Principles of Pharmacy Practice: Drug Info Resources

Question 1

Package inserts

Answer 1

• FDA requires drug manufacturers to supply a package insert for all prescription meds
• Also known as “prescribing information” or “PIs”
• Intended for use by healthcare professionals NOT patients

Question 2

Sections of package inserts, 1 (in order)

Answer 2

• highlights
• table of contents
• indications and usage
• dosage and administration
• contraindications
• warnings and precautions
• adverse reactions
• drug interactions
• use in specific populations

Question 3

Highlights

Answer 3

• Contains most important prescribing information about benefits and risks of using the drug
• Helps find important information quickly
• Contains boxed warnings, the most serious safety alerts

Question 4

Table of contents

Answer 4

• A reference area for the location of detailed or specific prescribing information

Question 5

Indications and usage

Answer 5

• Lists disease states/conditions the medication is approved to treat
• Off-label uses are NOT listed on the package insert

Question 6

Dosage and administration

Answer 6

• Contains recommended doses, dosing schedules, and administration requirements

Question 7

Contraindications

Answer 7

• Lists situations when the medication should NOT be used
‒ Certain disease states
‒ Interacting drugs
‒ Allergic reactions

Question 8

Warnings and precautions

Answer 8

• Lists situations that require caution while taking the medication
• Contains boxed warnings
• Lists lab tests that can affect the drug

Question 9

Adverse reactions

Answer 9

• Lists reported side effects from the drug’s testing phases
• Contains postmarketing experience
‒ Side effects reported AFTER the drug hit the market

Question 10

Drug interactions

Answer 10

• Lists the most significant drug-drug interactions involving the medication
• Lists lab tests that can affect the drug

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

Drugs that were approved BEFORE Just 30, 2001…

Answer 12

…are not required to follow the same formatting.

Question 13

The adverse reactions area of the Highlights section contains a phone number and web address for…

Answer 13

…FDA’s MedWatch Program.

Question 14

Reminder: off-label indications are…

Answer 14

…NOT listed in the package inserts. Inserts only list FDA-approved indications.

Question 15

The dosage forms and strengths section provides…

Answer 15

…info about the forms the medication comes in, such as tablets or capsules, plus the strength for each form.

Question 16

The contraindications section lists situations when…

Answer 16

…a drug can NOT be used.

Question 17

Side effects reported AFTER a drug hits the market are known as what kind of experience?

Answer 17

Postmarketing. This can be found under the Adverse Reactions section.

Question 18

Pregnancy ratings were…

Answer 18

…removed in 2020, as they oversimplified the risks to pregnancy.

Question 19

Sections of Package Inserts, 2 (in order)

Answer 19

• drug abuse and dependence
• overdosage
• product description
• clinical pharmacology
• nonclinical toxicology
• clinical studies
• how supplied
• patient counseling information
• package insert limitations

Question 20

Drug abuse and dependence

Answer 20

• Lists the medication’s controlled substance classification

* Lists the abuse and tolerance potential of the drug

Question 21

Overdosage

Answer 21

• Lists the signs, symptoms, and treatment options during an overdose situation

Question 22

Product description

Answer 22

• Provides the medication’s
– Chemical name
– Structural formula
– Active ingredients
– Inactive ingredients (dyes, fillers, flavorings, etc.)

Question 23

Clinical pharmacology

Answer 23

• Used mostly by pharmacists and prescribers
• Contains information on how the medication works (mechanism of action)
• Explains how the medication is absorbed, metabolized, and eliminated from the body
• Gives explanations of the studies performed with the medication, in different populations

Question 24

Nonclinical toxicology

Answer 24

• Used mostly by pharmacists and prescribers

* Lists any cancer and fertility risks from using the medication

Question 25

Clinical studies

Answer 25

* Used mostly by pharmacists and prescribers | * Provides information from the clinical studies showing how well the drug works for its approved indications

Question 26

How supplied

Answer 26

• Lists the medication’s – Dosage forms – Color – Markings – Special storage and handling instructions • Some package inserts will list the shape of the medication

Question 27

Patient counseling information

Answer 27

• Highlights the most important counseling points about the medication for the pharmacist or prescriber

Question 28

Package insert limitations

Answer 28

* Takes significant time to update since wording must be approved by FDA * May not have up-to-date information

Question 29

Examples of commonly seen and reliable drug information include:

Answer 29

Clinical Pharmacology, Micromedex, and Lexicomp

Question 30

The Orange Book...

Answer 30

* Informs which generics are equivalent to which brand name drugs * Helps determine if substitution is allowed * Contains “Therapeutic Equivalency” ratings or “TE codes”

Question 31

Therapeutically Equivalent Definition

Answer 31

• Generic products must be identical in active ingredients, strength, and dosage form to the brand name ‒ Must also absorb and release identically in the body • Expected to have the same safety profile and chemical effect

Question 32

Therapeutically Equivalent Ratings

Answer 32

• The rating code is usually comprised of two letters and sometimes numbers • TE Codes – 1st Letter ‒ Usually begins with “A” or “B” ‒ “A” designates products that demonstrate therapeutic equivalence ‒ “B” designates products that have not demonstrated therapeutic equivalence • TE Codes – 2nd Letter ‒ “A” indicates oral dosage form ‒ “B” indicates bioequivalence ‒ “N” indicates a product for aerosolization ‒ “P” indicates parenteral/injectable products ‒ “T” indicates topical dosage form

Question 33

Other drug info resources

Answer 33

• Journals • Professional magazines • Newsletters (Pharmacy Technician’s Letter) • May be available as electronic or print formats • Keeps technicians informed of new technology, new medications, recalled meds, and new trends affecting the practice of pharmacy

Question 34

Facts and comparisons eAnswers

Answer 34

* Online drug reference * Allows for side-by-side comparison of drugs * Contains a drug identification tool * Can search for product availability and generic alternatives * Print version Drug Facts and Comparisons has been discontinued

Question 35

Physicians’ Desk Reference or Prescribers’ Digital Reference (PDR)

Answer 35

• Print version Physician’s Desk Reference is a compilation of package inserts ‒ No longer published after June 2017 • Online reference is Prescribers’ Digital Reference • Provides same drug information as print version plus FDA safety updates • Includes information on medications from drug companies that are willing to pay to advertise • Contains the same drug information that is found in package inserts attached to drug bottles and packages

Question 36

United States Pharmacopeia-National Formulary (USP-NF)

Answer 36

• Defines the standards for medications: ‒ Dosage forms ‒ Drug substances ‒ Excipients or inactive ingredients • Contains the official title of a medication • Sets standards for strengths and purity • Sets procedures for proper handling and storage • Contains formulas for manufacture and preparation • Provides recipes and specific information for the materials used when compounding

Question 37

Handbook on Injectable Drugs

Answer 37

``` • Also referred to as Trissel’s • Provides information about parenteral meds ‒ Intravenous ‒ Intramuscular ‒ Subcutaneous • Available dosage forms • Trade or brand names • Administration requirements • Stability information • Special preparation requirements • Compatibility or incompatibility issues with other meds ```

Question 38

Natural Medicines

Answer 38

• Provides up-to-date information on dietary supplements, vitamins, minerals, and other natural remedies • Available as an online database • Has a drug-herb interaction checker and product ratings • Contains the Natural Medicines Watch • Allows healthcare professionals to alert researchers and FDA about any suspected adverse effects of supplements, vitamins, and minerals