DD French regulation

Question 1

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

Answer 1

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

Question 2

What are the 4 FDA categories of drugs.

Answer 2

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

Question 3

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

Answer 3

Who may prescribe

Question 4

Which government agency controls the prescription of controlled substances?

Answer 4

DEA

Question 5

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

Answer 5

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

Question 6

Define ?drug.?

Answer 6

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

Question 7

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

Answer 7

FALSE

Question 8

List the phases of drug development and approval.

Answer 8

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

Question 9

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

Answer 9

TRUE. Also look at selectivity and mechanism

Question 10

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

Answer 10

20-100

Question 11

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

Answer 11

TRUE

Question 12

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

Answer 12

TRUE

Question 13

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

Answer 13

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

Question 14

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

Answer 14

Placebo - single blind or open label

Question 15

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

Answer 15

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

Question 16

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

Answer 16

TRUE

Question 17

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?

Answer 17

Accelerated-development review

Question 18

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

Answer 18

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

Question 19

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

Answer 19

FALSE

Question 20

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

Answer 20

FALSE

Question 21

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

Answer 21

FALSE

Question 22

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

Answer 22

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

Question 23

How is bioequivalency measured for generic versus brand name drugs?

Answer 23

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

Question 24

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

Answer 24

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

Question 25

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

Answer 25

TRUE

Question 26

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

Answer 26

FALSE

Question 27

Define dietary supplement.

Answer 27

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

Question 28

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

Answer 28

TRUE

Question 29

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.

Answer 29

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

Question 30

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

Answer 30

TRUE

Question 31

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

Answer 31

FALSE

Question 32

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

Answer 32

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

Question 33

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

Answer 33

TRUE. Required since 2011

Question 34

When must a drug be limited to prescription use?

Answer 34

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

Question 35

Drug schedule is based on what 3 criteria?

Answer 35

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

Question 36

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

Answer 36

FALSE

Question 37

How many schedules of drugs are there?

Answer 37

5

Question 38

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

Answer 38

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

Question 39

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

Answer 39

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

Question 40

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

Answer 40

5 times in 6 months

Question 41

How many lbs in 1 kg?

Answer 41

2.2 lbs

Question 42

How many mLs in 1 fluid oz?

Answer 42

29.56 mL

Question 43

How many mLs in a tablespoon?

Answer 43

15 mL

Question 44

How many g in 1 oz?

Answer 44

28.35 g

Question 45

How many mgs in 1 grain?

Answer 45

64.8 mg

Question 46

Define qod.

Answer 46

Every other day

Question 47

Define qid.

Answer 47

Four times a day

Question 48

Define prn.

Answer 48

As needed (pro re nata)

Question 49

Define ad.

Answer 49

Right ear

Question 50

Define au.

Answer 50

Both ears

Question 51

Define ol.

Answer 51

Left eye

Question 52

Define po.

Answer 52

By mouth

Question 53

Define pr.

Answer 53

Per rectum

Question 54

Define Sig.

Answer 54

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

Question 55

What must a provider have to prescribe controlled substances?

Answer 55

DEA number

Question 56

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

Answer 56

Up to 1 year

Question 57

T or F: A prescription requires a prescribers signature.

Answer 57

TRUE

Question 58

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

Answer 58

FALSE

Question 59

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

Answer 59

FALSE

Question 60

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

Answer 60

TRUE

Question 61

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

Answer 61

TRUE

Question 62

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

Answer 62

TRUE

Question 63

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

Answer 63

FALSE