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CPHT > DRUG INFO RESOURCES > Flashcards

DRUG INFO RESOURCES Flashcards

1
Q 
Info about med
• Includes: 
	 - dosing
	 - drug interactions
         - side effects
A

PACKAGE INSERTS

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2
Q

WHO REQUIRES PACKAGE INSERT?

A

FDA

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3
Q 
Boxed warnings
Indications & Use
Dosage & Administration
Dosage form & strength
Contraindications 
Warning & Precautions
Adverse Reactions
Drug Interactions
Any Recent Major Changes to prescribing information
A

HIGHLIGHT SECTION

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4
Q

WHAT IS THE PURPOSE OF THE HIGHLIGHTED SECTION?

A

help you find important info quickly

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5
Q

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

A

Table of Contents Sections

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6
Q

ARE OFF LABEL INDICATIONS ON THE PACKAG INSERT?

A

No

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7
Q

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

A

Indications & Use

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8
Q

provide specific dosing for different diseases states, particular age groups

A

Dosage & Administration

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9
Q
  • 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
A

Dosage form & strength

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10
Q
  • 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
A

Contraindications

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11
Q

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
A

Warning & Precautions

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12
Q

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"
A

Adverse Reactions

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13
Q

side effects that were reported AFTER the drug hit the market

A

POSTMARKETING EXPERIENCE

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14
Q

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

A

Drug Interactions

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15
Q

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
A

Use in Specific Population

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16
Q

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

A

True

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17
Q

WHAT LETTER IN PREGNANCY CATEGORIES IS THE RISKIEST?

A

X

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18
Q

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

A

Drug Abuse and Dependence Section

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19
Q

illegal drugs

  ex: heroin  - highest potential for abuse and dependence
A

Schedule I

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20
Q

(controlled substances)

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

Schedule II

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21
Q

controlled substances)

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

Schedule III

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22
Q

(controlled substances)

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

Schedule IV

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23
Q

(controlled substances)

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

Schedule V

24
Q

Highest stringent requirements in the pharmacy

A

Schedule II drugs

25
Q

Lowest potential for abuse and addiction

A

Schedule V

26
Q

Highest potential for abuse and dependence

A

Schedule I

27
Q

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

A

Overdose Section

28
Q

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
A

Product Description Section

29
Q
  • 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
A

Clinical Pharmacology Section

30
Q
  • list any cancer risk from using the med
A

Nonclinical Toxicology Section

31
Q

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

A

Clinical Studies Section

32
Q
  • 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”
A

How Supplied/Storage and Handling

33
Q
  • highlights most important counseling points

- used by pharmacists and prescriber as a tool to ensure the patient understands how to take their med

A

Patient Counseling Information Section

34
Q

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

A

Biggest limitations

35
Q

The Approved Products w/ Therapeutic Equivalence Evaluations

A

Orange Book

36
Q
  • 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
A

Orange Book

37
Q

TE

A

Therapeutic Equivalence

38
Q

TE CODE

A

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

39
Q

TE CODE: A (first letter)

A

Demonstrated therapeutic equivalence

40
Q

TE CODE: B (first letter)

A

not therapeutic equivalent

41
Q

TE CODE: A (second letter)

A

A=oral dosage form

42
Q

TE CODE: N (second letter)

A

N=aerosolization

43
Q

TE CODE: P (second letter)

A

P=parenteral or injectable product

44
Q

TE CODE: T (second letter)

A

T=topical

45
Q

MOST COMMON TE CODE

A

AB rated

46
Q
  • Identical active ingredients
    • Identical strength
    • Identical dosage form
    • Absorb and release identically in the body
    • Have same safety profile and clinical effect
A

Therapeutic equivalence

47
Q

compilation of package inserts used to look up drug info

A

Prescriber’s Digital Reference (PDR)

48
Q

defines the standards for medications

A

US Pharmacopedia-National Formulary (USP-NF)

49
Q

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

A

Handbook on Injectable Drugs (Trissel’s)

50
Q

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

A

Natural Medicines

51
Q

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

A

Natural Medicine Watch

52
Q

Morphine, Oxycontin, Norco

A

Schedule II

53
Q

Tylenol #3, Suboxone

A

Schedule III

54
Q

Xanax, Ambien, Valium

A

Schedule IV

55
Q

Robitussin AC, Lomotil

A

Schedule V

CPHT (11 decks)

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