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DD Unit I > DD French regulation > Flashcards

DD French regulation Flashcards

1
Q

What are the 3 bigs things the FDA regulates when it comes to drugs?

A

1.) Categorization 2.) Evaluation for Safety and Efficacy 3.) Equivalence for generic vs brand name drugs

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2
Q

What are the 4 FDA categories of drugs.

A

1.) Prescription drugs 2.) Controlled Substances 3.) OTC drugs 4.) Dietary supplements

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3
Q

What is the main thing state governments control when it comes to drugs?

A

Who may prescribe

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4
Q

Which government agency controls the prescription of controlled substances?

A

DEA

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5
Q

What is the main thing local governments control when it comes to drugs?

A

Laws regarding drug use within their jurisdiction. (ex. no pot shops near schools)

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6
Q

Define ?drug.?

A

A drug is a therapeutic agent intended to treat, cure, prevent, or diagnose a disease.

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7
Q

T or F: Dietary supplements must be tested for safety and efficacy before they can be sold.

A

FALSE

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8
Q

List the phases of drug development and approval.

A

Animal testing (pre-clinical trials), Phase I, Phase II, Phase III, Phase IV (postmarketing)

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9
Q

T or F: Animal trials involve testing for safety, efficacy, and effect on reproduction.

A

TRUE. Also look at selectivity and mechanism

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10
Q

How many patients/volunteers usually participate in Phase I trials?

A

20-100

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11
Q

T or F: Phase I trials look at drug safety.

A

TRUE

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12
Q

T or F: Phase I trials look at drug pharmacokinetics.

A

TRUE

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13
Q

T or F: Phase II clinical trials involve volunteers who do not have the disease the drug is intended to treat.

A

FALSE. Phase II clinical trials test the drug on real patients with the disease the drug is intended to treat.

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14
Q

What is used to compare the a new drug to in Phase II clinical trials?

A

Placebo - single blind or open label

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15
Q

What is used to compare the a new drug to in Phase III clinical trials?

A

Placebo or current standard of treatment - double blind and cross-over techniques

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16
Q

T or F: If a drug is going to fail, it is mostly likely to fail out of Phase II clinical trials.

A

TRUE

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17
Q

If a new drug for a life-threatening condition appears promising in Phase III trials, what can its developers get to move it to market faster?

A

Accelerated-development review

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18
Q

T or F: It is possible for a generic drug to get FDA approval after demonstrating bioequivalency only.

A

TRUE. This is called getting an Abbreviated New Drug Application (ANDA). Otherwise they would have to show pharmaceutical equivalence as well.

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19
Q

T or F: The FDA can regulate how a drug is actually used by doctors.

A

FALSE

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20
Q

T or F: Once a drug reaches Phase IV (post-marketing), it no longer needs to be monitored for safety.

A

FALSE

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21
Q

T or F: Generic drugs are inferior to brand name drugs.

A

FALSE

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22
Q

When is it advisable to avoid switching between a generic and a brand name drug?

A

Narrow therapeutic window, poor bioavailability, non-linear pharmacokinetics. The slight differences in batches can make a difference in some cases.

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23
Q

How is bioequivalency measured for generic versus brand name drugs?

A

They must have the same extent of absorption (AUC) and rate of absorption (Cp max - same peak drug concentration)

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24
Q

What are the set limits for AUC and Cp max for a generic drug? (was in absorption lectures as well)

A

Ratio of Generic/Brand mean and 90% confidence interval of AUC and Cp max must be within 80-125%

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25
Q

T or F: Nonprescription drugs are evaluated the exact same way as prescription drugs.

A

TRUE

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26
Q

T or F: Dietary supplements are evaluated the exact same way as prescription drugs.

A

FALSE

27
Q

Define dietary supplement.

A

A product intended to supplement the diet taken by mouth as pill, capsule, tablet, or liquid that is not considered food.

28
Q

T or F: Dietary supplement manufacturer must provide reasonable evidence that their product is safe in humans.

A

TRUE

29
Q

T or F: If a dietary supplement proves to be unsafe once it is one the market, the FDA can remove it from the market.

A

TRUE, but only if they can prove that it is unsafe. The burden of proof lies with the FDA.

30
Q

T or F: A dietary supplement can make claims about effect on organ system function.

A

TRUE

31
Q

T or F: A dietary supplement can make claims about effects on a specific disease.

A

FALSE

32
Q

Name the information required on a dietary supplement label. (4 things)

A

Name of product, manufacturer, amount of contents, directions for use (Bonus: FDA has not evaluated this shit nigga)

33
Q

T or F: Dietary supplement manufacturers must abide by Good Manufacturing Practice (enforce identity, strength, purity of product)

A

TRUE. Required since 2011

34
Q

When must a drug be limited to prescription use?

A

If it is habit forming, cannot be used without professional supervision, if under a new drug application (NDA)

35
Q

Drug schedule is based on what 3 criteria?

A

1.) Medical use 2.) Abuse potential 3.) Potential for physical/psychological dependence

36
Q

T or F: Schedule I drugs have accepted medical use.

A

FALSE

37
Q

How many schedules of drugs are there?

A

5

38
Q

T or F: In Colorado, all schedule drugs require a prescription.

A

TRUE. In some states only drugs scheduled II-IV need a prescription.

39
Q

T or F: A drug scheduled II can be called into the pharmacist.

A

FALSE. French loves this question and will always ask it on the first test.

40
Q

How many times can a prescription be refilled before a new prescription is needed?

A

5 times in 6 months

41
Q

How many lbs in 1 kg?

A

2.2 lbs

42
Q

How many mLs in 1 fluid oz?

A

29.56 mL

43
Q

How many mLs in a tablespoon?

A

15 mL

44
Q

How many g in 1 oz?

A

28.35 g

45
Q

How many mgs in 1 grain?

A

64.8 mg

46
Q

Define qod.

A

Every other day

47
Q

Define qid.

A

Four times a day

48
Q

Define prn.

A

As needed (pro re nata)

49
Q

Define ad.

A

Right ear

50
Q

Define au.

A

Both ears

51
Q

Define ol.

A

Left eye

52
Q

Define po.

A

By mouth

53
Q

Define pr.

A

Per rectum

54
Q

Define Sig.

A

Label (refers to instruction on use: # of pills per day)

55
Q

What must a provider have to prescribe controlled substances?

A

DEA number

56
Q

Up to how long is a prescription good as specified by a physician?

A

Up to 1 year

57
Q

T or F: A prescription requires a prescribers signature.

A

TRUE

58
Q

T or F: A prescription does not need to specify a patient?s address.

A

FALSE

59
Q

T or F: A prescription does not need to specify drug quantity.

A

FALSE

60
Q

T or F: A prescription must specify name and strength of the drug.

A

TRUE

61
Q

T or F: A prescription must specify name, address, and phone number of the prescriber.

A

TRUE

62
Q

T or F: A prescription must specify the date of the prescription.

A

TRUE

63
Q

T or F: A prescription must specify name of the pharmacy of origin.

A

FALSE

DD Unit I (10 decks)

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