Chapter 2 Package Inserts

Question 1

Hightlights Section

Answer 1

“Most Important info”

• Boxed warnings (most serious info)
• Diseases/conditions approved to treat
• Drug doses
• Administration requirements
• Available dosage forms/strengths
• Contraindications (when a drug should not be used)
• Warnings/precautions
• Most common side effects (includes phone # and website for FDA’s MedWatch program, which is set up to report suspected adverse reactions that could be caused by drug)
• Significant drug interactions
• Recent major changes

Question 2

Table of contents

Answer 2

help locate information in insert

Question 3

Indications and Usage

Answer 3

lists disease states/conditions the med is approved to be treated (approved by FDA)

Question 4

Off Label Use

Answer 4

• when a drug is used for a disease state/condition not listed in Indications and Usage section of a PI

Question 5

PI

Answer 5

Package Insert

Question 6

Dosage and Administration

Answer 6

contains recommended doses (for disease states, particular age group), dosing schedules, and administration requirements

Question 7

Contraindications

Answer 7

lists situations whens the med should not be used

• Allergic reactions
• Interacting drugs
• warnings (about using in certain states)

Question 8

Warnings and Precautions

Answer 8

lists situations that require caution while taking med

• serious reactions
• serious side effects
• warnings of using med in certain populations
• Warnings of using med in those with certain disease states
• Lab tests may be affected

Question 9

Adverse Reactions

Answer 9

reported side effects (found in testing)

• side effect charts
• side effects reported after it hit the market “Post marketing experience”

Question 10

Drug Interactions

Answer 10

lists most significant drug-drug reactions involving the med

• mechanism of drug interactions
• explains how and why
• reviews the studies about how important the interaction is
• How drug affects lab tests

Question 11

Use in Specific Populations

Answer 11

lists safety concerns when using the drug during pregnancy, during labor, and delivery, while breastfeeding, in children, and in the elderly

Question 12

Pregnant Categories under Use in Specific Populations

Answer 12

A, B, C, D, X
A is the safest
X is the riskiest
- Categories assigned by FDA based on risks of harm to the developing fetus

Question 13

Drug Abuse and Dependence

Answer 13

lists the meds controlled substance classification (schedule), and the abuse and tolerance potential of the drug (if applicable)

Question 14

Overdosage

Answer 14

lists the signs/symptoms and treatment options during and overdose situation

Question 15

Product Description

Answer 15

lists the chemical name of med, a structural diagram of the med, active ingredients, and inactive ingredients

Question 16

Clinical Pharmacology

Answer 16

contains information on how the medication works, and how the med is absorbed, metabolized, and eliminated from the body

Question 17

Nonclinical Toxicology

Answer 17

lists any cancer and fertility risks from using the med

Question 18

Clinical Studies

Answer 18

provides information from the clinical studies showing how well the drug words for its approved indications

Question 19

How supplied

Answer 19

lists the med’s dosage forms, description by color, shape, and markings, and any special storage and handling instructions

Question 20

Patient Counseling

Answer 20

highlights the most important counseling points about eh med for the pharmacist or prescriber