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Pharmacy Tech Medication Brands > Principles of Pharmacy Practice: Drug Info Resources > Flashcards

Principles of Pharmacy Practice: Drug Info Resources Flashcards

1
Q

Package inserts

A
  • 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
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2
Q

Sections of package inserts, 1 (in order)

A
  • highlights
  • table of contents
  • indications and usage
  • dosage and administration
  • contraindications
  • warnings and precautions
  • adverse reactions
  • drug interactions
  • use in specific populations
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3
Q

Highlights

A
  • 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
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4
Q

Table of contents

A

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

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5
Q

Indications and usage

A
  • Lists disease states/conditions the medication is approved to treat
  • Off-label uses are NOT listed on the package insert
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6
Q

Dosage and administration

A

• Contains recommended doses, dosing schedules, and administration requirements

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7
Q

Contraindications

A

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

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8
Q

Warnings and precautions

A
  • Lists situations that require caution while taking the medication
  • Contains boxed warnings
  • Lists lab tests that can affect the drug
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9
Q

Adverse reactions

A

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

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10
Q

Drug interactions

A
  • Lists the most significant drug-drug interactions involving the medication
  • Lists lab tests that can affect the drug
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11
Q

Use in specific populations

A

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

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12
Q

Drugs that were approved BEFORE Just 30, 2001…

A

…are not required to follow the same formatting.

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13
Q

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

A

…FDA’s MedWatch Program.

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14
Q

Reminder: off-label indications are…

A

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

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15
Q

The dosage forms and strengths section provides…

A

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

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16
Q

The contraindications section lists situations when…

A

…a drug can NOT be used.

17
Q

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

A

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

18
Q

Pregnancy ratings were…

A

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

19
Q

Sections of Package Inserts, 2 (in order)

A
  • drug abuse and dependence
  • overdosage
  • product description
  • clinical pharmacology
  • nonclinical toxicology
  • clinical studies
  • how supplied
  • patient counseling information
  • package insert limitations
20
Q

Drug abuse and dependence

A
  • Lists the medication’s controlled substance classification

* Lists the abuse and tolerance potential of the drug

21
Q

Overdosage

A

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

22
Q

Product description

A 
• Provides the medication’s
– Chemical name
– Structural formula
– Active ingredients
– Inactive ingredients (dyes, fillers, flavorings, etc.)
23
Q

Clinical pharmacology

A
  • 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
24
Q

Nonclinical toxicology

A
  • Used mostly by pharmacists and prescribers

* Lists any cancer and fertility risks from using the medication

25
Q

Clinical studies

A
  • Used mostly by pharmacists and prescribers

* Provides information from the clinical studies showing how well the drug works for its approved indications

26
Q

How supplied

A

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

27
Q

Patient counseling information

A

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

28
Q

Package insert limitations

A
  • Takes significant time to update since wording must be approved by FDA
  • May not have up-to-date information
29
Q

Examples of commonly seen and reliable drug information include:

A

Clinical Pharmacology, Micromedex, and Lexicomp

30
Q

The Orange Book…

A
  • Informs which generics are equivalent to which brand name drugs
  • Helps determine if substitution is allowed
  • Contains “Therapeutic Equivalency” ratings or “TE codes”
31
Q

Therapeutically Equivalent Definition

A

• 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

32
Q

Therapeutically Equivalent Ratings

A

• 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

33
Q

Other drug info resources

A

• 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

34
Q

Facts and comparisons eAnswers

A
  • 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
35
Q

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

A

• 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

36
Q

United States Pharmacopeia-National Formulary (USP-NF)

A

• 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

37
Q

Handbook on Injectable Drugs

A 
• 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
38
Q

Natural Medicines

A

• 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

Pharmacy Tech Medication Brands (29 decks)

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