATED ON A PACKAGE INSERT?

Answer 5

Table of Contents Sections

Question 6

ARE OFF LABEL INDICATIONS ON THE PACKAG INSERT?

Answer 6

No

Question 7

explains what diseases or conditions that drug is approved to treat by FDA

Answer 7

Indications & Use

Question 8

provide specific dosing for different diseases states, particular age groups

Answer 8

Dosage & Administration

Question 9

• 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

Answer 9

Dosage form & strength

Question 10

• 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

Answer 10

Contraindications

Question 11

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

Answer 11

Warning & Precautions

Question 12

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"

Answer 12

Adverse Reactions

Question 13

side effects that were reported AFTER the drug hit the market

Answer 13

POSTMARKETING EXPERIENCE

Question 14

guide whether the interacting med must be avoided altogether or if using a different dose minimizes the interaction

Answer 14

Drug Interactions

Question 15

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

Answer 15

Use in Specific Population

Question 16

LETTER A PREGNANCY CATEGORIES IS THE SAFEST . (TRUE OR FALSE)

Answer 16

True

Question 17

WHAT LETTER IN PREGNANCY CATEGORIES IS THE RISKIEST?

Answer 17

X

Question 18

WHICH SECTION IN THE PACKAGE INSERT HAS THE LIST OF MED’S SCHEDULE CLASSIFCATION?

Answer 18

Drug Abuse and Dependence Section

Question 19

illegal drugs

  ex: heroin  - highest potential for abuse and dependence

Answer 19

Schedule I

Question 20

(controlled substances)

 ex: Morphine, Oxycontin, Norco
 - highest stringent requirements in the pharmacy  - high potential for abuse and phaysical dependence or addiction

Answer 20

Schedule II

Question 21

controlled substances)

  ex: Tylenol #3, Suboxone  - low abuse and addiction potential

Answer 21

Schedule III

Question 22

(controlled substances)

  ex: Xanax, Ambien, Valium  - lower potential for abuse and addiction

Answer 22

Schedule IV

Question 23

(controlled substances)

  ex: Robitussin AC, Lomotil
 - lowest potential for abuse and addiction  - limited amounts of the controlled substance in each dose

Answer 23

Schedule V

Question 24

Highest stringent requirements in the pharmacy

Answer 24

Schedule II drugs

Question 25

Lowest potential for abuse and addiction

Answer 25

Schedule V

Question 26

Highest potential for abuse and dependence

Answer 26

Schedule I

Question 27

list the signs, symptoms, and treatment options of an overdose situation

Answer 27

Overdose Section

Question 28

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

Answer 28

Product Description Section

Question 29

- 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

Answer 29

Clinical Pharmacology Section

Question 30

- list any cancer risk from using the med

Answer 30

Nonclinical Toxicology Section

Question 31

info on drug's clinical studies showing how well the drug works as its approved indications - mostly used by pharmacist and prescribers

Answer 31

Clinical Studies Section

Question 32

- 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"

Answer 32

How Supplied/Storage and Handling

Question 33

- highlights most important counseling points | - used by pharmacists and prescriber as a tool to ensure the patient understands how to take their med

Answer 33

Patient Counseling Information Section

Question 34

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

Answer 34

Biggest limitations

Question 35

The Approved Products w/ Therapeutic Equivalence Evaluations

Answer 35

Orange Book

Question 36

- 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

Answer 36

Orange Book

Question 37

TE

Answer 37

Therapeutic Equivalence

Question 38

TE CODE

Answer 38

ratings to show if substitution is allowed, has 2 letters - A or B

Question 39

TE CODE: A (first letter)

Answer 39

Demonstrated therapeutic equivalence

Question 40

TE CODE: B (first letter)

Answer 40

not therapeutic equivalent

Question 41

TE CODE: A (second letter)

Answer 41

A=oral dosage form

Question 42

TE CODE: N (second letter)

Answer 42

N=aerosolization

Question 43

TE CODE: P (second letter)

Answer 43

P=parenteral or injectable product

Question 44

TE CODE: T (second letter)

Answer 44

T=topical

Question 45

MOST COMMON TE CODE

Answer 45

AB rated

Question 46

- Identical active ingredients - Identical strength - Identical dosage form - Absorb and release identically in the body - Have same safety profile and clinical effect

Answer 46

Therapeutic equivalence

Question 47

compilation of package inserts used to look up drug info

Answer 47

Prescriber's Digital Reference (PDR)

Question 48

defines the standards for medications

Answer 48

US Pharmacopedia-National Formulary (USP-NF)

Question 49

provide info about parenteral meds, such as IV, intramuscular, subcutaneous meds

Answer 49

Handbook on Injectable Drugs (Trissel's)

Question 50

provide up-to-date info on dietary supplements, vitamins, menials, and other natural remedies

Answer 50

Natural Medicines

Question 51

gives healthcare professionals and pts the opportunity to alert researchers and FDA about any adverse effects of supplements, vitamins, etc

Answer 51

Natural Medicine Watch

Question 52

Morphine, Oxycontin, Norco

Answer 52

Schedule II

Question 53

Tylenol #3, Suboxone

Answer 53

Schedule III

Question 54

Xanax, Ambien, Valium

Answer 54

Schedule IV

Question 55

Robitussin AC, Lomotil

Answer 55

Schedule V